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A Cost-effective and Reliable Method to Predict Mechanical Stress in Single-use and Standard Pumps
Published on: August 5, 2015
Development of the PSU Child Pump
Christopher Scheib1, Raymond Newswanger1, Joshua Cysyk1
1From the Division of Applied Biomedical Engineering, Department of Surgery, College of Medicine, Penn State University, Hershey, Pennsylvania.
Insights
The PSU Child Pump, a new pediatric continuous-flow ventricular assist device (cf-VAD), shows promise for treating children with heart failure. Its design minimizes blood trauma, offering a safer option while awaiting heart transplantation.
Area of Science:
- Biomedical Engineering
- Cardiovascular Research
- Pediatric Cardiology
Background:
- Pediatric heart failure necessitates advanced mechanical circulatory support.
- Current ventricular assist devices (VADs) may not be optimally sized or safe for pediatric patients.
- The Pennsylvania State University (PSU) Child Pump is a novel centrifugal continuous-flow ventricular assist device (cf-VAD) designed for pediatric use.
Purpose of the Study:
- To evaluate the in-vitro hydraulic and hemodynamic performance of the PSU Child Pump.
- To assess the blood-contacting surfaces for potential hemolysis.
- To compare the physical size of the PSU Child Pump with existing VADs in a pediatric mock-up.
Main Methods:
- In-vitro testing on a mock circulatory loop using ovine blood to assess hydraulic and hemodynamic performance.
- Evaluation of Normalized Index of Hemolysis (NIH) under four different operating conditions.
- A mock fit study using a 3D-printed model of a pediatric thoracic cavity to compare device size.
Main Results:
- The PSU Child Pump demonstrated acceptable hydraulic and hemodynamic performance across tested conditions.
- Normalized Index of Hemolysis (NIH) values were generally low, indicating minimal blood trauma (ranging from 0.015 ± 0.006 to 0.027 ± 0.013 mg/dl).
- Mock fit study suggested the PSU Child Pump is appropriately sized for the target pediatric population compared to adult devices.
Conclusions:
- The PSU Child Pump is a potentially safer and appropriately sized cf-VAD for pediatric heart failure patients.
- The device shows promise in providing adequate support while minimizing risks of blood trauma.
- Further development and clinical evaluation are warranted to confirm its efficacy as a bridge to transplant for children.
Abstract:
The Pennsylvania State University (PSU) Child Pump, a centrifugal continuous-flow ventricular assist device (cf-VAD), is being developed as a suitable long-term implantable device for pediatric heart failure patients between 10 and 35 kg, body surface area (BSA) of 0.5-1.2 m 2 , 1-11 years of age, and requiring a mean cardiac output of 1.0-3.5 L/min. In-vitro hydraulic and hemodynamic performances were evaluated on a custom mock circulatory loop with ovine blood. Normalized index of hemolysis (NIH) was evaluated under four conditions: 1) 8,300 rpm, 3.5 L/min, Δ P = 60 mm Hg, 2) 8,150 rpm, 5.1 L/min, Δ P = 20 mm Hg, 3) 8,400 rpm, 3.2 L/min, Δ P = 70 mm Hg, and 4) 9,850 rpm, 5.0 L/min, Δ P = 80 mm Hg, resulting in normalized index of hemolysis = 0.027 ± 0.013, 0.015 ± 0.006, 0.016 ± 0.008, and 0.026 ± 0.011 mg/dl, respectively. A mock fit study was conducted using a three-dimensional printed model of a 19 kg patient's thoracic cavity to compare the size of the PSU Child Pump to the HeartMate3 and the HVAD. Results indicate the PSU Child Pump will be a safer, appropriately sized device capable of providing the given patient cohort proper support while minimizing the risks of blood trauma as they wait for a transplant.

