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"Compassionate" Cases of the Jarvik 2015 Ventricular Assist Device

Joseph A Spinner1, Hari P Tunuguntla1, Sebastian C Tume2

  • 1From the Pediatric Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.

ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|January 20, 2021
PubMed

Insights

The Jarvik 2015 Ventricular Assist Device (VAD) offers real-world insights in pediatric patients outside clinical trials. This study details two compassionate use cases, focusing on power consumption and hemocompatibility.

Area of Science:

  • Pediatric Cardiology
  • Biomedical Engineering
  • Medical Devices

Background:

  • The Jarvik 2015 Ventricular Assist Device (VAD) is a continuous-flow device for small children.
  • The Pump for Kids, Infants, and Neonates (PumpKIN) trial evaluates the Jarvik 2015 VAD in a select pediatric population.
  • Compassionate use cases provide valuable real-world data for devices with strict trial criteria.

Purpose of the Study:

  • To report on the performance of the Jarvik 2015 VAD in pediatric patients receiving compassionate use.
  • To specifically analyze power consumption and hemocompatibility (hemolysis and inflammatory markers) of the device.
  • To offer insights into real-world device performance beyond the controlled PumpKIN trial.

Main Methods:

  • Case series describing two pediatric patients who received the Jarvik 2015 VAD under compassionate use.
  • Detailed monitoring of device power consumption.
  • Laboratory analysis of hemolysis and inflammatory markers to assess hemocompatibility.

Main Results:

  • The Jarvik 2015 VAD was used in two pediatric patients who did not meet PumpKIN trial criteria.
  • Data on power consumption was collected.
  • Hemolysis and inflammatory lab profiles were analyzed to evaluate hemocompatibility.

Conclusions:

  • Compassionate use cases of the Jarvik 2015 VAD provide essential real-world data.
  • Understanding power consumption and hemocompatibility in these cases is crucial for device refinement.
  • These findings complement the ongoing PumpKIN trial by offering insights into broader clinical application.

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