FDA Calls for Improvements to Endovascular Aortic Repair Follow-Up Compliance

The United States Food and Drug Administration (FDA) published a letter to health care providers emphasizing the importance of regular imaging surveillance for patients with abdominal aortic aneurysm (AAA) endovascular aortic repair (EVAR).

EVAR is a safe and effective treatment for patients with AAA and EVAR implantation has largely replaced open surgery in the US. EVAR is associated with decreased risk for perioperative mortality within 30 days, but long-term mortality rates are similar for open surgery and EVAR. Throughout life, between 20% and 30% of patients will require reintervention, highlighting the importance of regular patient follow-up.

Imaging surveillance is used to detect aneurysm sac regression failure, endoleaks, device migration, or loss of patency. Patients should have an imaging evaluation follow-up within 30 days of receiving their EVAR implant and have annual follow-ups throughout the rest of their lives. If a patient has an abnormality during the 30-day follow-up, they should be reassessed at 6 months.

Despite this recommended follow-up schedule, imaging compliance is reported to be approximately 40%.

For patients who are considering EVAR, physicians should instruct them about the lifelong imaging follow-up requirement. When making treatment decisions, clinicians should take the patient’s willingness to comply to follow-up into consideration.

All detected device problems should be reported to the device manufacturer and the FDA’s voluntary MedWatch reporting system.

These recommendations do not change or affect current guidelines for patients with AAA EVAR.

The US FDA advisory panel suggests that a database should be established to assess for 10-year rates of mortality, aortic rupture, and reinterventions. The database should be designed to include high-quality imaging data on endoleaks, aneurysm size, and device patency.

The FDA pledges to work collaboratively with professional societies and industry to help improve follow-up compliance and data collection and calls for renewed efforts from clinicians and professional societies to promote compliance with current guidelines.

Reference

FDA Advisory Panel Recommendations on Lifelong Surveillance and Long-Term Postmarket Data Collection for Patients with AAA Endovascular Aortic Repair – Letter to Health Care Providers. United States (US) Food and Drug Administration (FDA). Published March 1, 2022. Accessed March 11, 2022. https://www.fda.gov/medical-devices/letters-health-care-providers/fda-advisory-panel-recommendations-lifelong-surveillance-and-long-term-postmarket-data-collection