Fifteen years' single-center experience with the ATS bileaflet valve.

BACKGROUND AND AIM OF THE STUDY: Since its introduction in May 1992, the bileaflet ATS Open Pivot valve has been implanted routinely at the authors' institution. The study aim was to analyze, retrospectively, the 15-year clinical results of these implanted ATS valves.

METHODS

Between May 1992 and December 2005, a total of 1,160 ATS valves (749 aortic, 381 mitral, 21 tricuspid, nine pulmonary) was implanted in 1,047 consecutive patients (655 males, 392 females; mean age 62.1 +/- 12.4 years). Preoperatively, 75% of the patients were in NYHA class III or higher (mean 3.1). The most frequent comorbidities included atrial fibrillation (n = 381), coronary disease (n = 288) and diabetes (n = 172).

RESULTS

The mean follow up was 78 months (range: 24-183 months); the total follow up was 6,887 patient-years (pt-yr) and was 99.8% complete. In-hospital mortality was 4% (n = 43; three valve-related). Survival (Kaplan-Meier) at five and 10 years was significantly better for aortic than for mitral valve patients (84% and 65% versus 75% and 41%, respectively) (Mantel-Cox, p < 0.001). A log rank analysis detected no statistical difference in the incidence of thromboembolism (p = 0.182) or bleeding (p = 0.375) between both groups. The overall linearized incidences were: thromboembolism 1.08%/pt-yr; bleeding 0.91%/pt-yr; endocarditis 0.22%/pt-yr; paravalvular leakage 0.33%/pt-yr; and valve thrombosis 0.21%/pt-yr. Multivariate analysis (Cox regression) indicated age > 70 years (p < 0.0001), NYHA class > or = III (p < 0.0001), non-sinus rhythm (p = 0.001), concomitant CABG (p = 0.008) and higher INR values (p = 0.013) to be significant risk factors for death.

CONCLUSION

This 15-year experience with the ATS bileaflet prosthesis showed excellent clinical outcomes for patients, with no structural failure and an acceptable incidence of adverse events.