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(Stroke. 2002;33:1308.)
© 2002 American Heart Association, Inc.

Original Contributions

Carotid Artery Stenting Protected With an Emboli Containment System

Patrick L. Whitlow, MD; Pedro Lylyk, MD; Hugo Londero, MD; Oscar A. Mendiz, MD; Klaus Mathias, MD; Horst Jaeger, MD; Juan Parodi, MD; Claudio Schönholz, MD Jose Milei, MD

From the Department of Cardiology, The Cleveland Clinic Foundation, Cleveland, Ohio (P.L.W.); Department of Neuroradiology, ENERI, Buenos Aires, Argentina (P.L.); Department of Cardiology, Fundacion Favaloro, Buenos Aires, Argentina (H.L., O.A.M.); Department of Radiology, Stadtische Kliniken Dortmund Academic Teaching Hospital, Dortmund, Germany (K.M., H.J.); Department of Vascular Surgery, Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina (J.P.); Department of Interventional Radiology, Clinica Sagrada Familia, Buenos Aires, Argentina (C.S.); and Department of Pathology, Cardiopsis-Conicet, Buenos Aires, Argentina (J.M.).

Correspondence to Patrick L. Whitlow, MD, Director, Interventional Cardiology, Department of Cardiology, F25, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195. E-mail whitlop{at}ccf.org

Background and Purpose— 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 µm in maximum diameter (mean, 203±256 µm). 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.

Key Words: carotid artery diseases • carotid endarterectomy • stents • stroke

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