TY - JOUR
T1 - Off-Label Use of the 8-F Angio-Seal for Closure of Greater than 8-F Common Femoral Arterial Access
T2 - A Systematic Review and Meta-Analysis
AU - Ghozy, Sherief
AU - El-Qushayri, Amr Ehab
AU - Reda, Abdullah
AU - Oussama Kacimi, Salah Eddine
AU - Kobeissi, Hassan
AU - Mouffokes, Adel
AU - Awad, Dina M.
AU - Kadirvel, Ramanathan
AU - Kallmes, David F.
N1 - Publisher Copyright:
© 2023 SIR
PY - 2023/11
Y1 - 2023/11
N2 - Purpose: To evaluate the safety of >8-F access closures using 8-F Angio-Seal. Materials and Methods: An electronic search was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines using Web of Science, Embase, Scopus, and PubMed databases from inception until January 17, 2022. Actionable and nonactionable bleeding events were defined in conjugation with the Bleeding Academic Research Consortium definition. Prevalence rates with corresponding 95% CIs were calculated using R software version 4.2.2. Eight articles, with 422 patients, were included in the analysis. Results: The overall groin adverse event rate was 5.92% (95% CI, 3.01–11.34). The most commonly reported adverse events were any bleeding (5.74%; 95% CI, 3.23–10.00) (nonactionable bleeding, 0.96% [95% CI, 0.10–8.30]; actionable bleeding, 2.30% [95% CI, 0.89–5.84]), pseudoaneurysm (1.18%; 95% CI, 0.49–2.81), and groin hematoma (1.28%; 95% CI, 0.23–6.79). The least commonly reported adverse events were device failure and vessel occlusion/stenosis, with rates 0.29% (95% CI, 0.01–7.41) and 0.45% (95% CI, 0.02–7.74), respectively. No studies recorded events regarding the following adverse events: mortality, infection, deep venous thrombosis, and retroperitoneal hematoma. Moreover, the results showed significant differences, based on the sheath size used, in actionable bleeding (P = .04) and the rate of need for surgical repair (P < .01). Conclusions: Common femoral artery access of >8-F can be effectively closed with the Angio-Seal with comparable outcomes to those of <8 F; however, larger access approaching 14 F is associated with a significant increase in morbidity. Further safety is needed, especially for the larger access sizes.
AB - Purpose: To evaluate the safety of >8-F access closures using 8-F Angio-Seal. Materials and Methods: An electronic search was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines using Web of Science, Embase, Scopus, and PubMed databases from inception until January 17, 2022. Actionable and nonactionable bleeding events were defined in conjugation with the Bleeding Academic Research Consortium definition. Prevalence rates with corresponding 95% CIs were calculated using R software version 4.2.2. Eight articles, with 422 patients, were included in the analysis. Results: The overall groin adverse event rate was 5.92% (95% CI, 3.01–11.34). The most commonly reported adverse events were any bleeding (5.74%; 95% CI, 3.23–10.00) (nonactionable bleeding, 0.96% [95% CI, 0.10–8.30]; actionable bleeding, 2.30% [95% CI, 0.89–5.84]), pseudoaneurysm (1.18%; 95% CI, 0.49–2.81), and groin hematoma (1.28%; 95% CI, 0.23–6.79). The least commonly reported adverse events were device failure and vessel occlusion/stenosis, with rates 0.29% (95% CI, 0.01–7.41) and 0.45% (95% CI, 0.02–7.74), respectively. No studies recorded events regarding the following adverse events: mortality, infection, deep venous thrombosis, and retroperitoneal hematoma. Moreover, the results showed significant differences, based on the sheath size used, in actionable bleeding (P = .04) and the rate of need for surgical repair (P < .01). Conclusions: Common femoral artery access of >8-F can be effectively closed with the Angio-Seal with comparable outcomes to those of <8 F; however, larger access approaching 14 F is associated with a significant increase in morbidity. Further safety is needed, especially for the larger access sizes.
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U2 - 10.1016/j.jvir.2023.05.039
DO - 10.1016/j.jvir.2023.05.039
M3 - Review article
C2 - 37468092
AN - SCOPUS:85169797856
SN - 1051-0443
VL - 34
SP - 1946-1954.e5
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
IS - 11
ER -