Percutaneous Mechanical Athero-Thrombectomy Using the Rotarex®S Device in Peripheral Artery In-Stent Restenosis or Occlusion: A French Retrospective Multicenter Study on 128 Patients

Abstract

Surgical thromboembolectomy was the mainstay of treatment for acute limb ischemia (ALI), but in recent years, different endovascular thrombectomy devices have been introduced as alternative treatment options. The aim of this study is to evaluate, in a controlled setting, the preliminary results in terms of early safety and effectiveness of the Penumbra/Indigo Systems in patients with acute lower limb malperfusion due to peripheral acute occlusions (INDIAN Study). Methods: Patients with diagnosis of ALI were collected and treated with Penumbra/Indigo devices. The primary outcome was the technical success of thromboaspiration (evaluated with the thrombolysis in myocardial infarction [TIMI] score classifications before and after use of the device) and the clinical success at follow-up (defined as an improvement of Rutherford classification at 1-month follow-up). The secondary endpoints include the absence of any serious adverse events at discharge, primary patency at 1 month, and limb salvage at 1 month. Results: A total of 136 patients were recruited. The mean Ankle brachial index (ABI) before the procedure 0.46, Rutherford class for ALI IIB was present in 39% of the patients, the mean lesion length was 110 mm, and TIMI score 0 was recorded in 79%. After the thromboaspiration alone, TIMI score 2-3 was restored in 89.6% of patients and after additional procedure in the 95.4%. At 1-month follow-up, Rutherford class for ALI I was present in 90.2% of patients and serious adverse events were reported in nine patients (6.6%, of whom 1 amputation 0.8%). Conclusion: Preliminary results of the INDIAN Study showed that aspirationbased extraction technique with Indigo/Penumbra is safe and effective for revascularization of acute peripheral arterial occlusion as a primary therapy, and it can represent a viable tool as a secondary therapy after other surgical or endovascular techniques.