Serration Angioplasty Is Associated With Less Recoil in Infrapopliteal Arteries Compared With Plain Balloon Angioplasty.

PURPOSE: Recoil following balloon angioplasty of tibial arteries is a known mechanism of lumen loss and widely considered to be a contributing factor in early failure or later restenosis. The Serranator balloon has been designed to provide a controlled lumen gain while minimizing vessel injury. The objective of this study was to assess the ability to define and measure postangioplasty recoil in infrapopliteal arteries and to compare recoil after serration angioplasty and plain balloon angioplasty (POBA). METHODS: This multi-center, sequential comparative study included patients with de novo or restenotic lesions of infrapopliteal arteries up to 22 cm in length. Patients were enrolled sequentially and underwent alternating POBA or serration angioplasty with Serranator. The study captured angiographic imaging at pre, immediately post, and 15-minute after angioplasty. Vessel recoil, final diameter stenosis, and dissection were compared using core laboratory analysis. RESULTS: This study enrolled 36 patients who underwent treatment of 39 infrapopliteal lesions. There was no significant difference between Serranator (n=20) and POBA (n=19) with respect to baseline demographics and lesion characteristics. Arterial recoil (>10%) occurred in 25% of Serranator-treated lesions versus 64% in POBA-treated lesions (p=0.02. Clinically relevant recoil (>30%) was present after serration angioplasty in 10% of patients and after POBA in 53% (p=0.01). There was no significant difference in technical success (100% for both), dissection rate between Serranator (5%) and POBA (5.2%). CONCLUSIONS: Arterial recoil occurs after infrapopliteal angioplasty. Serration angioplasty produces substantially less arterial recoil compared with POBA. Additional studies are needed to assess whether reduced arterial recoil translates into superior long-term clinical outcomes. CLINICAL IMPACT: Prior studies have demonstrated over 90% recoil in patients after balloon angioplasty (POBA) of the infrapopliteal vessels, which significantly impacts the durability and impact of endovascular interventions in this clinical space. This study compared recoil after infrapopliteal angioplasty with serration angioplasty and POBA. Serration angioplasty produces substantially less arterial recoil compared with POBA. Additional studies are needed to assess whether reduced arterial recoil translates into superior long-term clinical outcomes.

The histological analysis of the coronary medial thickness: Implications for percutaneous coronary intervention.

BACKGROUND: A deeper understanding of coronary medial thickness is important for coronary intervention because media thickness can limit the safety and effectiveness of interventional techniques. However, there is a paucity of detailed data on human coronary medial thickness so far. MATERIALS AND METHODS: We investigated the thickness of the media by histologic analysis. A total of 230 sections from 10 individuals from the CVPath autopsy registry who died from non-coronary deaths were evaluated. We performed pathological analysis on 13 segments of the following primary vessels from coronary arteries: the left main trunk, proximal left anterior descending artery (LAD), mid LAD, distal LAD, proximal left circumflex artery (LCX), mid LCX, distal LCX, proximal right coronary artery (RCA), mid RCA, and the distal RCA. The following side branches were also evaluated: diagonal, obtuse margin, and posterior descending artery branches. RESULTS: The average age of the studied individuals was 60.4±12.3 years. The median medial thickness for all sections was 0.202 (0.149-0.263) mm. The median medial thickness of the main branches was significantly higher compared to that of the side branches (p<0.001). Although the medial thicknesses of the main branch of LAD and LCX were significantly decreased from proximal to distal segments (p = 0.010, p = 0.006, respectively), the medial thickness of the main branch of RCA was not significantly decreased from proximal to distal (p = 0.170). The thickness of the media was positively correlated with vessel diameter, while it was negatively correlated with luminal narrowing (p<0.001 and p<0.001, respectively). CONCLUSIONS: The human coronary arteries demonstrate variation in medial thickness which tends to vary depending upon an epicardial coronary artery itself, as well as its segments and branches. Understanding these variations in medial thickness can be useful for both the interventionalists and interventional product development teams.

Early experimental and clinical experience with a focal implant for lower extremity post-angioplasty dissection.

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.