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Ann Thorac Surg 2002;74:2010-2015
© 2002 The Society of Thoracic Surgeons

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Original article: cardiovascular

Ten-year echocardiographic and clinical follow-up of aortic Carpentier-Edwards pericardial and supraannular prosthesis: a case-match study

^a Department of Echocardiography, Hôpital Cardiologique, Centre Hospitalier Régional et Universitaire de Lille, 59037 Lille Cedex, France
^b Department of Cardiac Surgery, Hôpital Cardiologique, Centre Hôpitalier Régional et Universitaire de Lille, Lille, France

Accepted for publication July 12, 2002.

* Address reprint requests to Dr Le Tourneau, Department of Echocardiography, Hôpital Cardiologique, Boulevard du Professeur J. Leclerc, 59037 Lille Cedex, France.
e-mail: thletourneau{at}yahoo.fr

	Abstract

Top Abstract Introduction Patients and methods Results Comment References

 
BACKGROUND: There are little comparative data on Carpentier-Edwards supraannular and pericardial second-generation bioprostheses. The aim of this work was to compare their hemodynamic and clinical outcomes in patients with aortic stenosis.

METHODS: We conducted a retrospective study including 150 patients operated on for aortic stenosis between 1989 and 1993. Patients undergoing aortic valve replacement with either a Carpentier-Edwards supraannular or pericardial prosthesis were matched for sex (49% male), age (72 ± 8 years), body surface area, valve size, associated procedures, and left ventricular ejection fraction.

RESULTS: Mean follow-up was 6.5 ± 3.3 years, giving a total follow-up of 983 patient-years. Thirty-day mortality and 10-year actuarial survival were, respectively, 8% and 51% in the supraannular group and 6.7% and 43.4% in the pericardial group. At 10 years, freedom from thromboembolism, structural failure, and all valve-related events were, respectively, 88.7%, 88.9%, and 68.7% in the supraannular group and 85%, 100%, and 82.2% in the pericardial group. There were four (5.3%) structural failures, and four (5.3%) reoperations for degeneration (n = 3) and endocarditis (n = 1) in the supraannular group. Freedom from structural dysfunction or reoperation was 87.3% in the supraannular group and 100% (p < 0.05) in the pericardial group. Echocardiographic review of 62 of 76 survivors (81.5%) demonstrated a trend toward a better hemodynamic profile of pericardial valves at the end of follow-up.

CONCLUSIONS: Ten years after aortic valve replacement for aortic stenosis, Carpentier-Edwards pericardial prostheses give comparable and probably better results than Carpentier-Edwards supraannular prostheses.

	Introduction

Top Abstract Introduction Patients and methods Results Comment References

 
In contrast to first-generation pericardial valves, pericardial Carpentier-Edwards prostheses have shown excellent clinical results in the aortic position for patients older than 65 years, with a very low rate of structural dysfunction at 10 years [1–7]. A suggested advantage of pericardial valves is their improved hemodynamic performance compared with porcine bioprostheses [7–10]. The supraannular porcine Carpentier-Edwards is a second-generation porcine valve with technological changes that aim to improve hemodynamic performance and durability [11–16]. Supraannular porcine and pericardial Carpentier-Edwards valves have now been available for more than 10 years, but little is known about their long-term comparative results. The aim of this retrospective study was to compare long-term hemodynamic and clinical outcomes in patients who underwent aortic valve replacement with either a supraannular porcine or pericardial Carpentier-Edwards valve between 1989 and 1993 in our institution. To have a homogeneous population, we focused our study on patients operated on for aortic stenosis without other significant valve disease.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment References

 
Patient population
We retrospectively reviewed the medical records of all patients who underwent aortic valve replacement for aortic stenosis with either a Carpentier-Edwards porcine supraannular or pericardial prosthesis (Edwards Lifesciences, Irvine, CA) in our institution between 1989 and 1993. Patients undergoing aortic valve replacement for predominant aortic regurgitation or undergoing double valve replacements were excluded from this study; however, patients undergoing concomitant procedures such as coronary artery bypass grafting were not excluded. Seventy-six patients with severe aortic stenosis received a Carpentier-Edwards pericardial prosthesis during this period. One patient lost to follow-up just after discharge was excluded from this study. Thus, 75 patients who received a Carpentier-Edwards pericardial prosthesis were matched for age, sex, date of operation, body surface area, implanted valve size, associated cardiac procedures, and left ventricular ejection fraction with 75 patients who underwent aortic valve replacement for aortic stenosis with a Carpentier-Edwards porcine supraannular prosthesis during the same period.

All operations were performed through a median sternotomy during cardiopulmonary bypass using mild hypothermia; the heart was protected and arrested with cold-blood antegrade cardioplegia. The main reason for the choice of a supraannular porcine or pericardial Carpentier-Edwards prosthesis was the age of the patient (>60 years). Some younger patients who refused anticoagulation and preferred a biologic valve received a bioprosthesis after being informed of the relative risks and benefits. The decision regarding the type of bioprosthesis was made by the surgeon during the preoperative medical staff meeting or at the beginning of operation. Neither anatomic nor clinical and echocardiographic variables directed the choice of the supraannular porcine or pericardial Carpentier-Edwards bioprosthesis. The pericardial bioprosthesis was used as a new and promising prosthesis. All patients were postoperatively anticoagulated for 3 months, with subcutaneous heparin for the first week, which was then replaced by warfarin (target international normalized ratio of 2.0 to 3.0). After 3 months, anticoagulation was continued in patients with atrial fibrillation or flutter, but discontinued in other patients.

Follow-up information was obtained by questionnaire and phone contact with patients, their family physician, or cardiologist during a 3-month period. Operative and long-term mortality and morbidity were recorded according to The Society of Thoracic Surgeons’ guidelines for reporting morbidity and mortality after cardiac valvular operations [17].

Echocardiography
Preoperative echocardiography was performed within 6 months before operation, early postoperative echocardiography within 1 year after operation, and late postoperative echocardiography during the follow-up period. All late postoperative two-dimensional echocardiographic and Doppler examinations were performed by one experienced investigator (T.L.T.) who was not aware of the type of prosthetic valve implanted, with either a Vingmed Five (General Electric Vingmed, Milwaukee, WI) or an Acuson Sequoïa (Acuson, Mountain View, CA) echocardiographic imaging system. Preoperative left ventricular ejection fraction was determined by the use of echocardiography or angiography. Flow velocities at the level of the left ventricular outflow tract or prosthetic valve ring and at the level of valve leaflets were measured in the apical five-chamber view, respectively by pulsed and continuous-wave Doppler, to determine mean and maximal transvalvular gradients, as well as the permeability index (subvalvular to transvalvular velocity–time integral ratio). Preoperative aortic valve area was determined with the continuity equation on echocardiography or with the Gorlin formula on angiography. Systolic pulmonary artery pressure was estimated from the maximal tricuspid regurgitation velocity. Established structural dysfunction was defined as valve dysfunction requiring reoperation (symptoms such as dyspnea related to heart failure, syncope, angina, and Doppler-echocardiographic evidence of aortic valve deterioration with mean transvalvular gradient equal to or greater than 40 mm Hg or of severe aortic regurgitation).

Statistical analysis
Results are expressed as mean ± standard deviation. Comparisons between groups were performed with ² tests or with paired or unpaired Student’s t tests, as appropriate. Calculation of the linearized rates included early and late events, and event-free actuarial survival rates were calculated by the Kaplan-Meier method. The Wilcoxon test was used to compare actuarial events. Probability values equal to or less than 0.05 were considered significant.

	Results

Top Abstract Introduction Patients and methods Results Comment References

 
Patient population
The patient population consisted of 150 matched patients who underwent aortic valve replacement for aortic stenosis with either a porcine supraannular (model 2650, size 21 to 27) or pericardial (model 2900, size 19 to 27) Carpentier-Edwards prosthesis. Mean age was 72 ± 8 years. There were 37 men (49%) and 38 women (51%) in each group. There were no differences in cardiovascular risk factors (cigarette smoking, hypercholesterolemia, hypertension, diabetes mellitus, or obesity), preoperative symptoms, atrial fibrillation, or mean and maximal transvalvular gradients between the two groups (Table 1). There were also no differences in mean New York Heart Association functional class before operation (supraannular, 2.51 ± 0.6 versus pericardial, 2.52 ± 0.6), early after operation (supraannular, 1.67 ± 0.53 versus pericardial, 1.69 ± 0.55), or late after operation (supraannular, 1.69 ± 0.56 versus pericardial, 1.67 ± 0.52).

Mean follow-up was 6.5 ± 3.3 years after operation, and total follow-up was 983 patient-years; no patient was lost to follow-up.

Mortality
Within 30 days of the operation, 6 patients died (mortality rate, 8%) after supraannular valve implantation and 5 patients (6.7%) after pericardial valve implantation. The cause of early death was cardiac failure in 5 patients, infectious complications in 4 patients, aortic root rupture in 1 patient, and sudden death in 1 patient after discharge.

There were 29 late deaths in the supraannular group and 34 in the pericardial group. In the supraannular and the pericardial groups the causes of late death were, respectively, cardiac-related in 11 (37.9%, 2.1% per patient-year) and 9 (26.4%, 1.9% per patient-year) patients, valve-related in 8 (27.6%, 1.5% per patient-year) and 5 (14.7%, 1.1% per patient-year) patients, and noncardiac in 18 (62%, 3.5% per patient-year) and 25 (64.7%, 4.7% per patient-year) patients. The overall death rate was 47% (35 patients) in the supraannular group and 52% (39 patients) in the pericardial group at the time of follow-up. The actuarial survival rate including early mortality was 51% (supraannular) and 43.4% (pericardial, p = 0.24) after 10 years (Fig 1).

View larger version (16K): [in this window] [in a new window]   Fig 1. Actuarial survival in 150 patients who underwent aortic valve replacement with either a supraannular porcine or pericardial Carpentier-Edwards (CE) valve.p= not significant (NS) between the two groups.

Four patients required valve reoperation in the supraannular group, giving an actuarial rate of freedom from reoperation of 89.4%, and of 100% (p = 0.19) in the pericardial group. Indications for valve reoperation in the supraannular group were fibrocalcific degeneration with severe stenosis (n = 1), stenosis and regurgitation (n = 2), and endocarditis with severe regurgitation (n = 1). Among the 4 patients with known structural valve dysfunction, 3 were reoperated on during the follow-up, and 1 was waiting for reoperation at the end of follow-up. Mean delay between valve implantation and the diagnosis of structural dysfunction was 7.6 ± 2.0 years (range, 6.1 to 10.3 years). The valves removed demonstrated shrinkage and calcification of the basal regions of the leaflets. A cusp tear was observed in one valve removed, but was associated with severe calcification and stenosis (Table 3).

View larger version (15K): [in this window] [in a new window]   Fig 2. Actuarial slope of freedom from structural valve dysfunction or reoperation in the supraannular and pericardial groups.p< 0.05 between the two groups. (CE= Carpentier-Edwards.)

	Comment

Top Abstract Introduction Patients and methods Results Comment References

Structural valve deterioration has been extensively documented as the main complication of bioprostheses necessitating reoperation, particularly in young patients. The Carpentier Edwards supraannular porcine prostheses is a second-generation porcine bioprostheses specially designed to reduce the incidence of structural valve deterioration and enhance hemodynamic performance compared with first-generation porcine bioprostheses [11–14]. This valve is structured with an Elgiloy stent to provide flexibility and reduce stress on the porcine tissue. After fixation with glutaraldehyde at 2 mm Hg, the porcine tissue is treated with polysorbate-80 to retard calcification. The supraannular configuration allows maximization of the effective area of the prosthesis, especially for small aortic sizes. Compared with porcine bioprostheses, pericardial valves have an allegedly improved hemodynamic profile [8, 10], and it was hoped that short-term and long-term results might be better. However, the first-generation of pericardial valve has been abandoned because of early valve failure owing to design failure [18] or tissue preparation failure [19]. The Carpentier-Edwards pericardial valve is a second-generation pericardial valve that has demonstrated excellent long-term clinical and hemodynamic results, particularly in patients older than 65 years [1–8]. This valve consists of three glutaraldehyde-preserved bovine pericardial leaflets mounted inside the support frame with no stitches to the posts to reduce the leaflet abrasion that limited the durability of previous pericardial valves. Another conceptual improvement, as in the supraannular porcine prosthesis, was represented by complete strut flexibility achieved with an Elgiloy wire maintaining physiologic aortic ring movements and decreasing shear stress. Pericardium for this valve is fixed with 0.6% buffered glutaraldehyde solution under very low pressure (free-floating method) [1–8]. After fixation, Carpentier-Edwards pericardial valves are also treated with polysorbate-80 to retard calcification.

The Carpentier-Edwards pericardial valve is thought to be at least as good as, and perhaps better than, porcine valves [20, 21]. This retrospective study gave us the opportunity to compare in a case-matched fashion the outcome of this pericardial valve with a second-generation porcine valve, the supraannular porcine Carpentier-Edwards valve. In Carpentier-Edwards porcine supraannular prostheses there is a stable and low risk of structural deterioration until 10 years and then a significantly increased risk [15]. In our study, there were four structural valve deteriorations (5.3%) and four valve reoperations (5.3%) in the supraannular group after a mean delay of 7.6 years, and none in the pericardial group. Despite a low rate of structural dysfunction in Carpentier-Edwards porcine supraannular prostheses, this study suggests earlier dysfunction compared with Carpentier-Edwards pericardial prostheses in the aortic position. This result is consistent with a previous study [21] reporting a greater freedom from structural valve deterioration at 10 years in pericardial than in supraannular Carpentier-Edwards bioprostheses after mitral valve replacement. This result is also in accordance with the review of Grunkemeier and Bodnar [20] published in 1995, suggesting a longer durability of Carpentier-Edwards pericardial valves compared with porcine valves. Indeed, pericardial Carpentier-Edwards valves are known to have a very low rate of structural deterioration, particularly in patients 65 years or older, as in our population [1, 6]. In a recent study, Aupart and colleagues [4] reported a linearized rate of structural valve deterioration of 0.2% per patient-year (mean follow-up, 4.1 years) after 589 aortic valve replacements with Carpentier-Edwards pericardial prostheses. In another study [5], the linearized rate of Carpentier-Edwards pericardial structural valve failure was only 0.9% per patient-year after a mean follow-up of 9.1 years.

Thromboembolic complications were not different between the two groups, but supraannular porcines valves exhibited a trend toward a higher incidence of late endocarditis (4 patients, 0.8% patient-years) than pericardial valves (0%). Whether pericardial and porcine prostheses are at the same risk of endocarditis remains controversial. In previous studies a higher rate of endocarditis was reported either in porcine [10] or in pericardial valves [22, 23], but this might depend on the valve design rather than on the type of valve component used.

Systematic echocardiographic screening during the review period, performed in a high proportion (81.5%) of survivors by the same experienced investigator (T.L.T.), allowed us to compare the hemodynamic profiles of the two valves. Despite comparable hemodynamic profiles early after operation, Carpentier-Edwards pericardial valves had a trend toward a better hemodynamic profile at the end of follow-up than Carpentier-Edwards supraannular valves with respect to mean and maximal transvalvular gradients. This result suggests an earlier and progressive deterioration of supraannular valve hemodynamic compared with pericardial valve.

The lack of randomization between the two types of bioprostheses is the main limitation of this study. Another obvious limitation of this study is the number of patients studied, related to the small number of Carpentier-Edwards pericardial valves implanted in the aortic position in our institution in the early 1990s. However, our retrospective case-match study provides the opportunity to test the equivalence of the two prostheses in one center, with the same team of experienced surgeons; moreover, our results are consistent with previous studies. In conclusion, after a mean follow-up period of 6.5 years, Carpentier-Edwards pericardial prostheses compared favorably with Carpentier-Edwards supraannular porcine prostheses in the aortic position.

	References

Top Abstract Introduction Patients and methods Results Comment References

 

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