3:45 PM Abstract No. 47 MicroStent: initial single-center experience at a vascular center of excellence

Abstract

(1) Brief overview on the treatments used in critical limb ischemia (CLI) arteries below the knee (BTK) and the current treatment landscape limitations. (2) Guide the reader on the composition of the MicroStent (Micro Medical Solutions, Wilmington, MA) (MS), dedicated for below-the-knee vessels in CLI. (3) Discuss our single-center experience via retrospective analysis and case examples Based on the angiographosome concept, vascular specialists have aimed to revascularize BTK vessels to improve in line flow to aid wound healing and promote limb salvage in Rutherford class (RC) 4-6 patients. Traditional methods spanning from POBA and bare-metal stenting to newer paclitaxel impregnated devices and atherectomy have been the mainstay to restore vessel patency and flow. However, there has been no dedicated peripheral stent for vessels BTK prior to recent advancements. Off label use of coronary stents, such as the 4-mm Resolute Onyx (Medtronic, Dublin, Ireland) have been used to salvage perfusion BTK. MS aims to create an ‘instructions for use’ (IFU) BTK stent for CLI therapy. Here, we share our experience with MS, exploring parameters beyond initial feasibility trials. Single center retrospective analysis in RC 4-6 CLI patients revascularized with MS. The first phase of the study included 8 patients treated from April–November 2018. Ultrasound was obtained for primary patency and hemodynamically significant stenosis with standardized protocol performed by a single technician on prescheduled follow-up visits at 15 days, 30 days, 3 months, 6 months and 1 year. Our analysis examined (1) primary patency, (2) secondary patency (defined as 1 reintervention at target lesion), (3) change of 1 or more RC, (4) wound healing, (5) major amputation and cardiovascular events, and (6) death. The second phase of the study is under enrollment with further analysis to be performed with larger sample size prior to publication. Exploring the safety and efficacy of novel devices for tibiopedal disease is imperative to develop IFU and treatment algorithms in this complex disease. Here, we share our early experience with MS in BTK arteries and what impact it may have to further the fight against amputation and CLI mortality.