Soga Yoshiharu, Okabayashi Hitoshi, Nishina Takeshi, Enomoto Sakae, Shimada Ichiro, Miyamoto Tadaomi-Alfonso, Ban Toshihiko
Department of Cardiovascular Surgery, Kokura Memorial Hospital, Kitakyushu, Japan.
Ann Thorac Surg. 2002 Feb;73(2):474-9. doi: 10.1016/s0003-4975(01)03424-5.
The aim of this study was to report midterm valve replacement (VR) results with the Carbo-Medics valve (Sulzer Carbomedics, Austin, TX).
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.
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%.
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.
本研究旨在报告使用Carbo-Medics瓣膜（苏尔寿卡波医疗器械公司，德克萨斯州奥斯汀）进行中期瓣膜置换（VR）的结果。
1991年至1999年，468例年龄在13至76岁（平均56岁）的患者接受了CarboMedics瓣膜的VR手术：239例主动脉瓣置换（A），167例二尖瓣置换（M），62例主动脉瓣加二尖瓣置换或双瓣膜置换（DVR）。平均随访时间为4.4年；在2016患者年（PY）中，随访完成率为99.1%。抗凝水平目标为国际标准化比值1.47至2.8。
医院死亡率为1.2%。整个组7年生存率的精算分析为87%±2.3%。瓣膜相关死亡的无事件生存率为94%±1.9%。血栓栓塞和出血事件的无事件生存率分别如下：对于主动脉瓣置换，82%±4.9%（2.4%/PY）和88%±2.9%（1.6%/PY）；对于二尖瓣置换，95%±2.1%（0.8%/PY）和91%±3.1%（1.3%/PY）；对于双瓣膜置换，96%±3.2%（0.7%/PY）和85%±9.7%（1.0%/PY）。再次手术的精算无事件生存率为98%±1.4%。
如日本人群所示，即使在低强度抗凝情况下，CarboMedics瓣膜植入后的早期死亡率也令人满意，且瓣膜相关事件发生率较低。
