Abstract:
The CorInnova cardiac compression device (CorInnova, Inc., Houston, TX, USA) is designed to provide direct biventricular support, increase cardiac output, and improve ventricular unloading in patients with heart failure. Placed within the pericardium and surrounding both ventricles, the device has two concentric sets of thin-film polyurethane chambers: (1) inner (epicardial) saline-filled chambers that conform intimately to the epicardial surface, eradicating any gaps in the interface between the device and the heart; and (2) outer air-filled chambers cycled to provide epicardial compression during systole and negative epicardial pressure during diastole, consistent with physiological cardiac contraction and relaxation. A superelastic, collapsible Nitinol frame gives the device structure, enables minimally invasive self-deployment, and enhances diastolic filling. Preclinical testing has been extremely promising, with improvements in cardiac output and other cardiac parameters in animal heart failure models. This potentially transformative technology is moving rapidly toward first-in-human use. The CorInnova device may provide an effective device-based solution for patients with heart failure who currently have few or limited mechanical cardiac support options, including patients with biventricular cardiac failure, those with right heart failure, those who are older, and those who are of smaller size. It can be removed easily and requires minimal maintenance. An important, unique feature of this technology is that it provides mechanical cardiac assistance without blood contact or need for anticoagulation. The CorInnova device may be particularly important for those patients who have contraindications to anticoagulation due to allergy, neurological bleeds, or preexisting hemorrhage. No other mechanical circulatory support device addresses these underserved heart-failure populations.
摘要:
CorInnova心脏按压装置(CorInnova,Inc.,休斯顿,TX,美国)旨在提供直接的双心室支持,增加心输出量,改善心力衰竭患者的心室卸载。放置在心包和两个心室周围,该装置具有两组同心的薄膜聚氨酯腔:(1)内部(心外膜)盐水填充室,与心外膜表面紧密贴合,消除装置和心脏之间界面的任何间隙;(2)循环的外部充气腔在收缩期提供心外膜压缩,在舒张期提供心外膜负压,与生理心脏收缩和舒张相一致。一种超弹性,可折叠的镍钛诺框架给出了设备结构,实现微创自我部署,并增强舒张充盈。临床前测试非常有希望,改善动物心力衰竭模型的心输出量和其他心脏参数。这种潜在的变革性技术正在迅速走向人类首次使用。CorInnova设备可以为目前很少或有限的机械心脏支持选择的心力衰竭患者提供有效的基于设备的解决方案。包括双室心力衰竭患者,那些患有右心衰竭的人,那些年长的人,以及那些体型较小的人。它可以很容易地删除和需要最少的维护。一个重要的,该技术的独特之处在于它提供机械心脏辅助,无需血液接触或抗凝。CorInnova装置对于那些因过敏而有抗凝禁忌症的患者可能特别重要,神经性出血,或先前存在的出血。没有其他机械循环支持设备可以解决这些服务不足的心力衰竭人群。