Anatomy-Driven Endograft Selection for Abdominal Aortic Aneurysm Repair S. Jay Mathews, MD, MS, FACC

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1 Anatomy-Driven Endograft Selection for Abdominal Aortic Aneurysm Repair S. Jay Mathews, MD, MS, FACC Interventional Cardiologist/Endovascular Specialist Bradenton Cardiology Center Bradenton, FL, USA

2 Disclosures Speaker s Bureau: Astra Zeneca Abbott Vascular Volcano Corporation Spectranetics Maquet Reflow Medical Consultant: Penumbra Spectranetics Grant/Research Support: Spectranetics Bard Medtronic Veryan Medical Terumo Cordis Reflow Medical Medical/Scientific Boards: Boston Scientific Abbott Vascular

The Hostile Neck Increasing Number of Patients Presenting with Hostile Necks - Anything that Exists Outside of the IFU Severe Angulation Short

to Treat More Pathology Prevent Endoleaks that Lead to Delayed Rupture/AAA Growth (Type 1A/B, 3A) How Do We Get There?

3 The Hostile Neck Increasing Number of Patients Presenting with Hostile Necks - Anything that Exists Outside of the IFU Severe Angulation Short Neck Large Diameter Significant Neck Thrombus Early EVAR Systems Originally Designed for Fairly Straight Anatomies Need for Flexible Systems to Treat More Pathology Prevent Endoleaks that Lead to Delayed Rupture/AAA Growth (Type 1A/B, 3A) How Do We Get There? Flexible Grafts Proximal/Suprarenal Fixation Endoscrews/Endoanchors Snorkel/Chimney and FEVAR (Will Discuss Later) 9 CM Rupture with a 27 mm Straight Neck- The Unicorn

The Hostile Neck Open Repair is a More Durable Option, But Not All Patients are Candidates ACE Trial 16% Reintervention Rate vs. 2.4% for Open With Favorable Neck Anatomies (p<0.

4 The Hostile Neck Open Repair is a More Durable Option, But Not All Patients are Candidates ACE Trial 16% Reintervention Rate vs. 2.4% for Open With Favorable Neck Anatomies (p<0.0001) ACE Trial No Significant Mortality Difference in the Low to Moderate Risk Population No Delayed Rupture with Open Hostile Neck Associated with Worse EVAR Outcomes 4.5 x More Likely Type 1 Endoleak with EVAR (p = 0.01) 9x Increased Mortality Risk (p = 0.013) Becquemin JP et al. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg 2011;53(5): Antoniou GA et al. A meta-analysis of outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile and friendly neck anatomy. J Vasc Surg. 2013;57(2): Arko F. Current Treatment Options for Hostile Neck Anatomy.

5 Forces Are Not Caudal Multiple Forces Acting on Endograft Multiple Factors Affect Migration Pulsatile Blood Pressure Vessel Compliance Friction Between Graft and Aorta Friction at Fixation Points Columnar Strength Friction Due to Hooks/Barbs In this Model, Total Force Acting on Model is Sideways, Not Caudal Angulation Increases Lateral Force Straight Iliacs Reduce This Force Figueroa CA. Effect of Curvature on Displacement Forces Acting on Aortic Endografts: A 3-Dimensional Computational Analysis J Endovasc Ther Jun; 16(3):

Forces Are Not Caudal Multiple Forces Acting on Endograft Multiple Factors Affect Migration Pulsatile Blood Pressure Vessel Compliance Friction Between Graft and Aorta Friction at Fixation Points

6 Forces Are Not Caudal Multiple Forces Acting on Endograft Multiple Factors Affect Migration Pulsatile Blood Pressure Vessel Compliance Friction Between Graft and Aorta Friction at Fixation Points Columnar Strength Friction Due to Hooks/Barbs In this Model, Total Force Acting on Model is Sideways, Not Caudal Angulation Increases Lateral Force Straight Iliacs Reduce This Force Lateral Forces Have Migrated The Stent Graft Sideways Over Time Figueroa CA. Effect of Curvature on Displacement Forces Acting on Aortic Endografts: A 3-Dimensional Computational Analysis J Endovasc Ther Jun; 16(3):

Graft Flexibility Bench Testing Shows How Extreme Angulation Can Affect Different Grafts May Predict Limb Occlusion May Predict Migration or Anatomic

7 Graft Flexibility Bench Testing Shows How Extreme Angulation Can Affect Different Grafts May Predict Limb Occlusion May Predict Migration or Anatomic Changes Post Implant Demanget N, et al. Finite Element Analysis of the Mechanical Performances of 8 Marketed Aortic Stent-Grafts. J Endovasc Ther. 2013;20:

Angle (60-90 ), and Severe Angle (>90 ) No Longer Available in the US Hoshina K, et al.

8 Graft Flexibility Zenith vs. Excluder Significant Straightening of Infrarenal Angle with Zenith over Excluder (p = 0.04) in HNA Proximal Migration Seen Up to 15 mm in Zenith with HNA AorFix PYTHAGORAS US Trial No 2 Year Differences in Graft Outcomes or Mortality Between Standard Angle (<60 ), High Angle (60-90 ), and Severe Angle (>90 ) No Longer Available in the US Hoshina K, et al. Outcomes and morphologic changes after endovascular repair for abdominal aortic aneurysms with a severely angulated neck- a device-specific analysis. Circ J 2013; 77: Malas MN. Performance of the Aorfix endograft in severely angulated proximal necks in the PYTHAGORAS United States clinical trial. J Vasc Surg Nov;62(5):

Proximal Fixation AneurX Was One of the Earliest Generation Grafts But No Active Fixation to Prevent Migration Cuff Reline Grafts Zenith Introduced the First Proximal Fixation Endurant Designed to

9 Proximal Fixation AneurX Was One of the Earliest Generation Grafts But No Active Fixation to Prevent Migration Cuff Reline Grafts Zenith Introduced the First Proximal Fixation Endurant Designed to Address Hostile Necks Concept to Anchor in the Healthy Segment of Aortic Tissue Less Likely to Expand and Prevent Downward Migration Chaer RA, et al. Treatment of Endovascular Leaks after Aortic Endografting.

Proximal Fixation Endurant Designed to Address Hostile Necks IFU: US- 60 infrarenal angle with 10 mm length OUS- 2 mm neck with > 15 mm overlap with a covered parallel stent (snorkel) and 60

10 Proximal Fixation Endurant Designed to Address Hostile Necks IFU: US- 60 infrarenal angle with 10 mm length OUS- 2 mm neck with > 15 mm overlap with a covered parallel stent (snorkel) and 60 infrarenal angle Electropolished Suprarenal Fixation Hooks Prevent Migration M-shaped Proximal Struts Increase Wall Apposition ENGAGE Registry 3.8% (Short Necks 8-15 mm) vs 2.4% ( 15 mm) Type I Endoleaks (p NS) at 4 Years 0% Migration at 3 years with 1.5% Overall Type 1 Endoleaks Medtronic Data on File

11 Proximal Fixation Suprarenal Fixation Not Associated with Greater Dislodgement Force to Prevent Migration in Animal Model Anaconda Best Fixation Dislodgement Force Improved with Greater Seal Suprarenal Fixation May Have Advantages in HNA Lee, et al. Suprarenal Fixation (Esp with Zenith) Allow Successful EVAR with Off IFU vs. IFU (p NS) Waasdorp, et al.- Infrarenal vs. Suprarenal Fixation More sideways displacement than patients with transrenal fixation of the stent graft (54% vs 25%; P =.001) More proximal stent graft migration (41% vs 19%; P =.003). Shorter proximal fixation 24 ± 10.8 mm vs 19 ± 8.2 mm; P =.002). Bosman, W.M.P.F. et al. The Proximal Fixation Strength of Modern EVAR Grafts in a Short Aneurysm Neck. An In Vitro Study. European Journal of Vascular and Endovascular Surgery. 2010;39(2): Lee JT, et al. EVAR deployment in anatomically challenging necks outside the IFU. Eur J Vasc Endovasc Surg Jul;46(1):65-73 Waasdorp EJ. Sideways displacement of the endograft within the aneurysm sac is associated with late adverse events after endovascular aneurysm repair. J Vasc Surg Apr;55(4):

EndoScrews/EndoAnchors Heli-FX Endoanchors Indicated for Treatment of Type 1 Endoleaks (25%) Can Be Utilized Prophylactically in HNA (75% Cases)- ANCHOR Registry 85% HNA No Type 1 Endoleaks Seen

12 EndoScrews/EndoAnchors Heli-FX Endoanchors Indicated for Treatment of Type 1 Endoleaks (25%) Can Be Utilized Prophylactically in HNA (75% Cases)- ANCHOR Registry 85% HNA No Type 1 Endoleaks Seen Immediately (178 pts) 96.6% Technical Success No Endoanchor Related Reinterventions 7.4 ± 5.9 Month F/U- 4% Type I Endoleaks Seen de Vries JP. Analysis of EndoAnchors for endovascular aneurysm repair by indications for use. J Vasc Surg. 2014;60(6): e1. Jordan WD. Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy. J Vasc Surg 2014;60:

13 EndoScrews/EndoAnchors Heli-FX Endoanchors Indicated for Treatment of Type 1 Endoleaks (25%) Can Be Utilized Prophylactically in HNA (75% Cases)- ANCHOR Registry 85% HNA No Type 1 Endoleaks Seen Immediately (178 pts) 96.6% Technical Success No Endoanchor Related Reinterventions 7.4 ± 5.9 Month F/U- 4% Type I Endoleaks Seen de Vries JP. Analysis of EndoAnchors for endovascular aneurysm repair by indications for use. J Vasc Surg. 2014;60(6): e1. Jordan WD. Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy. J Vasc Surg 2014;60:

6% Type IB Endoleak Altura D-Shape Parallel Stent Design 6 Product Sizes Early Results Promising, but No Long Term Data- No

14 Future Directions EVAS Endovascular Sealing with Polymer Prevent Migration Via Endobags (Sac Anchoring Rather than Neck Anchoring) US IDE Trial at 12 Months 2.3% Device Migration 0.6% Type IB Endoleak Altura D-Shape Parallel Stent Design 6 Product Sizes Early Results Promising, but No Long Term Data- No Migration or Type 1/3 Endoleaks at 90 Days Carpenter JP. One-year pivotal trial outcomes of the Nellix system for endovascular aneurysm sealing. J Vasc Surg Feb;65(2): Murray D. VEITHSymposium 2016.

15 Case Example 82 Year Old Woman From Columbia Shows Up in the U.S. With an Ultrasound Disc Showing 7.8 cm AAA 45 Kg Pulsatile Abdominal Mass CTA Severe Infrarenal Angle > 90 Iliac Tortuosity Good Access Vessels Case Plan Endurant IIs MB Preserve Both Hypogastrics Prophylactic Aptus Use Stiff Lunderquist Wire to Get Up Above the Renals But Swap Out During Case to See How Graft Will Fall (Did Not Use with Aptus)

16 Case Example Initial Films Acute Infrarenal Angle/Suprarenal Angle Fairly Long Neck Within the Angulated Segment

Case Example Initial Films Acute Infrarenal Angle/Suprarenal Angle Fairly Long Neck Within the Angulated Segment Endurant IIs Deployed Below

17 Case Example Initial Films Acute Infrarenal Angle/Suprarenal Angle Fairly Long Neck Within the Angulated Segment Endurant IIs Deployed Below the Renals Could Not Gain More Height Flared Limbs Within the Straight Segments of the Common Iliacs (Stayed Away From the Tortuous Externals)

18 Case Example Initial Films Acute Infrarenal Angle/Suprarenal Angle Fairly Long Neck Within the Angulated Segment Endurant IIs Deployed Below the Renals Could Not Gain More Height Flared Limbs Within the Straight Segments of the Common Iliacs (Stayed Away From the Tortuous Externals) Aptus Heli-FX Endoscrews Deployed (5 Total)

19 Case Example Initial Films Acute Infrarenal Angle/Suprarenal Angle Fairly Long Neck Within the Angulated Segment Endurant IIs Deployed Below the Renals Could Not Gain More Height Flared Limbs Within the Straight Segments of the Common Iliacs (Stayed Away From the Tortuous Externals) Aptus Heli-FX Endoscrews Deployed (5 Total) Final Angio Lost Some Height No Type IA Endoleak

20 Case Example Initial Films Acute Infrarenal Angle/Suprarenal Angle Fairly Long Neck Within the Angulated Segment Endurant IIs Deployed Below the Renals Could Not Gain More Height Flared Limbs Within the Straight Segments of the Common Iliacs (Stayed Away From the Tortuous Externals) Aptus Heli-FX Endoscrews Deployed (5 Total) Final Angio Lost Some Height No Type IA Endoleak

21 Case Example Initial Films Acute Infrarenal Angle/Suprarenal Angle Fairly Long Neck Within the Angulated Segment Endurant IIs Deployed Below the Renals Could Not Gain More Height Flared Limbs Within the Straight Segments of the Common Iliacs (Stayed Away From the Tortuous Externals) Aptus Heli-FX Endoscrews Deployed (5 Total) Final Angio Lost Some Height No Type IA Endoleak F/U CTA at 1 Month No Migration Patient Doing Well Pulsatile Mass Gone Immediately Post-op

Hostile Neck During EVAR, The Role Of Endoanchores

Hostile Neck During EVAR, The Role Of Endoanchores Samer Koussayer, MD, FACS, RVT Prof, Al Faisal University Section Head and consultant Vascular & Endovascular Surgery Division King Faisal Specialist