Carpentier-Edwards pericardial valves in the mitral position: ten-year follow-up.

OBJECTIVE: The first generation of pericardial valves was withdrawn from the market because of a high rate of premature failure.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.

The last generation of pericardial valves in the aortic position: ten-year follow-up in 589 patients.

BACKGROUND: The first generation of pericardial valves has been withdrawn from the market because of excessively high rates of premature failure. With its original design, the Carpentier-Edwards pericardial valve has promised improved results. METHODS: In our institution, 589 patients underwent an isolated aortic valve replacement with a Carpentier-Edwards pericardial bioprosthesis between July 1984 and December 1993. The patients' mean age was 67.5 +/- 11.2 years, and 49% of the patients were in New York Heart Association clinical class III or IV. The operative mortality rate was 2.3% (14 of 595). All patients but 4 were followed up for an average of 4.1 years after their operation, and total follow-up was 2,408 patient-years. RESULTS: At the time of the study, more than 85% of the patients were in New York Heart Association class I or II. There were 79 late deaths. After 10 years, the actuarial survival rate was 71% +/- 7%. Nineteen patients died of valve-related causes (3 endocarditis, 7 thromboembolic complications, 1 structural failure, and 8 sudden deaths). The actuarial rate of freedom from valve-related death was 94% +/- 3% at 10 years. Valve-related complications included 23 thromboembolic episodes (0.9% per patient-year), 14 endocarditis (0.5% per patient-year), 9 reoperations (0.4% per patient-year), and 4 structural valve failures with calcification and stenosis (0.2% per patient-year). After 10 years, freedom from valve-related complications was 84% +/- 6%, from reoperation 97% +/- 2%, and from valve failure 96% +/- 4%. CONCLUSIONS: Because of its low rate of valve-related events at 10 years and low rate of structural deterioration with no leaflet tears, this prosthesis is an outstanding choice for patients who need tissue valves and for patients aged 60 years or older.

Twelve-year experience with the 19 mm Carpentier-Edwards pericardial aortic valve.

BACKGROUND AND AIMS OF THE STUDY: In patients with small aortic annuli, the choice of prosthesis should be based on hemodynamics and valve durability. The Carpentier-Edwards pericardial valve offers good hemodynamic performance and long-term valve durability. We reviewed our 12-year experience with 121 patients who received a 19 mm prosthesis. METHODS: A total of 121 patients (97 females, 24 males; mean age 73.2 +/- 9.4 years) underwent isolated aortic valve replacement with a 19 mm Carpentier-Edwards pericardial bioprosthesis in our institution between July 1984 and December 1995. Patients were followed up for an average of 4.84 years after surgery; total follow up was 581 patient-years (pt-yr). RESULTS: The operative mortality rate was 3.3% (4/121). At the present time, 77 patients (86%) are in NYHA class I or II with a mean gradient of 18.0 +/- 6.9 mmHg and mean effective orifice area 1.1 +/- 0.23 cm2. There were 25 late deaths. After 12 years the actuarial survival rate was 42 +/- 26%. Eight patients died of valve-related cause (one endocarditis, one structural failure, two thromboembolisms, one anticoagulant-related hemorrhage, three sudden deaths). At 12 years, the actuarial rate of freedom from valve-related death was 61 +/- 37% and from non-sudden valve-related death 88 +/- 11%. Valve-related complications included six thromboembolic episodes (1.0%/pt-yr), one endocarditis (0.17%/pt-yr), two reoperations (0.34%/pt-yr) and two structural valve failures (0.34%/pt-yr). After 12 years, freedom from reoperation was 89 +/- 11%, from valve failure 92 +/- 8%, from thromboembolic episodes 82 +/- 16% and from endocarditis 99 +/- 1%. CONCLUSION: With a low rate of structural valve failure at 12 years and a good clinical performance, the Carpentier-Edwards prosthesis is a reliable alternative for small aortic annuli.

Double valve replacement with the Carpentier-Edwards pericardial valve: 10-year results.

BACKGROUND AND AIMS OF THE STUDY: The first generation of pericardial valves was withdrawn from the market because of an excessive rate of premature failure. With an original design, the Carpentier-Edwards pericardial valve promised improved results. MATERIALS AND METHODS: From July 1984 to December 1993, 71 patients underwent double mitral and aortic valve replacement with the Carpentier-Edwards pericardial valve. Mean age was 63.4 years. 58% were male, mean clinical status was 2.9 with 71% of patients in NYHA class III or IV, 55% were in atrial fibrillation. All patients were followed for an average of 4.17 years after their operation, and total follow up was 296 patients years. RESULTS: Operative mortality was 7% (5/71). At this point of the study, 70% of patients are in clinical NYHA class I or II, 42% of patients are in atrial fibrillation and 66% receive anticoagulation treatment. We observed 19 late deaths with an actuarial survival of 58% +/- 14% at ten years. Valve-related complications include four endocarditis, four reoperations, seven anticoagulant-related hemorrhages, two structural failures, one thromboembolic episode, and one sudden death. Two patients died of valve-related causes. After 10 years, freedom from valve related death is 97% +/- 3%, from endocarditis 90% +/- 8%, from reoperation 87% +/- 10%, from thromboembolic complications 98% +/- 2%, from valve failure 93% +/- 7%, and freedom from all complications is 58% +/- 18%. No failure in patients older than 60 years was noted and no leaflet tear was observed. CONCLUSIONS: The 10-year results of this pericardial bioprosthesis make this valve an outstanding choice when a bioprosthesis is required and in patients over 60 years old.

The influence of age on valve related events with Carpentier-Edwards pericardial valves.

From July 1984 to December 1991, 641 Carpentier-Edwards pericardial valves were used in 585 consecutive patients. There were 420 aortic valve replacements, 121 mitral valve replacements, and 50 double valve replacements. Mean age was 65.5 +/- 12 years. All patients but 10 were followed up at 3 months periods with a total follow-up of 2074 patients years and a mean follow-up of 3.7 years. Patients were subdivided in 4 groups: Group I: < 50 years, Group II: 50 < age < 65, Group III: 65 < age < 75, Group IV: > 75 years. Actuarial survival rates were 100% in group I, 80 +/- 9% in group II, 68 +/- 11% in group III, and 64 +/- 13% in group IV. Valve related complications included 54 patients and valve related deaths 17. Valve related death rates were 100%, 96 +/- 3%, 95 +/- 4%, 89 +/- 10% respectively (NS). We observed 4 structural failure of the values with respective rates of freedom from valve deterioration of: 92 +/- 6%, 98 +/- 2%, 100%, 100% (NS). No leaflet tears were observed. No difference was found between the 4 age groups in terms of valve related events except for thromboembolic accidents which were more frequent in patients older than 75 years. The absence of difference at 8 years and the absence of leaflet tears indicate the superiority of the Carpentier-Edwards pericardial over previous bioprostheses and the better stress behaviour of this valve. The coming years will allow us to determine the precise place of this pericardial device, especially in young patients and in the mitral position.