Balloon-Uncrossable Lesions: Significant Higher Recanalization-Success with Metallic-Tip Catheters 5-year Follow-Up Data from XableCath-Study

Abstract

Background: The metallic tip interventional recanalization catheter XableCath showed encouraging results (95.8percentage success rate) in crossing occluding atheroma in balloon uncrossable lesions after successful passage of a guide wire. Because successful crossing of balloon-uncrossable, mostly calcified atheromatous lesions may be associated with a higher complication rate, we investigated the long-term follow-up of all twenty-two patients (24 separate lesions), who have been included into the XableCath study. Patients and Methods: We investigated the long-term outcome (5-year follow-up) of 20 lesions in 18 patients, who had successfully been treated with the XableCath metallic tip interventional recanalization catheter (XableCath Inc., Salt Lake City, Utah) for balloon-uncrossable lesions (18 femoro-popliteal (90.0 percentage), 1 below-the-knee (5.0 %), 1 common iliac (5.0 percentage), 12 total occlusions (66.7 percentage). The primary study endpoint was the rate of target lesion patency resp. target lesion complications (e.a. perforation, aneurysms, dissections, or vessel closure) achieved by duplex-sonography. Secondary endpoints were the abscence of lesion associated major adverse events (MAE) as defined as limb amputations and/or cardiovascular death during the follow-up period of 5 years. Results: Follow-up informations after 5 years (incl. duplex-sonography) could have been achieved in 18 successfully treated patients (20 lesions). 3 patients (14.3percentage) died due to not-target lesion associated cardiovascular reasons. The primary endpoint (patency rate) was 85.0 percentage, target lesion associated complications (e.a. aneurysms, perforations or dissections) were not documented in any patient (0percentage), secondary endpoint (target lesion associated major adverse cardiovascular events) did not occur in any patient (0percentage). Conclusion: The metallic-tip interventional crossing catheter XableCath is a feasible, easy to use, time and money-saving option for successful angioplasty of balloon-uncrossable PAD-lesions without a higher rate of target lesion failure or target lesion-associated adverse events during a follow-up period of 5 years after successful recanalization of a balloon uncrossable lesion.