Oz Mehmet C, Konertz Wolfgang F, Kleber Franz X, Mohr Friedrich W, Gummert Jan F, Ostermeyer Jorg, Lass Michael, Raman Jai, Acker Michael A, Smedira Nicholas
Columbia-Presbyterian Medical Center, 117 Ft Washington Ave, New York, NY 10032, USA.
J Thorac Cardiovasc Surg. 2003 Oct;126(4):983-91. doi: 10.1016/s0022-5223(03)00049-7.
Surgical intervention is an option for treating the remodeled and dilated left ventricles of patients with heart failure. Providing end-diastolic support with an innovative mesh-like cardiac support device reduces mechanical stress, improves function, and reverses cardiac remodeling in animal models without safety issues. The objective of this study was to review the global clinical safety and feasibility experience of this device.
The Acorn CorCap cardiac support device (Acorn Cardiovascular, Inc, St Paul, Minn) has been implanted worldwide in more than 130 patients with dilated cardiomyopathy with or without concomitant cardiac surgery. The device is positioned around the ventricles and given a custom fit. A series of 48 patients were implanted with the device in initial safety and feasibility studies, of whom 33 also received concomitant cardiac surgery.
At implantation, 11 patients were in New York Heart Association class II, 33 were in class III, and 4 were in class IV. The average CorCap implantation time was 27 minutes. The mean intraoperative reduction in left ventricular end-diastolic dimension was 4.6% +/- 1%. There were no device-related intraoperative complications. Eight early and 9 late deaths occurred during follow-up extending to 24 months. Actuarial survival was 73% at 12 months and 68% at 24 months. There were no device-related adverse events or evidence of constrictive disease, and coronary artery flow reserve was maintained. Ventricular chamber dimensions decreased, whereas ejection fraction and New York Heart Association class were improved in patients overall and in those patients implanted with the CorCap device without concomitant operations.
The CorCap device appears safe for patients with dilated cardiomyopathy. Randomized clinical trials are underway in Europe, Australia, and North America.
手术干预是治疗心力衰竭患者左心室重塑和扩张的一种选择。在动物模型中，使用一种创新的网状心脏支持装置提供舒张末期支持可降低机械应力、改善功能并逆转心脏重塑，且无安全问题。本研究的目的是回顾该装置的全球临床安全性和可行性经验。
橡果心脏支持装置（Acorn Cardiovascular公司，明尼苏达州圣保罗）已在全球范围内植入130多名扩张型心肌病患者体内，这些患者有的接受了心脏手术，有的未接受。该装置环绕心室放置并进行定制适配。在最初的安全性和可行性研究中，有48例患者植入了该装置，其中33例还接受了心脏手术。
植入时，11例患者为纽约心脏协会II级，33例为III级，4例为IV级。橡果心脏支持装置的平均植入时间为27分钟。左心室舒张末期内径术中平均缩小4.6%±1%。术中无与装置相关的并发症。在长达24个月的随访期间，发生了8例早期死亡和9例晚期死亡。12个月时的精算生存率为73%，24个月时为68%。没有与装置相关的不良事件，也没有缩窄性疾病的证据，冠状动脉血流储备得以维持。心室腔尺寸减小，而总体患者以及未同时进行手术而植入橡果心脏支持装置的患者的射血分数和纽约心脏协会分级均有所改善。
橡果心脏支持装置对扩张型心肌病患者似乎是安全的。欧洲、澳大利亚和北美正在进行随机临床试验。
