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.