Numan Lieke, Ramjankhan Faiz Z, Oberski Daniel L, Oerlemans Martinus I F J, Aarts Emmeke, Gianoli Monica, Van Der Heijden Joris J, De Jonge Nicolaas, Van Der Kaaij Niels P, Meuwese Christiaan L, Mokhles Mostafa M, Oppelaar Anne-Marie, De Waal Eric E C, Asselbergs Folkert W, Van Laake Linda W
Department of Cardiology, University Medical Centre Utrecht, Utrecht University, Heidelberglaan 100, Utrecht, 3584 CX, The Netherlands.
Department of Cardiothoracic Surgery, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.
ESC Heart Fail. 2021 Apr;8(2):1596-1603. doi: 10.1002/ehf2.13267. Epub 2021 Feb 26.
Left ventricular assist device therapy has become the cornerstone in the treatment of end-stage heart failure and is increasingly used as destination therapy next to bridge to transplant or recovery. HeartMate 3 (HM3) and HeartWare (HVAD) are centrifugal continuous flow devices implanted intrapericardially and most commonly used worldwide. No randomized controlled trials have been performed yet. Analysis based on large registries may be considered as the best alternative but has the disadvantage of different standard of care between centres and missing data. Bias is introduced, because the decision which device to use was not random, even more so because many centres use only one type of left ventricular assist device. Therefore, we performed a propensity score (PS)-based analysis of long-term clinical outcome of patients that received HM3 or HVAD in a single centre.
Between December 2010 and December 2019, 100 patients received HVAD and 81 patients HM3 as primary implantation at the University Medical Centre Utrecht. We performed PS matching with an extensive set of covariates, resulting in 112 matched patients with a median follow-up of 28 months. After PS matching, survival was not significantly different (P = 0.21) but was better for HM3. The cumulative incidences for haemorrhagic stroke (P = 0.01) and pump thrombosis (P = 0.02) were significantly higher for HVAD patients. The cumulative incidences for major bleeding, ischaemic stroke, right heart failure, and driveline infection were not different between the groups. We found no interaction between the surgeon who performed the implantation and survival (P = 0.59, P = 0.78, and P = 0.89). Sensitivity analysis was performed, by PS matching without patients on preoperative temporary support resulting in 74 matched patients. This also resulted in a non-significant difference in survival (P = 0.07). The PS-adjusted Cox regression showed a worse but non-significant (P = 0.10) survival for HVAD patients with hazard ratio 1.71 (95% confidence interval 0.91-3.24).
Survival was not significantly different between both groups after PS matching, but was better for HM3, with a significantly lower incidence of haemorrhagic stroke and pump thrombosis for HM3. These results need to be interpreted carefully, because matching may have introduced greater imbalance on unmeasured covariates. A multicentre approach of carefully selected centres is recommended to enlarge the number of matched patients.
左心室辅助装置治疗已成为终末期心力衰竭治疗的基石，并越来越多地作为移植桥接或恢复后的目标治疗方法使用。HeartMate 3（HM3）和HeartWare（HVAD）是植入心包内的离心式连续流装置，在全球范围内最为常用。目前尚未进行随机对照试验。基于大型注册研究的分析可能被视为最佳替代方案，但存在各中心护理标准不同和数据缺失的缺点。由于使用哪种装置的决定并非随机，甚至更多中心仅使用一种类型的左心室辅助装置，因此会引入偏差。因此，我们对在单一中心接受HM3或HVAD治疗的患者的长期临床结局进行了基于倾向评分（PS）的分析。
2010年12月至2019年12月期间，乌得勒支大学医学中心有100例患者接受HVAD作为初次植入，81例患者接受HM3作为初次植入。我们使用大量协变量进行PS匹配，最终得到112例匹配患者，中位随访时间为28个月。PS匹配后，生存率无显著差异（P = 0.21），但HM3的生存率更好。HVAD患者出血性卒中（P = 0.01）和泵血栓形成（P = 0.02）的累积发生率显著更高。两组之间大出血、缺血性卒中、右心衰竭和导线感染的累积发生率无差异。我们发现进行植入手术的外科医生与生存率之间无相互作用（P = 0.59、P = 0.78和P = 0.89）。进行了敏感性分析，通过PS匹配排除术前接受临时支持的患者，最终得到74例匹配患者。这也导致生存率无显著差异（P = 0.07）。PS调整后的Cox回归显示，HVAD患者的生存率较差但无显著差异（P = 0.10），风险比为1.71（95%置信区间0.91 - 3.24）。
PS匹配后两组生存率无显著差异，但HM3的生存率更好，HM3的出血性卒中和泵血栓形成发生率显著更低。这些结果需要谨慎解读，因为匹配可能在未测量的协变量上引入了更大的不平衡。建议采用多中心方法，精心挑选中心以增加匹配患者数量。
