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| |  New Embolic Protection Device Yields Good Results During Carotid Stenting Procedures: Presented at SIR By Thomas R. Collins TAMPA, Fla -- March 16, 2010 -- A new cerebral protection device proved to be safe and effective during carotid artery stenting in patients considered to be at high surgical risk, according to results presented here at the Society of Interventional Radiology (SIR) 35th Annual Scientific Meeting. The cerebral protection device demonstrated particularly good results in the very elderly, said Barry Katzen, MD, FSIR, Baptist Cardiac and Vascular Institute, Miami, Florida, in a presentation on March 14. The rate of major adverse cardiac and cerebrovascular events (MACCE) was 2.7% after 30 days, compared with a typical MACCE rate of 13% in previous carotid stenting trials, with the major stroke rate after 30 days at about 1%. “The ARMOUR trial in the United States and Europe confirmed the safety and efficacy of Mo.Ma’s proximal protection in carotid angioplasty and stenting in this higher-risk-for-surgery cohort,” Dr. Katzen said. “[The device] has also demonstrated to be relatively facile to use, although it is associated with an increased device size compared to other embolic protection devices using filters.” This was a multicentre trial. Twenty of the centres in the study were in the United States, and 5 were in Europe. The study included 225 subjects. The average age was 75 years, with 56% aged >=75 years and 29% >=80 years. The device uses endovascular clamping. The external carotid artery is also clamped to prevent retrograde flow to avoid risk to the brain from embolic debris. “The idea is to protect the brain by avoiding any blood flow going antegrade to the ipsilateral hemisphere at the time of intervention,” Dr. Katzen said. “The so-called common carotid artery clamping is accomplished by a balloon occlusion, and all antegrade flow is blocked.” Intermittent aspiration was performed, and debris was collected in 44% of cases. A 94.6% technical success rate and a 93.2% procedural success rate were achieved. After 30 days, the myocardial infarction rate was <1% in the intent-to-treat group. The overall major adverse cardiac and cerebrovascular event rate was 2.7%, with 2.3% of the intent-to-treat subjects suffering stroke and 0.9% of those being major; 0.9% of patients died. Dr. Katzen said the results among patients aged >=80 years were particularly impressive. “The AHA [American Heart Association] guidelines are 3% for asymptomatic and 6% for symptomatic [patients], and these are octogenarians that are at 3.1%, which is, I think, an excellent outcome.” Funding for this study was provided by Invatec. [Presentation title: Use of the INVATEC Mo.Ma Proximal Cerebral Protection Device During Carotid Stenting (The ARMOUR Trial). Abstract 42]
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