ORIGINAL ARTICLE

Circulation Journal
Official Journal of the Japanese Circulation Society
http://www. j-circ.or.jp

Cardiovascular Surgery

Mid-Term Outcomes After Aortic Valve Replacement

With the 17-mm St. Jude Medical Regent Valve
Homare Okamura, MD; Atsushi Yamaguchi, MD; Hiroshi Nagano, MD; Satoshi Itoh, MD;
Hideki Morita, MD; Kazuhiro Naito, MD; Koichi Yuri, MD; Hideo Adachi, MD

Background: When aortic valve replacement (AVR) is performed in patients with a small aortic annulus, prosthesispatient mismatch (PPM) is of concern. We investigated the mid-term outcomes of AVR with a 17-mm mechanical
prosthesis.
MethodsandResults: Seventy-eight patients with aortic stenosis underwent AVR with a 17-mm St. Jude Medical
Regent prosthesis. Echocardiography was performed preoperatively, at discharge, and at follow-up (mean follow-up,
33 months). Patients were divided into 2 groups: with and without PPM at discharge. Between-group differences in
postoperative variables, particularly survival, were analyzed. Overall hospital mortality was 2.6%. Actuarial 1- and
5-year survival rates were 95% and 79%, respectively. Diabetes and renal insufficiency were associated with longterm mortality. Freedom from major adverse valve-related cardiac events at 1 year and 5 years was 97.3% and
93.9%, respectively. Diabetes was shown to be an independent risk factor for major adverse valve-related cardiac
events. Echocardiography 13 months after AVR showed a significant increase in mean effective orifice area index,
decrease in mean left ventricular-aortic pressure gradient, and decrease in mean left ventricular mass index. PPM
at discharge did not influence long-term survival or left ventricular mass regression.
Conclusions: The 17-mm Regent prosthesis provided satisfactory clinical and hemodynamic results. It is a reliable
choice for patients with a small aortic annulus. (Circ J 2012; 76: 365371)
Key Words: Surgery; Valves; Valvular diseases

ortic stenosis is an age-related disorder that is characterized by calcification of the aortic valve, local lipid
accumulation, inflammation, and neo-angiogenesis.1
Because the aged population is increasing, increased numbers
of patients are experiencing aortic stenosis, so the number of
patients requiring aortic valve replacement (AVR) is increasing.2 AVR still remains the standard therapy for symptomatic
severe aortic stenosis, although transcatheter aortic valve
implantation is considered as an alternative therapy for elderly
patients at high risk for perioperative complications.3 In Asian
countries in particular, female and elderly patients with aortic
valve stenosis often have a small aortic annulus.
Prosthesis-patient mismatch (PPM) is the difference bet
ween the area of the implanted prosthetic valve and that of the
patients native valve without a stenotic lesion. Previous studies have shown that PPM, defined as an effective orifice area
index (EOAI ie, effective orifice area divided by body surface
area (BSA)) <0.85cm2/m2, may negatively affect postoperative clinical status and survival.46 Thus, surgeons need a
prospective strategy for selection of the best prosthesis and
operative method to prevent PPM.

The 17-mm Regent prosthesis is an option in patients with

a small aortic annulus, although there are few reports of midterm outcomes after AVR with a 17-mm prosthesis in large
series of patients. Thus, the primary objective of this study
was to evaluate mid-term clinical outcomes after AVR with
the 17-mm Regent prosthesis and the effect of PPM.

Methods
Patients
From February 2005 through December 2009, 78 patients
(mean age, 72.97.7 years) with aortic stenosis underwent
AVR with a 17-mm Regent prosthesis (St. Jude Medical, St.
Paul, MN, USA). The study group comprised patients who
underwent AVR with 1 or more concomitant procedures other
than mitral valve replacement; 73 (94%) patients were women
and 35 patients (45%) were in New York Heart Association
(NYHA) functional class III or IV preoperatively. Mean BSA
was 1.440.12m2 (range, 1.211.77m2). Clinical characteristics of the patients are shown in Table1. Our study followed
the guidelines of the Ethical Review Board of Jichi Medical

Received July 13, 2011; revised manuscript received October 10, 2011; accepted October 18, 2011; released online December 1, 2011
Time for primary review: 28 days
Department of Cardiovascular Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan
Mailing address: Homare Okamura, MD, Department of Cardiovascular Surgery, Saitama Medical Center, Jichi Medical University, 1-847
Amanuma-cho, Omiya-ku, Saitama 330-8503, Japan. E-mail: homareokamura@hotmail.co.jp
ISSN-1346-9843 doi:10.1253/circj.CJ-11-0733
All rights are reserved to the Japanese Circulation Society. For permissions, please e-mail: cj@j-circ.or.jp
Circulation Journal Vol.76, February 2012

366

OKAMURA H et al.

Table1. Preoperative Patient Characteristics and Operative

Data (n=78)
Age (years)
Sex ratio (M/F)

72.97.7
5/73

NYHA class
III
IIIIV
Body surface area (m2)

43 (55.1%)
35 (44.9%)
1.440.12 (1.211.77)

Valve pathology
Senile degeneration

57 (73.1%)

Rheumatic

18 (23.1%)

Bicuspid

3 (3.8%)

Hypertension

50 (64.1%)

Diabetes

12 (15.4%)

Ischemic heart disease

18 (23.1%)

Atrial fibrillation

5 (6.4%)

Renal insufficiency*

9 (11.5%)

Preoperative dialysis

6 (7.7%)

Stroke

1 (1.3%)

Ejection fraction <0.4

4 (5.1%)

Cardiopulmonary bypass time (min)

16655

Cross-clamp time (min)

13641

Reoperation

2 (2.6%)

Concomitant procedure

29 (37.2%)

Coronary artery bypass grafting

13 (16.7%)

Tricuspid annuloplasty

12 (15.4%)

Mitral valve repair

4 (5.1%)

Septal myectomy

3 (3.8%)

In-hospital death

2 (2.6%)

Number of patients (%) or meanSD values are shown.

*Serum creatinine >1.5mg/dl.
NYHA, New York Heart Association.

University. All patients had previously granted permission for

use of their medical records for research purposes.
Operative Techniques
Aortic valve surgery was performed via standard median sternotomy. Cardiopulmonary bypass was initiated after cannulation of the ascending aorta, superior vena cava, and inferior
vena cava. A left ventricular vent was inserted via the right
upper pulmonary vein. Antegrade/retrograde cold blood cardioplegia was administered intermittently to maintain cardiac
arrest. Moderate hypothermia was applied. After complete
excision of the diseased aortic valve, the diameter of the aortic
annulus was measured with sizers (St. Jude Medical) for selection of the appropriate prosthesis. The 17-mm St. Jude Medical Regent prosthesis was implanted in the intra-annular position with the use of 2-0 polyester everting mattress sutures in
65 patients, 2-0 interrupted braided polyester sutures in 12
patients, and in the supra-annular aortic position in 1 patient.
Warfarin sodium was started on the day of surgery and continued thereafter so that the international normalized ratio of
prothrombin time was maintained in accordance with American College of Cardiology/American Heart Association guidelines. Operative data are shown in Table1.
Echocardiography
Standard M-mode dimensions were obtained according to the
American Society of Echocardiography criteria. The mean of
3 measures from 2 different cardiac cycles was taken. The

following variables were obtained: end-diastolic septal thickness, left ventricular end-diastolic dimension, and end-diastolic left ventricular posterior wall thickness. All Doppler
measurements were averaged from more than 3 cycles in
patients with sinus rhythm and more than 5 cycles in those
with atrial fibrillation. Maximum pressure gradients were calculated from the complete Bernoulli equation. Left ventricular
mass was calculated according to the Devereux formula.7 The
EOA was determined by the standard continuity equation and
indexed to BSA.
Follow-up
Follow-up transthoracic echocardiographic data were obtained for 35 (45%) of the 78 patients at 13.310.8 (meanSD)
months after surgery. The clinical status of each patient was
evaluated by means of direct hospital visits and telephone interviews. Follow-up was 100% complete. Mean follow-up
was 32.619.6 months (range, 570 months). A major adverse
valve-related event was defined according to the guidelines for
reporting after cardiac valve interventions.8
Statistical Analysis
Data are reported as meanSD. Preoperative and postoperative echocardiographic data for all patients were compared
and analyzed by paired Students t-test. Patients were divided
into 2 groups: with and those without PPM at discharge. Differences between the groups were analyzed by chi-square test
or unpaired Students t-test as appropriate. Logistic regression
was used to identify factors associated with in-hospital death.
Variables were entered into multivariate analysis if univariate analysis yielded a P-value <0.15. Actuarial survival was
calculated by the Kaplan-Meier method. A Cox proportional
hazards model was used to identify predictors of survival and
adverse events. Variables included in the multivariate analysis were those with P-value <0.15 in the univariate analysis.
The log-rank test was used to compare differences in actuarial survival between groups. All analyses were performed
with SPSS software (version 10.1; SPSS, Chicago, IL, USA).
P<0.05 was considered significant.

Results
Operative Morbidity and Mortality
Overall hospital mortality was 2.6% (2 patients). The causes
of hospital deaths were respiratory failure and intestinal necrosis. Univariate analysis identified renal insufficiency and preoperative dialysis as predictors of hospital mortality. However,
multivariate regression analysis yielded no independent predictor of hospital death. One patient required perioperative
intra-aortic balloon pumping and percutaneous cardiopulmonary support because of hemodynamic instability. Postoperatively, 1 patient suffered cerebral infarction. None required
pacemaker implantation.
Clinical Follow-up and Valve-Related Events
Two patients were readmitted because of heart failure. One
patient experienced late cerebral hemorrhage. Cerebral infarction, prosthetic endocarditis, structural failure of the prosthesis, reoperation, and paravalvular leakage did not occur in any
patient during the follow-up period. Freedom from major
adverse valve-related cardiac events at 1 year, 3 years, and 5
years was 97.3%, 93.9%, and 93.9%, respectively (Figure1).
The linearized rate of valve-related cardiac events was 2.3 per
100 patient-years. Major adverse valve-related cardiac events
are summarized in Table2. Univariate analysis revealed that

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Mid-Term Outcomes With 17-mm Regent for AVR

367

Figure1. Freedom from major adverse valve-related events.

Table2. Major Adverse Valve-Related Events During Follow-up

Freedom from major adverse valve-related events

Linearized rate*

At 1 year

At 3 years

At 5 years

All valve-related events

2.3

97.3% (93.6100%)

93.9% (87.8100%)

93.9% (87.8100%)

Bleeding event

0.5

98.6% (95.8100%)

98.6% (95.8100%)

98.6% (95.8100%)

Unexplained death

1.9

98.6% (95.8100%)

95.0% (89.4100%)

95.0% (89.4100%)

Linearized rate or % (95% confidence interval) values are shown.

*Per 100 patient-years.

Table3. Results of Cox Proportional Hazard Analysis for Death During Follow-up and Major Adverse
Valve-Related Cardiac Events
Risk factor

HR

95%CI

P value

Diabetes

4.9

1.120.8

0.032

Renal insufficiency*

12.5

1.792.7

0.014

16.1

1.7155.0

0.016

For mid-term death

For major adverse valve-related cardiac events

Diabetes
*Serum creatinine >1.5mg/dl.
HR, hazard ratio; CI, confidence interval.

age, preoperative NYHA class III or IV, hypertension, diabetes, and a concomitant procedure were associated with a
major adverse valve-related cardiac event. Multivariate analysis showed diabetes to be the only independent predictor of a
major adverse valve-related cardiac event (Table3). Freedom
from reoperation was 100%. Long-term survival and freedom
from cardiac death are shown in Figure2. Of the 76 survivors,
9 (12%) died during the follow-up period: malignancy (n=2),
heart failure (n=1), pneumonia (n=1), renal failure (n=1), and
unknown (n=4). Actuarial 1-year, 3-year, and 5-year survival
rate were 94.8%, 86.3%, and 78.7%, respectively. Univariate
analysis identified age, diabetes, renal insufficiency, ejection
fraction <0.4 and a concomitant procedure as predictors of

long-term mortality. Multivariate analysis showed diabetes

and renal insufficiency to be the independent predictors of
long-term mortality (Table3). Freedom from cardiac death
at 1 year, 3 years, and 5 years was 98.6%, 95.2%, and 91.4%,
respectively.
Functional NYHA Class Before Surgery and at Follow-up
All patients except the 2 who died in the hospital were
assessed for physical capacity according to NYHA classification during follow-up: 75 patients (99%) improved to class II
or better after AVR.

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OKAMURA H et al.

Figure2. Long-term postoperative

survival and freedom from cardiac
death.

Figure3. Follow-up echocardiographic variables of patients with (n=18) and

without (n=40) prosthesis-patient mismatch (PPM) at discharge. Follow-up
value in comparison to preoperative
value. LVAo-PG, left ventricular-aortic
pressure gradient; LVMI, left ventricular mass index.

Echocardiographic Variables
Preoperative echocardiography yielded a mean aortic valve
area index of 0.410.13cm2/m2, a mean left ventricular-aortic
pressure gradient (LVAo-PG) of 59.021.5mmHg, and a
mean left ventricular mass index (LVMI) of 17553g/m2.
Follow-up echocardiography revealed a significant decrease
in mean LVAo-PG (16.66.8mmHg), a significant decrease
in LVMI (11632g/m2), and a significant increase in mean

EOAI (0.970.21cm2/m2). There was no significant difference

between the preoperative and postoperative ejection fractions
(0.600.14 vs. 0.630.07).
Effect of PPM on Long-Term Survival and Echocardiographic
Variables
The EOA was obtained at discharge for 58 (74%) of 78
patients. Of these 58 patients, 18 (31%) had PPM with an

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Mid-Term Outcomes With 17-mm Regent for AVR

369

Figure4. Long-term postoperative

survival of patients with (n=18) and
without (n=40) prosthesis-patient
mismatch (PPM) at discharge.

EOAI <0.85cm2/m2 at discharge. Severe PPM with an EOAI

<0.65cm2/m2 was found in 4 of the patients. No valve-related
complication was seen in any of the 4 patients with severe
PPM. There was no significant difference between the patients
with and without PPM in terms of sex ratio or age. Mean BSA
was greater in patients with PPM than in patients without PPM
(1.520.08m2 with PPM vs. 1.400.10m2 without PPM,
P<0.001). Follow-up echocardiographic variables of the
patients in both groups are shown in Figure3. Reduction in
LVMI as well as LVAo-PG at follow-up did not differ between
the 2 groups. Neither was there a difference in long-term survival between the 2 groups (Figure4).

Discussion
Elderly Japanese are shorter in stature than their Western
counterparts, and the aortic annulus of the Japanese is smaller,
proportionate to their body size. Therefore, we often need a
strategy to deal with the problem of a small annulus. The
EOAI, which correlates with the postoperative transvalvular
gradient, has been used to characterize PPM. On the basis of
the relation between the EOAI and corresponding gradient,
Pibarot et al reported that the ideal EOAI should exceed
0.85cm2/m2 to avoid a residual pressure gradient.5,9 Thus, in
the case of patients with a small aortic annulus, careful evaluation is needed to achieve an EOAI >0.85cm2/m2 after AVR
surgery because PPM may predispose to an unfavorable outcome.46
The main consequence of PPM is generation of an abnormally high transprosthetic gradient across the aortic valve,
resulting in increased left ventricular work. Incomplete regression of the residual gradient across the prosthesis has been
associated with increased long-term mortality.10 The decrease
in the LVMI is considered to be a result of favorable remodeling derived from AVR. PPM is also associated with a smaller
decrease in the LVMI and more cardiac events during the fol-

low-up period.11,12 Prevention of PPM has also been reported

to improve postoperative functional class/exercise tolerance
and the incidence of late sudden death.6,13 However, some
investigators have reported that the influence of PPM on outcome after AVR surgery remains controversial.11,1416
Various surgical strategies, such as aortic root enlargement
and stentless valve implantation, have been used to avoid
PPM. Enlargement of the aortic annulus is based on the premise that a large-sized prosthesis favorably influences late clinical outcome.17 Castro et al performed aortic root enlargement
procedures in 114 patients to avoid PPM.18 However, aortic
annulus enlargement has been shown to result in prolonged
aortic cross-clamp times. In addition, recent advances in the
design of prostheses have improved hemodynamic performance considerably. Therefore, we choose to forgo annular
enlargement in favor of implantation of a high-performance
mechanical valve for patients with a small aortic annulus.
Supra-annular implantation of a larger valve is considered a
feasible option in some institutions. However, because the
subvalvular tissue is in close proximity to the prosthetic orifice
when the valve is implanted in the supra-annular position,
protrusion of subvalvular tissue into the prosthetic orifice,
which can lead to valve dysfunction, is of concern, especially
in AVR with a mechanical valve. Therefore, we generally use
intra-annular positioning for implantation of a mechanical
valve. The 17-mm St. Jude Medical Regent valve with an
EOA of 1.30cm2 can be used in patients with a BSA <1.5m2,
resulting in an EOAI >0.85cm2/m2.
Only a few authors have reported their experience with a
17-mm mechanical prosthesis, and controversy remains as to
whether this valve is beneficial and safe, especially in the long
term. Previously, we reported good hemodynamics and a 38%
decrease in LVMI after AVR with a 17-mm Regent valve, as
well as favorable clinical status.19 Other groups have shown
satisfactory clinical improvement and significant left ventricular mass regression after AVR with a 17-mm mechanical

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370

OKAMURA H et al.

prosthesis.20,21 These findings suggest that implantation of a

17-mm Regent valve provides not only excellent operative
results but also good survival, associated with the better hemodynamic results. Minardi et al reported satisfactory hemodynamic performance in 19 patients with the 17-mm Regent
valve under dobutamine stress as well as at rest.22
Garatti et al also showed good early and long-term outcomes after AVR with a 17-mm mechanical valve, although
their evaluation included only the 17-mm Sorin Bicarbon Slim
prosthesis (Sorin Biomedica, Saluggia, Italy), and the 17-mm
St. Jude Medical Hemodynamic Plus (St. Jude Medical).23 It
must be noted that the follow-up periods were relatively short
and the number of patients in each study was small. So, we
need to look more carefully into the safety and effectiveness
of the 17-mm valve in a large number of patients.
The drawback of a mechanical valve is lifelong anticoagulation, and close monitoring is required to prevent postoperative complications, including thromboembolism and anticoagulation-related bleeding. Some could argue that mechanical
valves (vs. bioprostheses) will increase mortality and morbidity as a result of anticoagulation.24 However, in our series, we
encountered cerebral hemorrhage in 2 patients, accounting for
a linearized rate of 0.5% per patient-year, but no cerebral
infarction. These complication rates are comparable to those
of patients given a bioprosthesis. Aupart et al studied clinical
outcomes of AVR in 1,133 patients who received a bioprosthesis and reported a bleeding complication rate of 0.3% per
patient-year and thromboembolism rate of 0.6% per patientyear.25 Despite the need for lifelong anticoagulation in patients
who receive a mechanical prosthesis, some reports have indicated no significant differences in postoperative quality of life,
survival, or incidence of complications between mechanical
and biological valves.26
The effect of PPM on prognosis and cardiac function
remains controversial. Mohty et al indicated that PPM negatively influences long-term survival in specific patient groups
such as those with low cardiac function or severe PPM.27
Moon et al reported that PPM had a negative impact on longterm survival only for patients 70 years of age or less.28
Vicchio et al showed that in patients over age 70, severe or
moderate PPM did not influence long-term outcome, left ventricular mass regression or quality of life.29 In our series, there
was no difference in survival or reduction in LVMI between
patients with and without PPM, although the incidence of
severe PPM was low. Also, our study included only a small
number of patients with low cardiac function or severe PPM.
Another mechanical valve currently available for a small
aortic annulus is the 16-mm ATS-Advanced Performance
valve (ATS Medical, Inc, Minneapolis, MN, USA). Kobayashi
et al reported on 15 patients in whom the 16-mm valve was
implanted.30 There was no in-hospital mortality or significant
postoperative reduction of LVMI despite a high incidence of
PPM. However, some of their patients given the 16-mm valve
showed no improvement in left ventricular diastolic function
at mid-term follow-up.
Study Limitations
The limitations of our study should be taken into consideration. The main limitation is the relatively low echocardiographic follow-up rate. Most of our patients were followed up
at another hospital or clinic, some of which were far from the
hospital where the operation was performed. In addition, the
study group comprised mostly elderly patients. Nearly half of
the patients were unable to return for echocardiographic
assessment. Whether or to what degree this low follow-up rate

affected our survival and LVMI regression data is unknown.

Furthermore, the low incidence of severe PPM in our series
might have obscured the potential affect of PPM on outcomes.

Conclusions
In summary, the 17-mm Regent prosthesis produced satisfactory results in terms of survival, physical capacity, and hemodynamic performance. Thus, the 17-mm prosthesis could be a
reasonable alternative, especially in patients with a small aortic annulus. Although we confirmed the safety and effectiveness of the prosthesis over 33 months of follow-up, we need
to evaluate outcomes over a longer period and in a substantially large study group.
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