Mihalj Maks, Reineke David, Just Isabell A, Mulzer Johanna, Cholevas Nikolaos, Hoermandinger Christoph, Veen Kevin, Luedi Markus M, Heinisch Paul Philipp, Potapov Evgenij, Gummert Jan F, Mohacsi Paul, Hagl Christian, Faerber Gloria, Zimpfer Daniel, de By Theo M M H, Meyns Bart, Gustafsson Finn, Hunziker Lukas, Siepe Matthias, Schober Patrick, Schoenrath Felix
Department of Cardiac Surgery, University Hospital Bern, University of Bern, Bern, Switzerland.
Department of Advanced Cardiopulmonary Therapies and Transplantation, University of Texas Health Science Center at Houston, McGovern Medical School, Texas Medical Center, Houston, TX, USA.
Eur J Heart Fail. 2024 Nov;26(11):2400-2409. doi: 10.1002/ejhf.3418. Epub 2024 Aug 29.
This EUROMACS study was conducted with the primary aim of investigating the association between a centre's annual caseload and postoperative outcomes among patients undergoing left ventricular assist device (LVAD) implantation.
A total of 4802 patients identified between 2011 and 2020 from 35 participating centres were dichotomized based on the annual caseload of the treating centre at the time of device implant (≤30 vs. >30 LVAD implantations/year). The primary endpoint was 1-year survival. Secondary outcomes included overall survival analysis, device-related adverse events and readmissions. Cumulative follow-up was 10 003 patient-years, with a median follow-up of 1.54 years (interquartile range 0.52-3.15). Patients from higher volume centres more frequently presented in INTERMACS levels 1 and 2, suffered from right heart dysfunction and needed inotropic support. No difference was observed in adjusted 1-year survival. Adjusted overall survival probability was lower in higher volume centres (p = 0.002). In the subgroup analysis of HeartMate 3 devices only, higher volume centres were associated with decreased odds of 1-year survival (adjusted odds ratio 0.43, 95% confidence interval 0.20-0.97, p = 0.041). Similar findings were observed in the cumulative (i.e. learning curve) caseload analyses.
In patients undergoing LVAD implantation, centre volume was not associated with 1-year survival, but was related to device-related adverse events. Patient profiles differed with respect to centre size. These findings underscore the necessity for ongoing quality improvement initiatives in all centres, regardless of their annual caseload. Efforts are needed to standardize patient selection and preconditioning to further improve patient outcome.
开展这项欧洲机械循环辅助装置注册研究（EUROMACS study）的主要目的是调查在接受左心室辅助装置（LVAD）植入的患者中，中心的年度病例数与术后结局之间的关联。
2011年至2020年间，从35个参与研究的中心识别出4802例患者，根据装置植入时治疗中心的年度病例数（≤30例与>30例LVAD植入/年）将患者分为两组。主要终点是1年生存率。次要结局包括总生存分析、与装置相关的不良事件和再入院情况。累积随访时间为10003患者年，中位随访时间为1.54年（四分位间距0.52 - 3.15）。来自病例数较多中心的患者更常表现为INTERMACS 1级和2级，患有右心功能不全且需要使用正性肌力药物支持。调整后的1年生存率未观察到差异。病例数较多的中心调整后的总生存概率较低（p = 0.002）。仅在HeartMate 3装置的亚组分析中，病例数较多的中心与1年生存几率降低相关（调整后的优势比为0.43，95%置信区间为0.20 - 0.97，p = 0.041）。在累积（即学习曲线）病例数分析中也观察到类似结果。
在接受LVAD植入的患者中，中心病例数与1年生存率无关，但与装置相关的不良事件有关。患者特征因中心规模而异。这些发现强调了所有中心持续开展质量改进举措的必要性，无论其年度病例数多少。需要努力规范患者选择和预处理，以进一步改善患者结局。
