Giri Jay, Yeh Robert W, Kennedy Kevin F, Hawkins Beau M, Weinberg Ido, Weinberg Mitchell D, Parikh Sahil A, Garasic Joseph, Jaff Michael R, White Christopher J, Rosenfield Kenneth
Cardiovascular Medicine Division, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
Catheter Cardiovasc Interv. 2014 Mar 1;83(4):595-602. doi: 10.1002/ccd.25090. Epub 2013 Nov 15.
BACKGROUND & PURPOSE: Embolic protection devices (EPD) may provide a mechanism to reduce peri-procedural strokes. They are advocated by consensus guidelines and mandated for Medicare reimbursement. However, outcomes data remain mixed. We aimed to characterize the population of patients undergoing unprotected carotid artery stenting (CAS) and assess the utility of distal filter EPD (F-EPD) in elective CAS.
We analyzed patients enrolled in the CARE Registry® undergoing CAS between May, 2005 and January, 2012. We assessed the relationship between distal F-EPD use versus no use (No-EPD) and the composite of in-hospital death or stroke (MAE) in unadjusted and 1:3 propensity-matched analyses.
Embolic protection was not attempted in a total of 579 out of 13,263 cases performed (4.4%). Patients in the No-EPD group had worse preprocedure neurologic risk factors including higher rates of acute evolving stroke, prior TIA/stroke, symptomatic lesion status, spontaneous carotid artery dissection, and use of general anesthesia intraprocedurally (all Standardized Differences{sd} >10). After exclusion of nonelective cases there was no significant difference in MAE between the No-EPD and F-EPD groups (1.6% vs. 2.3%, sd = 4.72). Additionally, after propensity matching, rates of MAE did not differ between the No-EPD (n = 355) and F-EPD (n = 1065) groups (1.7% vs. 2.5%, sd = 5.87).
Patients selected to undergo unprotected CAS in contemporary practice have high rates of adverse preprocedure neurologic risk factors. Our propensity-matched analysis did not demonstrate evidence of significant benefit or harm associated with use of F-EPD in elective CAS patients.
栓子保护装置(EPD)可能提供一种减少围手术期卒中的机制。它们得到了共识指南的提倡,并且医疗保险报销时要求使用。然而,结果数据仍然参差不齐。我们旨在描述接受非保护颈动脉支架置入术(CAS)的患者群体,并评估远端滤网式栓子保护装置(F-EPD)在择期CAS中的效用。
我们分析了2005年5月至2012年1月期间登记参加CARE Registry®并接受CAS的患者。我们在未调整和1:3倾向匹配分析中评估了使用远端F-EPD与未使用(无EPD)与住院死亡或卒中(主要不良事件,MAE)复合结局之间的关系。
在总共13263例手术中,共有579例(4.4%)未尝试进行栓子保护。无EPD组患者术前神经危险因素更差,包括急性进展性卒中、既往短暂性脑缺血发作/卒中、症状性病变状态、自发性颈动脉夹层以及术中使用全身麻醉的发生率更高(所有标准化差异{sd}>10)。排除非择期病例后,无EPD组和F-EPD组之间的MAE无显著差异(1.6%对2.3%,sd = 4.72)。此外,倾向匹配后,无EPD组(n = 355)和F-EPD组(n = 1065)之间的MAE发生率无差异(1.7%对2.5%,sd = 5.87)。
在当代实践中,选择接受非保护CAS的患者术前不良神经危险因素发生率很高。我们的倾向匹配分析未显示在择期CAS患者中使用F-EPD有显著益处或危害的证据。