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St. Jude Medical prosthesis: valve-related deaths and complications
Insights
This study evaluated 876 St. Jude Medical prostheses in 816 patients, finding a 7.7% operative mortality and 11.9% late mortality. Valve-related deaths were primarily due to thromboembolism and hemorrhage.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Clinical Outcomes Research
Background:
- Cardiac valve prostheses offer hemodynamic benefits but are associated with significant valve-related morbidity and mortality.
- Long-term outcomes of mechanical heart valve replacements require continuous evaluation.
Purpose of the Study:
- To assess the long-term safety and efficacy of St. Jude Medical prostheses.
- To identify the incidence and causes of valve-related complications and mortality.
Main Methods:
- A follow-up study of 816 patients who received 876 St. Jude Medical prostheses between 1977 and 1984.
- Data collection included operative mortality, late mortality, valve-related deaths, thromboembolic events, hemorrhage, thrombosis, endocarditis, and perivalvular leak.
- Mean follow-up was 42 months, with 98% patient follow-up completeness.
Main Results:
- Operative mortality was 7.7% (63 deaths), with late mortality at 11.9% (87 deaths).
- Valve-related deaths (13 total) were attributed to thromboembolism (7), hemorrhage (2), valve thrombosis (2), endocarditis (1), and perivalvular leak (1).
- Incidence rates per 100 patient-years: thromboembolism 1.78, hemorrhage 3.22. Valve thrombosis (0.6%), perivalvular leak (1.0%), and endocarditis (0.7%) were also reported.
Conclusions:
- St. Jude Medical prostheses demonstrated acceptable long-term performance with a low incidence of major complications.
- Thromboembolism and anticoagulant-related hemorrhage remain significant concerns requiring careful management.
- Reoperation was rarely needed, primarily for perivalvular leak, with no associated mortality.
Abstract:
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)