The Carpentier-Edwards Bioprosthesis: A Comparative Study Analyzing Failure Rates By Age

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Abstract
Bioprosthetic valve durability and the significance of patient age at implantation have received much attention recently. Indications and/or contraindications for implantation of the bioprosthesis in the very young and in the elderly have been reasonably well defined. Patients in the middle years (sixth and seventh decades) present a special problem In the choice of a prosthesis. To better elucidate the failure rate of the Carpentier-Edwards bioprosthesis in middle-aged patients, a comparative study of value failure rates was conducted using the Wilcoxon (Breslow) statistical technique.From September 1978 to December 1986, 502 patients underwent valve replacement with a Carpentier-Edwards bioprosthesis. All patients were operated on by a single surgical team using precisely the same method of valve implantation and myocardial preservation. The overall 30-day mortality was 8.4%. PATIENT SURVIVAL: Follow-up was obtained on all 460 hospital survivors and extends to 109.2 months with a mean of 36.8 months. The cumulative survival is 1,410.6 patient-years. VALVE SURVIVAL: The 481 patients that left the hospital were divided into two subgroups. Group I included patients aged 55 to 69 years; group II, 70 years and older. There were 8 valve failures in group I. The percent of valves free of failure plotted by the actuarial method is 95.4% at 5 years (SEM 1.7, 81 valves at risk) and 95% at 7 years (SEM 1.7, 23 valves at risk). In group II (age 70 and above), there were only two valve failures. The percent of valves free of failure by the same method is 99.5% at 5 years (SEM 0.05, 43 valves at risk) and 95% at 7 years (SEM 4.3, 14 valves at risk). This comparison generated no statistically significant difference beween the valve failure rate for the two groups (P = .144). This study suggests that the failure rate of the Carpentier-Edwards bloprosthesis in middle age and elderly patients is low and additional long-term evaluation appears warranted.