Patients with atrial fibrillation (AF) unsuitable for anticoagulation because of bleeding risk, require other strategies to prevent stroke. For some years, there have been in the market (limited to some places; not as part of the regular agenda of cardiologists and hematologists) devices to occlude the atrium that have been proved safe and effective.
These new devices are a completely different. They are permanent filters placed directly in both carotid arteries and are designed to capture >1.4 mm emboli.
This non-randomized, multicenter study has shown for the first time in humans the feasibility and safety of implanting this bilateral filter in patients with AF, high bleeding risk (CHA2DS2-VASc ≥ 2) unsuitable for anticoagulation, with common carotid arteries between 4.8 and 9.8 mm and stenosis < 30%.
Under ultrasound guidance and after direct puncture of the carotid with a 24 G needle, the filter is unfurled in the artery with a motorized system. All patients received aspirin and clopidogrel for 3 months, and aspirin thereafter.
Primary end points were procedural success (correct implantation of filter in both carotids) and composite of events at 30 days (death, stroke, major bleeding, filter migration, thrombus formation or stenosis). Ultrasound follow-up was carried out immediately after procedure, prior to discharge, at one week, one month and 3, 6 and 12 months.
The study included 25 patients with mean CHA2DS2-VASc of 4.4 ± 1, half of them had presented prior embolism.
Procedural success was 92%, in one patient, the device could be deployed only in one artery. There were no procedure related major events, only 20% of hematomas were puncture related.
After 6 months, no patients formed thrombi inside the filter, but 4 did capture emboli (one bilateral); none of these patients developed symptoms.
In all patients, thrombi were reabsorbed using low molecular weight heparin for some time. There were 2 minor strokes, but not in carotid territory.
Conclusión
The implantation of permanent carotid filters to prevent strokes is technically feasible and safe.
Original Title: A Percutaneous Permanent Carotid Filter for Stroke Prevention in Atrial Fibrillation: The CAPTURE Trial.
Reference: Vivek Y et al. Journal of the American College of Cardiology (2019). ACCEPTED MANUSCRIPT.
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