Long-term clinical and echocardiographic follow-up of the Freestyle stentless aortic bioprosthesis.

BACKGROUND Stentless aortic bioprostheses were designed to provide enhanced hemodynamic performance and potentially greater longevity. The present report describes the outcomes of patients with the Freestyle stentless bioprosthesis followed for ≤18 years. METHODS AND RESULTS Between 1993 and 2011, 430 patients underwent primary aortic valve replacement with a Freestyle bioprosthesis in the subcoronary position. Mean age was 68.2 ± 8.2 years. All of the clinical and echocardiographic data were collected prospectively. Mean overall follow-up was 9.1 ± 4.4 years and was complete in all of the patients. In-hospital mortality was 3.5% (n=15). Overall, 10- and 15-year survival were 60.7% and 35.0%, respectively. Fifty-one patients required reoperation during follow-up, including 27 for structural valve deterioration (SVD). Overall, freedom from reoperation was 91.0% and 75.0% at 10 and 15 years, whereas freedom from reoperation for SVD was 95.9% and 82.3%, respectively. At 10 and 15 years, freedom from reoperation for SVD was 94.0% and 62.6% for patients <60 years of age and 96.3% and 88.4% for patients ≥60 years of age (P=0.002). The median time to explant for SVD was 10.7 years. SVD presented mostly as acute, severe aortic insufficiency attributed to leaflet tear (77.8%). The independent risk factors for reoperation for SVD were age <60 years (P=0.001) and dyslipidemia (P=0.02). CONCLUSIONS Aortic valve replacement with the Freestyle bioprosthesis in a subcoronary position provides good long-term clinical and echocardiographic outcomes for patients >60 years of age. Severe aortic insufficiency with leaflet tear is the major mode of SVD leading to reoperation in these patients.