Three-Year Results of the Nellix Endovascular Aneurysm Sealing System for Treatment of Abdominal Aortic Aneurysms in Frail Patients with Poor Anatomical Features

• Published in: Scandinavian journal of surgery Vol. 110; no. 2; pp. 233 - 240
• Main Authors: Sonetto, A., Laukontaus, S., Vikatmaa, L., Aho, P., Venermo, M.
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01-06-2021
• Subjects: Aged; Aortic Aneurysm, Abdominal - surgery; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Frail Elderly; Humans; Prosthesis Design; Retrospective Studies; Stents; Time Factors; Treatment Outcome; endoleak; Endovascular aneurysm repair; endovascular aneurysm sealing; abdominal aortic aneurysm; unfit for surgery; aneurysm rupture
• ISSN: 1457-4969; 1799-7267
• DOI: 10.1177/1457496920917267

Introduction:
Endovascular aneurysm sealing represents an alternative to advanced technology devices for compromised patients with abdominal aortic aneurysms. We report our results of 15 fragile patients with very low-quality infrarenal necks treated with endovascular aneurysm sealing.
Material and methods:
All patients treated with Nellix device in our hospital between June 2015 and October 2016 were retrospectively reviewed. The primary endpoints are the following: overall survival and freedom from reintervention rates. The secondary endpoints are the following: technical success; 30-day mortality; abdominal aortic aneurysm–related mortality; and freedom from endoleak rate, complications, and surgical conversion rate.
Results:
Nellix was used in 15 patients, median age 75.5 years, of which 67% were unfit for open surgery. Mean aneurysm diameter was 60 mm. One-third (5/15) of the patients were inside the Nellix instructions for use. Technical success rate was 93.3%. No perioperative complications existed, and 30-day mortality was 0%. Median follow-up was 35 (interquartile range: 11–37) months. Survival rates at 1 and 3 years were 80% and 59.3%. Abdominal aortic aneurysm–related mortality occurred in 3 of 15 cases. Freedom from rupture rates at 1 and 3 years were 92.9% and 66%. Freedom from endoleak rates at 1 and 3 years were 92.9% and 74.5%. Freedom from reintervention rates at 1 and 3 years were 86.7% and 70.6%, with a dramatic drop to 37.1% at 4 years of follow-up. Three open surgery conversions were needed. There were no statistically significant differences in results between patients treated inside and outside instructions for use.
Conclusion:
The endovascular aneurysm sealing has shown encouraging short-term results, but its safety and effectiveness during time is questionable, because this system still carries high rates of reintervention, conversions for type IA endoleaks, and secondary aneurysm ruptures.