Thomas Palazzolo1, Matthew Hirschhorn1, Ellen Garven1, Steven Day2, Randy M Stevens3, Joseph Rossano4, Vakhtang Tchantchaleishvili5, Amy L Throckmorton1. 1. BioCirc Research Laboratory, School of Biomedical Engineering, Science, and Health Systems, Drexel University, Philadelphia, Pennsylvania, USA. 2. Department of Biomedical Engineering, Kate Gleason College of Engineering, Rochester Institute of Technology, Rochester, New York, USA. 3. College of Medicine, St. Christopher's Hospital for Children, Drexel University, Philadelphia, Pennsylvania, USA. 4. Division of Pediatric Cardiology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA. 5. Division of Cardiac Surgery, Department of Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
Abstract
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.
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.
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Authors: Carson S Fox; Thomas Palazzolo; Matthew Hirschhorn; Randy M Stevens; Joseph Rossano; Steven W Day; Vakhtang Tchantchaleishvili; Amy L Throckmorton Journal: Front Cardiovasc Med Date: 2022-08-04