Five-year clinical experience with the Omniscience cardiac valve.

Publication/Presentation Date

9-1-1984

Abstract

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.(ABSTRACT TRUNCATED AT 250 WORDS)

Volume

38

Issue

3

First Page

275

Last Page

280

ISSN

0003-4975

Disciplines

Medicine and Health Sciences

PubMedID

6476951

Department(s)

Department of Surgery

Document Type

Article

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