The findings of a recent study on reinterventions and sac dynamics after fenestrated endovascular aneurysm repair (FEVAR) with a physician-modified endograft (PMEG) for index aneurysm repair and following prior EVAR led researchers to conclude that “vigilant” surveillance and a low threshold for further interventions are “crucial.” The finding relates to PMEG for rescue of prior EVAR with loss of proximal seal.
Nicholas J. Swerdlow, MD, a vascular surgery fellow at Beth Israel Deaconess Medical Center in Boston, shared these findings during Plenary Session 4 last week at the 2023 Vascular Annual Meeting (VAM) on behalf of senior author Marc L. Schermerhorn, MD, chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center, and colleagues.
Swerdlow et al note in their study abstract that, while the high frequency of reinterventions after FEVAR with a PMEG has been well-studied, the impact of prior EVAR on reinterventions and sac behaviour following these procedures remains unknown. In the present study, therefore, the researchers analyzed three-year rates of reinterventions and sac dynamics following PMEG for index aneurysm repair compared with PMEG for prior EVAR with loss of proximal seal.
The investigators analyzed 122 consecutive FEVARs with PMEGs at a tertiary care center that was submitted to the Food and Drug Administration (FDA) in support of an investigational device exemption (IDE) trial. They excluded patients with aortic dissection, type I–III thoracoabdominal aneurysms, non-elective procedures and prior aortic surgery other than EVAR, for a final cohort of 92 patients.
Patients were divided into those who underwent PMEG for index aneurysm repair (index-PMEG) and those who underwent PMEG for rescue of prior EVAR with loss of proximal seal (rescue-PMEG).
Swerdlow shared with the audience that, of the 92 patients included in the analysis, 55 (60%) underwent index-PMEG and 37 (40%) underwent rescue-PMEG. He added that rescue-PMEG patients were older—78 years (interquartile range [IQR] 75–83) vs. 73 years (69–78), p<0.001. Otherwise, there were no statistically significant differences in baseline demographics and procedural characteristics p<0.001. Otherwise, there were no statistically significant differences in baseline demographics and procedural characteristics.
The presenter reported that perioperative mortality was 1.8% for index-PMEG and 2.7% for rescue-PMEG (p=0.8) and that, at three years, overall survival was 83% for index-PMEG and 72% for rescue-PMEG (p=0.08).
In addition, he noted that freedom from reintervention was significantly higher for index-PMEG than rescue-PMEG, specifically 79% vs. 45% at three years (p<0.001).
Swerdlow then shared sac dynamic findings. He revealed that, at three years following index-PMEG, aneurysm diameter was stable in 58% of patients and decreased in 42% of patients, with no cases of sac expansion.
At three years following rescue-PMEG, however, he noted that aneurysm diameter was stable in 31% of patients, decreased in 31% of patients and increased in 38% of patients (p=0.05).
The presenter stated in his conclusion that FEVAR with PMEGs for index aortic repair and rescue of prior EVAR with loss of proximal seal are “two distinctly different entities.” He summarized that, following FEVAR with a PMEG for index aneurysm repair, less than a quarter of patients had undergone reintervention at three years and sac expansion was “rare.”
At three years following PMEG rescue of prior EVAR with loss of proximal seal, however, it was observed that over half of patients had undergone reintervention and over a third had ongoing sac expansion, which led Swerdlow to underscore the importance of “vigilant” surveillance and a low threshold for further interventions in this group of patients.
Ahead of Swerdlow’s presentation, Schermerhorn shared some thoughts on the study findings with VS@VAM: “I have changed my practice now to reline the entire graft whenever I do a rescue PMEG. I believe that many of these patients have undetected type 3 endoleaks that lead to sac expansion and subsequent loss of the proximal seal.
“Extending the seal proximally fixes the 1a leak but does not address the original cause of sac expansion for the subgroup that had original expansion due to type 2 or 3 endoleak and we need to be alert to this possibility. I have now performed sacotomy on four patients for presumed type 2 endoleak with sac expansion (two of whom had prior rescue PMEG) and found fabric tears that were not detected by [computed tomography angiography], duplex, or angiography.”