The first endovascular aneurysm sealing (EVAS) all-comers, prospective registry shows very encouraging results in the treatment of abdominal aortic aneurysms, according to Andrew Holden, Auckland City Hospital, Auckland, New Zealand, who presented early data of the EVAS FORWARD Global Registry of 300 patients treated with the Nellix system at the VEITHsymposium (18–22 November, New York, USA).
We know that if we are going to treat hostile anatomies we are going to have a significantly higher number of endoleaks, migration and that will result in reinterventions. We know that we will have to monitor these patients closely, with a financial burden, radiation and contrast. Nellix represents a totally different way of treating aneurysms because it treats the aneurysm sac directly and overcomes the limitations of conventional endografts.
EVAS FORWARD is a real-world experience and enrolled 300 patients treated with Nellix at 30 centres, to be followed for five years. The primary investigators are Holden and Matt Thompson, London, UK. Enrolment was completed in September 2014, and the mean follow-up up to date is 165 days.
The patients were divided into four cohorts: cohort 1 were patients treated within the instructions for use, with neck length ≥10mm and infrarenal angle ≤60 degrees (n=190, 69%); cohort 2 had neck length 5–10mm and infrarenal angle 61–90 degrees (n=41, 15%); cohort 3 included patients with juxtarenal aneurysms – neck length 90 degrees (n=31, 11%) and included 16 chimney procedures; and cohort 4 included patients with ruptured aneurysms and EVAR revisions (n=12, 4%).
Holden highlighted that the EVAS FORWARD is different from other registries as it included much more complex aneurysm anatomies with short and highly angulated necks, ruptures and also those requiring chimney procedures.
At a mean follow-up of six months, the major adverse events rate was 3% within 30 days and 0.7% after 30 days. Six out of 289 patients (2.1%) experienced endoleaks in the first month after intervention, and all these happened in cohort 1. Five endoleaks were type IA and one was type II.
“It is fair to say that most of these endoleaks were attributed to early learning curve. Three of these five type IA endoleaks were addressed very easily with a secondary intervention in the first month.
By 30 days, Holden said, the overall incidence of endoleaks was 0.7%, with only two cases, one type IA and one type II, and at six months, there was only one additional endoleak of type II, a cumulative rate of 1.1%. With regards to reinterventions and conversion, he added that in addition to the three type IA endoleaks treated, there were three occlusions successfully treated, one intraoperative conversion, two cases of renal stenting and one iliac extension.
Holden said the results were “very encouraging”, and that the early experience underscores the importance of training and best procedural practices. “There were low rates of endoleak and reintervention despite treating a broad range of challenging anatomies across multiple cohorts,” he concluded.