Veen Kevin M, Ahmed Mazen, Stark Christoffer, Botta Luca, Anastasiadis Kyriakos, Bernhardt Alexander, Berchtold-Herz Michael, Caliskan Kadir, Reineke David, Damman Kevin, Fiane Arnt, Gkouziouta Angeliki, Gollmann-Tepeköylü Can, Najjar Emil, Hulman Michal, Iacovoni Attilio, Loforte Antonio, Merkely Bela, Musumeci Francesco, Comisso Marina, Němec Petr, Netuka Ivan, Özbaran Mustafa, Potapov Evgenij, Pya Yuri, Rábago Gregorio, Ramjankhan Faiz, Scandroglio Anna Mara, Pieri Marina, Reichenspurner Hermann, Dashkevich Alexey, Stockman Bernard, Vanderheyden Marc, Tops Laurens, Wahlers Thorsten, Przybyłowski Piotr, Zimpfer Daniel, Løgstrup Brian Bridal, Santer David, Färber Gloria, Gummert Jan, Meyns Bart, de By Theo M M H, Schoenrath Felix
Department of Cardiothoracic Surgery, Erasmus MC, Rotterdam, The Netherlands.
EUROMACS, EACTS House, Windsor, UK.
Eur J Cardiothorac Surg. 2025 Feb 4;67(2). doi: 10.1093/ejcts/ezaf016.
This 4th report aimed to provide insights into patient characteristics, outcomes and standardized outcome ratios of patients implanted with durable Mechanical Circulatory Support across participating centres in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) registry.
All registered patients receiving durable mechanical circulatory support up to August 2024 were included. The expected number of events was predicted using penalized logistic regression. Standardized outcome ratios (Observed/Expected events) were presented in plots to assess 30-day and 1-year mortality, ischaemic stroke and major bleeding outcomes. Expected events were estimated using penalized logistic regression using demographics and comorbidities as predictors. Centres with <90% follow-up completeness were excluded from standardized outcome ratio assessment.
Analysis included 6962 implants in 6408 patients (457 patients underwent repeated implants) registered in EUROMACS from 17 countries (32 centres) (median age: 58 years, 83% males, 17% Interagency Registry for Mechanically Assisted Circulatory Support class 1). Thirty-day mortality, major bleeding and ischaemic stroke probabilities were 9.6, 12.6% and 2.1%, respectively. Standardized mortality ratios showed variability between centres, ranging from 0 (95% CI 0-0) to 1.4 (95% CI 1.2-1.7). Higher standardized bleeding outcome ratios correlated with higher standardized ischaemic stroke ratio's (Spearman r: 0.56, P = 0.008).
Most included centres perform as expected given the demographics and comorbidities of patients. A positive correlation was found between standardized bleeding and ischaemic stroke ratios, reflecting the need of continuously monitoring of adverse events by quality improvement programs.
本第四次报告旨在深入了解欧洲机械循环支持患者注册研究（EUROMACS）中各参与中心植入耐用机械循环支持装置的患者特征、结局及标准化结局比率。
纳入截至2024年8月所有接受耐用机械循环支持的注册患者。使用惩罚逻辑回归预测事件的预期数量。标准化结局比率（观察到的/预期的事件）以图表形式呈现，以评估30天和1年死亡率、缺血性卒中和大出血结局。使用惩罚逻辑回归，以人口统计学和合并症作为预测因素来估计预期事件。随访完整性低于90%的中心被排除在标准化结局比率评估之外。
分析纳入了来自17个国家（32个中心）在EUROMACS注册的6408例患者中的6962次植入（457例患者接受了重复植入）（中位年龄：58岁，83%为男性，17%为机械辅助循环支持机构间注册研究1级）。30天死亡率、大出血和缺血性卒中概率分别为9.6%、12.6%和2.1%。标准化死亡率在各中心之间存在差异，范围从0（95%CI 0 - 0）到1.4（95%CI 1.2 - 1.7）。较高的标准化出血结局比率与较高的标准化缺血性卒中比率相关（斯皮尔曼r：0.56，P = 0.008）。
考虑到患者的人口统计学和合并症，大多数纳入的中心表现符合预期。标准化出血和缺血性卒中比率之间存在正相关，这反映了通过质量改进计划持续监测不良事件的必要性。
