FDA Urges Lifelong Follow-Up After Endovascular Aortic Repair

Megan Brooks

March 01, 2022

Patients who have undergone endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) need lifelong surveillance, including imaging, the US Food and Drug Administration (FDA) advises.

"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 says in a letter to healthcare professionals.

The letter highlights input received last November from the FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee on the long-term safety and effectiveness of endovascular stent grafts for AAA repair and recommendations regarding strengthening data collection on device performance.

The panel made several conclusions, which the FDA agrees with, including the following:

  • EVAR continues to be a safe and effective treatment option for appropriately selected AAA patients.

  • Patients should complete follow-up visits 30 days after implantation and annually thereafter. As outlined in current professional society guidelines, patients should have a 6-month follow-up visit if concerns are identified from imaging at 30-day follow-up.

  • 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 after EVAR.

  • A patient's willingness and ability to comply with annual imaging follow-up should be considered and discussed when determining the most appropriate treatment option.

  • Renewed efforts from physicians, health systems, and professional societies are needed to increase patient and physician compliance with follow-up imaging recommendations after EVAR.

The FDA calls for implementation of a real-world postmarket data-collection system to assess key clinical and imaging endpoints out to 10 years after EVAR.

The surveillance system would assess all-cause mortality, aneurysm-related mortality, aortic rupture, and aortic reintervention.

The surveillance system should capture imaging endpoints such as endoleaks, aneurysm size, and device patency because of their association with adverse clinical events, the FDA says.

These recommendations do not change or affect the Endologix AFX AAA endovascular graft recommendations issued in December 2020 and updated in January 2021.

The FDA continues to recommend "at least yearly, lifelong follow-up" to monitor for type III endoleaks in patients with any type of Endologix AFX endovascular graft, including AFX with Strata, AFX with Duraply, and AFX2.

The FDA also continues to recommend that before surgery, clinicians discuss the benefits and risks of all available AAA treatment options with patients.


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