Author + information
- Received February 4, 2020
- Revision received May 8, 2020
- Accepted May 12, 2020
- Published online September 21, 2020.
- Pasqualino Sirignano, MDa,∗ (, )
- Eugenio Stabile, MD, PhDb,
- Wassim Mansour, MD, PhDa,
- Laura Capoccia, MD, PhDa,
- Federico Faccenna, MDa,
- Francesco Intrieri, MDc,
- Michelangelo Ferri, MDd,
- Salvatore Saccà, MDe,
- Massimo Sponza, MDf,
- Paolo Mortola, MDg,
- Sonia Ronchey, MDh,
- Placido Grillo, MDi,
- Roberto Chiappa, MDj,
- Sergio Losa, MDk,
- Francesco Setacci, MDk,
- Stefano Pirrelli, MDl,
- Maurizio Taurino, MDm,
- Maria Antonella Ruffino, MDn,
- Marco Udini, MDo,
- Domenico Palombo, MDp,
- Arnaldo Ippoliti, MDq,
- Nunzio Montelione, MD, PhDr,
- Carlo Setacci, MDs,
- Gianmarco de Donato, MDs,
- Massimo Ruggeri, MDt and
- Francesco Speziale, MDa
- aVascular and Endovascular Surgery Unit, Department of Surgery Paride Stefanini, Sapienza University of Rome, Rome, Italy
- bDivision of Cardiology, Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy
- cUnit of Vascular and Endovascular Surgery, Annunziata Hospital, Cosenza, Italy
- dVascular and Endovascular Surgery Unit, Mauriziano Umberto I Hospital, Turin, Italy
- eDivision of Cardiology, Mirano Public Hospital, Mirano, Italy
- fDivision of Vascular and Interventional Radiology, Udine University Hospital, Udine, Italy
- gDepartment of Vascular and Endovascular Surgery, Galliera Hospital, Genoa, Italy
- hUnit of Vascular Surgery, Cardiovascular Thoracic Department, S. Filippo Neri Hospital, Rome, Italy
- iDivision of Cardiology, Sant’Anna Hospital, Catanzaro, Italy
- jDepartment of Vascular and Endovascular Surgery, S. Pertini Hospital, Rome, Italy
- kCardiovascular Department, MultiMedica IRCCS Scientific Institute, Milan, Italy
- lDivision of Vascular Surgery, San Carlo Poma Hospital, Mantova, Italy
- mUnit of Vascular Surgery, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy
- nDepartment of Diagnostic Imaging and Radiotherapy - Vascular Radiology, Città della Salute e della Scienza di Torino, Turin, Italy
- oVascular Surgery, Moriggia Pelascini Hospital, Gravedona, Italy
- pVascular and Endovascular Surgery Unit, IRCCS Ospedale Policlinico San Martino, University of Genoa, Genoa, Italy
- qVascular Surgery Unit, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy
- rVascular Surgery, University of Campus Biomedico of Rome, Italy
- sVascular and Endovascular Surgery Unit, Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy
- tVascular Surgery, San Camillo de Lellis Hopital, Rieti, Italy
- ↵∗Address for correspondence:
Dr. Pasqualino Sirignano, Vascular and Endovascular Surgery Division, Department of Surgery Paride Stefanini, Sapienza University of Rome, Policlinico Umberto I, Viale del Policlinico 155, 00161 Rome, Italy.
Objectives This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice.
Background When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque’s debris prolapsing through stent’s mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems.
Methods From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates.
Results Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%.
Conclusions This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received February 4, 2020.
- Revision received May 8, 2020.
- Accepted May 12, 2020.
- 2020 American College of Cardiology Foundation
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