Preclinical Proof-of-Concept of a Minimally Invasive Direct Cardiac Compression Device for Pediatric Heart Support.

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.