Mechanical rotational thrombectomy with Rotarex system augmented with drug-eluting balloon angioplasty versus stenting for the treatment of acute thrombotic and critical limb ischaemia in the femoropopliteal segment.

Abstract

Introduction Mechanical thrombectomy is an alternative to local thrombolysis for the treatment of severe ischaemia in the femoropopliteal segment, but stent implantation is usually required after this procedure. The use of drug-eluting balloons (DEBs) may overcome long-term problems associated with stents, but it remains unclear how often such a treatment is technically feasible and efficient. Aim This post hoc single-centre study was aimed at assessment of the feasibility, safety and efficacy of mechanical thrombectomy followed by application of DEBs. Material and methods Fifty-one patients, aged 69.1 ±11.6 years, were managed for acute thrombotic or chronic critical ischaemia in the femoropopliteal segment using the Rotarex device. Following mechanical thrombectomy, on condition that there was no significant residual stenosis or dissection, lesions were managed with paclitaxel-coated DEBs, which was a desired strategy (24 patients). The remaining 25 patients underwent stent implantations, which was regarded as bailout treatment. Final follow-up was scheduled 12 months after the procedure. Results The primary-assisted patency rate after mechanical rotational thrombectomy with additional balloon angioplasty and/or stenting was 97.1% (49 patients). The early mortality rate was 2.0% (1 patient) and the amputation rate was 4.1% (2 patients). There were no late mortalities or limb amputations at 12-month follow-up, but significant restenoses occurred in 13 (27.1%) patients. These restenoses were more frequent in patients who underwent stent implantation (45.5%) than those managed with DEBs (12.5%), and in patients managed for secondary lesions. Conclusions In selected patients mechanical rotational thrombectomy in the femoropopliteal segment followed by application of DEB is a safe, effective and long-lasting method of revascularisation.

Safety and Efficacy of Rotational Thrombectomy for Treatment of Arterial Occlusions of the Lower Extremities: A Large Single-Center Retrospective Study

“…3. These results are in contrast to a previous prospective trial by Latacz et al, who observed a reduction of restenosis rates from 45.5 % to 12.5 % [20] when combing RT and DCB. However, the cohorts differ regarding target vessels, lesion length, and patient demographics.…”

The effectiveness of percutaneous mechanical thrombectomy in the treatment of acute thromboembolic occlusions of lower extremity

“…Percutaneous mechanical thrombectomy has been used as an adjunctive method and offers advantages over CDT and surgery, with advantages of low invasiveness, prompt reperfusion, improved patency, and a low rate of bleeding complications. 8–10 As reported in previous studies, mean hospitalization duration and rate of major bleedings were significantly decreased in Rotarex therapy when compared to thrombolysis. 11 It also showed high technical success rate ranging from 92% to 100%, and a low mortality rate of 1.1%.…”

“…Postoperative anticoagulation was performed accordingly. 9,10,15 The patients with arterial embolism that was resulted from atrial fibrillation, coronary heart disease, rheumatic heart disease, and thoracoabdominal aortic aneurysm, received the following postoperative anticoagulation therapy: low molecular heparin (100 u/kg of injection) after the procedure and oral administration of Warfarin (INR: 2–3) or Rivaroxaban (20 mg per day) after discharge from hospital. The patients with cardiogenic emboli were maintained on long-term anticoagulation with warfarin sodium.…”

“…11 It also showed high technical success rate ranging from 92% to 100%, and a low mortality rate of 1.1%. 9,12,13…”

Femoro-popliteal endovascular interventions

“…Latacz et al . [ 42 ] studied 51 patients with acute thrombotic femoro-popliteal PAD or chronic critical ischemia and found that femoro-popliteal rotational atherectomy followed by DCB was an effective EVI for long-lasting revascularization.…”