A network meta-analysis of randomized trials and observational studies on left ventricular assist devices in adult patients with end-stage heart failure

Elena Cavarretta; Antonino G M Marullo; Sebastiano Sciarretta; Umberto Benedetto; Ernesto Greco; Leonardo Roever; Euclide Tonelli; Mariangela Peruzzi; Alessandra Iaccarino; Giuseppe Biondi-Zoccai; Giacomo Frati

doi:10.1093/ejcts/ezy285

A network meta-analysis of randomized trials and observational studies on left ventricular assist devices in adult patients with end-stage heart failure

Eur J Cardiothorac Surg. 2019 Mar 1;55(3):461-467. doi: 10.1093/ejcts/ezy285.

Authors

Affiliations

¹ Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.
² Department of Angio-Cardio-Neurology, IRCCS Neuromed, Pozzilli, Italy.
³ Bristol Heart Institute, School of Clinical Sciences, University of Bristol, Bristol, UK.
⁴ Department of Cardiovascular, Respiratory, Nephrological, Anesthesiological, and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
⁵ Department of Clinical Research, Federal University of Uberlândia, Uberlândia, Brazil.
⁶ Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy.
⁷ Department "Paride Stefanini" General and Specialist Surgery, Sapienza University of Rome, Rome, Italy.

PMID: 30137270
DOI: 10.1093/ejcts/ezy285

Abstract

Objectives: 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.

Methods: 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).

Results: 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.

Conclusions: 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.

Keywords: Heart failure; Left ventricular assist device; Meta-analysis; Network meta-analysis; Ventricular assist device.

Publication types

Comparative Study
Meta-Analysis

MeSH terms

Heart Failure / therapy*
Heart-Assist Devices*
Humans
Network Meta-Analysis
Observational Studies as Topic*
Prosthesis Design
Randomized Controlled Trials as Topic*
Severity of Illness Index
Treatment Outcome