Five-Year Clinical Experience with the Omniscience Cardiac Valve

Clinical data on the Omniscience cardiac valve prosthesis (sizes 19 to 31 mm) were obtained from 326 patients (155, aortic valve replacement AVR]; 125, mitral valve replacement MVR]; and 46, double-valve replacement) during a five-year period (650 patient-years) with 96% accountability. Mean age was 56 ± 12 years, and 40% (130) of the patients were 61 years old or older. Thirty-one percent (101) had prior or concomitant coronary artery bypass grafting procedures, 9% (28) had a previous malfunctioning prosthesis, and 17% (57) had other cardiac surgical procedures. Eighty percent were in New York Heart Association (NYHA) Functional Class III or IV preoperatively. Early mortality was 10% (34). Five-year actuarial thrombus-free rate is 96% for patients who underwent AVR and 95% for patients having MVR. Postoperatively, 89% (172/193) were in NYHA Class I or II, and 84% (163/193) improved by at least one Functional Class. A significantly high proportion of the postoperative hematological values fall within normal ranges: red blood cell count, 94% (176/187); hematocrit, 88% (166/188); and hemoglobin, 93% (176/190). Ninety-eight percent (287/292) are free from clinical anemia. Four of the 5 patients with clinical anemia had a preoperative history of this condition. Levels of lactic dehydrogenase in 3 patients suggested the probable presence of clinically significant hemolysis, although all 3 have normal hematological values. Actuarial five-year survival for patients who underwent AVR or MVR are similar (82% and 80%, respectively), indicating satisfactory and comparable levels of safety and performance. Based on the duration of the study and the absence of restrictive selection criteria, which would eliminate high-risk patients, these clinical data demonstrate a reliable degree of safety and performance for this prosthesis.