Proximal endovascular flow blockage for cerebral protection during carotid artery stenting: results from a prospective multicenter registry.
OBJECTIVE
To evaluate the feasibility of cerebral protection during carotid artery stenting (CAS) using the Mo.Ma device, which prevents cerebral embolization by proximal endovascular blockage of blood flow in the internal and external carotid arteries.


METHODS
In 14 European centers, 157 patients (121 men; mean age 68.0+/-8.3 years) were enrolled in a prospective registry between March 2002 and March 2003. Eligible patients had a symptomatic (>50%) or asymptomatic (>70%) stenosis of the internal carotid artery suitable for carotid stenting. Protected carotid stenting was performed with the Mo.Ma system, which occludes both the common and external carotid arteries via 2 independently inflatable compliant low-pressure balloons before any device is advanced across the lesion. Blood is aspirated through the catheter intermittently or at the end of the procedure.


RESULTS
The device was successfully positioned and stents were implanted in all cases. Diameter stenosis was reduced from 84.1%+/-7.8% to 6.7%+/-5.1%. The mean duration of flow blockage was 7.6+/-5.9 minutes. In 12 (7.6%) patients, transient intolerance to flow blockade was observed, but the procedures were completed successfully. In 124 (79.6%) cases, there was macroscopic evidence of debris after filtering the aspirated blood. In-hospital complications included 4 (2.5%) minor strokes, 8 (5.1%) transient ischemic attacks, no deaths, and no major strokes, resulting in a 2.5% death/stroke rate at discharge. At 30-day follow-up, there was 1 cardiac death, 1 major stroke, and 3 minor strokes, for an overall 5.7% 30-day death/stroke rate and a 30-day major stroke and death rate of 1.3%.


CONCLUSIONS
Cerebral protection with proximal endovascular blood flow blockage during CAS is feasible, with a high procedural success rate.
Reimers
Bernhard
B
Cardiology Department, Ospedale Civile, Mirano, Italy. emodinamica@ulss13mirano.ven.it
Sievert
Horst
H
Schuler
Gerhard C
GC
Tübler
Thilo
T
Diederich
Klaus
K
Schmidt
Andrej
A
Rubino
Paolo
P
Mudra
Harald
H
Dudek
Dariusz
D
Coppi
Gioacchino
G
Schofer
Joachim
J
Cremonesi
Alberto
A
Haufe
Mathias
M
Resta
Maurizio
M
Klauss
Volker
V
Benassi
Alberto
A
Di Mario
Carlo
C
Favero
Luca
L
Scheinert
Dierk
D
Salemme
Luigi
L
Biamino
Giancarlo
G
D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation*; D016893:Carotid Stenosis / Q000601:surgery*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D015607:Stents; D016896:Treatment Outcome