title: Proximal endovascular flow blockage for cerebral protection during carotid artery stenting: results from a prospective multicenter registry.
abstract: 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.
authors.affiliation: Cardiology Department, Ospedale Civile, Mirano, Italy. emodinamica@ulss13mirano.ven.it
authors.forename: Bernhard
authors.initials: B
authors.lastname: Reimers
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: Gerhard C
authors.initials: GC
authors.lastname: Schuler
authors.forename: Thilo
authors.initials: T
authors.lastname: Tübler
authors.forename: Klaus
authors.initials: K
authors.lastname: Diederich
authors.forename: Andrej
authors.initials: A
authors.lastname: Schmidt
authors.forename: Paolo
authors.initials: P
authors.lastname: Rubino
authors.forename: Harald
authors.initials: H
authors.lastname: Mudra
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Gioacchino
authors.initials: G
authors.lastname: Coppi
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.forename: Alberto
authors.initials: A
authors.lastname: Cremonesi
authors.forename: Mathias
authors.initials: M
authors.lastname: Haufe
authors.forename: Maurizio
authors.initials: M
authors.lastname: Resta
authors.forename: Volker
authors.initials: V
authors.lastname: Klauss
authors.forename: Alberto
authors.initials: A
authors.lastname: Benassi
authors.forename: Carlo
authors.initials: C
authors.lastname: Di Mario
authors.forename: Luca
authors.initials: L
authors.lastname: Favero
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Luigi
authors.initials: L
authors.lastname: Salemme
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Biamino
mesh_terms: 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