title: Safety of carotid stenting for stroke prevention: need of an independent outcome assessor.
abstract: Safety and efficacy of carotid artery stenting have still to be fully established. We propose a standardized registry of carotid artery stenting in use at our hospital to evaluate whether the presence of an independent neurologist performing basal, procedural and post-procedural observation increases the accuracy of outcome assessment. We collected a cohort of patients receiving carotid stenting. An external neurologist supervised the endovascular intervention and monitored the patient's clinical conditions during procedure and follow-up time (12 months). The procedure was carried out successfully in all cases. We registered two intra-procedural strokes and two strokes within 24 h. The risk of major complications in our study was 9.1% at 30 days. Our complication rate is higher than in previous studies. These findings could be partly explained by the unemployment of distal protection devices, but also by the presence of an independent observer that might have increased the accuracy of neurological evaluation.
authors.affiliation: Department of Neurological Sciences (Neurology Unit), Foundation Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan University, Via Francesco Sforza, 35, 20122, Milan, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Lanfranconi
authors.forename: A
authors.initials: A
authors.lastname: Bersano
authors.forename: E
authors.initials: E
authors.lastname: D'Adda
authors.forename: E
authors.initials: E
authors.lastname: Ballabio
authors.forename: M
authors.initials: M
authors.lastname: Gattinoni
authors.forename: C
authors.initials: C
authors.lastname: Cinnante
authors.forename: P
authors.initials: P
authors.lastname: Nuzzi
authors.forename: M
authors.initials: M
authors.lastname: Isalberti
authors.forename: V
authors.initials: V
authors.lastname: Branca
authors.forename: L
authors.initials: L
authors.lastname: Candelise
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000009:adverse effects* / Q000295:instrumentation / Q000706:statistics & numerical data; D016893:Carotid Stenosis / Q000601:surgery*; D015331:Cohort Studies; D004869:Equipment Safety / Q000706:statistics & numerical data / Q000639:trends; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009462:Neurology / Q000379:methods / Q000592:standards; D015588:Observer Variation; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011183:Postoperative Complications / Q000453:epidemiology*; D011446:Prospective Studies; D012042:Registries; D015203:Reproducibility of Results; D012449:Safety / Q000592:standards / Q000706:statistics & numerical data; D015607:Stents / Q000009:adverse effects* / Q000706:statistics & numerical data; D020521:Stroke / Q000453:epidemiology* / Q000517:prevention & control; D016896:Treatment Outcome