37. Long Term Experience with the St. Jude Medical Valve Prosthesis

James L. Zellner, John M. Kratz, Arthur J. Crumbley, Martha R. Stroud, Fred A. Crawford, Jr.

Medical University of South Carolina

Charleston, S.C.

All patients undergoing St. Jude valve replacement at the Medical University of South Carolina since January 1979 have been followed prospectively. Our previous reports have been focused on short (five year) or intermediate (10 year) experience. This report describes long term experience in 710 adult patients undergoing isolated aortic (AVR) (418) or mitral (MVR) (292) valve replacements with this prosthesis from January 1979 to December 1996. Age ranged from 19 to 84 years (mean 54.8 ± 15.1 AVR, 51.8 ± 12.9 MVR). Male sex predominated in the AVR group (70 percent) and female sex in the MVR group (62 percent). One hundred and fifty-seven patients (22 percent) had associated coronary artery bypass grafting (AVR 27 percent, AVR 15 percent). Thirty-day operative mortality was 5.3 percent (22/418) in the AVR group and 5.1 percent (51/292) in the MVR group. Follow-up is 96.9 percent complete and ranges from one month to 16.9 years (AVR, 2377 patient-years, mean 5.7 ± 4.5 years, MVR, 1871 patient-years mean 6.4 ± 4.8 years). In the AVR group, 120 late deaths have occurred and actuarial survival was 78.0 ± 2.3 percent, 58.0 ± 3.2 percent, and 36.8 ± 4.8; at five, 10 and 15 years, respectively. Forty-six patients have sustained thromboembolic events (TE) (2.4 percent patient-year) and the probability of remaining free of TE at five, 10 and 15 years was 92.6 ± 1.5 percent, 78.8 ± 3.3 percent and 73.0 ± 4.5 percent, respectively. The mean improvement in New York Heart Association (NYHA) functional class from preoperative to postoperative was 3.04 ± 0.79 to 1.7 ± 0.05 (p<0.05). In the MVR group, there have been 84 late deaths and the actuarial survival was 79 ± 2.5 percent, 60.1 ± 3.5 percent, 49.3 ± 4.1 percent; at 5, 10 and 15 years, respectively. Fifty-two patients have had TE (3.5 percent patient-year), and the probability of remaining free of TE at five, 10 and 15 years was 85.9 ± 2.4 percent, 74.5 ± 3.6 percent and 59.0 ± 7.0 percent, respectively. The mean improvement of NYHA functional class was from 3.32 ± 0.64 to 1.8 ± 0.06. Thirty-one patients have undergone 34 valve replacements for endocarditis (19), perivalvular leak (nine), thrombosis (four), aortic dissection (one), and hemolysis (one). There were no mechanical failures in either group. With a follow-up now extending to 17 years, the St. Jude Medical valve continues to be a reliable mechanical prosthesis with low and stable rates of valve related complications.