Incidence of Distal Embolization during Peripheral Intervention using the NAV-6 Embolic Protection System

Abstract

Purpose: To compare the rates of embolic debris (ED) generation during lower extremity arterial interventions and evaluate the safety and efficacy of the using an embolic protection device (EPD). Methods: This was a single-center retrospective review of 111 patients (114 vessels) having undergone peripheral arterial intervention with the use of an EPD (Emboshield NAV-6 device). A database was created through review of the electronic health record and images in PACS. The presence of ED was determined through visual inspection after retrieval of the device or from filling defects identified during digital subtraction angiography with the device deployed. Descriptive statistics were used to report the demographic and clinical information. Relative frequencies of debris generation were determined for vessel type, trans-atlantic inter-society consensus (TASC) classification, and type of intervention. Differences in frequencies between groups weer evaluated with the Chi-square test, and associations were examined using the logistic regression analysis. Results: Of the 114 vessels treated, 16 (14%) demonstrated true distal embolization (DE) past the filter basket and 58 (51%) demonstrated generation of ED as determined by filling of the filter basket. This was significantly higher in patients undergoing atherectomy (70%) compared with those undergoing thrombolysis (38%) or angioplasty with or without stenting (29%) (P < 0.001). Of those patients undergoing atherectomy, laser atherectomy had the lowest rate of DE (26%) compared with either orbital (67%) or directional atherectomy (57%) (P < 0.05). In regression analysis, atherectomy was the only factor with significant association with detection of ED (odds ratio: 4.52, P < 0.0001). There was no statistically significant difference in the frequency of debris generated based on vessel type or TASC classification. Conclusion: The frequency of ED is higher in patients undergoing atherectomy versus patients undergoing lysis or percutaneous transluminal balloon angioplasty with or without stenting. Laser atherectomy has a lower frequency of debris generation when compared to either orbital or directional atherectomy.