Latest study out of consortium details trends and outcomes after F/BEVAR procedures carried out over an eight-year period under consortium of 10 physician-sponsored IDEs.
Despite increasing repair extent and complexity, rates of technical failure, adverse events and reintervention remained “stable” following fenestrated and branched endovascular aneurysm repair (F/BEVAR) for abdominal aortic aneurysms (AAAs), a newly presented analysis of U.S. Aortic Research Consortium (ARC) data show. The positive outcomes are “likely secondary to evolutions in minimally invasive techniques and devices,” the ARC investigators report.
The data were presented by first-named author Eric Finnesgard, MD, a vascular surgery resident at UMass Chan Medical School in Worcester, Massachusetts, during the 2024 New England Society for Vascular Surgery (NESVS) annual meeting in Portland, Maine (Oct. 25–27). Finnesgard collected the R. Clement Darling Jr. Award—given for an outstanding original paper from a resident, fellow or medical student—for the work.
The analysis laid out a cumulative 30- day major adverse event (MAE) rate of 10% and a one-year secondary intervention rate of 18%, with adjusted observed-minus-expected cumulative sum used to evaluate outcomes over time. In the case of 30-day MAEs, which occurred in 240 patients, Finnesgard demonstrated a cumulative event rate oscillating around the baseline—reflecting “a stable process that is achieving expected outcomes over time,” he told NESVS 2024. For one-year reinterventions, of which there were 435 performed, the cumulative event rate followed a similar pattern, again reaching expected outcomes over time. Survival at 30 days was 97.3%.
The analysis included 2,377 F/ BEVAR patients—derived from ARC’s 10 prospective, non-randomized, physician-sponsored investigational device exemption (IDE) studies and treated between 2015–2023— with a median follow-up of 2.3 years. Finnesgard detailed how total device components, dissections and the proportion of thoracoabdominal aortic aneurysms (TAAAs) increased across the study period, while technical failure rates and hospital stays remained stable. Fusion imaging, low-profile devices and completely transfemoral repair were increasingly adopted over time, he continued, and there were nonsignificant downward trends in fluoroscopy times, procedure times, radiation dosage and blood loss throughout the study.
Significant determinants of 30-day MAEs included index procedure, technical failure, TAAA, patient age, operative time and baseline renal function. For secondary interventions, significant determinants included index procedure, off-the-shelf device use, technical failure, total target vessels incorporated and prior aortic dissection.
“These data demonstrate trends toward treatment of more complex and extensive aortic disease over the study period,” Finnesgard said, acknowledging study limitations that included the retrospective nature of the analysis and an inability to account for previous operator experience. “These multicenter data demonstrate that, despite an increase in practice complexity, cumulative event rates have actually remained relatively stable.”
Discussant David P. Kuwayama, MD, director of aortic surgery in the Division of Vascular Surgery and Endovascular Therapy at Yale University in New Haven, Connecticut, queried Finnesgard over the nature and outcomes of the reinterventions, as well as the study’s “incredibly low” paraplegia rates. Kuwayama said “the functional question” around reintervention is: “Are the aneurysms actually successfully excluded?”
Finnesgard detailed that 85% of the interventions were performed percutaneously for endoleaks, with type IIIc and Ic the most common, but said he did not have outcome data from these reinterventions on hand, and further acknowledged that “successful aneurysm exclusion” is “a the key metric we need to strive for.” On the paraplegia question, Finnesgard pointed toward practice changes over time—such as a shift toward staged procedures—as significantly helping patients, alongside “big changes to our multimodal protocols for management of spinal cord ischemia” postoperatively.
ARC data guide debate
Meanwhile, the analysis’ senior author, Andres Schanzer, MD, chief of vascular surgery at UMass, made the case for superior outcomes from F/BEVAR over open repair using ARC’s vast dataset during a debate at the 2024 VEITHsymposium in New York City (Nov. 19–23): “While open and endovascular repair are valuable, I believe it is time to stop starting and ending every talk with ‘Open repair is the gold standard,’ because it really no longer is.”
