Author + information
- Received April 8, 2019
- Revision received April 29, 2019
- Accepted April 30, 2019
- Published online August 12, 2019.
- Vivek Y. Reddy, MDa,b,∗ (, )@IcahnMountSinai,
- Petr Neuzil, MD, PhDa,
- Tom de Potter, MDc,
- Jan van der Heyden, MDd,
- Selma C. Tromp, MDe,
- Benno Rensing, MDd,
- Eva Jiresova, MDa,
- Libor Dujka, MDa and
- Veronika Lekesova, MDa
- aDepartment of Cardiology, Homolka Hospital, Prague, Czech Republic
- bDepartment of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York
- cDepartment of Cardiology, OLV Ziekenhuis, Aalst, Belgium
- dDepartment of Cardiology, Sint-Antonius Ziekenhuis, Nieuwegein, the Netherlands
- eDepartment of Clinical Neurophysiology, Sint-Antonius Ziekenhuis, Nieuwegein, the Netherlands
- ↵∗Address for correspondence:
Dr. Vivek Y. Reddy, Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, P.O. Box 1030, New York, New York 10029.
Background Patients with high stroke risk and atrial fibrillation who are unsuitable to oral anticoagulants (OACs) require other stroke prevention strategies. A novel permanent coil filter directly placed into both common carotid arteries (CCAs) was designed to capture emboli >1.4 mm in diameter.
Objectives The multicenter, nonrandomized, first-in-human clinical CAPTURE (Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients) trial sought to determine the feasibility and safety of bilateral CCA filter placement.
Methods Eligible patients had atrial fibrillation, CHA2DS2-VASc (Congestive heart failure, Hypertension, Age 75 years, Diabetes, Stroke/transient ischemic attack, Vascular disease, Age 65 to 74 years, Sex category) ≥2, OAC unsuitability, CCA size 4.8 to 9.8 mm, and no carotid stenosis >30%. Under ultrasound guidance, after direct transcutaneous carotid puncture with a 24-gauge needle, a motorized unit expels the filter to unfurl in the artery. Patients received aspirin/clopidogrel for 3 months, and aspirin thereafter. Primary endpoints were: 1) procedural success—bilateral, properly positioned CCA filters; and 2) 30-day incidence of major adverse events—death, stroke, major bleeding, filter migration, CCA thrombus, or stenosis. Carotid ultrasounds were conducted post-procedure, pre-discharge, at 1 week, and at 1, 3, 6, and 12 months.
Results At 3 centers, 25 patients were enrolled: age 71 ± 9 years, CHA2DS2-VASc = 4.4 ± 1.0, prior embolism in 48%. Procedure success was 92% (23 of 25 patients); 1 patient had unilateral deployment. There were no device/procedure-related major adverse events; minor puncture site hematomas/edema occurred in 5 of 25 (20%). After 6-month mean follow-up, asymptomatic thrombi were detected in 4 patients (1 bilateral, 4 unilateral), adjudicated as captured (n = 3), unclassified (n = 2), or in situ (n = 0). In all patients, the thrombi dissolved with subcutaneous heparin. In 1 patient, 2 device/procedure-unrelated minor strokes occurred.
Conclusions Permanent carotid filter placement for stroke prophylaxis is technically feasible and safe. (Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients [CAPTURE]; NCT03571789)
- atrial fibrillation
- carotid filter
- common carotid artery
- embolic protection
- oral anticoagulation
- stroke prevention
This trial was supported by the manufacturer of the carotid coil filter, Javelin Medical Ltd. Drs. Neuzil, Jiresova, and Dujka are supported by a scientific grant from the Czech Ministry of Health (DRO NNH 00023884 IG 180504). Dr. Reddy has served as a consultant for and has stock in Javelin Medical; has served as a consultant to Abbott, Acutus Medical, Affera, Apama Medical, Aquaheart, Autonomix, Axon, Backbeat, BioSig, Biotronik, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, Corvia Medical, East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Impulse Dynamics, Keystone Heart, LuxCath, Medlumics, Medtronic, Middlepeak, Nuvera, Philips, Stimda, Thermedical, Valcare, and VytronUS; and has equity in Acutus Medical, Affera, Apama Medical, Aquaheart, Autonomix, Backbeat, BioSig, Circa Scientific, Corvia Medical, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Middlepeak, Newpace, Nuvera, Surecor, Valcare, Vizara, and VytronUS. Drs. Neuzil, de Potter, van der Heyden, Tromp, and Rensing have received grant support from Javelin Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received April 8, 2019.
- Revision received April 29, 2019.
- Accepted April 30, 2019.
- 2019 The Authors