The Nellix endovascular aneurysm sealing system: current perspectives.

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, I 2=0%). Adjunctive procedures were carried out in 39% (95% CI =19-63; heterogeneity: P<0.0001, I 2=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, I 2=0%) and another five cases of rupture occurred during follow-up (0.8%, 95% CI =0.4-1.6; heterogeneity: P=0.958, I 2=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, I 2=18%) and 1.9% (95% CI =1.3-2.8; heterogeneity: P=0.887, I 2=0%), respectively. Sac enlargement was noted in 3.1% (95% CI =1.8-5.4; heterogeneity: P=0.419, I 2=0%) and device migration in 2.1% (95% CI =0.8-5.3; heterogeneity: P=0.004, I 2=65%). The early and late reintervention rates were 2.7% (95% CI =1.7-4.2; heterogeneity: P=0.183, I 2=27%) and 3.5% (95% CI =2.3-5.5; heterogeneity: P=0.061, I 2=42%), respectively. The pooled estimate of 30-day mortality was 1.5% (95% CI =0.9-2.6; heterogeneity: P=0.559, I 2=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, I 2=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.