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Updated: Jun 5, 2025
Implantation of Total Artificial Heart in Congenital Heart Disease
Published on: July 18, 2014
Implantable continuous-flow total artificial heart for newborns and small pediatric patients: First report of working
Jamshid H Karimov1,2,3, Chihiro Miyagi1, Taiyo Kuroda1
1Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
Insights
Researchers developed a miniature total artificial heart (TAH) for infants and newborns with heart failure. This device offers a potential life-saving option for small pediatric patients awaiting heart transplantation.
Area of Science:
- Biomedical Engineering
- Pediatric Cardiology
- Medical Device Development
Background:
- Severe heart failure (HF) in pediatric patients, particularly congenital HF, lacks adequate mechanical circulatory support (MCS) options for infants.
- Currently, no implantable total artificial heart (TAH) devices are available for small pediatric patients.
Purpose of the Study:
- To develop a fully implantable, continuous-flow total artificial heart (CFTAH) specifically designed for infants and newborns.
- To address the critical unmet need for safe and reliable MCS in very young children with advanced HF.
Main Methods:
- Engineered a miniature CFTAH (I-CFTAH) by reducing the displacement volume to 14% of the adult version.
- Significantly decreased pump diameter (6.2 cm to 2.6 cm) and axial length (9.8 cm to 4.8 cm) for infant compatibility.
- Successfully fit the device within the chest dimensions of infants and newborns (height ≥50 cm).
Main Results:
- The functional I-CFTAH prototype demonstrated stable hemodynamic support.
- Confirmed pump flow range of 0.5-1.5 L/min in mock circulatory testing.
- The device can support the intended cardiac output for small pediatric patients.
Conclusions:
- The development of the I-CFTAH proves the feasibility of miniature continuous-flow TAH for very small patient populations.
- The I-CFTAH shows potential as a therapeutic option, serving as a bridge to transplantation.
- This innovation aims to improve both the quality and duration of life for pediatric patients with advanced HF.
Objective:
The need for safe and reliable mechanical circulatory support (MCS) for smaller children with severe heart failure (HF) is well defined. More specifically, in pediatric patients with advanced congenital HF, there is no implantable total artificial heart (TAH) device available for small patients. Herein, we report the development of the infant continuous-flow total artificial heart (I-CFTAH), a fully implantable in infants and newborns.
Methods:
After extensive engineering analysis, we performed an unprecedented effort: reducing the I-CFTAH's displacement volume to be 14% of the adult CFTAH pump while simultaneously decreasing pump diameter (6.2 cm to 2.6 cm) and axial length (9.8 cm to 4.8 cm). Facilitated by these proportional reductions, for the first time, a durable total artificial heart device was successfully fit in the chest of infants and newborns (height of ≥50 cm).
Results:
The functional I-CFTAH prototype demonstrated capability to support stable hemodynamics and desired device performance. The pump flow range (0.5-1.5 L/min) was confirmed in a mock circulatory testing loop. Within the tested flow range, the I-CFTAH can support small patients that could benefit from the intended cardiac output.
Conclusions:
This successful effort demonstrated the feasibility of the miniature continuous-flow total artificial heart, intended for very small patient populations. I-CFTAH showed stable hemodynamics and could, therefore, become one of the few therapeutic options as a bridge to transplantation, aiming to enhance both the quality and duration of life for pediatric patients with advanced HF.
