Patient-specific in vitro testing for evaluating TAVR clinical performance-A complementary approach to current ISO...

Area of Science:

• Biomedical Engineering
• Cardiovascular Research

Background:

• Current in vitro testing for transcatheter aortic valves (TAV) uses idealized geometries, potentially overestimating performance.
• These idealized tests exclude factors crucial for TAVR (transcatheter aortic valve replacement) success in real patients.

Purpose of the Study:

• To compare TAV hemodynamic performance in idealized geometries versus patient-specific replicas.
• To assess the impact of deployment in patient-specific anatomies on TAV performance.

Main Methods:

• TAVs (balloon-expandable and self-expandable) were tested in an ISO 5840-3 compliant idealized mock-circulation system.
• The same TAVs were then tested in a mock-circulation system adapted for five patient-specific aortic replicas.

Main Results:

• TAV performance declined in patient-specific replicas compared to idealized testing.
• Performance variations correlated with TAV stent design, radial expansion, and eccentricity, as assessed by CT scans.

Conclusions:

• Idealized ISO testing is limited in characterizing baseline TAV performance due to excluded deployment effects.
• Patient-specific testing provides more realistic performance indicators, enhancing TAV development for improved safety and effectiveness.