Single-Center Study Supports Covidien's Trellis Device to Treat Acute Arterial Limb Ischemia

October 1, 2012—A single-center study was conducted to evaluate the efficacy of isolated pharmacomechanical thrombolysis/thrombectomy (IPMT) with the Trellis device (Covidien, Mansfield, MA) in managing acute limb ischemic (ALI). Raghav Gupta, MD, and Thomas Hennebry, MD, of the University of Oklahoma Health Sciences Center in Oklahoma City published the 30-day data in Catheterization and Cardiovascular Interventions (2012;80:636–643).

The investigators concluded that the results of this study suggest IPMT to be a promising and safer therapeutic option for ALI, likely due to its site-specific nature and limited thrombolysis exposure time. They noted that the study was composed of the largest series of ALI patients treated with IPMT and the first and largest series including 14 native infrainguinal arteries.

The background of the study is that ALI is both a life- and limb-threatening disease with a reported 9% to 15% mortality rate and a 15% to 25% limb-loss rate in the first month after presentation. The investigators stated that the 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. The treatment decreases systemic lytic exposure, procedure time, and distal embolism, stated the investigators.

As detailed in Catheterization and Cardiovascular Interventions, the investigators analyzed technical aspects, procedural success, and bleeding complications in 24 consecutive ALI patients treated with IPMT between October 2009 and September 2010.

In the 24 patients, 32 arteries were treated: 18 (56.25%) were suprainguinal, including three 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 3 flow, whereas 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 none of the patients underwent amputation, reported the investigators.