Use of the Parodi anti-embolism system in carotid stenting: Italian trial results.
OBJECTIVE
To investigate the safety and efficacy of the Parodi anti-embolism system (PAES) in establishing flow reversal in the internal carotid artery (ICA) as a means of protecting against embolic phenomena during carotid stenting.


METHODS
Seven centers participated in a nonrandomized, prospective trial of carotid angioplasty and stenting under PAES protection in 30 patients (22 men; mean age 72 years, range 49-88) with 15 symptomatic (>70%) and 15 asymptomatic (>80%) stenotic ICAs. Safety was defined as achieving sufficient brain oxygenation during flow reversal as determined by level of awareness and motor control. The presence of new or enhanced neurological deficits and death were endpoints. Performance was based on angiographic evidence of successful retrograde flow.


RESULTS
The PAES was positioned in all 30 patients, but technical error and access-related difficulties prevented establishment of reversed flow in 2. Among the 28 (93%) patients treated under PAES protection, 1 patient developed aphasia after flow reversal, necessitating balloon deflation between subsequent stages of the procedure. Three other adverse events included 1 case of bradycardia and 2 cases of hypotension, with dysarthria and facial paresis in one and temporary loss of consciousness in the other. All events resolved with appropriate therapy, and there was no change from baseline in the neurological status or brain scans at 24 hours. There were no strokes or neurological deficits at 30 days.


CONCLUSIONS
The PAES appears to be a safe and effective means of providing protection from embolic complications during carotid stenting.
Adami
Carlo A
CA
Department of Vascular Surgery, University of Verona, Italy. capigneto@tin.it
Scuro
Alberto
A
Spinamano
Luca
L
Galvagni
Elisabetta
E
Antoniucci
Davide
D
Farello
Gian A
GA
Maglione
Franco
F
Manfrini
Stefano
S
Mangialardi
Nicola
N
Mansueto
Gian C
GC
Mascoli
Francesco
F
Nardelli
Ettore
E
Tealdi
Domenico
D
D000368:Aged; D002340:Carotid Artery Diseases / Q000628:therapy*; D002343:Carotid Artery, Internal; D002404:Catheterization; D016894:Endarterectomy, Carotid; D005260:Female; D006801:Humans; D020766:Intracranial Embolism / Q000517:prevention & control*; D008297:Male; D011446:Prospective Studies; D015607:Stents