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Endovascular aneurysm sealing viable treatment for AAA at 2 years
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Endovascular aneurysm sealing applied within the instructions for use had “acceptable” results at 2 years, according to results published in the Journal of Endovascular Therapy.
To analyze the 2-year outcomes of the endovascular aneurysm sealing (EVAS; Nellix, Endologix) device based on the 2013 and 2016 versions of the instructions for use (IFU), the researchers conducted a retrospective cohort study consisting of 355 consecutive patients treated with the first-generation device from April 2013 to 2015 at three high-volume centers in the Netherlands.
Among the cohort, 264 patients underwent elective asymptomatic infrarenal EVAS procedures suitable for analysis.
According to the study background, procedures performed with the 2013 IFU raised concerns about migration, so the IFU was revised in 2016 to include a reduced maximum infrarenal neck diameter and a reduced degree of neck diameter.
In the cohort, 63.3% patients were treated within the IFU 2013 criteria, of whom 18.2% followed the 2016 IFU.
There was a 98.2% overall technical success rate among the patients in the IFU 2013 group, and the success rate was 97.9% of those in the IFU 2016 subgroup (P = .428).
Freedom from reintervention estimates at 2 years were 89.7% for the IFU 2013 group and 95.7% for IFU 2016, with more reinterventions in the first 45 cases (P = .005).
Estimated rates of stenosis or occlusion were 6.5% in the 2013 cohort and 4.2% in the 2016 cohort (P = .705).
The researchers observed a 5.4% endoleak rate in the 2013 cohort and a 2.1% rate in the 2016 group (P = .583).
Migration requiring intervention occurred in 7.1% of patients in the 2013 cohort, but none in the 2016 subgroup, according to the results.
Six percent of patients in the 2013 cohort demonstrated aneurysm growth; the rate was 4.2% in the IFU 2016 group.
At 2 years, overall survival was 90.9% in the 2013 group and 95.5% in the 2016 group, whereas freedom from aneurysm-related death estimates were 97.6% in the 2013 group and 100% among those in the 2016 cohort.
There were fewer complications in the 2016 cohort, according to the researchers.
In a related editorial, Francesco Torella, MD, FRCS, from the Liverpool Vascular and Endovascular Service, University of Liverpool, United Kingdom, and colleagues wrote that the findings should be interpreted with caution.
“We urge Nellix users to remain vigilant; long-term data are needed before wider use of EVAS can be recommended,” they wrote. by Dave Quaile
Disclosures: The study was funded by Endologix. Three authors report they are consultants for Endologix. Torella reports he is a consultant for Endologix and received educational support from Vascutek, research grants from Endologix and speaker fees from Abbott Medical. Please see the editorial for the other authors’ relevant financial disclosures.
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