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The Ultracor tilting disc heart valve prosthesis: a seven-year study
H H Li1, R R Jeffrey, K G Davidson
1Providence Health System, Portland, Oregon, USA.
The Journal of Heart Valve Disease
|December 31, 1998
Summary
The Ultracor heart valve shows comparable long-term outcomes to other mechanical valves. This study evaluated its performance in 446 patients, demonstrating acceptable survival and complication rates.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Prosthetic Devices
Background:
- The Ultracor heart valve represents an advancement in tilting disc valve technology.
- This study provides a clinical evaluation of the Ultracor valve from European centers.
Purpose of the Study:
- To summarize the clinical experience with the Ultracor heart valve prosthesis.
- To assess the safety and efficacy of the Ultracor valve in various cardiac procedures.
Main Methods:
- A total of 499 Ultracor heart valve prostheses were implanted in 446 patients between 1990 and 1996.
- Procedures included aortic, mitral, and double valve replacements with a follow-up of 751 patient-years for aortic valve replacement (AVR), 440 for mitral valve replacement (MVR), and 125 for double valve replacement (DVR).
- Follow-up was 98% complete, with nine patients lost to follow-up.
Main Results:
- Five-year actuarial survival rates were 90% for AVR, 77% for MVR, and 82% for DVR.
- Key linearized complication rates per year included late mortality (2.1% AVR, 4.0% MVR, 4.0% DVR), thromboembolism (0.1% AVR, 3.0% MVR, 0.8% DVR), and anticoagulant-related hemorrhage (2.0% AVR, 1.6% MVR, 1.6% DVR).
- Five-year freedom from complications rates were high, with no structural valve failure observed.
Conclusions:
- The Ultracor heart valve prosthesis demonstrates performance comparable to other mechanical heart valves.
- Extended clinical follow-up is recommended for further evaluation of the Ultracor valve's long-term outcomes.