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 CarboMedics 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.