Safety and efficacy of the Rotarex^®S catheter system – results from a large single center cohort

Aim To evaluate safety and efficacy of treatment with the Rotarex^®S catheter system in patients with acute, sub-acute or chronic arterial or bypass occlusion of the lower limb treated with percutaneous mechanical thrombectomy and adjunctive therapies.

Materials and Methods This retrospective study included data of 397 interventions in 294 patients with acute, sub-acute and chronic arterial occlusion of the lower limb. Native vessels were treated in n = 338 (85.1%) cases vs. bypass grafts in n = 59 (14.9%). Technical success and complications were recorded according to the CIRSE classification system.

Results Mean age was 69.8 ± 12.0 years. Revascularization was achieved in 361 (90.9%) cases. In total, 359 (90.4%) procedures were clinically successful. Distal peripheral embolization was observed in 89 (22.4%) interventions.) In 127 interventions (32%) a subsequent catheter directed thrombolysis was needed. Complications occurred in 87 cases (21.9%). Most frequent complications were, dissections (n = 38; 9.6%), followed by perforations (n = 17; 4.3%) with 11 perforations attributed to the application of the Rotarex^®S Catheter. A significant difference between treatment of bypass grafts and native vessels was observed regarding the need for adjunctive treatment with lysis (58.9% vs. 19.4%). Furthermore, treatment of the iliac arteries showed a higher rate of perforations (8.3% vs. 2.0%).

Conclusions The Rotarex^®S device is a useful option to treat acute, sub-acute or chronic arterial occlusions with a high technical success rate. However, treatment of iliac arteries and bypass bare a greater risk of complications. Prospective studies in this issue are recommended.

Publication History

Article published online:
11 May 2021