Feasibility of sheathless Impella for protected percutaneous coronary intervention: a single-center experience

Supported by the EuroIntervention Journal

Authors

Veronica Lio¹, Federico Beqaraj¹, Stefano Drago¹, Massimo Giammaria¹, Andrea Gagnor¹

Introduction

Impella CP (Abiomed, Danvers, MA) microaxial flow pump left ventricular (LV) support device helps in complete revascularisation during high-risk percutaneous coronary intervention (HR-PCI), improving hemodynamic stability and reducing major adverse cardiovascular events¹. However, standard implantation of 14F sheath is associated with a significant incidence of vascular complications, impacting patient prognosis and frequently requiring surgical intervention².

We report our initial experience with a sheathless Impella implantation technique, an off-label approach designed to reduce these complications.

Methods

We performed 29 Impella-protected HR-PCI procedures between 2021 and 2024. Of these, four patients in 2024 underwent sheathless Impella implantation via femoral access. Impella components are shown in Figure 1.

Pre-procedural imaging, including computed tomography or angiography, was conducted to assess aorto-ilio-femoral anatomy, excluding patients with severe calcification or tortuosity.

The sheathless technique requires the following steps (see Video 1):

1. Ultrasound-guided common femoral artery puncture and 8F sheath insertion;
2. Subcutaneous tissue dilation and pre-implantation of two suture-based vascular closure devices (VCDs);
3. Dilatation with 10F and 12F dedicated dilators;
4. Insertion of a 0.018” extra-support wire into the LV;
5. Direct advancement of the Impella catheter through the skin;
6. Advancement of the Repositioning Unit, checking for good hemostasis;
7. Impella positioning in the LV;
8. Wire removal and initiation of support;
9. PCI;
10. Impella removal and VCD closure.

The primary objective was to evaluate the feasibility and safety of sheathless Impella implantation, focusing on vascular complications.

Results

All four patients underwent successful revascularisation with optimal results.

Details are reported in Supplementary Table 1 and Supplementary Table 2.

Impella removal and VCD deployment were achieved without immediate or 30-day post-discharge complications.

Discussion

Impella CP is superior to intra-aortic balloon pumps (IABP) in HR-PCI, offering LV unloading and hemodynamic support³. However, larger sheath size compared to IABP contributes to a higher incidence of peripheral vascular complications, which are associated with increased mortality and morbidity^4,5. Impella sheath allows single-access PCI, usefully avoiding an additional arterial access when radial access is not available. However, this reduces guiding catheter (GC) steerability and requires to remove GC prior to Impella removal.

While existing data in cardiogenic shock and acute myocardial infarction, our study explores the potential benefits of sheathless Impella implantation in elective HR-PCI.

Pre-procedural imaging is crucial for access evaluation to minimize vascular complications.

The standard 14F sheath, with its large outer diameter and sharp profile, may pose challenges in patients with smaller vessels, particularly women. The sheathless technique, inspired by surgical axillary access, utilises the tapered and softer Repositioning Unit, potentially reducing vessel trauma. Furthermore, it eliminates the need for sheath peeling, a potential source of bleeding.

Our case series demonstrated successful sheathless Impella implantation without vascular complications. This technique offers potential advantages in minimizing intravascular encumbrance and reducing related complications.

Limitations include the small sample size, necessitating validation in larger studies.

Conclusion

Sheathless Impella implantation is a feasible and potentially safe alternative to standard sheath-based technique in selected patients undergoing HR-PCI.

Further studies are needed to confirm these findings and establish its applicability.

References

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Affiliation

1. Cardiology Department, Maria Vittoria Hospital, Turin, Italy

Conflicts of interest

All authors have no conflicts of interest to declare.