is there a role for use of endoanchors in evar and tevar...

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

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


Female gender 0.90 Risk factor .016

10mm distally Aortic diameter at lowest renal 0.179 Risk factor .003


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

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