Removal of Peripheral Arterial Occlusive Material with the Rotarex® S Device: Mechanical Atherothrombectomy.

Mechanical atherothrombectomy (MATH) with the Rotarex® S (Straub Medical AG, Wangs, Switzerland) catheter is an endovascular therapeutic technique for removing fragmentable occlusive material from the lumen of peripheral vessels. It can be used as a rapid, safe and efficacious initial modality for the treatment of acute or subacute ischemia of the lower limbs, even in patients with an immediately threatened extremity and those with a contraindication for surgical and/or thrombolytic therapy. Patient placement in an intensive care unit and routine embolic prevention with a filter are not necessary. In the literature, the technical success of MATH has varied from 92% to 100%, with lower rates in subgroups with occluded bypass grafts (78%) and a crossover approach (56%). The number of secondary surgical revascularization procedures has ranged from 0% to 5.3% and the mortality rate at 30 days has varied between 0% and 1%. The 30-day clinical success has varied from 68% to 98%, secondary patency from 68% to 97.6%, amputation-free survival from 94.4% to 100%, frequency of major complications from 0% to 6.9%, major hemorrhage from 0% to 2.6% and frequency of major debulking device-related complications from 0% to 0.4%.

Prospective Single-Arm Trial of Endovascular Mechanical Debulking as Initial Therapy in Patients With Acute and Subacute Lower Limb Ischemia: One-Year Outcomes.

PURPOSE: To report the results of a prospective, single-arm study to establish whether the initial treatment of acute or subacute limb ischemia (ALI and SLI, respectively) can be accomplished successfully using endovascular mechanical debulking of the target vessels to avoid the risks associated with thrombolysis and/or open surgery. MATERIALS AND METHODS: From April 2009 to April 2015, 316 consecutive patients (mean age 70.9±12 years; 184 men) with ALI (202, 63.9%) or SLI (114, 36.1%) were enrolled; the only exclusion criterion was irreversible ischemia. The ALI group included 146 (72.3%) participants with category IIb ischemia and 56 (27.7%) with category IIa. Critical limb ischemia was diagnosed in 74 (64.9%) of the 114 patients with SLI. Target occlusions of thrombotic (n=256) or embolic (n=60) origin were located in the femoropopliteal segment (n=231), prosthetic or venous femoropopliteal bypass grafts (n=75), and the aortoiliac segment (n=35). The mean occlusion length was 22.9±14.8 cm. RESULTS: The overall technical success (residual stenosis ≤30%) was 100% after debulking and adjunctive techniques (aspiration, dilation, stenting) at the level of the target lesions. No open surgical or thrombolytic modalities were necessary to bypass or recanalize the target vessels, and no death occurred in association with target occlusion therapy. Additional infrapopliteal interventions were performed in 195 (61.7%) patients (adjunctive thrombolysis in 29) to treat acute, subacute, and chronic lesions. Minor complications directly related to the debulking procedure occurred in 26 (8.2%) patients. Serious complications occurred in 11 (3.5%) patients, including hemorrhage in 8 (2.5%) patients (associated with infrapopliteal thrombolysis in 5). At 30 days, primary and secondary patency rates were 94.3% and 97.2%, respectively; mortality was 0.3% (1 fatal intracranial hemorrhage after adjunctive thrombolysis). Of 229 patients eligible for 1-year follow-up, amputation-free survival was estimated to be 87.4% in 199 patients with available data. CONCLUSION: In this all-comers study, mechanical debulking with the Rotarex alone or with adjunctive techniques is feasible as a primary therapy for occluded supratibial vessels in patients with ALI or SLI.