A novel carotid device for embolic diversion: lessons learned from a "first in man" trial in patients with atrial fibrillation.
OBJECTIVE
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.
CardioVascular Center Frankfurt, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany. info@cvcfrankfurt.de
Horst
H
Sievert
Jennifer
J
Franke
Ygael
Y
Grad
Boaz
B
Nishri
Yaron
Y
Assaf
Ofer
O
Yodfat
Albrecht
A
Römer
Greg C
GC
Robertson
Gregg W
GW
Stone
D000369:Aged, 80 and over; D017536:Carotid Artery, Common / Q000000981:diagnostic imaging* / Q000601:surgery*; D016893:Carotid Stenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D057505:Embolic Protection Devices; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011859:Radiography; D020521:Stroke / Q000517:prevention & control; D016896:Treatment Outcome; D014463:Ultrasonography; D014654:Vascular Patency