St. Jude Medical prosthesis: valve-related deaths and complications.
Despite the hemodynamic improvement in cardiac valve prostheses, valve-related deaths and complications have remained a substantial source of morbidity and mortality. This follow-up study was carried out in April, 1986, in a group of 816 patients who received 876 St. Jude Medical prostheses between October, 1977, and October, 1984. One hundred fifty-five patients (37%) of the 422 having aortic valve replacement (AVR) and 88 (29%) of the 300 having mitral valve replacement (MVR) had concomitant coronary artery bypass grafting, and 94 patients (12%) had miscellaneous procedures performed in addition to valve replacement. Sixty-three patients died within the operative period, an operative mortality of 7.7%. Follow-up was complete for 98% of the patients; the mean follow-up was 42 months. At that time, 87 more patients had died, a late mortality of 11.9%. There were 13 valve-related deaths (4 in the AVR group, 7 in the MVR group, and 2 in the miscellaneous group); the causes of death were thromboembolism (7), anticoagulant-related hemorrhage (2), valve thrombosis (2), prosthetic valve endocarditis (1), and perivalvular leak (1). There were 37 thromboembolic episodes (1.78/100 patient-years) and 67 anticoagulant-related hemorrhages (3.22/100 patient-years), 46% of which necessitated transfusion. The incidence of valve thrombosis was 0.6% (4 patients). Perivalvular leak and prosthetic valve endocarditis occurred in 7 patients (1.0%) and 5 patients (0.7%), respectively. Reoperation was carried out in 6 patients (0.8%), but only for perivalvular leak. There were no deaths, no complications, and no clinical evidence of malfunction of the prosthetic valve.(ABSTRACT TRUNCATED AT 250 WORDS)
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve; D002648:Child; D002675:Child, Preschool; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000401:mortality; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000150:complications / Q000401:mortality / Q000601:surgery; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000401:mortality*; D006470:Hemorrhage / Q000453:epidemiology / Q000401:mortality; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve; D011183:Postoperative Complications / Q000453:epidemiology / Q000401:mortality*; D013923:Thromboembolism / Q000453:epidemiology / Q000401:mortality