Renato Casana1, Valerio Tolva2, Andrea Odero3, Chiara Malloggi4, Aldo Paolucci5, Fabio Triulzi6, Vincenzo Silani7. 1. Department of Surgery, IRCCS Istituto Auxologico Italiano, Milan, Italy. Electronic address: r.casana@auxologico.it. 2. Department of Vascular Surgery, Policlinico Di Monza Hospital, Monza, Italy. 3. Department of Surgery, IRCCS Istituto Auxologico Italiano, Milan, Italy. 4. Vascular Surgery Research Experimental Laboratory, IRCCS Istituto Auxologico Italiano, Milan, Italy. 5. Department of Neuroradiology (F.T.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy. 6. Department of Neuroradiology (F.T.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, Milan, Italy. 7. Department of Neurology-Stroke Unit and Laboratory of Neuroscience, IRCCS Istituto Auxologico Italiano, Department of Pathophysiology and Transplantation, 'Dino Ferrari' Centre - University of Milan, Milan, Italy.
Abstract
OBJECTIVE/ BACKGROUND: Plaque protrusion through stent struts represents one of the principal causes of cerebral embolisation during carotid artery stenting (CAS) and the stent healing period. The aim of this study was to evaluate the safety (technical success) and efficacy (clinical success) of the CGuard stent system - a new nitinol stent covered by a closed-cell polyethylene terephthalate mesh designed to prevent embolic events. METHODS: Eighty-two consecutive patients who underwent CAS with CGuard from June 2015 were included in this study. The same surgeon performed all procedures. Primary endpoints included technical and clinical success. Clinical success was considered to be absence of death, major or minor stroke. The incidence of new ischaemic brain lesions was also evaluated by diffusion weighted magnetic resonance imaging (DW-MRI) in a subgroup of patients as a secondary endpoint. RESULTS: In this study, 82 patients (73.8 ± 8.5 years, 75% male, 19% symptomatic) underwent CAS procedures. Immediate technical success was 100%, with the stenosis diameter reduced from 81.4 ± 4.9% to 11.0 ± 3.5%. There was peri-operative technical and clinical success in 100% of symptomatic patients, and in 98.5% of asymptomatic patients, because of the occurrence of one acute stent thrombosis 4 hours post-CAS followed by a minor stroke. In the post-operative period (30 days), no new events were registered. The most recent 21 patients (24%) underwent DW-MRI in the peri-operative period: new ischaemic brain lesions were recorded in 23.8% of patients and the average lesion volume per patients was 0.039 ± 0.025 cm3. CONCLUSIONS: The technical and clinical outcomes of this single centre study suggest that the CGuard may be a safe and effective device for endovascular treatment of symptomatic and asymptomatic subjects, independent of aortic arch anatomy. Further larger comparative studies are needed to confirm these benefits.
OBJECTIVE/ BACKGROUND: Plaque protrusion through stent struts represents one of the principal causes of cerebral embolisation during carotid artery stenting (CAS) and the stent healing period. The aim of this study was to evaluate the safety (technical success) and efficacy (clinical success) of the CGuard stent system - a new nitinol stent covered by a closed-cell polyethylene terephthalate mesh designed to prevent embolic events. METHODS: Eighty-two consecutive patients who underwent CAS with CGuard from June 2015 were included in this study. The same surgeon performed all procedures. Primary endpoints included technical and clinical success. Clinical success was considered to be absence of death, major or minor stroke. The incidence of new ischaemic brain lesions was also evaluated by diffusion weighted magnetic resonance imaging (DW-MRI) in a subgroup of patients as a secondary endpoint. RESULTS: In this study, 82 patients (73.8 ± 8.5 years, 75% male, 19% symptomatic) underwent CAS procedures. Immediate technical success was 100%, with the stenosis diameter reduced from 81.4 ± 4.9% to 11.0 ± 3.5%. There was peri-operative technical and clinical success in 100% of symptomatic patients, and in 98.5% of asymptomatic patients, because of the occurrence of one acute stent thrombosis 4 hours post-CAS followed by a minor stroke. In the post-operative period (30 days), no new events were registered. The most recent 21 patients (24%) underwent DW-MRI in the peri-operative period: new ischaemic brain lesions were recorded in 23.8% of patients and the average lesion volume per patients was 0.039 ± 0.025 cm3. CONCLUSIONS: The technical and clinical outcomes of this single centre study suggest that the CGuard may be a safe and effective device for endovascular treatment of symptomatic and asymptomatic subjects, independent of aortic arch anatomy. Further larger comparative studies are needed to confirm these benefits.
Authors: Roman A Machnik; Piotr Pieniążek; Marcin Misztal; Krzysztof Plens; Marek Kazibudzki; Tomasz Tomaszewski; Andrzej Brzychczy; Robert Musiał; Mariusz Trystuła; Łukasz M Tekieli Journal: Postepy Kardiol Interwencyjnej Date: 2020-12-29 Impact factor: 1.426
Authors: Adam Mazurek; Krzysztof Malinowski; Kenneth Rosenfield; Laura Capoccia; Francesco Speziale; Gianmarco de Donato; Carlo Setacci; Christian Wissgott; Pasqualino Sirignano; Lukasz Tekieli; Andrey Karpenko; Waclaw Kuczmik; Eugenio Stabile; David Christopher Metzger; Max Amor; Adnan H Siddiqui; Antonio Micari; Piotr Pieniążek; Alberto Cremonesi; Joachim Schofer; Andrej Schmidt; Piotr Musialek Journal: J Clin Med Date: 2022-08-17 Impact factor: 4.964
Authors: Tomas Klail; Christoph Kurmann; Johannes Kaesmacher; Adnan Mujanovic; Eike I Piechowiak; Tomas Dobrocky; Sara Pilgram-Pastor; Adrian Scutelnic; Mirjam R Heldner; Jan Gralla; Pasquale Mordasini Journal: Clin Neuroradiol Date: 2022-09-07 Impact factor: 3.156