I still don't understand why you would medically need to stent a carotid artery or do an endarterectomy at all if the Circle of Willis is complete. (Unless the whole point is revenue and profit generation) It would seem to make more sense to just close it up and prevent problems from there. My right carotid artery was closed for 10 years and I cognitively functioned quite well with no episodes of fainting.
Didn't your competent? doctor tell you of these possible complications of endarterectomy? NO? So, your doctor isn't competent?
Possible problems:
Cognitive Dysfunction and Mortality After Carotid Endarterectomy
Carotid Interventions for Women: The Hazards and Benefits
Female Gender Increases Risk of Stroke and Readmission after CEA(Carotid endarterectomy) and CAS(carotid artery stenting)
Ticagrelor Induced Angioedema Following Carotid Artery Stenting
Cognitive Dysfunction and Mortality After Carotid Endarterectomy
Here is why your doctor needs to GUARANTEE NO complications from stenting!
stenting (22 posts to May 2011)
carotid stenting (21 posts to May 2016)
carotid artery stenting (7 posts to November 2021)
The latest here:
'Doubly Protected' Carotid Stenting Makes Stroke Less of a Risk
New stent-filter combination expected to boost carotid artery stenting
WASHINGTON -- The Neuroguard carotid stent system, with its integrated embolic filter, continued to show good results at 2 years for people with carotid artery stenosis deemed poor candidates for surgery, based on the PERFORMANCE II study.
After carotid artery stenting (CAS) with this system, there were zero instances of major stroke, neurological death, or stent thrombosis at the 2-year mark, while the incidence of target lesion revascularization (TLR) reached 2.7% (clinically-driven TLR 0.4%) and in-stent restenosis 3.9%, reported D. Chris Metzger, MD, of OhioHeart/Riverside Methodist Hospital in Columbus.
"Outcomes through 30 days and 1 year include the lowest 1-year stroke rates reported for any prospective, multicenter pivotal trial of carotid artery stenting, regardless of patient risk and high rate of diabetes and severe calcification," Metzger said at the Society for Cardiovascular Angiography and Interventions (SCAI) annual meeting. "The Neuroguard stent continues to perform well at 2 years, and the in-stent velocities remain low across all patient populations."
Notably, the Neuroguard system already received FDA approval for carotid revascularization in October based on 1-year results of PERFORMANCE II and an earlier study, PERFORMANCE I.
Will Carotid Stenting Get a Larger Slice of the Pie?
CAS is a minimally invasive alternative to carotid endarterectomy (CEA) for the treatment of carotid stenosis, an important cause of stroke.
Session moderator and SCAI past president Sunil Rao, MD, of NYU Langone Health in New York City, said he wondered if the ongoing innovation in CAS, along with recent improvements in CMS coverage, would make carotid stenting more routine than it has been.
Metzger said that change takes time in this space dominated by vascular surgery, but he predicted that CAS will ultimately show some growth over CEA.
What the Neuroguard device offers is additional protection against the embolic brain lesions that frequently arise after carotid stenting, with no need for catheter exchanges. While Neuroguard CAS can be expected to apply to most cases, there are nevertheless some anatomic factors like severe tortuosity, size, and position of the lesion, that would make CEA the better option, Metzger cautioned.
The Achilles heel of CAS has long been its association with periprocedural embolic cerebral complications compared with CEA. The CREST trial, for example, showed in 2010 that CAS and CEA had similar short- and longer-term outcomes in symptomatic and asymptomatic individuals at average surgical risk, though there was a disadvantage to CAS in its excess periprocedural strokes.
Since then, CAS technology has advanced -- with embolic protection among other improvements -- to the point that in 2023, CMS agreed to expand reimbursement for CAS(transfemoral CAS and transcarotid artery revascularization) to be on par with CEA. Before that, patients had to check the boxes for high surgical risk, symptomatic stenosis, and a stenosis of at least 70% for payment.
Neuroguard comprises a post-dilation balloon, integrated embolic filter (with 40-µm filter pores to capture microemboli), and a carotid stent. Study protocol mandated use of a standard, commercially available distal embolic protection device (EPD) that was placed before the Neuroguard system was advanced over the wire of the primary EPD (Neuroguard's own filter followed by its attached nitinol closed cell stent).
Metzger said Neuroguard patients are thus "doubly protected" as backed by the minor stroke rate now down to 1%.
He and the FDA cautioned that in practice, however, a separate EPD should still be used in tandem with the Neuroguard.
PERFORMANCE II Details
This was a multicenter single-arm study that enrolled 305 people who got the Neuroguard at 32 U.S. and European centers. Investigators sought people who were symptomatic with 50%-plus carotid artery stenosis, or asymptomatic with 80%-plus stenosis. Candidates had to have at least one risk factor marking them at higher surgical risk.
The cohort averaged age 69.6 and 65.9% were men. About 20% were symptomatic, 43% had diabetes, 10.5% had had a previous carotid endarterectomy, and 35.9% a prior coronary stenting or angioplasty.
The target lesion was in the internal carotid artery (ICA) alone in about 80% of cases; the remaining cases represented the ICA plus common carotid artery. Cases were roughly split between left- and right-side lesions.
Across study cases, the Emboshield NAV6 was the most commonly used primary EPD (80.7%), followed by FilterWire EZ (10.5%) and SpiderFX (8.9%).
Operators utilized pre-dilatation for nearly 64% of Neuroguard system placements.
PERFORMANCE II's primary outcome, 30-day periprocedural death, stroke, or myocardial infarction plus 12-month ipsilateral stroke, had come out to 2.8% on intention-to-treat analysis and 2.5% per-protocol.
Looking ahead, the CREST 2 trial is expected to provide a more contemporary comparison of CAS versus CEA. The study has completed enrollment of nearly 2,500 people and consists of two parallel tracks, one with patients randomized to intensive medical therapy or CEA, and the other intensive medical therapy or CAS.
![author['full_name']](https://assets.medpagetoday.net/media/images/author/nicoleLou_188.jpg)
Disclosures
The study was funded by Contego Medical.
Metzger disclosed personal honoraria from Abbott, Contego Medical, Boston Scientific, Medtronic, Penumbra, and Shockwave, as well as stock options from Inspire MD.
Rao had no disclosures.
Primary Source
Society for Cardiovascular Angiography and Interventions
Source Reference: Metzger DC "The PERFORMANCE II trial: a prospective multicenter single arm investigation of the Neuroguard IEP 3 in-1 carotid stent system with integrated embolic protection. Stent durability and patency at 2 years" SCAI 2025.
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