Long-term follow up of patients undergoing reoperative surgery with aortic or mitral valve replacement using a St. Jude Medical prosthesis.

BACKGROUND AND AIM OF THE STUDY: Between June 1978 and September 2002, a total of 440 reoperative open-heart patients (mean age 62 +/- 14 years; range: 18-91 years), following various primary cardiac operations, underwent single-valve replacement with the St. Jude Medical (SJM) heart valve. Of 241 patients having aortic replacement (AVR) and 199 mitral valve replacement (MVR), 86 (35%) and 42 (21%), respectively, underwent concomitant coronary artery bypass grafting. The study aim was to document patient survival and valve-related events in an experience extending up to 24 years after reoperative open-heart surgery with a single model cardiac valve prosthesis.

METHODS: The Cardiac Surgical Associates Research Foundation (CSARF) has maintained an independent database of those patients with the SJM prosthesis since the world's first implant in October 1977. Patients were contacted by questionnaire and/or telephone between November 2002 and June 2003. The hospital course and valve-related events were verified by patient chart review and/or physician contact.

RESULTS: Follow up was 94% complete, for a total of 3,114 patient-years (1,671 pt-yr after AVR; 1,443 pt-yr after MVR). The average follow up was 7 +/- 6 years (range: 0.1-24.3 years). The operative mortality was 9% (10% AVR, 8% MVR). Five deaths (13%) were valve-related. Freedom from all late mortality at 10 and 20 years, respectively, was 57% and 35% for AVR and 52% and 22% for MVR, and for valve-related mortality was 89% and 77% for AVR and 84% and 22% for MVR. Freedom from thromboembolic events at 10 and 20 years, respectively, was 93% and 93% after AVR and 92% and 81% after MVR; from anticoagulant-related hemorrhage it was 78% and 76% after AVR and 81% and 67% after MVR; and from reoperation it was 94% and 94% after AVR and 95% and 89% after MVR.

CONCLUSION: Reoperative valve replacement carries a significant operative morbidity and mortality. Long-term results with the SJM valve demonstrated a durable prosthetic valve, excellent long-term patient survival, and freedom from valve-related events followed reoperative open-heart valve replacement surgery. However, the early postoperative period carried an increased risk for valve-related events.