Abstract
Aims
Several randomized trials of patients with carotid stenosis show increased adverse neurological events with stenting versus endarterectomy in the 30-day post-procedure. This study examines the incidence of new ischaemic lesions in patients treated in our centre using the new Roadsaver stent.
Methods and results
Between September 2015 and January 2016, 23 consecutive patients (age 74.3 ± 7.3 years, 17.4 % female) underwent carotid artery stenting with the Roadsaver stent, a nitinol double-layer micromesh device. A distal protection device was used in all cases. Diffusion-weighted magnetic resonance imaging was performed 24 h before, and 24 h and 30 days after the procedure. The 24-h post-procedure imaging showed 15 new ipsilateral ischaemic lesions in 7 (30.4 %) patients: median volume 0.076 cm3 (interquartile range 0.065–0.146 cm3). All lesions were asymptomatic. The 30-day imaging showed complete resolution of all lesions and no new ischaemic lesions. Follow-up clinical and ultrasound examinations at 30 days and 6 months recorded no adverse cardiac or cerebrovascular events.
Conclusions
Protected stenting with micromesh Roadsaver stent showed good safety and efficacy in the treatment of carotid stenosis, with a low incidence of delayed embolic events and new ipsilateral ischaemic brain lesions. These preliminary results are encouraging, but need to be confirmed with larger populations.
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Author Contribution
MAR and RF designed the protocol of the study, MAR submitted it to ethical committee for approval. LB analysed the data and performed the statistical analysis, and PF and DR gave the final approval of the manuscript submitted. All the authors give their written consent to be named in the manuscript.
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There is no financial arrangement or other relationship that could be construed as a conflict of interest for each and every one of listed authors.
Ethical Approval
All procedures performed in this study were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study does not contain any studies with animals performed by any of the authors.
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Informed consent was obtained from all individual participants included in the study. Additional informed consent was obtained from all individual participants for whom identifying information is included in this article: does not apply.
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Ruffino, M.A., Faletti, R., Bergamasco, L. et al. Incidence of New Ischaemic Brain Lesions After Carotid Artery Stenting with the Micromesh Roadsaver Carotid Artery Stent: A Prospective Single-Centre Study. Cardiovasc Intervent Radiol 39, 1541–1549 (2016). https://doi.org/10.1007/s00270-016-1454-7
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DOI: https://doi.org/10.1007/s00270-016-1454-7