Medical Devices: Evidence and Research (Feb 2019)
The Nellix endovascular aneurysm sealing system: current perspectives
Abstract
Xin Y Choo,1 Shahab Hajibandeh,1 Shahin Hajibandeh,1 George A Antoniou1,2 1Department of Vascular and Endovascular Surgery, The Royal Oldham Hospital, Pennine Acute Hospitals NHS Trust, Manchester, UK; 2Division of Cardiovascular Sciences, School of Medical Sciences, University of Manchester, Manchester, UK Background: The Nellix endovascular aneurysm sealing (EVAS) system is a novel approach for the treatment of abdominal aortic aneurysm (AAA). We aimed to evaluate the efficacy of EVAS in the management of patients with AAA. Materials and methods: We searched PubMed/MEDLINE, CINAHL, and bibliographic reference lists to identify studies reporting clinical outcomes in patients with asymptomatic, non-ruptured AAA treated with EVAS with the Nellix device. We pooled dichotomous outcome data using random-effects models. Results: We identified 14 single-arm observational studies, reporting a total of 1,510 patients. The pooled estimate of technical success was 99% (95% CI =98–100; heterogeneity: P=0.869, I2=0%). Adjunctive procedures were carried out in 39% (95% CI =19–63; heterogeneity: P<0.0001, I2=88%). Two cases of aneurysm rupture were reported within 30 days of treatment (0.7%, 95% CI =0.3–1.6; heterogeneity: P=0.923, I2=0%) and another five cases of rupture occurred during follow-up (0.8%, 95% CI =0.4–1.6; heterogeneity: P=0.958, I2=0%). The pooled estimates of early (within 30 days) and late (during follow-up) type I endoleak were 2.8 % (95% CI =1.8–4.2; heterogeneity: P=0.254, I2=18%) and 1.9% (95% CI =1.3–2.8; heterogeneity: P=0.887, I2=0%), respectively. Sac enlargement was noted in 3.1% (95% CI =1.8–5.4; heterogeneity: P=0.419, I2=0%) and device migration in 2.1% (95% CI =0.8–5.3; heterogeneity: P=0.004, I2=65%). The early and late reintervention rates were 2.7% (95% CI =1.7–4.2; heterogeneity: P=0.183, I2=27%) and 3.5% (95% CI =2.3–5.5; heterogeneity: P=0.061, I2=42%), respectively. The pooled estimate of 30-day mortality was 1.5% (95% CI =0.9–2.6; heterogeneity: P=0.559, I2=0%) and the pooled estimate of aneurysm-related death during follow-up was 1.0% (95% CI =0.6–1.9; heterogeneity: P=0.872, I2=0%). Conclusion: Reported outcomes of EVAS are acceptable. Type I endoleak, sac enlargement, device migration, and aneurysm rupture are recognized complications. High-level research is required to investigate potential advantages of EVAS over conventional treatments. Keywords: endovascular aneurysm sealing, Nellix, aortic aneurysm, EVAS, AAA, endovascular aneurysm repair, EVAR
