Safety and Efficacy of Femoral Artery Closure with the FemoSeal Device After Cerebral Thrombectomy Using an 8 French Sheath

Abstract

The use of the FemoSeal device to close an 8F access sheath puncture site is feasible and safe, with a low complication rate.

FemoSeal® vascular closure device for antegrade common femoral artery access: Safety and technical notes

“…The FemoSeal VCD is intended for CFA retrograde approach hemostasis, where it has been proved to be safe and effective with vascular sheaths sized up to 8 Fr. 5,[9][10][11] The low rate (7%) and grading (1 and 2 based on CIRSE classification system for complications) 13 of adverse events observed in our study, combined with the high technical success rate (100%) in an unselected group of patients treated in daily routine, suggest high safety and efficacy of FemoSeal VCD in antegrade CFA puncture site hemostasis when using vascular sheaths ranging from 5 to 8 Fr. Therefore, FemoSeal VCD could be considered as a firstline hemostasis strategy in such cases.…”

“…Anyway, our complication rate was comparable with that reported in literature for FemoSeal or other VCDs or MC, while our technical success (100%) was even hig her. [1][2][3][4][5][6][7][8][9][10][11][14][15][16][17][18]…”

“…The safety and efficacy of this device, compared or not with MC, have been documented in several papers, 5,[9][10][11] but its use in antegrade common femoral access has not been yet investigated, although St Jude Medical does not advise against it in its "Instruction for use. "…”

Could real-time ultrasonography guidance be useful for the effective deployment of FemoSeal in common femoral arteriotomy?

“…The safety and feasibility of this VCD on retrograde femoral artery access have been investigated and verified in previous studies [1][2][3][4][5][6][7][8]. A recent article showed that the device could also be safely used even for anterograde femoral artery access [9].…”

“…A r t i c l e compression was followed when technical failure was brought out in many reviews [1][2][3][4]6,7]. Even though the remarkable event has not been found after following manual compression in some studies [4][5][6][7], large hematomas were found in 36% of technical failure cases according to one large-scale survey, CLOSE-UP study [2]. A clear description of the result of technical failure cannot be found in the ISAR-CLOSURE study, another large-scale study [1].…”