One hundred thirty-nine patients had isolated mitral valve replacement with the Starr-Edwards model 6310-6320 prosthesis during a 48-month period. The hospital mortality was 5% (seven patients). There have been 15 late deaths (11%) in a follow-up period that averaged 16.8 months. Ten patients (7%) had thromboembolic episodes, of which three were fatal. Twelve patients (9%) had complications related to anticoagulant therapy and four died. There have been no prosthetic infections or hemolytic complications requiring transfusion or removal of the prosthesis. Mechanical malfunction of the model 6320 prosthesis has not been observed. The improved operative mortality and the decline in the late mortality and in valve-related complications with the model 6320 prosthesis suggest that valve replacement should be offered to symptomatic patients before substantial myocardial dysfunction has occurred.
Allen WB, Karp RB, Kouchoukos NT. Mitral Valve Replacement: Starr-Edwards Cloth-Covered Composite-Seat Prosthesis. Arch Surg. 1974;109(5):642–647. doi:10.1001/archsurg.1974.01360050036009
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