The Food and Drug Administration (FDA) recently announced it has issued a letter to healthcare providers emphasizing the importance of lifelong surveillance, including imaging, for patients with abdominal aortic aneurysm (AAA) endovascular aneurysm repair (EVAR).
“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 communicates.
During an FDA meeting on Nov. 3, 2021, the Circulatory System Devices Panel of the Medical Devices Advisory Committee discussed the long-term safety and effectiveness of endovascular stent grafts for AAA treatment, how to strengthen data collection on real-world device performance for currently marketed and future devices, and input on the outcomes that are most important to capture during long-term follow-up.
According to the current announcement, the panel provided input on these topics and the FDA 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 is outlined in current professional society guidelines, a six-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
In their letter to healthcare providers, the FDA recommends 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 (IFU) and the Society for Vascular Surgery (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 six-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, healthcare providers should report them to the device manufacturer and the FDA’s Voluntary MedWatch Reporting system
These recommendations do not change or affect the Endologix AFX AAA endovascular graft recommendations from January 2022, the FDA advises.
The agency states that it will work collaboratively with key stakeholders to help drive the effort to improve EVAR patient follow-up and postmarket data collection forward and will continue to keep healthcare providers and the public informed if new or additional information becomes available.