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J Thorac Cardiovasc Surg 2004;127:1657-1663
© 2004 The American Association for Thoracic Surgery

Surgery for acquired cardiovascular disease

Eight-year results after aortic valve replacement with the Freestyle stentless bioprosthesis

^a Department of Medicine, Division of Cardiology, University of Michigan, Ann Arbor, Mich, USA
^b Department of Surgery, Section of Cardiothoracic Surgery, Bowman Gray School of Medicine, Winston-Salem, NC, USA
^c Department of Medicine, Division of Cardiology, University Laval, Ste-Foy, Quebec, Canada
^d Department of Cardiac Surgery, Kaiser Permanente Hospital, Los Angeles, Calif, USA
^e LDS Hospital, Salt Lake City, Utah, USA

Received for publication October 7, 2003; revisions received December 28, 2003; accepted for publication January 13, 2004.

^* Address for reprints: David S. Bach, MD, L3119 Women's-0273, 1500 E Medical Center Dr, Ann Arbor, MI 48109, USA
dbach{at}umich.edu

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.

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