The St. Jude Medical cardiac valve prosthesis: a 25-year experience with single valve replacement.

BACKGROUND From October 1977 to October 2002, 4,480 patients (age range, 17 to 94 years; average, 64 +/- 13 years) underwent single valve replacement with the St. Jude Medical heart valve. Of 2,982 aortic (AVR) and 1,498 mitral valve replacements (MVR), concomitant coronary artery bypass grafting was performed on 42% and 33%, respectively. METHODS Cardiac Surgical Associates has maintained an independent database of patients having valve replacement with the St. Jude Medical prosthesis since the world's first implant. Patients were contacted by questionnaire or phone from November 2002 through June 2003. Hospital course and valve-related events were verified by patient chart review or physician contact. RESULTS Follow-up was 95% complete. Operative mortality was 4% with AVR and 9% with MVR. Total follow-up was 32,190 patient-years (range, 1 month to 24.8 years; average, 7 +/- 5 years). During the study period, patient freedom from late mortality was 61% (AVR, 61%; MVR, 63%), and from valve-related mortality 92% (AVR, 93%; MVR, 91%). Freedom from thromboembolic events was 85% (86% AVR, 81% MVR), from bleeding events, 81% (81% AVR, 81% MVR), from reoperation, 98% (99% AVR, 97% MVR), from endocarditis, 98% (99% AVR, 98% MVR), and from valve thrombosis, 99% (99% AVR, 98% MVR). There was one MVR structural failure (0.06%). CONCLUSIONS The St. Jude Medical valve has proven to be an effective and durable valve prosthesis with a low event rate during the long term.