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You are here: Contents > 2004 > Volume 13 Number 6 November 2004 > DEVICE EVALUATION > The Stentless Cryo-Life O達rien Porcine Aortic Valve at 10 Years

The Stentless Cryo-Life O達rien Porcine Aortic Valve at 10 Years

Ulrik Hvass, Franck Baron, Abdallah Elsebaey, Din Nguyen, Erwan Flecher
Hôpital Bichat, Paris, France

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 ≥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.
The Journal of Heart Valve Disease 2004;13:977-983

The Stentless Cryo-Life O’Brien Porcine Aortic Valve at 10 Years

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