JVS-vascular science · 2025
Quantifying the effect of IMPEDE-FX packing rate and volume on pressure-normalized principal wall strain in an idealized 3D-printed aneurysm model.
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Kedwai Baqir, Geiger Joshua, Najjar Sam, Kruger Joel, Richards Michael, Yeh Chung, Dennehy Mary, Stoner Michael, Mix Doran
Аннотация
BACKGROUND: This study aimed to quantify the nonbiologic effects of Shape Memory IMPEDE-FX embolization plug deployment rate and packing volume on pressure-normalized wall strain ( ε ρ + ¯ /PP) of an idealized 3D-printed abdominal aortic aneurysm model.
METHODS: An endograft was deployed into an abdominal aortic aneurysm model and connected to an industry-validated hemodynamic simulator. Plugs were deployed into the excluded sac to packing volumes of 100%, 200%, 300%, and 400% under two conditions: (1) sequential and (2) immediate deployment. Axial ultrasound images were taken for each packing volume. Frame-to-frame displacements of the aneurysm wall were measured with ultrasound elastography over one cardiac cycle and normalized to the circuit's pulse pressure to calculate the mean principal strain ( ε ρ + ¯ /PP).
RESULTS: In the 100% packing condition, ε ρ + ¯ /PP was +113% above baseline at 15 minutes. After sequential deployment to 400%, the ε ρ + ¯ /PP trended down to +43% above baseline. Immediate packing was associated with a greater ε ρ + ¯ /PP reduction than sequential packing. When packed immediately to 400%, the ε ρ + ¯ /PP was -6.7% below baseline.
CONCLUSIONS: These modeling data suggest that an immediate deployment strategy and higher plug packing volumes are associated with lower ε ρ + ¯ /PP, which has been associated with decreased sac growth rates.
CLINICAL RELEVANCE: The present findings suggest that rapid, high-volume filling of IMPEDE-FX embolization plugs results in a reduction in wall ε ρ + ¯ /PP, independent of thrombus formation. Fully expanded embolization plugs in aggregate limit pulsatile aortic sac displacement likely contribute to a greater reduction in overall wall strain compared with low packing volumes. These findings may inform clinical application for this device, supporting a rapid and high-volume deployment strategy for greater reduction in ε ρ + ¯ /PP status post endovascular aneurysm repair.
METHODS: An endograft was deployed into an abdominal aortic aneurysm model and connected to an industry-validated hemodynamic simulator. Plugs were deployed into the excluded sac to packing volumes of 100%, 200%, 300%, and 400% under two conditions: (1) sequential and (2) immediate deployment. Axial ultrasound images were taken for each packing volume. Frame-to-frame displacements of the aneurysm wall were measured with ultrasound elastography over one cardiac cycle and normalized to the circuit's pulse pressure to calculate the mean principal strain ( ε ρ + ¯ /PP).
RESULTS: In the 100% packing condition, ε ρ + ¯ /PP was +113% above baseline at 15 minutes. After sequential deployment to 400%, the ε ρ + ¯ /PP trended down to +43% above baseline. Immediate packing was associated with a greater ε ρ + ¯ /PP reduction than sequential packing. When packed immediately to 400%, the ε ρ + ¯ /PP was -6.7% below baseline.
CONCLUSIONS: These modeling data suggest that an immediate deployment strategy and higher plug packing volumes are associated with lower ε ρ + ¯ /PP, which has been associated with decreased sac growth rates.
CLINICAL RELEVANCE: The present findings suggest that rapid, high-volume filling of IMPEDE-FX embolization plugs results in a reduction in wall ε ρ + ¯ /PP, independent of thrombus formation. Fully expanded embolization plugs in aggregate limit pulsatile aortic sac displacement likely contribute to a greater reduction in overall wall strain compared with low packing volumes. These findings may inform clinical application for this device, supporting a rapid and high-volume deployment strategy for greater reduction in ε ρ + ¯ /PP status post endovascular aneurysm repair.