Treatment of Critical Limb Ischemia

Overall Strategy for Treatment of Critical Limb Ischemia

Many of the principals of basic treatment discussed in relation to patients with intermittent claudication also
apply to patients with CLI, although the urgency for rapid treatment of the latter group will alter the emphasis. For
instance, the management of risk factors such as hyperlipidemia is not of any immediate importance in patients
with CLI. By contrast, other important aspects in the immediate basic treatment of patients with CLI, such as ade-
quate control of pain, do not apply to claudication.
The principal urgent components of basic treatment of CLI are the control of pain and any infection in the
ischemic leg, prevention of progression of thrombosis if this is thought to be a precipitating factor in the ischemia,
and the optimization of cardiac and respiratory function. While instituting basic treatment, the full precise mor-
phology of the PAD should be simultaneously established by some form of imaging technique. This will determine
further management of the arterial lesion. In a small group of patients, often delayed referrals, ischemia and gross
infection in the leg pose an immediate threat to the patients survival. An immediate major amputation is manda-
tory and can be life saving in these cases, for instance, in a patient with gas or septic gangrene.
In most patients, the various options for endovascular techniques, arterial surgery, or thrombolysis can be
carefully weighed. The primary aim is revascularization to provide sufficient blood flow to relieve the rest pain
and heal skin lesions. Most patients with CLI have multisegment arterial disease, and often the elimination of
the most proximal obstruction might be sufficient to achieve these aims. It is, however, important to resist the
temptation to only treat a relatively easy proximal lesion in the presence of extensive distal disease where the
marginal improvement in blood flow may be insufficient to achieve healing. This applies especially where there
has been tissue loss. For instance, angioplasty for relatively minor iliac stenosis is unlikely to achieve healing
of a foot ulcer in the presence of extensive infrainguinal disease (see also p. 210).
In general, if there is a balanced choice between an endovascular and a surgical procedure for a particular
lesion, then the former is preferred because it usually avoids a general anesthesia, poses a lesser systemic stress,
and has fewer serious complications. However, the choice between an endovascular and a surgical procedure
depends largely on the exact level and extent of the arterial disease; hence the need for a collaborative discus-
sion of each case between endovascular and surgical specialists. For the same reason, in this section the opti-
mal technique for revascularization is discussed on an anatomic basis.
Having identified the best interventional techniques in a particular case, the risks and chances of success have
to be weighed. There is no doubt that in some cases in which the risks of revascularization are high and the
chances of success low, there is a place for a primary major amputation or noninterventional therapy. Although a
number of techniques are available for assessing the risks and benefit of a particular revascularization procedure
in a particular patient, they are still far from perfect. This is reflected by the number of patients who have an attempt
at a series of revascularization procedures that fail to achieve their purpose even in the short term and culminate
in a major amputation.
There may be additional considerations in deciding whether to advise a patient to have a prim-ary amputation.
Not infrequently, patients with CLI will have other serious conditions limiting mobility, for instance, a neurological
deficit from previous stroke. In fitter patients, it is necessary to estimate the chances of a patient fully mobilizing
on an artificial limb. There may be an argument for primary amputation in a patient who is likely to mobilize well
on a prosthesis and in whom the chances of a successful revascularization are slight.
More recently, available treatment options have been extended by the possibility of pharmacotherapy as a prin-

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cipal treatment. Published evidence so far only relates to the use of pharmacotherapy in patients with CLI who
were unsuitable for any form of revascularization or in whom attempts at revascularization have already failed. In
these selected patients, pharmacotherapy may help to avoid or delay a major amputation and should be consid-
ered. The possibility of pharmacotherapy as a primary alternative to revascularization has not so far been stud-
ied. Its more established role is as an adjunct to either endovascular or surgical revascularization, where there is
some evidence that adjunctive pharmacotherapy improves early and medium-term results at very little risk.
In summary, the management of a patient with CLI should proceed rapidly in conjunction with delineation of
the arterial lesion. This is followed by a decision on the optimal form of revascularization, which, if successful, will
reverse the changes of CLI with minimum risk. If both surgery and endovascular techniques are equally feasible
and likely to succeed initially and durably, the latter is preferred to surgery. The second decision is whether to
apply this form of revascularization or proceed to a primary amputation. Pharmacotherapy is a useful adjunct, but
its role as primary treatment is not yet established.

Basic Treatment for Critical Limb Ischemia

Control of Pain
A hallmark of CLI is ischemic rest pain and painful ulceration. Etiology of the pain is multifactorial, but it is pri-
marily related to ischemia of the skin in the distal extremity. Pain control is a critical aspect of the management of
these patients. Ideally, relief of pain is achieved by reperfusion of the extremity. However, while setting up reper-
fusion, adequate pain control must be a goal of management in all patients. Furthermore, in patients for whom
revascularization is not possible, acetaminophen, nonsteroidal antiinflammatory drugs, or narcotics may be nec-
essary. Pain control should be individualized and multifactorial.
Physicians should assess pain severity and adequacy of pain relief in all patients at regular visits. Several pain
scales are available, but simple scales that range from 0 to 10, with 0 indicating no pain and 10indicating the
most severe pain, are useful. Such scales should be evaluated and recorded in the chart at each visit. Initial
attempts at pain relief should include the use of acetaminophen or nonsteroidal antiinflammatory drugs. Caution
should be used in the latter in patients with hypertension or renal insufficiency. Patients with severe unrelenting
ischemic pain also may require narcotics for adequate pain relief. Control of pain is usually more effective if anal-
gesia is given regularly rather than on demand. In patients undergoing intervention, narcotics also may be required
during the postoperative period. Placing the affected limb in the dependent position provides partial relief of ischemic
pain in some patients. Tilting the bed or use of a reclining chair therefore may be helpful measures in addition to
analgesia.
Spinal cord stimulation has also been used in patients with inoperable severe lower extremity ische-mia (see
also p. 280). However, it currently cannot be recommended in patients with CLI. See Recommendation
82 (below). Epidural block is another effective form of pain control in various ABPI cases.

RECOMMENDATION 82: Pain control in critical limb ischemia

Adequate treatment of ischemic pain is mandatory in all patients with critical limb ischemia and may
require short-term use of narcotics. Pain control should be individualized and multifactorial. However,
pain control treatment should not delay definitive treatment of the arterial lesion.

Foot Care in Patients With Critical Limb Ischemia

Patients with chronic CLI must pay particular attention to proper foot care and avoid trauma to their extremi-

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ties. These patients should be evaluated by a podiatrist and evaluated for proper foot care. Extremes of heat and
cold should be avoided. Even mild physical trauma can convert a patient from having intact skin to an ischemic
ulcer. Thus, local measures are extremely important in the overall management of these patients (see also The
Diabetic Foot, p. 187).

Treatment of Life-Threatening Coexisting Disease

Patients with CLI are at the highest risk for subsequent myocardial infarction, stroke, and vascular death. There-
fore, in addition to addressing the needs of their extremity, it is critical to reduce the systemic risk of mortality in
this patient population. Many of these patients have impaired cardiac and renal function, sometimes having frank
cardiac or renal failure. These coexisting conditions require active treatment by an expert in these areas. Improve-
ment of cardiac output also will inevitably improve peripheral perfusion and go some way toward treating the CLI.

Treatment of Ulcers and Gangrene

Topical therapy
Several attempts have been made to improve topical therapy for ischemic wounds in patients with CLI. This
includes the use of topical antibiotics, growth factors, and debriding agents. These treatments are attractive and
are often highly promoted by their sponsors. However, there are almost no controlled randomized trials to docu-
ment the benefits of any topical agent to augment wound healing in this patient population. There may be sub-
stantial risk to the use of this therapy, because allergic reactions leading to dermatitis can be common with topi-
cal antibiotics.1 Furthermore, reliance on topical therapy carries the risk of delaying reperfusion, and, except in
neuropathic ulcers, topical agents are unlikely to be successful as the sole therapy. These agents are also expen-
sive and often unnecessarily raise the expectation of the patient for a good result despite the absence of thera-
peutic efficacy.
Several novel dressings also have been proposed to treat these patients. These include hydrophilic dressings
and seaweed. Most of the experience with these dressings has been in venous ulcers and not arterial ischemic
ulcers. Again, there are no data to support their use. Local treatment should aim to save as much skin tissue as
possible; debridement should be avoided or kept at a minimum. Wet dressings, soaked in saline, can be used a
few times a day to eliminate pus and tissue debris. Moist dressings also may be useful in reducing pain. Only once
the ulcer has dried out should dry dressings be used. There is no indication for immobilizing a patient with an
ischemic ulcer, unless the ulcer is on a weight-bearing area. A review of a few studies with becaplermin (rhPDGF-
BB) gel suggests that ulcer healing may be improved.2 The effectiveness of current topical agentsantibiotics,
growth factors or hormones, debriding agents, or occlusive dressingsis not established.

RECOMMENDATION 83: Topical therapy for ischemic ulceration

Topical therapy for ischemic ulceration should be guided by the principles of wound care. The extrem-
ities should be kept clean, with appropriate debridement.

Systemic therapy
The use of systemic antibiotics may be indicated in patients with cellulitis. This is commonly seen in patients
with diabetes with ischemic wounds and may occur in any patient who converts from dry to wet gangrene, or who
develops an infected ulcer. Signs and symptoms include swelling, redness, and tenderness at the site of infec-
tion. Bacteriology of these wounds is often polymicrobial, particularly in patients with diabetes. Therefore, signs
of infection need to be aggressively treated. This often requires the use of systemic antibiotics to achieve ade-
quate blood levels. Additional systemic agents for treating ischemic wounds have not undergone rigorous trials.
Anticoagulation is generally not warranted except in an attempt to maintain graft patency (see Pharmacotherapy
Other Than Prostanoids, p. 215, and Other Drugs, p. 265). Antiplatelet therapy is useful as already described

210
to reduce the systemic risk of cardiovascular disease (see Recommendation 28, p S83).

RECOMMENDATION 84: Systemic antibiotic therapy in patients with critical limb ischemia
Systemic antibiotics are required in patients who develop cellulitis or spreading infection in ischemic
ulcers or gangrene but should not delay more definitive treatment.

Control of Risk Factors

Patients with CLI have the same cardiovascular risk factor profile as patients with claudication. However, patients
with CLI have a more diffuse and extensive degree of atherosclerosis. Therefore, their risk of cardiovascular events
and mortality is higher than that of patients with claudication. Despite the end-stage nature of this disease, aggres-
sive systemic risk factor modification is still warranted.

Smoking cessation
The progression of peripheral arterial disease from asymptomatic to claudication to ischemic rest pain is
highly associated with cigarette smoking. In patients with severe disease, graft patencies are clearly improved
by smoking cessation. This is true for both vein as well as prosthetic graft material. Amputation rates are also
highly correlated with persistent cigarette smoking. In two series, the amputation rate was between 11% and
23% in those who continued to smoke, versus 0 to 10% in those who were smoking abstinent.3 Finally, patient
survival at 1, 3, and 5 years is also highly correlated with smoking. Therefore, in patients with severe end-stage
disease, smoking cessation is still highly beneficial (see Recommendation 22, p. 84).

Hypertension
Hypertension is a risk factor for all forms of cardiovascular disease. Although blood pressure elevations are a
risk factor for peripheral arterial disease, maintaining an adequate blood pressure is important for limb perfusion.
In patients with claudication, aggressive treatment of hypertension is associated with a modest reduction in tread-
mill exercise performance. In patients with severe chronic limb ischemia, aggressive blood pressure treatment
may decrease limb perfusion and thus result in worsening ischemic rest pain or delayed healing of ischemic ulcers.
Historically, patients with CLI have been treated by plasma volume expansion to increase blood pressure,
thereby improving distal blood flow.4 This therapy may be associated with temporary benefit but does expose
the patient to the risk of stroke, congestive heart failure, and other untoward cardiovascular events. Therefore,
inducing hypertension in this patient population is not recommended. Conversely, patients hospitalized for treat-
ment of their severe leg ischemia should not have their blood pressure acutely lowered unless there is evidence
of active coronary ischemia or congestive heart failure. Because there is the possibility of vasoconstriction with
beta-blocker antihypertensive agents, their use in CLI should be carefully considered. When such antihyper-
tensives are used, CLI patients should be monitored for worsening of ischemic ulcers.

Diabetes
Diabetes is an important risk factor for all forms of peripheral arterial disease and also greatly contributes
to CLI (see Epidemiology, Natural History, Risk Factors, p. 5). In addition to the risk of atherosclerotic arter-
ial occlusive disease, patients with diabetes also develop neuropathy, which increases the risk for developing
nonhealing neurotrophic ulcers. In addition to the neuropathy, hyperglycemia will inhibit white cell function, thus
predisposing the patient to infection (see also The Diabetic Foot, p. 187). A comprehensive approach to treat-
ing patients with diabetes would include proper footwear, with attention to areas of trauma from poorly fitting
shoes (see Foot Care, p. 210). Patients with nonhealing ulcers often need to be treated in the hospital to pro-

211
vide comprehensive management, including wound care and eventually systemic antibiotics. In addition, aggres-
sive control of blood sugar is warranted in these patients, with an attempt to maintain fasting blood sugars below
120 mg/dL and postprandial sugars less than 180 mg/dL. Chronic management should attempt to normalize
glycohemoglobin levels to less than 7.0% (see Recommendation 23, p. 85).

Hyperlipidemia
The lipid risk profile for patients with peripheral arterial disease is similar between those with claudication and
those with CLI. There are no data regarding recommendations in the severe leg ischemia patient population. How-
ever, extrapolation from patients with intermittent claudication as well as from the National Cholesterol Education
Program Guidelines would recommend aggressive treatment of LDL cholesterol levels and attempts to raise the
HDL cholesterol and lower triglyceride levels. Therefore, patients with CLI should have an LDL cholesterol level
maintained at 100 mg/dL or less (see Recommendation 25, p. 86). The goals of therapy are to reduce the sys-
temic risk of myocardial infarction and cardiovascular death, as well as to delay the progression of peripheral ath-
erosclerosis.

References
1. Wilson CL, Cameron J, Powell SM, Cherry G, Ryan TJ. High incidence of contact dermatitis in leg-ulcer patients: implica-
tions for management. Clin Exp Dermatol 1991;16:250-253.
2. Wieman TJ. Clinical efficacy of becaplermin (rhPDGF-BB) gel. Becaplermin Gel Studies Group. Am J Surg 1998;176:74S-
79S.
3. Hirsch AT, Treat-Jacobson D, Lando HA, Hatsukami DK. The role of tobacco cessation, antiplatelet and lipid-lowering thera-
pies in the treatment of peripheral arterial disease. Vasc Med 1997;2:243-251.
4. Lassen NA, Larsen O, Sorensen AW, HallbrookT, Dahn I, Nilsen R, et al. Conservative treatment of gangrene using miner-
alocorticoid-induced hypertension. Lancet 1968;1:606-609.

Pharmacotherapy for Critical Limb Ischemia

Introduction
For decades, pharmaceutical and clinical research aimed at improving the morbidity of claudication has cen-
tered around vasodilators. Direct-acting vasodilators can increase blood flow in normal resting skeletal muscle.
However, it is unlikely that any vasodilator can significantly increase blood flow distal to a physical occlusion.
Autoregulatory mechanisms in skeletal muscle beds produce dilation in response to ischemia; hence, vasodila-
tors will increase blood flow primarily to nonischemic areas. The concept of vasodilatation has moved to vasore-
active or vasorecruiting drugs and more recently to agents improving unbalanced or compromised microcircula-
tion distal to an arterial obstruction. Another approach is to search for compounds that improve the blood rheol-
ogy. The use of thrombolytic drugs in CLI is also to be considered, most often to be followed by endovascular or
surgical treatment.
The ideal treatment for critical limb ischemia must be the elimination or bypass of the occlusions in the larger
arteries, but this is often impossible or else it fails. An alternative in these cases is to try to modify the conse-
quences of the low perfusion pressure on the distal microcirculation sufficiently by some form of pharmacother-
apy to reverse the rest pain and avoid amputation.
Pharmacological management of CLI must be based on an improved understanding of its pathophysiology.
The main components, lack of autoregulation of the microvascular flow-regulating system and inappropriate acti-
vation of the microvascular defense system, are both thought to be significantly regulated by prostacyclin.1 Break-
down of the microvascular flow-regulating system is manifested in particular by abnormal vasomotion and a mald-
istribution of blood flow away from the nutritive skin capillaries. Activation of the microvascular defense system

212
results in interacting activation of white blood cells, platelets, and the damaged endothelium. The resultant capil-
lary obstruction, increased capillary permeability, tissue edema, and the liberation of activated products of leuko-
cytes, such as oxygen free radicals, platelet-activating factor, and proteolytic enzymes, leads to a vicious cycle
with further capillary obstruction.

Prostanoids
Prostanoids have been shown to have beneficial effects on most of the microcirculatory components by pre-
venting the reciprocal potentiation of platelet activation, leukocyte activation, and the damaged vascular endothe-
lium.1 This is probably the reason why prostanoids have, in the last few years, been the most widely tested group
of drugs in this condition. Initially, PGE1 was mainly evaluated by intraarterial administration because of its well-
known rapid pulmonary inactivation.2 Intravenous studies with PGE1 were subsequently undertaken when it was
shown that after a temporary inactivation of PGE1 by the lung, 13,14-dihydro-PGE1 is formed. At least in regard
to antiplatelet activity, this has been shown to display biological activity comparable with the parent compound
PGE1.3 Furthermore, intraarterial and intravenously infused PGE1 in patients with intermittent claudication caused
a similar systemic inhibition of zymosan-stimulated radical production.4 The clinical benefit of the intravenous
administration route was later shown in a limited number of patients with PAD stage III in a single German center
by Diehm et al.5
Since the first report of the effects of intraarterial infusion of prostaglandin E1 in four patients with unrecon-
structable leg ischemia,6 there have been seven short-term (3-4 days) trials using PGE1 and PGI2 intraarterially7-
9 or intravenously10-13 showing inconclusive evidence of their efficacy in patients with unreconstructable limb

ischemia. Table XLI summarizes 13 subsequently performed long-term randomized open or double-blind trials
comparing intraarterial or intravenous infusions of PGE1, ciprostene, or iloprost, both more stable prostacyclin
analogs, with placebo in patients with advanced chronic limb ischemia (Fontaine stages III and IV).5 14-26
These studies all followed a similar protocol, although the duration of treatment varied from 2 to 4 weeks. The
clinical end points used were relief of rest pain, analgesic consumption, or promotion of ulcer healing. All of these
long-term studies administering prostanoids for more than 7 days showed a benefit in at least one of the chosen
end points, with only two trials failing to reach statistical significance. The response seemed to be greater when
prostanoids were administered for 4 weeks, compared with administration for 2 or 3 weeks. Data on major ampu-
tation at 3 or 6 months follow-up were available in three of the iloprost studies.23 25 26 Patients who received ilo-
prost were significantly less likely to have undergone a major amputation than patients in the placebo groups (23%
vs 39%, p<0.05) during the treatment and follow-up period. Most importantly, patients who received iloprost had
a significantly greater probability of completing the follow-up period alive with both legs than patients who received
placebo (35% vs 55%, p<0.05).27
Although these results are impressive, it is also important to be aware of their limitations. Total ulcer healing
was not used because it was too uncommon an event after a few weeks of treatment. Measurement of the decrease
in greatest diameter of the ulcer is subject to observer variation. Furthermore, where photographs were used in
attempt to overcome observer variation, they were often of inconsistent quality. With respect to pain relief, it has
to be kept in mind that this outcome measure is based on a subjective assess-ment by the individual patient. A
further bias may have been introduced by the side effects of prostanoids, allowing the observer to have an idea
of the patients treatment group. Further clinical trials with prostanoids are required to show evidence of efficacy
as primary medical treatment of critical limb ischemia.
The prostanoid investigated in the largest number of patients with advanced chronic limb ischemia in controlled
randomized studies is iloprost. The available data support its use in patients with CLI unsuitable for any reopen-
ing procedure or in whom revascularization attempts have failed. There is no available technique for identifying
those who will respond, but its relative safety suggests that it should be tried in all such patients unless an early
amputation is clearly unavoidable. Its use as an adjuvant to high-risk revascularization procedures is being assessed.

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TABLE XLI.Trials comparing long-term (7-28 days treatment) infusion of prostanoid with placebo or reference drug in
patients with severe arterial disease (Fontaine III and IV)14.
n Trial
Author (% diabetic) Drug Dosage Follow-up End points Results p design

Sakaguchi 65 PGE1 (IA) 0.05 or 0.15 end of ulcer size reduced by 0.039 DB
198415 niacinate oral ng/kg/min x 24 infusion pain higher dose
(200 mg continuous infusion vs. niacinate
6 x daily) for 2-6 wk + lower dose

Bhme et al., 34 PGE1 (IA) 10-20 g/60 end of ulcer size reduced NS O
198716 vs ATP min x 23 days infusion rest pain reduced NS

Trbestein et al., 57 PGE1 vs 30 20 mg over 60 3 wk analg. cons. reduced < 0.04 O

198717 mg ATP (IA) min daily x 3 wk ulcer size reduced < 0.02
amputation reduced 0.02

Diehm et al., 46 PGE1 vs 60 g/4 h/ 1 mo pain reduced < 0.04 DB

19885 placebo (IV) day x 3 wk analg. cons. reduced < 0.02
clinical stage improved 0.007

Ciprostene Study 211 PGE1 vs 120 ng/kg/min 4 mo ulcer size reduced < 0.005 DB
Group 199118 placebo (IV) x 8 h/day x 7 days by 50%

ICAI Study 1,560 PGE1 (IV) vs 60 g/day 6 mo CLI reduced odds 0.002 O
Group, 199819 routine x 28 days disappearance ratio 0.73
treatment

Trbestein et al., 70 PGE1 (IV) 2 x 40 g over 6 mo rest pain reduced NS O

198920 vs pentoxifylline 2 h daily x 4 wk analg. cons. reduced < 0.005
ulcer size reduced < 0.05

Balzer et al., 113 Iloprost vs 0.5-2 ng/kg/min end of analg. cons. reduced < 0.05 DB
198721 (34%) placebo (IV) x 6 h x 14 days infusion

Diehm et al., 101 Iloprost vs up to 2 ng/kg/ end of ulcer size reduced < 0.05 DB
198922 placebo (IV) min x 6 h x 28 days infusion

Norgren et al., 103 Iloprost vs 0.5-2 ng/kg/min 6 mo ulcer size reduced NS DB

199023 (32%) placebo (IV) x 6 h x 14 days

Brock et al., 109 Iloprost vs 0.5-2 ng/kg/min end of ulcer size reduced < 0.05 DB
199024 (100%) placebo (IV) x 6 h x 28 days infusion rest pain reduced < 0.05

UK Study Group, 151 Iloprost vs up to 2 ng/kg/min 1 mo ulcer healing reduced < 0.05 DB
199125 (31%) placebo (IV) x 6 h daily x 28 days 6 mo ulcer healing reduced < 0.01

Guilmot et al., 128 Iloprost vs up to 2 ng/kg/min 1 mo rest pain Reduced < 0.05 DB
199126 (58%) placebo (IV) x 6 hr daily x 21 days 1 mo rest pain Reduced NS

NS=not statistically significant; PGI2=prostaglandin I2; PGE1=prostaglandin E1; analg cons=analgesic consumption; CLI=critical limb ischemia;
O=open; DB=double-blind

RECOMMENDATION 85: Use of prostanoids in critical limb ischemia

Patients who have a viable limb in whom revascularization procedures are impossible, carry a poor
chance of success or have previously failed, and particularly when the alternative is amputation, may
be treated with prostanoids.

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 CRITICAL ISSUE 29: Use of prostanoids in earlier stages of critical limb ischemia
There is a need to test prostanoids in patients with earlier stages of critical limb ischemia and in whom
intervention is predicted to have a relatively low success rate as most randomized, open or double-
blind trials with intraarterial or intravenous prostanoids have been performed in patients with end-
stage critical limb ischemia.

Pharmacotherapy Other Than Prostanoids

Antiplatelet drugs
Long-term treatment with aspirin and ticlopidine is shown to reduce the progression of femoral atherosclerosis.28
Whether these antiplatelet agents can prevent thrombosis in prosthetic femoropopliteal grafts is uncertain (see also
Antiplatelet Therapy, p. 263). It should be noted that in a recent study the favorable effect of ticlopidine over 24
months has been demonstrated in patients after saphenous vein bypass grafting.29
There is a strong case for treatment of all patients with PAD with long-term antiplatelet therapy such as aspirin,
ticlopidine, or clopidogrel (see Recommendation 29, p. 90). Meta-analysis of the Final Report of the Second Cycle
of the Antiplatelet Trialists Collaboration shows clear evidence that these antiplatelet agents produce a 25% reduc-
tion of other vascular events (stroke, myocardial infarction, and vascular death) and also improve patency of periph-
eral arteries and grafts.30 However, neither these trials nor the recent CAPRIE study were conducted in PAD
patients with rest pain and ischemic ulcers.31

Anticoagulants
No clinical trials have been published on the use of unfractionated heparin for critical limb ischemia, although
recently an open study using low-molecular-weight heparin did show encouraging results with a decrease of rest
pain and healing of ulcers previously resistant to treatment.32 None of the publications on the effect of anticoag-
ulation exclusively concerns such patients. The use of oral anticoagulants improved the long-term patency of
infrainguinal bypass grafts, but this single study should be confirmed.33 (see also Adjuvant Therapy after Revas-
cularization, p. 263)

Hemodilution
The benefit of hemodilution has not been properly evaluated in patients with chronic CLI; however, if a patients
hematocrit remains 50% despite cessation of smoking and rehydration, hemodilution may be considered.

CRITICAL ISSUE 30: Use of long-term oral antithrombotic therapy in terms of limb survival
There is a need to determine whether long-term oral antithrombotic therapy is useful in terms of limb
survival.

Defibrinogenating agents
Despite many open trials reporting promising results with the use of defibrinogenating agents in 50% to 80%
of treated patients34-36 two recent placebo-controlled double-blind studies with ancrod failed to show any benefit
in terms of healing of ischemic ulcers or in reducing subsequent amputation rate.37 38

Other vasoactive drugs

Although a few vasoactive drugs may have a beneficial effect in vasospastic diseases by increasing cutaneous
capillary flow, there is little substantive evidence to support their use on patients with critical limb ischemia.39-44

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Most vasoactive drugs are said to have vasodilatory properties, whereas some claim to alter blood rheology,
improve tissue oxidative potential in the ischemic state, or act by increasing collateral flow through a serotonergic
blocking effect. Some of these drugs have been shown to be efficacious in intermittent claudication (see Phar-
macotherapy for Symptoms of Intermittent Claudication, p. 93), but none have been shown to have a clinically
beneficial effect in large properly controlled studies in patients with severe chronic limb ischemia.
L-Arginine is the precursor of endogenous nitric oxide that is a potent vasodilator, acting via the intracellular
second-messenger cyclic guanosine monophosphate (cGMP). In healthy humans, L-arginine induces peripheral
vasodilation and inhibits platelet aggregation because of increased nitric oxide production.45 46 The clinical bene-
fit of this in the treatment of CLI remains to be established.
Parenteral pentoxifylline have been investigated in patients with critical limb ischemia in two double-blind
placebo-controlled multicenter trials. In the two trials, 600 mg pentoxifylline was administered intravenously twice
daily for up to 21 days. In the European Study Group, the severity of rest pain was consistently and significantly
lower in the pentoxifylline group, but unfortunately the use of analgesics was allowed and uncontrolled (intention-
to-treat analysis).47 Treatment response was not influenced by the presence of diabetes or by eligibility for surgery.
The subsequent double-blind Norwegian study followed the same protocol but in a smaller number of patients.
This study confirmed a trend in the amelioration of rest pain but did not reach statistical significance between the
two treatment groups.48

RECOMMENDATION 86: Vasoactive drugs in treatment of critical limb ischemia

Very few vasoactive drugs have been properly investigated in patients with critical limb ischemia.
Because the results are unconvincing or negative, current drugs cannot be recommended in patients
with chronic critical limb ischemia.

Gene-Induced Therapeutic Angiogenesis

Recent investigations have established the feasibility of using recombinant formulations of angiogenic growth
factors to expedite or augment collateral artery development in animal models of hind limb ischemia. This novel
strategy for the treatment of vascular insufficiency has been termed therapeutic angiogenesis.49 No recombinant
protein formulation of an angiogenic cytokine has yet been made available for human studies of CLI. Gene trans-
fer constitutes an alternative strategy for accomplishing therapeutic angiogenesis. In the case of vascular endothe-
lial growth factor (VEGF), this is a particularly appealing strategy because the VEGF gene encodes a signal
sequence that permits the protein to be naturally secreted from intact cells50; the impact of the gene product is
thus not limited to the transfected cells, but can be amplified considerably by paracrine effects of the gene prod-
uct (VEGF protein) on endothelial cells responsible for neovascularization.
Gene therapy for therapeutic angiogenesis was performed initially in patients with CLI by arterial gene trans-
fer of VEGF plasmid DNA (phVEGF165).51 Using a dose-escalating design, treatment was initiated with 100 g
phVEGF165. Three patients presenting with rest pain (but no gangrene) and treated with 1,000 g were subse-
quently shown at 1 year follow-up to have improved blood flow to the ischemic limb and remain free of rest pain.52
With the increase in dose of phVEGF165 to 2,000 g, angiographic and histological evidence of new blood vessel
formation became apparent.53
More recently, the use of intramuscular (IM) gene transfer, employed initially as a means of treating patients
in whom vascular disease in the ischemic limb was too extensive to permit an intraarterial approach, resulted in
marked improvement in collateral vessel development in patients with CLI.54 The IM strategy was performed in
10 limbs of nine patients with nonhealing ischemic ulcers (n = 7/10) or rest pain (n = 10/10) attributable to periph-
eral arterial disease. A dose of 4,000 g phVEGF165 was injected directly into the muscles of the ischemic limb.
Gene expression was documented by a transient increase in VEGF serum levels using an enzyme-linked
immunosorbent assay (ELISA). The ankle:brachial pressure index improved significantly (from 0.33 0.05 to 0.48

216
( 0.03, p = 0.02); newly visible collateral blood vessels were documented by contrast angiography in seven limbs;
and MRA showed qualitative evidence of improved distal flow in eight limbs. Ischemic ulcers healed or markedly
improved in four of seven limbs, including successful limb salvage in three patients recommended for below-knee
amputation. Complications were limited to transient lower extremity edema in six patients, consistent with VEGF
enhancement of vascular permeability. These findings may be cautiously interpreted to indicate that intramuscu-
lar injection of naked plasmid DNA achieves constitutive overexpression of VEGF sufficient to induce therapeutic
angiogenesis in selected patients with CLI. Certain patients in this initial cohort and several others subsequently
(seven limbs in six patients) satisfied diagnostic criteria for Buergers disease.55

CRITICAL ISSUE 31: Use of gene-induced angiogenesis in patients with critical limb ischemia
There is a need, suggested by preliminary studies, for properly controlled studies of the use of gene-
induced angiogenesis in treatment of patients with critical limb ischemia.

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30. Antiplatelet Trialists Collaboration. Collaborative overview of randomised trials of antiplatelet therapy. II: Maintenance of vas-
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51. Isner JM, Walsh K, Symes JF, Pieczek A, Takeshita S, Lowry J, Rosenfield K, Weir L, Brogi E, Jurayj D. Arterial gene ther-
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transfer of phVEGF165 in patients with an ischaemic limb. Lancet 1996;348:370-374.
54. Baumgartner I, Pieczek A, Manor O, Blair R, Kearney M, Walsh K, Isner JM. Constitutive expression of phVEGF165 after
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55. Mills JL, Taylor LM, Porter JM. Buergers disease in the modern era. Am J Surg 1987;154:123-129.

Introduction to Interventional Treatment for Critical Limb Ischemia

The decision to proceed with vascular intervention on a patient with CLI is relatively straightforward, because
most require revascularization to avoid major amputation. The decision regarding the most appropriate interven-
tion, however, is complex, with a number of factors requiring consideration. In addition to the mortality and mor-
bidity, comorbid risk factors and life expectancy must be weighed against the initial success and long-term dura-
bility of the chosen intervention. The literature can provide only broad direction in the decision-making process
because most series report best results in a selected patient population characterized by more favorable anatomic
lesions.
Ideally, the patient should be treated with the least risky and least morbid but most successful and durable pro-
cedure. Comorbid risk factors will modify this ideal to give priority to patient safety. High-risk, frail patients may be
best treated with less invasive interventions, even though durability may not be optimal. In some patients, revas-
cularization procedures should be abandoned for primary amputation when patient factors suggest extremely high
morbidity and mortality or the arterial anatomy predicts a poor outcome of intervention. Conversely, the tempta-
tion to pursue the least invasive procedure even in the healthy individual should be resisted. In such cases, the
durability of the procedure over many years is important in reducing lifetime morbidity and cost.
In the following discussions, the results of open surgical and endovascular procedures are presented sepa-
rately in relation to proximal and distal levels of occlusive disease: aortoiliac or infrainguinal. This is followed by a
discussion of the usually preferred option for each broad category of lesion: aortoiliac or infrainguinal. The dis-
ease at each level not only must be considered in terms of its own severity, but all levels of disease must be com-
bined in considering the best approach to limb salvage and improved function. This is particularly true of CLI, in
which multilevel occlusive disease predominates and poor runoff is almost the norm. Although it is necessary to
present the results of open surgical and endovascular interventions separately, they ultimately must be consid-
ered together. Unfortunately, there is a tendency to choose either surgical or percutaneous revascularization tech-
niques exclusively in a given patient, but a multidisciplinary approach results in better choices, as may combining
procedures. Excellent results may be obtained when endovascular and open surgical procedures are combined
(eg, combined iliac dilatation with distal surgical revascularization).
Given the multilevel nature of the disease in patients with CLI and the lack of sufficient data in the literature
dealing with each of the multiple combinations of disease, it is not possible to make recommendations that cover
all eventuality. In principle, however, the most appropriate treatment should be applied to each individual occlu-
sive lesion, and combinations of treatment modalities should be considered as well as procedures that span more
than one level of disease. These and the other considerations previously mentioned should be kept in mind in the
discussions that follow. In the following sections, results from a variety of studies are presented. It is imperative
that the individual caring for the patient with CLI review the results obtained at their own institution (see also Rec-
ommendation 77, p. 190, and Vascular Registry Data, p. 276).

RECOMMENDATION 87: Choosing between techniques with comparable short- and long-term benefi
When two techniques of revascularization (endovascular and open surgery) give equivalent short-term
and long-term benefit, the technique with the least morbidity and mortality must be used first. Cost
also should be considered.

219
 Repeated from p. 190
RECOMMENDATION 77: Audit in critical limb ischemia
It is recommended that all units dealing with critical limb ischemia maintain accurate, audited records for patients
treated and their progress. The minimum follow-up analysis should be in terms of 1-year re-interventions, re-
admissions, amputation rates, mortality, and, ideally, other outcome measures.

Aortoiliac DiseaseSurgical Treatment

Introduction
The surgical treatment of aortoiliac disease offers better results, in terms of degree and duration of benefit,
than surgical treatment of more distal lesions. However, it is also generally associated with greater morbidity than
infrainguinal reconstruction, although the mortality risk is similar, primarily because of the higher incidence of dia-
betes (and thus systemic atherosclerosis) in the latter group.1 Whether one is dealing with primarily unilateral (iliac
artery) occlusive disease or bilateral disease (aortoiliac or bilateral iliac) has major bearing on the choice of treat-
ment and particularly the choice between bypass or endovascular revascularization. To permit the separation of
bilateral (usually more diffuse) disease from more localized unilateral disease, operations to treat each of these
conditions have been addressed separately.

Bilateral Disease
The aortobifemoral bypass
The aortobifemoral bypass (ABF) is considered the reference standard of treatment for aortoiliac occlusive dis-
ease, because it produces the best and most reliable overall results (see Table XLII). However, because most
patients with claudication and limited lesions are now treated by endovascular procedures, ABF is in general
reserved for those with extensive lesions and CLI rather than those with claudication. The stability of modern graft
materials and the durability of benefit in those patients who have undergone ABF grafting is such that other revas-
cularization procedures for aortoiliac disease must be compared with it. A number of alternatives to the standard
approach through a vertical incision have been suggested, including a transverse incision,2 retroperitoneal3 and
more recently, minimally invasive and laparoscopic approach.4 Overall patency rates are not different when end-
to-end versus end-to-side upper anastomoses are properly compared.5-7 Therefore, other considerations should
dictate the configuration of the aortic anastomosis. These include preservation of blood flow into the inferior mesen-
teric and internal iliac arteries, preservation of the hypogastric arteries, which may reduce the incidence of impo-
tence, aneurysmal changes, the aorta as a source of emboli, and juxtarenal aortic occlusion.

Aortoiliac endarterectomy
The durability of aortobifemoral bypass grafting led to a decrease in the performance of this more technically
challenging operation. Most centers reserve endarterectomy for young patients with very localized disease, but,
for the most part, aortoiliac endarterectomy now competes (unfavorably) with PTA and stenting.
The possible requirement for future aortic surgery should temper enthusiasm for this procedure except in the
ideal patient.8 Risks of infection are low, and internal iliac flow is preserved. It avoids the risk of graft infection, and
this promotes its use in patients with an ongoing increased risk of sepsis caused by infectious diseases elsewhere
(eg, recurrent urinary sepsis). In one study, a 10-year patency rate of 90.4% was reported, but in over half of these
patients the indication for surgery was claudication, and other authors have not attained similar good results.9
Selected results of primary patency rates for aortoiliac-femoral endarterectomies are presented in Table LXIV, with
5-year patency rates ranging from 60% to 94%. Most studies have a low incidence of operations for CLI, and

220
TABLE LXII.Primary patency results for aortobifemoral bypass ranked by percentage CLI patients and total sample size
(selected reports)
Primary patency (%)
Operative
Patients % CLI mortality (%) 1 yr 3 yrs 5 yrs 10 yrs Comments

>50% patients with CLI

Prendiville 134 limbs 75 3 94 89 CFA anastomosis
et al., 199212
Prendiville 151 limbs 65 3 95 92 PFA anastomosis
et al., 199212
Schneider 79 59 1.3 85
et al., 199113
Harris 177 59 4 91 incl 23 unilat
et al., 198514 procedures
Schneider 107 53 1 85
et al., 199215
Nevelsteen 912 53 5 94 83
et al., 199116
Brewster & 261 52 1.9 99 95 91 data from 1970-77
Darling, 197817
<50% patients with CLI
Mulcare 114 46 8.8 98 95
et al., 197818
Ameli 105 42 5.7 93
et al., 198919
Littooy 224 37 4.9 97 90 88 73
et al., 199320
Dunn 192 36 3 96 89 86
et al., 198221
Friedman 34 35 0 100 100 98 PTFE graft
et al., 199522
Friedman 26 31 0 100 100 93 Dacron graft
et al., 199522
Naylor 241 29 94 83 81
et al., 198923
Poulias 820 29 3.3 89 82
et al., 199224
Martinez et 376 28 5.6 95 92 88 78
al, 198025
Mason 59 25 7 92 89
et al., 198926
van den Akker 518 23 3.3 90
et al., 199227
Melliere 111 22 1.8 91 end to side
et al., 19907
Jensen & 56 21 0 96 92 89% @ 4yrs
Egeblad, 199029
van der Vleit 350 19 4.9 93.4 88.4 86.4 80.4
et al., 199430

where compared, patency rates are clearly better in patients treated for claudication. More localized endarterec-
tomies also offer more favorable results than those of the entire aortofemoral segment.

Tabulated Results for Aortoiliac Reconstruction

Treatment comparisons of surgical and endovascular modalities are not always stratified into unilateral (iliac
artery) and bilateral (aortoiliac and bilateral iliac) disease in the reported literature. The excellent patency rates for
aortobifemoral bypass grafts reflect good functional results (see Table LXII). It should be noted that, in many of
the studies cited, most subjects were patients with intermittent claudication. Approximately 95% of patients are
initially rendered asymptomatic or improved, and after 5 years, approximately 80% to 90% remain in this cate-
gory.10 A study from the United Kingdom indicates that, of patients fully employed before aortobifemoral bypass,

221
TABLE LXIII.Meta-analysis of primary patency in reconstructions performed after 1975 in patients with CLI31.

5-year primary patency:

Limb-based 87.5% (80-88)
Patient-based 80.4% (7282)
10-year primary patency:
Limb-based 81.8% (7085)
Patient-based 72.1% (6176)
Operative mortality 3.3%
Systemic morbidity 8.3%

TABLE LXIV.Results of primary patency rates from reports of aortoiliofemoral endarterectomy (selected reports).
Patency
Operative
Patients % CLI mortality (%) 1 yr 3 yrs 5 yrs Comments

Roder et al., 198546 55 67 1.7 60

van den Dungen et al., 199147 93 39 0 94 83
Vitale & Inahara, 199048 60 35 0 88 86 80
Oskam et al., 199649 94 11 0 83 68
Brewster & Darling, 197917 253 2.9 98 95 94 aortoiliac
195 7.6 95 85 80 aortoiliac-
femoral
92 1 66 iliofemoral
Lazaro et al., 198851 31 0 75 aortoiliac

85% return to full employment an average of 4 months after surgery.11 It should be noted that in this table some
older series, although reporting good patencies, not unexpectedly have higher mortality rates.
In a meta-analysis of pooled data from 1978 to 1996, de Vries and Hunink31 showed that after 1975 the aggre-
gate mortality rate had dropped from 4.6% to 3.3%, and the aggregate systemic morbidity risk dropped from 13.1%
to 8.3% (Tab. LXIII). Importantly, this study compared limb-based patency rates for patients with intermittent clau-
dication and those with CLI. For claudication, they were 91.0% and 86.8% at 5 and 10 years, respectively. This
study confirms two previous observations of the superiority of ABF over other bypasses: (1) its remarkable dura-
bility and (2) its patency is less affected by poor run-off, typified by CLI patients.

Axillofemoral bypass
The axillary artery may be used as an inflow source. Although some recent studies report excellent results with
extraanatomic bypass grafts, such as axillofemoral bypasses, these are in general limited to those patients with
exceptional surgical risks because of concurrent disease or to those in whom the abdominal approach is con-
traindicated (eg, infection, multiple adhesions, other intraabdominal pathological conditions). The improved recent
results with 5-year primary patencies of 75% to 80% are related to technical improvements. These include the use
of externally supported prostheses52 53 but liberalized indications also may play a role. In comparable cases, ABF
produces better patency, but axillobifemoral bypass produces lower morbidity and mortality. This tradeoff is more
difficult to justify in good-risk patients with intermittent claudication but it is clearly valuable in those with CLI when
there is a mandatory requirement for femoral inflow and the direct abdominal approach is contraindicated by a
prohibitive risk.
Adequate inflow for axillofemoral bypasses needs to be confirmed by duplex scan before operation. Calligaro
et al.54 recommended inflow arteriography because they found both a higher incidence of inflow disease (25%)
and the failure of noninvasive examination to detect disease in 75% of patients found to have significant stenoses

222
TABLE XLV. Results of aortoiliac proceduresprimary patency rates for extraanatomic bypass (selected reports).
Primary patency (%)
Operative
Patients CLI (%) mortality (%) 1 yr 3 yrs 5 yrs

Axillounifemoral
Ascer et al., 198555 34 100 5 44
Rutherford et al., 198737 27 100 13 48 19 19
Chang, 198641 23 100 33
Naylor et al., 199042 17 100 11 50
Hepp et al., 198834 90 80 5
Harrington et al., 199443 73 71 8.3
ElMassry et al., 199344 50 62 5 79
Axillobifemoral
Chang, 198641 26 100 75
Ascer et al., 198555 22 100 5 50
Naylor et al., 199042 17 100 11 68
Rutherford et al., 198737 15 81 11 78 62 62
Passman et al., 199653 108 80 3.4 90 74 74
Hepp et al., 198834 22 80 5
El Massry et al., 199344 29 62 5 76
Harrington et al., 199443 80 50 8.3
Harris et al., 199052 76 5 93 85 @ 4yr
Axillopopliteal
Ascer et al., 198555 55 100 8 58 45 40
Keller et al., 199245 41 100 20 70 43

with arteriography.
Results of axillounifemoral and axillobifemoral bypass grafts are presented in Table LXV. Primary patency results
at 5 years (axillounifemoral, 30% to 79%; axillobifemoral, 33% to 85%) are not as good as those for aortobifemoral
bypass grafts. In series in which the two have been compared, patency rates have been statistically significantly
better for axillobifemoral than for axillounifemoral bypass, or the mean patency rates have favored the former.
However, the cases may not be truly comparable, and the issue of whether to always perform a bilateral bypass
even in the face of unilateral ischemia has never been addressed by an appropriate trial.55-58

CRITICAL ISSUE 32: Axillobifemoral versus axillounifemoral bypass for critical limb ischemia
There is a need to determine whether a bilateral procedure should always be performed, even in the
case of unilateral ischemia, when constructing an axillofemoral bypass.

Thoracofemoral bypass
The thoracic aorta may provide a suitable inflow artery in patients with reasonable pulmonary and cardiac func-
tion. Most authors find that the use of the descending thoracic aorta with a retroperitoneal tunnel provides more
acceptable operative risk and acceptable patency rates.59-61 The proximal anastomosis is performed through a
lower thoracotomy with retroperitoneal tunneling and crossover femoral grafting to provide inflow to both legs.
Five-year patency rates of 86% have been reported.59

Special considerations in proximal surgical revascularizations

223
Management of juxtarenal aortic occlusion (aortofemoral bypass).Aortic occlusion progressing to the
juxtarenal position may be treated successfully by an aortobifemoral bypass graft. The aorta must be thrombo-
endarterectomized, either through the end of the divided infrarenal aorta (champagne cork operation) or through
a longitudinal arteriotomy in the infrarenal position after the renal arteries have been protected from emboliza-
tion.62 63 The additional morbidity has been reported specifically with respect to suprarenal clamping and renal fail-
ure as long as the clamping time of renal arteries is less than 30 minutes and there is no embolization of throm-
botic or atheromatous debris into the renal circulation.

Management of the small hypoplastic aorta.A subset of patients, mainly female, have congenital
markedly small aortas. There remains controversy about the best treatment for these patients. Aortoiliac
endarterectomy with a patch has been advocated by some, but the commonly preferred alternative is to use
an ABF with a wide end-to-side anastomosis. This gives acceptable results with meticulous technique.64

Management of coexisting infrainguinal occlusive disease

Many, if not most, patients with CLI have multilevel disease. Brewster et al.65 reported that 49% of patients
undergoing aortobifemoral bypass grafts would have occlusion of the superficial femoral artery. Many authors have
written about the ability to predict the success of an inflow procedure alone to relieve symptoms and salvage the
limb. The need for subsequent bypass has been estimated to be as high as 21% to 25%, although in Brewster et
als series only 4% were done simultaneously.65 66 One aspect of this is assessment of the hemodynamic signifi-
cance of iliac stenoses. It is accepted that inflow must be adequate before the performance of an outflow proce-
dure. Complete occlusions are easy to assess angiographically, but stenoses are difficult to gauge. Hemody-
namically significant stenoses may be missed on AP projections because iliac plaques build up posteriorly. Even
biplanar views may misjudge them. Conventional thinking is that proximal revascularization will suffice in most
cases (approximately 75%-85%). Identifying characteristics of the remainder include (1) the proximal lesion is of
modest hemodynamic significance; (2) there is occlusive disease in the profundageniculate collateral pathway
beyond that which can be dealt with by concomitant profundaplasty; (3) the popliteal artery or two of its branches
are occluded (poor runoff); and most importantly, (4) there is major tissue loss or infection in the foot.
The measurement of pressure gradients across the aortoiliac segment after the administration such as papaver-
ine has been deemed a suitable assessment of aortoiliac stenosis in determining the need for an inflow versus
an outflow procedure.67 Occasionally a drop in pressure will be evident only after distal reconstruction, and there-
fore these pressures should be monitored.68 There was no difference in infrageniculate graft patency at 4 years
when the anatomic degree of proximal iliac stenosis is compared.69 It must be stressed that it is the systolic com-
ponent of the arterial pressure that most accurately reflects the underlying hemodynamic status of the arterial seg-
ment being examined.70 71 Although pressure gradient measurement can be done readily during preprocedural
arteriography, it is less desirable as a separate procedure. For this reason, noninvasive imaging has been explored
as a substitute. The mean sensitivity of the clinical evaluation for aortoiliac disease has been reported to be in the
range 32% to 77%, which is not adequate for routine screening.72
Duplex scanning was found to be the most reliable single noninvasive test for aortoiliac disease, with a
mean sensitivity of 92%.73 Although duplex scanning usually gives a clear result, occasionally lesions are
close to the threshold between hemodynamically significant and insignificant lesions, and it is not possible
in some patients (eg, because of obesity or intestinal gas). MRA is gaining recognition as an appropriate
assessment of aortoiliac occlusive disease (sensitivity, 92%; specificity, 88%). 74 Such borderline lesions
require intraarterial pressure measurement with hyperemia at the time of arteriography. Hyperemia can be
induced either pharmacologically or mechanically. Such measurements ideally should be performed before
reconstruction but also can be performed at time of surgery on the operating table. Contrast arteriography
with pressure measurements, both at rest and after vasodilatation, is considered to be the reference stan-
dard, but duplex can distinguish all but the borderline lesions with accuracy.75-79 There remains considerable

224
controversy over what constitutes the threshold value for hemodynamically significant pressure gradients,
but it is generally accepted that peak systolic differences of 5 to 10 mm Hg at rest and 10 to 15 mm Hg after
vasodilatation are important (see Aortoiliac Stents, p. 106).

RECOMMENDATION 88: Intraarterial pressure measurements for assessment of multilevel disease

In a patient with multilevel disease, if there is doubt about the hemodynamic significance of partially
occlusive aortoiliac disease, it should be determined by intraarterial pressure measurements at rest
and with induced hyperemia before constructing an outflow bypass. This may be performed at the time
of angiography.

(Repeated from p. 106)

CRITICAL ISSUE 11: Use of pressure gradients to assess hemodynamic significance of stenoses
Pressure gradient criteria with or without vasodilators for assessing hemodynamic significance in iliac lesions
remain to be established.

CRITICAL ISSUE 33: Effect of distal disease on iliac artery pressure gradients
There is a need for future studies to investigate the extent to which severe distal disease may cause
an underestimation of translesion iliac artery pressure gradients.

Presuming significant proximal disease requiring revascularization is present, the other main consideration is
whether the coexisting distal disease must be dealt with by concomitant bypass or profundaplasty, or whether a
proximal revascularization alone will suffice. Most agree that major tissue loss or infection in the foot is an over-
riding consideration. In the absence of that finding, the choice regarding profundaplasty versus distal bypass is
still a matter of debate.80 The profunda is a durable outflow artery, and, in the presence of a superficial femoral
artery occlusion and stenosis of the origin of the profunda femoris artery, a profundaplasty should be performed
at the time of ABF. The value of concomitant profundaplasty when the proximal profunda is narrowed is well estab-
lished.
Even if profundaplasty is indicated and performed, decisions regarding the need for concomitant bypass, related
to indication (3) previously discussed, needs to be made, and this can be aided by segmental limb pressure. The
pressure index recommended for isolated profundaplasty is less useful in the face of a proximal revascularization.
However, attempts have been made to predict the need for concomitant distal bypass from hemodynamic data.
Rutherford et al.5 were able to develop a proportion formula relating the preoperative thigh and ankle brachial
indices. This predicted (correlated with the presence or absence of) hemodynamic failure when distal recon-
struction was not performed with 89% accuracy.5 Others have successfully incorporated this approach into their
practices.44

Unilateral Iliac Disease

Unilateral aorto or iliac to femoral bypass
When a single iliac artery is involved in the ischemic process, it may be desirable to conduct a unilateral pro-
cedure. Several studies suggest that unilateral aorta femoral bypass grafts can be safely performed and may have
higher patency rates than extraanatomic bypass grafts.81 The iliac artery also may provide a suitable inflow artery.
82-84 The risk of progression of occlusive disease in the contralateral iliac artery and the need for subsequent recon-

struction has given rise to cautionary note by some authors who prefer to perform a bilateral reconstruction.85 86

225
 TABLE LXVI.Results of aortoiliac proceduresprimary patency rates for unilateral reconstruction (selected reports).
Operative Primary patency (%)
CLI mortality )
Patients (%) (%) 1 yr 3 yr 5 yr Comments

Unilateral aorto/iliaciliac/femoral bypass

Piotrowski et al., 198885 17 53 0 48 48 compare with fem-fem results below
Kalman et al., 198732 50 44 0 96 92
van der Vleit et al., 199430 184 39 2 95 88
Mason et al., 198926 39 31 0 89
Ricco, 199233 69 18 1 97 90 compare with fem-fem results below

Femorofemoral bypass
Hepp et al., 198834 26 80 4 100 80
Lorenzi et al., 199435 165 67 4.2 91 81 75
Kalman et al., 198736 82 52 0 80 6773
Perler & Williams, 199689 26 46 1.4 87 79 79
Perler & Williams, 199689 44 50 1.4 81 73 59 with donor artery dilatation
Rutherford et al., 198737 60 45 0 79 67 67 without donor artery dilatation
Criado et al., 199338 110 44 4.5 83 71 60
Piotrowski et al., 198885 47 40 0 60 55 compare with iliofem results above
Ng et al., 199239 156 34 1.3 92
Ricco 199233 74 17 1 92 79 compare with iliofem results above
Farber 199040 71 4 82
Chang 198641 53 85

Femorofemoral bypass
Comparative studies have failed to yield comparable success rates for extraanatomic bypass grafts when com-
pared with the standard ABF, probably attribtable in part to progressive disease in the donor limb.87 88 Thus, the
inflow arterial system must be of an excellent quality if good results are to be obtained with crossover bypasses.
Inflow may be improved with PTA before crossover femoral grafting in those with some donor iliac artery steno-
sis. Comparative studies have shown similar patency rates when donor arteries are dilated or stented before
bypass in carefully selected patients.89 It is recommended that donor iliac artery PTA or stenting should be reserved
for the ideal lesions.
Results of direct revascularization and crossover grafts are depicted in Table LXVI. Controversy exists over
which of the two main choices of operation is preferred. In addition, unless the disease is truly localized to the uni-
lateral iliac system or the patients condition precludes an aortic procedure, ABF is recommended as the inflow
procedure of choice.49

CRITICAL ISSUE 34: Long-term results of crossover bypass grafts

There is a need for randomized studies comparing long-term results of crossover femorofemoral
bypass, iliofemoral bypasses, or endarterectomy and direct aortofemoral bypasses.

Axillounifemoral bypass
The application of this bypass is limited, because of its lower patency rate, primarily to secondary operations
for graft infections. It also is used in situations in which there is a pressing need for unilateral inflow but other inflow
donor arteries are not patent or accessible because of hostile anatomy or prohibitive anesthetic risk (see also Tab.
LXV, p. 223).

226
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Aortoiliac DiseaseEndovascular Treatment

For a detailed discussion of endovascular treatment of aortoiliac disease, see Aortoiliac PTA (p. 102). Endovas-
cular techniques such as PTA and stent placement have the advantage of lower morbidity and mortality risk com-
pared with open surgical revascularizations.1 The death and complication rates of aortoiliac PTA and stent place-
ment were analyzed in a meta-analysis of 2,116 reported patients.2 Death within hospital stay (not 30-day mor-
tality) averaged 0.14% for PTA and 0.3% for stent procedures. The 30-day mortality rate averaged 0.8% for PTA
and 1.0% for stent procedures (for detailed discussion of complications of endovascular procedures, see p. 114).
The mean systemic complication rate was 1.3%; the local complication rate, 9.6%; and the mean rate of major
complications necessitating treatment was 4.3% for PTA and 5.2% for stents, respectively.2
Endovascular procedures are generally performed on patients with less severe disease than those undergo-
ing surgical treatment. The risk for endovascular technique is much lower than for surgical treatment. However,
PTA and stents offer a lower durability of the result as compared with bifurcated graft surgery. The adjusted 4-year
primary patency rate for treatment of CLI, with technical failures included, was 53% after PTA and 67% after stent
placement for the treatment of stenoses.2 3 Analysis of variables that could potentially affect the patency results
shown some heterogeneity. However, disease severity (CLI vs claudication), lesion type (occlusion vs stenosis),
and lesion site (common vs external iliac) were found to affect patency in some studies.4 5
An analysis of the results of the endovascular treatment of aortoiliac disease has already been presented (see
Aortoiliac PTA, p. 102, and Aortoiliac Stents, p. 106) and is not repeated here. This is because these proce-
dures have been predominantly performed for claudication (proportion of patients undergoing procedures for clau-
dication: 77% of PTA performed for iliac stenoses, 82% of iliac PTA for occlusions, 78% of iliac stenting for steno-
sis, and 86% of iliac stenting for occlusion). It should therefore be pointed out, in reviewing these data in com-
parison with the surgical bypass data presented earlier (see p. 222), that the iliac PTA and stent data primarily
reflect the treatment of unilateral (iliac) disease, with lesions amenable to these modalities.

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Introduction to Preferred Therapeutic Options

The decision about what type of revascularization to recommend ideally should be made by a multidisciplinary
team. Important issues that may influence the recommended decision are:
lesion morphology;
risk of surgery for that particular patient;
previous procedures (ie, bypass or angioplasty);
patients life expectancy;
local expertise and experience with particular surgical or endovascular procedures.
In general, endovascular procedures are safer and require shorter hospitalization compared with surgical pro-
cedures. Durability of these endovascular procedures is, however, less well established. For most lesions, there
is no direct evidence comparing the results of endovascular or surgical treatment in a controlled, prospective, ran-
domized study.
The system used for preferred therapeutic options has been detailed (see Endovascular Procedures
for Intermittent Claudication, p. 101). Lesions are defined and then placed in four groups, each group
usually being treated in a similar way. The two extremes are type A lesions, in which endovascular approach
is the treatment of choice, and type D lesions, in which surgery is the treatment of choice. In between
these two groups are types B and C lesions, in which no firm recommendations can be made about the
preferred interventional option. However, endovascular treatment is more commonly used in type B lesions
and surgical treatment is more commonly used in type C lesions. There is insufficient solid evidence to
make any firm recommendations, particularly in the case of types B and C. Most patients with CLI have
multilevel disease, and it may be appropriate to use different techniques for different lesions.

Aortoiliac DiseasePreferred Therapeutic Options

The following and other similarly set out recommendations merely consider the probable relative merits of sur-
gical and endovascular treatment, on the assumption that intervention is desirable. It is therefore identical to Rec-
ommendation 31 (see p. 102). The final choice of intervention, particularly for category 2 and 3 lesions, will of
course depend on a number of other considerations, such as the patients overall health, the severity of the local
lesion, etc.

230
 (Repeated from p. 102)
RECOMMENDATION 31: Morphological stratification of iliac lesions
TASC Type A iliac lesions:
Single stenosis <3 cm of the CIA or EIA (unilateral/bilateral)
TASC Type B iliac lesions:
Single stenosis 310 cm in length, not extending into the common femoral artery (CFA)
Total of two stenoses <5cm long in the CIA and/or EIA and not extending into the CFA
Unilateral CIA occlusion
TASC Type C iliac lesions:
Bilateral 510-cm-long stenoses of the CIA and/or EIA, not extending into the CFA
Unilateral EIA occlusion not extending into the CFA
Unilateral EIA stenosis extending into the CFA
Bilateral CIA occlusion
TASC Type D iliac lesions:
Diffuse, multiple unilateral stenoses involving the CIA, EIA, and CFA (usually >10cm)
Unilateral occlusion involving both the CIA and EIA
Bilateral EIA occlusions
Diffuse disease involving the aorta and both iliac arteries
Iliac stenoses in a patient with an abdominal aortic aneurysm or other lesion requiring aortic or iliac
surgery

Abbreviations: CIA, common iliac artery; EIA, external iliac artery; CFA, common femoral artery.

(Repeated from p. 102)

RECOMMENDATION 32: Treatment of choice for TASC type A and D aortoiliac lesions
Endovascular procedure is the treatment of choice for type A lesions and surgery is the procedure of choice
for type D lesions.

(Repeated from p. 102)

CRITICAL ISSUE 10: Treatment of TASC type B and C lesions

More evidence is needed to make any firm recommendations about the best treatment for TASC types B and
C lesions.*
*CIRSE dissenting opinion:
Currently endovascular treatment is more commonly used for type B and C lesions, but more evidence is
needed to make any firm recommendations about best treatment.
Reason for dissenting opinion: Due to technical developments, type C lesions of iliac and femoral arteries can
be treated by endovascular means with a reasonable technical success rate (for references, see B 4.3), There-
fore, CIRSE believes that in clinical practice these lesions are more commonly treated by endovasular tech-
niques, although scientific evidence of any superiority over vascular surgery is lacking.

231
Combined Surgical and Endovascular Procedures

This discussion primarily concerns the choice between open surgical reconstruction and endovascular proce-
dures and is directed toward proximal revascularization. The common occurrence of multilevel disease in CLI
patients has already been alluded to and discussed in terms of the need for concomitant distal bypass. However,
combinations of endovascular and surgical procedures are increasingly being employed. Combined endovascu-
lar/surgical procedures have had some success in this regard. In considering the approach to a combined proce-
dure, either concurrently in the operating room or sequentially in the angiography suite with early subsequent
bypass, each lesion must be considered on its own merit. Iliac artery dilatation to improve inflow for a cross-femoral
graft has been reported to be successful in carefully selected patients.1 2 Those patients with pressure gradients
across aortoiliac stenoses should have these corrected before construction of a distal bypass graft.
For suitable lesions, balloon angioplasty, performed either intraoperatively or preoperatively, provides adequate
inflow to maintain the distal reconstruction. The quality of the endovascular and surgical components of the tech-
nique must not be compromised by skills and training of the individual performing either part of the procedure.
Also, in the absence of sufficient length of ideal conduit for a distal bypass, balloon angioplasty may remove a dis-
crete lesion distally, permitting longer-term patency of an otherwise compromised graft. The determination of com-
bining or performing the procedures sequentially will be determined by local circumstances.

References
1. Perler BA, Williams GM. Does donor iliac artery percutaneous transluminal angioplasty or stent placement influence the
results of femorofemoral bypass? Analysis of 70 consecutive cases with long term follow-up. J Vasc Surg 1996;24:363-370.
2. Walker PJ, Harris JP, May J. Combined percutaneous transluminal angioplasty and extraanatomic bypass for symptomatic
unilateral iliac artery occlusion with contralateral iliac artery stenosis. Ann Vasc Surg 1991;5:209-216.

232
 Infrainguinal DiseaseSurgical Treatment
The main guiding principles behind surgical reconstruction are to bypass into the best available outflow vessel
possible regardless of the anatomic level and to construct the bypass graft with autogenous vein. Further expla-
nation and exceptions to these principles are discussed in the following sections. The issue of above-knee
femoropopliteal bypass grafting has been addressed earlier (see Surgery for Intermittent Claudication, p. 117).
When a bypass graft is constructed to an outflow artery below the knee, autogenous tissue is accepted as the
preferred conduit.

Inflow
Before reconstruction of infrainguinal PAD, the surgeon must ensure adequate inflow to the groin level or site
of proximal anastomosis (see also Recommendation 88, p. 225). The common femoral artery or an inflow graft is
the usually accepted origin of a femoral distal bypass graft. A number of authors have reviewed experience with
more distal take-off of bypass grafts (profunda, SFA, popliteal) and have found that in appropriately chosen indi-
viduals there is no compromise to the bypass.1-3 For example, a stenosis of 20% or more in the native superficial
femoral artery proximal to a graft origin has been correlated with eventual graft failure.1 Because atherosclerosis
is a generalized and in many cases progressive disease, distal origin bypass grafts should be undertaken only
when inflow to that level is uncompromised. This issue is of some importance when alternative (and presumably
shorter) segments of vein must be used for bypass grafts.

RECOMMENDATION 89: Inflow artery for femorodistal bypass

Any artery, regardless of level (ie, not only the common femoral artery), may serve as an inflow artery
for a distal bypass provided that flow to that artery and the origin of the graft is uncompromised.

Outflow (Run-off) Arteries

The guiding principle here is to choose the distal outflow artery that allows the best perfusion of the foot. Any
distal artery, including the pedal arteries, may serve as a suitable outflow tract with acceptable expected patency
rates.4 5 The results of femorobelow-knee popliteal grafting are similar to femoral distal bypass grafting. The
choice of the site of the distal anastomosis should be based on the quality of the distal artery and its runoff and
not the length of the bypass. The main exceptions to this relate to the lack of adequate length of suitable vein.

Distal Bypass Grafts

The same principles as outlined in the previous section on femoral-popliteal lesions apply to more distal bypass
grafts. The increased length of the required conduit introduces some special problems in the absence of long
saphenous vein, and these are discussed in the following sections. There should be no effort to compromise the
length of bypass just to have the distal anastomosis in the popliteal artery rather than a distal artery. The best dis-
tal artery should be selected, because this will give the best long-term patency rates.

RECOMMENDATION 90: Femorofemoral distal bypass outflow vessel

In a femoral crural bypass, the least diseased distal artery with the best continuous run-off to the
ankle/foot should be used for outflow regardless of location, provided there is adequate length of suit-
able vein.

233
Isolated Popliteal Artery Segment
When there is no direct communication between the popliteal artery and the tibial vessels, this isolated popliteal
artery may be used as an outflow tract.6 This situation, which usually arises when there is a shortage of vein, is
an exception to the previously discussed guiding principle. The indication for such an operation would be CLI and
the absence of sufficient length of suitable vein for bypass into a more appropriate vessel. Five-year patency rates
for bypasses to an isolated popliteal segment were reported as PTFE, 55%; saphenous vein, 74%; and limb sal-
vage rates as PTFE, 56%; and saphenous vein, 79%.7 Suggested requirements for a successful bypass to the
blind popliteal artery were a segment of artery of at least 7 cm and at least one major collateral vessel draining
the segment. Large perigeniculate collateral arteries have been used successfully as outflow vessels in some
patients.8

RECOMMENDATION 91: Bypass to an isolated popliteal artery

Bypass to an isolated popliteal artery should be considered as an alternative when no crural or pedal
bypass is possible or realistic (eg, because of shortage of vein). An adequate segment of popliteal
artery with collateral outflow to the foot is required to ensure ongoing patency.

Choice of Conduit
(See Surgical Procedures, p. 118) For infrageniculate reconstruction, there is general agreement that the con-
duit should be constructed of autogenous vein. Good results have been achieved by a variety of techniques. How-
ever, the preferred reconstruction is with ipsilateral long saphenous vein (either in situ or reversed). If this is not
available, the preferred alternatives in order of preference are single-segment venous bypass (contralateral greater
saphenous vein, arm vein, etc.) followed by spliced veins from any source. Finally, composite or prosthetic grafts
with adjunct procedures (vein cuff, distal AV fistula) may be considered, provided expected patency is sufficiently
high to justify patient risk. Basic science and clinical investigations continue into the development of alternative
bypass conduits when autogenous vein is not available. These include arterial and venous homografts, but addi-
tional study is required to determine their efficacy. Results from a variety of conduits are shown in Table XLVII,
showing diminishing results as less favorable bypass grafts are used. Direct comparison studies (in addition to
those already shown) are shown in Table XLVIII.
For bypasses below the knee, autogenous tissue is far superior to any other conduit. A randomized control trial
comparing PTFE with autogenous vein found significantly improved results in bypass grafts distal to the knee when
vein was used in the reconstruction.9 This is confirmed in a meta-analysis by Hunink (see Table XLIX, p. 239).10
Initial good results with improved techniques for in situ bypass grafts led to claims of better long-term patency
rates. However, when this technique was compared with reversed saphenous vein graft, a number of random-
ized trials failed to support this statement.11 12 On the contrary, at 5 years the primary patency rate for in situ
bypasses was 46.2%, compared with 68.8% for reversed bypasses (p < 0.05).12 Such randomized comparisons
also reflect problems in comparing the two approaches, such as greater (learning curve) experience needed for
in situ bypass and greater need for secondary procedures to deal with residual arteriovenous fistulas (graft
stenoses being equivalent). In general, the techniques are considered equivalent, with tapering vein creating a
diameter mismatch in infrageniculate bypass being the solitary advantage to in situ bypass. Although some claim
that reversed vein has the advantage that it can be moved to the required location, antegrade use of dislocated
vein after valve disruption holds the same advantage and can be used to overcome diameter mismatch. How-
ever, the secondary patency rate was comparable in the two groups (71.6% in situ vs 79.4% reversed). This
demonstrates the need for meticulous follow-up of vein bypass grafts.
The quality of the vein can affect the outcome. A saphenous vein is optimal if the vessel wall is thin, the endothe-
lium intact, and the diameter at least 4 mm. The length and estimate of the diameter of available veins is frequently

234
TABLE XLVII.Selected results of infrainguinal bypass with various conduits.
Operative Primary patency (%) Secondary Patency (%)
CLI Mortality
Patients (%) (%) 1 yr 2 yrs 3 yrs 5 yrs 1 yr 2 yrs 3 yrs 5 yrs Comments

Reversed greater saphenous vein

Rutherford 100 75 63
et al., 198827
Taylor et al., 1990 22 100 75 63
Gentile et al., 199618 268 2 98 83 74 ipsilateral
Hall et al., 198561 52 23 85 68
In situ

Belkin et al., 1996 386 100 2 68 80

Feinberg et al., 199032 57 97 82 64
Alexander et al., 1996 119 92 1 81
Londrey et al., 199133 61 92 4 72 83 74 74 74

LS Vother

Belkin et al., 199662 168 100 1 66 75 Nonreversed

Londrey et al., 199133 93 92 4 59 76 68 61 59 Reversed vein
Londrey et al., 199417 169 88 2 78 67 59 52 Single length,
any vein
Myers et al., 199364 537 43 80 73 Reversed vein

Arm Vein
Chalmers et al., 199465 42 95 0 46 85 64% infrapopliteal
Harward et al., 199266 43 93 0 67 49 64 34% infrapopliteal
Harris et al., 198467 70 83 0 85 72 68 56% infrapopliteal
Myers et al., 199364 49 43 63
Spliced Vein
Harris et al., 198668 54 100 6 58 74 78% tibial
Chang et al., 199520 114 95 4.4 72 69 80 77 Part in situ
Londrey et al., 199417 88 88 2 56 53 39 29
Taylor et al., 198769 140 81 1.5 95 83 Other vein
Taylor et al., 198769 189 69 1.5 89 84 Partial ipsilateral
vein
Ankle/distal, all vein
Panayiotopoulos et al., 199670 109 100 7 27 45 Crural/pedal
Davidson & Callis, 199371 75 100 6 89 79 68 93 82 70 All vein to foot
Quinones- 46 100 0 72 72 Distal ankle
Baldrich et al., 199372
Shah et al., 199659 487 91 3.5 83 70 89 77
Composite partial prosthesis
Fichelle et al., 199573 145 100 3.3 41 35
McCarthy et al., 199274 67 100 0 72 64 48 64 40 Sequential 100%
infrapopliteal
DeMasi & Snyder, 199575 85 99 1 22 47 85% infrapopliteal
Feinberg et al., 199032 108 97 35 30
Londrey et al., 199133 45 92 4 26 55 50 44 28
Alexander et al., 199663 35 92 35 50
Distal prosthesis
Schweiger et al., 199341 211 100 3.3 37 23 45 25 100% infrapop-
liteal
Londrey et al., 199133 33 92 4 7 63 38 26 7

assessed preoperatively with duplex scanning, in the order of choice (ipsilateral greater saphenous, contralateral
greater saphenous, lesser saphenous, and arm veins). This practice and the abandonment of unnecessary dis-
qualification of patients with coronary disease (ie, saving veins for the heart) has greatly increased vein utiliza-
tion. It has been found that even those with previous partial greater saphenous removal for vein stripping, or har-

235
TABLE XLVIII.Selected results of comparative studies of infrainguinal bypass grafts.
Primary patency (%)
Operative
Patients CLI (%) mortality (%) 1 yr 3 yrs 4 yrs 5 yrs Comments

>90% Infrapopliteal comparisonsall studies

Vein type
Taylor et al., 199060 285 80 1 89 84 80 GSV
231 80 1 84 71 68 other vein
Gentile et al., 199618 268 2 98 83 74 ipsilateral GSV
58 2 85 82 82 contralateral GSV
133 1 83 75 72 other vein
Distal anastomosis
Donaldson et al., 199176 440 68 87 84 83 all grafts
299 100 2 83 81 81 CLI only
240 91 86 86 popliteal
anastomosis
200 82 81 78 distal anastomosis
Graft type
Veith et al., 19869 106 86 6 49 any vein
98 88 4 12 PTFE
Cranley & Hafner, 198277 40 100 2 59 any vein
13 100 33 HUV
Edwards & Mulherin, 198078 57 88 82 any vein
29 93 21 PTFE
15 93 7 HUV
Rutherford et al., 198827 50 98 88 88 in situ GSV
22 100 75 63 reversed GSV
14 71 25 17 PTFE
21 95 7 7 HUV
Hall et al., 198561 52 23 85 68 RSV
27 48 63 49 Composite
47 62 54 34 PTFE

vest for CABG or other bypasses, commonly have sufficient vein left in the same leg for an infrainguinal bypass.
13 Those veins that require modification for disease at the time of the original procedure are more apt to require

further modification to maintain patency.14 Arm vein is easily accessible and can provide excellent results over the
long term.15 The configuration of the arm vein may be a total segment of basilic or cephalic vein, which is either
reversed or undergoes valve destruction. An alternative is to use a basilic-cephalic loop with one segment requir-
ing valve lysis.16
Composite vein grafts composed entirely of vein but constructed from a number of different segments or
sources have proved adequate conduits. Sources of vein may include remnants of long saphenous vein, short
saphenous vein, and arm vein.17 Some studies report results as good as single-segment long saphenous vein
bypass grafts,18 and others suggest that, although good, the results are not comparable.19 The results of spliced
vein grafts to the popliteal and distal vessels at 4 years are: primary, 45%, and secondary, 61%. These results
are improved if at least some of the graft is in situ long saphenous vein.20 Although direct comparison trials
have not been performed, this approach would seem better than other alternatives, that is, the other adjunc-
tive procedures discussed in this section. However, the revision rate to maintain patency is approximately 20%,
and a careful program of surveillance is required to achieve optimum results.
Superficial femoral vein has been suggested as a suitable conduit with very acceptable patency rates. The
removal of the superficial femoral vein may be complicated by limb edema, but this generally settles with time and
elastic support.21 Size discrepancy may pose a problem in some patients. However, patency rates equivalent to
those for long saphenous vein bypass grafts have been reported.22 23

RECOMMENDATION 92: Femoral below-knee popliteal and distal bypass

An adequate long saphenous vein is the optimal conduit in femoral below-knee popliteal and distal
ypass. In its absence, other good-quality vein should be used.

236
Other Conduits
Available conduits for femoral popliteal bypass grafts include PTFE, HUV, and Dacron. Results are varied, and
reports tend to be selected case studies. A randomized trial comparing PTFE and Dacron at the popliteal level
gave similar results.24 25 Although some randomized trials have reported superiority of HUV over PTFE or Dacron
with respect to patency, this has not been a consistent finding26-28 and late degenerative changes in HUV with
aneurysm formation offset any potential patency advantage.29 The major determinant of graft patency is the type
of graft used, and vein is superior to any prosthesis.30 31

Composite grafts (prosthetic vein)

When insufficient autologous vein is available for distal bypass grafting, there is a question of whether there is
an advantage to constructing some of the bypass graft with vein (composite bypass graft) rather than use pros-
thesis entirely. Most studies show a difference or at least a trend toward improved patency with composite grafts32
33 but no randomized trial data are available comparing all prosthetic (with or without vein cuff) with composite

grafts. Studies are difficult to compare because there is usually minimal information regarding the percentage of
the graft that is composed of vein.

Role of the Profundaplasty Alone

The role for profundaplasty is well accepted as an adjunct to inflow procedures to maintain graft patency and
reduce the need for subsequent or simultaneous distal reconstruction (see also Management of Coexisting Infrain-
guinal Occlusive Disease, p. 224). The role of isolated profundaplasty is more controversial. Clinical success with
such a procedure has been achieved in 49% of patients at 3 years.34 A review of the literature has suggested that
requirements for success include (1) excellent inflow, (2) a greater than 50% stenosis in the proximal third of the
profunda, and (3) the presence of excellent collateral flow to the tibial vessels in continuity with a foot with no tis-
sue loss.35 In an attempt to evaluate collateral flow distal to the profundaplasty as a predictor of success, a high
segmental limb pressure gradient across the knee (AK-BK pressure/AK pressure >0.5) has been found to predict
clinical failure.36 There are no other successful objective predictors of success of isolated profundaplasty.

Assessing Run-off
In a large, nonrandomized, retrospective study, Darling et al.37 reviewed bypass grafts to the peroneal (n =
888) and dorsalis pedis artery (n = 291). No difference was found in patency or limb salvage at 1 and 5 years
between the two groups (5-year secondary patency peroneal, 76%; dorsalis pedis, 68%). These findings are con-
firmed by other authors.38 39 Even in the presence of pedal gangrene, the peroneal artery may be an appropriate
outflow tract.40
When performing a bypass for CLI, the outflow vessel must be widely patent, with adequate run-off, and this
principle must not be compromised to shorten the length of the bypass. At least one study has shown that long-
term patency may be predicted by the adequacy of the pedal arch.41 Three-year pedal artery graft patencies
were compared with more proximal crural bypass grafts and yielded comparable results (82% pedal vs 79% tib-
ial, secondary patency) as well as yielding comparable limb salvage rates (92% pedal vs 87% tibial).42
A variety of methods exist for the intraoperative assessment of graft flow and run-off resistance/impedance.
Variable results have been reported from a variety of sophisticated methods of assessment.43-45 Although these
methods have been shown to predict patency, they have not gained widespread acceptance because they
require completion of the bypass graft before predicting success. The SVS/ISCVS reporting standards for eval-
uating run-off resistance, taking into account a number of factors, has been modified and validated by Peterkin
et al.46 based on angiography and multiple linear regression analysis. However, it tends to be less predictive
of vein than prosthetic graft patency, the former faring much better in the face of poor run-off.

237
Adjuvant Procedures to Improve Patency
At times there is insufficient available autogenous tissue with which to construct a bypass graft. The results of
reinforced PTFE to arteries distal to the popliteal have been reported as 45% and 25% at 2 and 5 years, respec-
tively, but are generally lower. Patency rates were reduced if the bypass was a secondary procedure or if the pedal
arch was not intact. Many other surgeons are unable to match these results when performing prosthetic distal
bypass grafts. The following sections review adjuvant procedures to improve patency of the disadvantaged (espe-
cially prosthetic) bypass graft.

Arteriovenous fistula
This procedure has been advocated by some when distal bypass graft is constructed with PTFE. The princi-
ple is to decrease vascular resistance and thereby increase flow in the graft while not creating a hemodynamically
significant steal phenomenon. The two most common types are (1) thecommon ostia, where the artery and vein
are sutured in such a fashion that an arteriovenous fistula is created at the site of the distal anastomosis47 and
(2) a separate remote arteriovenous fistula constructed distal to the artery-prosthesis anastomosis.48 49
There is a lack of good data to support the use of arteriovenous fistula on a routine basis. Anecdotal reports
of graft patency of 71% and limb salvage of 83% have been published.50 In a prospective, randomized study,
Hamsho et al.51 compared graft patency and limb salvage after femoro-infrapopliteal bypass using ePTFE with
and without addition of adjuvant arteriovenous fistula. The differences in cumulative rates of primary patency and
limb salvage at 1 year after operation were not statistically significant (55.2% and 54.1% for patients with arteri-
ovenous fistula compared with 53.4% and 43.2%, respectively, for the control group).50 Follow-up with duplex
scanning suggests that ongoing venous patency is important to the continued function of the graft.52 Arteriove-
nous fistula, if used at all, should be reserved for tibial or peroneal bypasses in those situations with poor run-off
or a disadvantaged graft.

Vein interposition/cuff
Among the adjunct techniques, creating a venous patch or cuff at the distal anastomosis of a prosthetic graft
has been described by a number of authors. Miller53 has described a silo configuration, whereas Taylor inserts
a patch over just the distal toe of the anastomosis. Tyrrell and Wolfe54 have shaped the cuff to improve its con-
figuration (the so-called St Marys boot). In 1995, Raptis and Miller55 reported the results of primary femoropopliteal
PTFE grafting with and without an interposition vein cuff. There was no difference in the patency rates between
cuffed and direct suture for above-knee popliteal bypass grafts (69% and 68% for cuffed and direct suture, respec-
tively, at 36 months).56 There was, however, an appreciable difference for the below-knee bypass grafts (57% vs
29%, respectively, at 36 months).55 These figures were later confirmed by Stonebridge et al.56 in a randomized
trial. The results supported the use of an interposition vein cuff when PTFE grafts were anastomosed to the popliteal
artery below the knee, with 2-year patency rates for cuffed and uncuffed grafts of 52% and 29%, respectively (p
= 0.03). A more recent randomized study from Belgium did not support the initial positive results with the use of
vein interposition cuffs.57 A comparison of a current series with historical controls suggests that venous cuffs
increase patency for prosthetic grafts carried to crural vessels.58 Further studies are needed to establish the role
of adjuvant procedures in femoropopliteal or femoral crural prosthetic bypass grafts (see Critical Issue 35).

CRITICAL ISSUE 35: Adjunctive procedures with prosthetic infrainguinal bypass grafts
There is a need to determine whether an adjuvant procedure (such as arteriovenous fistula or vein
cuff) significantly improves patency when it is necessary to use a prosthetic conduit for a
femoropopliteal or femoral crural bypass.

238
Results of Infrainguinal Bypass Grafts
In large studies, the major determinant of long-term graft patency is the type of graft material used as well as
the continued use of tobacco.27 One review of a personal series of 2,274 bypass grafts reports primary patency
of in situ grafts as: 1 year, 84%; 5 years, 72%; 10 years, 55%; with no difference in patency detected when strat-
ified for inflow artery, outflow artery, and length of bypass59 (see Tab. XLVII and XLVIII). Average results are shown
in Figure 25 on page 250.

Results of Femoropopliteal Bypass Grafts

A meta-analysis performed by Hunink and colleagues10 involved strict entry criteria, which permitted pooling
of data with reanalysis of stratified categories of patients. Papers published between 1983 and 1995 were included
if they were original reports not duplicating previous data, included the numeric data for the Kaplan-Meier analy-
sis, defined patency as hemodynamic improvement, and reported the distribution of covariates. The reanalysis of
2,060 patients surgically treated allowed for the assessment of 1,572 patients with CLI. Overall results of femoral
distal bypass reports for CLI are depicted in Table XLIX, showing a clear advantage for vein bypass grafts.10
A review of reports of the results of infrainguinal revascularization procedures published between 1981 and
1990 was performed by Dalman and Taylor (Table L).79 Although limited information is given about inclusion cri-
teria, analysis techniques, or the raw data, they have confirmed the superiority of autogenous tissue in infrain-
guinal bypass. The previous comments comparing in situ and reversed vein should be considered before accept-
ing the superiority of one over the other (see Choice of Conduit, p. 234).

References
1. Rosenbloom MS, Walsh JJ, Schuler JJ, Meyer JP, Schwarcz TH, Eldrup-Jorgensen J, Durham JR, Flanigan DP. Long-term
results of infragenicular bypasses with autologous vein originating from the distal superficial femoral and popliteal arteries. J
Vasc Surg 1988;7:691-696.
2. Brothers TE, Robinson JG, Elliott BM, Arens C. Is infrapopliteal bypass compromised by distal origin of the proximal anas-
tomosis? Ann Vasc Surg 1995;9:172-178.
3. Shah DM, Darling RC, Chang BB, Bock DE, Leather RP. Durability of short bypasses to infragenicular arteries. Eur J Vasc
Endovasc Surg 1995;10:440-444.
4. Shah DJ, Darling RC, Chang BB, Kaufman JL, Fitzgerald KM, Leather RP. Is long vein bypass from groin to ankle a durable
procedure? An analysis of a ten year experience. J Vasc Surg 1992;15:402-407.
5. Pomposellei FB, Marcaccio EJ, Gibbons GW, Campbell DR, Freeman DV, Burgess AM, Miller A, LoGerfo FW. Dorsalis pedis
arterial bypass: durable limb salvage for foot ischemia in patients with diabetes mellitus. J Vasc Surg 1995;21:375-384.
6. Darke S, Lamont P, Chant A, Barros DSa A, Clyne C, Harris P, et al. Femoro-popliteal versus femoro-distal bypass grafting

TABLE XLIX.Summary of results of a meta-analysis of femoropopliteal bypass grafts (critical limb ischemia only)10.
Conduit Primary patency at 5 years

Vein (any level) 66%

Above-knee PTFE 47%
Below-knee PTFE 33%

TABLE L.Summary: below-knee femoropopliteal grafts79.

Conduit Primary patency at 4 years

Reverse saphenous vein 77%

In situ vein bypass 68%
Human Umbilical Vein 60%
Polytetrafluoroethylene (PTFE) 40%

239
 for limb salvage in patients with an isolated popliteal segment. Eur J Vasc Surg 1989;3(3):203-207.
7. Kram HB, Gupta SK, Veith FJ, Wengerter KR, Panetta TF, Nwosis C. Late results of two hundred seventeen femoropopliteal
bypasses to isolated popliteal artery segments. J Vasc Surg 1991;14:386-390.
8. Barral X, Salari GR, Toursarkissian B, Favre JP, Gournier JP, Reny P. Bypass to perigeniculate collateral vessels. A useful
technique for limb salvage: preliminary report on 22 patients. J Vasc Surg 1998;27:928-935.
9. Veith FJ, Gupta SK, Ascer E, White-Flores S, Samson RH, Scher LA, Towne JB, Bernhard VM, Bonier P, Flinn WR, Astelford
P, Yao JST, Bergan JJ. Six-year prospective multicentre randomized comparison of autologous saphenous vein and expanded
polytetrafluoroethylene grafts in infrainguinal arterial reconstructions. J Vasc Surg 1986;3:104-114.
10. Hunink MG, Wong JB, Donaldson MC, Meyerovitz MF, Harrington DP. Patency results of percutaneous and surgical revas-
cularization for femoropopliteal arterial disease. Med Decis Making 1994;14:71-81.
11. Moody AP, Edwards PR, Harris PL. In situ versus reversed femoropopliteal vein grafts: long term follow-up of a prospective,
randomized trial. Br J Surg 1992;79:750-752.
12. Watelet J, Soury P, Menard JF, Plissonnier D, Peillon C, Lestrat JP, Testart J. Femoropopliteal bypass: in situ or reversed
vein grafts? Ten year results of a randomized prospective study. Ann Vasc Surg 1997;11(5):510-519.
13. Rutherford RB, Sawyer JD, Jones DN. The fate of saphenous vein after partial removal or ligation. J Vasc Surg 1990;12:422-
428.
14. Bergamini TM, Towne JB, Bandyk DF, Seabrook GR, Richardson JD. Durability of the in situ bypass following modification
of abnormal vein segment. J Surg Res 1993;54:196-201.
15. Holzenbein TJ, Pomposelli FB, Miller A, Contreraras MA, Gibbons GW, Campbell DR, et al. Results of a policy with arm veins
used as first alternative to an unavailable ipsilateral greater saphenous vein for infrainguinal bypass. J Vasc Surg 1996;23:130-
140.
16. Andros G. Techniques and strategies using arm vein. Semin Vasc Surg 1995;8:179-187.
17. Londrey GL, Bosher LP, Brown PW, Stoneburner FD, Pancoast JW, Davis RK. Infrainguinal reconstruction with arm vein,
lesser saphenous vein, and remnants of greater saphenous vein: a report of 257 cases. J Vasc Surg 1994;20:451-457.
18. Gentile AT, Lee RW, Moneta GL, Taylor LM, Edwards JM, Porter JM. Results of bypass to the popliteal and tibial arteries with
alternative sources of autogenous vein. J Vasc Surg 1996;23:272-280.
19. Chang BB, Shah DM, Leather RP, Darling RC. Finding autogenous veins for reoperative lower extremity bypass: limitations
of veins other than the greater saphenous. Semin Vasc Surg 1994;7:173-177.
20. Chang BB, Darling RC, Bock DE, Shah DM, Leather RP. The use of spliced vein bypasses for infrainguinal arterial recon-
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21. Sladen JG, Downs AR. Superficial femoral vein. Semin Vasc Surg. 1995;8:209-215
22. Schulman ML, Badhey MR, Yatco R. Superficial femoral-popliteal veins and reversed saphenous veins as primary
femoropopliteal bypass grafts: a randomized comparative study. J Vasc Surg 1987;6:1-10.
23. Clagett GP, Valentine RJ, Hagino RT. Autogenous aortoiliac/femoral reconstruction from superficial femoral-popliteal veins:
feasibility and durability. J Vasc Surg 1997;25:255-270.
24. Abbott WM, Green RM, Matsumoto T, Wheeler JR, Miller N, Veith FJ, Suggs WD, et al. Prosthetic above-knee femoropopliteal
bypass grafting: results of a multicenter randomized prospective trial: Above-Knee Femoropopliteal Study Group. J Vasc
Surg 1997;25:19-28.
25. Pevec WC, Darling RC, LItalien GJ, Abbott WM. Femoropopliteal reconstruction with knitted, nonvelour Dacron versus
expanded polytetrafluoroethylene. J Vasc Surg 1992;16:60-65.
26. Aalders GJ, van Vroonhoven TJ. Polytetrafluoroethylene versus human umbilical vein in above-knee femoropopliteal bypass:
six year results of a randomized clinical trial. J Vasc Surg 1992;16:816-823.
27. Rutherford RB, Jones DN, Bergentz SE, Berqvist D, Comerota AJ, Dardik H, Flinn WH, Fry WJ, McIntyre K, Moore WS. Fac-
tors affecting the patency of infrainguinal bypass. J Vasc Surg 1988;8:236-246.
28. Eickhoff JH, Broome A, Ericsson BF, Buchardt Hansen HJ, Kordt KF, Mouritzen C et al. Four years results of a prospective,
randomized clinical trial comparing polytetrafluoroethylene and modified human umbilical vein for below-knee femoropopiteal
bypass. J Vasc Surg 1987;6(5):506-511.
29. Hasson JE, Newton WD, Waltman AC, Fallon KT, Brewster DC, Darling RC, et al. Mural degeneration in the glutaraldehyde-
tanned umbilical vein graft: incidence and implications. J Vasc Surg 1986;4:243-250.
30. Comparative evaluation of prosthetic, reversed, and in situ vein bypass grafts in distal popliteal and tibial-peroneal revascu-
larization. Veterans Cooperative Study Group. Arch Surg 1988;123:434-438.
31. Belkin M, Conte MS, Donaldson MC, Mannick JA, Whittemore AD. Preferred strategies for secondary infrainguinal bypass:
lessons learned from 300 consecutives reoperations. J Vasc Surg 1995;21:282-293.

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32. Feinberg RL, Winter RP, Wheeler JR, Gregory RT, Snyder SO, Gayle RG, Parent FN, Adcock GD. The use of composite
grafts for femorocrural bypasses performed for limb salvage: a review of 108 consecutive cases and comparison with 57 in
situ saphenous vein bypasses. J Vasc Surg 1990;12:257-263.
33. Londrey GL, Ramsey DE, Hodgson KJ, Barkmeier LD, Sumner DS. Infrapopliteal bypass for severe ischemia: Comparison
of autogenous vein, composite, and prosthetic grafts. J Vasc Surg 1991;13:631-636.
34. Kalman PG, Johnston KW, Walker PM. The current role of isolated profundaplasty. J Cardiovasc Surg 1990;31:107-110.
35. Tovar-Pardo AE, Bernhard VM. Where the profunda femoris artery fits in the spectrum of lower limb revascularization. Semin
Vasc Surg 1995;8:225-235.
36. Boren CH, Towne JB, Bernhard VM, Sallas-Cunha S. Profundapopliteal collateral index: a guide to successful profundaplasty.
Arch Surg 1980;115:1366-1372.
37. Darling RC, Chang BB, Shah DM, Leather RP. Choice of peroneal or dorsalis pedis artery bypass for limb salvage. Semin
Vasc Surg 1997;10:17-22.
38. Raftery KB, Belkin M, Mackey WC, ODonnell TF. Are peroneal artery bypass grafts hemodynamically inferior to other tibial
artery bypass grafts? J Vasc Surg 1994;19:964-969.
39. Bergaminin TM, George SM, Massey HT, Henke PK, Klamer TW, Lambert GE. Pedal or peroneal bypass: which is better
when both are patent? J Vasc Surg 1994;20:347-356.
40. Abou-Zamzam AM, Moneta GL, Lee RW, Nehler MR, Taylor LM, Porter JM. Peroneal bypass is equivalent to inframalleolar
bypass for ischemic pedal gangrene. Arch Surg 1996;131:894-899.
41. Schweiger H, Klein P, Lang W. Tibial bypass grafting for limb salvage with ringed polytetrafluoroethylene prostheses: results
of primary and secondary procedures. J Vasc Surg 1993;18:867-874.
42. Schneider JR, Walsh DB, McDaniel MD, Zwolak RM, Besso SR, Cronenwett JL. Pedal bypass versus tibial bypass with auto-
genous vein: a comparison of outcome and hemodynamic results. J Vasc Surg 1993;17:1029-1038.
43. Ascer E, Veith FJ, White-Flores SA, Morin L, Gupta SK, Lesser ML. Components of outflow resistance and their correlation
with graft patency in lower extremity arterial reconstruction. J Vasc Surg 1984;1:817-828.
44. Schwartz LB, Purut CM, Craig DM, Smith PK, Moawad J, McCann RL. Measurement of vascular input impedance in infrain-
guinal vein grafts. Ann Vasc Surg 1997;11:35-43.
45. Ascer EE, Veith FJ, White-Flores SA, Morin L, Gupta SK, Lesser ML. Intraoperative outflow resistance as a predictor of late
patency of femoropopliteal and infrapopliteal arterial bypasses. J Vasc Surg 1987;5:820-827.
46. Peterkin GA, Manabe S, LaMorte WW, Menzoian JO. Evaluation of a proposed standard reporting system for preoperative
angiograms in infrainguinal bypass procedures: angiographic correlates of measured runoff resistance. J Vasc Surg 1988;7:379-
385.
47. Ibrahim IM, Sussman B, Dardik I, Kahn M, Israel M, Kenny M, et al. Adjunctive arteriovenous fistula with tibial and peroneal
reconstruction for limb salvage. Am J Surg 1980;140:246-251.
48. Dardik H, Berry SM, Dardik A, Wolodiger F, Pecoraro J, Ibrahim IM. Infrapopliteal prosthetic graft patency by use of the dis-
tal adjunctive arteriovenous fistula. J Vasc Surg 1991;13:685-691.
49. Paty PS, Shah DM, Saifi J, Chang BB, Feustel PJ, Kaufman JL. Remote distal arteriovenous fistula to improve infrapopliteal
bypass patency. J Vasc Surg 1990;11:171-178.
50. Jacobs MJ, Gregoric ID, Reul GJ. Prosthetic graft placement and creation of a distal arteriovenous fistula for secondary vas-
cular reconstruction in patients with severe limb ischemia. J Vasc Surg 1992;15:612-618.
51. Hamsho A, Nott D, Harris PL. Prospective, randomised trial of distal arteriovenous fistula as an adjunct to femoro-infrapopliteal
PTFE bypass. Eur J Vasc Endovasc Surg 1999;17(3):197-201.
52. Alexander JB, Spence RK, Camishion RC. Serial duplex scans elucidate the evolving hemodynamics of distal arteriovenous
fistulas. Ann Vasc Surg 1991;5:176-181.
53. Miller JH, Foreman RK, Ferguson L, Faris I. Interposition vein cuff for anastomosis of prosthesis to small artery. Aust NZ J
Surg. 1984;54:283-285.
54. Tyrrell MR, Wolfe JHN. New prosthetic venous collar anastomotic technique: combining the best of other procedures. Br J
Surg 1991;78:1016-1017.
55. Raptis S, Miller JH. Influence of a vein cuff on polytetrafluoroethylene grafts for primary femoropopliteal bypass. Br J Surg
1995;82:487-491.
56. Stonebridge PA, Prescott RJ, Ruckley CV. Randomized trial comparing infrainguinal polytetrafluoroethylene bypass grafting
with and without vein interposition cuff at the distal anastomosis. J Vasc Surg 1997;26:543-550.
57. Nevelsteen A, Laroix H, Suy R. Factors influencing patency of infrainguinal bypasses with polytetrafluoroethylene. Cardio-
vasc Surg abstract V5.6, Paris, Sept 1998.
58. Pappas PJ, Hobson RW, Meyers MG, Jamil Z, Lee BC, Silva MB, et al. Patency of infrainguinal polytetrafluoroethylene bypass
grafts with distal interposition vein cuffs. Cardiovasc Surg 1998;6:19-26.
59. Shah DM, Leather RP, Darling RC, Chang BB, Paty PSK, Lloyd WB. Long term results of using insitu saphenous vein bypass.
Adv Surg 1996;30:123-140.
60. Taylor LM, Edwards JM, Porter JM. Present status of reversed vein bypass grafting: five-year results of modern series. J
Vasc Surg 1990;11:193-206.
61. Hall RG, Coupland GA, Lane R, Delbridge L, Appleberg M. Vein, Gore-Tex or composite graft for femoropoliteal bypass. Surg
Gynecol 1985;161:308-312.
62. Belkin M, Knox J, Donaldson MC, Mannick JA, Whittemore AD. Infrainguinal arterial reconstruction with nonreversed greater
saphenous vein. J Vasc Surg 1996;24:957-962.
63. Alexander JJ, Wells KE, Yuhas JP, Piotrowski JJ. The role of composite sequential bypass in the treatment of multilevel
infrainguinal arterial occlusive disease. Am J Surg 1996;172:118-122.
64. Myers KA, Fuller JA, Scott DF, Devine TJ, Denton MJ, Chan A. Multivariate Cox regression analysis of covariates for patency
rates after femorodistal vein bypass grafting. Ann Vasc Surg 1993;7:262-269.
65. Chalmers RT, Hoballah JJ, Kresowik TF, Sharp WJ, Synn AY, Miller E, Corson JD. The impact of color duplex surveillance
on the outcome of lower limb bypass with segments of arm vein. J Vasc Surg 1994;19:279-288.

241
66. Haward TR, Coe D, Flynn TC, Seeger JM. The use of arm vein conduits during infrageniculate arterial bypass. J Vasc Surg
1992;16:420-427.
67. Harris RW, Andros G, Dulawa LB, Oblath RW, Sallea-Cunha SX, Apyan R. Successful long-term limb salvage using cephalic
vein bypass grafts. Ann Surg 1984;200:785-792.
68.Harris RW, Andros G, Sallea-Cunha SX, Dulawa LB, Oblath RW, Apyan R. Totally autogenous venovenous composite bypass
grafts. Salavage of the almost irretrievable extremity. Arch Surg 1986;121:1128-1132.
69. Taylor LM, Edwards JM, Brant B, Phinney ES, Porter JM. Autogenous reversed vein bypass for lower extremity ischemia in
patients with absent or inadequate greater saphenous vein. Am J Surg 1987;153:505-510.
70. Panayiotopoulos YP, Tyrrell MR, Owen SE, Reidy JF, Taylor PR. Outcome and cost analysis after femorocrural and femorope-
dal grafting for critical limb ischemia. Br J Surg 1997;84:207-212.
71. Davidson JT, Callis JT. Arterial reconstruction of vessels in the foot and ankle. Ann Surg 1993;217:699-710.
72. Quinones-Baldrich WJ, Colburn MD, Ahn SS, Gelabert HA, Moore WS. Very distal bypass for salvage of the severely ischemic
extremity. Am J Surg 1993;166:117-123.
73. Fichelle JM, Marzelle J, Colacchio G, Gigou F, Cormier F, Cormier JM. Infrapopliteal polytetrafluoroethylene and composite
bypass: factors influencing patency. Ann Vasc Surg 1995;9:187-186.
74. McCarthy WJ, Pearce WH, Flinn WR, McGee GS, Wang R, Yao JST. Long-term evaluation of composite sequential bypass
for limb-threatening ischemia. J Vasc Surg 1992;15:761-770.
75. DeMasi RJ, Snyder SO. The current status of prosthetic-vein composite grafts for lower extremity revascularization. Surg Clin
North Am 1995;75:741-752.
76. Donaldson MC, Mannick JA, Whittemore AD. Femoral-distal bypass with in situ greater saphenous vein. long term results
using the Mills valvulotome. Ann Surg 1991;213:457-465.
77. Cranley JJ, Hafner CD. Revascularization of femoropoliteal arteries using saphenous vein, polytetrafluoroethylene, and umbil-
ical vein grafts. Arch Surg 1982;117:1543-1550.
78. Edwards WH, Mulherin JL. The role of graft material in femorotibial bypass grafts. Ann Surg 1980;191:721-726.
79. Dalman RL, Taylor LM. Basic data related to Infrainguinal revascularization procedures. Ann Vasc Surg 1990;4:309-312.

Infrainguinal DiseaseEndovascular Treatment

As with other interventions for CLI, the purpose of PTA is to salvage a functioning foot. Late restenosis or occlu-
sion after PTA may result in recurrent ulceration in some patients,1 but it rarely precludes subsequent surgery or
compromises additional vascular segments. PTA can spare saphenous vein for later use in the ipsilateral limb,
the contralateral limb, or the coronary circulation.
The categorical indications for endovascular treatment, based on clinical symptoms, include patients in the
grade I (severe claudication) grade II (rest pain), and grade III (tissue loss) of the Rutherford classification. For
limb salvage indications, the effectiveness of transluminal angioplasty of the femoropopliteal arteries and the
tibioperoneal arteries should be considered together rather than separately. This is because most patients with
rest pain and tissue loss will have multisegment occlusive disease, and effective treatment of both segments may
be necessary to alleviate signs and symptoms.2 3 Furthermore, effective restoration of tibioperoneal artery blood
flow is believed by some to increase the durability of femoropopliteal artery angioplasty.4 Unfortunately, few series
have analyzed PTA of the femoropopliteal and tibial segments together.5-7 Angioplasty techniques have improved
with time, allowing for technically successful percutaneous recanalization of virtually all short lesions.8-10 However,
appropriate selection of anatomically suitable lesions remains the key to achieving acceptable results in patients
with infrainguinal occlusive disease and chronic limb-threatening ischemia (see Recommendation 34, p. 108).

Factors Affecting the Outcome of Femoropopliteal Angioplasty

Percutaneous transluminal angioplasty has been applied to the superficial femoral and popliteal artery seg-
ments for almost 35 years. Confusion and controversy still exist concerning outcomes, because often the report-
ing of indications and results has not been standardized, and statistical analysis has not been optimal. Varying the
reporting criteria has been shown to result in as much as a twofold difference in reported 5-year patency.11 Many
reported studies suffer from grouping of claudication and limb salvage patients; others from failure to stratify results,
12 and still others from describing early experiences that antedate the latest developments in low-profile balloon

catheters and steerable, soft-tipped guidewires.13 14

242
Claudication versus chronic critical limb ischemia
Despite the grouping of claudication and limb salvage patients in most femoropopliteal PTA series, analysis of
subsets from these studies allows the clinical effectiveness of the method to be estimated in patients with chronic
CLI.

Lesion length
Currently, virtually all short femoropopliteal artery stenoses and occlusions can be percutaneously recanalized.
Still, long lesion length is considered one of the factors detracting from both technical success and durability of
femoropopliteal PTA.15-18 Although recent analyses often include a preponderance of patients with longer lesions,5
18-20 PTA of lesions longer than 7 to 10 cm offers limited potency, 16 18 whereas those 3cm in length or smaller fare

well with PTA.15 21

Stenosis versus occlusion

This variable was previously considered to be one of the most important determinants of both technical suc-
cess and durability of femoropopliteal PTA. Importantly, most symptomatic patients with femoropopliteal disease
presenting for angiography have occlusions rather than stenoses. Technical failures, though uncommon, usually
result from failure to cross the lesion with a guidewire and occur almost exclusively in cases of occlusion. Still,
approximately up to 90% of lesions up to 10 cm in length can be successfully traversed and dilated8 22 and even
a higher percentage success rate with longer lesions has been achieved.18 Nevertheless, relative to stenoses,
there is a difference in technical success that lowers the starting point of the life-table patency curve for occlu-
sions. However, once an occlusion is crossed with a guidewire and successfully dilated, it generally exhibits the
same expected patency as that of a stenosis of equivalent length, if all other factors are equal (ie, the life-table
curves are parallel).15 16 23 24 This means that occlusion is a confounding variable that lowers the initial technical
success but that has no other established impact on long-term patency.

Other target lesion morphological determinants

Concentric lesions respond better than eccentric lesions to PTA initially, and heavy lesion calcification appears
to exert a negative effect on success.15 16 Post-angioplasty residual stenosis predicts limited durability, and whether
duplex ultrasonography is a modality useful for making this determination is controversial.25-27

Runoff status
One of the most powerful predictors of long-term success that has great relevance in patients with chronic CLI
is the status of the runoff circulation. Patients with two- to three-vessel run-off have as much as two to three times
greater femoropoliteal PTA patency than those with 0- to one-vessel run-off at 2 to 3 years (71% to 78% vs 25%
to 37%, respectively)1721 and at 5 years (36% to 53% vs 16% to 31%, respectively).28 A retrospective analysis of
the literature with attention to run-off status indicated 3- and 5-year patency results of 67% and 62%, respectively,
for femoropopliteal stenosis and good run-off; 53% and 48%, respectively, for occlusion and good runoff; 49% and
43%, respectively, for stenosis and poor run-off; and 32% and 27%, respectively, for occlusion and poor run-off.29

Patient factors
Patient factors widely believed to adversely influence femoropopliteal artery PTA success are the presence of
diabetes mellitus and presentation for PTA with CLI rather than claudication.1921 28 30 However, it is likely that the
effects of diabetes and CLI are statistically confounded by run-off status and the extent of occlusive disease. Dia-
betic patients with good run-off fare better than those with poor run-off after femoropopliteal PTA.31 Diabetic patients
in whom continuous run-off can be restored by tibioperoneal PTA also fare well.32 It is also likely that patients with
end-stage renal disease fare worse than the angioplasty population as a whole, because of a combination of vas-

243
cular anatomic factors and local metabolic factors; these patients have been inadequately stratified in the PTA lit-
erature and may constitute up to 8% to 10% of the limb salvage population in some institutions.3

Summary of factors affecting the outcome of femoropopliteal angioplasty

Thus, although some have attempted to place a single value or range of values on the results of femoropopliteal
PTA, its efficacy is highly dependent on anatomic selection and, to a lesser extent, patient selection. For patients
with CLI, it is likely that only a minorityperhaps 5% to 35%are candidates for PTA if selected for favorable
anatomy.2 10 33-35 PTA of proximal popliteocrural obstructions to improve flow to collateral vessels in the absence
of straight-line flow to the foot will not help patients.32 Laser-assisted angioplasty and rotablator atherectomy of
crural arteries does not improve the technical and clinical results as compared with PTA alone.28 36-43 There is no
body of published data on the use of laser-assisted PTA and rotoblator atherectomy in infrapopliteal lesions.

Femoropopliteal Angioplasty Results

The results of several large studies are summarized in Table XXI, Endovascular Procedures for Intermittent
Claudication (p. 109) (see Femoropopliteal PTA, p. 107; Femoropopliteal Stents, p. 111). They are presented
in the intermittent claudication section because this indication dominates the data (72% of subjects in the studies
cited were patients with intermittent claudication). These listed results must be viewed with caution, because infrain-
guinal angioplasty depends heavily on patient selection factors. Nevertheless, by analyzing subsets of patients
described in these studies and others, one can estimate the clinical effectiveness of infrainguinal PTA performed
in patients with chronic CLI.
Table XXII (p. 111) shows the results from selected studies by lesion length cut-off point. Again these results
are presented in the intermittent claudication section because this indication dominates the data. Jeans et al.21
found that stenoses smaller than 1 cm fared significantly better than lesions larger than 1 cm at 5 years (pri-
mary patency, 76% vs. 50%, p < 0.05).21 Durability of femoropopliteal PTA in a subgroup of 37 patients with
stenoses and two- to three-vessel run-off was 78% at 3 years (SE9.4%); by contrast, occlusions with poor
runoff showed a 25% patency rate. Krepel et al.15 stratified results on durability and found that stenoses smaller
than 2 cm fared better at 5 years than stenoses longer than 2 cm (primary patency, 77% vs. 54%), whereas
1-year patency rates with occlusions smaller than 3 cm was 93%, versus only 50% in occlusions larger than
3 cm15 Gallino et al.17 found that patients with occlusions larger than 3 cm and poor distal run-off had elevated
reocclusion rates compared with those who had focal stenoses or occlusions smaller than 3 cm and two- to
three-vessel runoff (primary patency, 37% vs 71% at 2 years).17 Currie et al.44 defined lesions with a 5-cm cut-
off; at 6 months, 10 of 17 short occlusions or stenoses were patent (59%), whereas only 1 of 23 long lesions
were patent (4%). Unfortunately, there was a 22% technical failure rate in this series, and the authors did not
assess the effect of run-off on patency.44
In comparing 0- to 2-cm and 2- to 5-cm lesions with those larger than 10 cm, Capek et al.16 found highly sig-
nificant differences in success (p=0.007, p=0.015). There were also strong statistical trends when 0- to 2-cm lesions
were compared with 2- to 5-cm and 5- to 10-cm lesions (p=0.10, p=0.06). Capek et al. were unable to utilize Cox
multivariate regression because of sample size so they were unable to simultaneously analyze any run-off effect
on these stratified groups.16 Murray et al, dividing his patients at 7 cm, found that only 23% of long femoropopliteal
artery PTA were patent at 6 months.18 Because power estimates were not given, it is likely that some nonsignifi-
cant differences were due to small sample size.

Adjunctive use of stents in femoropopliteal lesions

The preponderance of patients in published series of femoropopliteal stents have been patients with intermit-
tent claudication, and although technical success is high, restenosis rates are considerable. Reported mean steno-
sis rates are 30% at 1 year (range, 19% to 53%) and 40% at 3 years (range, 28% to 82%) (see Table 23, p. 111;
Table 24, p. 113). This series does not stratify durability by clinical indication. Restenosis rates appear to be higher

244
in distal femoropopliteal segments or when lesions require multiple stents.45 46 Poor outflow and long occlusions
appear to increase the frequency of stent thrombosis.47 48
Because limb salvage indications are associated with poor run-off and more diffuse disease, femoropopliteal stents
probably do worse in CLI patients than in intermittent claudication, and they would be expected to fare worse than
the aggregate published stent population. However, there is accumulating evidence that stents can play an impor-
tant role in rescuing failed femoropopliteal PTA attributable to PTA-induced dissection, elastic recoil, or thrombosis.
49-51 There is little published evidence regarding the efficacy of tibial artery stents.

(Repeated from p. 108)

RECOMMENDATION 35: Treatment of choice for TASC type A and D femoropopliteal lesions
Endovascular procedure is the treatment of choice for type A lesions, and surgery is the procedure of choice
for type D lesions.

Infrapopliteal Angioplasty
Clinical class
The universally accepted indication for infrapopliteal artery PTA is limb salvage. Some reported series have
comprised a significant proportion of claudicators.4 52 64 Infrapopliteal PTA can be used to salvage failing distal
bypass grafts by restoring tibial artery outflow.63 A number of published reports have shown increased durability
of femoropopliteal PTA in patients with good distal run-off; thus, some authors have recommended tibial angio-
plasty as an adjunct to femoropopliteal PTA performed for either claudication or limb salvage when calf run-off is
poor.4

Diabetes and end-stage renal disease

Diabetes is present in 63% to 91% of patients undergoing tibial angioplasty for limb salvage indications. Although
most of these patients present with three-vessel calf occlusive disease, there is usually reconstitution of at least
one pedal artery. Patients with end-stage renal disease (who are often diabetic) appear to be the most difficult
group to treat because they have very diffuse disease with more involvement of the distal and pedal vessels, and
because there is heavier arterial calcification. The presence of end-stage renal disease (ESRD) probably has a
negative prognostic effect on the durability of tibial and femoropopliteal PTA, but it has not been accounted for in
published angioplasty series.3 53

Cardiovascular comorbidity
The median age of patients undergoing tibial angioplasty in published series is approximately 69 years. These
high-risk patients almost always have associated cardiac or cerebrovascular disease: hypertension, chronic renal
insufficiency, and history of TIA or stroke are common.32 Five-year survival in patients with limb salvage indica-
tions for surgical or percutaneous intervention is only approximately 50%; mortality is usually attributable to coro-
nary artery disease or stroke.2 The procedure-related mortality is lower with PTA than with bypass surgery. More
than 1,200 patients are reported in the literature.52

Lesion length and run-off status

The ideal tibial lesion is focal, with good run-off distally. Stenoses appear to have a better technical success
rate than occlusions. Only approximately 20% to 30% of patients with tibial disease have anatomy favorable for
PTA.3 10 Severe three-vessel disease is nearly universal in limb salvage patients; anatomy favorable for tibial PTA,

245
TABLE LI.Results of PTA in infrapopliteal lesions (from a review by Wagner & Rager 55).

CLI Diabetes Technical % Limb salvage

Author Limbs (%) (%) success (%) (follow-up period)

Schwarten & Cutcliff, 198810 114 100 60 97 86 (24 mo)

Lfberg et al., 199656 86 100 74 88 75 (24 mo)
Matsi et al., 19935 84 100 77 83 52 (24 mo)
Hauser et al., 199657 47 100 93 80 77 (24 mo)
Saab et al., 199258 14 100 69 100 79 (19 mo)
Buckenham et al., 199359 14 100 38 100 85 (8 mo)
Durham et al., 199460 14 100 100 100 77 (17 mo)
Brown et al., 198861 11 100= 91 82 73 (8 mo)
Bakal et al., 199032 57 98 85 78 NA
Wagner & Klose, 199762 87 93 64 92 71 (12 mo)
Brown et al., 199363 55 84 64 95 53 (24 mo)
Bull et al., 199264 168 76 52 100 85 (24 mo)
Bolia et al., 199465 24 71 43 86* NA
Wagner et al., 19937 158 68 46 95 88 (17 mo)
Starck et al., 198437 46 67 NA 76 NA
Dorros et al., 199066 151 53 46 90 NA
Sivanathan et al., 19946 41 53 13 96 NA
Varty et al., 199552 40 50 45 98 77 (12 mo)
Horvath et al., 19904 71 42 35 96 NA

*Subintimal angioplasty.

if present, is usually seen in one or two vessels. A concomitant procedure, usually femoropopliteal artery PTA, is
necessary in most patients undergoing tibial angioplasty because of the predominance of multilevel occlusive dis-
ease; thus, the results of femoropopliteal PTA and tibial PTA are closely associated. Restoration of straight-line
flow to the pedal arch by PTA in one or more tibial arteries is necessary for clinical success; dilatation of a proxi-
mal lesion when the distal artery is severely diseased will not yield lasting clinical benefit in limb salvage patients.32
63 64 This finding has since been corroborated by others. Crural disease in patients with long-standing diabetes

may, in rare cases, be the sole determinant of CLI, despite the absence of aortoiliac or femoropopliteal disease.
A small subset of these patients may be suitable for PTA. It is probable that the status of the pedal archnever
looked at in infrainguinal angioplasty studiesalso affects the outcome of distal angioplasty. Careful patient selec-
tion is thus important for both technical and clinical success.

Results of endovascular treatment of infrapopliteal lesions

Recent published technical success rates of infrapopliteal artery PTA using small vessel balloons have been
excellent, between 86% and 100%. Major complications have been reported in 2% to 6% of cases, most fre-
quently puncture site hematomas and vessel occlusions. Iatrogenic vascular occlusion usually responds to local
thrombolysis. Limb salvage has been reported to be between 60% and 86% at 2 years and appears to be depen-
dent on anatomic factors. For example, Bakal et al.32 found an 80% limb salvage rate in patients with straight
line flow to the foot in at least one tibial vessel after PTA, whereas limb salvage fell to 0% when distal outflow
was obstructed.32 In a later group of patients at the same institution, infrainguinal PTA performed for long-seg-
ment, more diffuse disease in patients with poor surgical options had a 1-year primary patency as low as 15%,
confirming the need for careful anatomic selection. Appropriate post-PTA surveillance with secondary inter-
vention appears to significantly prolong the patency of tibial PTA.52
In recent years, several reports with sufficient long-term follow-up of PTA in infrapopliteal lesions have appeared
in the literature (Table LI). Only technical success and limb salvage figures are given, because patency of one of
three crural vessels is impossible to determine by ABPI or other indirect measurements, especially because prox-
imal revascularization procedures may have been done concomitantly.

246
Summary
Substantial experience demonstrating the effectiveness and safety of infrainguinal angioplasty has been accu-
mulated. Although differences in reporting make it difficult to easily estimate the true effectiveness of infrainguinal
PTA, a consensus about its effectiveness can be obtained by critical analysis of the existing reports. Technical
success rates now approach 95% to 100%. Anatomic selection is most important. Patients with focal disease and
restorable runoff will generally benefit; conversely, patients with diffuse disease and poor run-off will not. Unfortu-
nately, because of the presence of diffuse disease in chronic CLI, endovascular techniques are only applicable in
a small portion of CLI patients. For femoropopliteal PTA, 50% to 77% of anatomically selected patients will show
clinical benefit at 2 years. Tibial PTA has generally been reserved for limb salvage patients, and with appropriate
patient selection, 2-year limb salvage rates of approximately 80% can be expected. Close surveillance and early
reintervention will probably increase the effectiveness of percutaneous treatment methods.

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angioplasty in diabetic patients. Radiology 1990;174:977-982.
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35. Veith FJ, Gupta SK, Wengerter KZ, Rivers SP, Bakal CW. Impact of nonoperative therapy on clinical management of periph-
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36. Pilger E, Lammer J, Bertuch H, Stark G, Decrinus M, Pfeiffer KP, et al. Nd:YAG laser with sapphire tip combined with bal-
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37. Starck EE, McDermott J, Crummy AB, et al. Angioplasty of the popliteal and tibial arteries. Semin Intervent Radiol 1984;4:269-
277.
38. Tamura S, Sniderman KW, Beinart C, Sos TA. Percutaneous transluminal angioplasty of the popliteal arteries and its branches.
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39. Lammer J, Pilger E, Decrinis M, Quehenberger F, Klein GE, Star KG. Pulsed excimer laser versus continuous wave Nd:YAG
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40. Okadome K, Muto Y, Ito H, Funahashi S, Komoni K, Sugimachi K. Operative transluminal laser angioplasty as the sole treat-
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41. Peripheral atherectomy with the rotablator: a multicenter report. The Combined Rotablator Atherectomy Group (CRAG). J
Vasc Surg 1994;19:509-515.
42. Gordon IL, Conroy RM, Tobis JM, Kohl C, Wilson SE. Determinants of patency after percutaneous angioplasty and atherec-
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43. Kim D, Gianturco LE, Porter DH, Orron DE, Kuntz RE Kent KC, et al. Peripheral directional atherectomy: 4-year experience.
Radiology 1992 Jun;183(3):773-778.
44. Currie JC, Wakely CJ, Cole SE, Wyatt MG, Scott DJ, Baird RN, et al. Femoropopliteal angioplasty for severe limb ischemia.
Br J Surg 1994;81:191-193.
45. Strecker EP, Hagen B, Liermann D, Schneider B, Wolf HR, Wambsganss J. Iliac and femoropoliteal occlusive disease treated
with flexible tantalum stents. CVIR 1993;16:158-164.
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50. White GH, Liew SC, Waugh RC, Stephens MS, Harris JP, Kidd J, et al. Early outcome and intermediate follow-up of vascu-
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ment with intravacular stents. Radiology 1989; 72:725-730.
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ful procedure. Eur J Vasc Endovasc Surg 1995;9:341-345.
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1998;168(5):415-420.
56. Lfberg AM, Lrelius LE, Karacagil S, Westman B, Almgren B, Bergquist D. The use of below-knee percutaneous translu-
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322.
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crural arterial stenoses in critical arterial occlusive disease. Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 1996;164:238-
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58. Saab MH, Smith DC, Aka PK, Brownlee RK, Killeen JD. Percutaneous transluminal angioplasty of tibial arteries for limb sal-
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60. Durham JR, Horowitz JD, Wright JG, Smead WL. Percutaneous transluminal angioplasty of tibial arteries for limb salvage in
the high-risk diabetit patient. Ann Vasc Surg 1994;8:48-53.

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64. Bull PG, Mendel H, Hold M, Schlegl A, Denck H. Distal popliteal and tibioperoneal transluminal angioplasty: long-term fol-
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Cardiovasc Diagn 1990;19:170-178.

Infrainguinal DiseasePreferred Therapeutic Options

Hunink et al.1 2 performed key decision and cost-effectiveness studies on femoropopliteal disease, by using
a range of values found in the literature and performing multiway sensitivity analyses. In their 1995 study, data
were included from 26 selected studies published after 1985, involving 4,800 PTA procedures and 4,511 surgi-
cal bypasses. Quality-adjusted life-years (QALY) were used as the main effectiveness measure. The pooled 5-
year PTA patency results were calculated for subgroups by lesion type (stenosis vs occlusion) and indication
(disabling claudication vs chronic critical limb ischemia); surgical bypass subgroups were based on indication,
conduit type, and distal anastomosis site (AK/BK).1 Notably, the potential covariates of lesion length and calf
runoff were not analyzed, in part because of the inadequate data descriptors provided in the original reports.
(The authors noted that because there was a statistically significant association between poor runoff and CLI in
an earlier paper,2 either model could be used.) Stenting or other adjunctive techniques were not considered. This
group concluded that for femoropopliteal stenosis and CLI, PTA should be the first treatment modality, but for
femoropopliteal occlusions and CLI, surgical bypass is preferable.
Pertinent to the recommendation to attempt PTA first in anatomically favorable lesions, Wilson et al.3 found
that for 100 femoropopliteal artery lesions, a failed PTA did not place the patient at higher risk for limb loss or sur-
gical failure. The mortality rate was 2.4% in the surgical group and 0% in the PTA group. However, the predomi-
nant presenting symptom in this study was intermittent claudication, and the results were not stratified by pre-
senting indication. Furthermore, this study has been criticized because of its high degree of selectivity, high initial
PTA technical failure rate, and the use of prosthetic conduit in many patients. Nevertheless, it did suggest that
PTA and surgery do have comparable results for a minority subset selected for anatomic criteria suitable for PTA.
The same general considerations apply as were discussed in the overall strategy of the treatment of aortoiliac
lesions, and the same system will be used for making recommendations. The following recommendations apply
to the choice between endovascular and open surgical intervention for CLI. They basically identify categorical lev-
els of increasing lesion severity in which the choice of intervention shifts progressively from endovascular to open
surgical intervention.

249
 Fig. 25.Average results for surgical treatment.

(Repeated from p. 108)

RECOMMENDATION 34: Morphological stratification of femoropopliteal lesions

TASC Type A iliac lesions:
Single stenosis <3 cm of the CIA or EIA (unilateral/bilateral)
TASC Type B iliac lesions:
Single stenosis 310 cm in length, not involving the distal popliteal artery*
Heavily calcified stenoses up to 3 cm in length
Multiple lesions, each less than 3 cm (stenoses or occlusions)
Single or multiple lesions in the absence of continuous tibial runoff to improve inflow for distal surgical
bypass
TASC Type C femoropopliteal lesions:
Single stenosis or occlusion longer than 5 cm*
Multiple stenoses or occlusions, each 3-5 cm, with or without heavy calcification
TASC Type D femoropopliteal lesions:
Complete common femoral artery or superficial femoral artery occlusions or complete popliteal and proximal tri-
furcation occlusions.
*CIRSE agrees except for the following changes:
Type B femoropopliteal lesions:
2. Single stenoses occlusions 3-10 cm long, not involving the distal popliteal artery
Type C femoropopliteal lesions:
6. Single stenoses or occlusion >10 cm long
Reason for dissenting opinion: The lower long-term clinical success rate of long stenoses and occlusions in earlier
studies was due to a low technical success rate. However, developments of catheters and wires have improved
the technical success rate, to be followed by higher patency rates.35 36 Studies comparing PTA with bypass
surgery in femoropopliteal lesions 4-10 cm long do not exist.

250
 (Repeated from p. 108)

RECOMMENDATION 35: Treatment of choice for TASC type A and D femoropopliteal lesions
Endovascular procedure is the treatment of choice for type A lesions, and surgery is the procedure of choice
for type D lesions.

(Repeated from p. 112)

RECOMMENDATION 36: Femoropopliteal stenting in PAD

Femoropopliteal stenting as a primary approach to the interventional treatment of intermittent claudication or
CLI is not indicated. However, stents may have a limited role in salvage of acute PTA failures or complica-
tions.

(Repeated from p. 102)

CRITICAL ISSUE 10: Treatment of TASC type B and C lesions

More evidence is needed to make any firm recommendations about the best treatment for types B and C
lesions.*

*CIRSE dissenting opinion:

Currently endovascular treatment is more commonly used for type B and C lesions, but more evidence is
needed to make any firm recommendations about best treatment.
Reason for dissenting opinion: Due to technical developments, type C lesions of iliac and femoral arteries can
be treated by endovascular means with a reasonable technical success rate (for references, see p. 101). There-
fore, CIRSE believes that in clinical practice these lesions are more commonly treated by endovascular tech-
niques, although scientific evidence of any superiority over vascular surgery is lacking.

RECOMMENDATION 93: Morphological stratification of infrapopliteal lesions

TASC Type A infrapopliteal lesions:

1. Single stenoses shorter than 1 cm in the tibial or peroneal vessels.
TASC Type B infrapopliteal lesions:
2. Multiple focal stenoses of the tibial or peroneal vessel, each less than 1 cm in length.
3. One or two focal stenoses, each less than 1 cm long, at the tibial trifurcation.
4. Short tibial or peroneal stenosis in conjunction with femoropopliteal PTA.
TASC Type C infrapopliteal lesions:
5. Stenoses 1-4 cm in length.
6. Occlusions 1-2 cm in length of the tibial or peroneal vessels.
7. Extensive stenoses of the tibial trifurcation.
TASC Type D infrapopliteal lesions:
8. Tibial or peroneal occlusions longer than 2 cm.
9. Diffusely diseased tibial or peroneal vessels.

251
 The choice of intervention, between open surgery and an endovascular procedure, can be difficult, often weigh-
ing risks to life and limb against each other in an attempt to save both. There are risks to limb and life involved in
any attempted revascularization procedure, particularly in some difficult surgical bypasses, but patients with CLI
have complex lesions not suitable for endovascular treatment, and amputation has the same risk. Accurately pre-
dicting the result of a particular revascularization in an individual is difficult based on available literature. The
assessment of chances of success in an individual case would be better based on the audited results obtained in
the relevant institution rather than published results from other centers (see p. 276). It is important to develop
guidelines regarding the likelihood of success below which a reconstruction should not attempted.

References
1. Hunink MG, Wong JB, Donaldson MC, Meyerovitz MF, de Vries J, Harrington DP. Revascularization for femoropopliteal dis-
ease: a decision and cost-effectiveness analysis. JAMA 1995;274:165-171.
2. Hunink MG, Wong JB, Donaldson MC, Meyerovitz MF, Harrington DP. Patency results of percutaneous and surgical revas-
cularizations for femoropopliteal arterial disease. Med Decis Making 1994;14:71-81.
3. Wilson SE, Wolf GL, Cross AP. Percutaneous transluminal angioplasty vs. operation for peripheral arteriosclerosis: report of
a prospective randomized trial in a selected group of patients. J Vasc Surg 1989;9:1-9.

General Issues Relating to Surgical TreatmentAnesthesia

Either general or regional anesthesia may be used for lower-extremity bypass grafts. Some centers advocate
the use of a combination of both techniques for aortic surgery for optimal patient comfort and minimal respiratory
depression. There have been reports of increased distal graft patency when epidural/spinal anesthesia are used.
However, the results of a recent randomized control trial failed to show any effect of the type of anesthesia on the
30-day patency rate of infrainguinal bypass grafts.1
The choice and conduct of the anesthetic technique is more important in the transabdominal aortoiliac recon-
structions. All inhalation anesthetics are myocardial depressants; intravenous narcotic analgesics such as fentanyl
are often used as an alternative to inhalation anesthetics because they produce minimal myocardial depression.
However, large doses of narcotics may be necessary to avoid hypertension during intraabdominal procedures,
and as a consequence may produce ventilatory depression. Spinal or epidural anesthesia has no direct effect on
the myocardium but may increase myocardial oxygen consumption because they may be associated with hyper-
tension and bradycardia resulting from sympathetic blockade. Prospective studies that have compared general
and epidural anesthesia have found no advantage to either technique in reducing perioperative cardiac complica-
tions in patients undergoing aortic surgery or infrainguinal procedures.2 3 Systemic anticoagulation is not a con-
traindication for epidural anesthesia if begun after catheter placement, although it is uncertain how long a delay
is necessary after catheter placement before anticoagulation can be instituted.4

Antibiotic Prophylaxis for Vascular Procedures

It is generally believed that graft contamination occurs most commonly at the time of the original operation.
This emphasizes the importance of a meticulous sterile technique with avoidance of skin contact by the use of
adherent plastic drapes. Several randomized studies have now demonstrated the efficacy of antibiotic prophylaxis
in reducing the incidence of vascular graft infection, and its perioperative use is now well accepted.5 6 There is
evidence that antibiotic prophylaxis should continue until drains and invasive monitoring lines are removed.6 7 The
same principles of sterile techniques must apply to endovascular procedures with stent implantation, evidence
that the same principles should apply to stents. Covered stents should be treated as prosthetic grafts in terms of
use of prophylactic antibiotics. However, the need for and effectiveness of antibiotic prophylaxis with other endovas-
cular techniques is unknown.8-11

252
 RECOMMENDATION 94: Use of prophylactic antibiotics with prosthetic grafts
Patients undergoing prosthetic grafts should have prophylactic antibiotic therapy perioperatively.

CRITICAL ISSUE 36: Duration of prophylactic antibiotics with prosthetic grafts

There is a need for more data to determine how long antibiotic prophylaxis is required when prosthetic
grafts are implanted.

Perioperative Care of the Diabetic Patient

Ideally, blood sugar should be normalized in the diabetic patient before surgical intervention. This may involve
the switch from oral agents to insulin in some patients. The control of sepsis in the diabetic foot may help control
hyperglycemia and ketoacidosis. Particular attention to the renal function is needed in patients with diabetes,
because investigations such as angiography may lead to deterioration. The rationale for striving to achieve near-
normal glucose has been established, but other factors must be considered in patients with diabetes who must
undergo surgery with less than optimal control of metabolism in an acute situation. Such patients can be hemo-
dynamically unstable during anesthesia because of dehydration and osmotic shifts. Furthermore, such patients
are more prone to infection, have decreased wound healing, and may have increased free fatty acids, the metab-
olism of which increases myocardial oxygen consumption.12 13

Treatment of the Failing Graft

The concept of the failing graft has been emphasized by several series documenting improved results when
intervention is directed at the time when the graft is still patent, that is, failing rather than failed. Graft surveillance
is necessary to detect a failing graft at this preocclusive stage. The details are dealt with in Surveillance after
Revascularization (see p. 269). Grafts may fail on the basis of intrinsic graft pathology or pathology in the inflow
or outflow segments. Inflow and outflow lesions should be managed according to the principles outlined elsewhere
in this document. Graft stenoses can be managed by either interposition or jump graft segmental bypass or patch
angioplasty, depending on the length of the lesion. Debate continues, but current opinion favors segmental bypass
or patch angioplasty rather than percutaneous balloon angioplasty for most lesions.

Treatment of Graft Thrombosis: The Failed Graft

The choice between thrombolysis and thrombectomy for graft occlusion is complicated by the fact that these
tend to be linked with PTA and surgical revascularization, respectively, in trials. As a result of this and also of a
significant technical failure rate, four major trials have failed to show an overall advantage for thrombolysis on an
intent-to-treat basis.14-17 However, its obvious potential advantages (stated previously) and the relative ease of the
procedure probably can be achieved only by selective application. Although urgent thrombectomy may be required
for immediate limb threat, and surgical reconstruction is preferred in delayed occlusions (>14 days duration),
thrombolysis holds the advantages in terms of mortality and amputation for less than 14 days occlusion.14 17 This
complex subject is dealt with in more detail in Contraindications to Thrombolysis (see p. 162).
Open surgical procedures have been the traditional approach for bypass graft occlusion, directing procedures at
thrombectomy, and revision or replacement of the existing graft, with the latter giving best results.18-20 Thrombolysis
has been advocated as a less invasive, alternative means of restoring graft function that also provides the oppor-
tunity to unmask stenotic lesions responsible for the occlusive event and to clear the run-off vessels.21 22 The
unmasked lesion is then addressed with an endovascular or operative approach after successful thrombolysis,
the choice depending on the characteristics of the lesion (eg, neointimal hyperplasia or diffuse or local athero-
sclerotic involvement). The most appropriate treatment for a valve cusp stenosis is operative patching or resec-

253
tion and reconstruction. The results for open repair are believed to be superior to dilatation and yield excellent
secondary patency rates.23 If the distal anastomosis is involved or should there be progression of disease, there
may be a need to extend the bypass graft. Whatever method is used, good success rates have been achieved
with the use of alternative vein sources.23 If an established bypass graft fails less than 6 months after construc-
tion, then graft replacement of this disadvantaged conduit is indicated.24

RECOMMENDATION 95: Treatment of chronic critical leg ischemia due to bypass graft occlusion
In patients with chronic critical leg ischemia, surgical revision or graft replacement is the preferred
treatment for bypass graft occlusion. Thrombolysis may be considered as a treatment option in patients
who present early after their bypass graft occlusion where the limb is not immediately threatened.

The treatment strategy for bypass graft occlusion must be tailored to the clinical setting and the risks and ben-
efits associated with the therapeutic options. In addition to the characteristics of the underlying lesion, the para-
meters that are important in determining appropriate therapy include the severity of the patients symptoms, the
duration of the occlusion, and the nature of occluded conduit (autogenous or prosthetic). For instance, in patients
with occluded lower-limb grafts who present with sudden-onset claudication, the clinician will need to consider the
original indications for the graft and possible future surgical options if no attempt is made to rescue the graft.

General Complications of Surgical Intervention

Cardiac mortality and morbidity
The most common source of morbidity and mortality after revascularization for PAD is myocardial ischemia.
Although operative mortality is decreasing steadily, long-term survival of these patients continues to be compro-
mised.
The cumulative long-term survival is 40% to 50% at 10 years. Patients with CLI, extensive arterial disease, or
diabetes have a less favorable long-term prognosis than patients with localized disease and claudication. Most late
deaths are also attributed to atherosclerotic heart disease.25 (see Fate of Patients With CLI, p. 23). Other specific
complications are outlined in the following paragraphs.

Deep vein thrombosis

A randomized prospective trial of deep venous thrombosis (DVT) prophylaxis in aortic surgery failed to show
any increased incidence after aortic surgery in the control group compared with the prophylaxis group.26 A second
study reported a DVT incidence of 9.8% in patients undergoing either aortic or distal revascularization (with the
highest incidence following amputation).27 All patients in this study had received DVT prophylaxis.
Therefore, although pharmacotherapy to avoid arterial thrombosis after revascularization also frequently reduces
the risk of DVT, this risk cannot be neglected entirely.

Complications of Aortoiliac Reconstruction

Currently, excellent early and late results of direct aortoiliofemoral reconstructions for occlusive disease can
be anticipated. Perioperative mortality rates are well under 3% in many centers, and patency rates of close to 85%
at 5 years and 75% at 10 years are expected.28 29 Though somewhat dated, a list of complications of aortoiliac
reconstruction other than graft failure are summarized in Table LII.

Acute complications; limb ischemia

Acute limb ischemia occurring shortly after aortic operation for occlusive disease is generally attributable to
acute thrombosis of the graft or one of its limbs and occurs in 1% to 3% of patients. The main causes are twist-

254
TABLE LII.Complication of aorto-iliac bypass grafts.
Complication Incidence (%) Etiology/Comments

Myocardial Infarction30 31 0.85.2 Concurrent cardiac disease

Death32-38 03.3 Usually myocardial
Intestinal ischemia39 1.1 Ligation IMAcolonic
Preexisting SMA disease
Renal failure40-43 0 4.6 Preexisting renal dysfunction increases risk
Ureteral injury44 1.6 Frequent association with graft complication
Spinal cord ischemia,45 46 0.25 Atheroemboli, occlusion vascular supply
Graft infection41 47 48 0.11.3 Higher incidence involving groin anastomosis
Aortoenteric fistula 47 48 0.10.5 Erosion, lack of reperitonealization,
aortic false aneurysms
Lymph fistula49 1.53.5 Division of lymphatics
False aneurysm47 48 50-52 35 Infection, native artery degeneration
Altered sexual function53 20

ing, kinking of the graft limb, or technical problems at the distal femoral anastomosis site. Acute limb ischemia
also can occur as a result of intraoperative thromboembolic events, all related to technique and all preventable.

Intestinal ischemia
Intestinal ischemia is more likely after aortic surgery for aneurysmal disease than after that for PAD but may
occur after the latter. A large or meandering inferior mesenteric artery (IMA) with upward flow warns of concomi-
tant celiac or superior mesenteric artery (SMA) disease deserving attention and mandates IMA preservation. Oth-
erwise, preservation of hypogastric internal iliac artery outflow is the key to avoiding intestinal ischemia, impo-
tence, or paraplegia (see next paragraph).39 As discussed earlier, this may dictate the choice between proximal
end-to-side and end-to-end anastomosis.

Erectile impotence
The incidence of iatrogenic erectile impotence after aortic reconstruction may approach 25%. Most often, impo-
tence implies inadequate preservation of the hypogastric artery and pelvic circulation. Retrograde ejaculation is
also a frequent occurrence and is attributable to disturbance of autonomic nerve fibers that course along the left
wall of the aorta and cross the common iliac arteries. As described by De Palma et al.,54 a nerve-sparing approach
to the infrarenal aorta is helpful, and preservation of the hypogastric artery flow by a variety of techniques is also
essential.

Anastomotic false aneurysms

The incidence of anastomotic false aneurysm formation after aortoiliac reconstruction varies from 1% to 5%
and is by far most common at the femoral anastomosis.55 Previously these were related to the use of silk sutures
and, rarely, prosthetic suture material may fracture. Degenerative changes within the host arterial wall leading
to weakness and dehiscence of the intact suture line appear to be the most common cause. Infection may be
a contributing cause and always needs to be considered as a possible causative factor.56
The true incidence of proximal aortic anastomotic aneurysm may be higher than previously thought after aor-
tic surgery for PAD; a study by Edwards et al.57 reported a 10% incidence, of mostly asymptomatic anastomotic
aneurysms, at a mean interval of 12 years after initial revascularization. These anastomotic aortic aneurysms are
more common after lateral anastomosis than after end-to-end anastomosis. This suggests that CT scans should
be a routine part of the late follow-up of patients with an aortic graft, that is, beginning at 3 years postintervention.

255
Aortoiliac, aortofemoral graft infection
The incidence of graft infection is between 1% and 5% after aortic surgery. It may be difficult to prove unequiv-
ocally that a graft is infected. Despite this, all efforts should be made to determine whether a perigraft collection
is present, whether graft infection is likely, and which infecting organisms are involved. Once this has been deter-
mined, the likelihood of infection must be balanced against the general condition of the patient, the extent of revi-
sion surgery, and the necessity for immediate intervention.
The organisms most commonly isolated from blood or from wounds are Pseudomonas, Staphylococcus, and
streptococcus species. Computed tomography scanning and magnetic resonance imaging are very helpful in
demonstrating fluid collections around a suspect aortic graft. Labeled white cell scans also can be useful if per-
formed more than 4 weeks after surgery. Treatment of aortic graft infection is challenging. Graft conservation with
local debridement of infected tissue followed by local irrigation with antibiotics has been advocated by some
authors.58
However, many authors believe that most graft infections involve the whole length of the prosthesis, even though
presentation or imaging may suggest a local sepsis. Graft excision has been recommended by most authors. This
decision should be made carefully, and, whenever possible, the patients condition needs to be optimized before
surgery.59 After excision, extensive retroperitoneal debridement must be done. A number of recent reports have
advocated direct in situ replacement with a rifampin-soaked Dacron or PTFE graft. However, these selected excep-
tions to the generally accepted policy of complete graft excision and extraanatomic bypass primarily involve late
indolent infections with Staphylococcus epidermidis with little associated systemic sepsis. Placement of a graft in
a site that is potentially infected might result in higher risk of future reinfection.60
Autogenous vein grafts provide an alternative to prosthetic material for in situ reconstruction, but sufficient vein
is difficult to obtain, and this technique is not practiced widely.61 However, recently good experiences have been
reported with the use of the superficial femoral vein for this purpose, because size mismatch is less of a prob-
lem.62 63 The consequences of harvesting this vein have been surprisingly mild.64 Cryopreserved homografts to
reconstruct the aortoiliac anatomy have recently been advocated for replacement of infected aortic prosthetic
grafts. Concern regarding long-term dilatation remain, although they seem resistant to reinfection.65
When complete graft excision with extraanatomic reconstruction using bilateral axillounifemoral bypasses is
not feasible because of extensive groin/thigh sepsis or previous extraanatomic bypass failure, in situ reconstruc-
tion using (superficial femoral or popliteal) veins may be the only remaining option. However, because of its sig-
nificant mortality and morbidity, it is reserved for situations in which life or limb loss would probably result without
revascularization.63-66 Some experience has been achieved using in situ allograft replacement.67

256
TABLE LIII.Complications of infrainguinal bypass.
Complication Incidence (%) Etiology/comments

Death68,69 1.36 Usually cardiac

Myocardial infarction68,84 1.93.4
Wound:
Vein69,74,75 1030
Prosthetic71 18
Exposure/blowout69 9.5/1.6
Infection:
Vein71 1.36
PTFE/Dacron71 3.56
HUV71 1.48
Leg edema72 50100 Resolution usually by 4 months
Lymph leak49,73 0.51.8 Lower with femoral distal than with
aortofemoral
Acute limb ischemia 12

Complications of Infrainguinal Vein Bypass Grafting (Tab. LIII)

Wound complications
The in situ technique has a recorded wound complication rate of 10% to 30%, with most problems occurring
in the distal wound or the mid thigh.74 75 Meticulous dissection without creation of flaps and tension-free closure
are emphasized to reduce this complication. A retrospective comparative study showed that the in situ technique
was associated with a higher rate of wound complications than nonreversed or reversed subcutaneously placed
long saphenous vein grafts (23% vs. 9.3%). A continuous incision was also associated with higher rates of wound
complications.70 A prospective randomized trial, however, failed to confirm this difference in wound complications
seen in situ (15%) and reversed vein (17%) graft reconstructions.69

Arteriovenous fistula
These are avoided by on table graft assessment (angiogram, Doppler assessment) but occasionally become
apparent after the operation. Arteriovenous fistulae may be treated by ligation or embolization under local anes-
thetic.

Leg swelling
Leg swelling after revascularization is an accepted complication of any infrainguinal bypass. The origin of the
swelling has been investigated and found to be related to the lymphatic disruption and interruption in the groin
along the path of vein harvest and increased lymph production during postoperative reactive hyperemia.76 77

Early graft occlusion

Early failure rates have been reported to be as high as 17% for grafts to the popliteal artery and 24% for grafts
to more distal arteries and is related to technical failure (eg, missed valve cusp, twist, anastomotic error).78-81 In
63% of the graft failures in one study, the cause was intrinsic to the graft or anastomosis.78 Early graft thrombo-
sis is usually attributed to technical error, hypercoagulable state, or periods of hypotension or hypoperfusion. A
randomized trial reported the benefit of Dextran 40 in preventing early graft thrombosis of difficult distal bypasses.
82 The 1-week occlusion rate was 20.5% in the control group and 6.9% (0% in vein grafts) in the Dextran 40 group.

The overall early graft occlusion rate can be reduced by good technique, intraoperative monitoring of the com-
pleted bypass, and adjuvant therapy (see Adjuvant Therapy After Revascularization p. 263; Surveillance after
Revascularization, p. 269).

257
Hemodynamic failure
This may be said to occur when limb viability is threatened or not reversed even in the face of a patent bypass
graft. Occasionally, limb loss may occur despite a patent graft. The current objective criteria for hemodynamic fail-
ure is failure to increase the ABPI or toe:brachial index more than 0.10.83

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General Issues Relating to Endovascular Treatment

Need for Surveillance

As with surgical bypass grafts, it is likely that surveillance and repeat intervention would improve the assisted
primary patency of PTA. In infrainguinal PTA, primary and assisted primary patency rates approximate each other
because re-intervention is attempted in a relatively small proportion of PTA patients.1-4 For example, Gallino et
al.4 repeated PTA on only 14% of failed or failing femoropoliteal PTA, whereas Capek et al.3 reported a re-inter-
vention rate of only 8%.4 However, when repeat PTA is performed in a higher percentage of patients, patency can
be improved. For example, Harris et al.5, in a series of PTA performed by surgeons, used surveillance and re-
intervention as needed with 57% primary 6-month patency and 82% assisted primary 6-month patency.
Although the ability of periprocedural duplex to predict ultimate PTA durability is controversial,6-8 duplex ultra-
sound may be useful in an appropriate longitudinal postprocedure surveillance program. Vroegindewij et al.9 found
that duplex ultrasound is sensitive in detecting restenosis and, along with clinical and other noninvasive follow-up,
it could be very useful in augmenting the durability of femoropopliteal PTA.

Comparison of Available Stents

Currently all intravascular stents in clinical use are permanent and metallic. Stent designs and technologies
used for managing peripheral vascular disease are continually evolving. The availability of and approved indica-
tions for specific stents vary by country. The ideal stent and delivery system should have the following character-
istics10-12 (see Table LIV).
Stents are generally stratified into balloon-expandable (eg, Palmaz, Strecker) and self-expandable. The self-

260
TABLE LIV.Ideal characteristics of stents and delivery systems
Characteristics

Allow for efficiency in and ease of deployment

Use percutaneous technique
have a low-profile delivery system
have a high expansion ratio
Be available in a wide range of diameters and lengths
Have longitudinal flexibility
Ability to be optimally and precisely positioned
have high radio-opacity
have minimal foreshortening
ability to be retrieved or repositioned
no slippage of stent on balloons; rupture-resistant balloon (for stent/balloon delivery system)
Yield durable clinical results
Reliably oppose elastic recoil, stenosis, or dissection flap
Be thromboresistant
Resist restenosis
Resist compression, deformation, or fracture
Be biologically compatible, to resist infection and minimize inflammatory reaction
Be incorporated into vessel wall with thin neointima/functional endothelium
Do not embolize or migrate
Be inexpensive
Allow for noninvasive imaging and follow-up with CT, MRA, and ultrasound.

expandable stents are generally based on one of two designs: (1) spring-open expansion after removal of restraint
(eg, Wallstent) or (2) thermal memory expansion at body temperature (eg, Memotherm, Nitinol stents). Currently
thermal stents are constructed of Nitinol (nickel-titanium alloy), and self-expandable spring and balloon-expand-
able stents are generally constructed from stainless steel. The long-term effects of stent design, such as poten-
tial for development of new intimal hyperplasia, are incompletely understood. This choice of a particular stent type
tends to be most related to anatomy and ease of placement (eg, flexibility) and cost considerations (eg, minimiz-
ing the number of stents needed to treat the target lesions).10-17

Role of Endovascular Procedures Other Than Angioplasty and Stenting

The role of directional and rotational atherectomy for treating atheromatous occlusions or stenoses remains
circumscribed. These devices do not appear to offer improved clinical and hemodynamic outcomes or superior
durability compared with PTA.9 18 19 Percutaneous atherectomy may have utility as a niche device in highly selected
patients, as an adjunct to PTA for treating occlusive flaps or eccentric calcified plaque.18 20 Similarly, the use of
lasers for crossing or debulking occlusive lesions generally has not been accepted as cost effective. As noted ear-
lier, in Factors Affecting the Outcome of Femoropopliteal Angioplasty (see p. 242), laser and atherectomy do not
appear to be broadly applicable to the infrapopliteal arteries.21-23

Role of Thrombolysis in CLI

The role of thrombolysis for treating chronic iliac and femoropoliteal artery occlusions in patients with chronic
CLI is controversial. Some authors favor lysis before stent placement24-26 and others favor stenting alone.27 Data
on comparative costs and morbidity, including the relative incidence of complications such as hemorrhage and
distal embolization, are lacking. Differences in patient selection, techniques, and reporting have hindered com-
parison of these two approaches.24 25 28

CRITICAL ISSUE 37: Role of thrombolysis in chronic iliac lesions

There is a need for studies to determine whether preliminary catheter-directed thrombolytic therapy
enhances the efficacy or safety of angioplasty and stenting of chronic iliac occlusions.

261
Incidence and Management of Complications
The incidence and management of complications after endovascular intervention is detailed in Complications
of Endovascular Procedures (see p. 114), and is not repeated here.

References
1. Bull PG, Mendel H, Hold M, Schlegl A, Denck H. Distal popliteal and tibioperoneal transluminal angioplasty: long-term follow
up. JVIR 1992;3:45-53.
2. Horvath W, Oertl M, Haidinger D. Percutaneous transluminal angioplasty of crural arteries. Radiology 1990;177:565-569.
3. Capek P, McLean GK, Berkowitz HD. Femoropopliteal angioplasty: factors influencing long term success. Circulation
1991;83(suppl I) I-70-I-80.
4. Gallino A, Mahler F, Probst P, Nachbur B. Percutaneous transluminal angioplasty of the arteries of the lower limbs: a 5 year
follow-up. Circulation 1984;70:619-623.
5. Harris RW, Dulawa LB, Andros G, Oblath RW, Salles-Cunha SX, Apyan RL. Percutaneous transluminal angioplasty of the
lower extremities by the vascular surgeon. Ann Vasc Surg 1991;5:345-353.
6. Mewissen MW, Kinney EV, Bandyk DF, Reifsnyder T, Seabrook GR, Lipchik EO, et al. The role of duplex scanning versus
angiography in predicting outcome after balloon angioplasty in the femoropopliteal artery. J Vasc Surg 1992:15:860-866.
7. Sacks D, Robinson ML, Summers TA, Marinelli DL. The value of duplex sonography after peripheral artery angioplasty in
predicting subacute restenosis. AJR 1994;162:179-183.
8. Yucel EK. Femoropopliteal angioplasty: can we predict success with duplex sonography? AJR 1994;162:184-186.
9. Vroegindewij D, Tielbeck AV, Buth S, van Kints MJ, Landman GH, Mali WP. Recanalization of femoropopliteal occlusive
lesions: a comparison of long term clinical, color duplex US, and arteriographic follow-up. JVIR 1995;6:331-337.
10. Becker GJ. Intravascular stents: general principles and status of lower-extremity arterial applications. Circulation 1991 Feb;
83(2 Suppl):I122-1136.
11. Palmaz JC. Intravascular stents:tissue-stent interactions and design considerations. AJR 1993;160:613-618.
12. Palmaz JC. Intravascular stenting: from basic research to clinical application. Cardiovasc Intervent Radiol 1992; 15:279-
284
13. Strecker E, Liermann D, Barth KH, Wolf HR, Hreudenberg N, Berg G, et al. Expandable tubular stents for treatment of arte-
rial occlusive diseases: experimental and clinical results. Radiology 1990;175:97-102.
14. Lossef SV, Lutz RJ, Mundorf J, Barth KH. Comparison of mechanical deformation properties of metallic stents with use of
stress-strain analysis. J Vasc Intervent Radiol 1994;5:341-349.
15. Palmaz JC, Garcia OJ, Schatz RA, Rees CR, Roeren T, Richter GM, et al. Placement of balloon-expandable intraluminal
stents in iliac arteries: first 171 procedures. Radiology 1990:174:969-975.
16. Long AL, Page PE, Raynaud AC, Beyssen BM, Fiessinger JN, Ducimetiere P, et al. Percutaneous iliac artery stent: angio-
graphic long-term follow-up. Radiology 1991;180:771-778.
17. Katzen BT, Becker GJ. Intravascular stents status of development and clinical application. Surg Clin North Am 1992;72:941-
957.
18. Batt M, Coulbois PM, Reix T, Marcade JP, Giraud C, Castellani L, et al. Recanalization of occluded superficial femoral artery
using the rotational transluminal angioplasty catheter system (ROTACS). Carciovasc Surg 1993:1; 541-546.
19. Ahn SS, Auth D, Marcus DR, Moore WS. Removal of focal atheromatous lesions by angioscopically guided high speed rotary
atherectomy. JVS 1988;7:292-300.
20. Kim D, Gianturco LE, Porter DH, Orron DE, Kuntz RE, Kent KC, et al. Peripheral directional atherectomy: 4-year experience.
Radiology 1992 Jun;183(3):773-778.
21. Pilger E, Lammer J, Bertuch H, Stark G, Decrinus M, Pfeiffer KP, et al. Nd:YAG laser with sapphire tip combined with bal-
loon angioplasty in peripheral arterial occlusions: long term results. Circulation 1991;83:141-147.
22. Lammer J, Pilger E, Decrinis M, Quehenberger F, Klein GE, Stark G, et al. Pulsed excimer laser versus continuous wave
Nd:YAG laser versus conventional angioplasty of peripheral arterial occlusions: prospective, controlled, randomized trial.
Lancet 1992;340:1183-1188.
23. Peripheral atherectomy with the rotablator: a multicenter report. The Combined Rotablator Atherectomy Group (CRAG). J
Vasc Surg 1994;19:509-515.
24. Murphy TP, Webb MS, Lambiase RE, Haas RA, Dorfman GS, Carney WI, et al. Percutaneous revascularization of complex
iliac artery stenoses and occlusions with use of Wallstents; three year experience. JVIR 1996;7:21-27.
25. Blum U, Gabelmann A, Redecker M, Noldge G, Dornberg W, Grosser G, et al. Percutaneous recanalization of iliac artery
occlusions: results of a prospective study. Radiology 1993;189:536-540.
26. Motarjeme A, Gordon GI, Bodenhagen K. Thrombolysis and angioplasty of chronic iliac artery occlusions. J Vasc Interv Radiol
1995;6:66S-72S.
27. Sapoval MR, Chatellier G, Long AL, Rovani C, Pagny JY, Raynaud AC, et al. Self-expandable stents for the treatment of iliac
artery obstructive lesions: long-term success and prognostic factors. AJR 1996;166:1173-1179.
28. Henry M, Amor M, Ethevenet G, Henry I, Amicabile C. Beron R, et al. Palmaz stent placement in iliac and femoropopliteal
arteries: primary and secondary patency in 310 patients with 2-4 year follow-up. Radiology 1995;197:167-174.

262
 Adjuvant Therapy After Revascularization

Introduction

Vascular and endovascular procedures suffer a risk of failure, either early, intermediate, or late. Several fac-
tors affect this risk, and the incidence differs considerably between various types of procedures. The main causes
of failure can be categorized as (1) early: technical flaws or low flow or increased thrombogenicity; (2) intermedi-
ate (6-24 months): intimal hyperplasia; and (3) late: progression of atheromatous disease.
Regarding open vascular procedures, factors that affect failure are the use of autogenous versus synthetic vas-
cular conduits, endarterectomy versus bypass procedures, and the location of the procedure, for example, an aor-
tic procedure compared with a distal reconstruction. This also relates to differences in the caliber of the recipient
arteries, occlusive lesions in the inflow or outflow vessels, and the capacity of the collateral circulation.
Bypass patency also depends on the caliber and length of graft to be used. Progression of disease and risk
factors such as smoking and blood lipids have a major implication on patency. At one extreme, an aortobifemoral
graft with a perfect outflow carries at least a 90% 1-year patency, whereas the corresponding figure for a pros-
thetic femorodistal bypass with restricted run-off might be 30% or even less. Technical problems, encountered dur-
ing surgery or caused by surgery, also greatly influence the immediate outcome of the procedure. The same kind
of factors presumably influence the outcome of endovascular procedures. However, some of these procedures
have only come into use recently, which means that less knowledge exists on the incidence and magnitude of the
problems.
Current adjuvant pharmacological treatment aims to reduce either early failures due to thrombosis, intermedi-
ate graft occlusions due to intimal hyperplasia, or further progression of atherosclerosis. Even though vein grafts
are at much less risk of developing occlusions than synthetic grafts, it is reasonable to discuss them together
because most of the expected problems are of the same kind, though not of the same magnitude. Various phar-
macological agents are in use to prevent thrombosis. The two most important categories are antiplatelet therapy
and anticoagulation. Recently also, prostanoids and nitric oxide have been tried clinically. Although exerting
antiplatelet effects, these compounds are discussed separately from antiplatelet therapy.

Antiplatelet Therapy

Acetylsalicylic acid

Acetylsalicylic acid (ASA) has been recommended on its own merits for reducing thrombotic events in all patients
with PAD (see Recommendation 28, p. 87). This discussion focuses on the use of ASA to assist the patency of
revascularization procedures. Acetylsalicylic acid has been investigated in randomized clinical trials, either alone
or in combination with dipyridamole. In a 1982 report, patients with PTFE grafts for either above-knee or below-
knee femoropopliteal bypass procedures were randomized to either placebo, ASA alone. or ASA plus dipyridamole,
starting preoperatively.1 For below-knee grafts, no difference was found between the groups, whereas those patients
on placebo undergoing an above-knee reconstruction had a significantly worse outcome than those receiving ASA
or ASA plus dipyridamole. In combined series with autologous veins and PTFE grafts, no patency differences were
seen with placebo versus ASA or ASA plus dipyridamole treatment given postoperatively in two series.2 3
In a large series, 549 patients, all with a femoropopliteal autologous vein bypass, were randomized to treat-
ment with either ASA plus dipyridamole or placebo.4 Patients were followed-up for 3 years, and there were no dif-
ferences in patency rates recorded between the groups. Conversely, the Antiplatelet Trialists in their meta-analy-
sis found that not only survival but also graft patency could be improved using ASA.5

263
 A theoretical explanation for an early benefit of ASA is given in a study by Goldman et al.,6 finding a lower
thrombogenicity index with ASA and dipyridamole treatment using 111Indium-labeled platelets. Based on current
knowledge, ASA is recommended for those undergoing interventions. A Danish review recently concluded that
there is evidence for lifelong treatment with ASA after infrainguinal vascular reconstructions.7 The authors also
recommended a rather high dose (300500 mg ASA daily).

RECOMMENDATION 96: Antiplatelets as adjuvant pharmacotherapy after revascularization

Antiplatelet therapy should be started preoperatively and continued as adjuvant pharmacotherapy after
an endovascular or surgical procedure. Unless subsequently contraindicated, this should be contin-
ued indefinitely. Caution should be used in patients in whom use of anticoagulants is proposed.

Ticlopidine
Ticlopidine, as a more recent antiplatelet drug, has proved effective in preventing vascular complications.8 A
reduced platelet uptake on aortobifemoral grafts has been shown.9 A recently published prospective, randomized,
multicenter study has shown that ticlopidine compared with placebo after femoropopliteal or femorotibial saphe-
nous vein bypass procedures in 143 patients increased both survival and 2-year patency of saphenous vein bypass
grafts in the legs.10 Some of the side effects of ticlopidine, such as thrombocytopenia,11 do not appear to be pre-
sent with newer ADP inhibitors such as clopidogrel.12

Anticoagulants
The use of unfractionated heparin (UFH) during vascular surgery is a widespread routine. Recently, it was
shown that low-molecular-weight heparin (LMWH) is as effective an anticoagulant as UFH during infrainguinal
bypass surgery.13 Conversely, UFH has been used more selectively during the postoperative course. The main
reason might be a risk of postoperative bleeding and a need for careful monitoring of coagulation parameters. The
development of LMWH has changed this perspective considerably, and studies have pointed at beneficial effects
of LMWH in the postoperative management of infrainguinal bypass.
A randomized controlled study comparing LMWH with ASA and dipyridamole14 showed significantly better
patency in the LMWH group, but restricted to patients with CLI. This study combined results achieved with both
synthetic grafts and vein grafts.
It has been suggested that the conclusions are less valid because only one fourth of the grafts were vein; the
remaining were various synthetic materials, and all patients received LMWH for the first week postoperatively,
after which the randomized scheme started. In another randomized controlled trial comparing LMWH and unfrac-
tionated heparin, it was shown that LMWH was superior and as safe as unfractionated heparin in prevention of
early graft thrombosis.15
Oral coumarin seems to increase patient survival, but controversies exist as to whether graft patency could be
influenced. In two studies from Austria, it has been shown that graft patency is improved in patients with saphe-
nous vein grafts receiving oral anticoagulation. Both primary graft patency and limb salvage were significantly
increased.16 17
In the first of these two studies, this effect was restricted to patients operated on for CLI. In this study, 12% of
patients randomized to coumarin were withdrawn for bleeding complications. Contrary to these findings, a Swedish
study, including patients receiving either vein grafts or synthetic grafts, did not indicate any better outcome in
patients receiving oral anticoagulation during a 3-year follow-up.18 The place for coumarin as adjuvant therapy
after revascularization procedures remains to be determined (see Critical Issue 30, p. 215).

264
Other Drugs
Dextran
Dextran is able to reduce platelet uptake on graft surfaces19 and was shown to be beneficial during follow-up
of difficult lower extremity revascularizations utilizing either veins or synthetic grafts.20 The graft occlusion rate
at 1 week was 20.5% in the control group and 6.9% (0% in vein grafts ) in the dextran 40 group. By the end of
the trial, the overall advantage of dextran 40 was statistically significant at all times up to and including 1 month
and in the subgroup with umbilical vein or prosthetic grafts, significant benefit lasted up to 32 months. However,
there was no advantage in vein graft bypasses unless they were carried to crural arteries.20 The latter has been
confirmed in a recent single-center prospective randomized trial.21
Dextran has been used extensively in Sweden, but there are few published studies that compare dextran
with other forms of treatment. Recently, dextran 70 was compared with LMWH for distal vascular reconstruc-
tions. New data indicate few differences, except considerably more side effects with dextran.22 Although ana-
phylactic reactions have been mitigated by pretreatment with the hapten, other complications such as wound
bleeding and vascular overload are not uncommon unless a strict protocol is followed and certain categorical
exclusions observed such as recent myocardial infarction, congestive heart failure, and renal insufficiency, par-
ticularly in patients with diabetes. On this basis, dextran 70 cannot be recommended as a routine measure and
should only be used in those distal bypasses in which there is a predictably high risk of early thrombosis (eg,
non-autogenous reconstructions or crural bypasses) and no contraindications.

Prostanoids
Prostanoids such as the prostacyclin analog iloprost have antiplatelet effects but also have effects on white
cell aggregation and adhesion as well as on vasoconstriction. Flow increases in vein grafts during distal vascular
reconstructions after iloprost injection have been shown.23 In a large European multicenter study on patients with
CLI comparing iloprost and placebo in distal vascular reconstructions using either vein grafts or synthetic grafts,
no significant improvement could be shown with respect to the 1-year patency.24 Whether this failure could be
attributed to the short time of drug administration, only during the day of surgery and 2 subsequent days, is uncer-
tain but may be a possibility. Interestingly, synthetic grafts performed better during the first month, when patients
were treated with iloprost.

Nitric oxide
In a small series, nitric oxide has been administered during infrainguinal bypass surgery, resulting in an aug-
mented graft flow and inhibition of depleted plasma antioxidants. Results on patency have not yet been presented.
25

New Approaches
Activation of the glycoprotein (GP)IIb/IIIa on the platelet surface is the final pathway of platelet aggregation,
regardless of the initiating stimulus. Inhibitors of GPIIb/IIIa receptors include monoclonal antibodies and peptidic
as well as nonpeptidic synthetic specific receptor blockers.
Abciximab exchanges between and binds to platelets for as long as 2 weeks, whereas synthetic GPIIb/IIIa
inhibitors block ex vivo platelet aggregation only a few hours after the end of an infusion but have the advantage
of also being orally active. New ways to interfere with the complex coagulation system abound. Direct inhibitors
of thrombin is one of the recent pharmacological approaches being evaluated in clinical trials. Other approaches
are synthetic inhibitors of factors VIII, IX or X, tissue factor pathway inhibitors, or inactivated factor VIII.26-28

Adjuvant Therapy After Endovascular Procedures

For endovascular procedures, especially PTCA, anticoagulation has been advised, including oral anticoagula-

265
tion. However, in recent studies, the need for oral anticoagulation has been questioned.29 Vascular stents in the
femoropopliteal region have been used without long-term anticoagulation, and reasonably acceptable early and
intermediate patency rates have been obtained,30 although other authors have routinely used coumarin.30-35 In a
Swedish multicenter study, patients were treated with ASA and dipyridamole or placebo after PTA of iliac and
infrainguinal vessels. No differences were recorded between the groups with respect to the 1-year patency rate.
36

Summary of Adjuvant Therapy

Even though randomized controlled studies are not entirely convincing, there seems to be consensus that adju-
vant pharmacotherapy is needed to prevent graft thrombosis. Aspirin is the therapy most used, administered in a
dose of 75 or 160 mg daily, although the low-dose/high-dose debate is not settled. In most of the trials suggest-
ing protected patency, the higher dose of aspirin was used.1-3 Conversely, compliance may be a problem with the
higher dose over time. Whether LMWH should replace aspirin, for example, for infrainguinal bypass, is not estab-
lished. It seems important to start the treatment preoperatively. It seems reasonable to use the same policy for
endovascular procedures as for surgical procedures, and a regimen with ASA is advised (see Recommendation
96, p. 264).

Intimal Hyperplasia
Proliferation of smooth muscle cells causing hyperplastic growth, especially in the distal anastomosis of a syn-
thetic graft or in the anastomoses or body of a vein graft, is the main cause of graft failure during a mid-term fol-
low-up. Strict programs for graft surveillance give an opportunity to treat the lesion before any deleterious clinical
effect, but most importantly, measures to prevent this hyperplastic growth have to be found. A major question is
whether drugs that may reduce thrombogenicity are usable for this purpose as well. Drugs to be discussed are
aspirin and heparin, UFH or LMWH. Clinical effects of aspirin and dipyridamole were seen after peripheral vas-
cular surgery; however, with a short-term follow-up, this only proves an effect on thrombus formation.37
Heparin (UFH) has been shown to inhibit proliferation and migration of smooth muscle cells even in vivo.38 In
animal models, an effect on intimal hyperplasia has been evident, however, any clinical benefit in humans has not
been proved.39 It has been suggested that a continuous heparin infusion has to be used and also that LMWH has
a greater effect on native arteries than on vein grafts.40 41 Another proposal is that very high doses of heparin are
needed.42 The study reported above, intending to compare aspirin and LMWH, claimed a beneficial effect of LMWH
on intimal hyperplasia.14 This conclusion is not entirely evident, because the effect was seen mostly in patients
with severe ischemia, in which case an effect on thrombogenicity might be as important as an effect on intimal
hyperplasia. Several experimental models have been tried to reduce intimal hyperplasia. Some of them are listed
in Table LV. In addition, radiation and drug delivery from, or together with, implanted stents are under evaluation.43
44

TABLE LV.Compounds used in animal model experimental settings to reduce intimal hyperplasia.
Compound Experimental setting Effect

Naroparcil45 arterial injury +

Scavengers46 vein grafts -
L-arginine47 48 vein grafts +
Angiotensin-converting enzyme inhibition49 PTA +
Cholesterol reduction50 vein grafts +
Ketanserin51vein grafts +
FGF saporin52 PTFE grafts +
VEGF53 vein grafts +
Cyclosporin54 aortic transplant +
Lazaroids55 vein grafts +

266
 Interestingly, almost all drugs reported in Table LV exert a positive effect in the respective experimental model.
Whether any of these findings will be possible to transfer to the human situation is too early to predict. Apparently,
cholesterol reduction is an interesting possibility, because it promises to reduce atherosclerosis, but apparently
also hyperplastic growth. Calcium channel antagonists, lipid-lowering drugs, and treatment of hypertension are all
associated with reduced progression of atherosclerosis, especially if combined with smoking cessation and exer-
cise. Whether this kind of treatment will also affect intimal hyperplastic growth has still to be proved. Both early
thrombosis and late hyperplastic growth are multifactorial events, and it therefore would be most astonishing if
one single drug could prevent them all. Concerning the cells involved, white cells, and to a lesser degree, platelets,
are crucial. Maybe there is a future in drugs acting in different ways to reduce platelet activity. Synergistic effects
have been shown with drugs acting on different pathways, and a combination of cGMP- and cAMP-elevating and
cyclooxygenase-inhibiting drugs may be useful. Most certainly, there will also be techniques to inhibit the effects
of activated white cells participating in the inflammatory response.

CRITICAL ISSUE 38: Agents to inhibit intimal hyperplasia

There is a need to determine the clinical efficacy of agents reported to inhibit intimal hyperplasia in
animal models. Because intimal hyperplasia is a major cause of failure of both percutaneous and open
surgical revascularization procedures, research aimed at its prevention is of critical importance.

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31. Do-dai-do, Triller J, Walpoth BH, Stirnemann P, Mahler F. A comparison study of self-expandable stents vs balloon angio-
plasty alone in femoropopliteal artery occlusions. Cardiovasc Intervent Radiol 1992;15:306-312.
32. Sapoval MR, Long AL, Raynaud AC, Beysson BM, Fiessinger JN, Gaux JC. Femoropopliteal stent placement: long-term
results. Radiology 1992;184:844-840.
33. Strecker EP, Boos IB, Gottmann D. Femoropopliteal artery stent placement: evaluation of long-term success. Radiology
1997;205(2):375-383.
34. Henry M, Amor M, Ethevenot G, Henry I, Amicabile C, Beron R, et al. Palmaz stent placement in iliac and femoropopliteal
arteries: primary and secondary patency in 310 patients with 2-4 year follow-up. Radiology 1995;197:167-174.
35. Martin EC, Katzen BT, Benanti JF, Diethrich EB, Dorros G, Graor RA, et al. Multicenter trial of the Wallstent in iliac and femoral
arteries. JVIR 1995;6:843-849.
36. Platelet inhibition with ASA/Dipyridamole after percutaneous balloon angioplasty in patients with symptomatic lower limb arte-
rial disease: a prospective double-blind trial. Study group on pharmacological treatment after PTA. Eur J Vasc Surg 1994;8:83-
88.
37. Clyne CA, Archer TJ, Atuhaire LK, Chant AD, Webster JH. Random control trial of a short course of aspirin and dipyridamole
(Persantin) for femorodistal grafts. Br J Surg 1987;74:246-248.
38. Clowes AW, Clowes MM. Kinetics of cellular proliferation after arterial injury. IV: Heparin inhibits rat smooth muscle mitoge-
nesis and migration. Circ Res 1986;58:839-845.
39. Clowes AW. Intimal hyperplasia and graft failure. Cardiovasc Pathol 1993;2:179S-186S.
40. Edelman ER, Karnovsky MJ. Contrasting effects of the intermittent and continuous administration of heparin in experimental
restenosis. Circulation 1994;89:770-776.
41. Wilson NV, Salisbury JR, Kakkar VV. The effect of low molecular weight heparin on intimal hyperplasia in vein grafts. Eur J
Vasc Surg 1994;8:60-64.
42. Varty K, Allen KE, Jones L, Sayers RD, Ratliff DA, Bell PR, London NJ. The influence of low molecular weight heparin on
neointimal proliferation in cultured human saphenous vein. Eur J Vasc Surg 1994;8:174-178.
43. Mayberg MR, Luo Z, London S, Gajdusek C, Rasey JS. Radiation inhibition of intimal hyperplasia after arterial injury. Radiat
Res 1995;142:212-220.
44. Muller DW, Gordon D, Topol EJ, Levy RJ, Golomb G. Sustained release local hirulog therapy decreases early thrombosis
but not neointimal thickening after arterial stenting. Am Heart J 1996;131:211-218.
45. Steg PG, Ziol M, Tahlil O, Robert C, Masson P, Pruneau D, et al. Reduction of intimal hyperplasia by naroparcil, a 4-methy-
lumbelliferyl beta-D-xyloside analogue, after arterial injury in the hypercholesterolemic rabbit. Circ Res 1995;77:919-926.
46. Gates JD, Hirsch GM, Karnovsky MJ. Suppressors of oxygen metabolites fail to reduce vein graft intimal hyperplasia. Arch
Surg 1995;130:976-980.
47. Davies MG, Dalen H, Kim JH, Barber L, Svendsen E, Hagen PO. Control of accelerated vein graft atheroma with the nitric
oxide precursor L-arginine. J Surg Res 1995;59:35-42.
48. Davies MG, Kim JH, Dalen H, Makhoul RG, Svendsen E, Hagen PO. Reduction of experimental vein graft intimal hyperpla-
sia and preservation of nitric oxide-mediated relaxation by the nitric oxide precursor L-arginine. Surgery 1994;116:557-568.
49. Van Belle E, Bauters C, Wernert N, Delcayre C, McFadden EP, Dupuis B, et al. Angiotensin converting enzyme inhibition
prevents proto-oncogene expression in the vascular wall after injury. J Hypertens 1995;13:105-112.
50. Klyachkin ML, Davies MG, Kim JH, Barber L, Dalen H, Svendsen E, et al. Postoperative reduction of high serum cholesterol
concentrations and experimental vein bypass grafts: effect on the development of intimal hyperplasia and abnormal vaso-
motor function. J Thorac Cardiovasc Surg 1994;108:556-566.
51. Massey MF, Davies MG, Svendsen E, Klyachkin ML, Schwartz LB, Barber L, et al. Reduction of experimental vein graft inti-
mal hyperplasia by ketanserin. J Surg Res 1993;54:530-538.
52. Mattar SG, Hanson SR, Pierce GF, Chen C, Hughes JD, Cook JE, et al. Local infusion of FGF-saporin reduces intimal hyper-
plasia. J Surg Res 1996;60:339-344.
53. Luo Z, Asahara T, Tsurumi Y, Isner JM, Symes JF. Reduction of vein graft intimal hyperplasia and preservation of endothe-
lial-dependent relaxation by topical vascular endothelial growth factor. J Vasc Surg 1998;27:167-173.

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54. Stoltenberg RL, Geraghty J, Steele DM, Kennedy E, Hullett DA, Sollinger HW. Inhibition of intimal hyperplasia in rat aortic
allografts with cyclosporine. Transplantation 1995;60:993-998.
55. Davies MG, Dalen H, Barber L, Svendsen E, Hagen PO. Lazaroid therapy (methylaminochroman: U83836E) reduces vein
graft intimal hyperplasia. J Surg Res 1996;63:128-136.

Surveillance After Revascularization

Introduction
Despite a high likelihood of immediate success, all lower-extremity revascularization procedures have a sig-
nificant rate of failure over time (see also Surgery for Intermittent Claudication, p. 117). It is now well recognized
that patency of the treated arterial segment is most effectively preserved through surveillance programs that are
capable of identifying flow-limiting lesions before complete occlusion of the conduit or vessel.1-4 Revision of fail-
ing reversed saphenous vein bypass grafts, for example, results in excellent long-term graft function, with assisted
primary patencies of 82% to 92% at 5 years.5 6 Once complete occlusion has occurred, thrombectomy and revi-
sion yields a poorer secondary patency of only 43% to 76% at 5 years.7-9 Similarly, the treatment of complete re-
occlusions of angioplasty sites has a lower likelihood of technical success, a higher incidence of complications,
and yields a less durable result.10 11
Clearly, the identification and treatment of flow-limiting lesions within the treated arterial segment before throm-
bosis of the segment provides a more durable result. Surveillance programs, therefore, represent a potentially
valuable adjunct to every type of vascular intervention performed for the preservation of lower extremity perfusion.
Because not all peripheral interventions are easily evaluated, the methods that provide the most cost-effective sur-
veillance in a given setting remain controversial.

Methods of Surveillance
A number of methods of posttreatment surveillance of patients undergoing lower extremity revascularization
have been practiced over the past several decades. These include clinical examination, ankle:brachial indices,
duplex imaging, and arteriography. Additional study methods have been used, such as segmental pressures and
plethysmography, but little information exists regarding the utility of these technologies.

Patient history and clinical examination

Most patients (66%) who have undergone femoropopliteal or femorotibial bypass procedures experience a
return of preoperative symptoms immediately on graft occlusion.12 Unfortunately, few of these patients develop
slowly progressive symptomatology during the development of flow-limiting or graft-threatening lesions.13 This is
especially true of those patients who do not participate in a postoperative exercise therapy program and remain
sedentary. Therefore, although patient history is an essential and valuable source of information, alone it is of lit-
tle value in detecting the development and evolution of luminal lesions capable of causing graft thrombosis.
Physical examination also lacks sufficient sensitivity for the detection of failing grafts or angioplasty sites.14 15 Iso-
lated stenoses of inflow or outflow vessels or of a graft infrequently alter physical examination. Similarly, pulse
examination of the patient at rest and the appearance of the foot may not be changed by the presence of a sig-
nificant isolated stenosis.16 Graft occlusion occurs in many patients before the onset of symptoms or alteration in
the quality and character of peripheral pulses. Therefore, clinical history and physical examination are inadequate
as the sole components for graft surveillance and the reliable detection of failing femoropopliteal or femorotibial
bypass grafts. Patient history and physical examination remain, however, essential components of any surveil-
lance program.

269
Ankle-brachial pressure indices (ABPI)
The use of resting ABPI for the detection of hemodynamically significant arterial occlusive disease has been
uniformly accepted, although they may be subject to measurement variability and study limitations. Individual
recordings of ABPI in a patient may vary by as much as 0.1 without a fixed reduction in peripheral blood flow. A
decrease in index of 0.15, the parameter most widely used as representative of a significant reduction in blood
flow, requires the development of a hemodynamically significant stenosis of at least 50%.17 These high-grade stenoses
are more likely to undergo sudden thrombotic occlusion. The inability to identify mild or moderate flow-reducing
lesions prevents the recording of slowly falling ABPI in patients with an evolving graft-related stenosis.18 19 Addi-
tionally, resting ABPI may be falsely elevated in patients with calcified distal arteries and may be of limited value
in patients who did not normalize their ABPI in the immediate postoperative period. These factors limit the use-
fulness of the resting ABPI for the detection of failing lower extremity revascularizations.
One group of investigators has documented equivalent graft failure rates in patients with hemodynamically sig-
nificant drops in resting ABPI (>0.2) and those with stable ABPI.18 Similarly, another group has shown that a
decrease in resting ABPI of 0.2 did not distinguish between patients who proceeded to graft occlusion and those
who did not.19 For these reasons, the resting ABPI cannot reliably provide the physician with information regard-
ing the development of stenoses and the probability of a thrombotic episode within angioplasty sites or bypass
grafts. Toe:brachial indices provide no better discrimination.20 The measurement of post-exercise ABPI may improve
the detection of flow-limiting stenoses. A well-recognized method for enhancing the detection of subcritical stenoses
in native vessels, post-exercise ankle-brachial indices have been shown to be of greater value than resting ABPI
for the identification of failing lower extremity angioplasty.21 A recent application of this form of ABPI assessment
showed that a significant number of patients with significant graft stenoses experienced a reduction in post-exer-
cise ABPI despite an unchanged resting ABPI.22 Thus, the post-exercise ABPI may be helpful in the detection of
suprainguinal reconstructions or lower extremity angioplasty procedures.

Color flow duplex scanning

Color flow duplex scanning has been widely used in surveillance programs because of its simplified ability to
identify stenoses in native arteries and vein grafts. Color guidance has reduced the amount of time required to
locate significant lesions within autogenous grafts and, therefore, has made rapid scanning of the entire graft length
in the lower extremity feasible. Scans can be performed longitudinally and can detect a variety of conditions that
may impact on graft function, including persistent arteriovenous fistulae, compressive hematoma, kinks or other
forms of graft malpositioning, and pseudoaneurysms.
A graft can be evaluated at each anastomosis and throughout its length. Areas of concern can be reexamined
at frequent intervals if clinically indicated to identify the extent and rate of development of stenotic lesions. Duplex
surveillance of lower extremity vein grafts is more easily accomplished than prosthetic grafts because of the abil-
ity to completely scan the graft and identify areas of stenosis and altered flow rates. The flow surface contours of
a normal vein graft should be smooth and parallel on longitudinal scan. A recent study has shown that baseline
graft peak flow velocities vary with the site of distal anastomosis (popliteal vs tibial) and quality of outflow tract.23
Vein grafts to the popliteal artery had a mean peak flow velocity of 89.5 cm/s, whereas those to the tibial vessels
had a mean peak flow velocity of 64 cm/s.
Although criteria for graft failure vary among laboratories, there are general guidelines for detection of the fail-
ing distal graft. These include an increase in peak systolic velocity to greater than 150 cm/s, a peak systolic veloc-
ity ratio of greater than 2.0 across a stenosis, and a reduction in peak systolic velocity to less than 45 cm/s. Because
luminal diameter is narrowed within a native artery or autogenous graft, peak systolic velocities within the lesion
increase. A peak systolic velocity of 150 to 170 cm/s correlates with a greater than 50% diameter reduction.24 A
peak systolic velocity of 180 cm/s or greater suggests a critical diameter reduction of 80% or more.25 As the peak
systolic velocity increases, end-diastolic velocity may also begin to rise.

270
 End-diastolic velocities of greater than 50 cm/s in conjunction with high peak systolic velocities indicate a greater
than 70% loss of luminal diameter.25 A reduction of peak systolic velocity to less than 45 cm/s at the site of the
smaller of the anastomoses (proximal in reversed vein grafts, distal in situ) suggests a proximal flow-limiting lesion
but is less specific than either peak systolic or end-diastolic velocity measurements.26
Because peak velocities within a vein graft may vary from the established baseline, velocity ratios have been
used to detect the presence of significant stenoses. The peak systolic velocity ratio is calculated by dividing the
peak systolic velocity at the site of the stenosis by that obtained in the normal segment. A ratio greater than 2.0
suggests the presence of a 50% diameter-reducing lesion.27 28 An elevated peak systolic velocity ratio in con-
junction with elevated peak velocities and the identification of an anatomic lesion on duplex image are strongly
suggestive of a significant, graft-threatening stenosis. The use of duplex imaging for the evaluation of prosthetic
bypass grafts is more limited. Because clear luminal images frequently cannot be obtained within synthetic grafts,
especially ePTFE, the benefit of duplex imaging is limited to the evaluation of the anastomoses and the inflow and
outflow vessels. The value of performing a truncated scan such as this remains controversial.
More recently, duplex imaging has been applied to the surveillance of transluminal angioplasty of the lower
extremity. Although the presence of significant amounts of calcium in the arterial wall may prevent clear visual-
ization of the specific angioplasty site, peak systolic flow velocities across the site can be determined, and peak
systolic velocity ratios can be calculated. These values are capable of detecting the presence of restenosis of the
angioplasty site or the worsening of occlusive disease in adjacent segments.10 29
The use of peak systolic velocities and velocity ratios enhance the ability of color flow duplex imaging to detect
mild, moderate, and severe stenoses. This surveillance modality is capable of detecting stenoses of less than
50%, permitting physicians to follow the evolution of these lesions and plan appropriate therapy. The greatest lim-
itation to this technique of patient evaluation is its operator dependency. Optimal results with color duplex imag-
ing for surveillance requires an experienced technologist who can not only identify the presence of a stenotic lesion
by velocity criteria but also provide information about the location and characteristics of the lesion. It might be that
MRA should be advised if patients have heavily calcified vessels, or if other reasons exist for ABPI being inade-
quate, or if good quality color duplex scanning either is not available or cannot be performed adequately because
of patient habitus.

Angiography
Angiography is well accepted as the gold standard for anatomic diagnostic studies. Biplanar arteriography is
associated with high positive and negative predictive values for the detection of stenoses within native arteries
and autogenous and prosthetic grafts. Appropriately performed, this diagnostic test can identify the presence, loca-
tion, and severity of occlusive lesion within the segment of arterial tree imaged. Unlike the noninvasive studies,
image clarity does not decrease above the inguinal ligament, and the mobility of newer imaging systems permits
a wide variety of views capable of providing significant anatomic information. The retrograde measurement of pres-
sure gradients across iliac lesions can contribute valuable hemodynamic information about inflow vessels.
The morbidity and mortality of angiography, though quite low, plus patient discomfort and cost, make this an
unacceptable routine method of surveillance.30 31 Its role as an adjunctive diagnostic modality to confirm nonin-
vasive duplex findings, or to provide additional anatomic detail about a specific stenotic lesion is, however, impor-
tant.

Appropriate Use of Graft Surveillance

Overall, surveillance programs have shown the benefit of duplex imaging for the detection of vein graft stenoses
that, if untreated, would result in graft occlusion.32 Postoperatively, the development of lesions that threaten graft
patency of saphenous vein bypasses occur most often within the body of the graft. In a study of occluded and fail-
ing saphenous vein grafts, 63% of the lesions were located within the graft, and 20% were at the anastomoses.33
As an easily repeated diagnostic test with excellent patient compliance, duplex imaging permits frequent assess-
ment of luminal irregularities and the detection of hemodynamically significant stenoses that, when corrected, help

271
preserve vein graft function. It has been suggested that surveillance may be restricted to the first 6 months after
operation in those patients who have a normal bypass during that period.34 Treatment of hemodynamically sig-
nificant lesions in nonoccluded but failing saphenous vein grafts results in primary assisted patency rates greater
than 80% at 5 years.1-6
The time of initiation of duplex imaging surveillance programs varies among practicing centers. Most, however,
obtain the first postoperative scan at 1 week or before discharge. The initial scan may detect a wide variety of
graft conditions that might impact on graft survival.35 These include the identification of persistent, large arteri-
ovenous fistulae that may divert distal flow in in situ bypasses, compressive hematoma, anastomotic pseudoa-
neurysms, as well as retained valves, adherent thrombus, and luminal flaps.
The detection of luminal pathology not discovered in the operating room at the time of graft placement has
been reported to occur in as many as 37% of patients, with 32% of these compromised grafts ultimately requiring
revision of the identified lesion.35 Subsequent surveillance studies have been performed on a wide variety of sched-
ules. Most commonly for patients with autogenous lower extremity bypass, graft surveillance studies are performed
at 1, 3, 6, 12, 18 and 24 months, and then yearly thereafter. The cost-effectiveness of frequent surveillance beyond
2 years is controversial because of the reduced incidence of graft failure after this period.3 36 The cost-effective-
ness of Duplex scanning during the first year has also been questioned.37

RECOMMENDATION 97: Surveillance program for vein bypass grafts

Patients undergoing vein bypass graft placement in the lower extremity for the treatment of claudica-
tion or limb-threatening ischemia should be entered into a surveillance program. This program should
consist of:
interval history (new symptoms);
vascular examination of the leg with palpation of proximal, graft, and outflow vessel pulses;
periodic measurement of resting and, if possible, post-exercise ankle:brachial indices;
duplex scanning of the entire length of the graft, with calculation of peak systolic velocities
and the velocity ratios across all identified lesions.
Surveillance programs should be performed in the immediate postoperative period and at regular inter-
vals for at least 2 years.

CRITICAL ISSUE 39: Cost-effectiveness of duplex imaging surveillance for vein grafts
There is a need for documenting the cost-effectiveness of using duplex imaging for vein graft sur-
veillance at all periods.

CRITICAL ISSUE 40: Frequency and duration of surveillance in vein and prosthetic grafts
There is a need to establish optimal frequency and duration of surveillance testing in vein and pros-
thetic grafts.

The indications for treatment of an identified lesion must be individualized for each specific patient. Numerous
variables impact on graft function and limb salvage. Nonetheless, the value of a surveillance program lies in its
ability to identify for the vascular specialist the graft threatened by flow-limiting lesions. The impact of such lesions
on long-term graft function has been well recognized and defined.38 39 Because stenotic lesions causing a greater
than 50% diameter reduction are at greater risk for acute thrombosis, the identification of such lesions should lead
the vascular specialist to consider treatment.40 Prompt, definitive evaluation of the entire graft, inflow, and outflow
vessels, with angiography if necessary, and intervention, if indicated, should be undertaken. Delay in the evalua-
tion and treatment of grafts at risk may result in graft failure and a poorer prognosis for the patient.41

272
 Duplex imaging, however, has not been uniformly effective for the detection of failing prosthetic grafts.42 43 Sur-
veillance of prosthetic bypasses with duplex imaging may not detect impending graft failure secondary to lesions
within the graft.44 Technical difficulties associated with scanning of the graft, especially those prosthetics with exter-
nal support, frequently yield suboptimal images. The benefit of surveillance in patient with prosthetic grafts lies in
the likelihood that the graft-threatening lesion usually does not occur within the body of the graft. Of 144 graft-
threatening lesions identified in 91 failing PTFE bypass grafts, only 10 stenoses (8%) were located within the graft.
The remainder were located within the inflow vessel (30%), outflow vessel (57%), or at an anastomosis (6%).45
Other studies have shown a benefit of duplex image surveillance for prosthetic grafts.46 47 Though the benefit of
duplex imaging alone appears to be limited, a surveillance program for patients who have undergone placement
of a synthetic bypass graft is indicated.

RECOMMENDATION 98: Surveillance program for prosthetic grafts

Patients undergoing prosthetic femoropopliteal or femorotibial bypass for claudication or limb-threat-
ening ischemia should be entered into a graft surveillance program, which consists of:
interval history (new symptoms)
vascular examination of the leg with palpation of proximal, graft, and outflow vessel pulses
ankle-brachial indices at rest and, if possible, after exercise testing
Surveillance programs should be performed in the immediate postoperative period and at regular inter-
vals for at least 2 years.

The benefit of surveillance programs for patients who have been treated with proximal vascular reconstruction,
such as aortoiliac or iliofemoral bypass, or transluminal angioplasty, remains controversial. Some studies have
demonstrated a benefit to surveillance with duplex imaging.10 29 48 Few studies have been rigorously performed
to determine the impact of a surveillance program on the long-term outcome of angioplasty.
A recent study of duplex sonography surveillance initiated within 48 hours of infrainguinal angioplasty and con-
tinued for more than 2 years failed to detect a difference in patency of angioplasty sites between those patients
who had abnormal results of duplex examinations and those whose examination results were normal.49 Similarly,
investigators have shown that resting ABPI does not identify patients with significant restenosis. Post-exercise
ABPI measurement is more likely to show the presence of hemodynamically significant lesions.21

RECOMMENDATION 99: Surveillance program for aortoiliac transluminal angioplasty

Patients undergoing aortoiliac vascular reconstruction or transluminal angioplasty for lower extrem-
ity revascularization should be entered into a surveillance program consisting of:
interval history (new symptoms);
vascular examination of the leg with palpation of proximal and outflow vessel pulses;
resting and, if possible, post-exercise ABPI recording.
Surveillance programs should be performed in the immediate post-PTA period and at intervals for at
least 2 years.

CRITICAL ISSUE 41: Surveillance program for angioplasty and other endovascular procedures
There is a need for confirmation that the surveillance program suggested for vein bypass grafts is also
beneficial after endovascular procedures.

273
Management of a Failing Lower Extremity Revascularization
The identification of a failing lower extremity autogenous bypass by duplex imaging surveillance frequently pro-
vides the physician with sufficient information to plan intervention. This is especially true of in situ saphenous vein
bypass grafts.1-6 The presence of hemodynamically significant stenoses within the graft or the progression of a
mild lesion to one of hemodynamic significance should indicate the need for intervention. Many techniques have
been used successfully to treat these lesions, including balloon angioplasty, patch angioplasty, and segmental
vein resection and interposition vein graft. The interposition of a prosthetic segment into a vein graft is of dubious
value.
The detection of a decreasing resting or post-exercise ABPI in a patient with a prosthetic infrainguinal bypass
should lead to angiographic assessment of the patient. Because duplex imaging fails to adequately image the flow
surface of prosthetic grafts, intervention requires a complete and detailed evaluation of the inflow, prosthetic, and
outflow vessels. Only then can appropriate intervention be planned. Patients with stenoses within the native inflow
or outflow arteries may be treated by conventional angioplasty or surgical techniques. Stenoses within the body
of the prosthetic graft are best treated by direct surgical revision. Angioplasty has not been of demonstrated ben-
efit in the treatment of these lesions.
A decrease in the resting or post-exercise ABPI in patients who were treated by transluminal angioplasty should
be studied by angiography to determine the feasibility of performing a redilation of the lesion. Duplex imaging of
lower-extremity angioplasty sites may be of value for the assessment of lesions in patients who do not clearly war-
rant intervention. Patients who have had rapid restenosis of an angioplasty site or who have required multiple
repeat angioplasties should be considered for surgical intervention. The point at which a graft stenosis becomes
critical, that is, the point beyond which thrombosis is very likely to occur, has not been determined. There appears
to be a transition from a low to high risk between a 50% and 75% stenosis.25 50 In addition, whether velocity cri-
teria from Duplex scanning or anatomic criteria from angiography best identify the critical risk point is debated.
More research is needed to settle this important issue.

CRITICAL ISSUE 42: Intervention during surveillance program

There is a need for further information to identify what degree of lesion(s) restenosis, as detected by
surveillance studies, must be corrected.

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scanning of infrainguinal bypass grafts. J Vasc Surg 1990;12:284-290.
29. Vroegindeweij D, TielBeek V, Buth J, Vos LD, van den Bosch HC. Patterns of recurrent disease after recanalization of
femoropopliteal artery occlusions. Cardiovasc Intervent Radiol 1997;20:257-262.
30. Hessel SJ, Adams DF, Abrams HL. Complications of arteriography. Radiology 1981;138:273-281.
31. Waugh JR, Sacharias N. Arteriographic complications in the DSA era. Radiology 1992;182:243-246.
32. Golledge J, Beattie DK, Greenhalgh RM, Davies AH. Have the results of infrainguinal bypass improved with the widespread
utilisation of postoperative surveillance? Eur J Vasc Endovasc Surg 1996;11:388-392.
33. Donaldson MC, Mannick JA, Whittemore AD. Causes of primary graft failure after in situ saphenous vein bypass grafting. J
Vasc Surg 1992;15:113-120.
34. Idu MM, Buth J, Cuypers P, Hop WC, van de Pavoordt ED, Tordoir JM. Economising vein-graft surveillance programs. Eur J
Vasc Endovasc Surg 1998;15:432-438.
35. Wilson YG, Davies AH, Currie IC, McGrath C, Morgan M, Baird RN, et al. The value of pre-discharge duplex scanning in
infrainguinal graft surveillance. Eur J Vasc Endovasc Surg 1995;10:237-242.
36. Machleder HI. Prognosis of the failed infrainguinal vascular graft. Semin Vasc Surg 1990;3:43-48.
37. Ihlberg L, Luther M, Tierala E, Lepntalo M. The utility of duplex scanning in infrainguinal vein graft surveillance: results from
a randomised controlled study. Eur J Vasc Endovasc Surg 1998;16:19-27.
38. Szilagyi DE, Elliot JP, Hageman JH, Smith RF, Dallolmo CA. Biologic fate of autogenous vein implants as arterial substitutes:
clinical, angiographic, and histopathologic observations in femoropopliteal operations for atherosclerosis. Ann Surg
1973;178:232-246.
39. Mills JL, Fujitani RM, Taylor SM. The characteristics and anatomic distribution of lesions that cause reversed vein graft fail-
ure: a five-year prospective study. J Vasc Surg 1993;17:195-206.
40. Chang BB, Leather RP, Kaufman JL, Kupinski AM, Leopold PW, Shah DM. Hemodynamic characteristics of failing infrain-
guinal in situ vein bypass. J Vasc Surg 1990;12:596-600.
41. Taylor T, Stonebridge PA, Allan PL, Kelman J, Andrade B, Davies MJ, et al. Duplex ultrasound surveillance of infrainguinal
bypass grafts: auditing the process. J Royal Coll Surg (Edinb) 1994;39:297-300.
42. Lalak NJ, Hanel KC, Hunt J, Morgan A. Duplex scan surveillance of infrainguinal prosthetic bypass grafts. J Vasc Surg
1994;20:637-641.
43. Dunlop P, Sayers RD, Naylor AR, Bell PR, London NJ. The effect of a surveillance programme on the patency of synthetic
infrainguinal bypass grafts. Eur J Vasc Endovasc Surg 1996;11:441-445.
44. Tong Y, Royle J. The value of duplex scanning in the surveillance of infra-inguinal vein and synthetic grafts. Aust N Z J Surg
1994;64:684-687.
45. Sanchez LA, Suggs WD, Veith FJ, Marin ML, Wengerter KR, Panetta TF. Is surveillance to detect failing polytetrafluoroeth-
ylene bypasses worthwhile? a twelve-year experience with ninety-one grafts. J Vasc Surg 1993;18:981-989.
46. Woodburn KR, Murtagh A, Breslin P, Reid AW, Leiberman DP, Gilmour DG, et al. Insonation and impedance analysis in graft
surveillance. Br J Surg 1995;82:1222-1225.
47. Calligaro KD, Musser DJ, Chen AY, Dougherty MJ, McAfee-Bennett S, Doer KJ, et al. Duplex ultrasonography to diagnose
failing arterial prosthetic grafts. Surgery 1996;120:455-459.
48. Winter-Warnars HAO, van der Graaf Y, Mali WPM. Ankle-arm index, angiography, and duplex ultrasonography after recanal-

275
 ization of occlusions in femoropopliteal arteries: comparison of long-term results. Cardiovasc Intervent Radiol 1996;19:234-
238.
49. Sacks D, Robinson ML, Summers TA, Marinelli DL. The value of duplex sonography after peripheral artery angioplasty in
predicting subacute restenosis. Am J Roentgenol 1994;162:179-183.
50. Idu MM, Blankenstein JD, de Gier P, Truyen E, Buth J. Impact of a color-flow duplex surveillance program on infrainguinal
vein graft patency: a five-year experience. J Vasc Surg 1993;17(1):42-52.

Vascular Registry Data

It is the responsibility of every surgeon...to monitor his experience with care. Only those surgeons with accept-
able results are ultimately qualified.1 Although this quotation comes from an editorial regarding carotid surgery, it
is undoubtedly true for all kinds of vascular and endovascular procedures. Carefully performed single-center audits
are obviously of value, but larger registries enabling comparisons between centers, between treatments, and the
study of time trends have an even higher impact and should be even more reliable. (See also Recommendation
77, p. 190).
Besides specific registries, such as the Vietnam Vascular Registry,2 a very early experience came from the
Cleveland Vascular Society, reporting a large-scale computerized registration.3 More recent registries have been
reported from the Society for Clinical Vascular Surgery4 and the Upstate New York Vascular Society.5 More recent
experiences come from Scandinavia with the Swedish Vascular Registry (SWEDVASC) starting in 1987, followed
by the FINN-VASC, the Danish KARBASE, and the Norwegian NORKAR.
An important difference between the Scandinavian and North American registries reported above is that the
former are intended to cover entire countries. Regarding SWEDVASC, this was accomplished from early 1994
after a successive increase of the number of hospitals from its initiation in 1987.6 Recently, experiences have been
presented from a New Zealand vascular registry, from Northern Ireland and from The Netherlands (personal com-
munication).

Problems With Vascular Registry Data

Limitations may be that long-term results are not easily obtained. Both FINNVASC and the Danish registry have
found data after 30 days difficult to retrieve.7-10 The Swedish Vascular Registry has a 1-year follow-up rate after
surgery for chronic limb ischemia of 92%, whereas endovascular procedures are less frequently reported. There
is an apparent risk that patients not followed-up are worse than those who are followed-up. In a study of femoral
distal bypass procedures, 12% were lost to follow-up. Compared with followed-up patients, those lost to follow-up
had mortality rates of 29% versus 19% and patency rates of 43% versus 68%.11 Also, a Danish follow-up has con-
vincingly shown that patients lost to follow-up had a significantly increased rate of graft thrombosis, limb amputa-
tion, and death.12 On average the 1-year follow-up rate in SWEDVASC now exceeds 90%. Longer-term follow-up
would be beneficial but is not realistic. Conversely, in countries in which it is possible to connect a national reg-
istry to a population registry, long-term mortality rates would at least be achievable. This has been used in stud-
ies based on outcome in the SWEDVASC registry.13
One problem is that epidemiology data are not easily retrieved, because nonintervention cases and amputa-
tions are not recorded in current registries. Another drawback is that if all operative details are considered impor-
tant, a registry protocol has to be extensive, and this can be cumbersome. Compromise, therefore, has to be the
solution, which means that uniformity, for instance using Reporting Standards, has not yet been possible.14-16

Advantages of Vascular Registries

Advantages of vascular registries include that surgeons frequently receive feedback, initiate professional debate,
improve self-assessment, and develop better decision making. One example is the accumulation of data from
treatment of ALI, which has expedited a change from hazardous thrombectomies to more reasonable thromboly-

276
sis.6 A registry may be a good guide to identify accumulation of sentinel events that need further investigation;
for example, although there is a risk of myocardial infarction after surgery for intermittent claudication, the risk of
this or amputation is higher after other kinds of vascular surgery. A vascular registry may allow deviations from
standards to be detected more quickly, and quality improvement measures then may be initiated.
Important questions have been raised concerning the validity and reliability aspects of a registry. This has been
discussed after the 10-year experiences of the SWEDVASC.6 The concern is primarily whether all procedures
have been included in the registry, whether all patients are followed-up, and whether the data included are cor-
rect and complete. As described, unfavorable results are reported less frequently than favorable results, which is
a drawback. For example, patency rates of 70% to 90% have been reported for femoral distal bypass after 1 year.
In a recent, fully audited study of more than 500 patients, the true patency rate was less than 60%.17 A reason-
able explanation may be that single centers may have different case mixes or that patients are lost to follow-up.
Whether all data need to be included is a matter of debate. One of the difficult issues is to have risk factors
reported. It was recently shown that smoking increased the risk for both reoperation in ALI and elective aortic
aneurysm surgery. Hypertension had the same effect in emergency aortic aneurysm surgery.18 It is therefore
assumed that risk factors are of great importance in a full audit.
Registries are of value to study time trends and differences between geographical areas. From the Swedish
Vascular Registry, it is evident that as much as 49% of all procedures are performed for CLI, but a larger propor-
tion than expected is performed for IC. The quotient IC/CLI varies between health care regions from 0.62 to 1.23.
From 11.7 to 37.0 procedures per 100,000 inhabitants are performed annually for CLI and reported to SWED-
VASCa figure lower than expected given that the proportion of new CLI patients ranges from 500 to 1,000 per
100,000 population annually.
Endovascular procedures are used increasingly. On average, 47% of interventional procedures registered in
the SWEDVASC between 1987 and 1996 were performed using endovascular techniques. In the proximal (aor-
toiliofemoral) region, endovascular procedures now constitute 73% of cases, compared with 30% in 1987. For the
distal (femoropopliteal) above-knee region, corresponding increases are from 25% to 50%. For CLI, infrainguinal
procedures constitute 88% of all procedures. The 30-day amputation and mortality rates range between 7% and
11% without significant differences between the various locations of lesions for surgical procedures. In a follow-
up of almost 5,000 surgical and endovascular procedures below the groin for CLI, the late survival rate was cal-
culated. The 6-year cumulative survival rate was significantly higher for patients with a patent reconstruction after
1 year and also for those who did not have amputations, despite an occluded reconstruction, compared with those
who underwent an amputation. This was particularly true after surgery, whereas after PTA only a patent segment
indicated a better cumulative survival rate.13
National vascular registries have a great impact on the attitude of vascular surgeons, provided that they are
involved in the process. Discussions and debates regarding the outcome of the registry variables might help to
understand drawbacks of treatments or variations in outcomes. At the very least, it is helpful to find out whether
treatments are of value for a particular patient category, for instance, whether a distal bypass procedure is of any
lasting benefit for the patient or whether severe complications to carotid surgery might reduce the value of carotid
endarterectomy.

CRITICAL ISSUE 43: Influence of vascular registries on patient management

There is a need to establish how vascular registries benefit the management of patients with periph-
eral arterial disease on a population basis.

References
1. Moore WS. Carotid endarterectomy: is it safe in the community? J Vasc Surg 1986;4:313-314.
2. Rich NM, Hughes CW. Vietnam vascular registry: a preliminary report. Surgery 1969;65:218-226.

277
 3. Plecha FR, Avellone JC, Beven EG, DePalma RG, Hertzer NR. A computerized vascular registry: experience of the Cleve-
land Vascular Society. Surgery 1979;86:826-835.
4. Karmody AM, Blumenberg RM, Wall CA. Preliminary experience with a large scale vascular registry. Am J Surg 1983;146:162-
163.
5. Karmody AM, Fitzgerald K, Branagh M. Leather RP. Development of a computerized vascular registry for large scale use. J
Vasc Surg 1984;1:594-600.
6. Auditing Surgical Outcome: 10 years with the Swedish Vascular Registry (SWEDVASC). Eur J Surg 1998;164(suppl)581.
7. Jensen LP, Schroeder TV, Madsen PV, Lorentzen JE. Vascular registers in Denmark based on personal computers. Ann Chir
Gynaecol 1992;81:253-256.
8. Lepntalo M, Salenius JP, Albck A, Ylnen K, Luther M. Frequency of repeated vascular surgery. A survey of 7616 surgi-
cal and endovascular Finnvasc procedures. Finnvasc Study Group. Eur J Surg 1996;162:279-285.
9. Lepntalo M, Salenius JP, Harjola PT. Trends in vascular surgery: an evaluation of operative activity in Finland 1976-1992.
Ann Chir Gynecol 1996;85:225-229.
10. Salenius JP. National vascular registry in Finland-Finnvasc. Finnvasc STUDY GROUP. Ann Chir Gynaecol 1992;81:257-260.
11. Elfstrm J, Stubberd A, Troeng T. Patients not included in medical audit have a worse outcome than those included. Int J
of Quality Health Care 1996;8:153-157.
12. Jensen LP, Nielsen OM, Schroeder TV. The importance of complete follow-up for results after femoro-infrapopliteal vascular
surgery. Eur J Vasc Endovasc Surg 1996;12:282-286.
13. Zdanowski Z, Troeng T, Norgren L. Outcome and influence of age after infrainguinal revascularization in critcal limb ischemia.
Swedish Vascular Registry (SWEDVASC). Eur J Vasc Endovasc Surg 1998;16:137-141.
14. Rutherford RB. Reporting standards for endovascular surgery: should existing standards be modified for newer procedures?
Semin Vasc Surg 1997;10:197-205.
15. Rutherford RB. Acute limb ischaemia: clinical assessment and standards for reporting. Semin Vasc Surg 1986;4:80-94.
16. Rutherford RB, Flanigan PD, Gupta SK, et al. Suggested standards for reports dealing with lower extremity ischemia. Pre-
pared by the Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery/North American Chapter, International
Society for Cardiovascular Surgery. J Vasc Surg 1986;4:80-94.
17. Effects of perioperative iloprost on patency of femorodistal bypass grafts. The Iloprost Bypass International Study Group. Eur
J Vasc Endovasc Surg 1996;12:363-371.
18. Reoperations, redo surgery and other site interventions constitute more than one third of vascular surgery. A study from Swed-
vasc (the Swedish Vascular Registry). The Swedish Society for Vascular Surgery. Eur J Vasc Endovasc Surg 1997;14:244-
251.

278
 Other Treatment Modalities
The treatment modalities considered here are not necessarily confined to CLI patients but are sometimes also
used in claudicants.

Transfusion of Ultraviolet Irradiated Autologous Blood

This technique is widely used in patients with PAD in all stages, mostly in eastern countries of Europe and Rus-
sia. Photohemotherapy consists of ultraviolet radiation of autologous blood. Although a few uncontrolled studies
showed an improvement of rheological properties of the blood, there is no controlled prospective study in patients
with IC or CLI showing a clear clinical benefit for the treated patients.1

Hyperbaric Oxygen
The initial reports on the use of hyperbaric oxygen in patients with early gangrene of the legs were encourag-
ing, because relief of pain was obtained and amputations could be postponed, even for several years.2 3 In an
uncontrolled study, 18% of diabetic patients with ulcers refractory to conventional treatment had complete heal-
ing, but all made at least a fair response. Seventy-five percent of atherosclerotic ulcers in nondiabetic patients
improved sufficiently to allow patients to return home and resume daily activities.4 The longest and largest expe-
rience was reported by Fredenucci,5 who collected data on more than 2,000 patients treated in over 70,000 ses-
sions between 1966 and 1983. Relief of rest pain and healing of limiting ulcers was observed in one third of patients
after 4 to 6 weeks of treatment. The therapy is cumbersome, and it is also unclear to what extent the clinical results
can be attributed to concomitant therapy, including heparin infusion. All of the reported studies were uncontrolled.
This treatment cannot be recommended until prospective controlled trials have shown it to be beneficial.

Local treatment with hyperbaric oxygen

Although local hyperbaric oxygen with topical hyperbaric oxygen chamber technique has undergone real waves
of enthusiasm, its use for treatment of ulcers due to CLI or for stump healing problems,6 7 remains to be more
clearly demonstrated by randomized clinical trials.

Ambulation, Intermittent Venous Compression, Negative Pressure Application

Limited walking and intermittent compression of the foot, calf, or both have been shown to increase blood flow
and foot TCPO2 in limbs with PAD.8-13 Limited walking in patients with chronic CLI was suggested in the Second
European Consensus Document on Chronic Critical Limb Ischemia,14 and Foley reported on the treatment of gan-
grene by walking.15 There is some evidence that increased blood flow in response to walking or intermittent venous
compression may be contributed to further in some cases by the inhibition of veno-arteriolar reflex vasoconstric-
tion or by endothelium-mediated mechanisms.11 12 Similarly, application of external negative pressure to the leg
increased skin blood flow in the foot of patients with PAD and increased walking distance in patients with IC.16 17
These and similar approaches may be of benefit in the management of patients with PAD, especially when inter-
ventional treatment is not indicated, but their value needs to be assessed by properly designed clinical trials.

CRITICAL ISSUE 44: Limited walking, intermittent pneumatic compression, negative pressure application
in peripheral arterial disease
There is a need for properly designed studies to determine the benefit of limited walking, intermittent
pneumatic compression, and negative pressure application in treatment of peripheral arterial disease.

Epidural Spinal Cord Stimulation

In some vascular centers in Europe, spinal cord stimulation (SCS) has been used since the late 1960s in

279
patients with intractable pain caused by CLI, as an alternative to amputation. The technique involves implantation
of an electrode at the level of L3L4 and a pulse generator subcutaneously. This method is used not only to relieve
leg pain but also as a means of maintaining circulation in the leg. In one uncontrolled study, 94% of the 38 patients
treated with SCS experienced pain relief, and in half of the patients, healing of ischemic ulcers occurred.18 In
another uncontrolled study, immediate relief of rest pain was seen in 18 of 20 CLI patients. Of these, 12 patients
had continued pain relief and healing of ischemic ulcers, with improved microcirculatory flow suggested by capil-
laroscopy.19 Nevertheless, the real mechanism of action of SCS is unknown, and the appropriate place for this
form of therapy remains to be determined. Prospective studies are needed to show the value of SCS20 21 (see
also Control of Pain, p. 209).
Two controlled studies have been published on the efficacy of SCS in patients with inoperable severe CLI.22 23 In
the first study, patients with inoperable severe CLI were randomized to either SCS or analgesic treatment only
with 18 months follow-up.22 Long-term pain relief was observed only in the SCS group. Limb salvage rates did
not differ at the end of the follow-up period, although tissue loss was significantly less in the SCS group, and a
subgroup analysis showed that patients without arterial hypertension had a lower amputation rate if treated with
SCS.22 In the second study, patients with inoperable severe CLI were randomized to either SCS plus best med-
ical treatment or best medical treatment only.23 Median follow-up was 605 days (interquartile range, 2441,771).
There was no difference in mortality between the two groups, and the major amputation rate was insignificantly
lower in the SCS plus medical treatment group (42% vs 48%, p = 0.47).

RECOMMENDATION 100: Spinal cord stimulation in critical limb ischemia

On current evidence, spinal cord stimulation cannot be recommended in the treatment of critical limb
ischemia.

Chelation Therapy
Chelation therapy has been promoted as a means to treat atherosclerosis and relieve symptoms of cardio-
vascular disease. However, there is no scientific basis to support these claims. Four randomized, double-blind,
multicenter trials of ethylenediaminetetra-acetic acid (EDTA) in patients with PAD have been recently reviewed.24
The drug was not shown to be effective in treating the symptoms of claudication in any of these studies, nor in
improving the ABPI. Furthermore, frequent infusions of EDTA may produce severe hypocalcemia and therefore
actually may be dangerous.

RECOMMENDATION 101: Chelation therapy in peripheral arterial disease

There is no scientific basis for the use of chelation therapy in the treatment of peripheral arterial dis-
ease.

Sympathectomy in the Management of Critical Limb Ischemia

Among patients with atherosclerotic arterial occlusion or thromboangiitis obliterans, lumbar sympathec-
tomy has been limited to patients with inoperable disease complicated by rest pain and tissue loss.

Sympathectomy to treat ischemic rest pain

Symptom relief has been reported in 47% to 71% of unselected patients, with limb salvage in 60% to 94%.25
The best results were obtained by Persson26 among 37 patients who had an ABPI greater than 0.3, no evidence

280
of neuropathy, and very limited tissue necrosis. In this series, 78% of patients had long-term relief of ischemic
pain, and 11% required amputation. The worst results were noted by Fulton and Blakely27 in 17 unselected patients
undergoing sympathectomy, with only 6% obtaining relief, whereas 70% required early amputation. Disappointing
results therefore can be expected when limb-threatening ischemia is unselectively treated by sympathectomy.

Sympathectomy to treat tissue loss

Less impressive results than for rest pain are generally noted, with 35% to 62% of patients showing complete
initial healing of the ischemic lesions. In addition, amputation rates were higher than in the rest pain group, with
a range of 27 to 38%.25 Persson et al.26 again reported the best results in 22 patients who had adequate inflow,
no neuropathy, and no evidence of infection; 77% had ulcer healing, and only 22% required amputation.

Sympathectomy as an adjunct for lower-extremity revascularization

Because lumbar sympathectomy increases lower-extremity blood flow at least temporarily, it has been sug-
gested as an adjunct during aortoiliac reconstruction in an attempt to improve outflow and graft patency. How-
ever, subsequent randomized trials failed to show any difference in clinical outcome or graft patency when sym-
pathectomy was added during aortofemoral bypass.28 29 Thus, this technique is no longer practiced. There have
not been trials of the effect of sympathectomy on infrainguinal bypass patency or efficacy, but the requirement
for a separate incision discourages this approach. A benefit of temporary chemical sympathectomy provided by
epidural anesthesia was suggested in one randomized trial that showed improved early infrainguinal graft patency.
30 However, two subsequent trials failed to show this effect.31 32 Currently, there is no established role for adju-

vant surgical sympathectomy to improve bypass graft patency or efficacy.

Current indications for lumbar sympathectomy

Primary indications for lumbar sympathectomy are limited to selected patients with inoperable distal arterial
occlusive disease secondary to arteriosclerosis or thromboangiitis obliterans. Current determination of inoperability
differs with expertise and availability of saphenous vein. In rare cases in which such revascularization procedures
are not feasible because of inadequate run-off, lumbar sympathectomy may be considered in the patients with (1)
ABPI greater than 0.3; (2) superficial tissue necrosis limited to digits; (3) absent neuropathy (diabetes); (4) symp-
tom relief after lumbar sympathetic blockade, and (5) acceptable surgical risk for a retroperitoneal approach. The
most common complications of lumbar sympathectomy are temporary neuralgia and inadequate clinical improve-
ment.26

RECOMMENDATION 102: Lumbar sympathectomy in critical limb ischemia

There is currently insufficient scientific evidence for the selection of patients likely to benefit from lum-
bar sympathectomy for the treatment of critical limb ischemia.

281
 References
1. Karandashov VI, Petukhov EB, Karalkin AV. The regional hemodynamics in patients with chronic arterial insufficiency of the
lower extremities after the transfusion of UV-irradiated autologous blood. Vestn Khir Im II Grek 1996;155(2):76-78.
2. Illingworth CFW. Treatment of arterial occlusion under oxygen at two atmospheres pressure. Br Med J 1962;2:1272.
3. Koomen AR. The influence of hyperbaric oxygen in chronic arterial obstruction of the peripheral arteries. J Cardiovasc Surg
1967;8:335-337.
4. Hart GB, Strauss MB. Responses of ischemic conditions to OHP. In: Smith G, ed. Hyperbaric Medicine. Aberdeen: Aberdeen
University Press, P312-314.
5. Fredenucci P. Oxygenotherapie hyperbare et arteropathies. J Mal Vasc 1985;10(Suppl A):166-172.
6. Fischer BH. Treatment of ulcers on the legs with hyperbaric oxygen. J Dermatol Surg 1975;1:55-58.
7. Diamond E, Forst MB, Hyman SA, Rand SA. The effect of hyperbaric oxygen on lower extremity ulcerations. J Am Podiatry
Assoc 1982;72:180-185.
8. Spacil J, Hlavova A, Linhart J, Prerovsky I. The effect of slow walking on the subcutaneous blood flow in the leg in patients
with ischemic disease of lower limbs. Vasa 1976;5:323-328.
9. Gaskell P, Parrott JC. The effect of a mechanical venous pump on the circulation of the feet in the presence of arterial obstruc-
tions. Surg Gynaecol Obstet 1978;146:583-592.
10. Carter SA. Effects of ambulation on foot oxygen tension in limbs with peripheral atherosclerosis. Clin Physiol 1996;16:199-
208.
11. Morgan RH, Carolan G, Psaila JV, Gardner AM, Fox RH, Woodcock JP. Arterial flow enhancement by impulse compression.
Vasc Surg 1991;25:8-15.
12. van Bemmelen PS, Mattos MA, Faught WE, Mansour MA, Barkmeier LD, Hodgson KJ, et al. Augmentation of blood flow in
limbs with occlusive arterial disease by intermittent calf compression. J Vasc Surg 1994;19:1052-1058.
13. Eze AR, Comerota AJ, Cisek PL, Holland BS, Kerr RP, Veeramasuneni R, et al. Intermittent calf and foot compression
increases lower extremity blood flow. Am J Surg 1996;172:130-134.
14. Second European Consensus Document on Chronic Critical Leg Ischaemia. European Working Group on Critical Leg
Ischaemia. Eur J Vasc Surg 1992;6(Suppl A):1-32.
15. Foley WT. Treatment of gangrene of the feet and legs by walking. Circulation 1957;15:689-700.
16. Agerskov K, Tofft HP, Jensen FB, Engell HC. External negative thigh pressure: effect upon blood flow and pressure in the
foot in patients with occlusive arterial disease. Dan Med Bull 1990;37:451-4.
17. Mehlsen J, Himmelstrup H, Himmelstrup B, Winther K, Trap-Jensen J. Beneficial effects of intermittent suction and pressure
treatment in intermittent claudication. Angiology 1993;44:16-20.
18. Augustinson LE, Carlson CA, Holm J, Jivegard L. Epidural electric stimulation in severe limb ischemia. Pain relief, increased
blood flow and a possible limb-saving effect. Ann Surg 1985;202:104-110.
19. Jacobs MJ, Jorning PJ, Beckers RCY, Ubbink DT, van Kleef M, Slaf DW, et al. Foot salvage and improvement of microvas-
cular blood flow as a result of epidural spinal cord electrical stimulation. J Vasc Surg 1990;12:354-360.
20. Skinner JA, Cohen AT. Amputation for premature peripheral atherosclerosis: do young patients do better? Lancet
1996;348:1396.
21. Tallis R, Jacobs M, Miles J. Spinal cord stimulation in peripheral vascular disease. Br J Neurosurg 1992;6:101-105.
22. Jivegard LE, Augustinsson LE, Holm J, Risberg B, Ortenwall P. Effects of spinal cord stimulation (SCS) in patients with inop-
erable severe lower limb ischemia: a prospective, randomised, controlled study. Eur J Vasc Endovasc Surg 1995;9(4)421-
425.
23. Spincemaille GH, Steyerberg EW, Habbema JD, van Urk H, for the ESES Study. Spinal-cord stimulation in critical limb
ischaemia: a randomised trial. ESES Study Group. Lancet 1999;353:1040-1044.
24. Ernst E. Chelation therapy for peripheral arterial occlusive disease: a systematic review. Circulation 1997;96;1031-1033.
25. Walker PM, Johnston KW: Predicting the success of a sympathectomy: a prospective study using discriminant function and
multiple regression analysis. Surgery 1980;87:216-221.
26. Persson AV, Anderson LA, Padberg FT. Selection of patients for lumbar sympathectomy. Surg Clin North Am 1985;65:393-
403.
27. Fulton RL, Blakeley WR. Lumbar sympathectomy: a procedure of questionable value in the treatment of arteriosclerosis oblit-
erans of the legs. Am J Surg 1968;116:735-744.
28. Satiani B, Liapis CD, Hayes JP, Kimmins S, Evans WE. Prospective randomized study of concomitant lumbar sympathec-
tomy with aortoiliac reconstruction. Am J Surg 1982 Jun;143(6):755-760.
29. Barnes RW, Baker WH, Shanik G, Maixner W, Hayes AC, Lin R, Clarke W. Value of concomitant sympathectomy in aortoil-
iac reconstruction: results of a prospective, randomized study. Arch Surg 1977 Nov;112(11):1325-1330.
30. Perler BA, Christopherson R, Rosenfeld BA, Norris EJ, Frank S, Beattie C, et al. The influence of anesthetic method on
infrainguinal bypass graft patency: a closer look.Am Surg 1995;61(9):784-789.
31. Schunn CD, Hertzer NR, OHara PJ, Krajewski LP, Sullivan TM, Beven EG. Epidural versus general anesthesia: does anes-
thetic management influence early infrainguinal graft thrombosis? Ann Vasc Surg 1998;Jan 12(1):65-69.
32. Pierce ET, Pomposelli FB, Stanley GD, Lewis KP, Cass JL, LoGerfo FW, et al. Anesthesia type does not influence early graft
patency or limb salvage rates of lower extremity arterial bypass. J Vasc Surg 1997;Feb;25(2):226-232; discussion 232-233.

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 Amputation
Because patients with severe lower extremity ischemia have a high incidence of coexisting myocardial, cere-
brovascular and renal disease, their operative risk is significantly elevated. Therefore the indications for amputa-
tion, selection of the appropriate level and surgical management of these patients must clearly be established prior
to the procedure to avoid the need for revision or re-amputation (see Risk Factors for Major Amputation, p. 26).

Indications for Amputation

Primary amputation

Primary amputation is defined as amputation of the ischemic lower extremity without an antecedent attempt at
revascularization. Amputation is considered as primary therapy for lower limb ischemia only in selected cases.
Unreconstructable arterial disease is generally due to the progressive nature of the underlying atherosclerotic
occlusive disease.
Newer imaging techniques, such as magnetic resonance angiography, duplex ultrasonography, and more
recently, high-resolution digital angiography, have improved the ability of physicians to pre-operatively detect
patent distal vessels that might serve as suitable recipient sites for the construction of a bypass.1 The complete
absence of detectable distal vessels, using modern imaging techniques, especially in the setting of advanced
distal ischemia associated with a low ABPI (<0.30), suggests that vascular reconstruction is not possible and
that major amputation is inevitable.2 3 These patients are best served by primary amputation.4

Ulceration and necrosis of the weight-bearing surface of the foot are frequent causes of amputation. In a
recent study of more than 200 patients requiring amputation loss of the foot pads at the level of the digits,
metatarsophalangeal joints and the heel was the indication for amputation in more than 75% of cases.5
Loss of the heel renders revascularization useless for preservation of ambulation.6 The use of myocuta-
neous free flaps for the replacement of necrotic muscle and skin has been reported as a technique for extend-
ing limb salvage in selected patients.7 This aggressive vascular reconstructive effort, however, may be associ-
ated with multiple procedures, a recuperative period of more than 6 months and yields flap survival in the range
of 50% to 62% and a functional foot in 50% to 86%, respectively.8-11 As vascular reconstruction in these patients
does not result in a functional extremity, primary amputation provides optimal therapy.

Nonambulatory elderly patients represent a particularly challenging group. Peripheral arterial occlusive disease
is often severe and associated with rest pain and tissue loss. These patients frequently have flexion contractures
which form from the prolonged withdrawal response to the pain. Aggressive vascular reconstruction does not pro-
vide these patients with a stable and useful limb. The surgical endeavor is significantly complicated by the pres-
ence of the flexion contraction as well as the frequent presence of decubitus ulcers in the region of the greater
trochanters.
These patients require only a stable, pain-free limb that can be used for positioning in bed or wheelchair. Relief
of pain and the removal of necrotic tissue and the creation of a stable limb can be most expeditiously achieved
through primary amputation.4 12

Finally, PAD patients with terminal or near terminal comorbid conditions often have physical as well as ethical
contraindications to aggressive lower-extremity arterial reconstructive surgery. These patients require relief from
pain of all etiologies.
Amputation affords these individuals expeditious relief of pain and a reduced hospital stay for definitive treat-
ment of their ischemia. Most remain non-ambulatory after amputation, regardless of the level.

283
 RECOMMENDATION 103: Indications for primary major amputation of the lower extremity
Primary major amputation for critical limb ischemia is indicated in advanced distal ischemia with uncon-
trollable pain or infection in the setting of:
unreconstructable arterial occlusive disease;
necrosis of significant areas of weight-bearing portion of the foot;
fixed, unremediable flexion contracture of the leg;
a terminal illness or very limited life expectancy because of comorbid conditions.

CRITICAL ISSUE 45: Selection of patients for primary major amputation

There is a need for data to determine predictors for which patients are best treated with primary major
amputation rather than bypass therapy for limb salvage.

Secondary amputation
Revascularization of the lower extremity remains the treatment of choice for most patients with significant arte-
rial occlusive disease.13-16 Re-do vascular reconstructive procedures are also of benefit for limb salvage and the
preservation of ambulatory ability.17 Unfortunately, in many patients, the continued progression of atherosclerosis
obliterates all major distal vessels, eliminating the possibility of further reconstruction.
Unreconstructable vascular disease has become the most common indication for secondary amputation, account-
ing for nearly 60% of patients.6 Persistent infection despite aggressive vascular reconstruction is the second most
common diagnosis.18 The goals of secondary amputation are the relief of ischemic pain, the complete removal of
all diseased, infected and necrotic tissue, the achievement of complete healing and the construction of a stump
suitable for ambulation with a prosthesis. The antecedent surgical procedures do not worsen the overall condition
of the leg. Failure of a lower-extremity vascular reconstruction does not predispose the patient to a higher level of
amputation.19 20 Therefore, initial attempts at vascular reconstruction of the lower extremity are indicated. Sec-
ondary amputation is indicated when vascular intervention is no longer possible or when the limb continues to
deteriorate despite the presence of a patent reconstruction.

Selection of Amputation Level

It is the implicit goal of amputation to obtain primary healing of the lower extremity at the most distal level pos-
sible. The energy expenditure of ambulation increases as the level of amputation rises from calf to thigh. Preser-
vation of the knee joint and a significant length of the tibia permits the use of lightweight prostheses, minimizes
the energy of ambulation, and enables older or more frail patients to walk independently.21 Therefore, the lowest
level of amputation that will heal is the ideal site for limb transection. Numerous methods have been used to iden-
tify this most distal site.
Historically, the most distal level of amputation that will heal has been determined by clinical examination of
the leg by the surgeon immediately before surgery. Factors that are most frequently considered include the warmth
and integrity of the skin, capillary refill, palpably normal muscle and the absence of infection at the site selected
for amputation. Attempts have been made to quantify skin temperature by objective measurement but this has
been of little proven value.22 Although the presence of a palpable pulse in the major artery immediately above
the level of amputation selected strongly suggests a high likelihood of primary healing, the absence of a palpa-
ble pulse does not in itself significantly reduce the likelihood of primary healing.23 24
The selected site is usually further evaluated in the operating room by the surgeon who observes the appear-
ance of the subcutaneous tissue and muscle and the presence or absence of bleeding from the transected tis-
sues. The appearance of ischemic or necrotic tissue or the absence of bleeding along the margins of transection

284
are used as indications to attempt amputation at a higher level. When made by experienced surgeons, clinical
determination of the amputation level results in uninterrupted primary healing of the below-knee stump in 75% to
85% and the above-knee stump in 85% to 93% of cases25-27 (see also Risk Factors for Major Amputation, p.
26).

Doppler pressure measurement

As Doppler pressure measurements became standardized for the assessment of PAD, they were applied to
the evaluation of the extremity requiring amputation. Initial results reported more than a decade ago suggested
that this non-invasive diagnostic study could identify the appropriate level of amputation. Using a discriminatory
arterial pressure of greater than 50 mm Hg at the level of amputation, several investigators reported primary heal-
ing in nearly 100% of patients.24 28 29 Despite these optimistic early reports, others have reported little benefit from
the pre-operative Doppler assessment of patients requiring amputation.22 30 31 Patients with severe lower-extrem-
ity arterial occlusive disease often have diffuse calcified atherosclerosis resulting in falsely elevated arterial pres-
sures. Those with long-standing rest pain frequently have significant edema preventing accurate pressure mea-
surement. Wagner and colleagues, in a study of 109 amputations, found that Doppler pressure measurements
were unreliable for the selection of amputation level.22
Determination of ankle and toe blood pressures may provide information about the likelihood of healing of infra-
malleolar amputations. These pressures, unfortunately, may not be measurable in patients with toe or foot lesions
requiring excision therapy because of calcification of the distal vessels or the presence of ulceration or gangrene
at the site of measurement. In a study of 161 consecutive diabetic patients who presented with foot lesions, Lars-
son and colleagues32 noted that ankle and toe pressures could not be obtained in 24% and 27%, respectively.
These investigators found no healing of a foot amputation with an ankle pressure of less than 50 mm Hg and no
healing of a toe amputation with a toe pressure less than 15 mm Hg.
In a study of 233 consecutive diabetic patients with foot infection, Eneroth and colleagues noted that an ankle
pressure greater than 80 mm Hg and a toe pressure of greater than 45 mm Hg are associated with primary heal-
ing of forefoot and toe amputations, respectively.33 Selection of the appropriate level of foot amputation is not
enhanced by determination of the ABPI.30 However, most vascular specialists routinely obtain Doppler arterial
assessments of patients with significant lower extremity ischemia and this diagnostic modality continues to be
widely used as a supportive study for the determination of the site of amputation.

Transcutaneous oxygen measurement

Transcutaneous oxygen determination by a small electrode attached to the skin has been used for the detec-
tion of viable skin and appropriate level of amputation for more than two decades. This electrode heats the under-
lying skin slightly to induce a hyperemia. It then records the increase in oxygen delivery as pressure. A reference
electrode, usually on the chest, is frequently used to standardize the result. Modifications of this diagnostic study
include the continuous recording of TCPO2 before and during the inhalation of oxygen34-36 and with the patient in
the supine, sitting, and leg elevated positions.36 37 The ability of the transcutaneous measurement of capillary skin
oxygen pressure to predict the likelihood of healing of a major amputation is dependent upon the discriminatory
value chosen.
A TCPO2 value of greater than 20 mm Hg at the site of amputation indicates an 80% likelihood of primary heal-
ing.38 Using a higher discriminatory pressure at the site of amputation may improve the chances for primary heal-
ing. With a TCPO2 pressure of greater than 35 mm Hg, several surgical groups have reported healing in more
than 95% of patients.22 37 39 40 Because skin perfusion may not be uniform, several measurements across the site
of amputation may be of benefit to determine areas of persistent ischemia.41 42 Overall, transcutaneous oxygen
pressure measurements may improve the surgeons clinical ability to determine the lowest amputation site that
will heal primarily.

285
Skin perfusion pressure measurement
Photoplethysmographic skin perfusion pressure measurement is a simple test performed by fixing a photo-
electrode on the patients skin at the proposed site of amputation and then surrounding it with a blood pressure
cuff. The cuff is inflated beyond systolic pressure eliminating all cutaneous skin flow and reducing skin perfusion
pressure to zero. The air is then slowly released from the cuff and the pressure at which capillary flow resumes
is detected by the photoelectric cell is considered the skin perfusion pressure.43 A variant of this test uses a laser
Doppler to detect the presence of flow in the skin.44 This measurement has been used to select the appropriate
site of amputation. With a discriminatory skin pressure of greater than 20 mm Hg as determined by photoelectric
cell, healing in more than 90% of patients can be expected.23 43 For laser Doppler pressure determination, a skin
perfusion pressure of greater than 30 mm Hg correlated with primary healing of the major amputation in all patients.44

Other diagnostic tests

Numerous other diagnostic tests designed to improve the rate of primary healing of a major amputation have
been reported. These include laser Doppler velocimetry which measures the velocity of skin capillary blood flow,45
isotopic measurement of skin perfusion with xenon-133,46 47 and fluoroscein dye assessment of skin perfusion.22
Each of these tests have had proponents, but, because of technical difficulty, significant variability of the test result,
or cost, they have not been widely used, and available information is limited (see Microcirculatory Investigations,
p. 194).

CRITICAL ISSUE 46: Diagnostic tests for selection of amputation level

There is a need for prospective studies to demonstrate that diagnostic tests improve selection of ampu-
tation level over clinical judgment.

Technical Principles of Amputation

Ray amputation48 and transmetatarsal amputation are the standard procedure distal to the ankle. The Lisfranc,
Chopart and Syme amputations are now rarely used, but can occasionally be useful in avoiding a below knee
amputation.49-51 A major amputation, that is above the foot, will require a prosthesis and meticulous technique is
essential to ensure a well-formed and well-perfused stump with soft tissue covering the transected end of the bone.
Major amputations are usually performed at the below-knee or above-knee level. However, a through-knee ampu-
tation has the advantage of a long lever for mobility and balance in bed in patients who are unlikely to be able to
use a prosthesis. It is possibly also indicated in extremely ill patients in whom a quick and less traumatic proce-
dure crucial. It is essential that antibiotic cover is provided for all patients undergoing amputations for ischemia to
prevent gas gangrene.

Outcome
The outcome of major amputation (see Fate of the Amputee, p. 27; and Summary: Major Amputation,
p. 28) and relatively high risk of re-amputation is detailed earlier (see Major Amputation, p. 26). The same
discussion applies to forefoot and toe amputations. In a study of 90 diabetic patients who had a great toe
amputation, 60% required a second amputation, 21% had a third, and 7% had a fourth.52 Overall, 17% sub-
sequently had a below-knee amputation. Similarly, Armstrong and colleagues reviewed the outcome of 1043
patients who had foot amputations. Of these, nearly 40% required a more proximal foot amputation to treat
a non-healing distal amputation.53 Distal ischemia is a frequent cause of non-healing transmetatarsal ampu-
tations requiring re-treatment by major amputation in patients with diabetes.54
A return to independent ambulation is the ultimate challenge for patients undergoing major amputation of the
lower extremity. Patients with a well-healed below-knee amputation stump have a 66% to 81% likelihood of inde-

286
pendent ambulation with a prosthesis. Those with an above-knee amputation have a less than 50% chance of
independent ambulation. Compared with an above-knee amputation55 56 the through-knee level provides a longer
stump for better leverage and movement and a greater likelihood of rehabilitation and ambulation with a prosthe-
sis.57-62 Independent ambulation with a prosthesis has been reported in 44% to 57%.61 62 Cardiac and pulmonary
limitations are the most common causes of failure to establish independent mobility.56 63
Although a conceptually simple and brief technical procedure, major amputation of the lower extremity is asso-
ciated with a significant morbidity and mortality. Operative mortality for major amputation of the lower extremity
ranges from 4% to 30%.18 21 Myocardial infarction is the most common cause of death in the perioperative period.18
Morbidity is also high after major amputation of the lower extremity, reported from 20% to 37%.16 18 64 Myocardial
infarction, stroke, and infection are the most significant causes (see also Major Amputation, p. 26).
The incidence of infection may rise to as high as 67% in patients with infected ischemic extremities before
amputation.65 The incidence of postoperative deep venous thrombosis ranges from 12.5% to 14.3%.66 67 Phan-
tom limb pain, though rarely reported, occurs in most patients after amputation and can be quite disturbing. Finally,
progression of occlusive disease resulting in loss of the contralateral extremity occurs in approximately 10% per
year.21 64 The contralateral extremity of patients undergoing major amputation of the lower extremity therefore must
be evaluated at 3- to 6-month intervals with physical examination and ABPI to identify and correct worsening
ischemia. Continued vigilance by both the patient and physician is essential in the care of patients requiring major
amputation for ischemia.

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 Management algorithm for patients with CLI

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