Key result
Mimicked neo-sinus on a PCU aortic valve increases in-vitro clot mass ~21% versus no neo-sinus.
Why the study?
The neo-sinus created after TAVR increases the thrombogenicity of transcatheter heart valves, but testing methods to evaluate this thrombogenicity in vitro are lacking.
Does the presence of a neo-sinus increase thrombogenicity in an in-vitro model of transcatheter aortic valve replacement?
Does the presence of a neo-sinus increase thrombogenicity in an in-vitro model of transcatheter aortic valve replacement?
Effect estimate: 21.21% higher mass
Absolute Event Rate: 0.064% vs 0.0528%
In an in-vitro model, the presence of a neo-sinus mimicking post-TAVR anatomy altered flow dynamics and increased clot formation compared to a valve without a neo-sinus, supporting clinical observations of subclinical leaflet thrombosis.
In-vitro clot increase with neo-sinus suggests design caution; leaves open clinical thrombosis risk.
PURPOSE: Transcatheter aortic valve replacement (TAVR) is the standard treatment for patients with aortic diseases at high surgical risk. Transcatheter heart valve prostheses (THV) are inserted into the aortic valve, creating a new area between the native and artificial leaflets. This area, known as neo-sinus, increases the thrombogenicity of THVs. But there is a lack of testing methods that evaluate thrombogenicity in vitro. METHODS: To analyze the flow field within the native sinus and the neo-sinus, Particle Image Velocimetry (PIV) was performed with a thrombosis tester. Additionally, a comparative study was conducted with porcine blood on two polycarbonate urethane valves, with and without neo-sinus, respectively. Blood samples collected every hour were analyzed for platelet count, coagulation via ROTEM parameters, and plasma-free hemoglobin. Thrombus formation was detected optically. RESULTS: The PIV measurements yield a physiological flow field in the aortic root that were consistent with those reported in literature. The analyzed blood parameters reveal no obvious difference between the valve with neo-sinus and the valve without. A higher amount of thrombus material for the valve with neo-sinus was found. CONCLUSION: The visualized flow field shows low velocities and stagnation zones due to the presence of native leaflets. Clot formation at the heart valve prostheses are in accordance with in-vivo findings. The benchmark of the two valves indicates an increased thrombogenic potential due to the neo-sinus. The thrombosis tester simulates the natural environment after TAVR. Thereby, newly developed THVs can be evaluated in vitro and consequently optimized regarding their thrombogenicity.
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Thoenissen et al. (2025) studied Aortic valve replacement (TAVR). Valve with neo-sinus vs. Valve without neo-sinus was evaluated on Total mass of clots (21.21% higher mass). The presence of a mimicked neo-sinus on a polycarbonate urethane aortic valve resulted in a 21.21% higher mass of clots compared to a valve without a neo-sinus in an in-vitro blood test.
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