Background—: Animal models suggest that the neurotransmitter inhibitor, botulinum toxin, when injected into the epicardial fat pads can suppress atrial fibrillation inducibility. The aim of this prospective randomized double-blind study was to compare the efficacy and safety of botulinum toxin injection into epicardial fat pads for preventing atrial tachyarrhythmias. Methods and Results—: Patients with history of paroxysmal atrial fibrillation and indication for coronary artery bypass graft surgery were randomized to botulinum toxin (Xeomin, Merz, Germany; 50 U/1 mL at each fat pad; n=30) or placebo (0.9% normal saline, 1 mL at each fat pad; n=30) injection into epicardial fat pads during surgery. Patients were followed for 1 year to assess maintenance of sinus rhythm using an implantable loop recorder. All patients in both groups had successful epicardial fat pad injections without complications. The incidence of early postoperative atrial fibrillation within 30 days after coronary artery bypass graft was 2 of 30 patients (7%) in the botulinum toxin group and 9 of 30 patients (30%) in the placebo group ( P =0.024). Between 30 days and up to the 12-month follow-up examination, 7 of the 30 patients in the placebo group (27%) and none of the 30 patients in the botulinum toxin group (0%) had recurrent atrial fibrillation ( P =0.002). There were no complications observed during the 1-year follow-up. Conclusions—: Botulinum toxin injection into epicardial fat pads during coronary artery bypass graft provided substantial atrial tachyarrhythmia suppression both early as well as during 1-year follow-up, without any serious adverse events. Clinical Trial Registration—: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01842529.

General physicochemical properties of the vascular grafts (VGs) produced from the solutions of Tecoflex (Tec) with gelatin (GL) and bivalirudin (BV) by electrospinning are studied. The electrospun VGs of Tec-GL-BV and expanded polytetrafluoroethylene (e-PTFE) implanted in the abdominal aorta of 36 Wistar rats have been observed over different time intervals up to 24 weeks. A comparison shows that 94.5% of the Tec-GL-BV VGs and only 66.6% of e-PTFE VGs (р = 0.0438) are free of occlusions after a 6 month implantation. At the intermediate observation points, Tec-GL-BV VGs demonstrate severe neovascularization of the VG neoadventitial layer as compared with e-PTFE grafts. A histological examination demonstrates a small thickness of the neointima layer and a low level of calcification in Tec-GL-BV VGs as compared with the control grafts. Thus, polyurethane-based protein-enriched VGs have certain advantages over e-PTFE VGs, suggesting their utility in clinical studies.

A stenting procedure aimed at blood flow restoration in stenosed arteries significantly improves the efficiency of vascular surgery. However, the current challenge is to prevent neointimal growth, which reduces the vessel lumen, in the stented segments in the long run. We tested in vivo drug-eluting coating applied by electrospinning to metal vascular stents to inhibit the overgrowth of neointimal cells via both the drug release and mechanical support of the vascular wall. The blend of polycaprolactone with human serum albumin and paclitaxel was used for stent coating by electrospinning. The drug-eluting stents (DESs) were placed using a balloon catheter to the rabbit common iliac artery for 1, 3, and 6 months. The blood flow rate was ultrasonically determined in vivo. After explantation, the stented arterial segment was visually and histologically examined. Any undesirable biological responses (rejection or hemodynamically significant stenosis) were unobservable in the experimental groups. DESs were less traumatic and induced weaker neointimal growth; over six months, the blood flow increased by 37% versus bare-metal stents, where it increased by at least double the rate. Thus, electrospun-coated DESs demonstrate considerable advantages over the bare-metal variants.