BACKGROUND The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery. METHODS We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial. RESULTS Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support. CONCLUSIONS This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02645539.

中文翻译：

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晚期心力衰竭患者使用动态反搏泵的临床结果和生活质量：多中心可行性试验的结果。

背景技术NuPulseCV血管内心室辅助系统（iVAS）通过放置在锁骨下动脉远端的耐用泵提供延长的门诊反搏。方法我们进行了一项前瞻性，单臂，多中心，美国食品药品监督管理局批准的iVAS治疗可行性试验，作为FIH（首次人类试验）试验的移植或决定的桥梁。结果招募了47位患者，其中45位患者（中位61岁，男37位，其中30位在器官共享联合网络上列出）接受了iVAS支持，中位时间为44天（25-87天）。没有术中并发症。成功定义为在iVAS治疗中存活或移植而无中风失能。30天（本研究的主要终点）和6个月时的成功率分别为89％和80％。在iVAS支持的6个月中，有2例患者死亡，2例患者出现神经功能障碍。在为期4周的iVAS支持期间，步行6分钟，步行2分钟的步伐测试和堪萨斯城心肌病问卷的评分得到改善。结论这项可行性试验证明了iVAS治疗有望在短期内取得成果，并改善治疗过程中的功能能力和生活质量。注册：URL：http：//www.clinicaltrials.gov。唯一标识符：NCT02645539。结论这项可行性试验证明了iVAS治疗有望在短期内取得成果，并改善治疗过程中的功能能力和生活质量。注册：URL：http：//www.clinicaltrials.gov。唯一标识符：NCT02645539。结论这项可行性试验证明了iVAS治疗有望在短期内取得成果，并改善治疗过程中的功能能力和生活质量。注册：URL：http：//www.clinicaltrials.gov。唯一标识符：NCT02645539。