Electromagnetic Intraoperative Positioning System (IOPS) Is Safe and Effective as a 3D Imaging Adjunct in Endovascular Aortic Surgery-A Safety and Feasibility Study.

BACKGROUND: Navigation of the aorta and its branch vessels using standard of care 2D X-ray fluoroscopy in thoracic, fenestrated, and infrarenal endovascular aortic aneurysm repair (TEVAR/FEVAR/EVAR) has multiple disadvantages including exposure to ionizing radiation, contrast agent administration, and limited visualization of complex anatomy. The objective of this study is to demonstrate the safety and efficacy of the electromagnetic-based intraoperative positioning system (IOPS) in providing accurate 3D vessel mapping and guidance for wire and catheter navigation as an adjunct to fluoroscopy during TEVAR/FEVAR/EVAR.

METHODS: Thirty patients with aortic aneurysms suitable for TEVAR/FEVAR/EVAR were enrolled across 2 sites in the United States from 2020 to 2022. Prior to repair, patients underwent computed tomography angiography to generate a 3D anatomical model that was fused with intraoperative cone beam computed tomography. The intervention was performed utilizing IOPS as a 3D guidance system for sensorized wire and catheter manipulation as an adjunct to 2D fluoroscopy. Technical success was defined as the ability to navigate the infrarenal, visceral, and descending thoracic aorta as well as cannulate any necessary aortic branch vessels. Successful cannulation was confirmed using fluoroscopy. Patients were monitored for serious adverse events (SAEs) and nonserious adverse events (non-SAEs) attributable to IOPS intraoperatively and postoperatively. Demographic and patient history data were collected.

RESULTS: Patients were predominantly White (83%) males (80%) with a history of coronary artery disease (66.7%) and hypertension (90%). The mean age was 75 years (standard deviation [SD] = 8.2). Interventions included EVAR, FEVAR, and TEVAR procedures. Physicians selected the most suitable graft for treatment, with grafts manufactured by Gore, Endologix, Terumo, Medtronic, and Cook. The fenestrated grafts utilized consisted of commercially available devices, custom made devices, and physician-modified endografts. Technical success was achieved in 100% of patients with IOPS providing adjunctive 3D guidance for wire and catheter manipulation during aortic navigation and branch vessel cannulation. There were zero SAEs and non-SAEs attributable to the IOPS system at the 10-day follow-up. A single sensorized guidewire was used in 80% of cases, and a single sensorized catheter was used in 90% of cases.

CONCLUSION: The electromagnetic-based (IOPS is safe and effective in providing adjunctive 3D guidance for wire and catheter manipulation in infrarenal and fenestrated endovascular abdominal aortic aneurysm repair in humans. The 3D anatomical maps generated allowed for accurate aortic navigation in all targets during TEVAR/FEVAR/EVAR. Future research is needed to investigate the potential for IOPS to reduce radiation exposure to patients and operators, reduce contrast usage, and overall reduce operative time.