Initial in vitro testing of a paediatric continuous-flow total artificial heart

Kiyotaka Fukamachi1, Jamshid H Karimov1, David J Horvath2

  • 1Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.

Insights

A new pediatric total artificial heart prototype shows promising self-regulation and performance for infants with congenital heart disease. This device aims to improve mechanical circulatory support options for children needing biventricular support.

Area of Science:

  • Biomedical Engineering
  • Pediatric Cardiology
  • Cardiovascular Surgery

Background:

  • Mechanical circulatory support is standard for adult heart failure, but pediatric options for congenital heart disease are limited.
  • Congenital heart disease often affects both ventricles, requiring biventricular support like heart transplantation or a total artificial heart.
  • Current pediatric mechanical circulatory support options are limited to paracorporeal devices or adult devices used off-label.

Purpose of the Study:

  • To evaluate the in vitro performance of a novel pediatric continuous-flow total artificial heart prototype.
  • To assess the device's ability to support both pulmonary and systemic circulations in a simulated pediatric setting.

Main Methods:

  • A pediatric continuous-flow total artificial heart prototype was developed by downscaling an adult device.
  • In vitro performance was evaluated using a mock loop simulating pediatric circulation.
  • Pump performance and atrial pressure differences were mapped across various systemic and pulmonary vascular resistance and pump speeds.

Main Results:

  • The pediatric total artificial heart prototype demonstrated a left pump flow range of 0.4-4.7 L/min at 100 mmHg delta pressure.
  • Atrial pressure balance was maintained within ±5 mmHg across a wide range of vascular resistance ratios (1.4-35).
  • The device exhibited passive self-regulation of atrial pressure, meeting design requirements.

Conclusions:

  • The pediatric continuous-flow total artificial heart prototype meets initial design requirements for self-regulation and performance.
  • Further in vivo studies are underway to validate the device's efficacy.
  • This development offers a potential advancement in mechanical circulatory support for pediatric end-stage heart failure.
Abstract

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