Endovascular Aneurysm Sealing Therapy with the Nellix System in Patients Not Suitable for Conventional EVAR – A Single Centre Experience

Abstract

Objective: Endovascular aneurysm sealing (EVAS) therapy with the Nellix system was introduced in 2013. In January 2019, the Medicines and Healthcare Regulatory Authority issued a Field Safety Notice to desist use. The aim was to review experience in the use of the Nellix device in a specific cohort of patients. Methods: A prospective study of 27 patients who underwent EVAS with the Nellix system in the Belfast Trust between December 2013 and January 2016. Use of the Nellix system was approved by the Trust Standards and Guidelines Committee. All cases were deemed not suitable for conventional endovascular aneurysm repair and judged suitable for EVAS by the product specialists as per the 2013 instructions for use criteria. Results: Up to April 2019, 17/27 patients had died. Three with confirmed ruptured AAA within an average of 1.8 years. The others were non-AAA related deaths. Four of 27 (14.8%) patients had a type I endoleak on first surveillance imaging, increasing to 10/27(37%) patients on follow up imaging. One out of 27 (3.7%) developed sac expansion. Of the 10 surviving patients, seven have an aneurysm related complication (six endoleaks and one sac expansion). One patient went on to rupture with successful conversion to open repair. Three patients were deemed not suitable or declined further intervention. The remainder of surviving patients will continue on yearly surveillance or await clinical review. Conclusion: The Nellix system is associated with unacceptably high morbidity and mortality rates in this specific cohort. While new technology is essential to progressing healthcare, specialised consent and stringent surveillance strategies are required when adopting new techniques.