Oz Mehmet C, Konertz Wolfgang F, Raman Jai, Kleber Franz X
Columbia-Presbyterian Medical Center, 117 Ft. Washington Avenue, New York, NY 10032, USA.
Congest Heart Fail. 2004 Mar-Apr;10(2):96-104; discussion 105. doi: 10.1111/j.1527-5299.2004.00291.x.
Preclincial studies have shown that an innovative meshlike cardiac support device (CorCap, Acorn Cardiovascular, Inc., St. Paul, MN) can provide end diastolic support to reduce mechanical stress, improve function, and reverse cardiac remodeling. The CorCap device has been implanted worldwide in more than 130 patients with dilated cardiomyopathy (idiopathic or ischemic), with or without concomitant cardiac surgery. A series of 48 patients was implanted in initial safety and feasibility studies (33 received concomitant cardiac surgery, 15 patients received the CorCap device only). At implant, 33 patients were in New York Heart Association functional class III, 11 in class II, and four in class IV. There were no device-related intraoperative complications, deaths, or adverse events. Eight early and nine late deaths occurred during follow-up extending to 18-24 months. During follow-up, chamber dimensions decreased, and ejection fraction and New York Heart Association functional class improved. The CorCap device is correlated with improvements in patient functional status. Randomized clinical trials are underway in Europe, Australia, and North America.
临床前研究表明，一种创新的网状心脏支撑装置（CorCap，橡果心血管公司，明尼苏达州圣保罗）可提供舒张末期支撑，以减轻机械应力、改善功能并逆转心脏重塑。CorCap装置已在全球130多名扩张型心肌病（特发性或缺血性）患者中植入，这些患者无论是否同时进行心脏手术。在最初的安全性和可行性研究中，对48例患者进行了植入（33例同时进行了心脏手术，15例仅接受了CorCap装置）。植入时，33例患者为纽约心脏协会心功能Ⅲ级，11例为Ⅱ级，4例为Ⅳ级。术中未发生与装置相关的并发症、死亡或不良事件。在长达18至24个月的随访期间，发生了8例早期死亡和9例晚期死亡。随访期间，心室尺寸减小，射血分数和纽约心脏协会心功能分级得到改善。CorCap装置与患者功能状态的改善相关。欧洲、澳大利亚和北美正在进行随机临床试验。
