We have located links that may give you full text access.
A Single Centre Long Term Follow Up of the Nellix Endovascular Aneurysm Sealing System.
European Journal of Vascular and Endovascular Surgery 2023 November 10
OBJECTIVE: To evaluate the clinical performance of endovascular aneurysm sealing (EVAS, Endologix Inc. Nellix, Irvine, CA, USA) in treatment of abdominal aortic aneurysm (AAA) at long term follow up.
METHODS: 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.
RESULTS: 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. 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 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.
CONCLUSION: 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.
METHODS: 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.
RESULTS: 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. 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 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.
CONCLUSION: 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.
Full text links
Related Resources
Trending Papers
Review article: Recent advances in ascites and acute kidney injury management in cirrhosis.Alimentary Pharmacology & Therapeutics 2024 March 26
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app