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欧洲心胸外科协会机械循环支持患者注册登记研究:第三份报告。

The European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery: third report.

机构信息

EUROMACS, EACTS House, Windsor, UK.

Department of Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.

出版信息

Eur J Cardiothorac Surg. 2022 Jun 15;62(1). doi: 10.1093/ejcts/ezac032.

Abstract

OBJECTIVES

In the third report of the European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery, outcomes of patients receiving mechanical circulatory support are reviewed in relation to implant era.

METHODS

Procedures in adult patients (January 2011-June 2020) were included. Patients from centres with <60% follow-ups completed were excluded. Outcomes were stratified into 3 eras (2011-2013, 2014-2017 and 2018-2020). Adverse event rates (AERs) were calculated and stratified into early phase (<3 months) and late phase (>3 months). Risk factors for death were explored using univariable Cox regression with a stepwise time-varying hazard ratio (<3 vs >3 months).

RESULTS

In total, 4834 procedures in 4486 individual patients (72 hospitals) were included, with a median follow-up of 1.1 (interquartile range: 0.3-2.6) years. The annual number of implants (range: 346-600) did not significantly change (P = 0.41). Both Interagency Registry for Mechanically Assisted Circulatory Support class (classes 4-7: 23, 25 and 33%; P < 0.001) and in-hospital deaths (18.5, 17.2 and 11.2; P < 0.001) decreased significantly between eras. Overall, mortality, transplants and the probability of weaning were 55, 25 and 2% at 5 years after the implant, respectively. Major infections were mainly noted early after the implant occurred (AER<3 months: 1.44 vs AER>3 months: 0.45). Bilirubin and creatinine levels were significant risk factors in the early phase but not in the late phase after the implant.

CONCLUSIONS

In its 10 years of existence, EUROMACS has become a point of reference enabling benchmarking and outcome monitoring. Patient characteristics and outcomes changed between implant eras. In addition, both occurrence of outcomes and risk factor weights are time dependent.

摘要

目的

在欧洲心胸外科协会机械循环支持患者注册处的第三份报告中,回顾了与植入时代相关的接受机械循环支持患者的结局。

方法

纳入了成年患者(2011 年 1 月至 2020 年 6 月)的手术。来自随访完成率<60%的中心的患者被排除在外。结局分为 3 个时代(2011-2013 年、2014-2017 年和 2018-2020 年)。计算不良事件发生率(AER)并分为早期(<3 个月)和晚期(>3 个月)。使用单变量 Cox 回归分析探索死亡的风险因素,时间相关危险比(<3 个月与>3 个月)逐步变化。

结果

共纳入 4834 例手术,涉及 4486 名患者(72 家医院),中位随访时间为 1.1 年(四分位间距:0.3-2.6)。植入物的年植入数量(范围:346-600)没有显著变化(P=0.41)。Interagency Registry for Mechanically Assisted Circulatory Support 分级(4-7 级:23%、25%和 33%;P<0.001)和住院死亡率(18.5%、17.2%和 11.2%;P<0.001)在各时代间均显著降低。总体而言,植入后 5 年的死亡率、移植和撤机率分别为 55%、25%和 2%。主要感染主要发生在植入后早期(AER<3 个月:1.44 vs AER>3 个月:0.45)。植入后早期胆红素和肌酐水平是显著的风险因素,但晚期不是。

结论

EUROMACS 在其 10 年的存在期间,已成为基准比较和结果监测的参考点。患者特征和结局在植入时代之间发生了变化。此外,结局的发生和风险因素权重都是时间依赖性的。

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