Abstract
Between January 1967 and August 1994 Starr-Edwards (Baxter Healthcare Corporation, Santa Ana, CA, USA) ball valve prostheses (model 6120) were implanted in 1129 patients whose ages ranged from 9 to 65 years (mean 29.5 ± 11.08 years). One hundred and ninety-three patients had a concomitant tricuspid valve repair and 36 underwent closure of an atrial septal defect. A closed mitral valvotomy had been carried out previously in 15%. The hospital (30-day) mortality rate was 10.9% (123/1129), which declined to 6.9% (32/461) in the last decade. The patients were administered warfarin to counter thrombogenesis and were regularly monitored with prothrombin time values. Over the last 10 years, aspirin was used as the sole anticoagulant in a cohort of 63 patients. Follow-up was achieved in 87% of cases; the follow-up period ranged from 1 to 25 years with a total follow-up of 8579.69 patient-years. Late death occurred in 132 patients. Anticoagulant-related hemorrhage occurred at a rate of 0.31 per 100 patient-years. Prosthetic valve endocarditis occurred at a linearized rate of 0.05 per 100 patient-years. The incidence of thromboembolic events was 0.5 per 100 patient-years. There was no incidence of structural valve dysfunction or prosthetic valve thrombosis. Forty young women subsequently delivered 47 healthy children. The long-term overall survival rate was 76.1% ± 3.17% at 20 years and 70.4% ± 4.31% at 25 years. These results confirm the long-term durability and superior thromboresistance of the Starr-Edwards ball valve. We conclude that this prosthesis is the device of choice for patients undergoing mitral valve replacement in Third World countries.
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