Purpose: To examine the influence of device positioning and infrarenal neck diameter on flow patterns in the Nellix endovascular aneurysm sealing (EVAS) system.

Methods: The transition of the aortic flow lumen into two 10-mm-diameter stents after EVAS creates a mismatched area. Flow recirculation may affect local wall shear stress (WSS) profiles and residence time associated with atherosclerosis and thrombosis. To examine these issues, 7 abdominal aortic aneurysm flow phantoms were created, including 3 unstented controls and 3 stented models with infrarenal neck diameters of 24, 28, and 32 mm. Stents were positioned within the instructions for use (IFU). Another 28-mm model was created to evaluate lower positioning of the stents outside the IFU (28-mm LP). Flow was visualized using optical particle imaging velocimetry (PIV) and quantified by time-averaged WSS (TAWSS), oscillatory shear index (OSI), and relative residence time (RRT) in the aorta at the anteroposterior (AP) midplane, lateral midplane, and renal artery AP midplane levels.

Results: Flow in the aorta AP midplane was similar in all models. Vortices were observed in the stented models in the lateral midplane near the anterior and posterior walls. In the 32-mm IFU and 28-mm LP models, a steady state of vortices appeared, with varying location during a cycle. In all models, a low TAWSS (<10 Pa) was observed at the anterior wall of the aorta with peak OSI of 0.5 and peak RRT of 10 Pa. This region was more proximally located in the stented models. The 24- and 28-mm IFU models showed flow with a higher velocity at the renal artery inflow compared to controls. TAWSS in the renal artery was lower near the orifice in all models, with the largest area in the 24-mm IFU model. OSI and RRT in the renal artery were near zero for all models.

Conclusion: EVAS enhances vorticity proximal to the seal zone, especially with lower positioning of the device and in larger neck diameters. Endobags just below the renal artery affect the flow profile in a minor area of this artery in 24- and 28-mm necks, while lower stent positioning does not influence the renal artery flow profile.

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http://dx.doi.org/10.1177/1526602817719465DOI Listing

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Background: The Nellix System (Endologix, Inc, Irvine, Calif) for endovascular aneurysm sealing (EVAS) is a novel approach to abdominal aortic aneurysm treatment and conceptually different from endovascular aneurysm repair, whereby polymer is employed to fill and actively manage the abdominal aortic aneurysm sac. One-year safety and effectiveness results of the Nellix pivotal trial demonstrated encouraging outcomes with very low morbidity and mortality and high procedural and treatment success. Two-year imaging revealed a signal of migration, leading to a field safety notification issued by the manufacturer on October 21, 2016, and a dedicated root cause analysis, resulting in refinements to the instructions for use (IFU).

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Purpose: To examine the influence of device positioning and infrarenal neck diameter on flow patterns in the Nellix endovascular aneurysm sealing (EVAS) system.

Methods: The transition of the aortic flow lumen into two 10-mm-diameter stents after EVAS creates a mismatched area. Flow recirculation may affect local wall shear stress (WSS) profiles and residence time associated with atherosclerosis and thrombosis.

View Article and Find Full Text PDF

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