Zenith Alpha Abdominale : Cas Cliniques et...
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Zenith Alpha Abdominale : Cas Cliniques et Expérience
J Sobocinski, R Azzaoui, S Haulon Aortic centre, CHU Lille, France
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EVAR – guidelines
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Disrespect of IFU’s 1st to 3rd generation devices =
Main cause of EVAR failure, with sac expansion
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EVAR - New devices = What for?
• To treat more patients with challenging
anatomies
• Would increase up to 60% patients eligible for
EVAR with LP stentgraftsKristmundsson T et al. Vascular 2014
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Outcomes with LP Stentgrafts
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Preoperative iliac morphology SP (107) LP(102)
SP LP p
Prox Ao neck length (mm, median, IQR) 33 [25-40] 33 [24-43] 0.971
Prox Ao neck thombus (median, IQR) 0 [0-1] 0 [0-1] 0.190
Prox Ao neck diam just below the lowest renal (mm, median,
IQR)23 [22-25] 24 [22-25] 0.273
Prox Ao neck diam 15mm below the lowest renal (mm,
median, IQR)25 [23-26] 24 [23-26] 0.788
Infrarenal neck shape inverted funnel 14.0% (15) 9.9% (10) 0.400(ɗ>+3mm)
regular 86.0% (92) 89.0% (88) 0.841 (-3mm>ɗ>+3mm)
funnel 0 2.0% (2) 0.235 (ɗ<-3mm)
maximal Ao diam (mm, median, IQR) 55 [52-59.3] 54 [50.8-59.5] 0.714
Aorto-iliac bifurcation diameter (mm, median, IQR) 23 [20-30] 26 [22-30] 0.554
tortuosity index ratio (median, IQR) Left 1.3 [1.2-1.4] 1.4 [1.2-1.5] 0.332
Right 1.3 [1.2-1.4] 1.3 [1.2-1.5] 0.341
Left 8 [7-9] 8 [6-9] 0.026
Right 8 [7-9] 8 [6-9] 0.046
External Iliac diameter <7mm of both iliac sides (left and
right)6.5% (7) 21.8% (22) 0.002
Iliac tortuosity ratio index>1.5 of both iliac sides (left and
right)8.4% (9) 11.9% (12) 0.492
Hostile external iliac arteries of both iliac sides (left and
right) 6.9% (7) 11.9% (12) 0.231
External Iliac diameter<7mm OR iliac tortuosity ratio
index>1.5 of both iliac sides (left and right) 15.8% (16) 30.8% (33) 0.003
External Iliac diameter<7mm OR hostile External Iliac of
both iliac sides (left and right) 8.4% (9) 21.8% (22) 0.011
Iliac tortuosity ratio index>1.5 OR hostile External Iliac of
both iliac sides (left and right) 15.0% (16) 23.8% (24) 0.116
External Iliac diameter<7mm OR iliac tortuosity ratio
index>1.5 OR hostile External Iliac of both iliac sides (left
and right) 16.8% (18) 30.8% (33) 0.026
Prox: Proximal; Ao: Aorta; diam: diameter; IQR: Interquartile range
Preoperative morphology
External Iliac artery diameter (median, IQR)
Aorta
Iliac
artery
More hostile preop iliac morphologies in LP group
Sobocinski J et al. JVS 2015
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Results
Follow-up / Reintervention
time (year) n.risk n.event survival 95% CI
SP group0 105 0 1 1 11 94 12 0.886 0.827 0.9492 91 5 0.838 0.771 0.9120 101 0 1 1 1
LP group 1 96 4 0.96 0.923 0.9992 89 6 0.899 0.842 0.96
LPSP
Log-rank p-value =.183
Sobocinski J et al. JVS 2015
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time (year) n.risk n.event survival 95% CI
SP group0 104 0 1 1 11 99 5 0.952 0.912 0.9942 94 5 0.904 0.849 0.9620 101 0 1 1 1
LP group 1 96 5 0.95 0.909 0.9942 92 4 0.911 0.857 0.968
Results
Follow-up / death
LPSP
Log-rank p-value=.861
Sobocinski J et al. JVS 2015
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Updated data in Lille, december 2016
• From jan 2012 to nov 2016:
480 EVAR
295 patients with either combination of LP+ZSLE or Alpha (ZIMB + ZISL)
Standard grafts with large aortic diameter(>32mm)
Aortic centre, CHU Lille data, dec 2016
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AAA - Case #1
Major aortic and iliac angulations
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AAA - Case #1
Excellent conformability
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AAA Case #2
Small & tortous access / major aortic angulation
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AAA Case #2
Excellent conformability
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AAA - Case #3
Tortous access
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AAA - Case #3
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AAA - Case #3
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AAA - Case #3
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AAA - Case #3
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AAA - Case #3
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AAA - Case #3
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Conclusion - Abdominal Alpha Stentgrafts
• Offer valuable alternatives for patients withbad anatomies (bad access++)
• Good outcomes in this subgroup of patients –towards modification of devices’ IFU?
• Easy-to-use devices
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Thank you