Background Mechanical circulatory support (MCS) devices, such as ventricular assist devices (VADs) and total artificial hearts (TAHs), have become a vital therapeutic option in the treatment of end-stage heart failure for adult patients. Such therapeutic options continue to be limited for pediatric patients. Clinicians initially adapted or scaled existing adult devices for pediatric patients; however, these adult devices are not designed to support the anatomical structure and varying flow capacities required for this population and are generally operated "off-design," which risks complications such as hemolysis and thrombosis. Devices designed specifically for the pediatric population which seek to address these shortcomings are now emerging and gaining FDA approval. Methods To analyze the competitive landscape of pediatric MCS devices, we conducted a systematic literature review. Approximately 27 devices were studied in detail: 8 were established or previously approved designs, and 19 were under development (11 VADs, 5 Fontan assist devices, and 3 TAHs). Results Despite significant progress, there is still no pediatric pump technology that satisfies the unique and distinct design constraints and requirements to support pediatric patients, including the wide range of patient sizes, increased cardiovascular demand with growth, and anatomic and physiologic heterogeneity of congenital heart disease. Conclusions Forward-thinking design solutions are required to overcome these challenges and to ensure the translation of new therapeutic MCS devices for pediatric patients.
Technology landscape of pediatric mechanical circulatory support devices: A systematic review 2010-2021
Creators
Thomas Palazzolo - Drexel University
Matthew Hirschhorn - Drexel University
Ellen Garven - Drexel University
Steven Day - Rochester Institute of Technology
Randy M. Stevens - St. Christopher's Hospital for Children
Joseph Rossano - Children's Hospital of Philadelphia
Vakhtang Tchantchaleishvili - Thomas Jefferson University Hospital
Amy L. Throckmorton - Drexel University
Publication Details
Artificial organs, v 46(8), pp 1475-1490
Publisher
Wiley
Number of pages
16
Grant note
Hartwell Foundation
R01HL153536 / National Heart, Lung, and Blood Institute of the National Institutes of Health; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Heart Lung & Blood Institute (NHLBI)
Drexel University's Research and Engineering for Pediatrics by Interdisciplinary Collaboration Leveraging Education and Partnerships for Pediatric Healthcare (R-EPIC LEAP for Pediatric Healthcare) for U.S. Department of Education's Graduate Assistance in A
Resource Type
Journal article
Language
English
Academic Unit
Pediatrics; School of Biomedical Engineering, Science, and Health Systems
Web of Science ID
WOS:000782470600001
Scopus ID
2-s2.0-85129046443
Other Identifier
991019167717004721
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