Scripties UMCG - Rijksuniversiteit Groningen
 
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Nellix within IFU : A multicenter, retrospective observational study to assess clinical outcomes of patients treated within the Instructions For Use of the Nellix EndoVascular Aneurysm Sealing System

(2017) Zoethout, A.C.

Introduction: Abdominal aortic aneurysms pose a considerable risk of sudden-death by aneurysm rupture and can be treated by Endovascular Aneurysm Repair (EVAR). However, the benefit of EVAR over open repair declines with time. The Nellix device is based on the novel concept of Endovascular Aneurysm Sealing (EVAS) and uses a dual polymer-filled endobag to obliterate the aneurysm sac. This is the first study to assess the outcome of EVAS used within the instructions for use (IFU 2013) and the revised instructions for use narrowing anatomical requirements (IFU 2016).
Methods: This is a 2-year, retrospective analysis of all patients who underwent a Nellix procedure in three high volume Dutch centers. Patients were included from the second quarter of 2013 to December 31st, 2015.
Results: Out of 355 patients, 168 were within IFU 2013 and 48 within IFU 2016. Median follow up time was 23 months. At 2 years, reintervention-free survival was 89.7% within IFU 2013 and 95.7% in IFU 2016. The survival and freedom from aneurysm-related mortality at 2-year follow-up was 90.9% and 97.6% in the IFU 2013 cohort and 95.5% and 95.0% within IFU 2016, respectively. Within IFU 2013 there were 5.4% endoleaks (IFU 2016 2.1%), 7.1% stenosis or occlusion (IFU 2016 4.2%), 7.1% migration (IFU 2016 0%) and 6.0% aneurysm growth (IFU 2016 4.2%) observed within 2-year follow-up. No significant differences in freedom from the above mentioned complications had been observed between the two IFUs.
Conclusion: The present study has shown that the EVAS device, when used within both IFU, demonstrates good 2-year results. No significant difference between the IFU were observed, however, longer follow-up is indicated.






 
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