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Twenty years' experience with the Medtronic Hall valve
E G Butchart1, H H Li, N Payne
1Department of Cardiothoracic Surgery, University Hospital of Wales, Heath Park, Cardiff CF14 4XN, Wales, UK.
The Journal of Thoracic and Cardiovascular Surgery
|June 1, 2001
Summary
The Medtronic Hall valve shows excellent durability and low thrombogenicity over 20 years. Patient risk factors, not the valve, primarily influence survival and thromboembolic events.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Clinical Outcomes Research
Background:
- Mechanical heart valves are crucial for replacing damaged native valves.
- The Medtronic Hall valve is a tilting-disk prosthesis used in cardiac surgery.
- Long-term performance data is essential for evaluating prosthetic valve efficacy.
Purpose of the Study:
- To evaluate the 20-year performance of the Medtronic Hall valve.
- To assess durability, hemodynamic function, and complication rates.
- To identify risk factors for mortality and adverse events.
Main Methods:
- Prospective follow-up of 1766 patients undergoing valve replacement (aortic, mitral, double) from 1979.
- 12,688 patient-years of follow-up with regular interval assessments.
- Collection and analysis of anticoagulation data (international normalized ratio).
Main Results:
- Low linearized rates of valve-related death (0.8-1.1%/year) and prosthetic endocarditis (0.4-0.7%/year).
- Adverse event rates: valve thrombosis (0-0.04%/year), thromboembolism (2.3-4.0%/year), stroke (0.6-0.8%/year), major hemorrhage (1.2-1.6%/year).
- Diabetes, age, hypertension, and concomitant procedures were risk factors for mortality and thromboembolism.
Conclusions:
- The Medtronic Hall valve exhibits excellent long-term durability and hemodynamic performance.
- It demonstrates very low thrombogenicity, with rates lower than bileaflet designs.
- Patient-specific risk factors significantly impact long-term survival and thromboembolic event rates.