Electromagnetic Intraoperative Positioning System Is Safe and Effective as a Three-dimensional Imaging Adjunct in Endovascular Aortic Aneurysm Repair: A Safety and Feasibility Study

Navigation of the aorta and aortic branch vessels using standard of care two-dimensional 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 guidance for accurate wire and catheter navigation as an adjunct to fluoroscopy during TEVAR/FEVAR/EVAR. Thirty patients with aortic aneurysms suitable for TEVAR/FEVAR/EVAR were enrolled across two sites in the United States from 2020 to 2022. Prior to repair, patients underwent computed tomography angiography to generate a three-dimensional (3D) anatomical model that was fused with intraoperative cone beam computed tomography scan. The intervention was performed utilizing IOPS as a 3D guidance system for wire and catheter manipulation as an adjunct to two-dimensional 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 and nonserious adverse events attributable to IOPS intraoperatively and postoperatively. Demographic and patient history data were collected. Patients were predominantly White (83%) males (80%) with a history of coronary artery disease (66.7%) and hypertension (90%). Mean age was 75 ± 8.2 years. Interventions included EVAR, FEVAR, and TEVAR procedures, with grafts manufactured by W. L. Gore & Associates, Endologix, Terumo, Medtronic, and Cook. Fenestrated grafts included 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 serious and nonserious adverse events attributable to the IOPS system at the 7-day follow-up. A single sensorized guidewire was used in 80% of cases and a single sensorized catheter was used 90% of cases. 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. Future research is needed to investigate the potential for IOPS to reduce radiation exposure to patient and operator, reduce contrast usage, and reduce operative time while providing better visualization of complex anatomy.