Single center experience with the Sorin Bicarbon prosthesis: A 17-year clinical follow-up

Objective: To evaluate the long-term results of aortic valve replacement (AVR) and mitral valve replacement (MVR) with the Sorin Bicarbon prosthesis (SBP). Methods: Five hundred seven patients (306 men, 201 women), mean age 62 +/- 10 years (range, 21-86 years), received an SBP between 1994 and 2000; AVR was performed in 344 (67%) and MVR in 163 (33%). The main concomitant procedure was coronary artery grafting in 79 patients (16%). Follow-up was 99% complete; mean follow-up was 12.7 +/- 4.0 years with a cumulative duration of follow-up of 6475 patient-years in the entire group (4348 patient-years for AVR and 2124 patient-years for MVR). Results: Hospital mortality was 2.7% (AVR, 2.03%; MVR, 4.3%). There were 169 late deaths (AVR, 128; MVR, 41). Actuarial survival at 17 years is 49.7% +/- 5.3% for AVR and 62.0% +/- 6.1% for MVR. At the last follow-up, 310 survivors (199 AVR, 111 MVR) are in New York Heart Association functional class I or II. At 17 years, actuarial freedom from valve-related deaths, embolism, and bleeding is 89.8% +/- 4.8%, 85.8% +/- 5.4%, and 96.2% +/- 1.2% after AVR, and 91.9% +/- 3.9%, 96.3% +/- 1.8%, 95.0% +/- 2.9% after MVR. Reoperation was required in 5 patients with AVR (thrombosis in 4 and perivalvular leak in 1). Actuarial freedom from reoperation is 98.1% +/- 0.8% after AVR and 100% after MVR; freedom from endocarditis is 100% after AVR and 99.2% +/- 0.7% after MVR. No cases of intrinsic structural valve failure were observed. Conclusions: The SBP has shown excellent results in terms of clinical improvement and freedom from valve-related complications, even up to 17 years after AVR and MVR. It therefore seems to be a safe option whenever a mechanical prosthesis is needed.