title: Carotid artery stenting protected with an emboli containment system.
abstract: OBJECTIVE
  Fear of distal embolization and stroke has aroused concern regarding carotid stenting. Devices to protect the cerebral circulation may make carotid stenting safer.
  
  
  METHODS
  A multidisciplinary study group tested a balloon occlusion-aspiration emboli entrapment device in conjunction with carotid stenting. The device consists of an elastomeric balloon on a steerable wire with a detachable adapter that inflates and deflates the distal temporary occlusion balloon. An aspiration catheter is used to remove trapped emboli after stenting and before occlusion balloon deflation.
  
  
  RESULTS
  Seventy-five patients with severe internal carotid artery stenosis were treated with stents deployed with this cerebrovasculature protection system. All 75 patients (100%) had grossly visible particulate material aspirated, and all were treated successfully without major or minor stroke or death at 30 days. Preintervention stenosis was 81+/-10%, and residual stenosis was 5+/-7%. Nine patients (12%) had angiographic evidence of thrombus before intervention, but no patient had thrombus or vessel cutoff after the procedure. Four patients (5%) developed transient neurological symptoms during protection balloon occlusion, but symptoms resolved with balloon deflation. The 22 to 667 particles aspirated per patient ranged from 3.6 to 5262 microm in maximum diameter (mean, 203+/-256 microm). These particles included fibrous plaque debris, lipid or cholesterol vacuoles, and calcific plaque fragments.
  
  
  CONCLUSIONS
  Protected carotid stenting was performed successfully and safely in this study early in the experience with cerebrovascular protection devices. Particulate emboli are frequent with stenting, and cerebral protection will likely be necessary to minimize stroke. Randomized trials comparing protected carotid stenting with endarterectomy are warranted.
authors: Department of Cardiology, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. whitlop@ccf.org
authors: Patrick L
authors: PL
authors: Whitlow
authors: Pedro
authors: P
authors: Lylyk
authors: Hugo
authors: H
authors: Londero
authors: Oscar A
authors: OA
authors: Mendiz
authors: Klaus
authors: K
authors: Mathias
authors: Horst
authors: H
authors: Jaeger
authors: Juan
authors: J
authors: Parodi
authors: Claudio
authors: C
authors: Schönholz
authors: Jose
authors: J
authors: Milei
mesh_terms: D000368:Aged; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D002339:Carotid Arteries / Q000473:pathology / Q000601:surgery; D016893:Carotid Stenosis / Q000473:pathology / Q000601:surgery*; D002404:Catheterization / Q000295:instrumentation* / Q000379:methods; D005260:Female; D005374:Filtration / Q000295:instrumentation; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D020766:Intracranial Embolism / Q000517:prevention & control*; D002546:Ischemic Attack, Transient / Q000209:etiology; D008297:Male; D010316:Particle Size; D015607:Stents; D013927:Thrombosis / Q000473:pathology / Q000517:prevention & control / Q000601:surgery; D016896:Treatment Outcome