Embolic Protection in Complex Femoropopliteal Interventions: Safety, Efficacy and Predictors of Filter Macroembolization

Michael Czihal,Christoph Bernau,Max Seidensticker,Jens Ricke,Marcus Treitl,Ulrich Hoffmann,Karla-Maria Treitl,Zeynep Findik

doi:10.1007/s00270-020-02717-w

Abstract

ObjectivesTo evaluate the safety and efficacy of a filter embolic protection device (FEPD) in endovascular interventions of the femoropopliteal arteries.MethodsPatients who underwent endovascular interventions of the femoropopliteal arteries between 2008 and 2016 and in whom the SpiderFXTM FEPD was applied were included in this retrospective study. Clinical and angiographic characteristics, filter macroembolization (FME), device-related complications, distal embolization, as well as the early clinical and hemodynamic outcome, were assessed. Potential risk factors for FME were evaluated by multivariate analysis.ResultsA total of 244 cases were identified (203 patients, claudication 60.4%, critical limb ischaemia 39.6%, mean lesion length 13.2 ± 12.9 cm, complete occlusions in 72.7%). Balloon angioplasty ± stenting (BAP), directional atherectomy ± balloon angioplasty ± stenting (DA) and rotational thrombectomy ± balloon angioplasty ± stenting (RT) were performed in 141, 61 and 42 cases, respectively. FEPD placement and retrieval were successful in all but one case each. Permanent filter-related vessel damage was not observed. The rate of FME was 37.3% (BAP 36.2%, DA 32.8%, RT 47.7%). Risk factors for FME in the BAP- and DA-group were total occlusion, lesion length > 19 cm, visible thrombus and diabetes mellitus. The distal embolization rate despite filter protection was 4.1 % (BAP 4.9%, DA 1.6%, RT 4.8%) and was higher in cases with FME compared with those without FME (8.7% vs. 1.5%, p = 0.02).ConclusionThe Spider FXTM device is safe and effective in capturing embolic debris during femoropopliteal interventions. A residual risk of peripheral embolization remains.Level of Evidence III, Cohort study

Highlights

Peripheral embolization is a well-recognized, potentially limb threatening complication of lower extremity endovascular procedures, resulting in clinically significant perfusion impairment at the cruropedal level in 1.6 to 4% of patients, with higher numbers reported in the treatment of acute thrombotic lesions [1, 2]
Data regarding the rational use of Filter embolic protection devices (FEPD) in lower extremity endovascular procedures are scarce and mainly limited to directional atherectomy [7, 8]
Distal embolization despite filter protection occurred in 4.1% of cases

Summary

Introduction

Peripheral embolization is a well-recognized, potentially limb threatening complication of lower extremity endovascular procedures, resulting in clinically significant perfusion impairment at the cruropedal level in 1.6 to 4% of patients, with higher numbers reported in the treatment of acute thrombotic lesions (up to 24%) [1, 2]. Data regarding the rational use of FEPD in lower extremity endovascular procedures are scarce and mainly limited to directional atherectomy [7, 8]. We sought to evaluate the procedural safety and efficacy of a FEPD in a large contemporary cohort of patients with acute, subacute and chronic obstructions of the femoropopliteal arteries, who either underwent balloon angioplasty ± stenting (BAP), directional atherectomy ± balloon angioplasty ± stenting (DA) or rotational thrombectomy ± balloon angioplasty ± stenting (RT). We further aimed to determine potential predictors of peri-procedural filter macroembolization (FME)

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