title: Clinical evaluation of the carbomedics prosthesis: experience at providence health system in Portland.
abstract: 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.
authors.affiliation: Providence Health System, Portland, Oregon 97225, USA.
authors.forename: Kenji
authors.initials: K
authors.lastname: Minakata
authors.forename: Yingxing
authors.initials: Y
authors.lastname: Wu
authors.forename: Kathryn J
authors.initials: KJ
authors.lastname: Zerr
authors.forename: Gary L
authors.initials: GL
authors.lastname: Grunkemeier
authors.forename: John R
authors.initials: JR
authors.lastname: Handy
authors.forename: Aftab
authors.initials: A
authors.lastname: Ahmad
authors.forename: Albert
authors.initials: A
authors.lastname: Starr
authors.forename: Anthony P
authors.initials: AP
authors.lastname: Furnary
mesh_terms: 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
chemical_list: D000925:Anticoagulants