Common femoral artery (CFA) access is still the leading approach for peripheral endovascular interventions of lower extremity arterial disease (LEAD), despite the development of radial artery access for coronary endovascular procedures.
For sheaths ≤8F, two groups of Vascular Closure Devices (VCDs) are described according to their mechanism of action: The polymer-based VCDs such as FemoSeal™ Vascular Closure System* (Terumo) and the suture-based VCDs like Perclose ProGlide™ Suture-mediated Closure System (Abbott).
The presence of rigid calcified structure or osteoid metaplasia in the CFA could jeopardize the successful deployment of suture-based VCDs which may not able to go through the calcifications. In this case polymer based VCD might be more efficient.
VCDs differ in term of secondary hemostasis, as bail-out technique. For ProGlide™ the guide wire is left in place and a second device can be used, whereas in the case of FemoSeal™ it is retrieved before implantation and no additional VCD can be deployed.
To compare the efficacy of the polymer-based VCD (FemoSeal™) and the suture-based VCD (ProGlide™) in achieving hemostasis at the femoral access site after lower limb arterial endovascular revascularization.
Technical success defined
as full & permanent hemostasis evaluated just after
and 5 h following the VCD application (patients’ ambulation ability for
100 m) without need in additional VCD, Manual Compression (MC) or other
site intervention, without
a 2-g/dL reduction in haemoglobin.
i.) major and minor complications rate
ii.) time to discharge
iii.) quality of life assessment
iv.) total cost of VCDs per treated leg evaluated at the same purchase price
Results for primary outcome
After sensitivity analysis (excluding patients that underwent MC) superiority of FemoSeal™ in term of technical success was confirmed (FemoSeal™ patients: 88.99% vs ProGlide™ patients: 62.39% (p<0.0001)).
Results for secondary outcomes
*FemoSeal™ Vascular Closure System is indicated for use in closing the femoral arterial puncture (arteriotomy) in patients who have undergone percutaneous catheterization using a 7F (2.33 mm) or smaller procedural sheath.
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