Embolic Protection in Complex Femoropopliteal Interventions: Safety, Efficacy and Predictors of Filter Macroembolization
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CLINICAL INVESTIGATION
ARTERIAL INTERVENTIONS
Embolic Protection in Complex Femoropopliteal Interventions: Safety, Efficacy and Predictors of Filter Macroembolization Michael Czihal1 • Zeynep Findik1,2 • Christoph Bernau1 • Max Seidensticker2 Jens Ricke2 • Ulrich Hoffmann1 • Marcus Treitl2,3 • Karla-Maria Treitl2
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Received: 8 July 2020 / Accepted: 16 November 2020 Ó The Author(s) 2020
Abstract Objectives To evaluate the safety and efficacy of a filter embolic protection device (FEPD) in endovascular interventions of the femoropopliteal arteries. Methods Patients 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. Results A 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%,
& Michael Czihal [email protected] 1
Division of Vascular Medicine, Medical Clinic and Policlinic IV, Hospital of the Ludwig-Maximilians-University, Pettenkoferstrasse 8a, 80336 Munich, Germany
2
Clinic and Policlinic for Radiology, Hospital of the LudwigMaximilians-University, Munich, Germany
3
Department of Radiology, Neuroradiology, Interventional Radiology, Berufsgenossenschaftliche Unfallklinik, Murnau, Germany
DA 32.8%, RT 47.7%). Risk factors for FME in the BAPand 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). Conclusion The 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 Keywords Peripheral arterial disease Percutaneous transluminal angioplasty Atherectomy Thrombectomy Embolization Filter
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]. Local pharmacol
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