Author + information
- Received April 8, 2019
- Revision received April 29, 2019
- Accepted April 30, 2019
- Published online May 11, 2019.
- Vivek Y. Reddy, M.D.a,b,∗ (, )@IcahnMountSinai,
- Petr Neuzil, M.D. Ph.D.a,
- Tom de Potter, M.D.c,
- Jan van der Heyden, M.D.d,
- Selma C. Tromp, M.D.d,
- Benno Rensing, M.D.d,
- Eva Jiresova, M.D.a,
- Libor Dujka, M.Da and
- Veronika Lekesova, M.D.a
- aHomolka Hospital, Prague, Czech RepublicHomolka Hospital, Prague, Czech Republic
- bIcahn School of Medicine at Mount Sinai, New York, New York, USAIcahn School of Medicine at Mount Sinai, New York, New York, USA
- cOLV Ziekenhuis, Aalst, BelgiumOLV Ziekenhuis, Aalst, Belgium
- dSint-Antonius Ziekenhuis, Nieuwegein, NetherlandsSint-Antonius Ziekenhuis, Nieuwegein, Netherlands
- ↵∗Address for correspondence: Vivek Y. Reddy, MD Helmsley Electrophysiology Center Icahn School of Medicine at Mount Sinai One Gustave L. Levy Place, PO Box 1030 New York, NY 10029 Telephone: +1-212-241-7114 Fax: +1-646-537-9691.
Background High stroke risk atrial fibrillation patients unsuitable to oral anticoagulants (OAC) require other stroke prevention strategies. A novel permanent coil filter directly placed into both common carotid arteries (CCAs) was designed to capture emboli >1.4mm diameter.
Objectives In a multicenter, non-randomized, first-in-human clinical trial (CAPTURE), to determine the feasibility and safety of bilateral CCA filter placement.
Methods Eligible patients had atrial fibrillation, CHA2DS2-VASc ≥ 2, OAC unsuitability, CCA size 4.8-9.8mm, and no carotid stenosis > 30%. Under ultrasound guidance, after direct transcutaneous carotid puncture with a 24G 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: i) procedural success – bilateral, properly positioned CCA filters, and ii) 30-day incidence of major adverse events (MAEs): death, stroke, major bleeding, filter migration, CCA thrombus or stenosis. Carotid ultrasounds were conducted post-procedure, pre-discharge, 1 week and 1/3/6/12 months.
Results At 4 centers, 25 patients were enrolled: age 71±9 years, CHA2DS2-VASc = 4.4±1.0, prior embolism in 48%. Procedure success was 92% (23/25 patients); one patient had unilateral deployment. There were no device/procedure-related MAEs; minor puncture site hematomas/edema occurred in 5/25 (20%). After 6 months mean follow-up, in situ thrombus was not observed. The filter captured emboli in 4 patients (1 bilateral, 4 unilateral), none developed symptoms. In all patients, the thrombi dissolved with subcutaneous heparin. In 1 patient, 2 minor strokes involving non-CCA territory strokes occurred.
Conclusions Permanent carotid filter placement for stroke prophylaxis is technically feasible and safe.
- Atrial fibrillation
- Carotid filter
- Common carotid artery
- Embolic protection
- Oral anticoagulation
- Stroke prevention
Funding: The trial was supported by the manufacturer of the carotid coil filter, Javelin Medical Ltd. A scientific grant from the Czech Ministry of Health (DRO NNH 00023884 IG 180504) supported P.N., E.J., L.D. and L.D.
Disclosures: VYR – Javelin Medical: stock, consultant; PN, TdP, JvdH, ST, BR – Javelin Medical: Grant support. EJ, LD, VL – None. In addition, VYR also has conflicts with other medical companies not related to this manuscript; these are listed in the online Supplement.
Twitter: “To prevent AFib-related stroke, a first-in-human study shows that a novel coil filter device can be placed by direct puncture atop carotid arteries.”
Clinical trial registration: CAPTURE: NCT#03571789
- Received April 8, 2019.
- Revision received April 29, 2019.
- Accepted April 30, 2019.
- 2019 The Authors