A prospective multicenter feasibility study of a miniaturized implantable continuous flow ventricular assist device in smaller children with heart failure.

Autor:	Almond CS; Stanford University School of Medicine, Palo Alto, California. Electronic address: calmond@stanford.edu., Davies R; University of Texas Southwestern, Dallas, Texas., Adachi I; Texas Children's Hospital, Houston, Texas., Richmond M; Columbia University, New York, New York., Law S; Columbia University, New York, New York., Tunuguntla H; Texas Children's Hospital, Houston, Texas., Mao C; Children's Healthcare of Atlanta, Atlanta, Georgia., Shaw F; Children's Healthcare of Atlanta, Atlanta, Georgia., Lantz J; University of Texas Southwestern, Dallas, Texas., Wearden PD; Nemours Children's Hospital, Orlando, Florida., Jordan LC; Vanderbilt University Medical Center, Nashville, Tennessee., Ichord RN; Children's Hospital of Philadelphia, Philadelphia, Pennsylvania., Burns K; National Heart, Lung, and Blood Institute, Bethesda, Maryland., Zak V; Carelon Research, Newton, Massachusetts., Magnavita A; Carelon Research, Newton, Massachusetts., Gonzales S; Stanford University School of Medicine, Palo Alto, California., Conway J; Stollery Children's Hospital, Edmonton, Alberta, Canada., Jeewa A; Toronto Sick Kids Hospital, Toronto, Ontario, Canada., Freemon D'; National Heart, Lung, and Blood Institute, Bethesda, Maryland., Stylianou M; National Heart, Lung, and Blood Institute, Bethesda, Maryland., Sleeper L; Boston Children's Hospital, Boston, Massachusetts., Dykes JC; Stanford University School of Medicine, Palo Alto, California., Ma M; Stanford University School of Medicine, Palo Alto, California., Fynn-Thompson F; Boston Children's Hospital, Boston, Massachusetts., Lorts A; Cinciannati Children's Hospital, Cincinnati, Ohio., Morales D; Cinciannati Children's Hospital, Cincinnati, Ohio., Vanderpluym C; Boston Children's Hospital, Boston, Massachusetts., Dasse K; University of Oklahoma, Tulsa, Oklahoma., Patricia Massicotte M; Stollery Children's Hospital, Edmonton, Alberta, Canada., Jaquiss R; University of Texas Southwestern, Dallas, Texas., Mahle WT; Children's Healthcare of Atlanta, Atlanta, Georgia.
Jazyk:	angličtina
Zdroj:	The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation [J Heart Lung Transplant] 2024 Jun; Vol. 43 (6), pp. 889-900. Date of Electronic Publication: 2024 May 07.
DOI:	10.1016/j.healun.2024.02.003
Abstrakt:	Background: There is no FDA-approved left ventricular assist device (LVAD) for smaller children permitting routine hospital discharge. Smaller children supported with LVADs typically remain hospitalized for months awaiting heart transplant-a major burden for families and a challenge for hospitals. We describe the initial outcomes of the Jarvik 2015, a miniaturized implantable continuous flow LVAD, in the NHLBI-funded Pumps for Kids, Infants, and Neonates (PumpKIN) study, for bridge-to-heart transplant. Methods: Children weighing 8 to 30 kg with severe systolic heart failure and failing optimal medical therapy were recruited at 7 centers in the United States. Patients with severe right heart failure and single-ventricle congenital heart disease were excluded. The primary feasibility endpoint was survival to 30 days without severe stroke or non-operational device failure. Results: Of 7 children implanted, the median age was 2.2 (range 0.7, 7.1) years, median weight 10 (8.2 to 20.7) kilograms; 86% had dilated cardiomyopathy; 29% were INTERMACS profile 1. The median duration of Jarvik 2015 support was 149 (range 5 to 188) days where all 7 children survived including 5 to heart transplant, 1 to recovery, and 1 to conversion to a paracorporeal device. One patient experienced an ischemic stroke on day 53 of device support in the setting of myocardial recovery. One patient required ECMO support for intractable ventricular arrhythmias and was eventually transplanted from paracorporeal biventricular VAD support. The median pump speed was 1600 RPM with power ranging from 1-4 Watts. The median plasma free hemoglobin was 19, 30, 19 and 30 mg/dL at 7, 30, 90 and 180 days or time of explant, respectively. All patients reached the primary feasibility endpoint. Patient-reported outcomes with the device were favorable with respect to participation in a full range of activities. Due to financial issues with the manufacturer, the study was suspended after consent of the eighth patient. Conclusion: The Jarvik 2015 LVAD appears to hold important promise as an implantable continuous flow device for smaller children that may support hospital discharge. The FDA has approved the device to proceed to a 22-subject pivotal trial. Whether this device will survive to commercialization remains unclear because of the financial challenges faced by industry seeking to develop pediatric medical devices. (Supported by NIH/NHLBI HHS Contract N268201200001I, clinicaltrials.gov 02954497). (Copyright © 2024 International Society for the Heart and Lung Transplantation. All rights reserved.)
Databáze:	MEDLINE
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