Adverse events in contemporary continuous-flow left ventricular assist devices: A multi-institutional comparison shows significant differences.

Abstract

OBJECTIVES:

We review differences in the incidence and timing of adverse events in patients implanted with continuous-flow left ventricular assist devices (LVADs), using the Mechanical Circulatory Support Research Network registry.

METHODS:

From May 2004 to September 2014, a total of 734 patients (591 men; median age: 59 years) underwent primary continuous-flow LVAD implantation at our institutions. Patients implanted with the HeartMate II (HMII) (560 [76%] patients), compared with the HeartWare ventricular assist device (HVAD; 174 [24%]) were more often receiving destination therapy (47% vs 20%; P < .01), had a lower preoperative creatinine level (1.2 vs 1.3; P = .01), and had less median preoperative right ventricular dysfunction (mild vs moderate; P < .01). Ischemic etiology, prior sternotomy, and median INTERMACS profile were similar.

RESULTS:

Overall mortality was 54 of 734 (7.4%); 41 of 560 (7.3%) in the HMII group, and 13 of 174 (7.5%) in the HVAD group (P = .95). Follow-up was available in 100% of early survivors for a median of 1 year (max: 10 years) and a total of 1120 patient-years of support (HMII: 940 patient-years [median: 1.1 years, max: 5.3 years] and HVAD: 180 patient-years [median: 0.6 year, max: 10.4 years]). On multivariable analysis, GI bleeding (P = .63), any infection (P = .32), driveline infection (P = .10), and pump thrombus (P = .64) were similar between devices while HeartWare HVAD was associated with higher risk of stroke (HR: 1.8, [1.25, 2.5], P = .003).

CONCLUSIONS:

In this pooled analysis, a trend was found for higher incidence of percutaneous driveline infections in patients treated with the HMII; a higher incidence of stroke and time-related cumulative risk of any infection and stroke was found in patients treated with the HVAD, which was independently associated with higher stroke risk.

• Authors: John M Stulak, Mary E Davis, Nicholas Haglund, Shannon Dunlay, Jennifer Cowger, Palak Shah, Francis D Pagani, Keith D Aaronson, Simon Maltais
• Journal: The Journal of thoracic and cardiovascular surgery (J Thorac Cardiovasc Surg) Vol. 151 Issue 1 Pg. 177-89 (Jan 2016) ISSN: 1097-685X [Electronic] United States
• PMID: 26545967 (Publication Type: Comparative Study, Journal Article, Multicenter Study)
• Copyright: Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Chi-Square Distribution
• Female
• Gastrointestinal Hemorrhage (epidemiology)
• Heart Failure (diagnosis, mortality, physiopathology, therapy)
• Heart-Assist Devices (adverse effects)
• Humans
• Incidence
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Multivariate Analysis
• Proportional Hazards Models
• Prosthesis Design
• Prosthesis-Related Infections (epidemiology, microbiology)
• Registries
• Retrospective Studies
• Risk Assessment
• Risk Factors
• Stroke (epidemiology)
• Thrombosis (epidemiology)
• Time Factors
• Treatment Outcome
• United States (epidemiology)
• Ventricular Function, Left
• Ventricular Function, Right
• Young Adult