A Novel Low-Profile Full-Flow Percutaneous Ventricular Assist Device

Area of Science:

• Cardiovascular Engineering
• Medical Devices
• Interventional Cardiology

Background:

• Percutaneous ventricular assist devices (pVADs) are crucial for managing cardiogenic shock (CS), but high adverse event rates necessitate improved designs.
• Existing pVADs require enhancements in cardiac power output (CPO) for better efficacy and reduced profile to minimize complications.

Purpose of the Study:

• To develop and evaluate a novel, low-profile pVAD with improved CPO and a unique delivery system.
• To assess the device's performance in vitro and in vivo, focusing on flow rates, durability, and impact on native heart function.

Main Methods:

• Development of a collapsible impeller using nitinol and polymer for low-profile insertion.
• Utilizing a unique 9 French (9Fr) delivery system for transcatheter implantation and retrieval.
• In vitro head-flow testing, durability trials, and acute in vivo studies in ovine models (healthy and CS).

Main Results:

• In vitro testing achieved 5.0 L/min at 80 mm Hg and 7.0 L/min at 60 mm Hg.
• Durability testing showed continuous operation for up to 20 days.
• In vivo studies demonstrated successful transcatheter delivery, retrieval, native heart support, adequate cardiac output (up to 7 L/min) with low hemolysis in CS models, and multiday function in healthy models.

Conclusions:

• The novel pVAD shows promising performance in achieving high CPO and supporting native heart function.
• The low-profile design and 9Fr delivery system facilitate less invasive implantation and retrieval.
• Further development is warranted to address adverse event rates and optimize pVAD therapy for CS patients.