For the treatment of juxtarenal aortic aneurysms, reinterventions after physician-modified endovascular grafts (PMEGs) are non-detrimental to long-term survival. This is one of the main findings of a recently published study by Ayumi Tachida (University of Washington School of Medicine, Seattle, USA) and colleagues.
The authors note in their Journal of Vascular Surgery (JVS) paper that the frequency and impact of reintervention on mortality after PMEGs in unknown. It was the aim of the present study, therefore, to describe reinterventions after PMEG for the treatment of juxtarenal aneurysms and their effect on survival.
Tachida et al used 11 years’ worth of data (2011–2022) from a prospective investigational device exemption clinical trial in their study. The trial in question—officially titled ‘Physician-modified endovascular grafts for the treatment of elective, symptomatic or ruptured juxtarenal aortic aneurysm: an investigator-initiated study’—is being led by Benjamin Starnes (University of Washington, Seattle, USA), who is also a co-author of the JVS paper. The trial aims to enrol 300 participants with an estimated completion date of January 2035.
On the Clinical Trials webpage for the study, it is mentioned that not all patients presenting with symptomatic or ruptured aortic aneurysms are candidates for endovascular repair, with the reasons for exclusion noted to predominantly involve a lack of a suitable proximal aortic neck. “Solutions to this problem involve multi-branched or ‘fenestrated’ endografts, which are being assessed in other clinical trials,” the study description continues. However, it is highlighted that grafts in these trials require between six and 12 weeks to manufacture and deliver to the investigational site.
“We seek to evaluate the safety and efficacy of PMEG using a US Food and Drug Administration [FDA]-approved, off-the-shelf device in order to increase the applicability of these technologies to more patients and thus save more lives,” the description reads.
In the study reported in JVS, reinterventions after PMEG were categorised as open or percutaneous and major or minor by Society for Vascular Surgery reporting standards according to high or low magnitude based on physiological impact. The investigators also categorised reinterventions by timing, as well as those interventions which occurred within one week of PMEG. They compared survival between patients who did and did not undergo reintervention and between reintervention subcategories.
Writing in JVS, Tachida and colleagues relay that a total of 170 patients underwent PMEG in the 11-year study time period, 50 (29%) of whom underwent a total of 91 reinterventions (mean reinterventions/patient, 1.8). They report that freedom from reintervention was 84% at one year and 60% at five years. The authors specify that reinterventions were most often percutaneous (80%), minor (55%) and low magnitude (77%), with the most common reintervention being renal stenting (26%). They also note that there were 10 early reinterventions within one week of PMEG and that two aortic-related mortalities occurred after reintervention.
There were no differences in survival between patients who underwent reintervention and those who did not, Tachida et al also communicate in the results section of the paper. However, they continue, survival differed based on the timing of reintervention.
Tachida and colleagues further share that, after adjusted analysis, reintervention within one week of PMEG was associated with an increased risk of mortality both compared with late reintervention (hazard ratio [HR], 11.1; 95% confidence interval [CI], 2.7–46.5) and no reintervention (HR, 5.2; 95% CI, 1.6–16.8).