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...

Full description

Saved in:
Bibliographic Details
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
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2666250724003596
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1849405529295683584
author 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
author_facet 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
author_sort Jamshid H. Karimov, MD, PhD
collection DOAJ
description 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.
format Article
id doaj-art-bc23294695a64d86b8bdc5108c8bc7e5
institution Kabale University
issn 2666-2507
language English
publishDate 2024-12-01
publisher Elsevier
record_format Article
series JTCVS Techniques
spelling doaj-art-bc23294695a64d86b8bdc5108c8bc7e52025-08-20T03:36:38ZengElsevierJTCVS Techniques2666-25072024-12-012812413110.1016/j.xjtc.2024.09.001Implantable continuous-flow total artificial heart for newborns and small pediatric patients: First report of working modelCentral MessagePerspectiveJamshid H. Karimov, MD, PhD0Chihiro Miyagi, MD, PhD1Taiyo Kuroda, MD2Anthony R. Polakowski, BS, MEng3Christine R. Flick, BS4Barry D. Kuban, BS5Kiyotaka Fukamachi, MD, PhD6Tara Karamlou, MD7Munir Ahmad, MD8Hani Najm, MD9Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio; Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio; Kaufman Center for Heart Failure, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Address for reprints: Jamshid H. Karimov, MD, PhD, Department of Biomedical Engineering/ND20, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195.Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OhioDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OhioDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OhioDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OhioDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OhioDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio; Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio; Kaufman Center for Heart Failure, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, OhioCleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OhioCleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OhioCleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OhioObjective: 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.http://www.sciencedirect.com/science/article/pii/S2666250724003596congenital heart failurepediatricmechanical circulatory supporttotal artificial heart
spellingShingle 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
Implantable continuous-flow total artificial heart for newborns and small pediatric patients: First report of working modelCentral MessagePerspective
JTCVS Techniques
congenital heart failure
pediatric
mechanical circulatory support
total artificial heart
title Implantable continuous-flow total artificial heart for newborns and small pediatric patients: First report of working modelCentral MessagePerspective
title_full Implantable continuous-flow total artificial heart for newborns and small pediatric patients: First report of working modelCentral MessagePerspective
title_fullStr Implantable continuous-flow total artificial heart for newborns and small pediatric patients: First report of working modelCentral MessagePerspective
title_full_unstemmed Implantable continuous-flow total artificial heart for newborns and small pediatric patients: First report of working modelCentral MessagePerspective
title_short Implantable continuous-flow total artificial heart for newborns and small pediatric patients: First report of working modelCentral MessagePerspective
title_sort implantable continuous flow total artificial heart for newborns and small pediatric patients first report of working modelcentral messageperspective
topic congenital heart failure
pediatric
mechanical circulatory support
total artificial heart
url http://www.sciencedirect.com/science/article/pii/S2666250724003596
work_keys_str_mv AT jamshidhkarimovmdphd implantablecontinuousflowtotalartificialheartfornewbornsandsmallpediatricpatientsfirstreportofworkingmodelcentralmessageperspective
AT chihiromiyagimdphd implantablecontinuousflowtotalartificialheartfornewbornsandsmallpediatricpatientsfirstreportofworkingmodelcentralmessageperspective
AT taiyokurodamd implantablecontinuousflowtotalartificialheartfornewbornsandsmallpediatricpatientsfirstreportofworkingmodelcentralmessageperspective
AT anthonyrpolakowskibsmeng implantablecontinuousflowtotalartificialheartfornewbornsandsmallpediatricpatientsfirstreportofworkingmodelcentralmessageperspective
AT christinerflickbs implantablecontinuousflowtotalartificialheartfornewbornsandsmallpediatricpatientsfirstreportofworkingmodelcentralmessageperspective
AT barrydkubanbs implantablecontinuousflowtotalartificialheartfornewbornsandsmallpediatricpatientsfirstreportofworkingmodelcentralmessageperspective
AT kiyotakafukamachimdphd implantablecontinuousflowtotalartificialheartfornewbornsandsmallpediatricpatientsfirstreportofworkingmodelcentralmessageperspective
AT tarakaramloumd implantablecontinuousflowtotalartificialheartfornewbornsandsmallpediatricpatientsfirstreportofworkingmodelcentralmessageperspective
AT munirahmadmd implantablecontinuousflowtotalartificialheartfornewbornsandsmallpediatricpatientsfirstreportofworkingmodelcentralmessageperspective
AT haninajmmd implantablecontinuousflowtotalartificialheartfornewbornsandsmallpediatricpatientsfirstreportofworkingmodelcentralmessageperspective