A Novel Carotid Device for Embolic Diversion: Lessons Learned from a 'First in Man' Trial in Patients with Atrial Fibrillation

Journal Article · Sun Apr 15 00:00:00 EDT 2012 · Cardiovascular and Interventional Radiology

DOI:https://doi.org/10.1007/S00270-011-0290-Z· OSTI ID:21608548

Sievert, Horst; Franke, Jennifer ^[1]; Grad, Ygael; Nishri, Boaz; Assaf, Yaron; Yodfat, Ofer ^[2]; Roemer, Albrecht; Robertson, Greg C ^[1]; Stone, Gregg W ^[3]

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1. CardioVascular Center Frankfurt (Germany)
2. Tel-Aviv University, Faculty of Engineering (Israel)
3. Columbia University Medical Center, Cardiovascular Research Foundation (United States)

Purpose: This study was designed to investigate a novel device that was developed to direct emboli away from the internal carotid artery to the external carotid artery to prevent embolic stroke while avoiding the necessity for anticoagulation with warfarin. Methods: A stent-like, self-expandable filter was developed consisting of fine cobalt alloy mesh. After promising preclinical animal testing, the device was implanted into the common carotid artery extending into the external carotid artery in three patients with atrial fibrillation, each of whom were at high-risk for cerebral emboli and were suboptimal candidates for anticoagulation. Follow-up was performed clinically and with carotid duplex ultrasound. Results: The implantation was successful in all three patients. Unrestricted flow through the filter was demonstrated in each patient at 6 months by duplex sonography. However, at 7 months ultrasound demonstrated occlusion of the internal carotid artery filter in one patient, which was subsequently confirmed by angiography. Subtotal filter occlusion occurred in a second patient at 14 months. Neither patient had clinical symptoms. Both internal carotid arteries were successfully recanalized using standard angioplasty techniques without complication. The third patient had completely normal carotid blood flow at 29 months follow-up. Conclusions: Implantation of a novel device intended to divert emboli away from the internal carotid artery was feasible, but resulted in occlusive neointimal proliferation in two of three patients. These results demonstrate a discrepancy from the findings of preclinical animal studies and human investigation.

• OSTI ID: 21608548
• Journal Information: Cardiovascular and Interventional Radiology, Vol. 35, Issue 2; Other Information: DOI: 10.1007/s00270-011-0290-z; Copyright (c) 2012 Springer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); Country of input: International Atomic Energy Agency (IAEA); ISSN 0174-1551
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
BIOMEDICAL RADIOGRAPHY
BLOOD FLOW
CAROTID ARTERIES
COBALT ALLOYS
EMBOLI
FILTERS
HAZARDS
MAN
PATIENTS
PROLIFERATION
SYMPTOMS
ALLOYS
ANIMALS
ARTERIES
BLOOD VESSELS
BODY
CARDIOVASCULAR SYSTEM
DIAGNOSTIC TECHNIQUES
MAMMALS
MEDICINE
NUCLEAR MEDICINE
ORGANS
PRIMATES
RADIOLOGY
TRANSITION ELEMENT ALLOYS
VERTEBRATES