This study was performed to assess the morbidity and mortality of 311 patients implanted with at least one Omniscience prosthetic valve between January 1992 and January 2000.

Following valve implantation all patients were followed up with routine interviews, physical examination and echocardiography.

The mean follow-up duration was 5.8±0.9 (standard error, SE) years with a mean follow-up interval of 8.5±0.7 (SE) months. The 311 patients received the following type (s) of valve: mitral, aortic, both or tricuspid valve, in 166 (47.9%), 99 (32.0%), 44 (19.5%) and 2 (0.6%) of cases, respectively. The cumulative follow up was 1143.4 patient-years (pt-yr). Death occurred in eight patients (0.7%/ pt-yr at linearized rate), and redo-operations were required in 27 patients (2.4%/pt-yr) due to valve failure. Actuarial freedom from all complication was 72.5%±8.2% (SE). Freedom from pannus formation, paravalvular leak, or thromboembolism plus anticoagulant related bleeding were 83.1%±3.5% (MVR/AVR 92.7%±4.7%/73.4%±2.8%), 95.2%±2.1% (MVR/AVR 96.8%±4.2%/93.6%±3.2%), and 96.1%±2.5% (MVR/AVR 95.6%±5.6%/96.7%±4.7%) respectively.

Our results with this prosthesis demonstrate relatively high incidences of valve related complication especially due to pannus formations and paravalvular leaks. We could reduce the incidences of mortality by earlier detection of complications, redo-operations and routine checks.