New data presented during Friday’s Plenary Session 6 (10–11 a.m. in the West Building, Skyline Ballroom) will shed light on trends in the adoption of fenestrated and branched endovascular aortic repair (F/BEVAR) outside of Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trials, and probe whether there are differences in mortality rates among patients treated inside and outside of the trial setting.
Presenting author Sara Zettervall, MD, an assistant professor of surgery at University of Washington in Seattle, tells VS@VAM that the results of the analysis should kickstart an important conversation about protocols for the use of F/ BEVAR, an approach that is “increasing dramatically” across the country.
Zettervall and colleagues have used Medicare claims data to identify patients undergoing endovascular treatment of the visceral aorta incorporating two or more visceral artery endoprostheses between 2014–2022, identifying cases performed at both IDE and non-IDE sites. The researchers compared the 30-day and three-year mortality rates between procedures performed within both the trial and non-trial locations. Through the analysis, the researchers have sought to quantify the use of F/BEVAR in the United States and to evaluate any association with case volume and mortality at IDE and non-IDE sites.
“We all suspect that physician-modified endografts are happening all over the place, but because published data are limited just from IDE sites, what is really going on in actual practice has not been widely studied,” Zettervall comments, looking ahead to her presentation of the analysis during Friday’s session, in which she will reveal the findings of the study for the first time. “There needs to be a starting point to know how much this is happening and how are these patients doing, because we really don’t have a marker outside of IDE sites at all,” she says.
Turning to the results, Zettervall explains that the analysis points to the fact that most of the sites at which these procedures are being performed are non-IDE centers, albeit that these sites are performing a much lower volume of procedures than those participating in the IDE trials.
“What we see is that there are a lot of these cases being done outside of IDE sites, in fact the majority of them, and it is increasing,” says Zettervall. “I think the most shocking thing is that the majority of folks who are doing this are doing one or two per year per hospital, which is super low volume.”
Through their research, Zettervall and colleagues have identified 7,977 patients treated with F/BEVAR at 551 hospitals during the eight-year period under the focus of the study. Of these, 25% of procedures were performed at 20 hospitals with an IDE.
The researchers have found that the median annual case volume per hospital was significantly higher at IDE sites, while their research also points towards differences in the 30-day and three-year mortality between patients treated inside or outside of IDE sites.
“When we look at the data, what we can see is that the folks who are doing it outside of [an] IDE are having worse perioperative survival, and I think we will need to do more research to understand the drivers of that,” Zettervall tells VS@VAM, adding that this will become increasingly important as devices such as the Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE)—the first off-the-shelf endovascular device for the treatment of complex aneurysmal disease involving the visceral aorta to receive FDA approval—gain wider usage.
“This is really the starting point,” says Zettervall of the research, as her team will be looking to release more data from their study in the coming months.
