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The Monostrut versus Medtronic Hall prosthesis: a prospective randomized study
Y I Kim1, E Lesaffre, I Scheys
1Department of Cardiac Surgery and Epidemiology, Katholieke Universiteit Leuven, University Hospital, Gasthuisberg, Belgium.
The Journal of Heart Valve Disease
|May 1, 1994
Summary
The Monostrut (MS) and Medtronic-Hall (MH) heart valve prostheses showed excellent long-term outcomes in valve replacement surgery. The Medtronic-Hall prosthesis demonstrated a marginally lower incidence of thromboembolism.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Clinical Trials
Background:
- Heart valve replacement is a critical procedure for patients with valvular heart disease.
- Tilting disc prostheses are commonly used, with Monostrut (MS) and Medtronic-Hall (MH) being prominent examples.
- Comparative studies are essential to determine the optimal prosthesis for patient outcomes.
Purpose of the Study:
- To compare the clinical outcomes of heart valve replacement using the Monostrut (MS) and Medtronic-Hall (MH) prostheses.
- To evaluate the safety and efficacy of these two tilting disc valves in a prospective randomized study.
Main Methods:
- Prospective randomized study involving 205 patients receiving MS valves and 198 receiving MH valves.
- Patients received lifelong anticoagulant therapy post-operation.
- Median follow-up of 5.06 years (1971.1 patient-years) with 96.6% completeness.
Main Results:
- No significant differences were observed between the MS and MH groups in 30-day mortality, late mortality, reoperation, bleeding, paravalvular leak, or endocarditis.
- A borderline increased hazard of thromboembolism (TE) was noted in the MS group (2.1%/pty) compared to the MH group (0.7%/pty) (p=0.0087).
Conclusions:
- Both Monostrut (MS) and Medtronic-Hall (MH) tilting disc valves offer excellent long-term clinical outcomes for valve replacement.
- The Medtronic-Hall prosthesis may be favored due to a marginally lower incidence of thromboembolism.