Bicarbon valve -- European multicenter clinical evaluation.
OBJECTIVE
Fifteen collaborating centers in eight countries present their pooled experience with the new Bicarbon bileaflet valve.


METHODS
Between 4/90 and 4/96, 1351 patients, 806 males and 545 females, aged 10 to 83, mean 58.4 +/- 12.4, underwent valve implantation.


METHODS
aortic valve replacement (AVR), 726; mitral valve replacement (MVR), 475; double valve replacement (DVR), 150. Additional procedures: CABG, 211; TV repair, 64; other, 152.


RESULTS
Mortality: 67 early (seven valve related) and 56 late (40 valve related). Valve thrombosis: six obstructive, three non-obstructive; embolism: nine major cerebral, 37 other. Major bleeding: 29. Hemolysis: two clinically significant. Non-structural dysfunction: 24 paravalvular leaks, one leaflet interference. No structural failure! Endocarditis: 24. Reoperation 48: 22 non-structural dysfunctions, 14 endocarditis, seven thrombosis and embolism, five other. Estimated 5-year freedom from valve-related deaths is 97.2% for AVR and 92.4% for MVR; 4-year freedom from valve related deaths for DVR is 90.5%. Mean calculated NYHA improvement is 1.24.


CONCLUSIONS
The Bicarbon mechanical prosthesis is well designed, durable, has good hemodynamic features and an acceptably low incidence of complications.
Bikur Cholim Hospital, Jerusalem, Israel. Borman@cc.huji.ac.il
J B
JB
Borman
W G
WG
Brands
L
L
Camilleri
M
M
Cotrufo
W
W
Daenen
I
I
Gandjbakhch
C
C
Infantes
A
A
Khayat
F
F
Laborde
A
A
Pellegrini
A
A
Piwnica
B
B
Reichart
R
R
Sharony
R
R
Walesby
H
H
Warembourg
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D004617:Embolism / Q000209:etiology; D005069:Evaluation Studies as Topic; D005260:Female; D006349:Heart Valve Diseases / Q000601:surgery*; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011474:Prosthesis Design; D012189:Retrospective Studies; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome