Patients Who Underwent Abdominal Aortic Aneurysm Repair Require Lifelong Surveillance, FDA Warns

The FDA estimates up to 30% of abdominal aortic aneurysm repair patients will suffer device failures and need additional life-saving surgery at some point in their life.

Following an abdominal aortic aneurysm repair surgery, federal health officials are warning that patients need surveillance for the rest of their lives to prevent serious side effects that may lead to death.

The Food and Drug Administration (FDA) issued a letter to health care providers on Monday, emphasizing the need for doctors to provide lifelong surveillance of patients after abdominal aortic aneurysm (AAA) endovascular aortic repair (EVAR) procedures.

Abdominal aortic aneurysm via endovascular aortic repair is a surgery that repairs a weakening of the upper part of the aorta using a stent graft. The procedure has largely replaced open surgical repair because it offers lower death rates within 30 days of the procedure. However, long-term survival is comparable to open surgery at three to five years.

This is why the Circulatory System Devices Panel of the Medical Devices Advisory Committee, an FDA advisory panel, indicated even though EVAR offers lower death rates in the short-term, long-term survival is lower. Roughly 20-30% of patients will suffer device failures and require re-interventions.

As a result of the long-term risks following abdominal aortic aneurysm repair, the panel has recommended life-long surveillance, and is calling for the FDA to conduct long-term postmarket data collection.

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According to the letter, doctors should provide regular imaging surveillance, first within 30 days of EVAR and then yearly after. This can help identify side effects like endoleaks, device migration, loss of patency, and failure of aneurysm sac regression, the agency advises. The FDA indicates identifying these serious side effects is key to preventing potentially life-threatening outcomes.

The imaging should focus in catching endoleaks, aneurysm size, and other potential clinical events, the FDA said.

The recommendations to conduct 30 day and annual follow-ups after the procedure were first issued in 2018, by the Society for Vascular Surgery. However, only about 40% of doctors comply with the recommendation. The FDA hopes the new warning letter will result in more widespread lifelong follow-up surveillance.

A recent study found that patients who underwent elective aortic aneurysm repair are less likely to face emergency situations during the procedure than those who undergo the repair due to acute syndrome symptoms. Early interventions for the condition help to prevent serious side effects compared to needing emergency surgery.

The FDA also recently recommended doctors not use the Endologix AFX Graft System because it can cause severe bleeding problems, leading to the need for additional surgeries. The grafts could allow blood to flow into the AAA, causing pressure to build up in the aneurysm sac, which could lead to a rupture. This requires immediate medical  attention to repair the bleed and can lead to death.

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