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Ann Thorac Surg 2002;73:1460-1465
© 2002 The Society of Thoracic Surgeons
a Department of Thoracic and Cardiovascular Surgery, Cleveland, Ohio, USA
b Department of Cardiology, Cleveland, Ohio, USA
c Department of Biostatistics and Epidemiology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
d Good Samaritan Hospital, Portland, Oregon, USA
e Montefiore Medical Center/Albert Einstein, Bronx, New York, USA
Accepted for publication January 4, 2002.
* Address reprint requests to Dr Banbury, The Cleveland Clinic Foundation, 9500 Euclid Ave, Desk F25, Cleveland, OH 44195 USA
e-mail: banburm{at}ccf.org
Background. Long-term stability of the hemodynamic performance of commercially available Carpentier-Edwards stented bovine pericardial aortic bioprostheses (Perimount RSR) is unknown. To anticipate the fate of this bioprosthesis, we examined its hemodynamic performance up to 17 years using echocardiographic studies in a Premarket Approval cohort.
Methods. Of 267 patients at four institutions in the Premarket Approval cohort, 85 had a total of 168 echocardiographic studies during a 17-year period of yearly follow-up examinations. These were reviewed and quantified in a core echocardiographic facility. Longitudinal data analysis was used to account for repeated, censored data.
Results. Mean transvalvular gradient was inversely related to prosthesis size (p = 0.01), and possibly (p = 0.06) increased somewhat during the first 10 years of follow-up, then stabilized. Effective orifice area was larger in larger valve sizes (p = 0.01), declined somewhat during the first 10 years, and then began to increase again. Ejection fraction declined minimally (p = 0.2). In contrast to the rather stable hemodynamics, aortic regurgitation steadily increased from none to 1 to 2+ (p = 0.005), but rarely (< 10% at 17 years) progressed to 3+ or 4+.
Conclusions. The Carpentier-Edwards aortic pericardial bioprosthesis can be anticipated to have an acceptable long-term transvalvular gradient and effective orifice size that will change trivially up to 17 years after implantation. Mild aortic regurgitation will develop progressively. This anticipated hemodynamic resilience supports continued clinical use of the Perimount Carpentier-Edwards bovine pericardial stented bioprosthesis.
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