Aortica's FEVAR Case-Planning Software Used for Physician-Modified Grafts to Treat Juxtarenal AAA

February 28, 2017—Benjamin W. Starnes, MD, Chief of Vascular Surgery at the University of Washington in Seattle, Washington, recently announced midterm results from an ongoing physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts (PMEGs) for the treatment of juxtarenal abdominal aortic aneurysms (AAAs) in patients who are deemed unfit for open repair. The study, which is administered in conjunction with Harborview Medical Center in Seattle, was published by Dr. Starnes et al in the Journal of Vascular Surgery (2017;65:294–302).

According to Dr. Starnes, the study is also assessing a new technology, the AortaFit automated FEVAR case planning software (Aortica Corporation), which could significantly reduce the need for invasive open surgery in patients with aneurysms originating too close to branch arteries that supply blood to vital organs. This system has replicated and automated the manual technique that Dr. Starnes has successfully usedin more than 300 cases. The AortaFit software was incorporated into his study in early 2016 and has been successfully used in more than 20 patients.

Dr. Starnes, who is the Medical Founding Director of Aortica, explained, “In our study, we utilize a system which dramatically simplifies the FEVAR procedure. The system digitizes a patient’s computed tomography scan, utilizes software algorithms to account for the effect of the implant on the geometry of the anatomy, and creates an exact replica of each patient’s aortic anatomy as it would look with the introduction of the implant. We then modify an ‘off-the-shelf’ endograft with fenestrations to precisely match each patient’s anatomy.” 

The midterm results (out to 4 years) in nonoperative candidates were highly favorable and confirm an early report of clinical success with low morbidity and mortality. In the study, 94% of patients met the primary effectiveness endpoint, and the overall major adverse event rate was low at 12%. In addition, no patient required conversion to open surgical repair.

Dr. Starnes commented, “With a remarkably low rate (6%) of aneurysm related mortality, 100% branch artery patency, and no type Ia endoleaks out to 4 years, along with a sac regression or stabilization rate of 95%, this report supports the use of fenestrated endografts as an effective and durable repair in patients who suffer from juxtarenal AAA."

He continued, “These midterm results exceed those of alternative therapies in high-risk patients and surpass even standard EVAR in several studies. We have found that a well-planned fenestrated EVAR will optimize two critical success factors. First is the ‘Effective Seal Zone Length,’ meaning by using fenestrations we place the graft higher up in the aortic anatomy and obtain seal from the proximal edge of the graft fabric all the way to the beginning of the aneurysm. This allows for secure anchoring of the endograft in healthy parallel walled aortic tissue. Second is ‘Circumferential Seal Zone,’ meaning by using fenestrations rather than scallops we create a circumferential seal along the entire effective seal zone length. I believe these are key factors contributing to the absence of type Ia endoleaks out to 4 years. We are securely anchoring and sealing the fenestrated endograft in healthy aortic tissue while allowing continued blood flow to vital arteries,” advised Dr. Starnes.

Dr. Starnes concluded, “As we gain more experience with the automated approach using Aortica’s AortaFit system, the next step will be collaboration with an endograft manufacturer, moving beyond ‘physician modification’ of endografts to a more elegant, simplified, and rapid ‘direct manufacture’ of a FEVAR graft. I believe FEVAR will then become the preferred method of treatment for the vast majority of juxtarenal AAA patients and perhaps any AAA patients with disease in the infrarenal neck.”