A scoring angioplasty balloon catheter for the management of complex tibial arterial lesions in critical lower limb ischaemia: A prospective study

Abstract

Introduction: Complex tibial lesions represent a challenging problem in a large proportion of patients presenting with critical limb ischemia. In this particular subset of patients, heavily calcified and fibrocalcific lesions in the distal tibial tree, embodies an exigent problem for the success of the procedure. Aim: To report our initial experience with the AngioSculptTM (ASC) scoring balloon catheter, which incorporates a laser-cut highly flexible three nitinol spiral struts which encircle a semi- compliant conventional balloon catheter to create focal concentration of the dilating force leading to scoring (indenting) the surface of calcific plaques. Methods: Patients scheduled for angioplasty of the tibial vessels for critical limb ischemia, were included in our study. Primary end points were limb salvage rate, clinical improvement, and primary patency. Secondary end points were, technical success, difficulties, and complications associated with the use of the scoring balloon. Results: Forty Eight patients underwent peripheral angioplasty procedures in our institute, of which 11 patients with complex lesions fulfilled the inclusion criteria. Mean lesion length was 35±12.2 mm, ostial lesion in 36.4% of patients. The AngiosculptTM balloon was used as sole therapy in all attempted tibial lesions. Limb salvage rate was 81.8%. Primary patency rate of the treated vessels was 63.6% at 6 months. Conclusion: The AngiosculptTM scoring balloon is a highly effective solution for challenging tibial complex lesions, and is associated with a very high technical success with low complication rate.