Seventy-six month experience with the Omniscience cardiac valve

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Clinical Outcomes Research

Background:

• The Omniscience cardiac valve was implanted in 440 patients between 1978 and 1984.
• Follow-up extended to 1056 patient-years, with 99% accountability.
• Many patients (42%) had concomitant major cardiac surgical procedures.

Purpose of the Study:

• To evaluate the long-term safety and efficacy of the Omniscience cardiac valve.
• To assess valve-related complications and overall survival rates.
• To determine the impact of patient age and additional procedures on outcomes.

Main Methods:

• Retrospective analysis of 440 Omniscience valve implants (aortic, mitral, and double valve replacements).
• Long-term follow-up (up to 76 months) to assess survival and complications.
• Calculation of actuarial survival and complication rates (%/patient-year).

Main Results:

• 5.5-year actuarial survival from valve-related causes was 97%; overall survival was 78%.
• Low complication rates: endocarditis (0.7), hemorrhage (1.0), perivalvular leak (1.5), pannus (0.6), TIA (1.2) per patient-year.
• 95% freedom from thrombotic complications at 5.5 years; advanced age and additional surgeries did not impact complication rates.

Conclusions:

• The Omniscience cardiac valve shows favorable long-term outcomes regarding survival and complications.
• Patient age and concomitant procedures did not adversely affect valve performance.
• The valve is a safe and effective option for cardiac valve replacement.