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.
Borman
J B
JB
Bikur Cholim Hospital, Jerusalem, Israel. Borman@cc.huji.ac.il
Brands
W G
WG
Camilleri
L
L
Cotrufo
M
M
Daenen
W
W
Gandjbakhch
I
I
Infantes
C
C
Khayat
A
A
Laborde
F
F
Pellegrini
A
A
Piwnica
A
A
Reichart
B
B
Sharony
R
R
Walesby
R
R
Warembourg
H
H
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