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The Annals of Thoracic Surgery, Vol 38, 275-280, Copyright © 1984 by The Society of Thoracic Surgeons
R DeWall, LC Pelletier, A Panebianco, G Hicks, B Schuster, R Bonan, JP Martineau and L Yip
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)
ARTICLES
Five-year clinical experience with the Omniscience cardiac valve
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