Corheart 6左心室辅助系统的安全性和有效性。

IF 2.3 3区 医学 Q2 ENGINEERING, BIOMEDICAL
Zhibing Qiu, Xiaochun Song, Hongwei Shi, Xiaomin Zhang, Wen Chen, Yunzhang Wu, Xin Chen
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引用次数: 0

摘要

评估Corheart 6左心室辅助系统(LVAS)在终末期心力衰竭患者中的有效性和安全性。在南京第一医院进行了一项回顾性队列研究,以评估2022年3月至2024年3月期间植入Corheart 6 LVAS的终末期心力衰竭患者的临床结果。共有28名患者入组。主要终点是植入后6个月无致残性卒中的综合生存率。对植入前后的结果进行统计学分析比较。无术中死亡或术后30天死亡。3个月生存率为100%,6个月生存率为89.3%,其中3例死亡归因于脑出血、设备报警管理不当和系统性淀粉样变性并发症。心功能明显改善。溶血指标保持稳定。不良事件包括出血性脑血管意外(3.6%)、室性心律失常(25%)、肺部感染(35.7%)、传动系统出口部位感染(3.6%)、肾功能衰竭(需要透析)(7.1%)和右心衰(3.6%)。无泵血栓、溶血及设备故障发生。Corheart 6 LVAS在危重心衰患者中表现出良好的中期生存和心功能改善,具有可控的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and Efficacy of the Corheart 6 Left Ventricular Assist System.

To assess the efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) in patients with end-stage heart failure. A retrospective cohort study was conducted at Nanjing First Hospital to evaluate the clinical outcomes of patients with end-stage heart failure who underwent implantation of the Corheart 6 LVAS between March 2022 and March 2024. A total of 28 patients were enrolled. The primary endpoint was a composite of survival free from disabling stroke at 6 months post-implantation. Statistical analyses were conducted to compare pre- and post-implantation outcomes. No intraoperative or 30 day postoperative mortality occurred. Survival rates were 100% at 3 months and 89.3% at 6 months, with three deaths attributed to cerebral hemorrhage, device alarm mismanagement, and systemic amyloidosis complications. Significant improvements in cardiac function were observed. Hemolysis markers remained stable. Adverse events included hemorrhagic cerebrovascular accident (3.6%), ventricular arrhythmias (25%), pulmonary infections (35.7%), driveline exit site infection (3.6%), renal failure (requiring dialysis) (7.1%), and right heart failure (3.6%). No pump thrombosis, hemolysis or device malfunction occurred. The Corheart 6 LVAS demonstrated favorable mid-term survival and cardiac functional improvement in critically ill heart failure patients, with a manageable safety profile.

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来源期刊
ASAIO Journal
ASAIO Journal 医学-工程:生物医学
CiteScore
6.60
自引率
7.10%
发文量
651
审稿时长
4-8 weeks
期刊介绍: ASAIO Journal is in the forefront of artificial organ research and development. On the cutting edge of innovative technology, it features peer-reviewed articles of the highest quality that describe research, development, the most recent advances in the design of artificial organ devices and findings from initial testing. Bimonthly, the ASAIO Journal features state-of-the-art investigations, laboratory and clinical trials, and discussions and opinions from experts around the world. The official publication of the American Society for Artificial Internal Organs.
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