Intermediate follow up of the TEKNA bileaflet valve.
OBJECTIVE
The study aim was to collect intermediate clinical data on the TEKNA bileaflet valve.


METHODS
This nine-center clinical study involved 884 patients implanted between June 1990 and October 1993. The population consisted of 522 (59.0%) males and 362 (41.0%) females. Mean age at implant was 59.1 +/- 11.8 years (range: 14.7 to 88.4 years). Indication for valve replacement was dependent on the position: stenosis was the predominant reason in the aortic position; regurgitation was more pronounced for the mitral position. A total of 261 (29.5%) patients underwent concomitant procedures. Mean follow up is 2.7 +/- 1.2 years; total follow up is 2386.1 patient-years (pt-yr).


RESULTS
Total operative (< or = 30 days postoperative) mortality rate was 3.7%; seven patients (0.8%) died due to valve-related causes. Total postoperative (> 30 days postoperative) mortality rate was 2.5%/pt-yr and included a valve-related mortality rate of 1.1%/pt-yr. The following valve-related complication rates (%/pt-yr) were reported for the long-term postoperative period: thromboembolism 0.6; valve thrombosis 0.3; bleeding events 1.5; non-structural deterioration 0.6; and endocarditis 0.4. No structural valve deterioration was reported. Actuarial freedom at four years was: overall survival rate 86.9 +/- 1.4%; valve-related survival rate 94.7 +/- 1.0%; freedom from thromboembolism 96.8 +/- 0.9%; valve thrombosis 99.3 +/- 0.3%; endocarditis 98.5 +/- 0.5%; bleeding events 94.3 +/- 1.0%; and non-structural deterioration 98.2 +/- 0.6%.


CONCLUSIONS
The data indicate that observed mortality is due mainly to non-valve-related disorders. Risk of thromboembolic and bleeding events was low (0.9%/pt-yr and 1.5%/pt-yr, respectively). We conclude that this valve is safe and efficacious for use.
Seybold-Epting
W
W
West-Pfalz Klinikum, Kaiserslautern, Germany.
Limet
R
R
Scheld
H
H
Frank
G
G
Hannekum
A
A
David
M
M
Tatou
E
E
Wolner
E
E
Loisance
D
D
Kassal
H
H
Ryba
E A
EA
D000206:Actuarial Analysis; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D018572:Disease-Free Survival; D004696:Endocarditis / Q000209:etiology* / Q000401:mortality; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000401:mortality / Q000601:surgery; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D006470:Hemorrhage / Q000209:etiology* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011474:Prosthesis Design; D011475:Prosthesis Failure; D015996:Survival Rate; D013927:Thrombosis / Q000209:etiology* / Q000401:mortality; D016896:Treatment Outcome