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

Abstract

BackgroundThis 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. MethodsBetween 2010 and 2018, in 32 consecutive patients (3 females; mean age 67±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™-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. ResultsTechnical 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-SealTM. 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 non-significant trend. Sheath-size, common femoral artery depth, or body weight were not indicative for occurrence of complications. ConclusionsIn selected cases, without availability of appropriate VCDs, a single Angio-SealTM-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.