Mesh-covered (Roadsaver) stent as a new treatment modality for symptomatic or high-risk carotid stenosis

Machnik, Roman; Paluszek, Piotr; Tekieli, Łukasz; Dzierwa, Karolina; Maciejewski, Damian; Trystuła, Mariusz; Brzychczy, Andrzej; Banaszkiewicz, Krzysztof; Musiał, Robert; Pienia̦żek, Piotr

doi:10.5114/pwki.2017.68139

Cited by 15 publications

(17 citation statements)

References 15 publications

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“…The article by Machnik et al [ 62 ] in the current issue of the Journal provides an important contribution to the growing clinical evidence for a low neurological complication rate with the novel mesh-covered [ 10 , 69 ] carotid stents. The single stroke in the series of mainly symptomatic (51.2%) patients, treated by these operators [ 62 ] using the Roadsaver/Casper stent [ 71 , 72 ] under predominantly proximal (65.8%) embolic protection, was a minor stroke that occurred after the common carotid artery cannulation with guiding catheter, i.e. prior to stent insertion and implantation [ 62 ].…”

Section: Mesh-covered Carotid Stents: Accumulating Clinical Evidencementioning

confidence: 99%

“…The single stroke in the series of mainly symptomatic (51.2%) patients, treated by these operators [ 62 ] using the Roadsaver/Casper stent [ 71 , 72 ] under predominantly proximal (65.8%) embolic protection, was a minor stroke that occurred after the common carotid artery cannulation with guiding catheter, i.e. prior to stent insertion and implantation [ 62 ].…”

Section: Mesh-covered Carotid Stents: Accumulating Clinical Evidencementioning

confidence: 99%

“…With the patient series by Machnik et al [ 62 ], the present body of clinical evidence has grown, considering studies that included at last 30 patients, to 551 CAS patients treated with mesh-covered carotid stents. This involved 190 subjects treated with Roadsaver/Casper [ 6 , 7 , 62 ] and 361 CAS patients treated using CGuard EPS [ 5 , 60 , 61 , 63 ].…”

Section: Mesh-covered Carotid Stents: Accumulating Clinical Evidencementioning

confidence: 99%

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One swallow does not a summer make but many swallows do: accumulating clinical evidence for nearly-eliminated peri-procedural and 30-day complications with mesh-covered stents transforms the carotid revascularisation field

Musiałek

Hopkins

Siddiqui

2017

pwki

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Atherosclerotic carotid artery stenosis (CS) continues to be a common cause of acute ischaemic stroke. Optimised medical therapy (OMT), the first-line treatment modality in CS, may reduce or delay – but it does not abolish – CS-related strokes. As per current AHA/ASA and ESC/ESVS/ESO guidelines, carotid artery stenting (CAS) is a less-invasive alternative to carotid endarterectomy (CEA) for CS revascularisation in primary and secondary stroke prevention.Ten-year follow-up from the CREST trial in patients with symptomatic and asymptomatic CS confirmed equipoise of CAS and CEA in the primary endpoint. Nevertheless CAS – using a widely open-cell, first-generation stent and first-generation (distal/filter) neuroprotection – has been criticised for its relative excess of (mostly minor) strokes by 30 days, a significant proportion of which were post-procedural.Atherosclerotic plaque protrusion through conventional carotid stent struts, confirmed on intravascular imaging, has been implicated as a leading mechanism of the relative excess of strokes with CAS vs. CEA, including delayed strokes with CAS. Different designs of mesh-covered carotid stents have been developed to prevent plaque prolapse. Several multi-centre/multi-specialty clinical studies with CGurad MicroNet-Covered Embolic Prevention Stent System (EPS) and RoadSaver/Casper were recently published and included routine DW-MRI cerebral imaging peri-procedurally and at 30 days (CGuard EPS).Data from more than 550 patients in mesh-covered carotid stent clinical studies to-date show an overall 30-day complication rate of ~1% with near-elimination of post-procedural events. While more (and long-term) evidence is still anticipated, these results – taken together with optimised intra-procedural neuroprotection in CAS (increased use of proximal systems including trans-carotid dynamic flow reversal) and the positive 12-month mesh-covered stent data reports in 2017 – are transforming the carotid revascularisation field today.Establishing effective algorithms to identify the asymptomatic subjects at stroke risk despite OMT, and large-scale studies with mesh-covered stents including long-term clinical and duplex ultrasound outcomes, are the next major goals.

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Section: Mesh-covered Carotid Stents: Accumulating Clinical Evidencementioning

confidence: 99%

Section: Mesh-covered Carotid Stents: Accumulating Clinical Evidencementioning

confidence: 99%

Section: Mesh-covered Carotid Stents: Accumulating Clinical Evidencementioning

confidence: 99%

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One swallow does not a summer make but many swallows do: accumulating clinical evidence for nearly-eliminated peri-procedural and 30-day complications with mesh-covered stents transforms the carotid revascularisation field

Musiałek

Hopkins

Siddiqui

2017

pwki

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“…Today we have a new generation of mesh stents, which can be used safely in high-risk lesions. First reports with Roadsaver and CGuard mesh stents are extremely promising due to their very low 30-day complication rates [6,7,17].…”

Section: %Ds -% Diameter Stenosis Nascet -North American Symptomaticmentioning

confidence: 99%

“…However, balloon-expandable metal stents are preferred for the treatment of ostial common carotid artery (CCA) stenosis and brachiocephalic trunk stenosis. Another option is the use of so-called mesh-covered stents, which may be a solution to eliminate late embolic complications after CAS [6,7]. However, these stents still require further long-term evaluation.…”

Section: Introductionmentioning

confidence: 99%

Prospective multicentre study of carotid artery stenting using the MER™ Stent – the OCEANUS study – 30-day and one-year follow-up results

Pienia̦żek¹,

Nowakowski²,

Ziaja³

et al. 2020

pwki

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A b s t r a c t Introduction: Constant technological progress in the field of carotid stenting translates into improved short-and long-term results of endovascular treatment. The introduction of a new generation, self-expanding, open-cell stent has provided a new treatment option in endovascular management of carotid stenosis. Aim: To evaluate 30-day and 1-year clinical outcomes of non-consecutive patients with high risk of carotid endarterectomy, who underwent 5F cylinder-tapered MER™ open-cell carotid stent implantation.Material and methods: It was a single-arm, prospective study conducted in four experienced catheterisation centres. The use of embolic protection devices was mandatory. The primary endpoint was stroke in 30-day follow-up. The secondary endpoints were 30day and 1-year cumulative incidence of death, stroke and myocardial infarction, 1-year target vessel revascularisation, procedural success (residual stenosis ≤ 30%), restenosis rate (%DS ≥ 50%), and Serious Adverse Device Effect (SADE) rate in 1-year follow-up.Results: In total 100 patients were recruited for the study, with the majority being males (n = 61). The mean age was 68.3 ±8.2 years, and most of the patients were asymptomatic (n = 56). In 55 (55%) patients direct stenting was performed, with the use of proximal protection devices in 19 (19%) patients. Mean internal carotid artery/common carotid artery stenosis before and after stent implantation was 81.98 ±9.15% and 12.52 ±8.70%, respectively (p < 0.001). Procedural success was achieved in all cases. One ischaemic stroke was observed at 30 days (1%, primary endpoint). At 1-year follow-up two myocardial infarctions and three deaths occurred with no additional stroke.Conclusions: The OCEANUS study indicated the safety and efficacy of the MER™ stent during 30-day and 1-year follow-up in both symptomatic and asymptomatic patients. The majority of patients were event-free. However, larger cohort studies are needed to evaluate MER™ stents in detail. Key words: carotid artery stenosis, carotid artery stenting, self-expanding carotid stents, open-cell stent. S u m m a r yThe OCEANUS study confirmed the safety and efficacy of the MER™ stent during 30-day and 1-year follow-up in both symptomatic and asymptomatic patients. The majority of patients were event-free. However, larger cohort studies are needed to evaluate MER™ stents in detail.

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Comparison of Restenosis Risk in Single-Layer versus Dual-Layer Carotid Stents: A Duplex Ultrasound Evaluation

Sýkora

Zeleňák

Vorčák

et al. 2022

Cardiovasc Intervent Radiol

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Mesh-covered (Roadsaver) stent as a new treatment modality for symptomatic or high-risk carotid stenosis

Cited by 15 publications

References 15 publications

One swallow does not a summer make but many swallows do: accumulating clinical evidence for nearly-eliminated peri-procedural and 30-day complications with mesh-covered stents transforms the carotid revascularisation field

One swallow does not a summer make but many swallows do: accumulating clinical evidence for nearly-eliminated peri-procedural and 30-day complications with mesh-covered stents transforms the carotid revascularisation field

Prospective multicentre study of carotid artery stenting using the MER™ Stent – the OCEANUS study – 30-day and one-year follow-up results

Comparison of Restenosis Risk in Single-Layer versus Dual-Layer Carotid Stents: A Duplex Ultrasound Evaluation

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