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Novel endograft system shows positive midterm results in AAA
A new endograft system had favorable midterm treatment outcomes in properly selected patients with abdominal aortic aneurysm, according to results of a study published in the Journal of Endovascular Therapy.
According to the study, endovascular aneurysm repair has largely replaced open surgery as the preferred treatment for patients with AAA, and although many devices are available for treatment of AAA, there is still room for improvement.
“Manufacturers have made significant advances in improving existing devices to compensate for short and angulated aortic necks. However, efforts have also been made to extend the proximal fixation zone in such patients to the suprarenal aorta by adding chimneys, snorkels, branches and fenestrations to existing endografts,” Dainis Krievins, MD, PhD, from the department of vascular surgery from the Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia, and colleagues wrote. “While early results of these techniques are promising, the procedures are complex and costly, and long-term results are lacking.”
Krievins and colleagues enrolled 84 patients with AAA (mean age, 73 years) at 10 clinical sites in two prospective, controlled clinical studies to report the initial clinical results of EVAR using a low-profile endograft system (Altura, Lombard Medical), which features a double “D-shaped” stent design with suprarenal fixation and modular iliac components that are deployed from distal to proximal.
The primary outcomes were mortality, major adverse events, including all-cause death, stroke, paraplegia, MI, respiratory failure, bowel ischemia and blood loss of at least 1,000 mL, and clinical success.
There was a 99% success rate for endograft implantation among the patients enrolled in the study. The single failure was due to delivery system malfunction before insertion in the early-generation device, the researchers wrote.
One patient died, and four patients underwent reinterventions (one type I endoleak, two iliac limb stenoses and one endograft occlusion) within the first 30 days, according to the results.
There were no aneurysm ruptures, surgical conversions or AAA-related deaths during a median follow-up of 12.5 months (range, 11.5-50.9).
There was a cumulative major adverse event rate of 3% at 6 months and 7% at 1 year.
Two patients underwent coil embolization of type II endoleaks at 6.5 months and 2.2 years, respectively.
Clinical success rates were 94% at 30 days, 98% at 6 months and 99% at 1 year.
According to the researchers, further clinical investigation is needed to evaluate the role the device in the treatment of AAA.
“Because this was the first-in-human experience with this endograft, the results may not be generalizable or reflect outcomes that may be obtained with the currently available CE-marked device,” they wrote.
The system has not yet been approved for use in the United States. by Dave Quaile
Disclosures: The study was funded by Lombard Medical. Krievins and another author report they are consultants for Lombard Medical.