Update of the Providence Health System experience with the CarboMedics prosthesis

The study aim was to update the authors' experience with the CarboMedics bileaflet mechanical prosthesis in terms of early and long-term outcomes.

Between July 1994 and April 2005, a total of 774 CarboMedics valves was implanted at two Providence Health System hospitals in Portland Service Area. Of these valves, 406 (59%) were aortic valve replacements (AVR), 196 (28.5%) were mitral valve replacements (MVR), and 86 pairs (12.5%) were double valve replacements (DVR).

The mean and maximum follow up was 4.6 and 10.2 years, respectively; total follow up was 3,150 patient-years (pt-yr) (total 3,503 valve-years). Operative mortality was 5.7% (4.4% for AVR, 7.7% for MVR, 7.0% for DVR). Five- and 10-year survivals respectively were 79 +/- 2% and 55 +/- 10% for AVR, 74 +/- 3% and 57 +/- 8% for MVR, and 64 +/- 6% and 39 +/- 11% for DVR (p = 0.009). Freedom from valve explant at five and 10 years respectively was 98 +/- 1% and 97 +/- 10% for AVR, 98 +/- 1% and 86 +/- 12% for MVR, and 96 +/- 3% and 96 +/- 3% for DVR (p = 0.950). Freedom from thromboembolism at five and 10 years respectively was 93 +/- 1% and 91 +/- 2% for AVR, 97 +/- 1% and 95 +/- 2% for MVR, and 90 +/- 4% and 90 4% for DVR (p = 0.226). Freedom from bleeding at five and 10 years respectively was 98 +/- 1% and 97 +/- 1% for AVR, 97 +/- 1% and 96 +/- 2% for MVR, and 91 +/- 4% and 91 +/- 4% for DVR (p = 0.006). Freedom from endocarditis at five and 10 years respectively was 99 +/- 1% and 99 +/- 1% for AVR, 98 +/- 1% and 98 +/- 1% for MVR, and 95 +/- 3% and 91 +/- 4% for DVR (p = 0.030). There were nine perivalvular leaks (six after AVR, three after MVR), and three valve thromboses (two after MVR, one after DVR). Freedom from overall valve-related events at five and 10 years respectively was 80 +/- 2% and 74 +/- 3% for AVR, 82 +/- 3% and 57 +/- 11% for MVR, and 69 +/- 6% and 66 +/- 6% for DVR (p = 0.074).

Long-term experience with the CarboMedics valve shows the clinical performance of the valve to be very good, with results comparable to those obtained with other mechanical valves.