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Published on: August 16, 2021
Preclinical Proof-of-Concept of a Minimally Invasive Direct Cardiac Compression Device for Pediatric Heart Support
Erica C Hord1, Melanie P Hager2,3, Christina M Bolch1
1CorInnova, Inc. JLABS @ TMC, 2450 Holcombe Blvd Suite J, Houston, TX, 77021, USA.
Insights
A new pediatric device offers temporary mechanical circulatory support (MCS) for heart failure (HF) without blood contact. This minimally invasive approach shows promise for improving outcomes in pediatric MCS.
Area of Science:
- Biomedical Engineering
- Pediatric Cardiology
- Medical Devices
Background:
- Extracorporeal membrane oxygenation (ECMO) is the primary mechanical circulatory support (MCS) for pediatric heart failure (HF), but survival rates are suboptimal (50-60%).
- Device-blood interactions and altered hemodynamics contribute to poor outcomes in current pediatric MCS.
- Minimally invasive, non-blood-contacting MCS is needed to improve pediatric HF treatment.
Purpose of the Study:
- To evaluate the preclinical feasibility of a novel, minimally invasive, non-blood-contacting pediatric device for temporary mechanical circulatory support (MCS).
- To demonstrate proof-of-concept in an in vivo animal model of heart failure (HF).
Main Methods:
- A pediatric prototype device was tested for minimally invasive deployment in an animal model of HF.
- Hemodynamic parameters including pressures and flows were monitored during device operation.
- The device was deployed and removed from a beating heart without cardiopulmonary bypass or anticoagulation.
Main Results:
- Successful minimally invasive deployment and removal from a beating heart were achieved without cardiopulmonary bypass or anticoagulation.
- The device increased cardiac output by 43% during HF while maintaining pulsatile hemodynamics.
- The device recovered up to 95% of ventricular stroke volume compared to the pre-HF baseline.
Conclusions:
- This preclinical study confirms the feasibility of a pediatric, minimally invasive, non-blood-contacting device for temporary MCS.
- The device demonstrated promising hemodynamic support and durability.
- Non-blood-contacting, pulsatile MCS offers a potential strategy to reduce mortality and morbidity associated with current blood-contacting MCS.
Purpose:
For pediatric patients, extracorporeal membrane oxygenation (ECMO) remains the predominant mechanical circulatory support (MCS) modality for heart failure (HF) although survival to discharge rates remain between 50 and 60% for these patients. The device-blood interface and disruption of physiologic hemodynamics are significant contributors to poor outcomes.
Methods:
In this study, we evaluate the preclinical feasibility of a minimally invasive, non-blood-contacting pediatric DCC prototype for temporary MCS. Proof-of-concept is demonstrated in vivo in an animal model of HF. Hemodynamic pressures and flows were examined.
Results:
Minimally invasive deployment on the beating heart was successful without cardiopulmonary bypass or anticoagulation. During HF, device operation resulted in an immediate 43% increase in cardiac output while maintaining pulsatile hemodynamics. Compared to the pre-HF baseline, the device recovered up to 95% of ventricular stroke volume. At the conclusion of the study, the device was easily removed from the beating heart.
Conclusions:
This preclinical proof-of-concept study demonstrated the feasibility of a DCC device on a pediatric scale that is minimally invasive and non-blood contacting, with promising hemodynamic support and durability for the initial intended duration of use. The ability of DCC to maintain pulsatile MCS without blood contact represents an opportunity to mitigate the mortality and morbidity observed in non-pulsatile, blood-contacting MCS.
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