EVENT STATUS OF THE STARR-EDWARDS AORTIC-VALVE TO 20 YEARS - A BENCHMARK FOR COMPARISON

Background. Considerable effort and expense has been invested in the e volutionary development of cardiac valvular prostheses with the goal o f reducing or minimizing specific events related to these prostheses. It is important to measure any improvement achieved with such developm ent by comparison against a historic standard. The Starr-Edwards caged -ball prosthesis model 1260 has been used for 30 years as the predomin ant or sole model of its kind for aortic valve replacement. This histo ric opportunity provides a benchmark for subsequent improvement and co mparison of current prostheses. Methods. Between 1969 and 1991, 1,100 patients (median age, 57 years; 838 men and 194 women) underwent aorti c valve replacement with or without coronary artery bypass grafting (a ortic valve replacement, 964; aortic valve replacement plus coronary a rtery bypass grafting, 136) with the 1260 Starr-Edwards caged-ball pro sthesis. Results. Operative mortality was 6.2% (68 patients). Univaria te patient characteristics predictive of early mortality were female s ex (p = 0.003), age (>56 years; p = 0.002), recent operative interval (1985 to 1991 versus 1969 to 1976 or 1977 to 1984; p = 0.002), presenc e of atrial fibrillation (p = 0.001), and small valve size (7A to 8A = 19 to 21 mm; p < 0.001). Follow-up extended to 11,293 patient-years ( mean, 24.8 years) and was 96.9% complete. Survival at 5, 10, 15, and 2 0 years for all patients including operative mortality was 76.6%, 59.6 %, 44.9%, and 31.2%, respectively. Operative variables predictive of p oor late survival were advanced New York Heart Association class (III or IV); (p = 0.0001), older age (>56 years; p = 0.0001), and lower (<0 .56) ejection fraction (p = 0.0001). Freedom from thromboemboli and an ticoagulant-related bleeding at 5 years was 90.8% and 98.7%, respectiv ely. Univariate model for greater risk of late thromboemboli identifie d female sex (p = 0.04), older age (>56 years; p = 0.0002), and New Yo rk Heart Association class III or IV (p = 0.0058), as risk factors. Mu ltivariate analysis for thromboemboli demonstrated older age (p = 0.00 07) and New York Heart Association class III or IV (p = 0.0041) as sig nificant. Alternatively, univariate analysis for late bleeding found o nly the most recent operative interval (p = 0.009) as significant, and the rarity of events prevented a multivariate query. There were no va lve failures. Conclusions. The late results of survival and freedom fr om late anticoagulant-related bleeding or thromboemboli are excellent, especially in larger (9A and above) sizes, and with the long implant record comparable with more recent prostheses, the Starr-Edwards valve provides an excellent, safe, and durable alternative in the aortic po sition and provides a benchmark against which to compare other prosthe ses. (C) 1997 by The Society of Thoracic Surgeons.