The Use of Embolic Protection Devices during Lower Extremity Peripheral Vascular Interventions

Abstract

The use of embolic protection device (EPD) during lower extremity peripheral vascular interventions (PVI) has been reported, but its impact on outcomes is unclear. The goal of this study was to assess the use and outcomes of EPDs during PVI. All PVI between 2010 and 2014 in the Vascular Study Group of New England (VSGNE) database were reviewed. The characteristics of patients and lesions treated with EPD were identified. A propensity-matched control group without EPD was selected. The outcomes of both groups were compared, and a multivariable analysis was performed. There were a total of 10,875 procedures. EPD was used in 2% of the procedures. From 2010 to 2014, EPD use significantly increased from 1.1 to 3.5% (P<0.001). Patients undergoing PVI with EPD were less likely to be white but more likely to have diabetes, chronic obstructive pulmonary disease, coronary artery disease, and history of prior PVI. After propensity matching, there were 182 procedures with EPD and 604 controls with no significant difference in risk factors. There was no difference in indication or anatomic level treated, with claudication (52.7% vs. 49.8%) being most common indication and the superficial femoral artery (65.4% vs. 62.1%), the most commonly treated artery. Patients undergoing PVI with EPD were more likely to be treated with excisional atherectomy (26.4% vs. 12.6%), whereas patients without EPD were more likely to be treated with orbital atherectomy (31.9% vs. 41.6%, P=0.017). There was no significant difference in the incidence of minor distal embolization (DE) (1.1% vs. 1.5%) or DE requiring endovascular treatment (2.8% vs. 2.6%) between the two groups, but EPD use was significantly associated with increased fluoroscopy time (P<0.001). There was no difference in technical success, patency, amputation, or mortality between the two groups. On multivariable analysis, there was no significant association between the use of EPD and patency (incidence relative risk (IRR) [95% CI]=1.1 [0.9-1.3]), amputation (IRR=0.7 [0.2-2.1]), or mortality (IRR=0.8 [0.6-1.2]). However, there was a significant difference in fluoroscopy time (mean ratio [95% CI]=1.2 [1.1-1.3]). The analysis was repeated after eliminating all procedures with DE in the EPD group (assuming that EPD use is 100% effective in preventing DE), and the results were no different. EPD use during PVI has significantly increased. Despite EPDs increasing procedural complexity and time, they do not seem to have any impact on PVI outcomes. Additional studies are needed to characterize which patients would benefit from EPDs.