SCVIR Reporting Standards for the Treatment of Acute Limb Ischemia with Use of Transluminal Removal of Arterial Thrombus

Abstract

ACUTE limb ischemia is any sudden decrease or worsening in limb perfusion that causes a potential threat to limb viability (1). Acute peripheral arterial occlusion may be caused by in situ thrombosis or embolus. In this article, the term “thrombus” will be used to describe arterial occlusion caused by in situ thrombosis or embolus. Percutaneous or “open” surgical techniques can be used to remove the thrombus. Current percutaneous methods for transluminal removal of thrombus (TRT) include thrombolytic therapy (ie, catheter-directed, pharmacomechanic), percutaneous aspiration thrombectomy (PAT), and percutaneous mechanical thrombectomy (PMT). These methods may be used in combination. Surgical techniques entail an “open” procedure that necessitates an arteriotomy for the removal of thrombus. Of the various TRT methods used to treat acute limb ischemia, catheterdirected thrombolytic therapy with urokinase has been the most widely studied. Catheter-directed thrombolytic therapy has at least three theoretical and practical advantages over surgical thromboembolectomy: less endothelial trauma, angiographic visualization of the underlying lesion(s) and runoff vessels, and, in many cases, ready access for definitive transluminal therapies that address the underlying lesion (1,2). In addition, it has been suggested that gradual, lowpressure reperfusion may offer certain advantages over sudden, high-pressure reperfusion associated with surgical revascularization (1,3,4). Recently, the Food and Drug Administration recalled urokinase (Abbokinase; Abbott Laboratories, Abbott Park, IL). As a result, a critical evaluation of alternate methods to treat acute limb ischemia with use of other thrombolytic drug strategies, PAT and/or PMT, will be needed. Reporting standards for the treatment of peripheral arterial disease (PAD) and practice guidelines for thrombolytic therapy for acute limb ischemia have been published (1,2,5– 7). However, there is insufficient evidence in the literature to determine the best therapy in a given case of acute limb ischemia. This is because the literature is replete with individual or institutional reports of surgical and thrombolytic therapy that are either biased or lack concurrent controls and standardized reporting practices (1). The purpose of this document is to establish reporting standards for subsequent studies pertaining to TRT in the treatment of acute limb ischemia. Consistent data reporting is needed to help precisely define the safety, efficacy, and long-term outcome of TRT procedures (1,8,9). Only then can the appropriate treatment be determined for patients presenting with acute limb ischemia.