Long-term results of heart valve replacement with bileaflet prostheses.

Bileaflet cardiac prostheses (St. Jude, CarboMedics, Duromedics, Bicarbon, Jyros) have shown a low incidence of complications and good haemodynamic performance. In the last twelve years, 783 bileaflet prostheses were implanted in 690 patients at our Institution. The population of our study comprises 591 bileaflet prostheses (418 CarboMedics, 124 St. Jude, 49 Bicarbon) implanted in the mitral (MVR) (n = 305) or aortic (AVR), (n = 286) position. The follow-up study evaluated 292 male and 295 female patients with age ranging from 13 and 79 years (mean 50.4 +/- 14.7 years). Hospital mortality was 6.6%. Follow-up was 97% complete, with 1822 +/- 33 patient/years and a mean follow-up of 37 months (range 1 to 144 months). Twelve years actuarial freedom from complication according to prosthetic site were calculated as follows (linearized rates in parentheses): late mortality AVR 97.6% +/- 0.6% (2.3%), MVR 96% +/- 0.5% (2.1%); thrombosis AVR 100%, MVR 96% +/- 0.9% (0.8%); embolism AVR 97% +/- 0.5% (1.5%), MVR 96.6% +/- 0.7% (1.8%). Global freedom from anticoagulant-related haemorrhage was 95% +/- 1.2% (2.3%) and 94.5% +/- 0.7% (2.2%) following AVR, 94 +/- 0.6% (2.1%) following MVR. The difference of the haemorrhagic risk for prosthetic site was not significant (p > 0.05). Functional improvement was confirmed by the low postoperative NYHA functional class. According to our results, cumulative experience with bileaflet valves has shown very good long-term results in term of low rate of complication, long-term survival and quality of life.