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 and 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 694 patients aged 15 to 83 years who undervent 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 aortic stenosis (n = 490) and regurgitation (n = 204) groups.
Results: Overall survival was 58%, 39%, and 37% at 10, 15, and 18 years, respectively. Only 12% of deaths (0.60%/ patient-year) were related to the valve with a 15-year freedom of 91%. Embolism (1.18%/patient-year) and anticoagulant-related bleeding (2.24%/patient-year) were the dominant complications 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 the former) and preoperative endocarditis in the regurgitation group. Freedom from serious complications (2.33%/patient-year) and all complications joined (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 variables were independent risk factors for mortality, thromboembolism, bleeding, serious complications, and all complications joined. Small valve (19 and 21 mm) adversely affected serious and all complications in the regurgitation group.
Conclusions: With a follow-up approaching 2 decades and exhibiting a low rate of valve-related deaths, acceptable low thrombogenicity, and absence of mechanical failure, the standard aortic St. Jude disc valve sets the standard for contemporary mechanical valves.