FDA Advisory Panel Issues Recommendations on Lifelong Surveillance for EVAR

February 28, 2022—The FDA announced it has issued a letter to health care providers on recommendations for lifelong surveillance, including imaging, for patients with abdominal aortic aneurysm (AAA) to be treated with endovascular aortic repair (EVAR).

The FDA stated, “Regular imaging surveillance, within 30-days of EVAR and annually thereafter, may help identify adverse events such as endoleaks, device migration, loss of patency, and failure of aneurysm sac regression before the occurrence of potentially serious and life-threatening adverse events.” The FDA announcement is available online here.

The recommendations support the conclusions of the Circulatory System Devices Panel of the Medical Device Advisory Committee of the FDA Center for Devices & Radiological Health, which held a 2-day meeting in November 2021 to address the use of EVAR devices for the treatment of AAAs. On the second day, the panel discussed and made recommendations on the continued safety and effectiveness of endovascular stent grafts for AAA treatment and ways to improve real-world data collection on long-term device performance for currently marketed devices and future technologies. Endovascular Today's report of that meeting is here.

In the current letter, the FDA stated it agrees with the panel’s conclusions, including

• EVAR continues to be a safe and effective treatment option for appropriately selected AAA patients.
• Patients should complete follow-up visits 30-days post implantation and lifelong annual follow-up thereafter. As outlined in the current Society for Vascular Surgery (SVS) practice guidelines, a 6-month follow-up visit should occur if concerns are identified from imaging at 30-day follow-up.
• A real-world surveillance system should be created to collect data through 10 years post-EVAR.
  • The surveillance system should assess the following clinical endpoints: all-cause mortality, aneurysm-related mortality, aortic rupture, and aortic reintervention.
  • The surveillance system should be designed to capture imaging endpoints including endoleaks, aneurysm size, and device patency because these endpoints are associated with adverse clinical events. Collection of high-quality imaging data using standardized imaging protocols and core lab review may be most feasibly accomplished at selected clinical centers.
• Renewed efforts from physicians, health systems, and medical professional societies are needed to increase patient and physician compliance with follow-up imaging recommendations post-EVAR.

The FDA recommendations to health care providers are the following:

• For patients that providers have treated or follow who are implanted with EVAR devices, regular clinical follow-up and imaging is critical to detect EVAR device and treatment failures to maintain favorable long-term results.
  • The FDA urges physicians to ensure compliance with the follow-up recommendations outlined in device Instructions for Use and the SVS guidelines. SVS guidelines recommend follow-up visits with imaging 30-days post implantation and annual follow-up thereafter, with concerning findings from the 30-day imaging prompting a 6-month follow-up visit.
• For patients under care who are being considered for EVAR, physicians should discuss the risks and benefits of all available AAA treatment options with patients (including open surgical repair), while emphasizing the need for lifelong follow-up imaging and the possibility of reinterventions following EVAR. A patient’s willingness and ability to comply with annual imaging follow-up should be considered and discussed in determining the most appropriate treatment option.
• If problems with devices are observed, health care providers should report them to the device manufacturer and the FDA’s Voluntary MedWatch Reporting system.

The FDA advised that these recommendations do not change or affect the recommendations outlined in the safety communication related to the Endologix AFX AAA endovascular graft announced by the FDA on January 13, 2022.

The FDA will collaborate with key stakeholders to improve EVAR patient follow-up and postmarket data collection and will continue to keep health care providers and the public informed if new or additional information becomes available, stated the agency.