# Development of a Universal Bi-ventricular Replacement System for the Failing Heart

> **NIH NIH R01** · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · 2024 · $745,926

## Abstract

Project Summary/Abstract
The objective of this project is to develop an implantable blood pump system as a total heart
replacement. The use of left ventricular assist devices (LVADs) for destination therapy for end
stage heart failure is expanding. However, right ventricular failure occurs in 10-40% of LVAD
patients. We are developing a system using separate centrifugal left and right pumps with a
common controller. The right pump is based on a right heart replacement pump developed for
failing Fontan patients. It has unique double inlet ports to connect to the superior and inferior
vena cavae, allowing the pump to be placed in the position of the right atrium. The left pump is a
single inlet pump of similar design. Compared to currently available biventricular assist systems
and total artificial hearts, our approach will: 1) allow unobstructed fit in the anatomy of smaller
patients, 2) achieve reliable operation for at least 10 years, 3) automatically adjust left and right
pump output to respond to the varied physiologic needs of the patient 4) balance left and right
pump outputs to safely control left atrial pressure over a wide range of systemic and pulmonary
vascular resistances and central venous pressures, 5) provide pulsatile flow, 6) reduce the
incidence of thromboembolism and pump thrombosis, 7) preserve high molecular weight von
Willebrand factor to reduce the incidence of bleeding, and 8) provide a development path to a
completely implantable, wireless system. Specific Aim 1- Build a biventricular replacement
device to replace the failing heart, with the right heart placed in the bicaval position and a left
pump anastomosed to the left atrium remnant. Integration of pressure sensors in both pumps
will measure inlet pressures (equivalent to right atrial and left atrial pressures), which will be
used as inputs to the automatic control system. Specific Aim 2- Develop an automatic control
system capable of physiologic control of both pumps. The controller will increase right pump
output in response to increased venous return, which mimics the normal Frank-Starling cardiac
output response, and control left pump output to maintain left atrial pressure within a physiologic
range. The controller will also modulate pump speeds to produce pulsatile flow. Specific Aim 3-
Test and optimize the TAH in chronic animal studies to: A) Demonstrate automatic Starling-like
cardiac output control and automatic balance control of the pumps over a wide range of
physiologic conditions including exercise, and B) examine the biocompatibility of the device by
assessing thrombus formation, thromboembolism, von Willebrand factor degradation, and
intestinal angiodysplasia. We will study both pulsatile and non-pulsatile modes.

## Key facts

- **NIH application ID:** 10896124
- **Project number:** 5R01HL153516-04
- **Recipient organization:** PENNSYLVANIA STATE UNIV HERSHEY MED CTR
- **Principal Investigator:** Joshua P Cysyk
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $745,926
- **Award type:** 5
- **Project period:** 2021-05-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10896124

## Citation

> US National Institutes of Health, RePORTER application 10896124, Development of a Universal Bi-ventricular Replacement System for the Failing Heart (5R01HL153516-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10896124. Licensed CC0.

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