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

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.

Keywords: Angio-Seal; transfemoral access; transradial access; vascular closure devices.

Figure 1.

The Flow diagram of study selection process.

Figure 2.

Forest plots with random-effect model demonstrate the risk of following complications after use of Angio-Seal closure device in transfemoral neuroendovascular procedures; (a) Overall Groin complication. (b) Groin hematoma. (c) Retroperitoneal hematoma. (d) Pseudoaneurysm formation. (e) Ipsilateral DVT. (f) Vascular surgery. (g) vascular occlusion/stenosis. (h) Infection. (i) Complication-associated mortality.

Figure 2.

Forest plots with random-effect model demonstrate the risk of following complications after use of Angio-Seal closure device in transfemoral neuroendovascular procedures; (a) Overall Groin complication. (b) Groin hematoma. (c) Retroperitoneal hematoma. (d) Pseudoaneurysm formation. (e) Ipsilateral DVT. (f) Vascular surgery. (g) vascular occlusion/stenosis. (h) Infection. (i) Complication-associated mortality.