Evaluation of the Sorin bicarbon bileaflet valve in 488 patients (519 prostheses)

The Sorin bicarbon bileaflet prosthesis was introduced in 1990. To evaluate the clinical performance of this prosthesis, we reviewed 519 prostheses that were implanted in 488 patients (275 men, 213 women; mean age 59 years; SD 10.8, range 19 to 88) from 1993 to 1997. Preoperatively, 82% of patients were in New York Heart Association (NYHA) functional class III or IV. There were 263 aortic valve replacements (AVRs) (54%), 194 mitral valve replacements (MVRs) (40%), and 31 AVRs and MVRs (both) (6%). Concomitant procedures were performed in 82 patients (17%). Follow-up was complete in 471 (97%) with a total cumulative follow-up of 866 patient-years. The 30-day mortality for patients with AVR was 5.7% (95% confidence interval [CI] 2.9 to 8.5), MVR 17.5% (CI 9.9 to 19.7), and both 19% (CI 7.6 to 51.1), with no early valve-related deaths. Patient survival at 55 months was 76% (SE 2.27%), with patients with AVR being 90%, MVR 63%, and both 61%. This was influenced by the following: (1) valve position, which was higher for MVR (p = 0.0001); (2) poor NYHA functional class (p = 0.0006); (3) reoperation (p = 0.02); and (4) age >70 years (p = 0.0001). Valve-related complications (expressed as percentage per patient year and number of events) were major thromboembolism at 0.9% per year (8), with AVR rates being 1.2% per year (6) and MVR 0.7% per year (2); major hemorrhage at 2.3% per year (20) with AVR rates being 2.4% per year (12) and MVR 2.5% per year (7); bacterial endocarditis at 0.2% per year (2); and nonstructural dysfunction rate of 0.7% per year (6). The reoperation rate was 0.9% per year (8) with AVR being 0.6% per year (3) and MVR 1.7% per year (5). At 55 months, actuarial freedom from major thromboembolism was 97% (SE 1.1%) with AVR being 96% and MVR 98%; major hemorrhage 89% (SE 3.1%) with AVR being 88.6% and MVR 91%; structural valve dysfunction 100% (SE 0.0%); and reoperation 97.1% (SE 1.10%) with AVR being 98.5% and MVR 94.6%. At follow-up, 88% of survivors were in NYHA class I or II. In this series, hospital mortality and overall survival in patients were influenced by the patients' clinical characteristics. There were no early valve-related deaths. Valve-related complications were similar to previously reported series with no episode of structural failure. Our experience with the Sorin bicarbon bileaflet prosthesis suggests that it has a satisfactory clinical performance, with low complication rates.