This new strategy to reduce the risk of stroke in patients with atrial fibrillation is technically feasible and safe, even though long-term outcomes are yet to be seen and despite the evidence available, for instance, left atrial appendage closure devices. It is true that they could be used simultaneously, but its synergy and cost have not been described yet.
Patients at high risk of stroke and atrial fibrillation that do not make good candidates for oral anticoagulation require alternative prevention strategies. These new permanent coil filters are implanted directly placed into both common carotid arteries and are capable of capturing >1.4 mm emboli.
The CAPTURE (Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients) recently published in J Am Coll Cardiol showed the safety and feasibility of this new device for the first time in humans.
Elegible patients had atrial fibrillation, CHA2DS2-VASc score ≥2 (cardiac failure, hypertension, over 75 years of age, diabetes, prior stroke/transient ischemic attack, peripheral vascular disease, age between 65 and 74, sex category) anticoagulation counterindication, common carotid diameter between 4.8 and 9.8, and stenosis no higher than 30%.
Under ultrasound guidance, after direct transcutaneous carotid puncture with 24 G needle, a motorized unit releases the filter. Patients received aspirin and clopidogrel for 3 months and aspirin alone thereafter.
Primary end points were: procedural success with properly positioned filters, major events at 30 days (death, stroke, major bleeding, filter migration, thrombus in common carotid, or significant stenosis.
Patients were followed up after procedure with carotid ultrasounds: before discharge, at 1 week, 1, 3 and 6 months, and one year.
This “first in human” included 25 patients of mean age 71±9, CHA2DS2-VASc score 4.4±1 and 48% had a history of embolism.
The study had 92% success rate (23 of 25 patients). One patient had unilateral deployment. There were no major events related to the device, there was only 20% edema or minor hematomas related to puncture.
After 6 months, they observed thrombi in 4 asymptomatic patients; in all patients thrombi were dissolved with subcutaneous heparin.
One patient presented stoke unrelated to the device.
This new and radical solution for patients with atrial fibrillation and anticoagulation counterindication seems safe and feasible in this “fist in human” trial.
Original title: Permanent Percutaneous Carotid Artery Filter to Prevent Stroke in Atrial Fibrillation Patients. The CAPTURE Trial.
Reference: Vivek Y. Reddy et al. J Am Coll Cardiol 2019;74:829–39.
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