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J Thorac Cardiovasc Surg 2002;124:146-154
© 2002 The American Association for Thoracic Surgery

Surgery for Acquired Cardiovascular Disease (ACD)

Late hemodynamic and clinical outcomes of aortic valve replacement with the Carpentier-Edwards Perimount pericardial bioprosthesis

From the Division of Cardiovascular Surgery of Toronto General Hospital and the University of Toronto, Toronto, Ontario, Canada.
The Karolinska Institute and the Swedish Institute provided financial support for Dr Dellgren.

Received for publication Aug 28, 2001. Revisions requested Sept 28, 2001; revisions received Oct 22, 2001. Accepted for publication Nov 1, 2001. Address for reprints: Tirone E. David, MD, Division of Cardiovascular Surgery, Toronto General Hospital, 200 Elizabeth St, EN 13-222, Toronto, Ontario M5N 2C4 Canada (E-mail: tirone.david{at}uhn.on.ca).

Objectives: The aim of this study was to investigate the long-term clinical and hemodynamic outcomes after aortic valve replacement with the Carpentier-Edwards Perimount bioprosthesis (Edwards Lifesciences, Irvine, Calif), which has been used in our institution since 1984.
Methods: From January 1984 to December 1995, the Carpentier-Edwards pericardial bioprosthesis was used for aortic valve replacement in 254 patients (male/female ratio 117:137) with a mean age of 71 years (range 25-87 years). Before the operation, 216 patients (85%) were in New York Heart Association functional class III or IV. The predominant diagnosis was aortic stenosis (n = 219, 86%). Associated surgical procedures included coronary artery bypass grafting in 130 cases (51%), mitral valve replacement in 11 cases (4%), and tricuspid or mitral valve repair in 12 cases (5%). Previous cardiac operations had been performed in 36 cases (14%). Follow-up was 100% complete at a mean of 60 ± 31 months. Univariate estimates of time-related cumulative probabilities were calculated by the Kaplan-Meier method. Multivariable adjustment was performed by Cox proportional hazards regression. Echocardiography was performed in 61% of long-term survivors.
Results: There were 11 early deaths (4%) and 58 late deaths. Actuarial survivals at 5, 10, and 12 years were 80% ± 3%, 50% ± 8%, and 36% ± 9%, respectively. At 12 years the freedom from cardiac death was 73% ± 7%, the freedom from valve-related death was 84% ± 11%, the freedom from valve reoperation was 83% ± 9%, the freedom from primary tissue failure was 86% ± 9%, the freedom from thromboembolism was 67% ± 13%, and the freedom from endocarditis was 98% ± 1%. Echocardiography was performed on long-term survivors (mean follow-up 67 ± 25 months) and showed that transvalvular peak and mean pressure differences measured with Doppler echocardiography were 23.2 ± 9.6 and 12.3 ± 4.8 mm Hg, respectively. Aortic regurgitation was found by Doppler echocardiography to be none or trivial, mild, moderate, and severe in 64%, 30%, 3%, and 1% of patients, respectively. Mean left ventricular mass index was 107.2 ± 35.3 g/m² (118.9 ± 40.2 g/m² in men and 98.8 ± 28.8 g/m² in women) at late follow-up. One third of all patients, regardless of sex (n = 26/64 women and n = 14/45 men), had evidence of left ventricular hypertrophy. However, our analyses indicate that the residual left ventricular hypertrophy was not caused by valve mismatch but was probably multifactorial.
Conclusion: The Carpentier-Edwards Perimount bioprosthesis has provided satisfactory clinical and hemodynamic outcome. However, at long-term follow-up about one third of the patients being investigated still had left ventricular hypertrophy examined by echocardiography.

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