Sheathless Femoral Impella Implantation: A Safer Hemodynamic Support in High-Risk PCI and Cardiogenic Shock.

BACKGROUND: The Impella CP percutaneous ventricular assist device is designed to provide hemodynamic support during high-risk percutaneous coronary intervention (PCI). However, its femoral insertion through the dedicated 14 F sheath is associated with a relevant incidence of vascular and bleeding complications, especially in patients with small or diseased femoral arteries. This study aimed to evaluate the feasibility and safety of a femoral sheathless technique for Impella implantation during different clinical scenarios, with the hypothesis that avoiding the 14 F sheath may reduce vascular complications. METHODS: We prospectively enrolled 18 consecutive patients in two Italian Cathlab to receive femoral sheathless Impella CP during high-risk PCI or cardiogenic shock. In this technique, the Impella CP catheter is advanced into the femoral artery over the 0.018" guidewire without sheath insertion, and the access is secured by the Repositioning Unit. Procedural success and periprocedural outcomes were assessed. RESULTS: Sheathless Impella implantation in the femoral artery was successful in the entire cohort. PCI was completed with adequate hemodynamic support and device stability. The Impella catheter was removed percutaneously in all cases without the need for surgical repair or endovascular bailout. No major vascular complications occurred. Hemostasis was achieved with standard closure devices. CONCLUSIONS: Femoral sheathless Impella implantation is feasible and safe in this initial series of patients undergoing high-risk PCI. This technique may be useful to reduce vascular complications and could be particularly valuable in patients with small-caliber femoral arteries or increased bleeding risk. Larger prospective studies are warranted to further validate these findings.