Abstract

Intra-Operative Positioning System (IOPS) (Centerline Biomedical, Cleveland, OH) is a 3D electromagnetic (EM) endovascular navigation system approved by the US Food and Drug Administration and developed as an adjunct to fluoroscopy. It provides real-time 3D display of sensorized material on an anatomical map on a flat screen. An investigational prototype based on IOPS incorporates the ability to map implanted stent grafts and visualize the stents and anatomy using augmented reality headset. The aim of this study was to compare the completion of bifurcated stent graft gate cannulation performed by participants of varying experience using fluoroscopy or different variations of IOPS. The task was cannulation of the gate of a bifurcated aortic endograft deployed into a 3D printed abdominal aortic aneurysm model connected to flow pump reproducing physiological conditions, performed in a hybrid operating room (GE Allia IGS 7). Each participant performed the tasks with fluoroscopy, EM guidance with flat screen display (EM-FS), and EM guidance with augmented reality headset (EM-AR) (Fig 1), in randomized order. All participants used the same sensorized guidewire and steerable sensorized 6F catheter for the three runs. Participants were classified in three groups of experience. Primary end points included cannulation time and technical success, defined as the advancement of the catheter over the guidewire within the graft main body. Fifteen minutes was the cutoff time for each trial. There were 26 participants including 13 endovascular naïve trainees (group 1), 12 in training surgeons (group 2) and one advanced level vascular surgeon. In group 1, mean cannulation time was lower using EM-AR versus fluoroscopy (4.3 ± 4.4 vs 7.1 ± 4.9 minutes; P = .04), with no difference between EM-FS and fluoroscopy (6.3 ± 4.5 vs 7.1 ± 4.9 minutes; P = .63). In group 1, technical success was 77% with fluoroscopy and 92% with both EM modalities (P = .59). In group 2, there was a trend toward shorter times with EM-FS or EM-AR as compared to fluoroscopy (mean of 2.5 ± 0.9, 4.4 ± 4.0 and 5.2 ± 4.5 minutes, respectively). In group 2, technical success was 92% with fluoroscopy and 100% with IOPS (P > .99). The advanced level vascular surgeon repeated the cannulation task four times for each endovascular approach, with 100% technical success and no difference in mean time (P = .89) (Fig 2). Augmented reality allows for reducing the gate cannulation time as compared to fluoroscopy in participants with no previous experience in endovascular navigation. This auspicious finding suggests that augmented reality can be beneficial for individuals early in their career and can mitigate the learning curve.Fig 2Mean cannulation times of bifurcated stent graft gate cannulation using electromagnetic (EM) guidance with flat screen display or augmented reality compared to fluoroscopy, performed by operators of varying experience.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

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