Ten-year outcome after aortic valve replacement with the freestyle stentless bioprosthesis

Background. Stentless aortic bioprostheses offer excellent hemodynamics and potentially improved durability compared with other bioprostheses. The present report describes the clinical and hemodynamic outcomes for the Freestyle aortic root bioprosthesis in a large, multicenter cohort prospectively followed up for 10 years. Methods. A total of 725 patients at 8 centers in North America (668 [92%] aged more than 60 years) were followed up prospectively after aortic valve replacement with the Freestyle stentless bioprosthesis. Implant technique was subcoronary in 509, total root in 178, and root inclusion in 38. Follow-up was 4,488 patient-years (mean 6.2 years/patient). Results. For subcoronary, full root, and root inclusion groups, 10-year actuarial freedom from structural valve deterioration was 97.0% +/- 2.2%, 96.0% +/- 4.5%, and 90.9% +/- 11.2%, respectively; and actuarial freedom from reoperation was 91.7% +/- 3.5%, 92.3% +/- 6.0%, and 92.0% +/- 10.7%, respectively. Mean pressure gradient at 10 years was 8.9 +/- 7.9 mm Hg for subcoronary, 7.0 +/- 4.1 mm Hg for full root, and 10.0 +/- 11.1 mm Hg for root inclusion groups; effective orifice area was 1.6 +/- 0.5 cm(2), 1.6 +/- 0.6 cm(2), and 1.7 +/- 0.5 cm(2), respectively. Freedom from moderate or more aortic regurgitation at 10 years was good for all three implant groups, but slightly higher for full root (97.7% +/- 1.6%) compared with subcoronary (87.2% +/- 2.8%) patients (p < 0.005). Conclusions. The Freestyle stentless aortic root bioprosthesis is a versatile option for aortic valve replacement. Measures of clinical outcomes and prosthesis durability remain excellent through 10 years.