Up to 8-year follow-up of valve replacement with carbomedics valve.
BACKGROUND
The aim of this study was to report midterm valve replacement (VR) results with the Carbo-Medics valve (Sulzer Carbomedics, Austin, TX).


METHODS
From 1991 to 1999, 468 patients aged 13 to 76 years (mean 56 years) underwent VR with CarboMedics valve: 239 aortic (A), 167 mitral (M), and 62 A+M or double valve replacement (DVR). Mean follow-up time was 4.4 years; follow-up was 99.1% complete for 2,016 patient-years (PY). The anticoagulation level was targeted to an international normalized ratio of 1.47 to 2.8.


RESULTS
The hospital mortality rate was 1.2%. Actuarial analysis for the entire group at 7 years for survival was 87%+/-2.3%. Freedom from valve-related death was 94%+/-1.9%. Freedom from thromboembolic and bleeding events, respectively, were as follows: for AVR, 82%+/-4.9% (2.4%/PY) and 88%+/-2.9% (1.6%/PY); for MVR, 95%+/-2.1% (0.8%/PY) and 91%+/-3.1% (1.3%/PY); and for DVR, 96%+/-3.2% (0.7%/PY) and 85%+/-9.7% (1.0%/PY). Actuarial freedom from reoperation was 98%+/-1.4%.


CONCLUSIONS
The CarboMedics valve can be implanted with satisfactory early mortality and a low incidence of valve-related events even under low-intensity anticoagulation, as shown in a Japanese population.
Soga
Yoshiharu
Y
Department of Cardiovascular Surgery, Kokura Memorial Hospital, Kitakyushu, Japan. sogakin@kuhp.kyoto-u.ac.jp
Okabayashi
Hitoshi
H
Nishina
Takeshi
T
Enomoto
Sakae
S
Shimada
Ichiro
I
Miyamoto
Tadaomi-Alfonso
TA
Ban
Toshihiko
T
D000293:Adolescent; D000328:Adult; D000368:Aged; D001021:Aortic Valve / Q000601:surgery*; D002423:Cause of Death; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000209:etiology / Q000401:mortality / Q000601:surgery*; D006350:Heart Valve Prosthesis; D017052:Hospital Mortality; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery*; D011183:Postoperative Complications / Q000209:etiology* / Q000401:mortality / Q000601:surgery; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation