FDA Advisory Panel Issues Recommendations on Lifelong Surveillance for EVAR
The U.S. Food and Drug Administration (FDA) issued a letter to healthcare providers regarding recommendations for lifelong surveillance of abdominal aortic aneurysm (AAA) patients treated with endovascular repair (EVAR).
The recommendations include regular imaging surveillance within 30 days of EVAR and annually thereafter which “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.”
These recommendations were developed as a result of the conclusions from the Circulatory System Devices Panel of the Medical Device Advisory Committee of the FDA Center for Devices and Radiological Health at their November 2021 meeting. Their discussion during this meeting included safety and effectiveness of EVAR for short-term and long-term outcomes; clinical and imaging event surveillance assessment of EVAR; and real world surveillance for long term EVAR performance.
The FDA urges physicians to ensure compliance with the follow-up recommendations outlined in the Instructions for Use (IFU) and the Society for Vascular Surgery (SVS) guidelines. Currently these guidelines recommend imaging at 30 days postoperatively, one-year postoperatively and annually thereafter. Despite the FDA’s emphasis on its importance, compliance is reported to be about 40 percent.
The FDA will continue to collaborate with patient representatives, professional societies, industry and existing post market data collection entities to help improve this process. It will also help keep the public and healthcare providers informed if new or additional information becomes available.
