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A prospective multicenter feasibility study of a miniaturized implantable continuous flow ventricular assist device
Christopher S Almond1, Ryan Davies2, Iki Adachi3
1Stanford University School of Medicine, Palo Alto, California.
Insights
The Jarvik 2015 left ventricular assist device (LVAD) shows promise for pediatric heart failure patients, enabling survival and improved activity levels. Further trials are planned despite manufacturer financial challenges.
Area of Science:
- Pediatric cardiology
- Medical device engineering
- Cardiovascular surgery
Background:
- No FDA-approved left ventricular assist device (LVAD) exists for smaller children, necessitating prolonged hospitalization.
- Current LVADs pose significant burdens on families and hospitals for pediatric patients awaiting heart transplant.
- The Jarvik 2015 is a miniaturized implantable continuous flow LVAD evaluated in the PumpKIN study for bridge-to-transplant.
Purpose of the Study:
- To assess the initial outcomes of the Jarvik 2015 LVAD in pediatric patients.
- To evaluate the feasibility of the Jarvik 2015 as a bridge-to-heart transplant device for children.
- To determine the safety and efficacy of the Jarvik 2015 in a small cohort of children.
Main Methods:
- Seven children weighing 8 to 30 kg with severe systolic heart failure were enrolled.
- Exclusion criteria included severe right heart failure and single-ventricle congenital heart disease.
- The primary endpoint was 30-day survival without severe stroke or device failure.
Main Results:
- All 7 children survived, with 5 undergoing heart transplant, 1 recovering, and 1 converted to a paracorporeal device.
- One patient experienced an ischemic stroke; another required ECMO for arrhythmias.
- Favorable patient-reported outcomes regarding activity levels were reported; the study was suspended due to manufacturer financial issues.
Conclusions:
- The Jarvik 2015 LVAD demonstrates potential for supporting hospital discharge in smaller children.
- The FDA has approved the device for a pivotal trial, but commercialization remains uncertain due to industry financial challenges.
- The Jarvik 2015 offers a promising option for pediatric bridge-to-transplant, pending resolution of manufacturing and financial viability.
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).
