Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25-year follow-up of 450 implantations.

OBJECTIVE: The aim of the present study was to evaluate the very-long-term results of the Carpentier-Edwards pericardial bioprosthesis in the mitral position. METHODS: From 1984 to 2011, 450 Carpentier-Edwards PERIMOUNT pericardial mitral bioprostheses were implanted in 404 consecutive patients (mean age, 68 years; 53% female). Patients undergoing multiple valve replacements were excluded. The clinical, operative, and follow-up data were prospectively recorded. The mean follow-up was 7.2±5.1 years, for a total of 3258 valve-years. The follow-up data were 97.8% complete. RESULTS: The operative mortality rate was 3.3%. A total of 188 late deaths occurred, for a linearized rate of 5.8%/valve-year. At 20 years, the overall actuarial survival rate was 16.9%±3.9%. Age at implantation, preoperative New York Heart Association class III or IV, and redo procedure were significant risk factors affecting late survival. The actuarial freedom from complications at 20 years was thromboembolism, 83.9%±7.6%; hemorrhage, 80.2%±10.8%; endocarditis, 94.8%±1.4%; structural valve deterioration, 23.7%±6.9%; and explantation owing to structural valve deterioration, 40.5%±8.0%. The competing risk analysis demonstrated an actual risk of explantation owing to structural valve deterioration at 20 years of 25.5%±2.9%. The expected valve durability was 16.6 years for the entire cohort (11.4, 16.6, and 19.4 years for patients aged <60, 60 to 70, and >70 years, respectively). CONCLUSIONS: With a low rate of valve-related events at 20 years and, in particular, a low rate of structural valve deterioration, the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis remains a reliable choice for a mitral tissue valve, especially in patients >60 years old.

Risk factors for valve-related complications after mechanical heart valve replacement in 505 patients with long-term follow up.

BACKGROUND AND AIM OF THE STUDY: Currently, valve thrombosis, thromboembolic events and bleeding events account for 75% of all complications that occur after mechanical heart valve replacement. The study aim was to determine the main risk factors for valve-related complications in patients undergoing mechanical heart valve replacement. METHODS: Data were available from the systematic follow up of patients who had received a CarboMedics bileaflet mechanical heart valve replacement at the authors' institution. Follow up examinations were conducted prospectively at two-year intervals, via questionnaires sent to the patients' general practitioners, or by telephone calls. RESULTS: Between January 1988 and December 2005, a total of 505 consecutive patients (300 males, 205 females; mean age 52 years; range: 5 to 77 years) underwent heart valve replacement using a CarboMedics mechanical prosthesis. Aortic valve replacement (AVR) was performed in 308 patients, mitral valve replacement (MVR) in 134 patients, and double-valve replacement (DVR) in 62 patients. The follow up was 95.4% complete; the mean follow up was 7.5 years, and the total follow up 3,718 patient-years. Thromboembolic and bleeding complications represented the leading cause of valve-related events (104/195), of valve-related mortality (15/25), and of the need for repeat surgery (9/16). Valve thrombosis occurred in 12 patients. Implantation in the mitral position was identified as a risk factor (HR = 15.07; CI: 8.41-23.07; p 0.0001). Thromboembolism occurred in 32 patients; the use of antiplatelet agents was found to be a protective factor (HR = 0.23; CI: 0.08-0.70; p = 0.01). Bleeding events occurred in 52 patients; risk factors for bleeding events included a history of thromboembolic or bleeding complications (HR = 2.70; CI: 1.33-5.26; p = 0.006) and an unstable International Normalized Ratio (INR) (HR = 2.86; CI: 1.01-8.08; p = 0.05). CONCLUSION: After mechanical heart valve replacement, the only risk factors for bleeding complications were an unstable INR and a history of thromboembolic or bleeding events. The use of antiplatelet agents proved to be a protective factor against thromboembolic events.

Perimount pericardial bioprosthesis for aortic calcified stenosis: 18-year experience with 1133 patients.

BACKGROUND AND AIM OF THE STUDY: Aortic stenosis (AS) is the most important cause of aortic valve disease, its prevalence increasing with patient age. The present study formed part of a long-term evaluation on use of the Perimount pericardial valve for aortic calcified stenosis. METHODS: A total of 1133 consecutive patients who underwent aortic valve replacement (AVR) with a Perimount pericardial bioprosthesis for degenerative AS between July 1984 and December 2003 at the authors' institution, was followed up in 2004. Among the patients (716 males, 417 females; mean age 72.6 years), 997 were in sinus rhythm, and the mean NYHA functional class was 2.3. Preoperative echocardiography indicated a mean gradient of 56 mmHg, a peak gradient of 89 mmHg, and an effective orifice area of 0.6 cm2. Associated procedures were required in 336 patients. RESULTS: All patients but 18 (1.5%) were followed up for an average of 5.5 years postoperatively; thus, the total follow up was 6,180 patient-years. Operative mortality was 2.8% (n=32), and there were 330 late deaths. At 18 years the actuarial survival rate was 22 +/- 4%. Among the 725 patients followed, 80% were in sinus rhythm and 98% in NYHA classes I or II. Valve-related complications included 39 thromboembolic episodes, 24 endocarditis, 22 anticoagulant-related hemorrhage, 28 reoperations, and 19 structural valve failures. A total of 54 patients died from valve-related causes (13 embolic events, two endocarditis, two hemorrhage, one structural failure, 36 unknown causes), and 57 died from cardiac failure. Neither thrombosis nor hemolysis was observed. At 18 years, freedom from embolism was 92 +/- 2%, from endocarditis 93 +/- 4%, from hemorrhage 95 +/- 2%, from reoperation 62 +/- 11%, from valve failure 68 +/- 12%, and from all complications 47 +/- 8%. Among patients aged >60 years, the 18-year actuarial freedom from reoperation was 76 +/- 14%, and from valve failure 85 +/- 8%. CONCLUSION: With a low rate of valve-related events at 18 years, and an especially low rate of structural failure, the Perimount pericardial prosthesis is a reliable choice for patients with aortic calcified stenosis.