Percutaneous isolated pharmaco-mechanical thrombolysis-thrombectomy system for the management of acute arterial limb ischemia: 30-day results from a single-center experience

Objective To study the efficacy of isolated pharmaco-mechanical thrombolysis-thrombectomy (IPMT) by Trellis (TM) device (Covidien, Mansfield, MA) in managing acute limb ischemic (ALI). Background ALI is both life and limb threatening disease with a reported 915% mortality and 1525% limb loss in the first month after presentation. Pitfalls of current endovascular techniques include major bleeding, distal embolism, and prolonged thrombolytic infusion. IPMT isolates the thrombus between two balloons and utilizes wire oscillation to increase the thombus-lytic exposure surface area followed by aspiration. It decreases systemic lytic exposure, procedure time, and distal embolism. Methods Technical aspects, success, and bleeding complications in 24 consecutive patients with ALI treated with IPMT between October 2009 and September 2010 were analyzed. In-hospital and 30-day mortality, amputation rates and treatment success rates were determined. Results 24 patients constituted 32 arteries; 18 (56.25%) were suprainguinal including 3 grafts (9.4%) and 14 (43.75%) were infrainguinal native arteries. Substantial or complete response was seen in >90% vessels with 87.5% patients revealing TIMI three flow while none demonstrated TIMI 2 or 3 pretreatment. Only three patients required adjunctive post-IPMT thrombolysis. In-hospital and 30-day all cause mortality was 4.16%. One patient died in-hospital and no patient underwent amputation. Conclusion Besides being the largest series of ALI patients treated with IPMT, this is the first and largest series including 14 native infrainguinal arteries. These results suggest IPMT to be a promising and safer therapeutic option in ALI, likely due to its site-specific nature and limited thrombolysis exposure time. (c) 2012 Wiley Periodicals, Inc.