Safety and efficacy of Angio-Seal device for transfemoral neuroendovascular procedures: A systematic review and meta-analysis

Muhammed Amir Essibayi, Harry Cloft, Luis E. Savastano, Waleed Brinjikji

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: Angio-Seal is a commonly used device for femoral hemostasis in neuroendovascular procedures. This meta-analysis investigates of the safety and efficacy of Angio-Seal in patients undergoing endovascular neurointerventional procedures. Methods: A systematic review and meta-analysis on all studies evaluating the Angio-Seal device in neurointerventional procedures from inception through 2020 were performed. We studied rates of groin hematoma, retroperitoneal hematoma, pseudoaneurysm, ipsilateral DVT, and ischemic complications. Meta-analysis was performed using the random-effects model. Results: 13 studies were included in our analysis. 2250 patients with 104 complications were found {4.5% (95% CI, 2.7%–6.3%)}. Of these complications, groin hematoma was the most common with a rate of 2.4% (95% CI, 1.1%–3.6%). Retroperitoneal hematoma {0.3% (95% CI, 0%–0.5%)}, pseudo-aneurysm {0.5% (95% CI, 0.2%–0.8%), and ipsilateral DVT {0.3% (95% CI, 0.1%–0.7%) were also not in negligible rate. The rate of other complications were as follows: vessel occlusion/stenosis; 0.2% (95% CI, 0%–0.4%), vascular surgery; 0.2% (95% CI, 0%–0.5%), and infection; 0.2% (95% CI, 0%–0.5%). One patient died as result of hemorrhagic complications {0.1% (95% CI, 0%–0.3%)}. Use of anticoagulant/antiplatelet therapy was found to be positively correlated with high risk of any groin complication and groin hematoma (p ≤.05). Female gender was associated with high risk of ipsilateral DVT (p ≤.05). Interestingly, large sheath size was associated with low risk of groin hematoma (p ≤.05). Conclusion: The safety and efficacy rate of Angio-Seal was approximately 95%. The most common complication was groin hematoma. Serious complications including retroperitoneal hematoma and femoral artery occlusion were rare.

Original languageEnglish (US)
JournalInterventional Neuroradiology
DOIs
StateAccepted/In press - 2021

Keywords

  • Angio-Seal
  • transfemoral access
  • transradial access
  • vascular closure devices

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine

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