Long-term experience with the St. Jude Medical valve prosthesis

Background. All patients undergoing St. Jude Medical valve replacement at t he Medical University of South Carolina since January 1979 have been follow ed prospectively at 12-month intervals. Methods. This report describes long-term experience in 710 adult patients u ndergoing isolated aortic (AVR) (418) or mitral valve replacements (MVR) (2 92) with this prosthesis from January 1979 to December 1996. Results. Ages ranged from 19 to 84 years (54.8 +/- 15.1 AVR, 51.8 +/- 12.9 MVR; mean +/- SD). Male gender predominated in the AVR group (70%) and fema le gender in the MVR group (62%). One hundred and fifty-seven patients (22% ) had associated coronary artery bypass grafting (AVR 27%, MVR 15%). Thirty -day operative mortality was 5.3% (22/418) in the AVR group and 5.1% (15/29 2) in the MVR group. Follow-up is 96.9% complete and ranges from 1 month to 16.9 years (AVR, 2,376 patient-years, mean 5.7 +/- 4.5 years; MVR, 1,868 p atient-years, mean 6.4 +/- 4.8 years). In the AVR group, 120 late deaths ha ve occurred and actuarial survival was 78.0 +/- 2.3%, 58.0 +/- 3.2%, and 36 .8 +/- 4.8%; at 5, 10, and 15 years, respectively. Forty-six patients have sustained 55 thromboembolic (TE) events (2.3%/patient-year). Fifty-one pati ents had anticoagulant-related bleeding complications (2.7%/patient-year). The mean improvement in New York Heart Association (NYHA) functional class from preoperative to postoperative was 3.0 +/- 0.8 to 1.7 +/- 0.1 (p < 0.05 ). In the MVR group, there have been 84 late deaths, and the actuarial surv ival was 79.3 +/- 2.5%, 60.1 +/- 3.5%, and 49.3 +/- 4.1% at 5, 10, and 15 y ears, respectively. Fifty-two patients have had 64 TE events (3.5%/patient- year). Twenty-three patients had anticoagulant-related bleeding complicatio ns (1.6%/patient-year). The mean improvement in NYHA functional class was f rom 3.3 +/- 0.6 to 1.8 +/- 0.1, There were no mechanical failures in either group. Conclusions. With a follow-up now extending to 17 years, the St. Jude Medic al valve continues to be a reliable mechanical prosthesis with low and stab le rates of valve-related complications. (C) 1999 by The Society of Thoraci c Surgeons.