Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.
Department of Angio-Cardio-Neurology, IRCCS Neuromed, Pozzilli, Italy.
Eur J Cardiothorac Surg. 2019 Mar 1;55(3):461-467. doi: 10.1093/ejcts/ezy285.
The use of left ventricular assist devices (LVADs) is an approved treatment option for end-stage heart failure. Several devices have been developed over the years, including 2 newer ones (HeartMate 3 and HeartWare), but an overall comparative analysis has never been performed. We conducted a network meta-analysis of randomized trials on LVAD for adults with end-stage heart failure.
Pertinent studies were searched in several databases. Selected outcomes were extracted, including death, stroke and bleeding. Incident relative risks were computed with network meta-analysis with 95% confidence intervals (CIs) and P-scores (with highest values indicating the best therapy).
Four randomized clinical trials and 4 observational studies were identified, totalling 2248 patients. Using HeartMate XVE/VE as the benchmark, all LVADs provided a significant better outcome for survival rate in comparison with medical therapy, without significant differences among newer LVADs. The relative risk for death was 0.79 (95% 0.60-1.04; P-score 0.89) for HeartMate II, 0.85 (95% CI 0.62-1.17; P-score 0.64) for HeartWare, 0.88 (95% CI 0.59-1.31; P-score 0.60) for HeartMate 3 and 1.48 (95% CI 1.21-1.80; P-score 0.01) for medical management. While appraising other outcomes, new generation devices (HeartMate 3 and HeartWare) proved better than older generation devices for bleeding, device thrombosis, hepatic dysfunction, renal dysfunction, respiratory dysfunction, right ventricular failure and sepsis with significant differences among them.
In the management of end-stage heart failure, LVADs provided significant improvement in terms of survival rate compared to medical therapy, but no significant differences exist among LVADs. Despite the reduction of adverse events over time, further technological refinements will be crucial to improve this technology to better address decision-making and to improve clinical outcomes.
左心室辅助装置（LVAD）的使用是治疗终末期心力衰竭的一种已批准的治疗选择。多年来已经开发了几种装置，包括 2 种较新的装置（HeartMate 3 和 HeartWare），但从未进行过总体比较分析。我们对用于治疗终末期心力衰竭的成人的 LVAD 的随机试验进行了网络荟萃分析。
在多个数据库中搜索相关研究。提取了死亡、卒中和出血等相关结局，并采用网络荟萃分析计算了每个事件的相对风险（RR），置信区间（CI）和 P 评分（最高值表示最佳治疗）。
共纳入 4 项随机临床试验和 4 项观察性研究，共计 2248 例患者。以 HeartMate XVE/VE 为基准，与药物治疗相比，所有 LVAD 都显著提高了生存率，且新型 LVAD 之间无显著差异。HeartMate II 的死亡风险 RR 为 0.79（95%CI 0.60-1.04；P 评分 0.89），HeartWare 为 0.85（95%CI 0.62-1.17；P 评分 0.64），HeartMate 3 为 0.88（95%CI 0.59-1.31；P 评分 0.60），而药物治疗为 1.48（95%CI 1.21-1.80；P 评分 0.01）。在评估其他结局时，新一代设备（HeartMate 3 和 HeartWare）在出血、设备血栓形成、肝功能障碍、肾功能障碍、呼吸功能障碍、右心室衰竭和败血症方面优于老一代设备，且存在显著差异。
在治疗终末期心力衰竭方面，与药物治疗相比，LVAD 可显著提高生存率，但 LVAD 之间无显著差异。尽管随着时间的推移不良事件有所减少，但进一步的技术改进对于改进该技术以更好地进行决策和改善临床结局至关重要。
