A Novel Electromagnetic Coil (EMAG) Fenestrated Stent-Graft for Rapid Cannulation to Reduce Use of Contrast Agent and Radiation Exposure During Fenestrated EVAR.

Abstract

Endovascular aortic repair (EVAR) has emerged as a popular option for minimally invasive treatment of abdominal and thoracic aortic aneurysms, offering advantages over traditional open surgical methods by reducing immediate postoperative morbidity and mortality. Although the endovascular repair option is attractive, it can potentially increase patient risks associated with x-ray exposure during the procedure, as significant levels of ionizing radiation are generated during preoperative diagnostic angiography, perioperative device placement, and lifelong follow-up imaging. For treatment of complex aortic aneurysms involving visceral vessels, radiation exposure during fenestrated stent-graft repair is typically double that of conventional unfenestrated stent-graft delivery and placement, which puts patients and clinicians at risk of reaching lifetime radiation limits and potentially developing cancer. To address this issue, a novel electromagnetic (EMAG) system has been developed and studied to potentially reduce radiation overexposure during the procedures by expediting a key step of the process, namely cannulation of fenestrations. The solenoid electromagnetic EMAG system embedded surrounding the ostia of the fenestrations attracts the magnetized tip of either a guidewire or catheter into a side branch, rapidly and selectively cannulating branch vessels in the aorta. The EMAG prototype was designed and fabricated with selective design requirements. A comparative study between the EMAG system and a standard guidewire demonstrated that the average time to cannulate with the EMAG system was 5.73 ± 2.67 seconds, which was significantly less than the average time taken to cannulate with the standard guidewire (34.37 ± 39.91 seconds, P < .01). In addition, the feasibility of the EMAG device was evaluated by characterizing its attraction force, dislodging force, and temperature rise. This device has the potential to reduce radiation exposure during EVAR procedures, offering a promising approach to improve patient safety in an increasingly common procedure.Clinical ImpactThe findings of this study demonstrate the feasibility of the EMAG system as a novel approach for assisting branch-vessel cannulation during fenestrated endovascular aortic repair. By advancing this technology through further preclinical and clinical studies, the EMAG system has the potential to improve workflow, enhance procedural consistency, reduce fluoroscopy dependence, and contribute to safer and more efficient complex endovascular interventions.