Percutaneous mechanical atherothrombectomy using the Rotarex®S device in peripheral artery in-stent restenosis or occlusion: a French retrospective multicenter study on 128 patients

Romaric Loffroy; Nizam Edriss; Gilles Goyault; Alain Chabanier; Jean-Marc Pernes; Antoine Sauguet; Mehdi Touil; Bernard Woerly; Dionyssios Pongas; Olivier Chevallier; Nicolas Falvo; Christophe Galland; Marco Midulla; Nathalie Garnier; Marie-Pierre Guenfoudi; Mathieu Boulin; Serge Aho-Gléglé; Stéphanie Bost

doi:10.21037/qims.2019.11.15

Percutaneous mechanical atherothrombectomy using the Rotarex^®S device in peripheral artery in-stent restenosis or occlusion: a French retrospective multicenter study on 128 patients

Quant Imaging Med Surg. 2020 Jan;10(1):283-293. doi: 10.21037/qims.2019.11.15.

Authors

Romaric Loffroy¹, Nizam Edriss², Gilles Goyault³, Alain Chabanier⁴, Jean-Marc Pernes⁵, Antoine Sauguet⁶, Mehdi Touil², Bernard Woerly³, Dionyssios Pongas⁵, Olivier Chevallier¹, Nicolas Falvo¹, Christophe Galland¹, Marco Midulla¹, Nathalie Garnier⁷, Marie-Pierre Guenfoudi⁷, Mathieu Boulin⁷, Serge Aho-Gléglé⁸, Stéphanie Bost⁷

Affiliations

¹ Department of Vascular and Interventional Radiology, Centre Hospitalier Universitaire François-Mitterrand, Dijon, France.
² Department of Vascular Surgery, Centre Hospitalier Artois-Ternois, Arras, France.
³ Department of Vascular and Interventional Radiology, Clinique de l'Orangerie, Strasbourg, France.
⁴ Department of Interventional Cardiology, Centre Hospitalier de la Côte Basque, Bayonne, France.
⁵ Department of Interventional Radiology and Cardiology, Hôpital Privé d'Antony, Paris, France.
⁶ Department of Interventional Cardiology, Clinique Pasteur, Toulouse, France.
⁷ Department of Pharmacy, Statistics and Clinical Research, Centre Hospitalier Universitaire François-Mitterrand, Dijon, France.
⁸ Department of Epidemiology, Statistics and Clinical Research, Centre Hospitalier Universitaire François-Mitterrand, Dijon, France.

Abstract

Background: To ascertain the safety and mid-term outcomes of Rotarex^®S rotational atherectomy plus thrombectomy device (Straub Medical AG, Wangs, Switzerland) with or without adjunctive treatment (e.g., percutaneous transluminal angioplasty, PTA/drug-coated balloon, DCB/stenting) in patients with in-stent restenosis (ISR) or occlusion in the iliac and/or infrainguinal arteries.

Methods: French multicenter retrospective study of all patients treated by in-stent percutaneous mechanical debulking (PMD) of the lower limbs with Rotarex^®S device between January 2013 and November 2018.

Results: The cohort consisted of 128 patients (88 men and 40 women), aged 39-94 years (mean, 66.7±12 years). All patients presented with cardio-vascular risk factors. Overall, 51.5% of patients had critical limb ischemia. The study demonstrated a technical success of 96.9% in the population with PMD and adjunctive PTA (95/128, 74.2%) or adjunctive DCB (16/128, 12.5%) or both (13/128, 10.2%). At 12-months follow-up, the primary clinical success/patency rate was 92.3% and the secondary clinical success/patency rate was 91.4%. Rate of limb salvage was 93.7%. Overall 32 (25%) reinterventions were reported with mean time from Rotarex^®S treatment to reintervention of 7.1±8.2 months. Target lesion revascularization (TLR) was 19.5% (25/128). Seven (5.5%) patients developed distal embolism that responded to endovascular treatment. At mean follow-up, major adverse events (MAE) observed were death (18/128, 14.1%), myocardial infarction (MI) (9/128, 7.0%), stroke (2/128, 1.6%) and renal failure (3/128, 2.3%).

Conclusions: Recanalization with Rotarex^®S rotational atherectomy plus thrombectomy device is a practical choice for arterial ISR/occlusions of the iliac and/or infrainguinal arteries, regardless of the age of the thrombus, with satisfying TLR. Only adjunctive PTA is often necessary to further improve the recanalization.

Keywords: Lower limb ischemia; drug-coated balloon (DCB); in-stent occlusion; in-stent restenosis (ISR); rotational atherectomy angioplasty.