Single Angio-Seal vascular closure device for transfemoral access exceeding 8F

Abstract

Background: This was a retrospective single-center evaluation for off-label use of a single Angio-Seal-VIP 8F vascular closure device (VCD) (Terumo Interventional Systems, Somerset, NJ, USA) for retrograde transfemoral arterial access exceeding 8F. Methods: Between 2010 and 2018, in 32 consecutive patients (3 females; mean age 67 AE 9; range 46-86 years) retrograde femoral access was performed in 48 groins for aortoiliac stent or stent graft implantations using 9-14F sheaths. For vascular closure, one single Angio-Seal TM -VIP 8F was used. Procedural success, closure-related complications, and risk factors were retrospectively evaluated using patient characteristics, duplex-ultrasound, and contrast-enhanced computed tomography angiography (CTA). Receiver-operating-characteristics were used for statistical analysis. Results: Technical success for deployment of VCD was 100%. Visual inspection and duplex-ultrasound confirmed immediate hemostasis in 100%. Postinterventional CTA depicted major vascular access site complications in 6.3% (3/48 groins) requiring surgical treatment. A subgroup of 13 patients underwent surgical cut-down one day after VCD deployment as part of a two-staged complex endovascular aortic aneurysm repair procedure, allowing for visual assessment of prior used undersized Angio-Seal TM . Patient's height (p = 0.028) and severe access site calcifications (p = 0.028) proved as predictors for one vessel occlusion and two pseudoaneurysms. Low body-mass-index (BMI) showed a nonsignificant trend. Sheath-size, common femoral artery depth, or body weight were not indicative for occurrence of complications. Conclusions: In selected cases, without availability of appropriate VCDs, a single Angio-Seal TM -VIP 8F served as a feasible option to achieve sufficient hemostasis of transfemoral access exceeding 8F without relevant bleeding complications. Very low BMI, tall body-height, and severe atherosclerosis were identified to predispose to access site complications.

Removal of the intra-aortic balloon pump: Why and in what way?

“…It contributes to shorter hemostasis times and early mobilization compared to standard manual compression. In addition, since greater vascular access is required in attempts to repair endovascular aortic aneurysms, VCDs can eliminate the need for surgical intervention [2]. In their study, the authors investigated whether the VCD could be used safely and could achieve hemostasis when removing an IABP.…”

“…In addition, very low body mass index, tall height, and severe atherosclerosis at the vascular access site are important factors that increase complication rates during VCD applications [2]. In a study investigating the effectiveness of VCD in IABP removal applications, such as the discussed study [1], the authors should also consider these situations.…”