In-vivo evaluation of an augmented reality enhanced ultrasound needle guidance system for minimally invasive procedures in porcine models: a preclinical comparative study

This study compared the accuracy, safety, and efficacy of standard-of-care (SOC) ultrasound and augmented reality needle guidance system (ARNGS) used adjunctively for percutaneous needle placement in porcine models. Four live swine underwent a model creation procedure in which metallic fiducials were percutaneously implanted into the livers (n = 8 per animal; 32 total) and kidneys (n = 4 per animal;16 total) to serve as "lesions." Computed tomography was used to create three-dimensional volumetric images of the anatomy. Four physicians, with limited previous ARNGS experience and blinded to the target locations, positioned needles at the targets using either SOC alone or ARNGS + SOC. No adverse events occurred. Mean target registration error (TRE) was 3.0 mm (95% confidence interval CI, 2.4-3.6 mm; n = 22) with SOC (an average needle depth, 8.0 cm) and 2.9 mm (95% CI, 2.2-3.5 mm; n = 24) with ARNGS + SOC (an average needle depth, 7.6 cm). The first-attempt success rate was 39.1% (9/23) for SOC and 41.7% (10/24) for ARNGS + SOC. There was not a significant difference in TRE or first-pass success rate between the two groups (p > 0.05). Needle repositions were significantly less when using the ARNGS + SOC (0.8 vs. 3.0, p = 0.01). In a preclinical study, the ARNGS + SOC was as accurate and safe as SOC in needle targeting of implanted targets. A reduction in needle repositioning suggests its potential to streamline procedures and reduce the risk of complications. This novel image fusion method merits further evaluation.