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Research ArticleORIGINAL RESEARCH

Proximal protection devices for carotid artery stenting – A benchtop assessment of flow reversal performance

Jiahui Li, Esref A. Bayraktar, Cem Bilgin, Yang Liu, Yigit C. Senol, Jonathan Cortese, Ramanathan Kadirvel, Waleed Brinjikji and David F. Kallmes
American Journal of Neuroradiology January 2025, ajnr.A8664; DOI: https://doi.org/10.3174/ajnr.A8664
Jiahui Li
From the Department of Radiology (J.L., E.A.B., C.B., J.C., R.K., W.B., D.F.K), and Department of Neurologic Surgery (Y.C.S., R.K., W.B.), Mayo Clinic, Rochester, MN, United States; Department of Stroke Research (J.L.), Vall d’Hebron Research Institute, Barcelona, Spain; From the Global Institute of Future Technology (Y.L.), Shanghai Jiao Tong University, Shanghai, China; Department of Neurointerventional Radiology (J.C.), Bicetre University Hospital, Le Kremlin Bicetre, France.
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Esref A. Bayraktar
From the Department of Radiology (J.L., E.A.B., C.B., J.C., R.K., W.B., D.F.K), and Department of Neurologic Surgery (Y.C.S., R.K., W.B.), Mayo Clinic, Rochester, MN, United States; Department of Stroke Research (J.L.), Vall d’Hebron Research Institute, Barcelona, Spain; From the Global Institute of Future Technology (Y.L.), Shanghai Jiao Tong University, Shanghai, China; Department of Neurointerventional Radiology (J.C.), Bicetre University Hospital, Le Kremlin Bicetre, France.
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Cem Bilgin
From the Department of Radiology (J.L., E.A.B., C.B., J.C., R.K., W.B., D.F.K), and Department of Neurologic Surgery (Y.C.S., R.K., W.B.), Mayo Clinic, Rochester, MN, United States; Department of Stroke Research (J.L.), Vall d’Hebron Research Institute, Barcelona, Spain; From the Global Institute of Future Technology (Y.L.), Shanghai Jiao Tong University, Shanghai, China; Department of Neurointerventional Radiology (J.C.), Bicetre University Hospital, Le Kremlin Bicetre, France.
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Yang Liu
From the Department of Radiology (J.L., E.A.B., C.B., J.C., R.K., W.B., D.F.K), and Department of Neurologic Surgery (Y.C.S., R.K., W.B.), Mayo Clinic, Rochester, MN, United States; Department of Stroke Research (J.L.), Vall d’Hebron Research Institute, Barcelona, Spain; From the Global Institute of Future Technology (Y.L.), Shanghai Jiao Tong University, Shanghai, China; Department of Neurointerventional Radiology (J.C.), Bicetre University Hospital, Le Kremlin Bicetre, France.
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Yigit C. Senol
From the Department of Radiology (J.L., E.A.B., C.B., J.C., R.K., W.B., D.F.K), and Department of Neurologic Surgery (Y.C.S., R.K., W.B.), Mayo Clinic, Rochester, MN, United States; Department of Stroke Research (J.L.), Vall d’Hebron Research Institute, Barcelona, Spain; From the Global Institute of Future Technology (Y.L.), Shanghai Jiao Tong University, Shanghai, China; Department of Neurointerventional Radiology (J.C.), Bicetre University Hospital, Le Kremlin Bicetre, France.
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Jonathan Cortese
From the Department of Radiology (J.L., E.A.B., C.B., J.C., R.K., W.B., D.F.K), and Department of Neurologic Surgery (Y.C.S., R.K., W.B.), Mayo Clinic, Rochester, MN, United States; Department of Stroke Research (J.L.), Vall d’Hebron Research Institute, Barcelona, Spain; From the Global Institute of Future Technology (Y.L.), Shanghai Jiao Tong University, Shanghai, China; Department of Neurointerventional Radiology (J.C.), Bicetre University Hospital, Le Kremlin Bicetre, France.
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Ramanathan Kadirvel
From the Department of Radiology (J.L., E.A.B., C.B., J.C., R.K., W.B., D.F.K), and Department of Neurologic Surgery (Y.C.S., R.K., W.B.), Mayo Clinic, Rochester, MN, United States; Department of Stroke Research (J.L.), Vall d’Hebron Research Institute, Barcelona, Spain; From the Global Institute of Future Technology (Y.L.), Shanghai Jiao Tong University, Shanghai, China; Department of Neurointerventional Radiology (J.C.), Bicetre University Hospital, Le Kremlin Bicetre, France.
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Waleed Brinjikji
From the Department of Radiology (J.L., E.A.B., C.B., J.C., R.K., W.B., D.F.K), and Department of Neurologic Surgery (Y.C.S., R.K., W.B.), Mayo Clinic, Rochester, MN, United States; Department of Stroke Research (J.L.), Vall d’Hebron Research Institute, Barcelona, Spain; From the Global Institute of Future Technology (Y.L.), Shanghai Jiao Tong University, Shanghai, China; Department of Neurointerventional Radiology (J.C.), Bicetre University Hospital, Le Kremlin Bicetre, France.
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David F. Kallmes
From the Department of Radiology (J.L., E.A.B., C.B., J.C., R.K., W.B., D.F.K), and Department of Neurologic Surgery (Y.C.S., R.K., W.B.), Mayo Clinic, Rochester, MN, United States; Department of Stroke Research (J.L.), Vall d’Hebron Research Institute, Barcelona, Spain; From the Global Institute of Future Technology (Y.L.), Shanghai Jiao Tong University, Shanghai, China; Department of Neurointerventional Radiology (J.C.), Bicetre University Hospital, Le Kremlin Bicetre, France.
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ABSTRACT

BACKGROUND AND PURPOSE: Proximal protection devices, such as TransCarotid Artery Revascularization (TCAR, SilkRoad Medical, Sunnyvale), aim to yield better outcomes in carotid artery stenting (CAS) than distal protection devices by preventing plaque embolization to the brain. However, transfemoral catheters may not fully reverse flow from the external carotid artery (ECA) to the internal carotid artery (ICA). We assess a new balloon-sheath device, Femoral Flow Reversal Access for Carotid Artery Stenting (FFRACAS), for this purpose.

MATERIALS AND METHODS: The FFRACAS prototype (ID = 0.117”; L=80cm) was compared to TCAR (ID=0.104”, L=30cm) and MoMa (Medtronic, Minneapolis; ID=0.083”, L=90cm) in a pulsatile flow model with blood simulant at 800mL/min. MoMa was used according to labeled instructions, with both CCA and ECA balloon inflation, without CCA-femoral vein shunt placement, and in an off-label fashion with single balloon occlusion in the CCA and shunt. Flow rates of the ICA, ECA, and shunt, when applicable, were monitored during CAS stages: CCA flow arrest, shunt activation, and stent delivery. Experiments were conducted under two ECA inflow conditions (-10 and -20 mL/min). Statistical comparison of ICA flow rates was conducted using ANOVA and Tukey’s post-hoc tests.

RESULTS: MoMa’s on-label use maintained retrograde ICA flow (-0.3 mL/min) throughout CAS. Upon shunt activation, TCAR and FFRACAS reversed ICA flow similarly under low ECA inflow (ICA=-5.10 mL/min vs. -4.83 mL/min; p=0.349), but neither achieved ICA flow reversal under high ECA inflow or during stent delivery. MoMa off-label use failed to reverse ICA flow.

CONCLUSIONS: FFRACAS presents a potential alternative to TCAR, achieving similar degrees of flow reversal from a transfemoral approach to that achieved with the transcarotid approach. The MoMa system reliably prevents anterograde flow in ICA during CAS.

ABBREVIATIONS: CAS = Carotid Artery Stenting; TCAR = Transcarotid Arterial Revascularization; CCA = Common Carotid Artery; ICA = Internal Carotid Artery; ECA = External Carotid Artery; VA = Vertebral Artery; FFRACAS = Femoral Flow Reversal Access for Carotid Artery Stenting; ID = Inner Diameter; OD = Outer Diameter.

Footnotes

  • The remaining authors report no conflicts of interest.

  • © 2025 by American Journal of Neuroradiology

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Accepted Manuscript
Jiahui Li, Esref A. Bayraktar, Cem Bilgin, Yang Liu, Yigit C. Senol, Jonathan Cortese, Ramanathan Kadirvel, Waleed Brinjikji, David F. Kallmes
Proximal protection devices for carotid artery stenting – A benchtop assessment of flow reversal performance
American Journal of Neuroradiology Jan 2025, ajnr.A8664; DOI: 10.3174/ajnr.A8664

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Accepted Manuscript
Proximal protection devices for carotid artery stenting – A benchtop assessment of flow reversal performance
Jiahui Li, Esref A. Bayraktar, Cem Bilgin, Yang Liu, Yigit C. Senol, Jonathan Cortese, Ramanathan Kadirvel, Waleed Brinjikji, David F. Kallmes
American Journal of Neuroradiology Jan 2025, ajnr.A8664; DOI: 10.3174/ajnr.A8664
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