In a letter to healthcare providers, the FDA urged physicians to conduct regular follow-up examinations of patients who have been implanted with endovascular aneurysm repair (EVAR) devices to treat abdominal aortic aneurysms instead of undergoing open surgery.
The tube-shaped devices are stentlike grafts that are inserted within the vessel via a catheter sent through a small incision in the groin area. Once in place, they reinforce weakened blood vessel walls and direct bloodflow away from aneurysms—which form when weak spots in the vessel walls bulge outward and fill with blood—ideally causing the aneurysm sac to shrink.
The FDA has zeroed in on EVAR devices used specifically to treat abdominal aortic aneurysms. These are enlargements of the aorta in the region of the abdomen that, like other aneurysms, can be life-threatening if their growth isn’t stopped and they burst.
A handful of EVAR devices are currently cleared by the FDA for use in treating these aneurysms including implants from Medtronic, Endologix, W.L. Gore and more.
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EVAR procedures have largely replaced open surgery to repair abdominal aortic aneurysms, the FDA noted, since the minimally invasive implant placement carries a much lower risk of immediate surgery-related complications—but that advantage doesn’t carry over long-term if the devices aren’t regularly examined.
The agency cited data showing the mortality rates of both EVAR and surgical repair even out within three to five years after the procedure.
Those increased mortality rates are linked to postop instances in which the aneurysm sac either stays the same size or continues growing after either treatment approach—rather than growing smaller as the blood is diverted away—which will either require another operation to correct the repair or could lead to serious injury or death.
In the case of EVAR, specifically, about 20% to 30% of procedures require reintervention, the majority of which occur because of an endoleak, where the implant doesn’t fully seal off the aneurysm, allowing blood to trickle back in. Other complications occur when the device becomes blocked or moves within the blood vessel.
According to the FDA’s letter, these and other complications could be detected much earlier—potentially reducing long-term mortality rates—if patients and physicians stick to a regular checkup schedule. Currently, though the Society for Vascular Surgery recommends follow-up appointments 30 days after the implant and then every year afterward, the FDA said only about 40% of EVAR patients follow those protocols.
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Alongside urging physicians to conduct lifelong surveillance of their EVAR patients, the FDA is recommending real-world data from at least the first 10 years of postop check-ins be compiled in a single location. The database should be able to analyze rates of all-cause mortality, aneurysm-related mortality, aortic rupture and aortic reintervention, the agency said, as well as to collect imaging data regarding conditions related to adverse events including endoleaks, aneurysm size and device patency.
Additionally, the FDA said, “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.”
The recommendations were originally put forth by a panel dedicated to circulatory system devices within the FDA’s medical devices advisory committee at a meeting in November, and the regulator affirmed its agreement with the panel’s conclusions in the Feb. 28 letter to providers.