A Single Centre Long Term Follow Up of the Nellix Endovascular Aneurysm Sealing System

Abstract

To evaluate the clinical performance at long term follow up of endovascular aneurysm sealing (EVAS, Endologix Inc. Nellix, Irvine, CA, USA) in the treatment of abdominal aortic aneurysm (AAA). Observational, prospective, single centre study of primary AAA interventions with EVAS (n= 117) from November 2013 to November 2016. Endpoints were primary technical success, Nellix device failure, freedom from open surgical conversion (OSC), freedom from secondary intervention, sac rupture, total mortality, and aneurysm related mortality at long term follow up. The median age was 75 years (interquartile range [IQR] 70, 81 years) and 83% were male. The median AAA diameter was 58 mm (IQR 54, 60 mm). The median length of follow up was 6.2 years (IQR 5.6, 6.8 years). Primary technical success was 100%. Median time to Nellix failure was 5.6 years (IQR 3.3, 7.4 years). Freedom from Nellix failure at five and seven years was 54% (95% confidence interval [CI] 54.2 - 63.8%) and 36% (95% CI 22.3 - 49.7%), respectively. Freedom from OSC at five and seven years was 63% (95% CI 53.2 - 72.8%) and 59% (95% CI 47 - 71%), respectively. The secondary intervention rate was 11.4/100 person years. Freedom from secondary intervention at five and seven years was 52% (95% CI 42.2 - 61.8%) and 51% (95% CI 41.2 - 60.8%), respectively. The cumulative mortality rate at five and seven years was 36% and 54%, respectively. Secondary sac rupture occurred in 9.4% (11/117) with a rate of 2/100 person years. Aneurysm related mortality was 12% (14/117) with a rate of 2.5/100 person years. The median survival was four years (IQR 3, 5.6 years). Thirty day mortality for acute OSC was 67% (n= 3) and 17.1% (6/35) for elective OSC. Long term follow up showed an increased failure rate. Diligent surveillance after endovascular AAA treatment is mandatory, especially when promising new devices are put into clinical use.