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As Dean Arnaoutakis, MD, describes it, failed endovascular aortic aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) because of poor proximal fixation of the implanted endograft is a small but increasing problem. So much so, he estimates that they likely account for about a third of his current practice at Tampa General Hospital (TGH).
As things stand, there is a paucity of options available to vascular surgeons tackling this type of failed EVAR, known as a type Ia endoleak.
With the traditional rescue option for this largely elderly, co-morbid population—open conversion of the compromised endograft—often dire, Arnaoutakis and colleagues in the TGH Aortic Disease Program have emerged among the leading specialists in Florida and nationally in the push to offer alternative methods of fixing failed EVARs.
“The gold standard of EVAR explant is a maximally invasive operation and, unfortunately, most of the patients we see with a failed EVAR are in their 70s and 80s with a number of medical issues, and their ability to tolerate the procedure is rather limited in terms of their subsequent quality of life and independence afterwards,” says the TGH Aortic Disease Program medical director and associate professor of surgery at the University of South Florida (USF).
“With the advent of our physician-modified endograft [PMEG] program at our institution, under the auspices of our physician-sponsored investigational device exemption [IDE] trial, we have shifted our treatment approach for these patients such that, in the majority of them, if candidates anatomically, we are attempting to salvage their endografts with a PMEG to obtain more proximal seal.”
Recently presented data show the extent to which PMEGs, or physician-modified fenestrated or branched EVAR (F/BEVAR), have moved the needle at TGH.
Arnaoutakis and colleagues compared patients who underwent repair for a failed EVAR from 2015–2023 into two groups: those who received a PMEG IDE (35 patients) and those who had an open conversion (41).
What they found was illuminating. Average hospital length of stay among PMEG recipients was less than half that of open explant patients; similarly, 30-day mortality was 0% vs. 15% and postoperative complications 23% vs. 73% in favor of patients undergoing PMEG. The patients, drawn from a prospective database of consecutively treated aortic patients, were mostly male with an average age of 75 and typical comorbidities associated with the complex aortic patient population. The data were reported at the 2024 Southern Association for Vascular Surgery (SAVS) annual meeting in Scottsdale, Arizona (Jan. 24–27), by Trung Nguyen, DO, a vascular surgery resident at the USF Health Morsani College of Medicine.
The TGH practice pattern curve shows that over the last 10 years, the number of EVAR explants the TGH team have completed has steadily declined, with the PMEG program taking over since its onset, notes Arnaoutakis. “The outcomes between the two are dramatically different in terms of perioperative and 30-day mortality, and major complication rates. It’s significantly better in the PMEG group than in the open explant group, which is obviously a good thing.” That said, Arnaoutakis concedes that open explant will always have a role as some patients have prohibitive anatomy or underlying aortic infection.
The complex pathology of the patient group presenting with failed EVARs with poor proximal seal means that very few medical centers in Florida are equipped with the expertise and infrastructure to provide the care they require, explains Arnaoutakis.
A similar story plays out for advanced care teams like that at TGH who, when confronted with the problem of patients increasingly presenting with such complexity, are faced with few Food and Drug Administration (FDA)-cleared options with which to treat them. The recent FDA-approved Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE) device might be one avenue, Arnaoutakis says. The Cook Medical Zenith Fenestrated+ (ZFEN+) endovascular graft, whose pivotal IDE trial recently began enrolling at U.S. study sites that include TGH, however, does not permit inclusion of patients with a prior EVAR in place—similar to the TAMBE device while it was still under clinical trial, he adds.
“We need better solutions from industry in the future to help us address what is going to be a growing problem of the type I endoleak across the paravisceral segment in people who have prior EVARs in place,” Arnaoutakis says. “There’s no trial in the pipeline that allows us to look at a device in this scenario.”
Which leaves the TGH PMEG IDE well placed to serve the Florida population in need of alternative options for complex aortic repair.
As Nguyen noted at the SAVS meeting in Scottsdale, TGH is among the tertiary medical centers leading the way. “Endovascular salvage of failed prior EVAR due to poor proximal seal using a PM-F/BEVAR is safe and effective,” he told those gathered. “A strategy utilizing a PMEG under the auspices of a physician-sponsored IDE clinical trial should be strongly considered as first-line therapy in patients with failed EVAR.”