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Impella 5.5:当前文献的系统评价。

Impella 5.5: A Systematic Review of the Current Literature.

机构信息

College of Medicine, University of Florida, Gainesville, FL, USA.

Division of Cardiovascular Surgery, College of Medicine, University of Florida, Gainesville, FL, USA.

出版信息

Innovations (Phila). 2024 Jul-Aug;19(4):380-389. doi: 10.1177/15569845241266527. Epub 2024 Sep 12.

Abstract

OBJECTIVE

Impella 5.5 (Abiomed, Danvers, MA, USA) is a temporary mechanical circulatory support device used for patients in cardiogenic shock. This review provides a comprehensive overview of the device's clinical effectiveness, safety profile, patient outcomes, and relevant procedural considerations.

METHODS

We conducted a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using the PubMed/MEDLINE database. The search query included articles available from October 6, 2022, through January 13, 2023. Our initial search identified 75 studies. All records were screened by 2 independent reviewers using the Covidence software for adherence to our inclusion criteria, and 8 retrospective cohort studies were identified as appropriate for inclusion.

RESULTS

Across the included studies, the sample size ranged from 4 to 275, with predominantly male cohorts. Indications for Impella support varied, and the duration of support ranged from 9.8 to 70 days. Overall, Impella support appeared to be associated with favorable survival rates and manageable complications in various patient populations. Complications associated with Impella use included bleeding, stroke, and device malfunctions. Two studies compared prolonged and Food and Drug Administration-approved Impella support, showing similar outcomes and adverse events.

CONCLUSIONS

Impella 5.5 continues to be an attractive option for bridging patients to definitive therapy. Survival during and after Impella 5.5 was favorable for patients regardless of initial indication. However, device use was associated with several important complications, which calls for judicious use and a precontemplated exit strategy. Limitations of this literature review include biases inherent to the retrospective studies included, such as selection and publication bias.

摘要

目的

Impella 5.5(美国雅培公司,马萨诸塞州丹弗斯)是一种用于心源性休克患者的临时机械循环支持设备。本综述全面概述了该设备的临床效果、安全性、患者结局和相关操作注意事项。

方法

我们根据系统评价和荟萃分析的首选报告项目指南,使用 PubMed/MEDLINE 数据库进行了系统评价。搜索查询包括 2022 年 10 月 6 日至 2023 年 1 月 13 日期间可获得的文章。我们的初始搜索确定了 75 项研究。两名独立评审员使用 Covidence 软件筛选所有记录,以遵守我们的纳入标准,并确定了 8 项符合纳入标准的回顾性队列研究。

结果

在纳入的研究中,样本量从 4 到 275 不等,主要为男性队列。Impella 支持的适应证各不相同,支持时间从 9.8 到 70 天不等。总体而言,在各种患者人群中,Impella 支持似乎与较高的生存率和可管理的并发症相关。与 Impella 使用相关的并发症包括出血、中风和设备故障。两项研究比较了延长和美国食品和药物管理局批准的 Impella 支持,显示出相似的结局和不良事件。

结论

Impella 5.5 仍然是桥接患者至确定性治疗的有吸引力的选择。无论初始适应证如何,患者在 Impella 5.5 期间和之后的生存率都很好。然而,设备使用与一些重要的并发症相关,这需要审慎使用和预先考虑退出策略。本文献综述的局限性包括纳入的回顾性研究固有的偏倚,如选择和发表偏倚。

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