Background: This study was undertaken to evaluate the long-term clinical and echocardiographic outcome after aortic valve replacement with the Bravo Cardiovascular Model 400 stentless xenograft.
Methods: Between February 1992 and January 1994, 67 patients underwent aortic valve replacement with the Bravo 400 bioprosthesis. The valvular pathology was aortic stenosis in 36 patients (53.7%), aortic insufficiency in 17 patients (25.4%), and mixed lesion in 14 patients (20.9%). Mean follow-up time was 9.8 +/- 2.73 years and median follow-up time was 11 years. Cumulative follow-up time was 659 patients-years and was 94% complete.
Results: No early deaths were observed. Overall survival estimates at 11 years were 74.71% +/- 5.47%. The actuarial freedom from valve-related death at 11 years was 91.04% +/- 3.84%; from cardiac-related death at 11 years it was 87.95% +/- 4.29%; and from noncardiac death at 11 years it was 85.14% +/- 4.58%. Eleven-year Kaplan-Meier survival of patients younger than 65 years was 90.91% +/- 6.13% versus 66.08% +/- 7.38% for older patients (p = 0.0307, log-rank test). The actuarial freedom from all valve-related morbidity and mortality at 11 years was 80.3% +/- 5.4%. The mean transvalvular gradient decreased significantly after aortic valve replacement with a corresponding increase in effective orifice area. Left ventricular mass index at 10-year follow-up was 68.5% of the preoperative value.
Conclusions: The Bravo Cardiovascular Model 400 stentless xenograft has provided good clinical and hemodynamic results up until 11 years of follow-up.