Department of Anesthesiology, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany.
Department of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany.
ESC Heart Fail. 2022 Aug;9(4):2455-2463. doi: 10.1002/ehf2.13942. Epub 2022 May 5.
Implantation of left ventricular assist devices (LVADs) as a bridge to transplant or as destination therapy is increasing. The selection of suitable patients and outcome assessment belong to the key challenges. Mortality has traditionally been a focus of research in this field, but literature on quality of life is very limited. This study aimed to identify perioperative factors influencing patients' life as measured by days alive and out of hospital (DAOH) in the first year after LVAD implantation.
This retrospective single-centre cohort study screened 227 patients who underwent LVAD implantation at the University Hospital Duesseldorf, Germany, between 2010 and 2020. First, the influence of 10 prespecified variables on DAOH was investigated by univariate analysis. Second, multivariate quantile regression was conducted including all factors with significant influence on DAOH in the univariate model. Additionally, the impact of all variables on 1 year mortality was investigated using Kaplan-Meier curves to oppose DAOH and mortality. In total, 221 patients were included into analysis. As pre-operative factors, chronic kidney disease (CKD), pre-operative mechanical circulatory support (pMCS), and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) stadium < 3 were associated with lower DAOH at 1 year [CKD: 280 (155-322) vs. 230 (0-219), P = 0.0286; pMCS: 294 (155-325) vs. 243 (0-293), P = 0.0004; INTERMACS 1: 218 (0-293) vs. INTERMACS 2: 264 (6-320) vs. INTERMACS 3: 299 (228-325) vs. INTERMACS 4: 313 (247-332), P ≤ 0.0001]. Intra-operative additional implantation of a right ventricular assist device (RVAD) was also associated with lower DAOH [RVAD: 290 (160-325) vs. 174 (0-277), P ≤ 0.0001]. As post-operative values that were associated with lower DAOH, dialysis and tracheotomy could be identified [dialysis: 300 (252-326) vs. 186 (0-300), P ≤ 0.0001; tracheotomy: 292 (139-325) vs. 168 (0-269), P ≤ 0.0001]. Multivariate analysis revealed that all of these factors besides pMCS were independently associated with DAOH. According to Kaplan-Meier analysis, only post-operative dialysis was significantly associated with increased mortality at 1 year (survival: no dialysis 89.4% vs. dialysis 70.1%, hazard ratio: 0.56, 95% confidence interval: 0.33-0.94; P = 0.031).
The results of this study indicate that there can be a clear discrepancy between hard endpoints such as mortality and more patient-centred outcomes reflecting life impact. DAOH may relevantly contribute to a more comprehensive selection process and outcome assessment in LVAD patients.
作为心脏移植或作为终末期心衰治疗的桥接手段，左心室辅助装置（LVAD）的植入正在不断增加。合适患者的选择和结局评估属于关键挑战。传统上，死亡率一直是该领域研究的重点，但关于生活质量的文献非常有限。本研究旨在确定 LVAD 植入后第一年影响患者生活的围手术期因素，通过存活且脱离医院天数（DAOH）来衡量。
本回顾性单中心队列研究筛选了 2010 年至 2020 年期间在德国杜塞尔多夫大学医院接受 LVAD 植入的 227 例患者。首先，通过单变量分析研究了 10 个预设变量对 DAOH 的影响。其次，将所有在单变量模型中对 DAOH 有显著影响的因素纳入多元分位数回归。此外，使用 Kaplan-Meier 曲线研究所有变量对 1 年死亡率的影响，以反对 DAOH 和死亡率。共纳入 221 例患者进行分析。作为术前因素，慢性肾脏病（CKD）、术前机械循环支持（pMCS）和 INTERMACS 分期<3 与 1 年 DAOH 较低相关[CKD：280（155-322）与 230（0-219），P=0.0286；pMCS：294（155-325）与 243（0-293），P=0.0004；INTERMACS 1：218（0-293）与 INTERMACS 2：264（6-320）与 INTERMACS 3：299（228-325）与 INTERMACS 4：313（247-332），P≤0.0001]。术中额外植入右心室辅助装置（RVAD）也与较低的 DAOH 相关[RVAD：290（160-325）与 174（0-277），P≤0.0001]。作为与较低 DAOH 相关的术后值，可以确定透析和气管切开术[透析：300（252-326）与 186（0-300），P≤0.0001；气管切开术：292（139-325）与 168（0-269），P≤0.0001]。多变量分析显示，除 pMCS 外，所有这些因素均与 DAOH 独立相关。根据 Kaplan-Meier 分析，只有术后透析与 1 年死亡率显著相关（存活：无透析 89.4%与透析 70.1%，危险比：0.56，95%置信区间：0.33-0.94；P=0.031）。
本研究结果表明，死亡率等硬性终点与反映生活影响的更以患者为中心的结局之间可能存在明显差异。DAOH 可能有助于 LVAD 患者更全面的选择过程和结局评估。
