The U.S. Food and Drug Administration (FDA) is emphasizing to physicians and other health care providers the importance of lifelong surveillance, including imaging, for patients with abdominal aortic aneurysm (AAA) endovascular aortic 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.
During the FDA’s November 3, 2021 meeting, 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.
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 guidelines1, 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.
- For patients you 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) guidelines1. 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 your 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.
These recommendations do not change or affect the Endologix AFX AAA Endovascular Graft recommendations from January 2022.
In the U.S., endovascular aortic repair (EVAR) has largely replaced open surgery for AAA because of lower perioperative mortality rates (occurring within 30 days after surgery) compared with surgical repair. However, this survival advantage is not maintained long-term; mortality rates are comparable between EVAR and open surgery three to five years after the procedure. Large studies show that long-term survival is higher in patients with aneurysm sac regression vs. no change in sac size or sac expansion.2 Both sac expansion or no reduction in sac size post-EVAR are associated with endoleaks, and endoleaks are the most common reason for aortic reintervention.3 Reinterventions to address device or treatment failures, including endoleaks, are estimated to occur in 20-30% of EVAR patients.4
Current follow-up recommendations outlined in EVAR device Instructions for Use and the 2018 Society for Vascular Surgery (SVS) guidelines update1 recommend imaging at 30 days and one-year post-procedure and annually thereafter. However, despite these important recommendations, it is notable that imaging follow-up compliance is reported to be only about 40%.1
The FDA will work collaboratively with key stakeholders (for example: patient representatives, professional societies, industry, and existing postmarket data collection infrastructures) to help drive the effort to improve EVAR patient follow-up and post-market data collection forward. The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.
Reporting Problems to the FDA
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with EVAR devices.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE):
- Email: DICE@FDA.HHS.GOV
- Phone: 800-638-2041 or 301-796-7100
- Type III Endoleaks Associated with Endovascular Graft Systems - Letter to Health Care Providers
- Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems – FDA Safety Communication
1. Chaikof EL, Dalman RL, Eskandari MK, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018. https://www.jvascsurg.org/article/S0741-5214(17)32369-8/fulltext
2. T.F.X. O'Donnell et al. Aneurysm sac failure to regress after endovascular aneurysm repair is associated with lower long-term survival. J Vasc Surg. 2019 69: 414-422.
3. Fairman AS et al. Characterization and outcomes of reinterventions in Food and Drug Administration-approved versus trial endovascular aneurysm repair devices. J Vasc Surg. 2017 67(4): 1082-1090. https://www.jvascsurg.org/article/S0741-5214(17)32102-X/fulltext
4. J. A. Columbo et al. A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review. J Vasc Surg. 2019 69(1): 74-79. https://www.jvascsurg.org/article/S0741-5214(18)30916-9/fulltext