AT THE 2015 VASCULAR ANNUAL MEETING
CHICAGO (FRONTLINE MEDICAL NEWS) – During 5 years of follow-up, there was one aneurysm-related death among 150 patients who received Endurant stent grafts for abdominal aortic aneurysms, according to outcome data from Endurant’s manufacturer, Medtronic.
The single death was in a man who developed a type I endoleak 2 years after implant. He declined further intervention, presented at about 3 years with a ruptured aneurysm, and died shortly thereafter. If that patient had been treated, it’s possible that Endurant’s freedom from aneurysm-related death would have been 100% at 5 years, instead of 99%.
Endurant “has proven to be safe and effective through 5 years of follow-up. Long-term outcomes indicate that it’s a durable repair with very low aneurysm-related mortality and a limited need for secondary interventions,” said Dr. Michael Singh, associate professor of surgery at the University of Pittsburgh, who presented the findings at a meeting hosted by the Society for Vascular Surgery.
The presentation completed Medtronic’s U.S. regulatory trial. The Food and Drug Administration approved the device in 2010 based on 30-day safety and 12-month efficacy data. Endurant is currently used in about half of endovascular triple A repairs worldwide, Medtronic said in a press release announcing the 5 year results.
The 150 subjects in the trial had aneurysms of at least 50 mm, with neck lengths of at least 10 mm, neck angulations no more than 60 degrees, and iliac fixation lengths of at least 15 mm. They were 73 years old, on average, and most were men. Endurant deployment was successful in all but one.
Twenty-five patients (17.7%) died during follow-up, all but the type I endoleak patient from causes expected in a triple A cohort, including stroke and lung disease. Six additional patients were lost to follow-up, and 18 withdrew for a variety of reasons, including physician advice.
At 5 years, aneurysm sacks had shrunk in about two-thirds of patients, and remained stable in most of the rest. Endurant didn’t fracture, migrate, or disconnect during follow-up.
Fifteen patients required 18 secondary endovascular interventions, including two for type I endoleaks, 10 for type II endoleaks, three for limb occlusion before 2 months, one for limb occlusion after 2 months, one for limb stenosis, and one for thromboembolism.
When asked to explain the robust outcomes, Dr. Singh noted that “we are dealing with trial patients … with very selective inclusion and exclusion criteria” and favorable anatomy, “so you expect optimal results. In real-world experience, we might see something slightly” less optimal.
The type I endoleak patient who declined treatment might have had “the device placed in a degenerated aorta. We have come across this in our own practice regardless of the device that is utilized. I think the foundation” of endograft placement “is making sure that you are deploying the device in normal aorta,” at least as much as possible, he said.
The trial was funded by Medtronic. Dr. Singh said he has no relevant disclosures. The principal investigator is a Medtronic consultant.