November 2002
Circulatory Assist Units, Intra-Aortic Balloon
Scope of this Product Comparison
This Product Comparison covers intra-aortic bal-
loon pump (IABP) consoles and intra-aortic balloon
(IAB) catheters. IAB catheters are disposable and
are often supplied by the IABP manufacturer. Ac-
cessories such as balloon interconnects (for use
when one manufacturer’s balloon is used on an-
other manufacturer’s IABP), training simulators,
and cardiac-output computers are not included. For
more information, see the Product Comparison ti-
tled CARDIAC OUTPUT UNITS, THERMAL DILUTION.
UMDNS information
This Product Comparison covers the following
device term and product code as listed in ECRI’s
Universal Medical Device Nomenclature System™
(UMDNS™):
• Circulatory Assist Units, Intra-Aortic Balloon
[10-846]
Purpose
The IABP is a mechanical counterpulsation device
that benefits the patient by reducing afterload as well
as increasing coronary and systemic blood flow. A
balloon is placed in the aorta, and its inflation and
deflation results in a more favorable myocardial sup-
ply-and-demand balance. This balance reduces after-
load and augments the heart’s diastolic pressure,
leading to an increased cardiac output (Christenson et
al. 1997). Because IABP therapy reduces the workload
and oxygen demand of the heart while increasing oxy-
gen supply and cardiac output, it can be used to treat
a number of cardiovascular conditions. IABPs provide
214897 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA
424-008 Telephone +1 (610) 825-6000 ● Fax +1 (610) 834-1275
additional support to pharmacologic treatments to par-
tially restore cardiac function, as well as act as an aid
to the heart before, during, and after cardiac surgery.
IAB pumping is often used to treat patients with
unstable angina, patients who have suffered a myocar-
dial infarction (augmenting coronary perfusion helps
develop collateral circulation to aid the healing of
ischemic areas of the myocardium) or other pump
failure, and patients undergoing percutaneous trans-
luminal coronary angioplasty or myocardial revascu-
larization. It is also used for weaning patients with
inadequate cardiac output from cardiopulmonary by-
pass surgery.
Principles of operation
The coronary arteries, which originate at the base
of the ascending aorta, supply blood and oxygen to the
heart. As the heart contracts (systole), these vessels
are compressed, reducing coronary perfusion. As a
result, 70% to 90% of coronary perfusion occurs during
the heart’s filling stage (diastole). To assist in the
perfusion of the coronary arteries, the counterpulsa-
tion technique — inflation and deflation in synchrony
with the cardiac cycle — was developed.
In preparation for counterpulsation, the balloon
catheter, which is mounted on a flexible radiopaque
catheter, is inserted, typically percutaneously with a
guide wire through the femoral artery into the aorta.
Less commonly, the balloon catheter can also be surgi-
cally placed into the aorta using a prosthetic graft. The
balloon catheter is attached to the IABP console, which
displays heart rate, arterial pressure, balloon pressure
and volume, alarm conditions, setup instructions, and
electrocardiogram (ECG) readings. The console uses
the R wave of the ECG for automatic timing control for
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Healthcare Product Comparison System

the inflation and deflation of the balloon. Balloons are

available in several volumes; 30 to 50 cc balloons are
most commonly used for adult patients. Pediatric sizes
from 2.5 to 20.0 cc are also available, although not all
IABPs can accommodate them.
The IAB forces the blood toward the heart during
each diastolic phase of the cardiac cycle. During this
phase, the aortic valve is closed, and the blood is
channeled into the coronary and carotid arteries, in-
creasing coronary and cerebral perfusion (see Fig. 1).
Blood is also displaced systemically as the balloon is
inflated, improving systemic perfusion. Catheters are
typically double lumen and have an outer gas lumen
and a central lumen through which aortic pressures
can be monitored and dye can be injected to determine
the position of the balloon catheter.
The physician maneuvers the balloon catheter until
it occupies the descending aorta; fluoroscopy, chest
x-ray, or transesophageal echocardiography verifies
positioning. Balloon size is selected so that 75% to 90%
of the aortic lumen is occluded when the balloon is
inflated. The balloon is made of a thrombosis-resistant
polymer and has either one or two chambers. Dual-
chambered balloons are designed for unidirectional
flow (toward the heart); the more widely used single-
chambered balloons encourage bidirectional flow.
The balloon is cyclically inflated and deflated using
helium shuttle gas kept in a storage compartment in
the console. A pneumatic system automatically moves
a preset volume of gas to and from the balloon by
alternately applying pressure and vacuum. Helium is
a low-density gas that is better suited for pumping
(particularly with narrow catheters for percutaneous
insertion), and it is now used instead of carbon dioxide.
However, because of its small molecular size, helium
tends to diffuse through the balloon wall more rapidly
than carbon dioxide, requiring more frequent replen-
ishing; therefore, most pumps have automatic purging
and refilling at fixed intervals.
Inflation and deflation must be synchronized with
the cardiac cycle to maximize effectiveness. Timing
markers are displayed on the ECG or on the aortic
pressure waveform on the IABP monitor to indicate pressure or vacuum loss, balloon leak or disconnect,
inflation and deflation periods. The duration of each is power loss, heart rate change, or inflation during sys-
set to be a fraction of the diastolic and systolic intervals tole (late inflation). Inflate/deflate controls allow the
(see Fig. 2). Most units feature automatic timing adjust- adjustment of timing logic according to the patient’s
ment using beat-to-beat analysis of the ECG waveform heart rate. All the listed units have built-in electrosur-
to correct for rate changes and arrhythmias. Weaning gical interference suppression (ESIS) and pacemaker-
the patient from an IABP is accomplished by gradually signal rejection.
decreasing inflation volume or pumping frequency.
IAB pumping is sometimes performed during trans-
Audible and visual alarms may occur under the port, either within the hospital or in transit (e.g.,
following conditions: loss or change of trigger stimulus, between hospitals). Many IABPs include a battery

2 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Circulatory Assist Units, Intra-Aortic Balloon

Systole Diastole A number of clinical problems have been reported

in the literature. Perforation of the arterial wall during
To Carotid
Arteries insertion is an obvious danger, especially when nego-
tiating circuitous vessels. Total occlusion of the aorta
Aortic can result in aortic wall trauma and damage to red
Valve
blood cells and platelets; therefore, balloons should be
selected to be nonocclusive, according to appropriate
guidelines. The balloon should be periodically inflated
Inflated and deflated, regardless of the therapy, to prevent
Balloon thrombus formation in its folds when deflated. Other
problems include kinking, insertion into false chan-
Descending nels, and plaque dislodgment. Limb and kidney is-
Aorta chemia caused by poor circulation, trauma, or catheter
Coronary obstruction have also been reported.
Arteries
IABs are fragile and must be handled with care to
help prevent leaks. Although balloon perforations are
From ECG relatively rare, they are generally the problem most
Balloon Electrodes
commonly reported to ECRI, and they can have very
Catheter
serious consequences, such as gas embolism. The first
From Pressure indication of perforation is often blood in the catheter.
Transducer
Most reported perforations have been caused by calci-
Intra-aortic
fied plaques. Studies (Cohen et al. 1995; Cox et al.
Balloon Pump 1995) have shown that using smaller IABs in shorter
Control
patients may reduce the incidence of IAB perforations
because it enables the tip of the IAB to be positioned
C289UN3A

Femoral
Arteries
(Left and Right Leg)
Figure 1. Pumping action of a single-chambered
intra-aortic balloon; arrows indicate the direction of
blood flow
pack that allows over two hours of operation. Some
manufacturers offer additional battery packs for ex-
tended operation. Some units have handles and casters
for easier mobility and securing brackets for air or
ambulance transport.
Reported problems
Balloons of one manufacturer can be interconnected
to the pump of another manufacturer only after the
following criteria are met:
• The diffusion and purity of the shuttle gas are
compatible with the inserted balloon.
• The connections are leak-free.
within the descending thoracic aorta rather than the
abdominal aorta, which generally has more calcified
plaque. Other sources of perforations include abra-
sions and punctures that occur during handling and
introduction, as well as manufacturing defects. Manu-
facturers continue to improve the quality of balloon
materials and catheters. Careful review of the instruc-
tions for insertion and contraindications for use, along
with prompt removal when blood is observed in the
catheter, are the most prudent approaches to prevent-
ing injuries from perforated balloons. See “Intra-aortic
Balloon Perforations” in ECRI’s Health Devices (cited
below) for more information.
R R
Arterial
Pressure
T T
P P
ECG
Q Q
S
S

• The correct volume of shuttle gas is placed in the

C289UN3B

balloon. Balloon Deflated Inflated Deflated

State (Systole) (Diastole) (Systole)
• The inflation and deflation times are not compro-
mised by inadequate gas volumes or increased re-
sistance of interconnect components. Figure 2. Relationship among the ECG, arterial
• All alarm systems remain operative and unaffected pressure, and balloon state
by the interconnection.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 3
Healthcare Product Comparison System
Given that IABP patients are typically critically ill
and sometimes even balloon dependent, malfunction
of an IABP without a backup unit available can be
disastrous. While IABPs are generally very reliable,
they are complex devices, and malfunctions have been
known to occur in all brands. Therefore, ECRI recom-
mends that during in-hospital use, at least one backup
IABP be on hand at all times in case of malfunction.
Purchase considerations
The IABP is not appropriate for use in every hospital.
Patients require constant, intensive, highly skilled care
that is beyond the capability of many facilities. Compe-
tency involves regular use of the technology, which is a
problem if IABPs are in small hospitals that have infre-
quent opportunities to treat patients requiring an IABP.
Before purchasing an IABP, the hospital must assess its
ability to effectively use and support this technology.
IABPs are life-support systems; therefore, alarms
should be distinct and easily identified. Alarms asso-
ciated with critical parameters (e.g., trigger loss, vac-
uum loss, trigger change, balloon disconnect, balloon
leak, balloon overinflation) should activate both audi-
ble and visual alarms and deflate the balloon. If the
alarm is silenced, a visual display should clearly indi-
cate which alarm is disabled. It should also be possible
for the operator to silence certain alarms while leaving
others active.
The unit’s design should facilitate transport, includ-
ing operation and maneuverability in an elevator. The
pump should also protect against disconnection and
catheter dislodgment during transport and should be
rugged enough to withstand the mechanical shocks
that it may encounter during transport. In addition,
moving the pumps should not cause undue physical
strain to the clinical staff.
Cost containment
Because IABPs require the use of disposable balloon
catheters for each procedure, the pump’s initial acquisi-
tion cost does not accurately reflect the total cost of
ownership. Therefore, a purchase decision should be
based on issues such as life-cycle cost (LCC), local service
support, discount rates and non-price-related benefits
offered by the supplier, and standardization with exist-
ing equipment in the department or hospital (i.e., pur-
chasing all balloon catheters from one supplier).
An LCC analysis can be used to compare high-cost
alternatives and/or to determine the positive or nega-
tive economic value of a single alternative. For exam-
ple, hospitals can use LCC analysis techniques to
examine the cost-effectiveness of leasing or renting
4 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
equipment versus purchasing the equipment outright.
Because it examines the cash-flow impact of initial
acquisition costs and operating costs over a period of
time, LCC analysis is most useful for comparing alter-
natives with different cash flows and for revealing the
total costs of equipment ownership. One LCC tech-
nique — present value (PV) analysis — is especially
useful because it accounts for inflation and for the time
value of money (i.e., money received today is worth
more than money received at a later date). Conducting
a PV/LCC analysis often demonstrates that the cost of
ownership includes more than just the initial acquisi-
tion cost and that a small increase in initial acquisition
cost may produce significant savings in long-term op-
erating costs. The PV is calculated using the annual
cash outflow, the dollar discount factor (the cost of
capital), and the lifetime of the equipment (in years)
in a mathematical equation.
The following represents a sample seven-year
PV/LCC analysis for an IABP.
Present Value/Life-Cycle Cost Analysis
Assumptions
• Operating costs are considered for years 1 through 7
• Dollar discount factor is 6%
• The facility uses the IABP for 150 procedures/year
Capital Costs
• Balloon pump = $50,000
Total Capital Costs = $50,000
Operating Costs
• Balloon catheters for 150 procedures =
$112,500/year
Total Operating Costs = $112,500/year
PV = ($780,257)
Other costs not included in the above analysis that
should be considered for budgetary planning include
those associated with the following:
• Utilities
• Other disposables and accessories, including he-
lium
• Contributions to overhead
As illustrated by the above sample PV/LCC analy-
sis, the initial acquisition cost is only a fraction of the
total cost of operation over seven years. Therefore,
rather than making a purchase decision based solely
on the acquisition cost of a balloon pump, buyers

should consider operating costs over the lifetime of the
equipment.
For further information on PV/LCC analysis, cus-
tomized analyses, and purchase decision support,
readers should contact ECRI’s SELECT™ Group.
Because many hospitals do not purchase service
contracts or cannot afford to have a pump out of service
until a service representative responds, the ease of
servicing is often an important consideration. The
service and operator’s manuals should be comprehen-
sive, clearly written, and well organized. The pumps
should be designed to allow easy service and mainte-
nance. The printed circuit boards should be easily
accessed, and it should be easy to identify defective
boards. Some suppliers offer software to help the facil-
ity’s biomedical engineering staff diagnose equipment
problems and perform routine maintenance.
Stage of development
Many changes have occurred since IABPs were first
clinically used in 1968. Improvements in IABP tech-
nology — in particular, simplification of controls and
greater use of automation — have eased the initiation
and management of treatment. Manufacturers are
making the units smaller and lighter to facilitate
transport; reduce catheter diameter; and change bal-
loon size and shape to improve the hemodynamic effect
of pumping. Multilumen catheters with ECG, pres-
sure, and cardiac output capabilities are more preva-
lent. The percutaneous method of insertion is more
widely used because it allows balloon insertion to be
performed outside the operating room (e.g., in the
catheterization lab). ESIS and timing technologies are
being improved through microprocessor algorithms
that can track many cardiac arrhythmias. IABPs may
become further automated by the development of mi-
croprocessor-based closed-loop feedback systems, re-
quiring less direct clinical intervention. Arterial
pressure wave triggering yielding direct timing infor-
mation is being refined to prevent interference from
the inflated balloon.
The applications of IABPs are also changing. For
example, technology advances have allowed their use
in pediatric cases. A major trend is starting IABP use
earlier in the course of therapy, increasing its role in
prevention. IABPs may also see more frequent use in
cases requiring increased cerebral blood flow. Double-
balloon pumping (in the pulmonary artery and aorta)
is being investigated, and dual pneumatic pumps may
be designed for this purpose. Left-ventricular assist
devices provide a partial bypass of the left ventricle
(from the left atrium to the aorta) and can be used
in conjunction with an IABP. Some models have
©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Circulatory Assist Units, Intra-Aortic Balloon
interfaces for pulse oximeters, and at least one model
can transmit data via modem.
Bibliography
Aksnes J, Abdelnoor M, Berge V, et al. Risk factors of
septicemia and perioperative myocardial infarction
in a cohort of patients supported with intra-aortic
balloon pump (IABP) in the course of open heart
surgery. Eur J Cardiothorac Surg 1993;7(3):153-7.
Armstrong B, Zidar JP, Ohman EM. The use of in-
traaortic balloon counterpulsation in acute myocar-
dial infarction and high risk coronary angioplasty.
J Interv Cardiol 1995 Apr;8(2):185-91.
Benn A, Feldman T. The technique of inserting an
intra-aortic balloon pump. J Crit Illn 1992
Mar;7(3):435-45.
Buchanan SA, Langenburg SE, Mauney MC, et al.
Ambulatory intraaortic balloon counterpulsation.
Ann Thorac Surg 1994 Nov;58(5):1547-9.
Christenson JT, Badel P, Simonet F, et al. Preopera-
tive intraaortic balloon pump enhances cardiac per-
formance and improves the outcomes of redo CABG.
Ann Thorac Surg 1997 Nov;64(5):1237-44.
Christenson JT, Simonet F, Badel P, et al. Evaluation
of preoperative intra-aortic balloon pump support in
high risk coronary patients. Eur J Cardiothorac
Surg 1997 Jun;11(6):1097-103.
Cohen M, Patel JJ, Dohad S, et al. Pilot prospective
evaluation of counterpulsation with different intra-
aortic balloon volumes on cardiac performance in hu-
mans. Cathet Cardiovasc Diagn 1995 Sep;36(1):82-7.
Cox PM Jr, Kellett M, Goran SF, et al. Plaque abrasion
and intra-aortic balloon leak. Chest 1995
Dec;108(6):1495-8.
Darovic GO. Hemodynamic monitoring: invasive and
noninvasive clinical application. 3rd ed. Philadel-
phia: WB Saunders; 2001.
Frederiksen JW, Smith J, Brown P, et al. Arterial
helium embolism from a ruptured intraaortic bal-
loon. Ann Thorac Surg 1988 Dec;46(6):690-2.
Göl MK, Bayazit M, Emir M, et al. Vascular complica-
tions related to percutaneous insertion of intraaor-
tic balloon pumps. Ann Thorac Surg 1994 Nov;
58(5):1476-80.
Gott JP. Intraaortic balloon pump counterpulsation.
In: Mora CT, ed. Cardiopulmonary bypass. New
York: Springer-Verlag; 1997.
5
Healthcare Product Comparison System
Kantrowitz A, Cardona RR, Freed PS. Percutaneous
intra-aortic balloon counterpulsation. Crit Care
Clin 1992 Oct;8(4):819-37.
Nishida H, Koyanagi H, Abe T, et al. Comparative
study of five types of IABP balloons in terms of
incidence of balloon rupture and other complica-
tions: a multi-institutional study. Artif Organs 1994
Oct;18(10):746-51.
Ohman EM, George BS, White CJ, et al. Use of aortic
counterpulsation to improve sustained coronary ar-
tery patency during acute myocardial infarction:
results of a randomized trial. Circulation 1994
Aug;90(2):792-9.
Sakamoto T, Arai H, Maruyama T, et al. New algo-
rithm of intra aortic balloon pumping in patients
with atrial fibrillation. ASAIO J 1995 Jan-
Mar;41(1):79-83.
Underwood MJ, Firmin RK, Graham TR. Current con-
cepts in the use of intra-aortic balloon counterpul-
sation. Br J Hosp Med 1993 Oct;50(7):391-7.
Webster JG, ed. Encyclopedia of medical devices and
instrumentation. Vol. 3. New York: John Wiley &
Sons; 1988:1661.
Standards and guidelines
Note: Although every effort is made to ensure that the
following list is comprehensive, please note that other
applicable standards may exist.
American College of Cardiology/American Heart Asso-
ciation. ACC/AHA guidelines for the management
of patients with acute myocardial infarction. G03.
J Am Coll Cardiol 1999 Sep;34(3):890-911.
Guidelines for the evaluation and management of
heart failure. Committee on Evaluation and Man-
agement of Heart Failure. G013. Circulation 1995
Nov;92(9):2764-84 (revised 2001).
American National Standards Institute/Association
for the Advancement of Medical Instrumentation.
Safe current limits for electromedical apparatus
[standard]. 3rd ed. ANSI/AAMI ES1-1993. 1985 (re-
vised 1993).
International Electrotechnical Commission. Medical
electrical equipment — part 1: general requirements
for safety [standard]. IEC 60601-1 (1988-12). 1988.
Medical electrical equipment — part 1: general re-
quirements for safety. Amendment 1 [standard].
IEC 60601-1-am1 (1991-11). 1991.
6 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Medical electrical equipment — part 1: general re-
quirements for safety. Amendment 2 [standard].
IEC 60601-1-am2 (1995-03). 1995.
Medical electrical equipment — part 1: general re-
quirements for safety. Section 1. Collateral standard:
safety requirements for medical electrical systems.
IEC 60601-1-1 (1992-06). 1992.
Medical electrical equipment — part 1: general re-
quirements for safety. Section 1. Collateral standard:
safety requirements for medical electrical systems.
Amendment 1 [standard]. IEC 60601-1-1-am1 (1995-
11). 1995.
Medical electrical equipment — part 1: general re-
quirements for safety. Section 2. Collateral standard:
electromagnetic compatibility — requirements and
tests. IEC 60601-1-2 (2001-09). 2001.
Citations from other ECRI publications
Health Devices
Intra-aortic balloon perforations [hazard]. 1989
Dec;18(12):440-1.
Undetected pacemaker spike signals on IABP patients
[hazard]. 1989 Dec;18(12):441-2.
Low utilization of intra-aortic balloon pump [User
Experience Network™]. 1992 Sep;21(9):335.
Intra-aortic balloon pumps: inspection and infrequent
use [User Experience Network™]. 1993 Feb;22(2):96.
Blood residue in Datascope System 97 IABP can cause
malfunction [hazard]. 1997 May;26(5):219.
Intra-aortic balloon perforations [hazard update].
1997 May;26(5):217-8.
Intra-aortic balloon pumps [evaluation]. 1997 May;
26(5):184-215.
Premature depletion of Datascope 97 intra-aortic bal-
loon pump helium cylinders. 1998 Mar;27(3):117-8.
Health Devices Inspection and Preventive Maintenance
System
Intra-aortic balloon pumps. Procedure no. 432.
Healthcare Risk Control
Intra-aortic balloon pumps [risk analysis].
1996;4:Critical care:2.
 Circulatory Assist Units, Intra-Aortic Balloon

Supplier information start of inflation to the start of deflation. The defla-

tion interval is the period from the start of deflation
Aisin Human Systems to the start of inflation.
Aisin Human Systems Co Ltd [304377] Triggering modes: Methods used for triggering infla-
2-3 Showa-cho tion of the balloon. Units can be triggered from the
Kariya-shi, Aichi Pref 448-8650 R wave of the QRS complex. Inflation can also be
Japan triggered from the arterial pressure waveform,
Phone: 81 (566) 248222 pacemaker spike (atrial, ventricular, or atrial-ven-
Fax: 81 (566) 249377 tricular sequential), external monitor input signal,
E-mail: omura@ai-aisin.co.jp or internal IABP trigger.
Internet: http://www.aisin.co.jp
Max pump rate, bpm: The maximum rate, in beats per
Arrow International minute, at which full inflation and deflation occur
for given inflation and deflation times.
Arrow International CR as [384439]
Prazska 209 Frequency weaning: A ratio that is set to gradually
CZ-500 04 Hradec Kralove decrease pumping frequency at the end of therapy.
Czech Republic Volume weaning by decreasing the balloon inflation
Phone: 420 (49) 5759111 volume is also possible.
Fax: 420 (49) 5759222 Balloon sizes, cc: The balloon volume, measured in
E-mail: jitka_vodstrcilova@arrow.cz cubic centimeters (DL — double lumen; SL — single
Internet: http://www.arrowintl.com lumen).
Arrow International Inc [101060] Compatibility: Some systems are compatible for use
2400 Bernville Rd with other manufacturers’ balloons.
Reading PA 19605
Operating time, hr: The portable operating time of the
Phone: (610) 378-0131, (800) 233-3187
unit. This depends on either the battery or the gas
Fax: (610) 478-3199
supply.
E-mail: webmaster@arrowintl.com
Internet: http://www.arrowintl.com Abbreviations:
CE mark — Conformite Europeene mark
Datascope
Datascope Corp CLA — City of Los Angeles
Cardiac Assist Div [107876] DL — Deciliter
15 Law Dr
Fairfield NJ 07004-0011 ECG — Electrocardiogram
Phone: (973) 244-6100, (800) 777-4222
ESU — Electrosurgical unit
Fax: (973) 244-6279
E-mail: monitoring-dtld@datascope.com ETL — ETL Testing Laboratories
Internet: http://www.datascope.com
FDA — U.S. Food and Drug Administration
Datascope GmbH [153264]
Fabrikstrasse 35 HR — Heart rate
D-64625 Bensheim
Germany IABP — Intra-aortic balloon pump
Phone: 49 (6251) 17050 ICU — Intensive care unit
Fax: 49 (6251) 67877
E-mail: monitoring-dtld@datascope.com IEC — International Electrotechnical Commission
Internet: http://www.datascope.com
LCD — Liquid crystal display

About the chart specifications MDD — Medical Device Directives

The following terms are used in the chart: OR — Operating room
Timing logic: The timing of inflation and deflation psi — Pounds per square inch
points in the cardiac cycle is operator adjustable.
The inflation and deflation intervals are also adjust- QRS — Wave complex representing the beginning
able. The inflation interval is the period from the of ventricular contraction

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 7
Healthcare Product Comparison System

UL — Underwriters Laboratories features and characteristics are standard and which

Note: The data in the charts derive from suppli-
ers’ specifications and have not been verified through
independent testing by ECRI or any other agency.
Because test methods vary, different products’ specifi-
cations are not always comparable. Moreover, prod-
ucts and specifications are subject to frequent changes.
ECRI is not responsible for the quality or validity of
the information presented or for any adverse conse-
quences of acting on such information.
When reading the charts, keep in mind that, unless
otherwise noted, the list price does not reflect supplier
discounts. And although we try to indicate which
are not, some may be optional, at additional cost.
For those models whose prices were supplied to us
in currencies other than U.S. dollars, we have also
listed the conversion to U.S. dollars to facilitate com-
parison among models. However, keep in mind that
exchange rates change often.
Need to know more?
For further information about the contents of this
Product Comparison, contact the HPCS Hotline at +1
(610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or
hpcs@ecri.org (e-mail).

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 Circulatory Assist Units, Intra-Aortic Balloon

Product Comparison Chart

MODEL AISIN HUMAN SYSTEMS ARROW INTERNATIONAL ARROW INTERNATIONAL ARROW INTERNATIONAL

Corart BP21 ACAT 1 PLUS AutoCAT H-8000 TransAct IABP

WHERE MARKETED Japan Worldwide Worldwide Worldwide

FDA CLEARANCE Not specified Yes Yes Yes

CE MARK (MDD) Not specified Yes Yes Yes
TIMING LOGIC Auto timing adjust Auto timing adjust Auto timing adjust Auto timing adjust
for rate changes and for rate changes and based on analysis of for rate changes and
arrhythmias based on arrhythmia based on ECG, AP (if arrhythmia based on
beat-beat analysis; beat-beat analysis, available), and BPW real-time beat-beat
in manual mode, auto timing on to optimize assist, analysis, inflate
inflation point set setup, predictive automatically point auto adjusts
at dicrotic notch, and real-time detects irregular HR changes (Weissler
deflation point set modes selectable rhythms, implements Formula), deflate at
before systolic by clinician; ECG specialized timing R wave to 160 msec
upstroke at R wave trigger: 20-80% R-R algorithms, before R wave, hold
if R wave occurs (inflation), 30-120% compensates for deflate to R wave in
first R-R (deflation); premature beats atrial fib (ECG mode
pressure trigger: only); pressure-
0-35% (inflation), trigger timing com-
35-75% (deflation) pensation, time set-
tings between modes
require min adjust
INFLATION VOL ADJUST
Increments, cc NA, automatic 0.5 1 1
TRIGGERING MODES R wave (pattern, R wave, QRS, R wave, pressure, R wave with pacer
peak, pacer V), pressure, atrial pacer AV, internal, spike rejection,
aortic pressure (10, fib, pacer A, pacer pacer V peaks, pacer AV,
15, 20, 25 mm Hg) * V, internal pressure, internal

MAX PUMP RATE, bpm 200 200 200 200

FREQUENCY WEANING 1:1, 1:2, 1:3, 1:4 1:1, 1:2, 1:4, 1:8 1:1, 1:2, 1:3, 1:8 1:2, 1:3, 1:4, 1:8

SIGNAL INPUTS ECG, pressure ECG, pressure ECG, pressure ECG, pressure

AUTO CONDENSATION
REMOVAL Not specified Without interruption Without interruption 2 hr purge
DISPLAY LCD LCD High-resolution Flat vacuum
electroluminescent fluorescent dot type
Type/size 640 x 480 pixels 3 trace (4 color) 3 trace 2 trace/3.6 x 4.9"
Parameters ECG; aortic blood ECG, arterial pres- ECG, arterial pres- ECG, arterial
pressure; trigger sure, balloon pres- sure, balloon pres- pressure, balloon-
inflate/deflate sure, HR, freeze sure, HR, freeze gas pressure, HR,
status waveforms; mode, balloon mode, balloon volume arterial pressure
digital values for volume, helium and set, balloon volume (digital values),
systolic, diastolic, battery reserve, pumped, helium and ECG lead, assist
augmented, and mean timing reference battery reserve, frequency, battery
blood pressure; HR; display, diagnos- timing reference gauge
battery voltage; tics, trigger high- display, diagnos-
He tank pressure; lights on ECG wave- tics, cursor for AP,
volume-weaning form, timing refer- numerical values of
status; error ence with numerical inflation and
messages; time/date settings, new help, deflation pressures,
cursor for AP & BPW AC or DC operation **
Heart rate alarm No No (trigger loss) No No (trigger loss)
QRS indicator Yes Yes Yes Yes
Pressure alarm Yes MAP/PDP MAP No (trigger loss)
Lead select Not specified 3- or 12-lead 3- or 12-lead 3-lead

Colons separate data on similar models of a device. This is the first of

* Also fixed rate (60, 90, 120 bpm). two pages covering
** Also mode of operation (operator or AutoPilot). the above model(s).
These specifications
continue onto the
next page.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 9
Healthcare Product Comparison System

Product Comparison Chart

MODEL AISIN HUMAN SYSTEMS ARROW INTERNATIONAL ARROW INTERNATIONAL ARROW INTERNATIONAL

Corart BP21 ACAT 1 PLUS AutoCAT H-8000 TransAct IABP

ALARMS
Trigger loss/change Yes/yes Yes/no Yes/no Yes/no
Vac/pressure loss Not specified No/yes Yes/yes Yes/yes
Balloon disconnect Yes Yes Yes Yes
Balloon leak Yes Yes Yes Yes
Balloon overinflate Yes Yes Yes Yes
Systolic inflate No Yes Yes No *
Loading failure No Yes Yes Yes
High pressure Yes Yes Yes Yes
Power loss Yes Yes Yes Yes
BALLOON SIZES, cc 32, 40 30, 40, 50 30, 40, 50 Any 20-50 volume
(percutaneous DL), (percutaneous DL), controlled in 1 cc
sheathless sheathless increments
Compatibility All suppliers Datascope Datascope Datascope

HELIUM CYLINDER SIZE

Volume, L 0.49 See footnote ** See footnote ** 95 cc
Pressure 14.7 mPa See footnote ** See footnote ** 2,150 psi
OPERATING TIME, hr 2 2/4 (1 batt/2 batt) 2 ≥2 @ 120 bpm
CHARGING TIME, hr 8 8 (90%), 4 (80%) 4 (80%), 6 (100%) 6-8
LINE POWER, VAC 100 90-264, 47-63 Hz 100/120, 220/240; 90/132, 184/264
47-63 Hz
H x W x D, cm (in) 84 x 34 x 61 71 x 30.5 x 50.8 71 x 30.5 x 50.8 61 x 48.3 x 22.9
(33.1 x 13.4 x 24) (28 x 12 x 20) (28 x 12 x 20) (24 x 19 x 9)
WEIGHT, kg (lb) 39.5 (87.1) 40.9 (90) 44.4 (98) 27.3 (60)

PURCHASE INFORMATION
Price, unit Not specified $48,975 $53,975 $45,750
Balloons Not specified $715-750 $715-750 $750
Warranty 1 year 1 year, negotiable 1 year, negotiable 1 year
Year first sold 2001 1997 2000 1993
Fiscal year April to March October to September October to September October to September
OTHER SPECIFICATIONS Built-in 5 cm wide, No external or No external or Designed to hang
2-channel strip- replaceable parts; replaceable parts; from the rails or
chart recorder; auto purge and auto auto purge and auto footboard of an ICU
automatic documenta- helium refill w/o helium refill w/o bed; 3-position cart
tion of alarm pumping interrup- pumping interrup- for OR use; auto
conditions with tion; continuously tion; continuously purge (2 beats)
waveforms, alarm displayed calibrat- optimized AP scale every 2 hr; ECG
information, and ed/scaled BPW indi- for display; contin- baseline noise
date/time stamp. cates IABP or cathe- uously displayed filter suppresses
ter malfunction; calibrated/scaled shift; diagnostic
timing-error alert BPW indicates IABP mode displays all
for >100% deflation; or catheter malfunc- operating parameters
auto print on alarm tion; auto print (15 including inflate/
(2 min to 4 hr); min to 4 hr) on deflate times;
auto weaning; alarm selectable by separate high-fill-
annotation includes user; ECG w/continu- pressure and kinked-
trigger mode, alarm ous gain; annotation line alarms;
status, assisted and includes date, time, approved for use in
unassisted values, *** mode of operation, aircraft; has added
date, and time. † 2-channel waveform, aircraft cart. †
ECG lead select. ††

Colons separate data on similar models of a device.

* Automatic timing adjustment maintains proper timing as heart rate changes.
** 33 L @ 500 psi, disposable; optional 105 L @ 2,216 psi refillable D tank, 100 L @ 2,900 psi refillable D tank.
*** Quality assurance log and electronic key recognition of volume.
†
Prints select 2-channel waveform, patient hemodynamics, assist ratio, balloon volume, and ECG lead. The H-8000 TransAct IABP
is CLA and ETL approved and meets requirements of IEC 601-1 and UL 544.
††
Annotation also includes trigger, alarm status, assisted and unassisted numerics, 360-degree rotatable screen (removable for
remote mounting), and real-time modem.

10 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Circulatory Assist Units, Intra-Aortic Balloon

Product Comparison Chart

MODEL ARROW INTERNATIONAL DATASCOPE

KAAT II PLUS System 98XT with

CardioSync2 Software *
WHERE MARKETED Worldwide Worldwide

FDA CLEARANCE Yes Yes

CE MARK (MDD) Yes Yes
TIMING LOGIC Auto timing adjust Adapts ECG defla-
for rate changes and tion, ECG timing and
arrhythmia based on triggering to pro-
beat-beat analysis, vide better augmen-
auto timing on tation, unloading,
setup, predictive and tracking of iso-
and real-time lated PVCs, bi-
modes selectable geminy, couplets,
by clinician; ECG and atrial fibrilla-
trigger: 20-80% R-R tion; pressure
(inflation), 30-120% trigger detects
R-R (deflation); sustained arrhyth-
pressure trigger: mias; adjusts and
0-35% (inflation), optimizes deflation
35-75% (deflation) and assisted beats

INFLATION VOL ADJUST

Increments, cc 0.5 NA
TRIGGERING MODES R wave, QRS, R wave w/pacer spike
pressure, atrial rejection; pressure
fib, pacer A, pacer with auto threshold
V, internal adjustment; pacer
V/A-V; pacer A **
MAX PUMP RATE, bpm 200 200
FREQUENCY WEANING 1:1, 1:2, 1:4, 1:8 1:1, 1:2, 1:3

SIGNAL INPUTS ECG, pressure ECG, arterial

pressure
AUTO CONDENSATION
REMOVAL Without interruption Fully automatic
DISPLAY LCD Electroluminescent

Type/size 3 trace (4 color) 8.3 x 6.2"

Parameters ECG, arterial pres- ECG, arterial pres-
sure, balloon pres- sure (values
sure, HR, freeze for syst, diast,
mode, balloon mean, augmented),
volume, helium and dR, HR trend, ECG
battery reserve, lead, ECG size,
timing reference pressure scale and
display, diagnos- trigger threshold,
tics, trigger high- balloon dynamics,
lights on ECG augmentation alarm
waveform set, opt balloon
pressure waveform,
trigger source,
timing and fill mode
Heart rate alarm No (trigger loss) Yes
QRS indicator Yes Yes
Pressure alarm No (trigger loss) Yes
Lead select 3-lead 12-lead

Colons separate data on similar models of a device. This is the first of

* Model listed is currently marketed; specifications current as of June 2001. two pages covering
** Variable internal rate. the above model(s).
These specifications
continue onto the
next page.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 11
Healthcare Product Comparison System

Product Comparison Chart

MODEL ARROW INTERNATIONAL DATASCOPE

KAAT II PLUS System 98XT with

CardioSync2 Software *
ALARMS
Trigger loss/change Yes/no Yes/yes (standby)
Vac/pressure loss No/yes Yes/no (aug alarm)
Balloon disconnect Yes Yes
Balloon leak Yes Yes
Balloon overinflate Yes NA, autofill control
Systolic inflate Yes NA, auto control
Loading failure Yes Autofill failure
High pressure Yes Yes
Power loss Yes Yes
BALLOON SIZES, cc 30, 40, 50 34, 40 (8 Fr);
(percutaneous DL), 25, 34, 40 (9.5 Fr);
sheathless 40, 50 (10.5 Fr) **
Compatibility Datascope Arrow International,
Xemex, TMP

HELIUM CYLINDER SIZE

Volume, L See footnote *** 0.5 L; 0.69 L
Pressure See footnote *** 2,900; 2,200 psi
OPERATING TIME, hr 3 2.25
CHARGING TIME, hr 8 (90%), 4 (80%) 18
LINE POWER, VAC 90/132, 180/250 100-120, 220-240

H x W x D, cm (in) 88.9 x 30.5 x 63.5 109 x 42.7 x 56.6

(35 x 12 x 25) (43.3 x 16.8 x 22.3)
WEIGHT, kg (lb) 56.1 (124), 62.3 27.7 (61), cart;
(137) with optional 15.4 (34), battery;
D tank 39.1 (86.3), console
PURCHASE INFORMATION
Price, unit $48,975 $53,790
Balloons $715-750 $745-895
Warranty 1 year 1 year
Year first sold 1992 2000
Fiscal year October to September July to June
OTHER SPECIFICATIONS No external or 1-button start-up;
replaceable parts; print strip mode;
auto purge and auto manual fill mode; 2
helium refill w/o hr auto purge; ESU
pumping interrup- noise suppression w/
tion; continuously ECG amplifier; blood
displayed calibrat- detect sensor;
ed/scaled BPW indi- defibrillator over-
cates IABP or cathe- load protection; RS-
ter malfunction; 232 connector; diag-
timing-error alert nostic output;
for >100% deflation; service diagnostics
auto print on alarm software; universal
(2 min to 4 hr); transport system;
annotation includes R-Trac automatically
trigger mode, alarm matches the most
status, date, and appropriate
time; flash card for deflation timing
user-defined setup method to the
and storage, modem patient's rhythm.
for remote communi- †
cations. ††

Colons separate data on similar models of a device.

* Model listed is currently marketed; specifications current as of June 2001.
** 8 Fr is co-lumen, 9.5 Fr is dual lumen. Pediatric sizes: 2.5, 5, 7, 12, and 20 cc.
*** 33 L @ 500 psi, disposable; optional 105 L @ 2,216 psi refillable D tank, 100 L @ 2,900 psi refillable D tank.
†
Quality assurance log and electronic key recognition of volume.
††
Prints select 2-channel waveform, patient hemodynamics, assist ratio, balloon volume, and ECG lead. The H-8000 TransAct IABP
is CLA and ETL approved and meets requirements of IEC 601-1 and UL 544.

12 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.