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A six-year study of the Omniscience valve in four Canadian centers
Insights
This study evaluated the Omniscience valve in 413 survivors, finding a 5-year survival rate of 89%. While freedom from endocarditis and periprosthetic leak was high, thrombotic complications and valve-related issues require attention.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Clinical Outcomes Research
Background:
- The Omniscience valve has faced scrutiny, necessitating a comprehensive follow-up study.
- Previous data on the long-term performance and complication rates of this specific prosthesis were limited.
Purpose of the Study:
- To assess the safety and efficacy of the Omniscience valve in a cohort of hospital survivors.
- To determine the incidence of various complications and overall survival rates following valve replacement procedures.
Main Methods:
- A follow-up study of 413 hospital survivors who received the Omniscience valve between 1979 and 1985.
- Data collection included aortic valve replacement (AVR), mitral valve replacement (MVR), tricuspid valve replacement (TVR), and multiple valve replacements.
- Follow-up of 96% of patients for a mean of 2.6 years, with complication grading and actuarial rate analysis.
Main Results:
- Actuarial survival at 5 years was 89% (AVR: 89%, MVR: 91%).
- High freedom from endocarditis (96%) and periprosthetic leak (99%).
- Lower freedom from thrombotic complications (87%) and all valve-related complications (77%), with a reoperation rate of 1.2% per patient-year.
Conclusions:
- The Omniscience valve demonstrates acceptable long-term survival and low rates of endocarditis and periprosthetic leak.
- Thrombotic complications and overall valve-related complications warrant continued monitoring and potential improvements.
- The study provides crucial data on the performance of the Omniscience valve in a Canadian cohort.
Abstract:
Stimulated by the recent controversy over the Omniscience valve, we conducted a follow-up study on 413 hospital survivors in whom this prosthesis was implanted at four Canadian centers from 1979 to 1985. One hundred forty-seven underwent aortic valve replacement (AVR), 203 had mitral valve replacement (MVR), 10 had tricuspid valve replacement (TVR) and 53 underwent multiple valve replacement (45 AVR + MVR, 5 MVR + TVR, and 3 AVR + MVR + TVR). The mean age was 50.8 +/- 13 years (range, 2 months to 75 years). Follow-up of 96% was achieved for a mean of 2.6 years and a maximum of 6 years with a total of 1,076 patient-years. Complications were defined and graded according to severity. Analyses were performed to yield linearized and actuarial rates for complications. There were 30 late deaths (2.8% per patient-year). At 5 years, the actuarial survival was 89 +/- 3% (AVR, 89 +/- 3% and MVR, 91 +/- 3%). Percentages for freedom from each complication are as follows: endocarditis, 96 +/- 1% (AVR, 96 +/- 2% and MVR, 98 +/- 1%); periprosthetic leak, 99 +/- 0.6% (AVR, 98 +/- 1% and MVR, 99 +/- 0.6%); thrombotic complications, 87 +/- 3% (AVR, 84 +/- 6% and MVR, 90 +/- 3%); valve thrombosis 99.4% (AVR and MVR, 100%); anti-coagulant-related hemorrhage, 94 +/- 2% (AVR, 97 +/- 2% and MVR, 94 +/- 2%); and all valve-related complications, 77 +/- 3% (AVR, 77 +/- 6% and MVR, 79 +/- 4%). Reoperation was required at the rate of 1.2% per patient-year.(ABSTRACT TRUNCATED AT 250 WORDS)