The use of mechanical assist devices in the pediatric population

Bryant, Roosevelt; Wisotzkey, Bethany; Velez, Daniel A.

doi:10.1016/j.sempedsurg.2021.151041

Cited by 6 publications

(11 citation statements)

References 35 publications

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“…Transplantation in pediatric patients is complicated by challenges in donor-recipient size matching and anticipated growth potential ( 9 ). Despite ~74% of children being matched and transplanted within 90 days of listing, the mortality rate range for patients awaiting a donor organ remains high (5–39%) ( 7 , 10 , 11 ). Thus, this necessitates the use of alternative therapies, such as mechanical circulatory support (MCS) devices, including blood pumps.…”

Section: Clinical Significance and Motivationmentioning

confidence: 99%

“…Complex congenital heart defects and exposure to viruses and bacteria that attack the cardiac muscle lead to severely depressed ventricular function and usually require surgical and therapeutic intervention (4,5). Annually, more than 10,000 children in the United States are hospitalized with CHF-related symptoms, with a mortality rate of 7-15% (6)(7)(8). These pediatric patients often require a heart transplantation, the current standard of care.…”

Section: Clinical Significance and Motivationmentioning

confidence: 99%

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Development of the Centrifugal Blood Pump for a Hybrid Continuous Flow Pediatric Total Artificial Heart: Model, Make, Measure

Fox

Palazzolo

Hirschhorn

et al. 2022

Front. Cardiovasc. Med.

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Clinically-available blood pumps and total artificial hearts for pediatric patients continue to lag well behind those developed for adults. We are developing a hybrid, continuous-flow, magnetically levitated, pediatric total artificial heart (TAH). The hybrid TAH design integrates both an axial and centrifugal blood pump within a single, compact housing. The centrifugal pump rotates around the separate axial pump domain, and both impellers rotate around a common central axis. Here, we concentrate our development effort on the centrifugal blood pump by performing computational fluid dynamics (CFD) analysis of the blood flow through the pump. We also conducted transient CFD analyses (quasi-steady and transient rotational sliding interfaces) to assess the pump's dynamic performance conditions. Through modeling, we estimated the pressure generation, scalar stress levels, and fluid forces exerted on the magnetically levitated impellers. To further the development of the centrifugal pump, we also built magnetically-supported prototypes and tested these in an in vitro hydraulic flow loop and via 4-h blood bag hemolytic studies (n = 6) using bovine blood. The magnetically levitated centrifugal prototype delivered 0–6.75 L/min at 0–182 mmHg for 2,750–4,250 RPM. Computations predicted lower pressure-flow performance results than measured by testing; axial and radial fluid forces were found to be <3 N, and mechanical power usage was predicted to be <5 Watts. Blood damage indices (power law weighted exposure time and scalar stress) were <2%. All data trends followed expectations for the centrifugal pump design. Six peaks in the pressure rise were observed in the quasi-steady and transient simulations, correlating to the blade passage frequency of the 6-bladed impeller. The average N.I.H value (n = 6) was determined to be 0.09 ± 0.02 g/100 L, which is higher than desired and must be addressed through design improvement. These data serve as a strong foundation to build upon in the next development phase, whereby we will integrate the axial flow pump component.

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Section: Clinical Significance and Motivationmentioning

confidence: 99%

Section: Clinical Significance and Motivationmentioning

confidence: 99%

Development of the Centrifugal Blood Pump for a Hybrid Continuous Flow Pediatric Total Artificial Heart: Model, Make, Measure

Fox

Palazzolo

Hirschhorn

et al. 2022

Front. Cardiovasc. Med.

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“…Although pharmacological agents are prescribed, these only slow the progression toward end‐stage HF 6 . Approximately 15 000 children in the USA are hospitalized with HF‐related conditions each year, and there is a mortality rate of 7%–15% 7‐9 . Cardiac transplantation is the standard of care, but each year, the number of patients in need of a transplant exceeds the number of donor organs available; the eligible patient population continues to increase annually, ensuring lasting difficulty in donor procurement 10 .…”

Section: Background and Motivationmentioning

confidence: 99%

Technology landscape of pediatric mechanical circulatory support devices: A systematic review 2010–2021

et al. 2022

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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 "offdesign," 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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“…The development of mechanical circulatory support (MCS) devices for pediatric use has been greatly outpaced by adult devices, despite there being a critically unmet clinical need. Up to 14,000 children in the US are hospitalized with heart failure (HF)-related conditions each year with a mortality rate of 7–15% [ 1 – 3 ]. While 74% of children undergo heart transplantation within 90 days of listing [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

“…Between the third and fourth Pedimacs reports, the use of MCS increased from 508 devices implanted [ 8 ] to 1031 [ 9 , 10 ] through bridge to transplant (49% of pediatric assist device recipients) and bridge to candidacy (38%) strategies [ 9 ]. The majority of pediatric MCS recipients are those diagnosed with cardiomyopathy, followed by congenital heart disease (with 70% of hospital admissions in these patients occurring within the first year of life) and myocarditis [ 1 , 9 ]. Actuarial survival of pediatric assist device recipients is 74% at 6 months, with age, severity of illness, and type of device used playing a complex role in patient outcomes [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

Feasibility testing of the Inspired Therapeutics NeoMate mechanical circulatory support system for neonates and infants

et al. 2022

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Inspired Therapeutics (Merritt Island, FL) is developing a mechanical circulatory support (MCS) system designed as a single driver with interchangeable, extracorporeal, magnetically levitated pumps. The NeoMate system design features an integrated centrifugal rotary pump, motor, and controller that will be housed in a single compact unit. Conceptually, the primary innovation of this technology will be the combination of disposable, low-cost pumps for use with a single, multi-functional, universal controller to support multiple pediatric cardiopulmonary indications. In response to the paucity of clinically available pediatric devices, Inspired Therapeutics is specifically targeting the underserved neonate and infant heart failure (HF) patient population first. In this article, we present the development of the prototype Inspired Therapeutics NeoMate System for pediatric left ventricular assist device (LVAD) support, and feasibility testing in static mock flow loops (H-Q curves), dynamic mock flow loops (hemodynamics), and in an acute healthy ovine model (hemodynamics and clinical applicability). The resultant hydrodynamic and hemodynamic data demonstrated the ability of this prototype pediatric LVAD and universal controller to function over a range of rotary pump speeds (500–6000 RPM), to provide pump flow rates of up to 2.6 L/min, and to volume unload the left ventricle in acute animals. Key engineering challenges observed and proposed solutions for the next design iteration are also presented.

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The use of mechanical assist devices in the pediatric population

Cited by 6 publications

References 35 publications

Development of the Centrifugal Blood Pump for a Hybrid Continuous Flow Pediatric Total Artificial Heart: Model, Make, Measure

Development of the Centrifugal Blood Pump for a Hybrid Continuous Flow Pediatric Total Artificial Heart: Model, Make, Measure

Technology landscape of pediatric mechanical circulatory support devices: A systematic review 2010–2021

Feasibility testing of the Inspired Therapeutics NeoMate mechanical circulatory support system for neonates and infants

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