Die Sicherheit in der Off-Label-Verwendung eines Verschluss-Systems (Angio-Seal™) nach Punktion der Arteria femoralis communis in der interventionellen Radiologie

Background: Compared to manual compression, the Angio-Seal ™ vascular closure device shortens the hemostasis time after diagnostic and therapeutic endovascular interventions, enables early mobilization and increases patient comfort. Several studies demonstrated its safety and efficacy when used properly. However, there is little data available on the safety of the device for off-label use. In this study, we address this gap and present data on the safety and efficacy of the Angio-Seal ™ for off-label use. Method: We conducted a retrospective analysis of all patients who received a 6-F or 8-F Angio-Seal ™ after puncture of the femoral artery between November 2013 and July 2016 at the Department of Diagnostic and Interventional Radiology of the University of Marburg. Patients who had the Angio-Seal ™ were divided into two groups according to on-label and off-label criteria. We compared the complication rate in the off-label group to that in the on-label group. We also analyzed the likelihood of complications after ante- compared to retrograde puncture and evaluated the influence of possible risk factors on the complication rate. Results: The Angio-Seal ™ 6 F or 8 F was used for a total of 471 punctures. Of these, 94 (20.0%) met the off-label criteria and 377 (80%) were on-label. Successful device deployment was achieved in 98.9% of cases. Complications occurred in 23 (4.9%) patients out of 471 (3.6% minor and 1.3% major complications). The complication rate for off-label use was statistically different from that of on-label use (10.6% vs. 3.4%, OR 3.33, 95% CI: 1.40-7.93, p = 0.012). Nine patients out of 216 (4.2%) had local complications following antegrade Angio-Seal ™ application compared to 5.5% (14 out of 255) following retrograde administration. The difference was not statistically significant (p = 0.529, OR 1.34, 95% CI: 0.57-3.15). Nicotine abuse, long-term lysis with urokinase for more than 24 hours, dwelling time of the sheath in the vessel > 24 hours and an INR > 2 following Marcumar therapy were positively associated with higher likelihood of experiencing complications at the vascular access site. Practical conclusion: The increased risk of complications in the off-label group was mainly because of its higher percentage of patients with long-term lysis therapy. At 46.8% (44 out of 94), these patients represented the largest share of the off-label group in this study. They received a therapy with urokinase for an average of 55.63 hours and, accordingly, the sheath remained in the vessel for the duration of this therapy. Out of a total of 10 complications in the off-label group, 7 complications occurred in these lysis patients alone. With this in mind, we see an increased risk of local complications after using Angio-Seal ™ closure device with lysis therapy lasting more than 24 hours. As a result, we advise against the routine use of Angio-Seal ™ after lysis therapy for longer than 24 hours which is in line with the manufacturer's instructions. Even for patients who are anticoagulated with Marcumar, the closure device should be used only after careful consideration. With the exception of nicotine abuse, none of the predictive factors known from previous studies to be responsible for local complications were found to cause a statistically significant increase of the events. Nicotine plays a central role in the development and progression of arteriosclerosis. Consequently, advanced vascular calcification may lead to limitations in the use of Angio-Seal ™. An angiogram of the puncture vessel should be routinely made prior to the application of the Angio-Seal ™ to verify the condition of the vascular segment and aid in the decision to apply. After both antegrade and retrograde puncture, the use of the Angio-Seal ™ was safe and efficient within a reasonable risk.