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欧洲机械循环支持患者注册中心(EUROMACS):第三份儿科报告(Paedi-EUROMACS)。

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): third Paediatric (Paedi-EUROMACS) report.

机构信息

EUROMACS, EACTS House, Windsor, United Kingdom.

Department of Congenital Pediatric Surgery, Children's Hospital Zürich, Zürich, Switzerland.

出版信息

Eur J Cardiothorac Surg. 2022 Jul 11;62(2). doi: 10.1093/ejcts/ezac355.

DOI:10.1093/ejcts/ezac355
PMID:35758622
Abstract

OBJECTIVES

A third paediatric report has been generated from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). The purpose of EUROMACS, which is operated by the European Association for Cardio-Thoracic Surgery, is to gather data related to durable mechanical circulatory support for scientific purposes and to publish reports with respect to the course of mechanical circulatory support therapy. Since the first report issued, efforts to increase compliance and participation have been extended. Additionally, the data provided the opportunity to analyse patients of younger age and lower weight.

METHODS

Participating hospitals contributed pre-, peri- and long-term postoperative data on mechanical circulatory support implants to the registry. Data for all implants in paediatric patients (<19 years of age) performed from 1 January 2000 to 31 December 2020 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events including neurological dysfunction, device malfunction, major infection and bleeding.

RESULTS

Twenty-five hospitals contributed 537 registered implants in 480 patients. The most frequent aetiology of heart failure was any form of cardiomyopathy (59%), followed by congenital heart disease and myocarditis (15% and 14%, respectively). Competing outcomes analysis revealed that a total of 86% survived to transplant or recovery or are ongoing; at the 2-year follow-up examination, 21.9% died while on support. At 12 months, 45.1% received transplants, 7.5% were weaned from their device and 20.8% died. The 3-month adverse events rate was 1.59 per patient-year for device malfunction including pump exchange, 0.7 for major bleeding, 0.78 for major infection and 0.71 for neurological events.

CONCLUSIONS

The overall survival rate was 79.2% at 12 months following ventricular assist device implant. The comparison of survival rates of the early and later eras shows no significant difference. A focus on specific subgroups showed that survival was less in patients of younger age (<1 year of age; P = 0.01) and lower weight (<20 kg; P = 0.015). Transplant rates at 6 months continue to be low (33.2%).

摘要

目的

欧洲机械循环支持患者注册中心(EUROMACS)生成了第三份儿科报告。EUROMACS 由欧洲心胸外科协会运营,旨在收集与耐用机械循环支持相关的数据,用于科学目的,并发布有关机械循环支持治疗过程的报告。自发布第一份报告以来,已经努力提高了参与度和合规性。此外,所提供的数据还提供了分析年龄更小、体重更轻的患者的机会。

方法

参与医院向该注册中心提供了机械循环支持植入物的术前、术中和术后长期数据。分析了 2000 年 1 月 1 日至 2020 年 12 月 31 日期间在儿科患者(<19 岁)中进行的所有植入物的数据。本报告包括患者特征、植入物频率、结果(包括死亡率、移植和恢复率)以及不良事件(包括神经功能障碍、设备故障、严重感染和出血)的更新。

结果

25 家医院共提供了 537 例在 480 例患者中注册的植入物。心力衰竭最常见的病因是任何形式的心肌病(59%),其次是先天性心脏病和心肌炎(分别为 15%和 14%)。竞争结果分析显示,共有 86%的患者存活并接受了移植或恢复治疗,或仍在继续治疗;在 2 年随访检查时,21.9%的患者在支持治疗期间死亡。在 12 个月时,45.1%的患者接受了移植,7.5%的患者从设备中脱机,20.8%的患者死亡。3 个月时,设备故障(包括泵更换)的不良事件发生率为每患者年 1.59 次,大出血为 0.7 次,严重感染为 0.78 次,神经事件为 0.71 次。

结论

心室辅助装置植入后 12 个月的总体生存率为 79.2%。早期和晚期生存数据的比较显示无显著差异。对特定亚组的关注表明,年龄较小(<1 岁;P=0.01)和体重较轻(<20kg;P=0.015)的患者生存率较低。6 个月时的移植率仍然较低(33.2%)。

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