Permanent Bilateral Carotid Filters for Stroke Prevention in Atrial Fibrillation
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INVASIVE ELECTROPHYSIOLOGY AND PACING (E. KEVIN HEIST, SECTION EDITOR)
Permanent Bilateral Carotid Filters for Stroke Prevention in Atrial Fibrillation Tom De Potter 1 & Ofer Yodfat 2 & Guy Shinar 2 & Avraham Neta 2 & Vivek Y. Reddy 3 & Petr Neuzil 4 & Roland Veltkamp 5,6,7 & Stuart J. Connolly 8
# The Author(s) 2020
Abstract Purpose of Review A novel permanent carotid filter device for percutaneous implantation was developed for the purpose of stroke prevention. In this review, we cover rationale, existing preclinical and clinical data, and potential future directions for research using such a device. Recent Findings The Vine™ filter was assessed for safety in sheep and in 2 observational human studies, the completed CAPTURE 1 (n = 25) and the ongoing CAPTURE 2 (planned n = 100). CAPTURE 1 has shown high procedural and longterm implant safety. A control group was not available for comparison. Summary A mechanical filter for permanent stroke prevention can be implanted bilaterally in the common carotid artery safely and efficiently. A randomized trial is planned for 2021 (n = 3500, INTERCEPT) to demonstrate superiority of a filter + anticoagulation strategy over anticoagulation alone in patients at high risk for ischemic stroke. Keywords Atrial fibrillation . Carotid filter . Common carotid artery . Embolic protection . Stroke prevention
This article is part of the Topical Collection on Invasive Electrophysiology and Pacing * Tom De Potter [email protected] Ofer Yodfat [email protected]
1
Cardiovascular Center, OLV Hospital, Moorselbaan 164, B-9300 Aalst, Belgium
2
Javelin Medical Ltd., Yokne’am, Israel
3
Helmsley Electrophysiology Center, Division of Cardiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA
4
Department of Cardiology, Homolka Hospital, Prague, Czech Republic
5
Department of Brain Science, Imperial College London, London, UK
6
Department of Neurology, Alfried Krupp Krankenhaus, Essen, Germany
7
Department of Neurology, University Heidelberg, Heidelberg, Germany
8
Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada
Guy Shinar [email protected] Avraham Neta [email protected] Vivek Y. Reddy [email protected] Petr Neuzil [email protected] Roland Veltkamp [email protected] Stuart J. Connolly [email protected]
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Abbreviations AF Atrial fibrillation CCA Common carotid artery OAC Oral anticoagulants NOAC New oral anticoagulants
Introduction Stroke prevention in atrial fibrillation (AF) patients is an important medical need with major consequences if left unmet. In the USA, AF prevalence is > 6 million, with an incidence of 1.2 million cases per year [1, 2]. Nearly 800,000 Americans suffer from stroke each year, and one out of three is associated with AF (67% of them with prior AF) [3]. Stroke risk in AF patients is commonly estimated using the CHA2DS2-VASc scoring system [4]. In AF patients not taking oral anticoagulants (OAC), the average annual stroke risk is ~ 5%/year
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