Clinical evaluation of the carbomedics prosthesis: experience at providence health system in Portland.
OBJECTIVE
This study details the authors' experience with the CarboMedics bileaflet mechanical prosthesis, and assesses the valve's efficacy in terms of early mortality and long-term morbidity.


METHODS
Between July 1994 and December 2000, a total of 696 CarboMedics valves was implanted in 616 patients. Aortic valve replacement (AVR) was performed in 350 (57%) patients, mitral valve replacement (MVR) in 161 (26%), double (aortic + mitral) valve replacement (DVR) in 79 (13%), and other procedures in 26 (4%).


RESULTS
There were 32 operative deaths. Operative mortality was 4.3% for AVR, 6.8% for MVR, and 7.6% for DVR. Linearized rates for late death were 3.4%/patient-year (pt-yr), 5.5%/pt-yr and 7.7%/pt-yr for AVR, MVR and DVR, respectively. Survival at five years was 80.1% for AVR, 73.0% for MVR, and 64.6% for DVR (p = 0.004). Freedom from reoperation at five years was 97.6% for AVR, 98.1% for MVR, and 94.1% for DVR (p = 0.718); freedom from thromboembolism at five years was 96.3% for AVR, 98.6% for MVR, and 88.3% for DVR (p = 0.04). Linearized rates of late thromboembolism were 0.7%/pt-yr, 0.4%/pt-yr and 2.3%/pt-yr, respectively. Freedom from PVE at five years was 98.4% for AVR, 97.0% for MVR, and 89.7% for the DVR group (p = 0.172). Linearized rates of PVE were 0.5%/pt-yr, 0.9%/pt-yr and 1.8%/pt-yr, respectively. Freedom from anticoagulant-related bleeding at five years was 98.0% in the AVR group, 97.8% in the MVR group, and 88.3% in the DVR group (p <0.001); linearized rates of this event were 0.4%/pt-yr, 0.6%/pt-yr and 3.2%/pt-yr, respectively. One valve thrombosis was found after MVR, and another in the mitral position after DVR.


CONCLUSIONS
Early and intermediate-term follow up of the CarboMedics prosthesis indicates that the clinical performance of this valve is satisfactory, and results are comparable with those obtained for other mechanical valves.
Minakata
Kenji
K
Providence Health System, Portland, Oregon 97225, USA.
Wu
Yingxing
Y
Zerr
Kathryn J
KJ
Grunkemeier
Gary L
GL
Handy
John R
JR
Ahmad
Aftab
A
Starr
Albert
A
Furnary
Anthony P
AP
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects; D001021:Aortic Valve / Q000601:surgery; D002423:Cause of Death; D018572:Disease-Free Survival; D004696:Endocarditis / Q000453:epidemiology / Q000209:etiology / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000188:drug therapy / Q000401:mortality / Q000601:surgery; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery; D009922:Oregon / Q000453:epidemiology; D019106:Postoperative Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D016459:Prosthesis-Related Infections / Q000453:epidemiology / Q000209:etiology / Q000628:therapy; D012086:Reoperation; D012307:Risk Factors; D013923:Thromboembolism / Q000453:epidemiology / Q000209:etiology / Q000628:therapy; D013997:Time Factors; D016896:Treatment Outcome
D000925:Anticoagulants