Ralf R. Kolvenbach

Verbund Katholischer KlinikenGefäßzentrum Augusta Krankenhaus Düsseldorf

6 Mos

15 mm

migration

Endograft migration

Stent no longer above renal artery

Do we really needany adjuncts to EVAR and TEVAR ?

» Rates of 2nd interventions in EVAR are high and not improving

adequately

• Average re-intervention rate of 3.7%/yr from recent registry data1 IDE trial data demonstrate average rate of 4.1%/yr2

» Complicated anatomy results in more Type I endoleaks &

higher re-intervention risk

• Short neck length (<15mm)3,4

• Neck angulation (>40º)5

• More complicated patients are being treated as EVAR devices improve

» There is acceptance that current standard follow-up imaging…

+ Carries risk (radiation, contrast media)1,6

+ Is expensive1,6

+ Confers suboptimal benefit (<10% of re-interventions are triggered by routine follow-up imaging findings)6

No other solutions exist for ‘radial fixation’ to break the cycle of this dilating disease

Re-intervention-free survival1

1 yr 89.9%

2 yr 86.9%

5 yr 81.5%

Increased odds of type I endoleak and need for re-intervention

Risk Factor OR (95% CI)

Neck Length < 15 mm

2.2 (1.4-3.5)3,†

6.2 (2.9-13)4,†

4.3 (2.1-8.7)4,‡

Neck angulation > 40° 5.9 (1.3-27.6)5,*

1. Nordon IM et al. Eur J Vasc Endovasc Surg 2010;39(5):547-54

2. Lifeline Registry data report. J Vasc Surg 2005;42(1):1-10

3. Leurs LJ et al. J Endovasc Ther 2006;13(5):640-8

4. Aburahma AF et al. J Vasc Surg 2009;50(4):738-48

5. Sternbergh WC et al. J Vasc Surg 2002;35(3):482-6

6. Dias NV et al. Eur J Vasc Endovasc Surg 2009;37(4):425-30

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Study Sample Size Major Grafts

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

Meta-Analysis of 7 major studies in EVAR by Antoniou et al1

comparing outcomes in hostile vs. friendly neck anatomies

1Antoniou GA et al. J Vasc Surg. 2013;57(2):527-38.

Total sample size: N=1559 patients

Hostile Necks Continue to Challenge Durability

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» Adjunctive procedures more frequent in challenging proximal necks

» Type I endoleaks 4.5x more likely at 1-year after endograft implantation in hostile proximal aortic neck anatomy (P = .010)

» Aneurysm-related mortality risk 9x greater in hostile neck anatomy (P= .013)

Major findings:

Antoniou GA et al. J Vasc Surg. 2013;57(2):527-38.

Hostile Necks Continue to Challenge Durability

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Author Follow-Up

Grafts studied Proximal Neck Dilatation Rate

Outcomes in dilated necks

Oberhuberet al.1

39 mosaverage

Zenith (N=29), Talent (N=35), Excluder (N=39)

22% (defined as >2mm diamincrease)

31% re-interventions

Pintoux etal.2

57 mosaverage

Talent (N=33), Aneurx(N=25)

24%(defined as >3mm diamincrease)

5% late type Iaendoleak16% migration

BastosGonçalveset al.3

5 yrsmedian

Excluder (N=144) 37% overall,66% in pts >7 yrs f/u (defined as >2mm diamincrease)

Increased odds of migration (≥5mm) 5.5x

1Oberhuber A et al. J Vasc Surg 2012 April;55(4): 929-342Pintoux D et al. Ann Vasc Surg. 2011 Nov;25(8):1012-93Bastos Goncalves F et al. J Vasc Surg. 2012 Oct;56(4):920-8

Multiple recent studies confirm neck dilatation in EVAR remains REAL

Neck Dilatation: A Cause for 2nd Intervention

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1Byrne J et al. Ann Vasc Surg. 2013 May;27(4):401-11.2Jim J et al. J Vasc Surg. 2011 Aug;54(2):307-315.

3Peynircioğlu B et al. Diagn Interv Radiol. 2008 Jun;14(2):111-5.4Chun JY et al. Eur J Vasc Endovasc Surg. 2013 Feb;45(2):141-4.

• Byrne et al reported:

• Persistent type Ia endoleak in 8.6% (14/162) pts at the end of primary procedure1

• Can preclude future re-interventions, e.g. FEVAR, EndoAnchors

Palmazeffectiveness

is limited

• Jim J et al. reported:

• 12% (18/151) re-developed Type I/III Endoleaks at 43 mos average f/u post Zenith Renu placement2

Mixed results with Cuffs

• Require precise ID of leak paths: non-target embolization risk3

• Time consuming4

• Onyx could create CT artifacts precluding identification of endoleaks in F/U4

Limitations with Coils and

Onyx

• None of these resist further neck dilatation

• Frequently multiple devices needed, adding time & cost

• Palmaz, coils, Onyx not indicated for Tx of Type I Endoleak

Current solutions do not offer consistent effectiveness

Strategies for Treating Type I Endoleaks

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EndoAnchoringSurgical Anastomosis

Case images courtesy of John Aruny MD, Bart Edward Muhs, MD, PhD and and Burkhart Zipfel, MD.

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BRINGING THE STABILITY OF SURGICAL ANASTOMOSIS TO EVAR

Enhanced endograft fixation

Dis

pla

cem

ent

forc

ein

Ne

wto

ns EndoAnchoring

150

100

50

0

Talent Endurant Excluder Zenith Mean Hand Sewn

No EndoAnchors With EndoAnchors

Replicate surgical anastomosis, arrest neck dilatation

Prevent late term seal complications in primary setting

Treat seal complications & prevent recurrence in revision setting

Mitigate reinterventions, expandcandidates for EVAR

Reduce follow-up by preventingtype I leaks and sac growth

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• Melas et al J Vasc Surg. 2012;55(6):1726-1733

• Gomero-Cure et al J Vasc Surg. 2012;55:1S

Feasibility in

replicating surgical anastomosis and arresting

neck dilatation

• Perdikides et al J Endovasc Ther. 2012;19.Experience in

Primary EVAR

• Hogendoorn W et al. Ann Vasc Surg 2013; doi: 10.1016/j.avsg.2013.07.028

• Avci et al J Cardiovasc Surg. 2012; 53:419-26.

• de Vries et al J Vasc Surg. 2011;54:1792-1794.

Experience in

EVAR Revision

• Kasprzak et al. J Endovasc Ther. 2013 Aug;20(4).TEVAR experience

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» The Heli-FX EndoAnchor System is intended to provide fixation and augment sealing between endovascular aortic grafts and the aorta

» The Heli-FX EndoAnchor System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications

» The Aptus EndoAnchor and Heli-FX have been evaluated and determined to be compatible with the following endografts:

Cook Zenith®Gore Excluder® Medtronic Endurant®

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No late Type 1 endoleak in 4-5 year f/u

˃ STAPLE-1 & 2 IDE study

High success in treating late Type I Endoleaks

˃ >90% success in revision cases per ANCHOR registry1

Demonstrated safety in >2,000 ptstreated

˃ In >10,000 implanted EndoAnchors to-date, no reported late Anchor Dislocations, Fractures, Graft Damage or Fistula2

˃ 400MM cycles fatigue testing2

Heli-FX™ for Managing Late Seal Complications

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1Based on article: ANCHOR registry demonstrates safety and technical success of utilizing endoanchors in primary and revision EVAR Vascular News 11 Oct 20132Based on commercial and study data on file at Aptus

No damage post 400M cycles, equivalent to 10 years in vivo

Images courtesy of Aptus Endosystems, Inc.

Over 350 Patients enrolled as of Feb 2014

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Registry DesignProspective, observational, international, multi-center, dual-arm Registry

Treatment Arms“Primary” – Up to 1000 pts, Prophylactic

“Revision” – Up to 1000 pts, Therapeutic

Duration 5 Years

Follow-up Per Standard of Care at each center & discretion of Investigator

Current Use of EndoAnchorsTreatment of Acute or Remote Type I endoleaks

Prophylactic (Applicationevidence of endoleak)

of EndoAnchors without

ARM ARM

ANCHOR REGISTRY

PRIMARY REVISION

PROPHYLACTIC INTRA-OP

USE TYPE IA ENDOLEAKS(61.3%) (38.7%)

Cross Bar

3 mm

1.0 mm

3.5 mm

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Images courtesy of Aptus Endosystems, Inc.

Aptus™ Heli-FX™ Thoracic EndoAnchor ™System

Aptus™ Heli-FX™EndoAnchor™ System

16Fr OD,62cm working length

18Fr OD,90cm working length

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Images courtesy of National Institute of Health and Aptus Endosystems, Inc.

EndoAnchor Deployment Animation

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TREATMENTPROPHYLAXIS

Hostile Anatomy

Overcoming concerns for implant stability

Challenging neck anatomies

(e.g. wide, short, conical, angulated)

Difficult landing

(e.g. birdbeaking, close to branched

vessels)

Normal Anatomy

Mitigating risk of re-interventions

Severe comorbidities that preclude safe re-

intervention

Patients potentially lost during F/U

Long remaining life expectancy (young

pts)

Resolve proximal seal failures

Acute type I endoleaks during primary

procedure

Late-term type I endoleaks

Augmenting stability in migrated grafts

EndoAnchors: Which Patients Can Benefit?

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• Short, reverse taper proximal neck• Intraoperative Type I post-implantation of Cook Zenith• 6 EndoAnchors implanted - Type I endoleak resolved

Image s from article: Gandi RT and Katzen BT, Treating a Type IaEndoleak Using EndoAnchors, Endovascular Today, March 2012

Case Example – EndoAnchors in Primary EVAR

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• 3 year F/U showed migrated Talent with type Ia endoleak• Endurant cuff and EndoAnchors implanted - endoleak resolved

Images from article: de Vries JP et al, Use of Endostaples to Secure Migrated Endografts and Proximal Cuffs after Failed Endovascular Abdominal Aortic Aneurysm Repair, J Vasc Surg 2011; 54:1792-4.

Case Example – EndoAnchors in EVAR Revision

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Type I Leak - Endostaples

J.P.P.M. de Vries1 · W.D. Jordan Jr.2 · ANCHOR registry collaborators1 Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein

2 Department of Vascular Surgery and Endovascular Therapy, University of Alabama at

Birmingham, Birmingham

English version of „Verbesserte Fixierungvon

abdominalen und thorakalen Endografts

unter Verwendung von EndoAnchors zur

Vermeidung von

Abdichtungsproblemen”

Gefässchirurgie 2014 · 19:212–219

DOI 10.1007/s00772-014-1309-y

© Springer-Verlag Berlin Heidelberg 2014

Improved fixation of abdominaland thoracic endografts withuse of EndoAnchors to overcome sealing issues

Fig. 17a Pre-operative

determination of localized

calcium or thrombus in

the clockface orientation

of the infrarenal neck. b

Optimal position of 6

EndoAnchors in a

proximal neck with lo-

calized thrombus. c

During implantation of

EndoAn- chors the C-arm

should al- ways be

perpendicular to the tip of

the Heli-FX en- doguide

Gefässchirurgie 3 · 2014 | 1

» Major EVAR studies highlight late durability limitations

˃ e.g. ‘EVAR 1,’ ‘ACE,’ ‘DREAM’

˃ Proximal seal stability remains key

» EndoAnchors designed to bring long-term stability of surgical anastomosis to EVAR

» High safety and efficacy

˃ Demonstrated safety profile

˃ High success in type I endoleak Tx per ANCHOR registry

˃ More definitive data for prevention in-process

Conclusions

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