OBJECTIVE: The first generation of pericardial valves was withdrawn from the market because of a high rate of premature failure. With an original design, Carpentier-Edwards pericardial valves promised improved results. METHODS: One hundred fifty patients who underwent isolated mitral valve replacement, between July 1984 and December 1993, with Carpentier-Edwards pericardial bioprostheses in our institution were followed up. Patient mean age was 62.9 +/- 11.9 years. Operative mortality was 3.3%. All but three patients were followed up for an average of 4.7 years after operation, and total follow-up was 710 patients-years. RESULTS: At the time this article was written, over 80% of patients were in New York Heart Association class I or II. After 10 years, actuarial survival rate was 71% (confidence limit 61% to 81%). Valve-related complications included the following: six valve-related deaths (0.8% patient-year), five thromboembolic episodes (0.7% patient-year), three cases of endocarditis (0.4% patient-year), four reoperations (0.5% patient-year), and four structural valve failures with calcification and stenosis (0.5% patient-year). After 10 years, freedom from valve-related complications was 66% (confidence limit 46% to 86%), from valve-related death 94% (confidence limit 89% to 99%), from reoperation 90% (confidence limit 82% to 98%), and from valve failure 76% (confidence limit 62% to 90%). 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 choice for patients over 60 years of age.
OBJECTIVE: The first generation of pericardial valves was withdrawn from the market because of a high rate of premature failure. With an original design, Carpentier-Edwards pericardial valves promised improved results. METHODS: One hundred fifty patients who underwent isolated mitral valve replacement, between July 1984 and December 1993, with Carpentier-Edwards pericardial bioprostheses in our institution were followed up. Patient mean age was 62.9 +/- 11.9 years. Operative mortality was 3.3%. All but three patients were followed up for an average of 4.7 years after operation, and total follow-up was 710 patients-years. RESULTS: At the time this article was written, over 80% of patients were in New York Heart Association class I or II. After 10 years, actuarial survival rate was 71% (confidence limit 61% to 81%). Valve-related complications included the following: six valve-related deaths (0.8% patient-year), five thromboembolic episodes (0.7% patient-year), three cases of endocarditis (0.4% patient-year), four reoperations (0.5% patient-year), and four structural valve failures with calcification and stenosis (0.5% patient-year). After 10 years, freedom from valve-related complications was 66% (confidence limit 46% to 86%), from valve-related death 94% (confidence limit 89% to 99%), from reoperation 90% (confidence limit 82% to 98%), and from valve failure 76% (confidence limit 62% to 90%). 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 choice for patients over 60 years of age.