Permanent Percutaneous Carotid Artery Filter to Prevent Stroke in Atrial Fibrillation Patients The CAPTURE Trial

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F19%3A00008242" target="_blank" >RIV/00023884:_____/19:00008242 - isvavai.cz</a>

Result on the web

<a href="http://www.onlinejacc.org/content/74/7/829" target="_blank" >http://www.onlinejacc.org/content/74/7/829</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jacc.2019.04.035" target="_blank" >10.1016/j.jacc.2019.04.035</a>

Result language

angličtina

Original language name

Permanent Percutaneous Carotid Artery Filter to Prevent Stroke in Atrial Fibrillation Patients The CAPTURE Trial

Original language description

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, CHA(2)DS(2)-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, CHA(2)DS(2)-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/procedurerelated 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) (C) 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30201 - Cardiac and Cardiovascular systems

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2019

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Journal of the American College of Cardiology

ISSN

0735-1097

e-ISSN

—

Volume of the periodical

74

Issue of the periodical within the volume

7

Country of publishing house

US - UNITED STATES

Number of pages

11

Pages from-to

829-839

UT code for WoS article

000480387100002

EID of the result in the Scopus database

2-s2.0-85071350433