Endovascular Aneurysm Sealing (EVAS). Outcomes and Anatomical Suitability, a Single Centre Experience.

Abstract

Introduction: EVAS has been introduced in 2013, since then the instructions for use (IFU) have changed in order to improve safety of the technique. The most significant changes were a maximum neck diameter reduction to 28mm and a ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen <1,4. The aim of this study is firstly to assess the suitability of EVAS and to report our preliminary results of elective repair of abdominal aortic aneurysm (AAA) using the original IFU. Secondly we want to identify if the patients of our original cohort would have also been suitable for EVAS using the new IFU. Methods: We have investigated all patient treated with EVAS between June 2013 and December 2016. All patients undergoing elective AAA repair where eligible to enter the analysis. We have identified age, co-morbidity, aneurysm size, anatomical morphology, mortality and complications. Patients were followed until October 2017. Regular Follow up consists of routine computertomograpy angiogram and Doppler ultrasound. Of each included patient, we investigated if the aneurysm morphology would still make them suitable to undergo EVAS repair under the new IFU. Results: 61 patients (median age 77,5 years, range 56-90; 51 men) with an abdominal aortic aneurysm were treated with the Nellix EVAS system at our institution. The median aneurysm diameter was 60mm (range 53-82). Aneurysm morphology was compliant in 47 patients (77%) with the old IFU and 11 patients (18%) with the new IFU. The majority of cases 42 (69%) were not suitable because of a high ratio between thrombus and flow lumen (≥ 1,4). Patients were followed up until the first October 2017 or date of death. Median follow up was 33 months. In follow up we identified 13 (21%) type 1A endoleaks of which 5 patients were inside the new IFU, 4 (7%) ruptures, and 4 (7%) limb occlusions. Overall mortality was 18% of which 10% (6 patients) was aneurysm related and 7% (4 patients) died of unknown cause. Conclusion: In conclusion EVAS with the new IFU for the management of AAA is only suitable for a small percentage of our patients and in our cohort there was a high mortality rate and incidence of Type 1a endoleaks.