[St Jude's bi-leaflet aortic valve prosthesis throughout two decades. Quality profile and risk factors]

The St Jude standard aortic bi-leaflet disc valve is still the most widespread. With almost 20 years of follow-up, the present material may describe the quality profile of the valve and the relevant risk factors throughout the remainder of most patients' lives.

A 100% complete follow-up was conducted of 694 adult patients who had an aortic valve replacement with the St Jude valve during 1980-1993. The Cox regression analysis was used to identify independent risk factors.

Survival was 79%, 58%, 39%, and 37% at 5, 10, 15, and 18 years, respectively. Only 12% of the deaths (0.60%/patient-year) were valve-related 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 15-year freedoms of 80% and 72%. Valve thrombosis was noted in two patients (0.04%/patient-year) who were off anticoagulation. Mechanical failure was not observed. Endocarditis (0.42%/patient-year) had a 15-year freedom of 92% compared with 72% and 54%, respectively, for major valve (2.33%/patient-year) and all valve-related complications together (4.33%/patient-year) and 96% for aortic valve reoperation (0.36%/patient-year). Age of the patient and heart-related variables were identified as independent risk factors for mortality and valve-related complications.

With a follow-up of almost two decades showing a low incidence of valve-related deaths, acceptable thrombogenicity, and absence of mechanical failure, the St Jude bi-leaflet aortic disc valve sets the standard for contemporary mechanical valves.