Embolic Protection Devices are Not Associated with Improved Outcomes of Atherectomy for Lower Extremity Revascularization.

ABSTRACT

BACKGROUND: Atherectomy is associated with a risk of distal embolization, but the role of embolic protection devices (EPDs) during atherectomy is not well-defined. This study examines the utilization and impact of EPD on the outcomes of atherectomy during peripheral vascular interventions (PVIs). METHODS: The annual trend in utilization of EPD during atherectomy in the Vascular Quality Initiative PVI files (2010-2018) was derived. Patients with concomitant open surgery, acute limb ischemia, emergent-status, concomitant thrombolysis, missing indication, missing EPD use, and missing long-term follow-up data were excluded. The characteristics of patients undergoing atherectomy with and without EPD were compared. Propensity matching based on age, gender, race, chronic obstructive pulmonary disease, coronary artery disease, end-stage renal disease, prior PVI, indication, urgent-status, TransAtlantic interSociety Consensus classification, and anatomical location of lesion was performed. The perioperative and 1-year outcomes of the matched groups were compared. RESULTS: EPD was used in 23.3% of atherectomy procedures (n = 5,013/21,500). The utilization of EPD with atherectomy increased from 8.8% to 22.7% (P = 0.003) during the study period. Patients undergoing atherectomy without EPD were more likely to have ESRD (7.8% vs. 5.2%; P < 0.001), tissue loss (31% vs. 23.1; P < 0.001), tibial intervention (39.6% vs. 23.3%; P < 0.001), higher number of arteries treated (1.78 ± 0.92 vs. 1.68 ± 0.93; P = 0.001), and longer length of lesion (21.15 ± 21.14 vs. 19 ± 20.27 cm; P = 0.004). Conversely, patients undergoing atherectomy with EPD were more likely to be White (81.1% vs. 74%; P < 0.001), have a history of smoking (80.6% vs. 74.5%; P < 0.001), chronic obstructive pulmonary disease (24.8% vs. 21.6%; P < 0.037), coronary artery disease (38.5% vs. 33.2%; P = 0.002), prior percutaneous coronary intervention (24.3% vs. 19.9%, P = 0.005), prior coronary artery bypass grafting (32.3% vs. 24.9%; P < 0.001), and prior PVI (49.2% vs. 45.1%; P = 0.023). After propensity matching, there were 1,007 patients in each group with no significant difference in baseline characteristics. There was no significant difference in short-term outcomes including the rate of distal embolization, technical success, dissection, perforation, discharge to home, and 30-day mortality. The use of EPD was, however, associated with longer fluoroscopy time. At 1-year, there was also no difference in primary patency, ipsilateral minor or major amputation, ankle brachial index improvement, reintervention, or mortality rate between patients who underwent atherectomy with and without EPD. CONCLUSIONS: EPD has been increasingly used in conjunction with atherectomy especially in patients with claudication and femoropopliteal disease. However, the use of EPD during atherectomy does not seem to impact the outcomes. Further research is needed to justify the additional cost and fluoroscopy time associated with the use of EPD during atherectomy.