Ten-year analysis of the Björk-Shiley standard aortic valve

Long-term performance characteristics of the Björk-Shiley standard aortic valve were determined by analyzing the follow-up of 514 patients undergoing operation between 1971 and 1981. Cumulative follow-up was 2,601 patient-years (average, 5.3 +/- 3.8 years); 53% (238/452) of hospital survivors have been followed more than 5 years. Valve-related complications expressed as both actuarial event-free percents (+/- standard error at 10 years) and first-event linearized determinations (percent per patient-year) occurred at the following rates: thromboembolism, 82 +/- 3 and 2.3 +/- 0.3, respectively; anticoagulant-related hemorrhage, 60 +/- 4 and 5.6 +/- 0.5; prosthetic valve endocarditis, 94 +/- 2 and 0.8 +/- 0.2; valve thrombosis, 97 +/- 1 and 0.4 +/- 0.1; reoperation, 94 +/- 2 and 0.6 +/- 0.2; valve failure, 82 +/- 4 and 1.6 +/- 0.2; and composite valve-related morbidity and mortality, 46 +/- 4 and 8.8 +/- 0.2. Overall survival was 72 +/- 2% at 5 years and 55 +/- 3% at 10 years; valve-related complications accounted for 22% of the late deaths. Although no instance of structural valve failure could be identified, 25% of valve-related complications resulted from valve failure, of which 67% were fatal. By 10 years, 54% of patients had experienced at least one form of major valve-related complication, 16% of which proved fatal. The Björk-Shiley standard aortic valve has late valve-related complications similar to other existing mechanical prostheses that have been subjected to long-term analysis.