The cases are part of Starnes’ US Food and Drug Administration (FDA)-approved physician-sponsored investigational device exemption (IDE) study.
Complexity can arise when branch arteries are too close to the origin of the aneurysm and complicate or preclude safely deploying a standard endograft. In a FEVAR procedure, fenestrations are carefully created on the endograft to line up with branch arteries that supply blood to vital organs.
Both the planning of where to place the fenestrations and the delivery of the fenestrated endograft can be highly complex and time-consuming, significantly limiting adoption.
Starnes’ IDE study is evaluating technologies and methods to dramatically simplify both the case planning and the delivery of FEVAR endografts.
Since 2016, Aortica’s AortaFit planning software has been a part of this study. Results from these first 30 patients using the software were presented at the Western Vascular Society meeting (23–26 September; Blaine, USA).
“I have now used Aortica’s AortaFit…successfully in 30 patients overall, using standard endografts from three of the major manufacturers—Bolton, Cook and Medtronic,” stated Starnes. “The software digitises a patient’s computed tomography scan and utilises an algorithm to account for the effect of the implant on the geometry of the anatomy to create an exact replica of each patient’s aortic anatomy as it would look with the introduction of the implant.
“The entire process takes just a few minutes to create an accurate multi-vessel fenestrated graft plan. This compares to the hours it takes to plan cases using manual planning and today’s existing technology. Because the graft plan is so precise, the software also simplifies the process of aligning and placing the endograft in the patient,” Starnes continued.
“The results in these first 30 patients are highly favourable with low morbidity and mortality. Graft implantation was successful in 100% of patients (30/30), with 97% of branch arteries preserved at index (84/87). The three branch arteries not cannulated were due to complications not related to the graft plan. There have been no type 1a or type 3 endoleaks through 30 days. Two deaths were reported, but both were unrelated to AAA disease.”
William Quinones-Baldrich, professor of surgery at UCLA (Los Angeles, USA) commenting on the results stated, “This is the future. Everyone at this conference [WVS] should remember you saw this here today.