Realistic Vascular Replicator for TAVR Procedures.

Area of Science:

• Biomedical Engineering
• Cardiovascular Research
• Medical Device Testing

Background:

• Transcatheter aortic valve replacement (TAVR) is a key treatment for severe aortic stenosis (AS).
• Current TAVR valve testing relies on simplified left heart simulators (LHS) with non-anatomical geometries, potentially overestimating device performance.
• There is a need for more accurate testing platforms that reflect patient-specific anatomy.

Purpose of the Study:

• To introduce and evaluate a novel patient-specific arterial replicator for TAVR device testing and physician training.
• To compare TAVR valve performance in the replicator versus a standard LHS.
• To assess the replicator's ability to provide clinically relevant outcomes.

Main Methods:

• Development of a patient-specific arterial replicator modeling human vasculature with a Windkessel mechanism for physiological flow.
• Fabrication and implantation of calcified aortic valve models for TAVR procedures using the Inovare valve.
• Testing of TAVR and a mechanical valve (St. Jude) in the replicator and a commercial ISO-compliant LHS.
• Monitoring of effective orifice area (EOA), pressures, and angiograms pre- and post-TAVR.

Main Results:

• The patient-specific replicator demonstrated a significant decrease in TAVR valve performance compared to the simplified LHS, with EOA and pressures aligning with clinical data.
• The mechanical valve showed minimal performance changes in the replicator.
• The replicator proved effective for TAVR testing, offering conservative and clinically relevant outcomes.

Conclusions:

• The novel arterial replicator is a valuable platform for accurate TAVR device testing, especially in challenging anatomies.
• This system complements existing LHS by providing more realistic, clinically relevant performance data.
• The replicator is beneficial for new valve testing, physician training, and procedural planning in interventional cardiology.