FDA reaffirms importance of yearly imaging follow-up after EVAR
Click Here to Manage Email Alerts
The FDA has issued a letter to health care providers emphasizing the importance of annual follow-up in patients who received endovascular grafts for abdominal aortic aneurysm.
According to the letter, although endovascular aortic repair largely replaced open surgery for AAA due to lower 30-day mortality, death at 3 to 5 years is similar between treatments.
Guidelines on the care of patients with AAA from the Society for Vascular Surgery reported that physician and patient compliance with the current imaging follow-up recommendations is approximately 40%.
During the November 2021 meeting, the Circulatory System Devices Panel discussed the long-term efficacy and safety of stent grafts used in EVAR procedures. The panel concluded that renewed efforts from physicians, health systems and societies are needed to increase patient and physician compliance with the current follow-up imaging recommendations from the FDA and SVS.
Therefore, the FDA issued the following recommendations for EVAR follow-up, as stated in the letter:
- Physicians are urged comply with follow-up recommendations outlined in the device instructions for use and the Society for Vascular Surgery guidelines. The guidelines recommend follow-up visits with imaging 30-days post implantation and annual follow-up thereafter. Concerning findings from the 30-day imaging may prompt a 6-month follow-up visit.
- The risks and benefits of all available AAA treatments, including open surgical repair, should be discussed with patients while emphasizing the need for lifelong follow-up imaging and risk for reinterventions following EVAR. A patient’s willingness and ability to comply with imaging follow-up should be considered and discussed in determining the most appropriate treatment option.
- If problems with devices are observed, physicians should report them to the device manufacturer and the FDA’s Voluntary MedWatch Reporting system.
According to the letter, these recommendations do not change or affect the recommendations related to the Endologix AFX AAA Endovascular Graft issued in January.
References:
- Chaikof EL, et al. J Vasc Surg. 2018;doi: 10.1016/j.jvs.2017.10.044.
- Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems – FDA Safety Communication. www.fda.gov/medical-devices/safety-communications/update-risk-type-iii-endoleaks-use-endologix-afx-endovascular-aaa-graft-systems-fda-safety-0. Published Jan. 13, 2022. Accessed Feb. 28, 2022.
Click Here to Manage Email Alerts