Four years' experience with the Edwards-Tekna bileaflet valve prosthesis.
OBJECTIVE
Although over 20,000 Edwards-Duromedics valves were implanted worldwide between 1982 and May 1988, use of the valve was voluntarily suspended by the manufacturer in May 1988 on the basis of reported leaflet escapes. In 1990, a modified version was introduced to the market, the Edwards-Tekna. The study aim was to evaluate the short-term outcome with this revised valve.


METHODS
Between 1994 and 1998, 137 patients (67 males, 70 females; mean age 36.3+/-9.1 years) underwent heart valve replacement with the Edwards-Tekna prosthesis. Among these patients, 72 had isolated mitral valve replacement, 59 isolated aortic valve replacement, and six double-valve replacement.


RESULTS
Early hospital mortality was 0.72% (n = 1). Follow up was 95% complete (129/136 patients discharged from hospital). Mean follow up was 24.9+/-10.5 months (range: 2 to 48 months); total follow up was 282.9 patient-years (pt-yr). Actuarial freedom from complications at two-year follow up and linearized incidence (%/pt-yr) of these events were: late mortality 87.8+/-8.5% (1.77%/pt-yr); thromboembolism 89.8+/-4.9% (2.12%/pt-yr); anticoagulation-related bleeding 97.8+/-1.5% (0.71%/pt-yr); prosthetic valve endocarditis 99.1+/-0.9% (0.35%/pt-yr); valve-related mortality 98.2+/-1.2% (0.71%/pt-yr); and valve-related morbidity and mortality 85.0+/-5.0% (4.24%/pt-yr). There was no structural valve failure such as leaflet escape in this series. Clinically significant hemolysis was not encountered (mean postoperative plasma LDH level 345+/-124 IU/l). Preoperatively, 69% of patients were in NYHA classes III/IV; at two years postoperatively 90% of survivors were in classes I/II.


CONCLUSIONS
The Edwards-Tekna mechanical valve prosthesis has shown excellent overall clinical performance in the short term, though long-term data are needed to confirm its durability.
Calkavur
Tanzer
T
Ege University Hospital, Department of Cardiovascular Surgery, Bornova, Izmir, Turkey.
Yagdi
Tahir
T
Apaydin
Anil
A
Islamoglu
Fatih
F
Posacioglu
Hakan
H
Durmaz
Isa
I
Ozbaran
Mustafa
M
D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects; D001021:Aortic Valve / Q000473:pathology / Q000601:surgery; D004696:Endocarditis / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000188:drug therapy / Q000401:mortality / Q000601:surgery; D006350:Heart Valve Prosthesis; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000473:pathology / Q000601:surgery; D009017:Morbidity; D011474:Prosthesis Design; D016459:Prosthesis-Related Infections / Q000209:etiology; D012086:Reoperation; D012189:Retrospective Studies; D016019:Survival Analysis; D013923:Thromboembolism / Q000453:epidemiology / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D014421:Turkey / Q000453:epidemiology
D000925:Anticoagulants