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

• Published in: Catheterization and cardiovascular interventions Vol. 90; no. 1; pp. 124 - 129
• Main Authors: Dimas, V. Vivian, Morray, Brian H., Kim, Dennis W., Almond, Christopher S., Shahanavaz, Shabana, Tume, Sebastian C., Peng, Lynn F., McElhinney, Doff B., Justino, Henri
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01-07-2017
• Subjects: Adolescent; Aorta; Bleeding; Cardiomyopathy; Case reports; Child; Child, Preschool; Children; Circulation; congenital heart disease; Coronary artery disease; Data collection; Feasibility Studies; Female; Fontan Procedure - adverse effects; Graft rejection; Heart Defects, Congenital - physiopathology; Heart Defects, Congenital - surgery; Heart diseases; Heart transplantation; Heart-Assist Devices; Hemolysis; Humans; Indication; Ischemia; Leg; Male; mechanical support; Myocarditis; Pediatrics; Prosthesis Design; Recovery of Function; Regurgitation; Retrospective Studies; Risk Factors; Sepsis; Stroke; Time Factors; Transplants & implants; Treatment Outcome; United States; Ventricle; Ventricular Dysfunction, Left - etiology; Ventricular Dysfunction, Left - mortality; Ventricular Dysfunction, Left - physiopathology; Ventricular Dysfunction, Left - therapy; Ventricular Function, Left; Young Adult; congenital heart disease; mechanical support; pediatrics
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.26973

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. © 2017 Wiley Periodicals, Inc.