Safety and Effectiveness of the Novel Catheter 3.0 System for Diagnostic Cerebral Angiography: A Pilot Study.

Abstract

The purpose of this study was to evaluate the safety and effectiveness of a new angiographic system (Catheter 3.0 system) using a 5 French (Fr), large-bore angiography catheter, a 0.032-inch stiff guidewire, and a continuous flushing system in diagnostic cerebral angiography. This retrospective study included 30 consecutive patients who underwent transfemoral cerebral angiography using the Catheter 3.0 system from October 2019 to March 2020. As the control group, we included 30 consecutive patients examined before the Catheter 3.0 system was introduced. Procedural outcomes, including technical success, procedure time, dose metrics, procedure-related complications, and image quality were reviewed and analyzed. All transfemoral cerebral angiographies were performed for a diagnosis of unruptured intracranial aneurysms. The Catheter 3.0 system showed a significantly shorter fluoroscopy time (6.2 vs. 9.7 minutes, P=0.008) and lower fluoroscopy dose (387.2 vs. 614.4, P=0.002) compared with the conventional 4-Fr catheter system. The Catheter 3.0 system also showed better results in terms of procedural time (21.0 vs. 22.5 minutes, P=0.072) and technical success rate (98.1% vs. 94.0%, P=0.078), although a statistical significance was not reached. The complication rate and qualitative assessment of the digital subtraction angiography (DSA) image quality were similar between the two groups. The Catheter 3.0 system using a 5 Fr catheter with a large inner diameter was convenient, effective, and safe compared with the conventional system in diagnostic cerebrovascular angiography.