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Ann Thorac Surg 1987;43:513-521
© 1987 The Society of Thoracic Surgeons

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Articles

A Six-Year Study of the Omniscience Valve in Four Canadian Centers

From the Divisions of Cardiovascular and Thoracic Surgery, the University of Alberta Hospital, Edmonton, Alta, Victoria Hospital, London, Ont, The Montreal Heart Institute, Montreal, Que, and the University of Sherbrooke Hospital, Sherbrooke, Que, Canada

Accepted for publication July 28, 1986.

^* Address reprint requests to Dr. Callaghan, 550, 8409-112 St, Edmonton, Alta, Canada T6G 1K6

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%); anticoagulant-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. Ninety-eight percent of patients obtained improvement in functional status.

Our data indicate that the Omniscience valve is safe (no structural failures), has a low incidence of complications, and gives excellent results.

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