All of the recurrent stenosis occurred in open cell stents. None of the patients had associated neurologic symptoms. Of the 116 stents followed in this cohort, only five stents required reintervention for restenosis of greater than 70%. The impact of stent deformation and fracture on restenosis is unclear. Thus, open cell stents are thought to be more flexible and to conform better to angulated and irregular vessels. 7 Open cell stents have a lower density of struts and generally larger free cell areas compared with closed cell stents. This finding is consistent with the 11% stent changes “that could be confused for fracture” reported by Varcoe et al., because 92% of the stents placed in that series were open cell stents. Stent deformation appear to be significantly more common in open cell stents compared with closed cell stents (hazard ratio 28, P=0.001). While prior studies have examined carotid stent fractures in some detail, significant stent deformation in the absence of an observed stent strut break has not been addressed. noted a similarly high Xact stent fracture rate of 24% (8 of 34). Stent fractures following CAS were significantly associated with the closed cell nitinol stent design, Xact stents, with a rate of 15% in stents older than 1 year. 6 A correlation between extensive calcification and a higher rate of fracture had also previously been demonstrated in coronary stents. That study observed that the presence of carotid artery calcification on plain film was associated with nearly an eight-fold increase in the odds of stent fracture. 6,7 The development of either stent fracture or deformation was found to be approximately six times more common in the setting of highly calcified carotid arteries, as reflected by easily visible calcification on plain films of the neck (P=0.003) ( Fig. These measurements tend to corroborate the rates noted in the two published series in which carotid stent changes were common, ranging from 13% to 29%. The prevalence of stent fracture was observed to be 4% and that of stent deformation to be 23%. 7 In a third series, which is the largest to date, the incidence of stent fracture and/or deformation following carotid bifurcation stenting approached a combined rate of 50% at 4 years. described a fracture rate of 2% in 51 carotid stents and noted no clinical sequelae. reported a carotid stent fracture prevalence of 29% in 48 stents and also observed a higher restenosis rate of 21% in fractured stents compared with 9% in stents without fracture. Powell MD, Nikolaos Zacharias MD, FSVS, FACS, in Complications in Endovascular Surgery, 2022 Late ComplicationsĬarotid stent fracture and deformation may be more common than previously thought and are related to stent design ( Fig. XACT Carotid Stent System 9.0 mm x 30 mm Tapered XACT Carotid Stent System 9.0 mm x 30 mm Straight XACT Carotid Stent System 9.0 mm x 20 mm Straight XACT Carotid Stent System 8.0 mm x 40 mm Tapered XACT Carotid Stent System 8.0 mm x 30 mm Tapered XACT Carotid Stent System 8.0 mm x 30 mm Straight XACT Carotid Stent System 8.0 mm x 20 mm Straight XACT Carotid Stent System 7.0 mm x 30 mm Straight XACT Carotid Stent System 7.0 mm x 20 mm Straight XACT Carotid Stent System 10.0 mm x 40 mm Tapered XACT Carotid Stent System 10.0 mm x 30 mm Tapered XACT Carotid Stent System 10.0 mm x 30 mm Straight XACT Carotid Stent System 10.0 mm x 20 mm Straight Do not expose to organic solvent or ionizing radiation.ĭevice Entry Metadata Public Version Status XACT 82091-01 GUDID 08717648010279 XACT Carotid Stent System 8.0 mm x 30 mm Tapered ABBOTT VASCULAR INC.īare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Primary Device IDĬustomer Support Contacts and Storage Conditions Special Storage Condition, Specifyīetween 0 and 0 *Store in a cool, dry, dark location.
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