Ten-year clinical evaluation of isolated mitral valve and double-valve replacement with the Starr-Edwards prostheses

From 1974 through 1983, 689 hospital survivors of Starr-Edwards (SE) valve replacement were identified; 279 (40.4%) patients with complete follow-up had an isolated mitral valve (SE model 6120 or 6400) replacement: 60.6% of these patients were women, 33.4% were in sinus rhythm, 32.3% had predominantly mitral stenosis, and 23.6% had predominantly regurgitation. Forty-six (6.7%) patients had mitral and aortic valve (SE model 1260 or 2400) replacement, 60.9% were women, and 13% were in sinus rhythm. To determine the long-term outcome of these SE valve prostheses, 325 (97.8%) patients were observed for up to 10 years. Total 10-year mortality was 40 patients (2.54% patients/yr) in the mitral group, of which 26 deaths (9.3%) were cardiac in origin; 8 deaths (2.8%) were directly valve related. Eight patients died (3.47% patients/yr) in the double-valve group, of which 5 deaths (10.8%) had a cardiac cause; 2 deaths (4.3%) were directly valve related. Primary valve failure was never proved. Actuarial estimates of survival at 10 years were 82 +/- 2.6% for the mitral valve group and 81 +/- 6% for the double-valve group. Actuarial estimates of freedom from valve-related morbidity were 87 +/- 2% for the mitral valve group and 59 +/- 7% for the double-valve group. Actuarial estimates of freedom from thromboembolism were 93 +/- 2% for the mitral valve group and 70 +/- 7% for the double-valve group. This prosthesis-based assessment has shown satisfactory long-term performance characteristics of the SE mitral models 6120 and 6400 without any recorded episodes of mechanical valve dysfunctions.