No Neck Is Needed! Treat the Aneurysm Instead! Andrew Holden, MD Associate Professor of Radiology Auckland City Hospital

No Neck Is Needed! Treat the Aneurysm Instead! Andrew Holden, MD Associate Professor of Radiology Auckland City Hospital

Disclosures Andrew Holden, MBChB, FRANZCR No financial investment to disclose Investigator and Medical Advisory Board Member for Endologix Inc.

Limitations of the Infra-renal Neck Conventional EVAR requires an adequate length of reasonably parallel neck for graft-wall apposition and seal Type 1A endoleaks and device migration (early and late) are the risks of treating short, conical or angulated necks

Treating hostile neck anatomy with conventional EVAR is associated with: Significant increase in late type 1 endoleaks Significant increase in re-interventions Ninefold increased risk of ARM within 1 year of treatment Stather et al, EJVES 2012:44:556-561 Antoniou et al, JVS 2013:57:527-538

Re-interventions after EVAR HN defined as neck diameter > 28 mm, neck angulation > 60, neck length < 15 mm, neck thrombus or neck flare 25% 20% 15% 10% 5% Favorable Neck (353 pts) Hostile Neck (199 pts) 9% 7% 5% 5% 6% 3% 10% 8% 10% 15% 12% 20% 0% 30d 1Y 2Y 3Y 4Y 5Y Antoniou et al, JVS 2013:57:527-538

Nellix EndoVascular Aneurysm Sealing System A radically different endovascular system for AAA repair

Nellix Endovascular System Aneurysm sac and proximal and distal landing zones are sealed This prevents aneurysm rupture and minimizes the risk of migration and endoleak This paradigm shift can impact on anatomical limitations of the infra-renal neck especially short and conical necks

Nellix Deployment Introduce both catheters over 0.035 guidewires Expand both stents Polymer Fill Cures in ~ 3-5 min

Post-procedural Surveillance

Conical Infra-renal Neck Conical neck is a real sweet spot for Nellix The compliant endobag seals the irregular blood lumen The secure fixation of aneurysm sac filling prevents migration Renders other strategies such as fenestrated or chimney EVAR, endostaples or open repair unnecessary

EVAS for Conical Neck Anatomy

EVAS for Conical Neck Anatomy

EVAS for Conical Neck Anatomy Pre-Fill

EVAS for Conical Neck Anatomy

Short Infra-renal Neck IFU for Nellix includes neck length 10mm Secure attachment of the endobag to the bottom of the top stent element means short and even no neck AAAs can be treated (top stent partially crossing renal arteries) Pre-fill of endobags improves confidence for treating short necked aneurysms

Pre-fill of Endobags Routinely done with saline +/- dilute contrast Allows accurate planning of polymer fill volume Some re-positioning of the Nellix devices is usually possible in pre-fill angiography unsatisfactory

5mm long neck EVAS for Short Neck Anatomy

EVAS for Short Neck Anatomy

EVAS for Short Neck Anatomy

EVAS for Short Neck Anatomy LAO 15 o, Cran 15 o LAO 15 o, Cran 15 o

Ba wa fill ex Juxta-renal AAA Chimney EVAS The compliant endobags promise to fill the space around chimney grafts better than conventional grafts Chimneys: Proof of concept Off-label proven configurations with bench testing Both balloon expandable and self expanding chimney stents successfully used Two experiments Ba ch po ex Jan D. Blankensteijn, Images Wouter courtesy Niepoth, Jan Blankensteijn, Kakkhee Amsterdam Yeung,

Chimney EVAS (Ch-EVAS) At least 30 Ch-EVAS have been performed All have been technically successful Most have been single vessel chimneys Mostly balloon expandable chimney grafts (Atrium V12)

Chimney EVAS (Ch-EVAS)

Nellix stent deployment and endobag pre-fill performed before renal stent deployment Minimizing renal ischaemic time

6 Months

Results of Nellix EVAS Over 850 cases completed worldwide since Feb 2013 (CE Mark) Low reported reintervention rate ~ 0.5% overall re-interventions for endoleaks ~ 1.5% overall re-interventions for occlusions, 3 in last 600 cases Retrospective study of the first 177 patients after CE mark in process publication expected in late 2014 Multiple registries now underway: 300 patients; 30 sites 180 patients; up to 30 sites Both studies include 5 year follow up

EVAS Forward Registry Update 134 patients enrolled as of May 21, 2014 First 75 patients results presented at CX 2014: 100% procedural technical success 68% of Pts. meet current IFU 66 (88%) infra-renal AAA; 2 (2.7%) CIIA 7 (9.3%) juxta-renal AAA 1 (1.3%) ruptured AAA 30-Day Outcomes No endoleaks 1 crural embolus, treated conservatively 1 asymptomatic limb occlusion Next Data Update July 2014 MM0682 Rev 2

Conclusion EVAS with Nellix changes the paradigm for treating AAAs Adverse neck anatomies can be successfully treated Experience is rapidly growing and encouraging data continues to be accumulated