Use of 8Fr angio-seal for closure of femoral arteriotomy following use of 8Fr and 9Fr sheaths in patients undergoing mechanical thrombectomy for acute ischaemic stroke

Abstract

BACKGROUND: Little is known about the safety of off-label use of an 8Fr Angio-Seal VIP for large-bore arteriotomies in patients treated with mechanical thrombectomy (MT) and intravenous thrombolysis (IVT) for acute ischaemic stroke (AIS). We aimed to identify differences in the groin complication rate using an 8Fr Angio-Seal VIP for common femoral arteriotomy closures following the use of 8Fr and 9Fr sheaths. METHODS: All AIS patients who underwent MT at our tertiary neuroscience unit between January 2018 and March 2020 were retrospectively reviewed. RESULTS: 161 patients were included in the study, of whom 56 and 105 patients underwent an arteriotomy using an 8Fr sheath (36 of them receiving IVT) and a 9Fr sheath (57 of them receiving IVT). Overall, 17 groin complications were identified (10.5%) in 5 patients (8.9%) who had had 8Fr sheaths inserted and 12 patients (11.4%) who had had 9Fr sheaths inserted. Major complications were identified in only 2 patients (1.2%), one patient in each of the 8Fr and 9Fr cohorts suffering a pseudoaneurysm requiring intervention. No retroperitoneal haematoma, infection, acute limb ischaemia or ipsilateral DVT was identified. No significant difference in groin complications was observed between the 8Fr and 9Fr femoral arteriotomy cohorts or between the MT patients that did or did not receive adjunctive IVT. CONCLUSION: In the setting of MT with IVT, off-label use of an 8Fr Angio-Seal VIP for closure of a femoral arteriotomy following use of a 9Fr sheath has a similar safety profile to the licensed use of an 8Fr Angio-Seal VIP for closure of a femoral arteriotomy following use of an 8Fr sheath or smaller. Copyright © 2021 Elsevier Ltd. All rights reserved.