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

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 hrs (1–1224 hrs). 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 3 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.

Patient size parameters to guide use of the Impella device in pediatric patients

“…In the largest pediatric study, serious adverse events were uncommon. The most common adverse events reported in this study were hemolysis ( n = 3) and access related complications ( n = 2) . More experience and data are necessary to further understand the boundaries of this technology in pediatric patients.…”

“…There are limited temporary MCS options for pediatric patients. Recent studies of the Impella microaxial pump in pediatric and adolescent patients demonstrated that younger patients can be supported with this device . Although a patient as small as 15 kg was supported in that study, the average patient was closer to adult size and there remain questions about the smallest patients that can be safely supported with this technology.…”

“…The Impella circulatory support devices (Abiomed, Inc., Danvers, MA) are percutaneously placed devices approved in adult patients for circulatory support during high‐risk procedures and for short‐term support in the setting of cardiogenic shock. Recently, off‐label experience with the Impella devices was described in pediatric and adolescent patients as well as in patients with congenital heart disease . These studies demonstrated that the device can provide circulatory support with limited complications in these patient populations.…”

“…The youngest patient supported with Impella in the recent pediatric study was 4 years old and weighed 15 kg with a body surface area (BSA) of 0.67 m 2 . Other studies have demonstrated successful implants in patients as small as 20 kg with a BSA of 0.8–0.9 m 2 .…”

Dynamic measurement of centering forces on transvalvular cannulas

“…Several studies confirm the successful application of such devices . However, several potential complications were reported, such as increase in aortic regurgitation during cardiac support, aortic or mitral valve damage, or thrombus formation . Transvalvular pumps have even been used in combination with biologic and transcatheter aortic valve replacements …”