Up to eight years' follow-up of 997 patients receiving the CarboMedics prosthetic heart valve.
BACKGROUND
The aim of the study was to evaluate our clinical experience with the CarboMedics Heart Valve Prosthesis.


METHODS
Nine hundred ninety-seven consecutive patients underwent mechanical valve implantation (aortic, 771; mitral, 169; double, 52; tricuspid, 5) with this prosthesis from September 1987 through December 1993. The mean age was 62.3+/-13.7 years (range, 0.4 to 84 years); 56.6% (564 patients) were men. Four hundred seventy patients (47.1%) underwent additional surgical procedures. Mean follow-up was 4.1+/-2.2 years (range, 0 to 8.3 years) with a total of 4,040 patient-years.


RESULTS
Early mortality was 5.0% (50/997; aortic, 4.4%; mitral, 6.4%; double, 9.6%). Late mortality was 14.8% (140/947). Survival at 7 years was 75.9%+/-1.8% (aortic, 78.4%+/-2%; mitral, 70.7%+/-4.5%; double, 60.8%+/-7.4%). When matched for sex and age and compared with the normal Norwegian population, our patients had an increased standard mortality ratio in both men (1.9+/-0.4) and women (2.9+/-0.6). The linearized rate of major thromboembolism was 0.9% per patient-year, valve thrombosis 0.2% per patient-year, major bleeding event 0.6% per patient-year, paravalvular leak needing reoperation 0.5% per patient-year, prosthetic valve endocarditis 0.1% per patient-year, and of all reoperations 0.6% per patient-year.


CONCLUSIONS
The CarboMedics Heart Valve Prosthesis has incidences of morbid events comparable with or better than reported for other mechanical valves.
Fiane
A E
AE
Department of Surgery A, Rikshospitalet, University of Oslo, Norway.
Geiran
O R
OR
Svennevig
J L
JL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve; D002648:Child; D002675:Child, Preschool; D004696:Endocarditis / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve; D011183:Postoperative Complications; D011475:Prosthesis Failure; D012086:Reoperation; D015996:Survival Rate; D014261:Tricuspid Valve