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Six years of experience with the St. Jude Medical valvular prosthesis
Insights
This study on St. Jude Medical valve replacements found no mechanical prosthetic failure. Complications like hemolysis, infection, and embolization were rare, indicating good long-term outcomes for patients.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Prosthetic Devices
Background:
- The St. Jude Medical mechanical valve prosthesis has been widely used for valve replacement surgery.
- Long-term outcomes and complication rates are crucial for assessing the efficacy of prosthetic valves.
Purpose of the Study:
- To review the outcomes of St. Jude Medical valve replacements in a large patient cohort.
- To evaluate operative and late mortality, prosthetic failure, hemolysis, infection, and embolization rates.
Main Methods:
- Retrospective review of 680 consecutive patients undergoing valve replacement with St. Jude Medical prostheses.
- Warfarin anticoagulation was administered to all patients.
- Follow-up averaged 24 months, with 95% patient compliance.
Main Results:
- Overall operative mortality was 6.6%, with variations based on valve type and additional procedures.
- Overall late mortality was 7.7%.
- No mechanical prosthetic failures were reported; clinically significant hemolysis (<1%), prosthetic infection (<0.5%), and low embolization rates were observed.
Conclusions:
- St. Jude Medical mechanical valves demonstrated excellent durability with no instances of mechanical failure in this cohort.
- Low rates of complications such as hemolysis, infection, and embolization suggest favorable long-term safety profiles.
- The study supports the use of St. Jude Medical prostheses in valve replacement surgery, with careful patient monitoring for anticoagulation management.
Abstract:
The cases of 680 consecutive patients who underwent valve replacement with the St. Jude Medical prostheses by one group of surgeons from October 1977 through October 1983 were reviewed. The operative mortality for the entire group was 6.6% (3.7% for aortic valve replacement [AVR], 1.6% for AVR and coronary artery bypass [CAB], 14.3% for AVR and miscellaneous procedures; 7.9% for mitral valve replacement [MVR], 15.5% for MVR and CAB, 33% for MVR and miscellaneous procedures; 5% for double valve replacement [DVR], 8.3% for DVR and CAB, and 0% for DVR and miscellaneous procedures). Warfarin (Coumadin) anticoagulation was recommended for all the patients. The mean follow-up of 24 months was completed in 95% of the patients (14,737 patient-months). The overall late mortality was 7.7% (6.2% for AVR, 6.3% for AVR and CAB, 8.3% for AVR and miscellaneous procedures; 7.9% for MVR, 6.7% for MVR and CAB, 33% for MVR and miscellaneous procedures; 15.8% for DVR, 18.2% for DVR and CAB, and 0% for DVR and miscellaneous procedures). There were no cases of mechanical prosthetic failure. Clinically significant hemolysis occurred in only five patients (less than 1%) with paravalvular leak after MVR. Only three patients (less than 0.5%) experienced prosthetic infection. Incidence of embolization was 0.7 per 100 patient-years in the patients who underwent AVR and 2.2 per 100 patient-years in those who underwent MVR.(ABSTRACT TRUNCATED AT 250 WORDS)