OBJECTIVE: The first generation of pericardial valves was withdrawn from the market because of too high a rate of premature failure. With an original design, the Carpentier-Edwards pericardial valve promised improved results, especially in small sizes. METHODS: Ninety patients who underwent an isolated aortic valve replacement with a 19 mm Carpentier-Edwards pericardial bioprosthesis in our institution between July 1984 and December 1993 were followed up. The mean age was 72.2 +/- 10.1 years. Fifty percent of the patients were in NYHA clinical status III or IV. The operative mortality rate was 3.7% (3/90). All patients were followed up for an average of 4.45 years after their operation and the total follow-up was 398 patient-years. RESULTS: At this time of the study, over 80% of the patients are in NYHA class I or II. There were nine late deaths. After 10 years the actuarial survival rate was 80 +/- 12%. Three patients died of valve-related causes (1 endocarditis, 1 structural failure and 1 sudden death). The actuarial rate of freedom from valve-related death was 93 +/- 6% at 10 years. Valve-related complications included two thromboembolic episodes (0.5% patient-year), one endocarditis (0.3% patient-year), one reoperation (0.3% patient-year) and one structural valve failure with calcification and stenosis (0.3% patient-year). After 10 years, freedom from reoperation was 99 +/- 1%, from valve failure 98 +/- 2%, from thromboembolic episodes 95 +/- 4% and from endocarditis 98 +/- 2%. The mean gradient was 18.8 mmHg and mean effective orifice area 1.1 cm2. CONCLUSIONS: With a low rate of valve-related events at 10 years and a low rate of structural deterioration with no leaflet tear, this prosthesis is a reliable alternative for small aortic annuli.
OBJECTIVE: The first generation of pericardial valves was withdrawn from the market because of too high a rate of premature failure. With an original design, the Carpentier-Edwards pericardial valve promised improved results, especially in small sizes. METHODS: Ninety patients who underwent an isolated aortic valve replacement with a 19 mm Carpentier-Edwards pericardial bioprosthesis in our institution between July 1984 and December 1993 were followed up. The mean age was 72.2 +/- 10.1 years. Fifty percent of the patients were in NYHA clinical status III or IV. The operative mortality rate was 3.7% (3/90). All patients were followed up for an average of 4.45 years after their operation and the total follow-up was 398 patient-years. RESULTS: At this time of the study, over 80% of the patients are in NYHA class I or II. There were nine late deaths. After 10 years the actuarial survival rate was 80 +/- 12%. Three patients died of valve-related causes (1 endocarditis, 1 structural failure and 1 sudden death). The actuarial rate of freedom from valve-related death was 93 +/- 6% at 10 years. Valve-related complications included two thromboembolic episodes (0.5% patient-year), one endocarditis (0.3% patient-year), one reoperation (0.3% patient-year) and one structural valve failure with calcification and stenosis (0.3% patient-year). After 10 years, freedom from reoperation was 99 +/- 1%, from valve failure 98 +/- 2%, from thromboembolic episodes 95 +/- 4% and from endocarditis 98 +/- 2%. The mean gradient was 18.8 mmHg and mean effective orifice area 1.1 cm2. CONCLUSIONS: With a low rate of valve-related events at 10 years and a low rate of structural deterioration with no leaflet tear, this prosthesis is a reliable alternative for small aortic annuli.