Initial clinical experience with a new sheathless guiding catheter designed for direct insertion

Type of funding sources: None.

Radial access for percutaneous coronary intervention (PCI) is growing rapidly as this approach has been shown to improve patient comfort and reduce complications. Use of a sheathless guiding catheter for transradial PCI has the potential reduce trauma to the radial artery and to further expand the type of cases where this approach can be utilised. The new Sheathless Hyperion system allows direct insertion of the Sheathless Hyperion guiding catheter using a 20 G needle or IV cannula, a 0.25" Silverway wire and a custom dilator.

We report the first clinical experience with the new Sheathless Hyperion guiding catheter designed for direct insertion.

We prospectively evaluated outcomes in consecutive patients who underwent PCI using the Sheathless Hyperion catheter at our institution between June 2020 and March 2021.  All procedures were performed via radial access. There were no exclusion criteria.

Eighty one patients were included with 99 lesion being treated using 85 Sheathless Hyperion catheters. Mean age 67.7 ± 11.8 years, 77.8% male, 22.2% diabetic and 38.8% had acute coronary syndromes. The Sheathless Hyperion was inserted directly into the radial artery in 46 (54.1%) cases with 100% success rate and inserted following initial sheath insertion for the remaining 39 (45.9%). Of the Sheathless Hyperion catheters used 30 (35.3%) were 6F in 55 (64.7%) were 7F. The Sheathless Hyperion was passed into the ascending aorta successfully in all cases. The target coronary artery was successfully engaged in 85 (98.8%). In one case the coronary could not be engaged because of excessive brachiocephalic tortuosity and conversion to femoral access occurred. In 4 cases the Sheathless Hyperion catheter had to be exchanged for one with a small curve. The majority of lesions were complex: 18.2% CTO, 39.4% heavily calcified, 44.4% long lesions and 31.3% bifurcation lesions. Adjunctive devices included rotational atherectomy (12.1%), intravascular lithotripsy 14.1%, IVUS (56.6%) and OCT (28.3%). Angiographic success was achieved in 100%. Peri-procedural non-ST-elevation myocardial infarctions defined by the 4th Universal definition occurred in 3 (3.7%) patients. No patient meet the SCAI criteria for periprocedural MI. There was no in-hospital target vessel revascularisation or death. Radial artery occlusion was infrequent occurring in one patient.  No major haematomas or vascular complications occurred.

First clinical experience with the Sheathless Hyperion demonstrates that direct insertion is safe and effective and that it allows complex interventions to be undertaken transradially with a high success rate.