Comparison and Analysis between the NAV6 Embolic Protection Filter and SpiderFX EPD Filter in Superficial Femoral Artery Lesions.

Prakash Krishnan,Serdar Farhan,Annapoorna Kini,Haroon Kamran,Allen Gee,Arthur Tarricone,Samin Sharma,Faisal Latif

doi:10.1155/2021/9047596

Prakash Krishnan, Serdar Farhan + Show 6 more

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https://doi.org/10.1155/2021/9047596

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Abstract

Objective To compare the safety and efficacy between the SpiderFX EPD and Emboshield NAV6 filter in the collection of embolic debris created from lower limb atherectomy procedures in patients with PAD. Materials and Methods Between January 2014 and October 2015, 507 patients with symptomatic peripheral artery disease were treated with directional atherectomy (SilverHawk), rotational atherectomy (JetStream), or laser atherectomy (Turbo Elite) based on operator discretion. Emboshield NAV6 (n = 161) and SpiderFX (n = 346) embolic protection devices were used with each of the 3 atherectomy devices. The primary study endpoint was 30-day freedom from major adverse events (MAEs). An MAE was defined as death, MI, TVR, thrombosis, dissection, distal embolization, perforation at the level of the filter, and unplanned amputation. A descriptive comparison of the MAE rates between Emboshield NAV6 and SpiderFX embolic protection devices was conducted. Results The freedom from major adverse event (MAE) rate was 92.0% (CI: 86.7%, 95.7%) in patients who received an Emboshield NAV6 filter compared to 91.6% (CI: 88.2%, 94.3%) in patients who received the SpiderFX filter (p=0.434). The lower limit of 86.7% freedom from major adverse event rate in the Emboshield NAV6 group was above the performance goal of 83% (p < 0.0008). Conclusions There were no significant clinical outcome differences between Emboshield NAV6 and SpiderFX EPD filters in the treatment of lower extremities. This evaluation indicates the safety and efficacy to use either filter device to treat PAD patients with lower extremity lesions.

Highlights

Peripheral artery disease (PAD), defined as the atherosclerotic disease of the lower extremity, affects over 200 million people worldwide, and its prevalence rises in aging populations [1,2,3,4]. e use of atherectomy in endovascular treatment may cause distal embolization (DE) [5]
E use of current Food and Drug Administration- (FDA-) approved embolic protection devices (EPDs) in the lower extremities such as the SpiderFX EPD and WIRION has been shown to be effective in reducing the rates of major adverse events (MAEs) [9]. e Emboshield NAV6 Embolic Protection System (Emboshield NAV6) is an EPD that is approved for carotid use and has demonstrated its efficacy and safety [10, 11]
A comprehensive database of PAD patients treated at a single center where both the Emboshield NAV6 and SpiderFX devices were used provided the necessary procedural and safety data to complete the study objective. e study’s primary objective was to compare the safety and efficacy of the Emboshield NAV6 filter with the SpiderFX EPD filter in the collection of embolic debris created during lower limb endovascular procedures in patients with PAD

Summary

Introduction

Peripheral artery disease (PAD), defined as the atherosclerotic disease of the lower extremity, affects over 200 million people worldwide, and its prevalence rises in aging populations [1,2,3,4]. e use of atherectomy in endovascular treatment may cause distal embolization (DE) [5]. E Emboshield NAV6 Embolic Protection System (Emboshield NAV6) is an EPD that is approved for carotid use and has demonstrated its efficacy and safety [10, 11]. E objective of this study was to evaluate and compare the safety and efficacy of the Emboshield NAV6 with the currently approved SpiderFX filter. A comprehensive database of PAD patients treated at a single center where both the Emboshield NAV6 and SpiderFX devices were used provided the necessary procedural and safety data to complete the study objective. E study’s primary objective was to compare the safety and efficacy of the Emboshield NAV6 filter with the SpiderFX EPD filter in the collection of embolic debris created during lower limb endovascular procedures in patients with PAD A comprehensive database of PAD patients treated at a single center where both the Emboshield NAV6 and SpiderFX devices were used provided the necessary procedural and safety data to complete the study objective. e study’s primary objective was to compare the safety and efficacy of the Emboshield NAV6 filter with the SpiderFX EPD filter in the collection of embolic debris created during lower limb endovascular procedures in patients with PAD

Methods

Results

Conclusion