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Comparative clinical results with Omniscience (STM1), Medtronic-Hall, and Björk-Shiley convexo-concave (70 degrees) prostheses in mitral valve replacement

1986; Elsevier BV; Volume: 91; Issue: 2 Linguagem: Inglês

10.1016/s0022-5223(19)36076-3

1097-685X

José Cortina, J. Martinell, V. Artiz, J. Fraile, Gregorio Rábago,

Aortic Disease and Treatment Approaches

The intermediate clinical results of 289 patients undergoing isolated mitral valve replacement with three different low-profile mechanical prostheses have been retrospectively analyzed and compared. Between June, 1980, and September, 1983, 70 patients received the Omniscience prosthesis, 159 patients the Medtronic-Hall valve, and 60 patients the convexo-concave 70 degree Björk-Shiley prosthesis. Hospital mortality was 15% for the Björk-Shiley group, 4.4% for the Medtronic-Hall group, and 7.1% for the Omniscience group. Cumulative follow-up was 88 years (mean 1.7 years) for the Björk-Shiley, 229 years (mean 1.5 years) for the Medtronic-Hall, and 223 years (mean 3.3 years) for the Omniscience group. All patients were placed on a program of anticoagulant therapy (dicumarol) postoperatively. Actuarial survival rates (±SE) 2 years postoperatively were comparable for the three groups: Björk-Shiley, 90% ± 4.7%; Medtronic-Hall, 93% ± 2.2%; and Omniscience, 88% ± 4.1% (p = NS). Late mortality, expressed at linearized rates (percent patient-year ±SE), was 3.4% ± 1.9% for the Björk-Shiley group, 1.7% ±0.8% for the Medtronic-Hall group, and 3.6% ± 1.2% for the Omniscience group (p = NS). Actuarially determined rates of freedom from thromboembolic complications (systemic embolism and valvular thrombosis) 2 years postoperatively were 97% ± 2.2% for the Björk-Shiley group, 94% ± 2.1% for the Medtronic-Hall, and 84% ± 4.7% for the Omniscience group (p = 0.05, Omniscience versus Medtronic-Hall; p = 0.02, Omniscience versus Björk-Shiley). The actuarial probability of being free from reoperation 2 years postoperatively was 92 ± 3.5 for the Björk-Shiley group, 92 ± 2.9 for the Medtronic-Hall group, and 82 ± 3.9 for the Omniscience group (p = 0.04). The major cause for reoperation in the Omniscience group was valve thrombosis (seven patients), yielding a linearized incidence (±SE) of 3.1 ± 1.1 (p = 0.01). No statistically significant differences were obtained regarding the incidence of prosthetic infective endocarditis or perivalvular leak. Overall rates of anticoagulant-related hemorrhage were comparable for the three groups.