Standard aortic St. Jude valve at 18 years: Performance profile and determinants of outcome

Background. The standard St. Jude disc valve has been in use for 20 years a nd remains the dominant mechanical valve of today. With nearly 19 years of follow-up, the present large series could indicate the performance profile and its determinants in the very long term. Methods. A detailed follow-up was performed to a maximum of 18.6 years in 6 94 patients aged 15 to 83 years who underwent aortic valve replacement (AVR ) with the standard St. Jude valve during 1980 to 1993. The Cox regression analysis was used to identify independent determinants of outcome in the ao rtic stenosis (n = 490) and regurgitation (n = 204) groups. Results. Overall survival was 58%, 39%, and 37% at 10, 15, and 18 years, re spectively. Only 12% of deaths (0.60%/patient-year) were related to the val ve with a 15-year freedom of 91%. Embolism (1.18%/patient-year) and anticoa gulant-related bleeding (2.24%/patient-year) were the dominant complication s with 10-year/15-year freedoms of 90%/80% and 85%/72%, respectively. Only 24% of bleeding events were classified as major. Valve thrombosis occurred in 2 patients (0.04%/patient-year): 1 did not receive vitamin K antagonist treatment and International Normalized Ratio was below target level in the other. There were no mechanical failures. Endocarditis (0.42%/patient-year) and paravalvular leak (0.42%/patient-year) occurred with 15-year freedoms of 92% and 96%, respectively, with a relation between the latter (but not t he former) and preoperative endocarditis in the regurgitation group. Freedo m from serious complications (2.33%/patient-year) and all complications joi ned (4.33%/patient-year) were 72% and 54%, respectively, at 15 years with a 96% freedom from redo AVR (0.36%/patient-year). Age- and heart-related var iables were independent risk factors for mortality, thromboembolism, bleedi ng, serious complications, and all complications joined. Small valve (19 an d 21 mm) adversely affected serious and all complications in the regurgitat ion group. Conclusions. With a follow-up approaching 2 decades and exhibiting a low ra te of valve-related deaths, acceptable low thrombogenicity, and abscence of mechanical failure, the standard aortic St. Jude disc valve sets the stand ard for contemporary mechanical valves. (C) 2000 by The Society of Thoracic Surgeons.