Individualized Follow-up Stratified by Type of Device for Patients Post Standard Endovascular Aortic Repair

T. Cohnert, G. Siegl, H. Portugaller, S. Koter

Purpose: Endovascular aneurysm repair (EVAR) is an accepted treatment method for selected patients presenting with abdominal aortic aneurysm (AAA). However, long-term results and device durability are problematic in some devices, already recognized by the Food and Drug Administration with warnings issued for the treatment using specific devices. For the Endologix AFX plus Vela, the problem of component separation is a specific complication with the risk of acute AAA rupture.

Materials and Methods: All patients who underwent standard EVAR using an Endologix AFX plus Vela device between October 2015 and September 2022 were actively recalled and underwent physical examination , plain abdominal x-ray examination, and computed tomography angiography.

Results: Between October 2015 and September 2022, a total of 556 patients underwent open surgical or endovascular treatment for AAA. A total of 323 patients underwent open surgery, and 233 patients underwent standard EVAR. For EVAR, an Endologix AFX system using two components was implanted in 26 selected patients with a narrow aortic bifurcation (21 men, 5 women; mean age, 75.6 + 5.9 years). No intra- or perioperative deaths occurred. During follow-up, 11 patients (11 of 26; 42%) died after a median follow-up of 23 months (range, 1–49 months). Of these, 1 patient died post 49 months because of confirmed AAA rupture caused by component dislocation. Three patients were lost to follow-up. The median survival time in the 12 patients alive is 54 months. In 4 patients, the AAA is shrinking; in 4 patients, it is stable but not shrinking; in 3 patients, it is growing under surveillance; and in 1 patient, successful relining to treat component separation was performed 68 months after  primary implantation. Fifteen of the 26 patients did not adhere to the given follow-up schedule and did not present for the appointments scheduled. This may be exaggerated by the COVID-19 pandemic. Regarding the radiologic follow-up, the Endologix device causes severe artifacts on magnetic resonance imaging and requires computed tomographic controls if aneurysm growth is suspected. Also, plain x-ray examination for detection of device or component migration gains importance.

Conclusions: Life-long follow-up after EVAR is important. A strategy needs to be developed by the centers implanting EVAR devices to ensure that patients follow the appointments and radiographic controls. A device-specific follow-up plan needs to be developed because some implants show specific risks during long-term treatment, and their implementation in AAA treatment guidelines should be considered.