A comparative study on endovascular treatment of (sub)acute critical limb ischemia: mechanical thrombectomy vs thrombolysis

Abstract

ObjectiveThe aim of this study was to compare different interventional methods for treatment of (sub)acute limb ischemia upon thrombotic occlusions of the lower extremity in terms of their safety and efficacy in a tertiary hospital setting.DesignThis is a retrospective, single-center study of non-randomized data.MethodsA total of 202 patients, including 26 critically ill patients, underwent rotational thrombectomy (Rotarex®), local thrombolysis (recombinant tissue plasminogen activator), or combination of both at the University Hospital Heidelberg (2006–2015). The different interventional procedures were compared in terms of overall and amputation-free survival, as well as patency in a 1-year follow-up (Kaplan–Meier analysis).ResultsThe study demonstrated a primary revascularization success of >98% in all groups. One year after revascularization, primary and secondary patency after mechanical thrombectomy alone were significantly better in comparison to local thrombolysis or a combination of Rotarex® and lysis (63% and 85%, P<0.05). Overall survival 12 months after intervention reached up to 96% in noncritically ill patients, and amputation-free survival was 94.3% in all three groups. Mean hospitalization duration and rate of major bleedings were significantly increased after thrombolysis compared to Rotarex® (P<0.05).ConclusionIn patients with (sub)acute limb ischemia, Rotarex® mechanical thrombectomy represents a safe and effective alternative to thrombolysis and is associated with a reduced rate of major bleedings, shorter hospitalization durations, and lower costs.

Editor's Choice – European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia

“…149e151 A comparative (nonrandomised) study of Rotarex vs. thrombolysis showed similar technical results but better primary and secondary patency rates with fewer complications and shorter hospital stay in the Rotarex group. 152 This device can also aspirate more organised clot but cannot be used in smaller arteries below the knee. 153 Vessel perforation has been described as a device related complication.…”

Successful endovascular treatment in patients with acute thromboembolic ischemia of the lower limb including the crural arteries

“…Several studies have demonstrated the efficacy of this system in the treatment of patients with ALI[ 14 - 18 ]. In this regard, a high success rate of > 98% was reported in a recent study, which elegantly demonstrated that purely mechanical thrombectomy by the Rotarex ® S system was safer and more effective than thrombolysis, which was associated with higher rates of major bleedings, longer hospitalization durations and higher costs[ 19 ]. Potential complications associated with the Rotarex ® S endovascular system is peripheral embolization of thrombotic debris in peripheral foot arteries (in most of the cases after additional balloon angioplasty and not directly related to Rotarex ® S thrombectomy) and vessel dissection or perforation in smaller vessels.…”

Protein S deficiency complicated with repetitive peripheral arterial thrombosis successfully treated by mechanical thrombectomy device with Rotarex system

“…It has been recognized as an efficient and safe method to treat acute, subacute or even chronic occlusions or stenosis of peripheral vessels. [9][10][11][12][13][14] In addition, the company of Rotarex system also has another device -Aspirex which is created for thrombus aspiration for venous system such as deep venous thrombosis. [15] Due to venous valve issue, generally Rotarex system can not be used in venous system for thrombus aspiration.…”