Intermediate-term results with 1,019 carbomedics aortic valves.
BACKGROUND
A retrospective study was conducted to evaluate the intermediate-term outcome in patients with the Carbomedics aortic valve prosthesis.


METHODS
The study included 1,019 primary valve replacements between 1989 and 1997. Seventy-two percent of patients were men; mean (standard deviation) age was 61 (10) years. The preoperative New York Heart Association functional class was III or IV in 70% of patients. Follow-up at 9 years was 99.6% complete, comprising 2,730 patient-years (mean, 2.7 years).


RESULTS
Patient survival, including operative deaths, was 80% at 7 years. The linearized death rate was 2.9%/year. Statistically significant risk factors for mortality were diabetes, pure valve insufficiency, advanced age at operation, and advanced preoperative functional class. Linearized rates were thrombosis, 0.1%/year; thromboembolism, 1.0%/year; hemorrhage, 1.7%/year; endocarditis, 0.1%/year; paravalvular leak, 0.1%/year; reoperation, 0.1%/year; and all events, 3.0%/year. The 7-year estimates of freedom from complications were thrombosis, 99%; thromboembolism, 93%; hemorrhage, 89%; endocarditis, 99%; paravalvular leak, 99.7%; reoperation, 99%; and all events, 82%. No structural valve failure was observed.


CONCLUSIONS
The low incidence of valve-related complications favors the continued use of the Carbomedics valve in the aortic position.
Li
H H
HH
Herz- und Gefaessklinik, Bad Neustadt, Germany. huihuali@msn.com
Hahn
J
J
Urbanski
P
P
Torka
M
M
Grunkemeier
G L
GL
Hacker
R W
RW
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000401:mortality* / Q000601:surgery*; D001705:Bioprosthesis; D002423:Cause of Death; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods / Q000401:mortality*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012189:Retrospective Studies; D018570:Risk Assessment; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome