A novel procedure in which permanent coils are implanted into both common carotid arteries (CCAs) to capture emboli >1.4 mm diameter was feasible and safe in a small cohort of patients with atrial fibrillation (AFib) at high risk of stroke. Findings from this first-in-human study were presented at the Heart Rhythm Scientific Sessions in San Francisco, and simultaneously published in the Journal of the American College of Cardiology.

The CAPTURE study, conducted by Vivek Y. Reddy, MD, et al., assessed 25 patients with AFib who were unsuitable for oral anticoagulation and with CHA2DS2-VASc ≥2. The primary safety endpoint was device or procedure-related major adverse events (MAE) at 30 days. The primary feasibility endpoint was procedure success along with proper filter positioning in each CCA, also at 30 days.

Overall, 23 of the 25 patients (92 percent) received properly positioned filters bilaterally. Of the remaining two patients, one received a properly positioned filter unilaterally and the other underwent an unsuccessful procedure attempt due to poor ultrasonic visibility. Additionally, the filter captured six thromboemboli in four patients, none of whom developed stroke symptoms.

Researchers noted an overall per-patient procedural success rate of 92 percent and an 84 percent rate of successful filter deployment. At 30 days, the MAE rate was 0 percent, with minor adverse events occurring in five patients (20 percent). "During an average follow-up of 6 months, there was no evidence of in situ thrombus formation or CCA stenosis," researchers said.

Moving forward, Reddy and colleagues said the CAPTURE findings suggest "deployment of a permanent coil filter in the human CCA is feasible and safe." However, they note the small sample size with only a few operators are limitations to the study. "Indeed, this non-randomized first-in-human trial is best interpreted as a proof-of-concept study requiring further randomized trials to adequately establish the therapy's place in clinical practice," they said.

Clinical Topics: Arrhythmias and Clinical EP, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Atrial Fibrillation, Constriction, Pathologic, Ultrasonics, Thromboembolism, Embolism, Stroke, Contracture, Arachnodactyly, Thrombosis, Carotid Artery, Common

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