Prevalence of bleeding events in real-world Japanese registry for Percutaneous Ventricular Assist Device.

IF 1.1 4区 医学 Q4 ENGINEERING, BIOMEDICAL
Takashi Nishimura, Koichi Toda, Junya Ako, Atsushi Hirayama, Koichiro Kinugawa, Yoshio Kobayashi, Minoru Ono, Naoki Sato, Takahiro Shindo, Akira Shiose, Morimasa Takayama, Satoshi Yasukochi, Yoshiki Sawa
{"title":"Prevalence of bleeding events in real-world Japanese registry for Percutaneous Ventricular Assist Device.","authors":"Takashi Nishimura, Koichi Toda, Junya Ako, Atsushi Hirayama, Koichiro Kinugawa, Yoshio Kobayashi, Minoru Ono, Naoki Sato, Takahiro Shindo, Akira Shiose, Morimasa Takayama, Satoshi Yasukochi, Yoshiki Sawa","doi":"10.1007/s10047-023-01429-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Bleeding complication is a critical risk factor for outcomes of acute heart failure patients requiring mechanical circulatory support (MCS), including percutaneous catheter-type heart pumps (Impella). The Japanese registry for Percutaneous Ventricular Assist Device (J-PVAD) is an ongoing, large-scale, real-world registry to characterize Japanese patients requiring Impella. Here we analyzed bleeding complication profiles in patients who received Impella.</p><p><strong>Methods: </strong>All consecutive Japanese patients who received Impella from October 2017 to January 2020 were enrolled. The 30-day survival and bleeding complications were analyzed.</p><p><strong>Results: </strong>A total of 1344 patients were included: 653 patients received Impella alone, 685 patients received a combination of veno-arterial extracorporeal membrane oxygenation and Impella (ECPELLA), and 6 patients had failed Impella delivery. Overall 30-day survival was 67.0%, with Impella alone at 81.9% and ECPELLA at 52.7%. Overall bleeding/hematoma adverse events with a relation or not-excluded relation to Impella was 6.92%. Among them, the rates of hematoma and bleeding from medical device access sites were 1.41% and 4.09%, respectively. There was no difference between etiologies for these events.</p><p><strong>Conclusion: </strong>This study represents the first 3-year survival and the safety profile focused on bleeding adverse events from the J-PVAD registry. The results show that the real-world frequency of bleeding adverse events for patients who received Impella was an expected range from previous reports, and future real-world studies should aim to expand this data set to improve outcomes and adverse events.</p>","PeriodicalId":15177,"journal":{"name":"Journal of Artificial Organs","volume":null,"pages":null},"PeriodicalIF":1.1000,"publicationDate":"2024-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Artificial Organs","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1007/s10047-023-01429-5","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ENGINEERING, BIOMEDICAL","Score":null,"Total":0}
引用次数: 0

Abstract

Purpose: Bleeding complication is a critical risk factor for outcomes of acute heart failure patients requiring mechanical circulatory support (MCS), including percutaneous catheter-type heart pumps (Impella). The Japanese registry for Percutaneous Ventricular Assist Device (J-PVAD) is an ongoing, large-scale, real-world registry to characterize Japanese patients requiring Impella. Here we analyzed bleeding complication profiles in patients who received Impella.

Methods: All consecutive Japanese patients who received Impella from October 2017 to January 2020 were enrolled. The 30-day survival and bleeding complications were analyzed.

Results: A total of 1344 patients were included: 653 patients received Impella alone, 685 patients received a combination of veno-arterial extracorporeal membrane oxygenation and Impella (ECPELLA), and 6 patients had failed Impella delivery. Overall 30-day survival was 67.0%, with Impella alone at 81.9% and ECPELLA at 52.7%. Overall bleeding/hematoma adverse events with a relation or not-excluded relation to Impella was 6.92%. Among them, the rates of hematoma and bleeding from medical device access sites were 1.41% and 4.09%, respectively. There was no difference between etiologies for these events.

Conclusion: This study represents the first 3-year survival and the safety profile focused on bleeding adverse events from the J-PVAD registry. The results show that the real-world frequency of bleeding adverse events for patients who received Impella was an expected range from previous reports, and future real-world studies should aim to expand this data set to improve outcomes and adverse events.

Abstract Image

日本经皮心室辅助装置真实世界登记中的出血事件发生率。
目的:出血并发症是需要机械循环支持(MCS)(包括经皮导管型心脏泵(Impella))的急性心衰患者预后的关键风险因素。日本经皮心室辅助装置登记处(J-PVAD)是一个正在进行中的大规模真实世界登记处,旨在描述需要使用 Impella 的日本患者的特征。我们在此分析了接受 Impella 患者的出血并发症情况:方法:2017 年 10 月至 2020 年 1 月期间接受 Impella 的所有连续日本患者均被纳入。结果:共纳入 1344 名患者:结果:共纳入 1344 名患者:653名患者单独接受了Impella治疗,685名患者接受了静脉-动脉体外膜氧合和Impella(ECPELLA)联合治疗,6名患者Impella治疗失败。30 天总存活率为 67.0%,其中单独使用 Impella 的存活率为 81.9%,ECPELLA 的存活率为 52.7%。与Impella相关或不排除相关的出血/血肿不良事件总发生率为6.92%。其中,血肿率和医疗器械接入部位出血率分别为 1.41% 和 4.09%。这些事件的病因没有差异:本研究是 J-PVAD 登记中首次以出血不良事件为重点的 3 年存活率和安全性概况。结果表明,接受 Impella 治疗的患者在真实世界中发生出血不良事件的频率与之前的报告相比在预期范围内,未来的真实世界研究应致力于扩大该数据集,以改善预后和不良事件。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Journal of Artificial Organs
Journal of Artificial Organs 医学-工程:生物医学
CiteScore
2.80
自引率
15.40%
发文量
68
审稿时长
6-12 weeks
期刊介绍: The aim of the Journal of Artificial Organs is to introduce to colleagues worldwide a broad spectrum of important new achievements in the field of artificial organs, ranging from fundamental research to clinical applications. The scope of the Journal of Artificial Organs encompasses but is not restricted to blood purification, cardiovascular intervention, biomaterials, and artificial metabolic organs. Additionally, the journal will cover technical and industrial innovations. Membership in the Japanese Society for Artificial Organs is not a prerequisite for submission.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信