Late Neck Related Adverse Events are Rare Among Patients with Wide Aortic Neck Undergoing Endovascular Aneurysm Repair with the Ovation Endograft

Abstract

Patients with wide aortic necks undergoing Endovascular Aneurysm Repair (EVAR) have been shown to be at a higher risk for neck-related complications. We aim to examine outcomes of EVAR with an endograft exerting minimal outward pressure (Ovation-Endologix) in patients with a large baseline neck diameter. We performed a retrospective single center study, including consecutive patients undergoing EVAR with the Ovation system from May 2011 to April 2021. Patients were divided in Groups 1 and 2 if the 20, 23, 26, 29 mm or the 34mm proximal diameter main body was used, respectively. According to the instructions for use of the device, for neck diameters 27-30mm the 34mm main body is required. Primary endpoint was rate of neckrelated complications during follow-up, (type Ia endoleak, migration >10mm and neck-related re-interventions) and rate of aortic neck dilatation (AND). AND was determined based on multiple aortic neck diameters that were recorded and compared between the 1-month computed tomography angiography (CTA) after EVAR and the last available follow-up CTA.Secondary endpoints were peri-procedural and follow-up outcomes such as endoleaks, reinterventions and overall mortality. In total 281 patients were included, 222 in Group 1 and 59 in Group 2. Patients in Group 2 presented significantly shorter neck length, higher neck angulation and more common reversed tapered configuration. Median follow-up was 36months (Range: 6-106). Early and late type Ia endoleak was observed in 4 and 2 patients in each group, respectively (P=0.063 and P=0.195, respectively). Distal migration was observed in 2 patients in Group 2 and AND was recorded in 2 patients in each group (P=0.195). Freedom from the primary endpoint was estimated at 98%, 94%, 94% at 12-, 36-, 60-months for Group 1 and at 98%, 95%, 86% for Group 2 (P-Value 0.266). Probability of survival was 95%, 86%, 75% at 12-, 36-, 60-months for Group 1 and 83%, 77%, 72% for Group 2 (P-Value 0.226).Multivariate regression analysis identified neither Group 1 versus Group 2 nor absolute value of aortic neck diameter as significant predictors of neck-related adverse events. Neck diameters did not display significant differences over time in any of the levels evaluated. EVAR with the Ovation endograft results in low rates of late neck related complications which is also true for patients with wide baseline aortic necks.