PMID- 37951384
OWN - NLM
STAT- Publisher
LR  - 20240111
IS  - 1532-2165 (Electronic)
IS  - 1078-5884 (Linking)
DP  - 2023 Nov 10
TI  - A Single Centre Long Term Follow Up of the Nellix Endovascular Aneurysm Sealing 
      System.
LID - S1078-5884(23)00897-3 [pii]
LID - 10.1016/j.ejvs.2023.11.010 [doi]
AB  - OBJECTIVE: To evaluate the clinical performance at long term follow up of 
      endovascular aneurysm sealing (EVAS, Endologix Inc. Nellix, Irvine, CA, USA) in 
      the treatment of abdominal aortic aneurysm (AAA). 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. The 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 rate 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.
CI  - Copyright (c) 2023 European Society for Vascular Surgery. Published by Elsevier 
      B.V. All rights reserved.
FAU - Mathisen, Sven R
AU  - Mathisen SR
AD  - Department of Vascular Surgery, Innlandet Hospital Trust, Hamar, Norway. 
      Electronic address: svenross@gmail.com.
FAU - Berge, Simen T
AU  - Berge ST
AD  - Department of Vascular Surgery, Innlandet Hospital Trust, Hamar, Norway; Faculty 
      of Medicine, University of Oslo, Oslo, Norway.
LA  - eng
PT  - Journal Article
DEP - 20231110
PL  - England
TA  - Eur J Vasc Endovasc Surg
JT  - European journal of vascular and endovascular surgery : the official journal of 
      the European Society for Vascular Surgery
JID - 9512728
SB  - IM
OTO - NOTNLM
OT  - AAA
OT  - EVAR
OT  - EVAS
OT  - Endoleaks
OT  - Open surgical conversion
OT  - Secondary interventions
EDAT- 2023/11/12 00:41
MHDA- 2023/11/12 00:41
CRDT- 2023/11/11 19:16
PHST- 2023/03/31 00:00 [received]
PHST- 2023/10/20 00:00 [revised]
PHST- 2023/11/08 00:00 [accepted]
PHST- 2023/11/12 00:41 [pubmed]
PHST- 2023/11/12 00:41 [medline]
PHST- 2023/11/11 19:16 [entrez]
AID - S1078-5884(23)00897-3 [pii]
AID - 10.1016/j.ejvs.2023.11.010 [doi]
PST - aheadofprint
SO  - Eur J Vasc Endovasc Surg. 2023 Nov 10:S1078-5884(23)00897-3. doi: 
      10.1016/j.ejvs.2023.11.010.