PURPOSE OF REVIEW: A novel permanent carotid filter device for percutaneous implantation was developed for the purpose of stroke prevention. In this review, we cover rationale, existing preclinical and clinical data, and potential future directions for research using such a device. RECENT FINDINGS: The Vine™ filter was assessed for safety in sheep and in 2 observational human studies, the completed CAPTURE 1 (n = 25) and the ongoing CAPTURE 2 (planned n = 100). CAPTURE 1 has shown high procedural and long-term implant safety. A control group was not available for comparison. A mechanical filter for permanent stroke prevention can be implanted bilaterally in the common carotid artery safely and efficiently. A randomized trial is planned for 2021 (n = 3500, INTERCEPT) to demonstrate superiority of a filter + anticoagulation strategy over anticoagulation alone in patients at high risk for ischemic stroke.

• MeSH
• arteria carotis communis MeSH
• cévní mozková příhoda * etiologie   prevence a kontrola   MeSH
• fibrilace síní * komplikace   MeSH
• lidé MeSH
• ovce MeSH
• protézy a implantáty MeSH
• výsledek terapie MeSH
• zvířata MeSH
• Check Tag
• lidé MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

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, CHA2DS2-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, CHA2DS2-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/procedure-related 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).

• MeSH
• antikoagulancia terapeutické užití   MeSH
• arteria carotis communis * diagnostické zobrazování   MeSH
• Aspirin terapeutické užití   MeSH
• cévní mozková příhoda prevence a kontrola   MeSH
• fibrilace síní komplikace   MeSH
• fibrinolytika terapeutické užití   MeSH
• heparin terapeutické užití   MeSH
• inhibitory agregace trombocytů terapeutické užití   MeSH
• injekce subkutánní MeSH
• intervenční ultrasonografie MeSH
• klopidogrel terapeutické užití   MeSH
• lidé MeSH
• plicní embolie prevence a kontrola   MeSH
• pomůcky zabraňující embolii * MeSH
• primární prevence přístrojové vybavení   MeSH
• prospektivní studie MeSH
• senioři MeSH
• tromboembolie diagnostické zobrazování   farmakoterapie   prevence a kontrola   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• audiovizuální média MeSH
• časopisecké články MeSH
• klinické zkoušky MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH