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. 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. 2020 Quantitative Imaging in Medicine and Surgery. All rights reserved.
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. 2020 Quantitative Imaging in Medicine and Surgery. All rights reserved.
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