Aagaard J, Hansen C N, Tingleff J, Rygg I
Department of Cardiothoracic Surgery, National University Hospital, Copenhagen, Denmark.
J Heart Valve Dis. 1995 Nov;4(6):628-33.
Seven and a half year clinical experience with the CarboMedics prosthetic heart valve is presented. A total of 287 valves were inserted in 277 patients. The first 132 patients were followed in a prospective, and the remaining 145 patients in a partly prospective and partly retrospective manner. The follow up was 98.9% complete with a total of 1,055 patient-years. Actuarial survival at 7.5 years was 74.0% +/- 3.5% overall; 76.0% +/- 4.3% for single aortic, 75.0% +/- 6.5% for single mitral and 76.0% +/- 11.4% for double valve replacements. The actuarial rates of freedom from complications were as follows: valve thrombosis 99.6% +/- 0.4%, embolism 96.0% +/- 1.7%, and anticoagulant-related bleeding 88.0% +/- 2.4%. There was no hemolysis, prosthetic valve dysfunction, or structural deterioration. The linearized rates per 100 patients-years were as follows: valve thrombosis 0.09 (mitral 0.30); embolism 0.75 (aortic 0.31, mitral 1.80); anticoagulant related bleeding 2.84; paravalvular leakage overall 0.19 (aortic 0.31); prosthetic valve endocarditis 0.19 (aortic 0.31). Over a 7.5-year time frame, the CarboMedics prosthetic heart valve has been highly reliable with a low incidence of valve related complications.
本文介绍了使用CarboMedics人工心脏瓣膜的七年半临床经验。共为277例患者植入了287枚瓣膜。前132例患者接受前瞻性随访，其余145例患者接受部分前瞻性和部分回顾性随访。随访完成率为98.9%，总随访时间为1055患者年。7.5年时的总精算生存率为74.0%±3.5%；单主动脉瓣置换术后为76.0%±4.3%，单二尖瓣置换术后为75.0%±6.5%，双瓣膜置换术后为76.0%±11.4%。无并发症的精算发生率如下：瓣膜血栓形成99.6%±0.4%，栓塞96.0%±1.7%，抗凝相关出血88.0%±2.4%。未发生溶血、人工瓣膜功能障碍或结构恶化。每100患者年的线性化发生率如下：瓣膜血栓形成0.09（二尖瓣0.30）；栓塞0.75（主动脉瓣0.31，二尖瓣1.80）；抗凝相关出血2.84；瓣周漏总体发生率0.19（主动脉瓣0.31）；人工瓣膜心内膜炎0.19（主动脉瓣0.31）。在7.5年的时间里，CarboMedics人工心脏瓣膜高度可靠，与瓣膜相关的并发症发生率较低。
