Results and complications with the Omniscience prosthesis.

A clinical trial with the Omniscience heart valve was conducted from June, 1980, until May, 1981. In this period 166 patients underwent heart valve replacement: mitral valve replacement (MVR) 70 patients, aortic valve replacement (AVR) 37, and combined mitral-aortic valve replacement (M/AVR) 59 patients. There were 20 hospital deaths, for a mortality of 12%. Total follow-up was 226 patient-years (range 6 to 28 months, mean 18 months). There were eight late deaths (MVR 4.6%, AVR 3.1%, and M/AVR 8.1%). All patients were taking oral anticoagulants. The incidence of valve-related complications (expressed as events per 100 patient-years) was as follows: Systemic embolism--MVR 2, AVR 4.7, and M/AVR 2.5; and anticoagulant complications--MVR 1.9, AVR 2.3, and M/AVR 0. The incidence of valvular dysfunction (expressed as events per 100 patient-years) was as follows: valvular thrombosis--MVR 4.8, AVR 0, and M/AVR 1.2; perivalvular leakage--MVR 1.9, AVR 2.3, and M/AVR 2.5; and infective endocarditis--MVR 0.96, AVR 0, and M/AVR 1.2. The actuarial probability of being free of valvular dysfunction 30 months postoperatively is 73% for the MVR group, 90% for the AVR group, and 71% for the M/AVR group. Despite a short follow-up, the incidence of valvular dysfunction has been significant. For this reason, we have discontinued using these prostheses for heart valve replacement.