Zuk Katarzyna, Gahl Brigitta, Susac Martina, Vierecke Juliane, de By Theo M M H, Windecker Stephan, Englberger Lars, Carrel Thierry, Hetzer Roland, Gummert Jan, Mohacsi Paul
Department of Cardiology, University Hospital Bern, Bern, Switzerland.
Department of Cardiology and Cardiovascular Surgery, University Hospital Bern, Bern, Switzerland.
Eur J Cardiothorac Surg. 2017 Jan;51(1):127-134. doi: 10.1093/ejcts/ezw256. Epub 2016 Oct 27.
Mechanical circulatory support (MCS) is an established therapy for end-stage heart failure. The EUROMACS registry was created to promote research in patients with MCS and became a committee of the European Association for Cardio-Thoracic Surgery (EACTS) in 2014. Since 1 January 2011, increasing numbers of European centres implanting durable MCS have reported their patient data to EUROMACS. The aim of this study is to compare, as an example of internal quality control, data from a single centre (Bern) with those from the EUROMACS database with respect to mortality rates and preoperative patient characteristics and to describe complications in Bern.
Patients implanted with MCS between 1 January 2011 and 30 June 2014 in participating centres were included, with extended follow-up as of 31 December 2014. Patient characteristics, operative and postoperative data, clinically significant adverse events and routine follow-up data were reported to the registry. The entire EUROMACS cohort (including the Bern data) was compared with patients from Bern only. Baseline characteristics, operative data and outcomes were compared using standard 95% confidence intervals (CIs) for means, Wilson's continuity corrected CIs for categories and Kaplan-Meier estimates with CIs.
Kaplan-Meier estimates show a higher survival rate in the Bern cohort than in the entire EUROMACS cohort at 6 (92%, CI 73-98, vs 66%, CI 62-69), 12 (85%, CI 57-95, vs 56%, CI 52-60) and 18 months (85%, CI 57-95, vs 51%, CI 47-55) after the index operation, respectively. This difference might be caused by the earlier implantation time in Bern (implantation at INTERMACS levels 3-4) versus that of the entire EUROMACS cohort (implantation at INTERMACS levels 2-3). The median number of follow-up records per patient was 2 in the entire EUROMACS cohort and 4 in the Bern (P = 0.001) cohort. During follow-up, neurological dysfunction occurred in 42% of patients, a bleeding event occurred in 42% of patients, significant infection occurred in 36% of patients and a device malfunction occurred in 31% of patients within 12 months of implantation in the Bern patients.
MCS is a valuable therapeutic option with excellent survival rates; nevertheless, it is associated with clinically significant complication rates. International registries are important tools that allow, as an example, internal quality control of mortality, complication and morbidity rates from a single centre compared with the EUROMACS database.
机械循环支持（MCS）是终末期心力衰竭的既定治疗方法。欧洲机械循环支持注册研究（EUROMACS）旨在促进对接受MCS治疗患者的研究，并于2014年成为欧洲心胸外科学会（EACTS）的一个委员会。自2011年1月1日起，越来越多植入耐用MCS的欧洲中心开始向EUROMACS报告其患者数据。本研究的目的是作为内部质量控制的一个例子，比较来自单个中心（伯尔尼）的数据与EUROMACS数据库中关于死亡率和术前患者特征的数据，并描述伯尔尼中心的并发症情况。
纳入2011年1月1日至2014年6月30日在参与中心植入MCS的患者，并随访至2014年12月31日。患者特征、手术及术后数据、具有临床意义的不良事件和常规随访数据均报告至该注册研究。将整个EUROMACS队列（包括伯尔尼的数据）与仅来自伯尔尼的患者进行比较。使用标准的95%置信区间（CI）对均值、Wilson连续性校正CI对分类变量以及带有CI的Kaplan-Meier估计值来比较基线特征、手术数据和结局。
Kaplan-Meier估计显示，在索引手术后6个月（92%，CI 73-98，vs 66%，CI 62-69）、12个月（85%，CI 57-95，vs 56%，CI 52-60）和18个月（85%，CI 57-95，vs 51%，CI 47-55）时，伯尔尼队列的生存率高于整个EUROMACS队列。这种差异可能是由于伯尔尼中心（植入时INTERMACS级别为3-4）的植入时间早于整个EUROMACS队列（植入时INTERMACS级别为2-3）。在整个EUROMACS队列中，每位患者随访记录的中位数为2条，而在伯尔尼队列中为4条（P = 0.001）。在随访期间，伯尔尼中心的患者在植入后12个月内，42%的患者发生神经功能障碍，42%的患者发生出血事件，36%的患者发生严重感染，31%的患者发生设备故障。
MCS是一种具有优异生存率的有价值的治疗选择；然而，它与具有临床意义的并发症发生率相关。国际注册研究是重要工具，例如可用于对单个中心与EUROMACS数据库相比的死亡率、并发症和发病率进行内部质量控制。
