Percutaneous Rotational Mechanical Atherectomy Plus Thrombectomy Using Rotarex S Device in Patients With Acute and Subacute Lower Limb Ischemia: A Review of Safety, Efficacy, and Outcomes

Abstract

Acute and subacute ischemia of lower limbs is associated with high risk of amputation and potential severe life-threatening complications. Despite a lack of clear therapeutic recommendations, surgical treatments such as thrombectomy or bypass and/or catheter-directed thrombolysis (CDT) have been first-line procedures in both acute and subacute limb ischemia, but each therapy may lead to significant morbidity and mortality. Such situations demand fast restoration of appropriate flow to preclude limb loss and other complications. Percutaneous mechanical atherectomy plus thrombectomy (MATH) represents a minimally invasive approach for quickly recanalizing thrombus-containing lesions whatever the age of thrombus. Indeed, many chronic patients can present with critical limb ischemia, with thrombus-containing occlusive lesions triggered by underlying atherosclerotic disease. MATH offers various advantages over surgery and CDT, with lower invasiveness, faster recanalization, and the possibility to immediately treat the underlying lesions, with a lower rate of bleeding complications and no need for intensive care unit stay. Currently, several mechanical thrombectomy devices are offered as an alternative therapy and can be divided into pure rotational MATH systems and rheolytic thrombectomy devices. The only pure rotational MATH device currently available on the market is the Rotarex S device. We aimed to review contemporary clinical data regarding the safety, efficacy, and outcomes of MATH therapy using Rotarex S catheter in acute and subacute thrombus-containing arterial lesions of lower limbs. Future perspectives of Rotarex S MATH treatment and cost-effectiveness of its routine use will be also discussed.

Percutaneous Mechanical Thrombectomy for Acute Limb Ischemia With Aorto-iliac Occlusion

“…The Rotarex catheter is a commonly used device and has been proved to be safe and effective in the treatment of peripheral artery diseases with 95% success rate ( 19 ). It could simply and directly remove the blood clots and restore the blood flow quickly without delaying the treatment compared to the conventional operation procedure ( 8 , 20 ). It is feasibility in patients with high risk of bleeding when thrombolysis in contraindicated (hepatic failure, recent surgery, trauma, or a neurovascular accident) ( 21 ).…”

“…Several percutaneous mechanical thrombectomy (PMT) devices are available for treating ALI recently. For artery occlude below the groin area, it has been proved as an effective device ( 8 ). It's endovascular and minimal invasive, and able to rapidly remove thrombus with low risk of bleeding.…”

Percutaneous Mechanical Atherectomy Plus Thrombectomy Using the Rotarex®S Device Followed by a Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-stent Restenosis: A Prospective Single-Center, Single-Arm Efficacy Trial (PERMIT-ISR Trial)

“…An adjunctive thrombus is considered as a major limiting factor for treating patients with FP stenosis or occlusion via a DCB-alone approach (17). This is an appropriate application of the characteristics of the debulking device of the Rotarex R S. The Rotarex R S system is an effective MATH device and represents a minimally invasive approach for quickly recanalizing thrombus-containing lesions regardless of the age of the thrombus (12). However, atherectomy alone for FP-ISR may be an insufficient choice.…”

“…Acute and subacute life-endangering limb ischemia could be driven by reduced arterial perfusion to a limb due to ISR ( 12 ). Despite the refinement of endovascular techniques, the role of endovascular therapy in the treatment of PF-ISR remains intractable.…”

“…In-stent restenosis lesions are associated with refractory restenosis and remarkably differ from de novo atherosclerotic lesions; restenotic tissue consists primarily of a collagen-rich extracellular matrix with an inner layer of smooth muscle cells ( 13 ) that has limited the therapeutic effect of endovascular techniques. Recently, mechanical thrombectomy devices including the MATH that have the advantage of lower invasiveness, lower risk of complications, and shorter treatment duration, are available as an alternative approach ( 12 ). A systematic review and meta-analysis suggested that debulking devices combined with DCBs may be a promising way for FP-ISR complex lesions ( 14 ).…”