Многоцентровой ретроспективный анализ использования устройства «Angioseal» для осуществления первичного и осложненного гемостаза

Background. Femoral approach in endovascular surgery remains relevant being, however, associated with the risk of fatal and non­fatal complications. Modern techniques for instrumental haemostasis achieved with the Angio­Seal device (Terumo Corporation, Japan) provide an opportunity to reduce the number of fatal and non­fatal complications.  Aim. A multicentre assay of the efficacy and safety of instrumental puncture closure using Angio­Seal devices (Terumo Corporation, Japan) in various settings and clinical situations. Materials and methods . A multicentre retrospective analysis of 1088 use cases of the Angio­Seal device  (Terumo Corporation, Japan) for “primary” and “complicated” instrumental haemostasis after femoral access  has been conducted for the years 2018–2020. The mean patient age was 62.3 ± 11.6 years, including 845 men (78.0%) and 243 women (22.0%). Five centres for routine and emergency endovascular radiology participated in the study. Results. The Angio­Seal device (Terumo Corporation, Japan) demonstrated a high method efficiency, with a  97.0% success rate of “primary” instrumental haemostasis (1055 of 1088 total successful haemostatic  procedures) in various clinical settings. Arterial thrombosis at the approach side had a 3.0% complication rate  (5 of 33 observations), all other complication types associated with haemorrhagic events (8 cases) or device malfunction and damage (20 cases). Discussion . The assay conducted suggests that the incidence of “complicated” instrumental haemostasis  relates to technical drawbacks of the device application that required advance planning. The key identified  prerequisites for a successful Angio­Seal application (Terumo Corporation, Japan) are the alignment of anchor tube­delivery through soft tissue into the vessel lumen and its positioning inside the vessel. Conclusion. The constructive features and instrumental haemostatic technique realised in the Angio­Seal  device (Terumo Corporation, Japan) enable an effective and safe primary sealing of arterial puncture site in 97% cases.