A multicenter study of the impella device for mechanical support of the systemic circulation in pediatric and adolescent patients

• Type of Material: Article
• Authors: V Vivian Dimas, University of Texas Southwestern Medical Center; Brian H Morray, Seattle Children's Hospital; Dennis Kim, Emory University; Christopher SD Almond, Lucille Packard Children’s Hospital at Stanford; Shabana Shahanavaz, Washington University School of Medicine; Sebastian C Tume, Texas Children’s Hospital; Lynn F. Peng, Lucille Packard Children’s Hospital at Stanford; Doff B McElhinney, Lucille Packard Children’s Hospital at Stanford; Henri Justino, Texas Children’s Hospital
• Language: English
• Date: 2017-07-01
• Publisher: Wiley: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2017 Wiley Periodicals, Inc.
• Final Published Version (URL): http://dx.doi.org/10.1002/ccd.26973
• Title of Journal or Parent Work: Catheterization and Cardiovascular Interventions
• ISSN: 1522-1946
• Volume: 90
• Issue: 1
• Start Page: 124
• End Page: 129
• Grant/Funding Information: Data collection and management for this study were supported in part by a NIH Small Business Innovation Research Grant 5R44HL099192 to Abiomed, Inc. (PIs: Scott Corbett PhD, Sonya Bhavsar MSc, Noam Josephy MD, MSc, MBA)
• Keywords: CHILDREN; INTERAGENCY REGISTRY; PUMP; PEDIMACS; CARDIOGENIC-SHOCK; mechanical support; Science & Technology; VENTRICULAR ASSIST DEVICES; MYOCARDIAL-INFARCTION; Cardiac & Cardiovascular Systems; congenital heart disease; HEMODYNAMIC SUPPORT; EFFICACY; Cardiovascular System & Cardiology; Life Sciences & Biomedicine; EXTRACORPOREAL MEMBRANE-OXYGENATION; pediatrics
• Research Categories: Health Sciences, General; Health Sciences, Medicine and Surgery

Abstract

Objectives: The objective was to review the use of Impella devices (Abiomed Inc, Danvers, MA) for temporary circulatory support in pediatric and adolescent patients (age ≤ 21 yrs). Background: Options for minimally invasive circulatory support in children are limited, and published data are confined to case reports and small case series. Methods: This was a retrospective, multicenter review of Impella implants in pediatric and adolescent patients from 2009-15, using standardized data collection and INTERMACS definitions. Results: A total of 39 implants were performed in 38 patients from 16 centers. Median age and weight were 16 yrs (4–21 yrs) and 62 kg (15–134 kg). The primary indication for implant was cardiogenic shock in 28 patients (72%). Cardiac allograft rejection, myocarditis, or cardiomyopathy were the underlying diagnosis in 23 patients (59%); 11 patients had congenital heart disease. The median duration of support was 45 hr (1–1224 hr). Indications for explant included ventricular recovery in 16 patients, transition to another device in 12, death in 5, and transplant in 1. Survival was 85% at 7 days and 68% at 30 days. Major adverse events occurred in 8 patients: hemolysis in 3, bleeding in 2, stroke in 1 (unclear if related to Impella), sepsis in 1, and critical leg ischemia in 1. An increase in aortic regurgitation was noted in three patients, with no evidence of valve injury. Conclusion: Temporary circulatory support with Impella devices is feasible in pediatric and adolescent patients, with acceptable risk profiles. More experience and follow up is needed to improve technical performance and patient selection.