Eight-Year Clinical Experience with the St. Jude Medical® Cardiac Prosthetic Valve

Abstract

This clinical study reviews 683 patients who had 144 ST. JUDE MEDICAL® cardiac valves implanted over 8.2 years. Beginning in October 1978, 226 patients had isolated aortic valve replacement (AVR), 222patients had isolated mitral valve replacement (MVR), 53 patients had aortic and mitral valve replacement (AVR + MVR), 115 patients had aortic valve replacement combined with coronary artery bypass (AVR + CAB), 59 patients had mitral valve replacement combined with coronary artery bypass (MVR + CAB), and 8 patients had AVR + MVR + CAB. Follow-up ranged from 2 months to 98 months (8.2 years). The overall operative mortality for the series was 6.3%. One hundred nine patients were lost to follow-up; the remaining 531 patients (83%) were followed for a mean period of 45 months (3.75 years). The overall late death occurrence over the 8-year period was 15.6% among the 531 patients. The mean late death rate was 4.2% per year. Major complications occurred postoperatively in 8% of the patients and minor complications in 6%. Valve-related complications occurred in 11.7% of the patients. Thromboembolic complications (TE) of cerebrovascular accident (CVA) occurred in 3.8% overall, for an incidence of 1.0% per patient-year. Bleeding complications relating to anticoagulation occurred in 3.0% overall for an incidence of 0.8% per patient-year. Prosthetic endocarditis occurred in 1.7%, with reoperative replacement of the infected valve required in 2 patients. The incidence of documented paravalvular leak was 1.9%, with 1 patient requiring reoperation. Significant hemolysis occurred in 0.4%, relating to a paravalvular leak in both patients. The functional status of 448 patients followed for a mean of 45 months was evaluated; 77% were in New York Heart Association (NYHA) Class I, 20% in NYHA Class II, and only 3% in NYHA Class III. The majority of patients were relieved of symptoms of failure and angina. There were no documented instances of primary valve failure. This continued excellent clinical experience makes us consider this prosthesis our valve of choice.