Implantable continuous-flow total artificial heart for newborns and small pediatric patients: First report of working modelCentral MessagePerspective

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 pa...

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Main Authors: Jamshid H. Karimov, MD, PhD, Chihiro Miyagi, MD, PhD, Taiyo Kuroda, MD, Anthony R. Polakowski, BS, MEng, Christine R. Flick, BS, Barry D. Kuban, BS, Kiyotaka Fukamachi, MD, PhD, Tara Karamlou, MD, Munir Ahmad, MD, Hani Najm, MD
Format: Article
Language:English
Published: Elsevier 2024-12-01
Series:JTCVS Techniques
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Online Access:http://www.sciencedirect.com/science/article/pii/S2666250724003596
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Summary: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.
ISSN:2666-2507