Mechanical Thrombectomy by Rotarex® Device versus Chemical Thrombolysis in The Management of Acute Lower Limb Ischemia (prospective randomized study)

Abstract Background Acute limb ischemia (ALI) is one of the most frequent causes for amputation and a potentially life-threatening condition, affecting approximately 1.5 persons per 10 000 per year worldwide. Aim of the Work To compare safety (peri operative complications) and efficacy (the success rate, the patency rate and the limb salvage rate) of Percutaneous Mechanical Thrombectomy (PMT) versus Catheter Directed Thrombolysis (CDT) in the management of acute thrombotic lower limb ischemia. Patients and Methods This prospective randomized study was conducted on 50 patients with acute thrombotic lower limb ischemia (Rutherford class I, II A) at Ain Shams University Hospitals and Helwan University Hospitals in the period between September 1st, 2021, and August 31st, 2023. Patients were randomized into two groups: Group A: included 25 patients, who were treated with percutaneous mechanical thrombectomy using the Rotarex™S device (Becton, Dickinson and Company, New Jersey, USA) and Group B: included 25 patients, who were treated with catheter directed thrombolysis using drug Actilyse® (Boehringer Ingelheim, Ingelheim am Rhein, Germany) and catheter Fountain® Infusion System with Squirt® (Merit Medical Systems, Inc. California, USA). Results In our study, we achieved technical success rate 96% (n = 24) and 80% (n = 20) in group A and group B respectively. Regarding peri operative complications, group A showed 2 cases (8%), (1 perforation and 1 distal embolization / trash foot), and group B showed 2 cases (8%), (1 intracranial hemorrhage and 1 puncture site pseudo aneurysm). 30-day mortality wasn’t reported in any case in group A, while 2 cases were reported in group B. At 1 month follow-up, primary patency rate was 84.0% (21/25) and 81% (17/21) in group A and group B respectively and this rate declined to 62.5% (15/24) and 55.6% (10/18) at 1 year follow up. Late complications (major amputations) were recorded, 1 patient in group A and 2 patients in group B had below knee amputation, non of the patients had above knee amputation in group A, while 3 patients had above knee amputation in group B. Conclusion Despite that the results of percutaneous mechanical thrombectomy and catheter directed thrombolysis were comparable, percutaneous mechanical thrombectomy is considered more safe and efficient technique. Percutaneous mechanical thrombectomy was done in single session. PMT had lower mortality and morbidity, higher limb salvage and patency rate than CDT, but in PMT special attention should be given to the potential for distal embolism.