Article Text
Abstract
Purpose In several studies, TransCarotid Artery Revascularization (TCAR) has been shown to have lower risks of major adverse outcomes, such as stroke, than transfemoral carotid artery stenting (CAS). These outcomes have raised questions about the competency of the catheters used in transfemoral CAS for flow reversal. This study evaluates a new balloon-sheath device, the Femoral Flow Reversal Carotid Artery Stenting (FFRACAS) device.
Materials and Methods The FFRACAS prototype (ID = 0.117’; OD = 0.140’; L=80cm), TCAR-equivalent prototype (ID=0.104’; OD = 0.110’; L=30cm), and MoMa (Medtronic, Minneapolis; ID=0.083’; OD = 0.112’; L=90cm) were compared in a pulsatile flow model using a blood simulant at a flow rate of 800 mL/min. The venous system was simulated by an elevated saline reservoir set at a pressure of 10 mmHg. MoMa was tested under common carotid artery (CCA) balloon occlusion, both with and without external carotid artery (ECA) balloon occlusion. MoMa without ECA balloon occlusion was tested with the arteriovenous shunt system. The flow rates within the internal carotid artery (ICA), ECA, and shunt (if applicable) were monitored throughout the CAS stages (CCA flow arrest, shunt activation, and stent delivery). The study followed two different (ECA) inflow conditions after CCA occlusion: -10 mL/min and -20 mL/min. Statistical comparisons of the flow rates were performed using ANOVA and Tukey’s post-hoc tests.
Results Throughout CAS, MoMa placement with ECA occlusion maintained retrograde ICA flow. A flow rate of -0.3 mL/min was observed during stent insertion. However, MoMa placement without ECA occlusion failed to reverse ICA flow under low (ICA=0.6 ± 0.5 mL/min) and high (12.8 ± 0.7 mL/min) ECA inflows. Under low ECA inflow, FFRACAS and TCAR prototypes reversed ICA flow similarly to each other after shunt activation (ICA= -4.8 ± 0.5 mL/min vs. -5.1 ± 1 mL/min, respectively, p=0.35). However, neither FFRACAS nor TCAR prototypes reversed ICA flow during stent delivery (ICA= 1.4 ± 0.5 mL/min vs. 3.1 ± 0.4 mL/min). Under high ECA inflow, FFRACAS (9.2 ± 0.8 mL/min) and TCAR (7.7 ± 0.7 mL/min) failed to reverse the ICA flow when the arteriovenous shunt was activated without a stent inserted.
Conclusion FFRACAS offers an alternative to TCAR by achieving similar degrees of flow reversal from a transfemoral approach to that achieved with the transcarotid approach. The MoMa system with ECA balloon occlusion reliably maintains retrograde flow in ICA during CAS.
Disclosures E. Bayraktar: None. J. Li: None. J. Cortese: 1; C; Medtronic, Phenox, Balt, French Society of Radiology (Bourse de Recherche Alain Rahmouni SFR-CERF), Philippe Foundation, French Society of Neuroradiology (Bourse de Mobilité Anne Bertrand SFNR). 3; C; Balt. C. Bilgin: None. Y. Senol: None. R. Kadirvel: 1; C; Cerenovus, Sensome, Neurogami Medical, Insera Therapeutics, Medtronic, Monarch Biosciences, MiVi Biosciences, Stryker, NIH, NSF, Piraeus Medical, Bionaut Labs. 4; C; Monarch Biosciences, Bionaut Labs. W. Brinjikji: 1; C; NIH. 2; C; Medtronic, Stryker, Imperative Care, MIVI Neurovascular, Cerenovus, Asahi, Balt, Microvention. 4; C; Nested Knowledge, Superior Medical Editors, Piraeus Medical, MIVI Neurovascular, Sonoris Medical. 5; C; MIVI Neurovascular, Marblehead Medical LLC, Interventional Neuroradiology (Editor in Chief), Piraeus Medical, WFITN. 6; C; Medtronic, Balloon Guide Catheter Technology. D. Kallmes: 1; C; Cerenovus, Sensome, Neurogami Medical, Insera Therapeutics, Medtronic, Microvention, Balt, Monarch Biosciences, Brainomix, MiVi, Stryker, NIH. 2; C; NoNO Inc, Vesalio. 4; C; Medtronic, Nested Knowledge, LLC, Superior Medical Experts, LLC, Marblehead Medical, LLC, Conway Medical, LLC, Monarch Biosciences, Piraeus Medical, Balloon guide technology, Spine augmentation. 6; C; Brainomix.