Feasibility and efficacy of balloon-based neuroprotection during carotid artery stenting in a single-center setting. - Feasibility and efficacy of balloon-based neuroprotection during carotid artery stenting in a single-center setting.

Oct 04, 2002
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Date Presented:
01/01/2002
Date Published:
01/01/2002
Date Updated:
10/04/2002
Original Posted Date:
10/04/2002
References

Description:

The authors sought to evaluate the feasibility and in-hospital efficacy of the PercuSurge GuardWire temporary balloon-occlusive system for neuroprotection during carotid angioplasty and stenting (CAS).

Study Design

Study Design:

Patient Populations:

Carotid bifurcation disease undergoing carotid stenting

Drug/Procedures Used:

The study design was a prospective registry of 96 consecutive patients with carotid bifurcation disease. These 96 patients underwent a total of 102 CAS procedures with the intention to use the GuardWire for neuroprotection.

Principal Findings:

GuardWire deployment was achieved in 99 procedures performed in 93 patients with a success rate of 97%. Device failure (n = 3) and severe neurologic responses to balloon occlusion of the targeted carotid artery (n = 2) accounted for five additional procedures that were performed without neuroprotection. Thus a total of 94 procedures were performed as intended in 88 patients (92% feasibility rate). There were no in-hospital deaths; but three patients (3.1%) sustained strokes, and two patients experienced transient ischemic attacks, for a total periprocedural complication rate of 5.2%. One major stroke occurred with the GuardWire in place, whereas two minor strokes were observed in patients in whom the device could not be deployed. Thus, successful neuroprotected CAS without major neurologic events was achieved in 87 patients (91%).

Interpretation:

Among patients with carotid bifurcation disease undergoing carotid stenting, the GuardWire temporary balloon-occlusive system is technically feasible as an adjunct in the majority of patients and associated with a 3.1% rate of major periprocedural neurologic complications. Adverse neurologic reactions to balloon occlusion may prohibit effective use of the system in only 2% of patients. Carotid angioplasty and stenting is emerging as an alternative to endarterectomy and is being evaluated in a number of prospective trials. A major concern with this procedure as well as endarterectomy is distal embolization as even a small embolus may have disastrous consequences in the cerebral circulation. A variety of neuroprotective devices are currently being investigated as an adjunct to carotid stenting. The present study is a prospective registry of consecutive patients undergoing carotid stenting using one of the currently available neuroprotective devices, the PercuSurge GuardWire temporary balloon-occlusive system. This study demonstrated that the device can be placed successfully in most patients and associated with a low peri-procedural complication rate. However, the study did not demonstrate a significant decrease in peri-procedural complications compared to prior studies with unprotected carotid stenting. Demonstration of such a benefit may require an adequately powered randomized trial.

References:

Schlüter M, Tübler T, Mathey DG, Schofer J. Feasibility and efficacy of balloon-based neuroprotection during carotid artery stenting in a single-center setting. J Am Coll of Cardiol 2002; 40: 890-895.

Keywords: Endarterectomy, Carotid Artery, Common, Stroke, Ischemic Attack, Transient, Balloon Occlusion, Embolism, Angioplasty, Equipment Failure, Stents


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