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Results and complications with the Omniscience prosthesis
The Journal of Thoracic and Cardiovascular Surgery
|January 1, 1984
Summary
This clinical trial found significant valvular dysfunction with the Omniscience heart valve, leading to its discontinuation. Researchers observed notable rates of complications and dysfunction across mitral, aortic, and combined valve replacements.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Clinical Trials
Background:
- The Omniscience heart valve was evaluated in a clinical trial to assess its safety and efficacy.
- Heart valve replacement is a critical procedure for patients with valvular heart disease.
Purpose of the Study:
- To evaluate the clinical performance and complication rates of the Omniscience heart valve.
- To determine the incidence of valvular dysfunction and related complications following heart valve replacement.
Main Methods:
- A prospective clinical trial involving 166 patients undergoing mitral valve replacement (MVR), aortic valve replacement (AVR), or combined M/AVR.
- Data collection included hospital mortality, late deaths, systemic embolism, anticoagulant complications, valvular thrombosis, perivalvular leakage, and infective endocarditis.
- Follow-up extended to 226 patient-years, with actuarial probability of being free of valvular dysfunction calculated at 30 months.
Main Results:
- Hospital mortality was 12% (20 deaths).
- Late mortality rates varied by procedure type (MVR 4.6%, AVR 3.1%, M/AVR 8.1%).
- Significant incidences of valvular dysfunction, including thrombosis and leakage, were observed, with 30-month freedom from dysfunction rates ranging from 71% to 90% depending on the valve type.
Conclusions:
- The Omniscience heart valve demonstrated a significant incidence of valvular dysfunction.
- Due to these findings, the use of Omniscience prostheses for heart valve replacement was discontinued.
- Further research into alternative prosthetic valves is warranted.