Carpentier-Edwards Prosthesis Research Articles

Long-term outcome after biologic versus mechanical aortic valve replacement in 841 patients

Objective: The purpose of this study was to optimize selection criteria of biologic versus mechanical valve prostheses for aortic valve replacement. Methods: Retrospective analysis was performed for 841 patients undergoing isolated, first-time aortic valve replacement with Carpentier-Edwards (n = 429) or St Jude Medical (n = 412) prostheses. Results: Patients with Carpentier-Edwards and St Jude Medical valves had similar characteristics. Ten-year survival was similar in each group (Carpentier-Edwards 54% ± 3% versus St Jude Medical 50% ± 6%; P = .4). Independent predictors of worse survival were older age, renal or lung disease, ejection fraction less than 40%, diabetes, and coronary disease. Carpentier-Edwards versus St Jude Medical prostheses did not affect survival ( P = .4). Independent predictors of aortic valve reoperation were younger age and Carpentier-Edwards prosthesis. The linearized rates of thromboembolism were similar, but the linearized rate of hemorrhage was lower with Carpentier-Edwards prostheses ( P <.01). Perivalvular leak within 6 months of operation was more likely with St Jude Medical than with Carpentier-Edwards prostheses ( P = .02). Estimated 10-year survival free from valve-related morbidity was better for the St Jude Medical valve in patients aged less than 65 years and was better for the Carpentier-Edwards valve in patients aged more than 65 years. Patients with renal disease, lung disease (in patients more than age 60 years), ejection fraction less than 40%, or coronary disease had a life expectancy of less than 10 years. Conclusions: For first-time, isolated aortic valve replacement, mechanical prostheses should be considered in patients under age 65 years with a life expectancy of at least 10 years. Bioprostheses should be considered in patients over age 65 years or with lung disease (in patients over age 60 years), renal disease, coronary disease, ejection fraction less than 40%, or a life expectancy less than 10 years. (J Thorac Cardiovasc Surg 1999;117:890-7)

Determinants of reoperation after 960 valve replacements with Carpentier-Edwards prostheses

During the period of 1977 to 1990, 960 Carpentier-Edwards standard prostheses (Baxter Healthcare Corp., Santa Ana, Calif.) were placed in 875 operations. Freedom from reoperation at 10 years was 57% +/- 4%, 76% +/- 3%, and 95% +/- 5% for mitral, aortic, and tricuspid valve replacement, respectively. Age was the only independent determinant of reoperation for both aortic and mitral valves. Likelihood of reoperation decreased with age, with freedom from reoperation after 10 years in patients aged less than 60 years versus 60 or more years being 65% +/- 5% versus 90% +/- 4% after aortic valve replacement and 48% +/- 5% versus 75% +/- 6% after mitral valve replacement. For mitral valve replacement, larger valve size made reoperation more likely, with freedom from reoperation at 10 years being 71% +/- 6% for sizes median less than 31 mm and 57% +/- 5% for sizes 31 mm or larger. For aortic valve replacement, prior median sternotomy reduced freedom from reoperation at 10 years from 80% +/- 3% to 25% +/- 5%. The low prevalence of reoperation affirms the suitability of the Carpentier-Edwards prosthesis for selected elderly patients and for tricuspid valve replacement. Because of their influence on the probability of reoperation, valve size and prior cardiac procedures also merit consideration in the choice of valvular prosthesis.

Early and Late Phase Events Following Bioprosthetic Tricuspid Valve Replacement

From 1961 through 1987, 9,247 patients underwent an intracardiac repair for valvular heart disease. Five hundred thirty patients had a procedure that included a tricuspid valve operation (6%), with tricuspid valve replacement performed in 175 patients (2%), of whom 154 had a bioprosthetic valve implanted (1.7%). These 154 patients with a bioprosthetic valve in the tricuspid position are the subject of this review. There were 27 males and 127 females. Ages ranged from 10 to 75 years. There was tricuspid valve insufficiency in 139 patients (90%), and stenosis plus insufficiency in 15 (10%). Carpentier-Edwards prostheses were implanted in 83 (54%), Ionescu-Shiley in 55 (35%), Hancock in 12 (8%), and Mitroflow in 4 (3%). Concomitant procedures were performed in 146 patients (95%). At least one previous operation had been performed in 86 patients (56%). Preoperatively, 139 patients were in functional Class III or IV (90%). Hospital death occurred in 20 patients (13%). Logistic regression analysis revealed that incremental risk factors for hospital death included increasing peripheral edema preoperatively (p = 0.04), and use of a Hancock prosthesis in the tricuspid position (p = 0.03). All 134 hospital survivors were followed at a mean of 66.01 months, range 1 to 162 months. There were 70 late deaths (52%). Log-rank test indicated that incremental risk factors for late death were: longer cross-clamp time at repair (p = 0.0007); higher pulmonary artery systolic pressure preoperatively (p = 0.01); earlier date of surgery (p = 0.03); and larger tricuspid prosthesis size (p = 0.06).(ABSTRACT TRUNCATED AT 250 WORDS)

Progressive Functional Deterioration of Bioprostheses Assessed by Doppler Ultrasonography

Doppler echocardiography was used to study the function of bioprosthetic heart valves by noninvasive means in 32 patients aged 29 to 72 years at various postoperative intervals. There were 24 Ionescu-Shiley, four Hancock, and four Carpentier-Edwards prostheses, 19 in the aortic and 13 in the mitral position. Initial studies were performed at a mean of 2.3 years after implantation and were repeated one, two, and three years thereafter. Flow velocities in the mitral orifice, left ventricular outflow tract, and ascending aorta, as well as mitral pressure half-time, were measured from pulsed-wave or continuous-wave Doppler recordings. Mitral and aortic valve areas and aortic pressure gradients were calculated. In aortic prostheses the valve area decreased and pressure gradient increased progressively in relation to the time from implantation. The mean value (+/- SD) of the aortic valve area was 67 +/- 17 percent of the manufacturer's nominal value at the first examination and 57 +/- 20 percent one year later, 51 +/- 14 percent two years later, and 46 +/- 11 percent three years later (overall differences, p less than 0.01). In mitral prostheses, reduction of the valve area was not related to the time from implantation. The mean mitral valve area was 45 +/- 12 percent of the nominal value at rest and increased to 68 +/- 18 percent during exercise at a mean of 45 months after implantation. There was no change in these values at the one-year repeat study. It is concluded that in a population with predominantly pericardial bioprostheses, (1) aortic tissue prostheses showed a progressive functional deterioration demonstrable by Doppler echocardiography, most probably due to degenerative changes; and (2) in mitral tissue prostheses, there was no significant reduction of orifice area in relation to time from implantation. Reduction of mitral valve areas may, to some extent, reflect a less than full opening at rest.

The necessity of reoperation for patients with Bjork-Shiley, St Jude Medical, Hancock and Carpentier-Edwards prostheses

The purpose of this study was to determine the criteria of valve selection from the long-term results of Hancock, Carpentier-Edwards, St Jude Medical and Bjork-Shiley prostheses, taking into special account the frequency of reoperation. Reoperations on the Hancock bioprosthesis were performed on six patients for tissue leaflet disruption with an incidence of 2.2 per cent/patient-year. Reoperations on the Carpentier-Edwards bioprosthesis were performed on 24 patients for tissue leaflet disruption in 23 patients and prosthetic valve endocarditis (PVE) in one, with an incidence of 3.8 per cent/patient-year. Reoperations on the Bjork-Shiley prosthesis were performed in two patients for severe hemolysis, with an incidence of 0.32 per cent/patient-year. Reoperations on the St Jude Medical prosthesis were performed on 3 patients, for valve thrombosis in one patient, PVE in one, and hemolysis in one, with an incidence of 0.23 per cent/patient-year. The overall mortality rate was 20 per cent, or 7 patients, and the indications for reoperation affected this. Patients with primary tissue failure had a mortality rate of 10.3 per cent; those with a thrombosed valve, 0 per cent; those with hemolysis, 66.7 per cent; and those with valve infection, 100 per cent. A good chance of survival may be achieved in patients facing prosthetic valve complications by performing reoperation as soon as possible after early detection, since mortality is high following emergency reoperation and in patients with severe symptoms. Currently, we recommend mechanical prostheses for valve replacement except in patients over 70 years old and in younger patients with absolute contraindications to anticoagulative therapy.

Valve replacement in children under 14 years of age: a review of 22 years of experience.

From 1964 to 1986, a total of 18 valve replacement operations were performed in 15 children under 14 years of age, with 13% operative mortality. Eleven children had a mitral valve replacement, with 3 subsequently requiring reoperation. Twelve Starr-Edwards caged ball prostheses, 1 Björk-Shiley and 1 Carpentier-Edwards prosthesis were implanted in the mitral position, with 18% operative mortality. Three children underwent aortic valve replacement, 1 with a Björk-Shiley prosthesis and 2 with a Starr-Edwards. One patient had tricuspid valve replacement utilizing a Starr-Edwards valve. Thirteen patients had one or more cardiac operations prior to valve replacement. Two late deaths occurred 8 and 18 months, respectively, group, 1 from a cardiac arrhythmia and 1 from fulminating prosthetic valve endocarditis. There were no late deaths in other patients. There was one thromboembolic episode in the entire group. At follow-up, 10 patients were classified as New York Heart Association Functional Class I and 1 patient was Class III. Valve replacement in children can be carried out with low mortality and good long-term results using the Starr-Edwards caged ball prosthesis.

An eight-year experience with porcine bioprosthetic cardiac valves

A total of 589 porcine bioprostheses were implanted in 509 patients from January, 1976, through December, 1983. Of the valves implanted, 390 were Hancock and 199 were Carpentier-Edwards. A total of 1,633 patient-years was accrued, with a mean follow-up of 38 months per patient. Two hundred eight patients had aortic valve replacement, 209 had mitral valve replacement, and 79 had multiple valve replacements, of which 46 were aortic and mitral replacements. The mortality for isolated aortic valve replacement was 5.8%; for isolated mitral replacement, 8.6%, and for all patients, 10.9%. Late mortality was 3.9% per patient-year. The actuarial survival rate at 5 years was 79% for aortic, 68% for mitral, and 76% for aortic-mitral valve replacement. There were 12 thromboembolic events (0.73% per patient-year). Two episodes occurred in patients with an aortic bioprosthesis, nine in patients with a porcine mitral valve, and one in a patient with mitral and tricuspid bioprosthetic valves. The probability of remaining free of thromboembolism at 5 years was 99% for the group having aortic valve replacement, 93% for those having mitral replacement, and 100% for the group having aortic-mitral valve replacements. Thirteen episodes of endocarditis occurred (0.8% per patient-year). Seven of the 13 patients died as a direct result of endocarditis. The probability of remaining free of prosthetic endocarditis at 5 years was 97% for the aortic valve replacement group, 95% for the mitral group, and 97% for the aortic-mitral group. There were 20 instances of xenograft failure (1.2% per patient-year). The probability of remaining free of valve failure at 5 years was 96% for the aortic valve replacement group, 93% for the mitral group, and 93% for the aortic-mitral replacement group. Primary tissue failure of a prosthesis occurred in seven patients, all with Hancock valves (0.43% per patient-year). As yet there has been no primary tissue failure of the Carpentier-Edwards prosthesis. There also appears to be a lower incidence of thromboembolism (Edwards, 0.3% per patient-year; Hancock, 0.8% per patient-year) and endocarditis (Edwards, 0.6% per patient-year; Hancock, 1.0% per patient-year). The low incidence of complications with the porcine bioprosthetic valve, especially the Carpentier-Edwards, encourages us to recommend its continued use, especially in situations in which anticoagulation is contraindicated.

Performance of Glutaraldehyde-Preserved Porcine Bioprosthesis as a Mitral Valve Substitute in a Young Population Group

Porcine bioprostheses were implanted in the mitral position in 289 patients. The mean age was 25.8 ± 13.7 years. One hundred thirty-five patients (47%) were 20 years old or younger. Most patients had chronic rheumatic valvulitis (74%). Mitral regurgitation and mixed mitral valve disease were the dominant lesions. Hancock, Angell-Shiley, and Carpentier-Edwards prostheses were implanted in 84, 14, and 191 patients, respectively. There were 19 early and 64 late deaths. Mean follow-up was 5.04 ± 1.03 patient-years. Fifty-eight patients (6.71% per patient-year) were reoperated on for degenerated prostheses, with 13 deaths. Twelve patients died without reoperation, and 17 await reoperation for degenerated valves. The rate of structural failure (total, 87 patients) was 21.07% and 3.04% per patient-year for patients less than and older than 20 years, respectively ( p < 0.001). The 6-year actuarial survival for these two groups was 50% and 68%, respectively. However, for patients 20 years old or younger, survival free from degeneration was only 20% at 6 years ( p < 0.001). Bioprostheses have a high failure rate and should not be implanted in young patients or in patients with a life expectancy exceeding 10 years.