Ralf R. Kolvenbach. Verbund Katholischer Kliniken Gefäßzentrum Augusta Krankenhaus Düsseldorf

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1 Ralf R. Kolvenbach Verbund Katholischer Kliniken Gefäßzentrum Augusta Krankenhaus Düsseldorf

2 Endograft migration Stent no longer above renal artery 15 mm migration 6 Mos

3 Do we really need any adjuncts to EVAR and TEVAR?

4 » Rates of 2nd interventions in EVAR are high and not improving adequately Average re-intervention rate of 3.7%/yr from recent registry data 1 IDE trial data demonstrate average rate of 4.1%/yr 2» 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 expensive 1,6 + 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 survival 1 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 ( ) 3, 6.2 (2.9-13) 4, 4.3 ( ) 4, Neck angulation > ( ) 5, * 1. Nordon IM et al. Eur J Vasc Endovasc Surg 2010;39(5): Lifeline Registry data report. J Vasc Surg 2005;42(1): Leurs LJ et al. J Endovasc Ther 2006;13(5): Aburahma AF et al. J Vasc Surg 2009;50(4): Sternbergh WC et al. J Vasc Surg 2002;35(3): Dias NV et al. Eur J Vasc Endovasc Surg 2009;37(4):

5 Hostile Necks Continue to Challenge Durability Meta-Analysis of 7 major studies in EVAR by Antoniou et al 1 comparing outcomes in hostile vs. friendly neck anatomies Study Sample Size Major Grafts Torsello et al, Endurant AbuRahma et al, AneuRx, Excluder, Zenith, Talent Hoshina et al, Excluder, Zenith Abbruzzese et al, AneuRx, Excluder, Zenith Choke et al, Talent, Zenith, Excluder, AneuRx Fulton et al, AneuRx Fairman et al, Talent Total sample size: N=1559 patients 1 Antoniou GA et al. J Vasc Surg. 2013;57(2):

6 Hostile Necks Continue to Challenge Durability Major findings:» 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) Antoniou GA et al. J Vasc Surg. 2013;57(2):

7 Neck Dilatation: A Cause for 2 nd Intervention Multiple recent studies confirm neck dilatation in EVAR remains REAL Author Follow- Up Grafts studied Proximal Neck Dilatation Rate Outcomes in dilated necks Oberhuber et al mos average Zenith (N=29), Talent (N=35), Excluder (N=39) 22% (defined as >2mm diam increase) 31% re-interventions Pintoux et al mos average Talent (N=33), Aneurx (N=25) 24% (defined as >3mm diam increase) 5% late type Ia endoleak 16% migration Bastos Gonçalves et al. 3 5 yrs median Excluder (N=144) 37% overall, 66% in pts >7 yrs f/u (defined as >2mm diam increase) Increased odds of migration ( 5mm) 5.5x 1 Oberhuber A et al. J Vasc Surg 2012 April;55(4): Pintoux D et al. Ann Vasc Surg Nov;25(8): Bastos Goncalves F et al. J Vasc Surg Oct;56(4):

8 Strategies for Treating Type I Endoleaks Current solutions do not offer consistent effectiveness Palmaz effectiveness is limited Byrne et al reported: Persistent type Ia endoleak in 8.6% (14/162) pts at the end of primary procedure 1 Can preclude future re-interventions, e.g. FEVAR, EndoAnchors Mixed results with Cuffs Jim J et al. reported: 12% (18/151) re-developed Type I/III Endoleaks at 43 mos average f/u post Zenith Renu placement 2 Limitations with Coils and Onyx Require precise ID of leak paths: non-target embolization risk 3 Time consuming 4 Onyx could create CT artifacts precluding identification of endoleaks in F/U 4 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 8 1 Byrne J et al. Ann Vasc Surg May;27(4): Jim J et al. J Vasc Surg Aug;54(2): Peynircioğlu B et al. Diagn Interv Radiol Jun;14(2): Chun JY et al. Eur J Vasc Endovasc Surg Feb;45(2):141-4.

9 BRINGING THE STABILITY OF SURGICAL ANASTOMOSIS TO EVAR Surgical Anastomosis EndoAnchoring Case images courtesy of John Aruny MD, Bart Edward Muhs, MD, PhD and and Burkhart Zipfel, MD. 9

10 Displacement force in Newtons Enhanced endograft fixation EndoAnchoring Talent Endurant Excluder Zenith Mean Hand Sewn No EndoAnchors With EndoAnchors

11 Prevent late term seal complications in primary setting Treat seal complications & prevent recurrence in revision setting Mitigate reinterventions, expand candidates for EVAR Reduce follow-up by preventing type I leaks and sac growth Replicate surgical anastomosis, arrest neck dilatation 11

12 Feasibility in replicating surgical anastomosis and arresting neck dilatation Melas et al J Vasc Surg. 2012;55(6): Gomero-Cure et al J Vasc Surg. 2012;55:1S Experience in Primary EVAR Perdikides et al J Endovasc Ther. 2012;19. Experience in EVAR Revision Hogendoorn W et al. Ann Vasc Surg 2013; doi: /j.avsg Avci et al J Cardiovasc Surg. 2012; 53: de Vries et al J Vasc Surg. 2011;54: TEVAR experience Kasprzak et al. J Endovasc Ther Aug;20(4). 12

13 » 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: Medtronic Endurant Gore Excluder Cook Zenith 13

14 Heli-FX for Managing Late Seal Complications 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 registry 1 Demonstrated safety in >2,000 pts treated In >10,000 implanted EndoAnchors to-date, no reported late Anchor Dislocations, Fractures, Graft Damage or Fistula 2 400MM cycles fatigue testing 2 No damage post 400M cycles, equivalent to 10 years in vivo Images courtesy of Aptus Endosystems, Inc Based on article: ANCHOR registry demonstrates safety and technical success of utilizing endoanchors in primary and revision EVAR Vascular News 11 Oct Based on commercial and study data on file at Aptus

15 Registry Design Treatment Arms Duration Follow-up Prospective, observational, international, multi-center, dual-arm Registry Primary Up to 1000 pts, Prophylactic Revision Up to 1000 pts, Therapeutic 5 Years Per Standard of Care at each center & discretion of Investigator Over 350 Patients enrolled as of Feb

16 Current Use of EndoAnchors Treatment of Acute or Remote Type I endoleaks Prophylactic (Application of EndoAnchors without evidence of endoleak) ANCHOR REGISTRY PRIMARY ARM REVISION ARM PROPHYLACTIC USE INTRA-OP TYPE IA ENDOLEAKS (61.3%) (38.7%)

17 3 mm Cross Bar 1.0 mm 3.5 mm Images courtesy of Aptus Endosystems, Inc. 17

18 Aptus Heli-FX Thoracic EndoAnchor System 18Fr OD, 90cm working length Aptus Heli-FX EndoAnchor System Images courtesy of National Institute of Health and Aptus Endosystems, Inc. 16Fr OD, 62cm working length 18

19 EndoAnchor Deployment Animation 19

20 EndoAnchors: Which Patients Can Benefit? PROPHYLAXIS TREATMENT Hostile Anatomy Overcoming concerns for implant stability Normal Anatomy Mitigating risk of reinterventions Resolve proximal seal failures Challenging neck anatomies (e.g. wide, short, conical, angulated) Difficult landing (e.g. birdbeaking, close to branched vessels) Severe comorbidities that preclude safe reintervention Patients potentially lost during F/U Long remaining life expectancy (young pts) Acute type I endoleaks during primary procedure Late-term type I endoleaks Augmenting stability in migrated grafts 20

21 Case Example EndoAnchors in Primary EVAR 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 Ia Endoleak Using EndoAnchors, Endovascular Today, March

22 Case Example EndoAnchors in EVAR Revision 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:

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29 Type I Leak - Endostaples

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33 J.P.P.M. de Vries 1 W.D. Jordan Jr. 2 ANCHOR registry collaborators 1 Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein 2 Department of Vascular Surgery and Endovascular Therapy, University of Alabama at English version of Verbesserte Fixierung von abdominalen und thorakalen Endografts unter Verwendung von EndoAnchors zur Vermeidung von Abdichtungsproblemen Gefässchirurgie : DOI /s y Springer-Verlag Berlin Heidelberg 2014 Birmingham, Birmingham Improved fixation of abdominal and thoracic endografts with use of EndoAnchors to over come 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 localized 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

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38 Conclusions» 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 38

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