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一项关于Impella装置用于小儿和青少年患者体循环机械支持的多中心研究。

A multicenter study of the impella device for mechanical support of the systemic circulation in pediatric and adolescent patients.

作者信息

Dimas V Vivian, Morray Brian H, Kim Dennis W, Almond Christopher S, Shahanavaz Shabana, Tume Sebastian C, Peng Lynn F, McElhinney Doff B, Justino Henri

机构信息

Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX.

Division of Cardiology, Seattle Children's Hospital, Seattle, WA.

出版信息

Catheter Cardiovasc Interv. 2017 Jul;90(1):124-129. doi: 10.1002/ccd.26973. Epub 2017 Mar 15.

DOI:10.1002/ccd.26973
PMID:28295963
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5511055/
Abstract

OBJECTIVES

The objective was to review the use of Impella devices (Abiomed Inc, Danvers, MA) for temporary circulatory support in pediatric and adolescent patients (age ≤ 21 yrs).

BACKGROUND

Options for minimally invasive circulatory support in children are limited, and published data are confined to case reports and small case series.

METHODS

This was a retrospective, multicenter review of Impella implants in pediatric and adolescent patients from 2009-15, using standardized data collection and INTERMACS definitions.

RESULTS

A total of 39 implants were performed in 38 patients from 16 centers. Median age and weight were 16 yrs (4-21 yrs) and 62 kg (15-134 kg). The primary indication for implant was cardiogenic shock in 28 patients (72%). Cardiac allograft rejection, myocarditis, or cardiomyopathy were the underlying diagnosis in 23 patients (59%); 11 patients had congenital heart disease. The median duration of support was 45 hr (1-1224 hr). Indications for explant included ventricular recovery in 16 patients, transition to another device in 12, death in 5, and transplant in 1. Survival was 85% at 7 days and 68% at 30 days. Major adverse events occurred in 8 patients: hemolysis in 3, bleeding in 2, stroke in 1 (unclear if related to Impella), sepsis in 1, and critical leg ischemia in 1. An increase in aortic regurgitation was noted in three patients, with no evidence of valve injury.

CONCLUSION

Temporary circulatory support with Impella devices is feasible in pediatric and adolescent patients, with acceptable risk profiles. More experience and follow up is needed to improve technical performance and patient selection. © 2017 Wiley Periodicals, Inc.

摘要

目的

本研究旨在回顾Impella装置(美国马萨诸塞州丹弗斯市Abiomed公司)在儿科和青少年患者(年龄≤21岁)中用于临时循环支持的情况。

背景

儿童微创循环支持的选择有限,已发表的数据仅限于病例报告和小病例系列。

方法

这是一项对2009年至2015年儿科和青少年患者中Impella植入情况的回顾性多中心研究,采用标准化数据收集和INTERMACS定义。

结果

来自16个中心的38例患者共进行了39次植入。中位年龄和体重分别为16岁(4至21岁)和62千克(15至134千克)。植入的主要指征是28例患者(72%)的心源性休克。23例患者(59%)的潜在诊断为心脏移植排斥反应、心肌炎或心肌病;11例患者患有先天性心脏病。中位支持时间为45小时(1至1224小时)。移除装置的指征包括16例患者的心室恢复、12例患者过渡到另一种装置、5例患者死亡和1例患者移植。7天时生存率为85%,30天时生存率为68%。8例患者发生了主要不良事件:3例溶血、2例出血、1例中风(是否与Impella相关尚不清楚)、1例脓毒症和1例严重下肢缺血。3例患者主动脉瓣反流增加,但无瓣膜损伤证据。

结论

Impella装置用于儿科和青少年患者的临时循环支持是可行的,风险可接受。需要更多经验和随访以改善技术性能和患者选择。©2017威利期刊公司

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