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Permanent Percutaneous Carotid Artery Filter to Prevent Stroke in Atrial Fibrillation Patients: The CAPTURE Trial
Vivek Y Reddy1, Petr Neuzil2, Tom de Potter3
1Department of Cardiology, Homolka Hospital, Prague, Czech Republic; Department of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York.
Insights
Permanent carotid filters offer a safe stroke prevention strategy for high-risk atrial fibrillation patients unsuitable for oral anticoagulants. The CAPTURE trial demonstrated technical feasibility and safety of bilateral filter placement.
Area of Science:
- Cardiovascular Medicine
- Medical Devices
- Interventional Cardiology
Background:
- Patients with atrial fibrillation and high stroke risk often cannot take oral anticoagulants (OACs).
- Novel permanent coil filters are designed to capture emboli in the common carotid arteries (CCAs) to prevent stroke.
- This technology targets embolic protection for patients ineligible for traditional OAC therapy.
Purpose of the Study:
- To assess the feasibility and safety of bilateral common carotid artery (CCA) filter placement in patients with atrial fibrillation.
- The CAPTURE trial evaluated a new embolic protection device for stroke prevention.
- Determine the primary endpoints of procedural success and 30-day major adverse events.
Main Methods:
- The multicenter, nonrandomized CAPTURE trial enrolled patients with atrial fibrillation and high stroke risk (CHA2DS2-VASc ≥2) unsuitable for OACs.
- Bilateral CCA filter placement was performed under ultrasound guidance via transcutaneous carotid puncture.
- Patients received dual antiplatelet therapy followed by aspirin, with follow-up including carotid ultrasounds.
Main Results:
- Procedural success was achieved in 92% of 25 enrolled patients, with no device/procedure-related major adverse events.
- Minor complications included puncture site hematomas/edema in 20% of patients.
- Asymptomatic thrombi were detected in 4 patients post-procedure, all resolving with heparin therapy.
Conclusions:
- Permanent carotid filter placement is a technically feasible and safe stroke prophylaxis method.
- The CAPTURE trial supports the use of bilateral CCA filters for stroke prevention in specific patient populations.
- This novel approach offers an alternative for patients with atrial fibrillation who cannot tolerate oral anticoagulants.
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).
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