OBJECTIVES: We sought to describe the hemodynamic and clinical outcomes for the Freestyle aortic root bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in a large multicenter cohort prospectively followed for 8 years. METHODS: A total of 700 patients (651 [93%] >60 years of age) at 8 centers in North America were followed prospectively after aortic valve replacement with the Freestyle stentless bioprosthesis; the implant technique was subcoronary in 500, total root in 162, and root inclusion in 38. Follow-up was 3395 patient-years (4.9 +/- 2.3 years per patient). Clinical and echocardiographic follow-up was prospectively obtained at yearly intervals. RESULTS: For the subcoronary, total root, and root inclusion groups, actuarial freedom from valve-related death was 96.8% (SE 3.0%), 92.3% (SE 7.7%), and 90.9% (SE 11.2%), respectively, and freedom from structural deterioration was 98.6% (SE 2.0%), 100.0% (SE 0.0%), and 100.0% (SE 0.0%), respectively. Hemodynamics remained excellent at 6 years. Freedom from moderate or more aortic regurgitation was 86.0% (SE 5.1%), 98.7% (SE 3.9%), and 97.3% (SE 6.6%), respectively. Gradients were slightly lower (P =.0009), and the effective orifice area (P =.02) and freedom from aortic regurgitation were slightly higher (P =.03) with total root than subcoronary implantation. CONCLUSIONS: The Freestyle stentless aortic root bioprosthesis is a versatile option for aortic valve replacement. Measures of clinical outcomes and prosthesis durability remain excellent in multicenter follow-up through 8 years in a population predominantly older than 60 years at the time of the operation.
OBJECTIVES: We sought to describe the hemodynamic and clinical outcomes for the Freestyle aortic root bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in a large multicenter cohort prospectively followed for 8 years. METHODS: A total of 700 patients (651 [93%] >60 years of age) at 8 centers in North America were followed prospectively after aortic valve replacement with the Freestyle stentless bioprosthesis; the implant technique was subcoronary in 500, total root in 162, and root inclusion in 38. Follow-up was 3395 patient-years (4.9 +/- 2.3 years per patient). Clinical and echocardiographic follow-up was prospectively obtained at yearly intervals. RESULTS: For the subcoronary, total root, and root inclusion groups, actuarial freedom from valve-related death was 96.8% (SE 3.0%), 92.3% (SE 7.7%), and 90.9% (SE 11.2%), respectively, and freedom from structural deterioration was 98.6% (SE 2.0%), 100.0% (SE 0.0%), and 100.0% (SE 0.0%), respectively. Hemodynamics remained excellent at 6 years. Freedom from moderate or more aortic regurgitation was 86.0% (SE 5.1%), 98.7% (SE 3.9%), and 97.3% (SE 6.6%), respectively. Gradients were slightly lower (P =.0009), and the effective orifice area (P =.02) and freedom from aortic regurgitation were slightly higher (P =.03) with total root than subcoronary implantation. CONCLUSIONS: The Freestyle stentless aortic root bioprosthesis is a versatile option for aortic valve replacement. Measures of clinical outcomes and prosthesis durability remain excellent in multicenter follow-up through 8 years in a population predominantly older than 60 years at the time of the operation.