The Stentless Cryo-Life O'Brien porcine aortic valve at 10 years.

BACKGROUND AND AIM OF THE STUDY: If stentless devices--with their physiological advantages--are to remain attractive, their long-term durability must equate with that of reference stented valves. METHODS: Between August 1991 and August 2001, 650 patients (mean age 72.0+/-4.2 years) received a Cryo-Life O'Brien Stentless aortic porcine bioprosthesis. The mean follow up was 4.6 years; total follow up was 2,644 patient-years (pt-yr). Among patients, 79% were in NYHA classes III-IV. Calcific aortic stenosis accounted for 93% of patients, who were predominantly female (75%), with associated coronary surgery in 19% and mitral surgery in 10.3%. Follow up was based on serial echocardiography, referring cardiologists' reports, and direct home telephone calls. Data were gathered over a six-month period. RESULTS: Operative mortality was 8.1% (n = 51). Of these deaths, 2.7% were in isolated cases (mean age 72.0+/-4.2 years) and 14% with associated procedures (mean age 77.0+/-5.3 years). There were 103 late deaths (3.9% per pt-yr). Valve-related complications included 14 deaths (linearized rate 0.52% per pt-yr), reoperation in 22 (0.8% per pt-yr), eight operated valvular endocarditis (0.3% per pt-yr), two valve thrombosis (0.07% per pt-yr), 11 embolic events (0.3% per pt-yr), and 14 anticoagulant-related bleeding (0.52% per pt-yr). Actuarial survival was 76+/-6% at 10 years, with a freedom from structural deterioration of 99.75% in patients aged > or =65 years (mean age 76+/-8 years), and 86% in patients aged <65 years (mean age 44+/-15 years). The gradients remained low, and the echocardiographic aspect was close to that of a normal valve. CONCLUSION: At 10 years, the Cryo-Life O'Brien Stentless provided excellent results in terms of durability associated with all the stentless advantages relating to physiology--gradients, orifice areas, and mass regression--that translate into an appropriately adapted left ventricular exertion profile.