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.

1-Month results from a prospective experience on cas using cguard stent system. The ironguard 2 study / Sirignano, Pasqualino; Stabile, Eugenio; Mansour, Wassim Ahmad; Capoccia, Laura; Faccenna, Federico; Intrieri, Francesco; Ferri, Michelangelo; Saccà, Salvatore; Sponza, Massimo; Mortola, Paolo; Ronchey, Sonia; Grillo, Placido; Chiappa, Roberto; Losa, Sergio; Setacci, Francesco; Pirrelli, Stefano; Taurino, Maurizio; Antonella Ruffino, Maria; Udini, Marco; Palombo, Domenico; Ippoliti, Arnaldo; Montelione, Nunzio; Setacci, Carlo; de Donato, Gianmarco; Ruggeri, Massimo; Speziale, Francesco. - In: JACC: CARDIOVASCULAR INTERVENTIONS. - ISSN 1936-8798. - 13:18(2020), pp. 2170-2177. [10.1016/j.jcin.2020.05.026]

1-Month results from a prospective experience on cas using cguard stent system. The ironguard 2 study

Pasqualino Sirignano
Primo
Writing – Original Draft Preparation
;
Wassim Mansour;Laura Capoccia;Federico Faccenna;Francesco Setacci;Maurizio Taurino;Nunzio Montelione;Francesco Speziale
Ultimo
2020

Abstract

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.
2020
carotid artery disease; carotid artery stenting; stroke
01 Pubblicazione su rivista::01a Articolo in rivista
1-Month results from a prospective experience on cas using cguard stent system. The ironguard 2 study / Sirignano, Pasqualino; Stabile, Eugenio; Mansour, Wassim Ahmad; Capoccia, Laura; Faccenna, Federico; Intrieri, Francesco; Ferri, Michelangelo; Saccà, Salvatore; Sponza, Massimo; Mortola, Paolo; Ronchey, Sonia; Grillo, Placido; Chiappa, Roberto; Losa, Sergio; Setacci, Francesco; Pirrelli, Stefano; Taurino, Maurizio; Antonella Ruffino, Maria; Udini, Marco; Palombo, Domenico; Ippoliti, Arnaldo; Montelione, Nunzio; Setacci, Carlo; de Donato, Gianmarco; Ruggeri, Massimo; Speziale, Francesco. - In: JACC: CARDIOVASCULAR INTERVENTIONS. - ISSN 1936-8798. - 13:18(2020), pp. 2170-2177. [10.1016/j.jcin.2020.05.026]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1438912
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