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CAPTURE: Carotid filter may safely prevent stroke in AF
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SAN FRANCISCO — The placement of a permanent carotid filter was safe in patients with atrial fibrillation and a high stroke risk who were not suitable for oral anticoagulation, according to data from the CAPTURE trial presented at the Heart Rhythm Society Annual Scientific Sessions.
Findings from this study were also published in the Journal of the American College of Cardiology.
AF with elevated stroke risk
In this first-in-human trial, Vivek Y. Reddy, MD, director of cardiac arrhythmia services for The Mount Sinai Hospital and the Mount Sinai Health System and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn School of Medicine at Mount Sinai, and colleagues analyzed data from 25 patients (mean age, 71 years; 74% men) with persistent or permanent AF who were ineligible for oral anticoagulation and had a CHA2DS2-VASc score greater than 4. Forty-eight percent of the patients in this trial had a history of transient ischemic attack, stroke or thromboembolism.
All patients underwent a procedure with a permanent carotid coil filter (Vine, Javelin Medical) to capture emboli greater than 1.4 mm in diameter.
“This carotid coil filter is placed not through a transvascular approach as we typically perform, but actually by direct puncture into the carotid artery under ultrasound guidance,” Reddy said during the press conference. “The idea is to use ultrasound, watch the needle puncture directly into the carotid artery and then the system has a mechanism that has a motorized unit that extrudes the coil directly into the carotid artery.”
Patients were prescribed 75 mg per day clopidogrel for 3 months and 81 mg to 100 mg per day aspirin for the duration of the study. Follow-up with ultrasound imaging, neurological assessments and clinical assessments was conducted at 1 day, 1 week, 1 month, 3 months, 6 months and 12 months after the procedure.
The primary safety endpoint was device- or procedure-related major adverse events at 30 days, which was defined as a composite of stroke, death, filter migration, major bleeding, common carotid artery thrombus, common carotid artery stenosis greater than 70% or any common carotid artery complication requiring endovascular treatment or surgery. The primary feasibility endpoint was procedure success at 30 days, defined as proper filter positioning in each common carotid artery and the absence of device- or procedure-related major adverse events. Secondary endpoints were the proper positioning of the filter in each common carotid artery and the absence of device-related major adverse events at 3, 6 and 12 months, in addition to successful filter deployment attempts.
Proper bilateral positioning of the filter was seen in 92% of patients. The filter was unilaterally positioned properly in one patient because of common carotid artery atheromatous plaque that was not seen at screening.
Postprocedural events
No major adverse events occurred during the procedure. Immediately after the procedure, 20% of patients had hematoma with or without concomitant edema. In situ thombi was not seen in patients after a mean follow-up of 6 months.
Emboli was captured by the filter in four patients, which did not result in any symptoms of stroke. Subcutaneous heparin dissolved the thrombi in all patients.
One patient had consecutive minor strokes that were not related to the device.
“We were able to safely implant the carotid coil ... and there was some hint of efficacy,” Reddy said during the press conference. “Obviously, additional trials will need to be performed.” – by Darlene Dobkowski
References:
Reddy VY, et al. LBCT04-04. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 8-11, 2019; San Francisco.
Reddy VY, et al. J Am Coll Cardiol. 2019;doi:10.1016/j.jacc.2019.04.035.
Disclosures: The trial was supported by Javelin Medical. Reddy reports he has stock in and consults for Javelin Medical. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Moussa Mansour , MD, FHRS
The idea of this procedure is very intriguing. Many cases of stroke are due to small particles that come from the heart and elsewhere to the carotid arteries. Most of the current stroke prevention devices target only the left atrial appendage. But patients can have clots from places other than the LAA. If the clot comes from somewhere else in the heart or the ascending aorta, LAA closure devices will not be able to prevent it. This tool is designed to prevent any clot, regardless of where it comes from, from going to the carotid arteries. The procedure turned out to be less complicated than was expected given that it involved the carotid arteries. I was pleasantly surprised that a procedure in a very sensitive area such as the carotid artery could be performed with such a low risk for complications.
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