Early Experimental and Clinical Experience With a Focal Implant for Lower Extremity Post-Angioplasty Dissection

• Published in: JACC. Cardiovascular interventions Vol. 8; no. 2; pp. 347 - 354
• Main Authors: Schneider, Peter A., MD, Giasolli, Robert, MS, Ebner, Adrian, MD, Virmani, Renu, MD, Granada, Juan F., MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-02-2015
• Subjects: Aged; Aged, 80 and over; Angiography; angioplasty; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - instrumentation; Animals; Arterial Occlusive Diseases - therapy; Cardiovascular; Disease Models, Animal; dissection; Feasibility Studies; Female; Follow-Up Studies; Humans; Lower Extremity - blood supply; Lower Extremity - injuries; Male; Middle Aged; Patient Safety; Peripheral Vascular Diseases - therapy; Prospective Studies; Stents; Swine; tack; MAE; percutaneous transluminal balloon angioplasty; tack; superficial femoral artery; PTA; major adverse event; angioplasty; dissection; SFA
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2014.07.032

Abstract Objectives This study provides preliminary data on the safety and feasibility of the use of a novel focal implant for managing post–percutaneous transluminal balloon angioplasty (post-PTA) dissection. Background Post-PTA dissection of the lower extremity arteries is managed with stent placement. This provides an acceptable post-intervention result but has long-term disadvantages, such as in-stent restenosis. Focal treatment of post-PTA dissection and avoidance of stents are the objectives of the Tack-It (Intact Vascular, Inc., Wayne, Pennsylvania) device. Methods A preclinical study and first-in-human data are presented. Seven swine underwent superficial femoral artery device placement, with a self-expanding nitinol stent on 1 side and a series of 4 Tack-It devices on the other side. Specimens were harvested at 28 days. The clinical study included 15 limbs that underwent revascularization for critical limb ischemia (n = 9) or claudication (n = 6). Twenty-five lesions were treated in the superficial femoral (n = 8), popliteal (n = 7), and tibial (n = 10) arteries. Results The preclinical study demonstrated a reduction in stenosis with the Tack-It (16.8 ± 2.6%) compared with stents (46.4 ± 9.8%). Neointimal thickness and injury score decreased with the Tack-It. Clinically, Tack-It placement resulted in acute technical success with resolution of the post-PTA dissection in 100% of lesions. There were no device-related complications or major amputations. Eighteen of the 25 lesions were available for angiographic follow-up at 1-year, and patency was 83.3%. Conclusions Preclinical data suggest that the Tack-It device causes minimal vessel injury. Clinical use of the Tack-It to manage post-PTA dissection was safe and feasible in this early study and resulted in apposition of dissection flaps without stent placement.