is there a role for use of endoanchors in evar and tevar...
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Is There a Role for Use of EndoAnchors in EVAR and TEVAR
Procedures?
Apostolos K. TassiopoulosProfessor and Chief
Division of Vascular and Endovascular SurgeryStony Brook Medicine
Disclosures
• Consultant for Medtronic, Bolton, Endologix, Terumo
With EVAR, predictors for
rupture (endoleaks and
migration) increase with time
DREAMDe Bruin et al. NEJM 2010
EVAR-1Greenhalgh et al. NEJM 2010
ACEBecquemin et al. JVS 2011
In ACE, 16% re-interventions
in EVAR vs. 2.4% for open
repair at 3 yr median f/u
Late ruptures in EVAR, none in
open surgery
Large prospective trials highlight need for lifelong surveillance in EVAR
Hostile proximal neck predicts challenges
1 Antoniou GA et al. JVS. 2013;57(2):527-38.
Type I endoleaks 4.5x more likely at 1-year after endograftimplantation in hostile proximal aortic neck anatomy (P = .010)
Aneurysm-related mortality risk 9x greater in hostile neck anatomy at 1-year (P= .013)
Meta-Analysis of 7 major studies in EVAR by Antoniou et al1 compared outcomes in hostile vs. friendly neck anatomies (total patients N = 1559)
Study Sample Size Endografts
Torsello et al, 2011 177 Endurant
AbuRahma et al, 2010 238 AneuRx, Excluder, Zenith, Talent
Hoshina et al, 2010 129 Excluder, Zenith
Abbruzzese et al, 2008 565 AneuRx, Excluder, Zenith
Choke et al, 2006 147 Talent, Zenith, Excluder, AneuRx
Fulton et al, 2006 84 AneuRx
Fairman et al, 2004 219 Talent
Outcome N Hostile Neck Favorable Neck Odds Ratio
(95% CI)P
30-Day: All Studies
Primary Technical Success
61036
(96.8%)3497 (98.3%) 0.45 (0.19, 1.06) 0.07
Intraoperative Adjuncts 5 991 (15.4%) 3199 (8.8%) 1.88 (1.15, 3.07) 0.01
Stent-graft Migration 4 1245 (1.6%) 4225 (0.9%) 2.08 (1.20, 3.62) 0.009
All Studies
Early Type I 8 1290 (6.5%) 3849 (4.0%) 2.92 (1.61, 5.30) 0.0004
Early Type II 3 867 (8.5%) 3106 (10.8%) 0.74 (0.56, 0.97) 0.03
Late Type I 8 2454 (7.1%) 7719 (3.8%) 1.71 (1.31, 2.23) <0.0001
Late Type II 6 1292 (9.1%) 3617 (10.5%)0.74 (0.55,
0.99)0.05
Hostile proximal neck predicts procedural challenges
Stather et al. JEVT. 2013;20:623–637
Total sample size: N=11,959 patients
Meta-analysis by Stather et al. of 16 major studies confirms higher risks in hostile necks
More than 1 hostile neck parameter
substantially increases mortality,
major adverse events, intra-op
endoleaks and adjunctive
procedures
Influence of multiple hostile neck parameters
Speziale et al, Annals VS. 2014
Neck Hostility
Intra-op
Adjunctive
Procedures
Intra-op
Endoleaks
All Cause
Mortality
On Label 9.9% 0.5% 1.1%
2 Hostile Neck Parameters
26.7% 6.7% 13.3%
>2 Hostile Neck Parameters
50% 16.7% 16.7%
The risk of proximal seal complications increases as the number of hostile neck parameters increases
Cross Bar
3 mm
1.0 mm
3.5 mm
HeliFX EndoAnchor And Delivery System
EndoAnchoring
0
50
100
150
Talent Endurant Excluder Zenith Mean Hand Sewn
No EndoAnchors With EndoAnchors
Dis
pla
cem
en
t fo
rce
in N
ew
ton
s
Enhanced endograft fixation
Current Use of EndoAnchorsTreatment of Acute or Remote Type I endoleaksProphylactic (Application of EndoAnchors without evidence of endoleak)
ANCHOR REGISTRY
PRIMARY ARM
REVISION ARM
PROPHYLACTIC USE
(61.3%)
INTRA-OP TYPE IA ENDOLEAKS
(38.7%)
ANCHOR Registry* Primary arm represents 74% of pts
*Data cut Aug 10, 2015
ANCHOR REGISTRY593 Subjects
(74.9% US/25.1% OUS)
PRIMARY ARM
439
REVISION ARM
154
593
Stent Grafts - Primary Arm
Medtronic Endurant™Gore Excluder™Cook Zenith™
Jotec™
Stent Grafts - Revision Arm
Metronic Endurant™Medtronic Talent™Medtronic AneuRx™Gore Excluder™
86 year old female 11 years s/p EVAR with AneuRx
Endograft Revision for Remote Type IA Endoleak
Stabilization of AneuRx with EndoAnchors and Proximal extension
Stabilization of AneuRx with Aptus and Proximal extension
Repair of Remote Type IA endoleak1-month post repair
81 year old male with a juxtarenal 5.7cm AAA
Type IA EndoleakDid not correct with repeat ballooning
Anchors placed below renal stents bilaterally
1 year post op
Small Type 2 Endoleak
Resolved Type IA Endoleak
USE ENDOANCHOR™ IMPLANTS PROPHYLACTICALLY TO…
Prevent/Mitigate Risk for Type Ia Endoleaks
Improve the Durability of EVAR for “Hostile” AAA Necks
Thrombus and CalciumShort, Wide, Angled, Conical
Prophylactic Subjects
Baseline characteristics & aneurysm measurements*
* Mean Core Lab measurements based on 205 pts with baseline CTs
Infrarenal Diameter:
25.7 mm
Infrarenal
Angulation: 35°
Neck Length:
16.6 mm
Aneurysm
Diameter:
55.5 mm
Conical Neck
(>10%/10mm):
41.0%
Avg Neck Calcium
Thickness: 1.1 mm
Mean Age: 74.4 Years
Male: 78%
Female: 22%
HOSTILE NECKS: 77.6%
Diameter at renals >28mm
Proximal Neck Length <10mm
Neck Angulation >60°
Conical (>10%/10mm)
Thrombus/Calcium >2mm OR
Thrombus/Calcium >1mm / 180°
Anchor Registry Prophylactic Subjects
Adverse Events Mean follow-up 21.3 months | N=269
Patients with Events
Procedure-Related SAE 17 6.3%
Endograft-Related SAE 1 0.4%
EndoAnchor-Related SAE 0 0.0%
Aneurysm-Related SAE 9 3.3%
All-Cause Mortality 13 4.8%
Technical Success: 94.8%Procedureal Success: 92.2%
Anchor Registry Prophylactic Subjects
Proximal Endoleaks and MigrationMean follow-up 8.2 months
1.7%(3/177)
Type Ia Endoleaks
0.0%(0/112)
Endograft Migration (>10mm)
Migration was assessed in comparison to the 1-month CT scan
72 yo male with severe COPD and a rapidly enlarging AAA
EVAR with EndoAnchors in proximal neck
1 year post op CTANo evidence of endoleak
59 year old female with distal descending TAA and tapered distal landing zone
59 year old female with distal descending TAA and tapered distal landing zone
Completion arteriogram
Postoperative CTA
• 1-year post-op CTA– No proximal migration– No Type IB endoleak– Endoanchors secured in
the aortic wall– No significant distal neck
dilatation
Postoperative CTA
Aortic Neck Dilation After EVAR Has Been Described And Calculated To Be Approximately 20% At 2-years When
Compared To The Pre-implantation Diameter
NECK DILATATION STYDY IN ANCHOR REGISTRY
• Assessment of proximal neck enlargement in patients undergoing EVAR with EndoAnchors
• 267 prospectively enrolled patients undergoing EVAR with HeliFX EndoAnchor
• 39 investigational sites
Aortic diameter measured by independent core lab at:Suprarenal level (20mm proximal to lowest main renal artery)Three (3) levels within proximal neck (distal to lowest main renal artery)
0mm5mm10mm
Age (years)
Weight (kg)
Height (cm)
BMI
Number EndoAnchors
Baseline AAA Diameter (mm)
Suprarenal aortic diameter (mm)
Aortic Diameter at Renals
Proximal Neck Length
Visual Neck Length
Suprarenal Angulation
Infrarenal Angulation
Infrarenal Angulation to Bifurcation
Neck Thrombus Average Thickness
Neck Thrombus Circumference
Neck Calcium Average Thickness
Neck Calcium Circumference
Neck Tortuosity Index
Oversizing
SR Change
Level 0 Change
Level 5 Change
Level 10 Change
*Variables with multicollinearity defined by r > 0.7 were excluded from the regression analysis
Variables Tested
Results
• Perioperative Diameter Change• Using a 3mm threshold, aortic neck enlargement (ADAPTIVE
ENLARGEMENT) occurred in 5.3%, 12.5% and 14.6% of patients at the three infrarenal levels respectively, and in 1.8% of patients at the SR level
• Postoperative Diameter Change• Using a 3mm threshold, aortic neck enlargement
(DILATATION) occurred in 3.1%, 7.7% and 4.6% of patients at the three infrarenal levels respectively, and in 1.5% of patients at the SR level
Predictors Of Aortic Neck Dilation Between The 1-month Post-operative And 12-month CT
Aortic Level Predictors of Dilatation at Specified Level Coefficient* Effect P Value
Lowest renalEndograft type 0.563 * .006
Aortic aneurysm sac diameter -0.038 Protective .020
Aortic diameter at lowest renal 0.162 Risk factor <.001
Aortic neck length -0.022 Protective .021
Infrarenal Angulation 0.022 Risk factor .016
Endograft oversizing 5.280 Risk factor .001
5mm distally Aortic diameter at lowest renal 0.157 Risk factor .001
Endograft oversizing 5.627 Risk factor .001
Female gender 0.90 Risk factor .016
10mm distally Aortic diameter at lowest renal 0.179 Risk factor .003
Endograft oversizing 5.073 Risk factor .032
Number of EndoAnchors placed -0.266 Protective .037
Suprarenal level Suprarenal aortic diameter 0.085 Risk factor .021
• EndoAnchors are a useful adjunct in the treatment of select patients with acute and remote Type IA endoleaks
• They can provide increased fixation and improved seal in EVAR and TEVAR patients with hostile neck anatomy
• Their application is safe, not significantly time consuming, and does not interfere with other techniques aiming to treat seal zone complications
• Whether their prophylactic use is beneficial or cost effective remains to be proven
Summary
THANK YOU