Sorin Bicarbon bileaflet valve: a 10-year experience.
OBJECTIVE
To present a large 10 year experience of a collaborative evaluation of the Sorin Bicarbon (SB) mechanical prosthesis carried out in 14 centers in eight Western European countries.


METHODS
Between 4/90 and 12/96, 2078 SB valves were implanted in 1875 patients aged 4-84 years (mean 58), 1108 males and 767 females. The valves inserted were 1026 aortic valve replacement (AVR), 656 mitral valve replacement (MVR) and 203 double valve replacement (DVR), additional procedures performed in 467 patients (282 coronary artery bypass grafting).


RESULTS
Early mortality was 97 (5%), overall survival at 8 years was 71.8% AVR, 69.4% MVR, 81.4% DVR. Total late valve-related deaths were 55; overall freedom from valve-related death at 8 years was 95%. New York Heart Association (NYHA) status after surgery: 78% improved and 17% unchanged. Twenty-two valve thrombosis were observed, one fatal; overall freedom from thrombosis at 8 years was 98.5%. Embolism occurred in 95 patients, 77 cerebral events (16 deaths), overall freedom from embolism was 90.7% at 8 years. Six hemolytic events and 26 non-structural dysfunction (all periprosthetic leaks) were reported. Major bleeding occurred in 66, with mortality rate of 32% mainly when intracerebral. Overall freedom from bleeding was 90.8% at 8 years. Endocarditis occurred in 31 patients, 29% were fatal; overall freedom from endocarditis was 97.8% at 8 years. Reoperation was performed in 49 cases--periprosthetic leak 20, infective endocarditis 14, thrombosed valve 13 (and non-valve related-2). Mortality (early and late) occurred in three reoperated patients.


CONCLUSIONS
This is a durable and effective mechanical valve substitute with low morbidity and mortality and good functional results.
Borman
J B
JB
Hadassah University Hospital, Cardiac Surgery Research Center, P.O. Box 12000, Jerusalem 91120, Israel. jbborman@netvision.net.il
De Riberolles
C
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000401:mortality / Q000601:surgery*; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve; D011183:Postoperative Complications; D012086:Reoperation; D015996:Survival Rate