# Development of a Fully-Implantable Ventricular Assist Device for Neonates and Children with Heart Failure - with Magnetic Levitation to Improve Hemocompatibility

> **NIH NIH R01** · TEXAS HEART INSTITUTE · 2021 · $640,106

## Abstract

PROJECT SUMMARY
The annual incidence of pediatric heart failure due to congenital heart disease (CHD) is 1 to 2 cases per 1000
births. Whereas 10,000 to 14,000 children are hospitalized annually in the United States waiting for a new heart,
only 444 transplants were performed in 2016, illustrating the drastic shortage of donor hearts. The only long-
term treatment alternative to a heart transplant is the implantation of a ventricular assist device (VAD), a pump
that helps the failing heart to pump blood until a new heart is available. However, these VADs are too large to
be fully implantable in children under 4 years of age; therefore, these VADs are placed externally near the
abdomen, with tubes running through the skin. These tubes can lead to infection, and they prevent the children
from leaving the hospital for the duration of pump support, which can exceed 1 year. Additionally, the survival
rate of patients weighing less than 5 kg with the currently available VADs is dismal; more than 60% of these
children die after VAD implantation, stroke being the most common cause of death. Therefore, there is a need
to design a safer, fully implantable pediatric VAD to improve the survival of both infants and young children. This
VAD also needs to be adjustable with the child’s growth and development, meaning that it must provide higher
blood flow and pressure as the child grows. The objective of this study is to develop the first fully implantable
VAD (NeoVAD) for infants and young children, which would help the failing heart until a suitable donor heart is
available. In Aim 1, development of a miniature magnetic levitation system to eliminate mechanical wear and
optimize the pump performance is proposed, which will provide a long-term circulatory support. The
hemodynamic performance of the NeoVAD in steady-state flow environments at different physiological operating
points will be investigated in Aim 2. Finally, in Aim 3, systemic hemocompatibility and hemodynamic
performance of the NeoVAD will be evaluated by in vitro and large-animal studies. This pump, after implantation,
would allow pediatric heart failure patients to return to a near-normal life outside the hospital.
This research will give new insights into designing a pump that can support the failing heart for a wide range of
patients, from infants to children weighing up to 20 kg. This wide range of support would eliminate the need to
change VADs or undergo multiple heart transplants as the child grows, both of which are risky procedures. Also,
this research will include an in-depth study of pump-blood interaction across the patient age range, allowing us
to study how blood shear stress is affected by changes in blood flow rate and pressure as the child grows. This
study will enable us to design the first safe, fully implantable VAD for young children, which would
reduce the risk of stroke, bleeding, and infection and improve their chances of survival. We expect that
with the implanted NeoVAD...

## Key facts

- **NIH application ID:** 10223928
- **Project number:** 5R01HL153538-02
- **Recipient organization:** TEXAS HEART INSTITUTE
- **Principal Investigator:** O. H. FRAZIER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $640,106
- **Award type:** 5
- **Project period:** 2020-08-01 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10223928

## Citation

> US National Institutes of Health, RePORTER application 10223928, Development of a Fully-Implantable Ventricular Assist Device for Neonates and Children with Heart Failure - with Magnetic Levitation to Improve Hemocompatibility (5R01HL153538-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10223928. Licensed CC0.

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