Faculty Disclosure New and Improved Choices for Endografts: - PowerPoint PPT Presentation

4/19/2013 Faculty Disclosure New and Improved Choices for Endografts: � Consultant in AAA field: WLGore, Medtronic, Cordis Matching Anatomy to Device � Grant/research support in AAA field from Cook, WLGore, Cordis, Medtronic, Bolton, Trivascular, Lombard Michel Makaroun MD Co-Director, UPMC Heart and Vascular Institute Professor and Chair, Division of Vascular Surgery University of Pittsburgh, School of Medicine Available Commercial Choices in 2013 The First EVAR Device 1991 Talent AneuRx Zenith Excluder Powerlink Endurant Ovation Aorfix Zenith Endurant AUI Fenestrated Ancure 1993-2004 1

4/19/2013 Material Fatigue: Suture Miniholes Device Performance is Critical to EVAR Success Device Delivery Procedural Success & Deployment Improved Durability Long term Outcomes Design Features Over the last 10 years, Significant Device Improvements have been implemented through lessons learned from analysis of failure modes and causes of complications Courtesy of K. Ouriel Short Overlap: Limb Disconnection No Active Fixation: Migration Treated with New Endograft inside first one 2

4/19/2013 Large Profile: Iliac Injuries Why New Devices? 1. Commercial Interest among Industry Competitors 2. Drive for Lower Complications, Improved Performance and Longer Durability 3. Expanding Applicability of EVAR 25 Fr 27 Fr Early Days of commercially available 4 Randomized Clinical Trials Stent Grafts for EVAR (1998-2002) � EVAR trial in the UK Several Industry Anatomic Criteria for EVAR � DREAM trial in Holland Regulatory � Iliac artery access >8mm � OVER trial:VA Cooperative Study Trials � Neck: � 20-26 mm � ACE trial in France � Angulation <60 degrees � 15 mm length without reverse taper � No Significant thrombus Early Results of EVAR � No Severe Calcifications Are Superior to Open Repair In Patients with Good Anatomy Almost any Graft will do with Good Long Term Results 3

4/19/2013 How Applicable is EVAR Anatomically? General Community Application NY State 2000-2002 � # Hospitals performing EVAR increased from 24-60 � 2002 Open EVAR P # Patients 783 871 Mortality 4.21% 0.8% < .0001 LOS 10.3 days 3.6 days < .0001 “Only 30% of unselected AAA’s are suitable for EVAR” Anderson PL et al. A statewide experience with endovascular abdominal aortic aneurysm repair: Rapid diffusion with excellent early results. JVS 2004, 39:10 Br J Surg 2001;88:77-81 US Administrative Databases: Medicare Dillavou et al. J Vasc Surg 2006;43:446-52 41.4%* 36.1%* Dillavou et al. J Vasc Surg 2006;43:230-8 J Vasc Surg 2009;50:722-9 4

4/19/2013 50-64 y 65-74 y 75-84 y > 85 y EVAR OAR EVAR OAR EVAR OAR EVAR OAR Hospital LOS, mean, d 2.5 7.3 2.9 8.2 3.2 9.5 3.5 9.9 In-hospital mortality, % 0.3 1.2 0.8 2.5 1 5.6 1.5 9.5 Discharge to home, % 98.1 94.9 96.1 88 92.3 71.5 85.6 50.2 complications, % 8.8 27.3 11 34.1 15.7 41 17.9 48.9 Unfavorable Anatomy: TheNeck 115 91 Oct 1999-July 2002 (34 months) � 165 had open repair. 104 (64%) due to neck anatomy Short Neck 56 Suprarenal AAA 10 Large Neck 34 Angulated Neck 4 Extensive Thrombus 2 No Neck issue 59 Ancure Endograft: Unsupported unibody + infrarenal hooks. Good Results in Challenging Anatomy depend on � 322 EVAR’s . 116 excluded (in trials) But: Limited size range and Large profile of 27 Fr Sheath � 206 Not in trials: 91 Hostile necks and 115 Good necks � Close familiarity with device peculiarities Complex deployment. J Vasc Surg 2003;657-63 No Longer marketed after 2004. � Using the device that fits the particular challenge 5

4/19/2013 Additional Interventions Occasionally Required: Adequate results in very difficult necks Palmaz stents or Aortic extenders Giant Type I endoleak Uneven Neck Palmaz Must Understand Behavior of particular Devices Beyond Instructions For Use: Anatomic challenges that cause Exclusion Challenging Iliac Anatomy Change over time 1997-2000 2000-2003 PRE POST Moise MA et al. Vasc Endovasc Surg 2006;40:197-203 6

4/19/2013 Beyond Instructions For Use: Results are not always acceptable: Reinterventions Challenging Neck Anatomy Fold because of Oversizing WB: 12 cm AAA 10 mm Neck, severely Tapered neck with 95 degrees Angulation Results are not always acceptable: Reinterventions 3 years later 10228 patients (1999-2008) 59% <5.5 cm Migration � Compliance with EVAR device guidelines was low Occlusion of � Post EVAR sac enlargement was high The right limb � 41% had Sac enlargement @ 5 years � ONLY 42% of EVAR’s had anatomy that fit guidelines Emergency Fem fem Late conversion 7

4/19/2013 Devices in 2013 have Available Commercial Choices in 2013 Expanded the Anatomic Limits of EVAR Talent AneuRx Zenith Excluder Powerlink Endurant Ovation Aorfix � Decreasing device profile makes access a non issue: 13-14 Fr devices (Incraft** / Ovation….) � More Size offerings can now treat neck diameters of 16-32 mm (Ovation / Zenith / Excluder / Endurant…) � Improved Accurate deployment systems can now treat shorter necks. (C3 Excluder / Endurant / Incraft**…) � Fenestrated Grafts can treat very short to non existent necks ( Fenestrated Zenith / Ventana**…) � Innovative seals in diseased necks (Ovation…) or endostaplers for better fixation (HeliFX..) 1999 Ancure 2013 Ovation Sheath 27 F OD Sheath 14 F OD � Very Flexible design to treat very angulated necks (Aorfix) ** Caution : Investigational Device / Limited by United States Law to Investigational Use MC:82 y woman with AAA + severe iliac disease Lower Profile: Use smaller iliacs, Expand use in Women, Decrease vascular complications � AFX Endologix � Zenith LP** � Ovation � InCraft ** 17 French 16 French 14-15 French 13-14 French 6mm Balloons ** Caution : Investigational Device / Limited by United States Law to Investigational Use 8

4/19/2013 MC:82 y woman with AAA + severe iliac disease Percutaneous Approach: Preclose Technique Most Modern EVAR devices have a low enough profile for percutaneous use!! Personal Percutaneous Use since 2003 > 98% New 14 Fr devices will encourage more users 14 Fr Device Active Fixation: Reduce Migration Flexible Construction: Accommodate Anatomy � Endurant � Aptus HeliFX � Incraft** � Excluder � Endurant � Zenith-flex � Aorfix � Zenith � Excluder � Aorfix � Ovation Most Flexible is the Aorfix: Both Iliacs and Necks ** Caution : Investigational Device / Limited by United States Law to Investigational Use 9

4/19/2013 MB: Accurate Deployment and good Circular Concentric Rings Designed to conformability in Short Angulated Neck Accommodate Tortuous and Angulated Anatomy The Aorfix (Lombard) Doing well at 1 year BT: Accurate Deployment and good MH: Accurate Deployment and good conformability in Severely Angulated Neck conformability in Severely Angulated Neck One Month: 51 mm 1 year Two years: 38 mm Doing well at one year Doing well at 3 years 10

4/19/2013 Very Accurate and Controlled Deployment: RO: Accurate Deployment in Very Short Neck Improve Seal Zones + Use Shorter Necks The Endurant (Medtronic) Based on delayed release of fixation until final position IFU: Neck length > 10 mm Adequate Seal and Good Comformability Recapture after Initial Deployment: KP: Accurate Deployment in Very Angulated Neck Improve Safety and Use of Seal Zone The C3 Excluder deployment (WLGore) Based on a constraining mechanism Adequate Seal and Good Comformability 11

4/19/2013 Molds to irregularities in Sealing Zone TM: Reverse Taper Neck with Thrombus The Ovation Endograft (Trivascular) Based on Biopolymer fill Diam@ Renals: 22mm 13 mm lower: 31 mm Must Understand Behavior of particular Devices Allows Extension over Branches Fenestrated Endografts: Concept The Zenith Fenestrated Graft Custom Made � An unfavorable or short proximal aortic neck is the most common factor limiting the applicability of EVAR � A fenestrated graft extends the seal zone to the more stable para-visceral aorta while allowing perfusion of the visceral vessels through fenestrations in the stent graft 12

4/19/2013 Allows Extension over Branches off the shelf MV 85 year old F: Very Short Neck The Ventana Endograft (Endologix) Based on a movable fenestration 1 month:51 x 55 mm 1 year : 38 x 46 mm Type II endoleak treated at 3 years / well at 6 years (92y) ** Caution : Investigational Device / Limited by United States Law to Investigational Use JT 84 year old F: Very Short Neck How should we pick an Endograft? Doing well at 3 months 13