O-128 - LONG-TERM OUTCOMES OF THE GORE EXCLUDER WITH LOW PERMEABILITY DESIGN FOR THE TREATMENT OF INFRARENAL AORTIC ANEURYSMS

TOPIC:
Abdominal Aortic Aneurysms
AUTHORS:
De Bruin J.L. (Erasmus medical center ~ Rotterdam ~ Netherlands)
Introduction:
Objective The aim of this study is to evaluate long-term outcomes after EVAR using the GORE excluder device with low permeability (LP) technology, from multiple high-volume hospitals in the Netherlands. Design Retrospective multicentre study using real life data on treatment of infrarenal aortic aneurysms (AAA) with low permeability LP technology.
Methods:
Methods All patients who have been treated for an infrarenal AAA utilizing the GORE Excluder LP between June 2004 and January 2017 in four large Dutch teaching hospitals. Clinical outcomes were defined at all outpatient clinical visits available starting from the first day of follow-up, with the absence of symptomatic or ruptured aneurysm, growth (>10mm), reintervention, clinically significant migration and limb occlusions. Technical success was defined as the deployment of the GORE Excluder LP in the planned location and without unintentional coverage of both internal iliac arteries or any visceral aortic branches. All follow-up visits were collected from the patient electronic file, and imaging was reviewed by the imaging core centre on complications and AAA diameter.
Results:
Results Between June 2004 and January 2017, 514 consecutive patients were treated with a Gore LP device in four centres in The Netherlands for an infrarenal abdominal aortic aneurysm (AAA). The majority of these patients were elective cases (90%), 29 patients were symptomatic (urgent; 5.6%) and 23 patients were treated for a rAAA (4.5%). Of these treated patients, 65% were treated within IFU. Therefore, one third was outside IFU mainly due to neck anatomy. Only one patient developed a type 4 endoleak, which confirmed the intended improvement of this Low Permeability design. The number of patients developing type 1A endoleak was 4.7% in five years of follow-up, 22 (4.3%) patients developed a type 1B endoleak. The number of types 2 endoleak requiring reintervention was remarkably low (5.3%) and occurred in 27 patients. Type 3 endoleak occurred in two patients (0.4%) and was a rare cause for reintervention in these patients. Nine patients (1.8%) underwent conversion to open repair and of these patients four (0.8%) were primarily treated either due to rAAA or sAAA in an emergency setting in their first procedure (EVAR). Aneurysm diameter diminished with an average of 10 mm after 3 years and remains stable thereafter which is reassuring and confirming these low endoleak rates.
Conclusion:
Conclusions This multicentre registry of real-life data substantiates the Low Permeability design of this endoprosthesis including low occurrence of type IV endoleak and other endoleaks requiring reintervention. Despite one-third of patients being treated outside IFU, there is a low reintervention rate. There is a relatively high prevalence of conversion rates to open repair after urgent cases compared to elective cases, however not frequent overall.