Prospective evaluation of efficacy and safety of distal radial and radial artery access using a novel articulating-tip guidewire.

Abstract

Guidewire-facilitated access to peripheral vessels is commonplace in vascular access, but guidewire insertion into small vessels, such as the radial and distal radial arteries, can still be challenging. Failure to gain access on the first attempt may contribute to increased risks of procedural complications, such as vessel dissection, spasm, and occlusion. This research assessed the safety and efficacy of radial and distal radial artery access using a novel, FDA-cleared, small-core-diameter guidewire with an articulating tip, under ultrasound guidance. This was a prospective, single-arm, single-center trial. Patients in need of vascular access were screened for participation and enrolled in the study. Guidewire insertion was attempted by four physicians (three interventional radiologists and an interventional nephrologist) at 162 arterial sites-65 radial and 97 distal radial, having a mean diameter of 2.0 mm. First-attempt successful placement of the guidewire in the artery occurred at 87.6% of access sites (142/162) and differences in the success rate between the radial and distal radial arteries or between vessels with diameter smaller or larger than 2 mm were not observed (62/68 and 67/77, respectively; p = 0.6). Four of the five reported adverse events were unrelated to the study device or procedure. Two of the three distal radial artery spasms occurred before the guidewire was used. The other two events were a radial artery spasm, and a distal radial artery site hematoma. All adverse events resolved spontaneously. First-attempt placement of a novel articulating tip guidewire in the radial and distal radial arteries occurred at a high rate in our study and was not associated with safety concerns.