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Michel Makaroun MD

Co-Director, UPMC Heart and Vascular Institute Professor and Chair, Division of Vascular Surgery

University of Pittsburgh, School of Medicine

New and Improved Choices for Endografts:

Matching Anatomy to Device� Consultant in AAA field: WLGore, Medtronic, Cordis

� Grant/research support in AAA field from Cook, WLGore, Cordis, Medtronic, Bolton, Trivascular, Lombard

Faculty Disclosure

The First EVAR Device 1991

Ancure 1993-2004

Available Commercial Choices in 2013Talent AneuRx Zenith Excluder Powerlink Endurant Ovation Aorfix

ZenithFenestrated

Endurant AUI

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Over the last 10 years, Significant Device Improvements have been implemented through lessons learned from analysis of failure modes and causes of complications

Device Performance is Critical to EVAR Success

Device DeliveryDeploymentDurabilityDesign Features

Procedural Success & Improved

Long term Outcomes

Material Fatigue: Suture Miniholes

Courtesy of K. Ouriel

No Active Fixation: Migration

Treated with New Endograft inside first one

Short Overlap: Limb Disconnection

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25 Fr 27 Fr

Large Profile: Iliac Injuries

1. Commercial Interest among Industry Competitors

2. Drive for Lower Complications, Improved Performance and Longer Durability

3. Expanding Applicability of EVAR

Why New Devices?

4 Randomized Clinical Trials� EVAR trial in the UK

� DREAM trial in Holland

� OVER trial:VA Cooperative Study

� ACE trial in France

Early Results of EVAR Are Superior to Open Repair

Several Industry Regulatory Trials

In Patients with Good Anatomy

Early Days of commercially available Stent Grafts for EVAR (1998-2002)

Anatomic Criteria for EVAR� Iliac artery access >8mm� Neck:� 20-26 mm

� Angulation <60 degrees

� 15 mm length without reverse taper

� No Significant thrombus

� No Severe Calcifications

Almost any Graft will do with Good Long Term Results

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How Applicable is EVAR Anatomically?

Br J Surg 2001;88:77-81

“Only 30% of unselected AAA’s are suitable for EVAR”

� # 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

NY State 2000-2002

Anderson PL et al. A statewide experience with endovascular abdominal aortic aneurysm repair: Rapid diffusion with excellent early results. JVS 2004, 39:10

General Community Application

US Administrative Databases: Medicare

Dillavou et al. J Vasc Surg 2006;43:446-52

Dillavou et al. J Vasc Surg 2006;43:230-8 36.1%*41.4%*

J Vasc Surg 2009;50:722-9

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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 9.9In-hospital mortality, % 0.3 1.2 0.8 2.5 1 5.6 1.5 9.5Discharge to home, % 98.1 94.9 96.1 88 92.3 71.5 85.6 50.2complications, % 8.8 27.3 11 34.1 15.7 41 17.9 48.9

J Vasc Surg 2003;657-63

Oct 1999-July 2002 (34 months)

� 165 had open repair. 104 (64%) due to neck anatomyShort Neck 56 Suprarenal AAA 10Large Neck 34 Angulated Neck 4Extensive Thrombus 2 No Neck issue 59

� 322 EVAR’s . 116 excluded (in trials)� 206 Not in trials: 91 Hostile necks and 115 Good necks

Unfavorable Anatomy: TheNeck

115 91

Good Results in Challenging Anatomy depend on

� Close familiarity with device peculiarities

� Using the device that fits the particular challenge

Ancure Endograft: Unsupported unibody + infrarenal hooks. But: Limited size range and Large profile of 27 Fr Sheath

Complex deployment. No Longer marketed after 2004.

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Additional Interventions Occasionally Required:Palmaz stents or Aortic extenders

Uneven Neck Type I endoleakGiant Palmaz

Adequate results in very difficult necks

Must Understand Behavior of particular Devices

Moise MA et al. Vasc Endovasc Surg 2006;40:197-203

Anatomic challenges that cause Exclusion

1997-2000

2000-2003

Change over time

Beyond Instructions For Use: Challenging Iliac Anatomy

PRE POST

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WB: 12 cm AAA10 mm Neck, severely Tapered neck with

95 degrees Angulation

Beyond Instructions For Use: Challenging Neck Anatomy

Fold because ofOversizing

Results are not always acceptable: Reinterventions

3 years later

Migration

Occlusion of The right limb

EmergencyFem fem

Late conversion

Results are not always acceptable: Reinterventions

10228 patients (1999-2008)59% <5.5 cm

� Compliance with EVAR device guidelines was low � Post EVAR sac enlargement was high

� 41% had Sac enlargement @ 5 years� ONLY 42% of EVAR’s had anatomy that fit guidelines

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Devices in 2013 have Expanded the Anatomic Limits of EVAR� 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..)� Very Flexible design to treat very angulated necks (Aorfix)

**Caution : Investigational Device / Limited by United States Law to Investigational Use

Available Commercial Choices in 2013Talent AneuRx Zenith Excluder Powerlink Endurant Ovation Aorfix

2013 Ovation Sheath 14 F OD

1999 Ancure Sheath 27 F OD

Lower Profile: Use smaller iliacs, Expand use in Women, Decrease vascular complications

�AFX Endologix �Zenith LP** �Ovation �InCraft **

**Caution : Investigational Device / Limited by United States Law to Investigational Use

17 French 16 French 14-15 French 13-14 French

MC:82 y woman with AAA + severe iliac disease

6mm Balloons

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14 Fr Device

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

Active Fixation: Reduce Migration

� Endurant

**Caution : Investigational Device / Limited by United States Law to Investigational Use

�Aorfix

�Incraft**

� Zenith � Excluder�Ovation

�Aptus HeliFXFlexible Construction: Accommodate Anatomy

� Excluder � Endurant � Zenith-flex � Aorfix

Most Flexible is the Aorfix: Both Iliacs and Necks

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Circular Concentric Rings Designed to Accommodate Tortuous and Angulated Anatomy

The Aorfix (Lombard)

MB: Accurate Deployment and good conformability in Short Angulated Neck

Doing well at 1 year

Doing well at one year

1 year

BT: Accurate Deployment and good conformability in Severely Angulated Neck

MH: Accurate Deployment and good conformability in Severely Angulated Neck

One Month: 51 mm

Two years: 38 mm

Doing well at 3 years

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Very Accurate and Controlled Deployment:Improve Seal Zones + Use Shorter Necks

The Endurant (Medtronic)Based on delayed release of fixation until final position

IFU: Neck length > 10 mm

RO: Accurate Deployment in Very Short Neck

Adequate Seal and Good Comformability

Recapture after Initial Deployment: Improve Safety and Use of Seal Zone

The C3 Excluder deployment (WLGore)Based on a constraining mechanism

KP: Accurate Deployment in Very Angulated Neck

Adequate Seal and Good Comformability

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Molds to irregularities in Sealing Zone

The Ovation Endograft (Trivascular)Based on Biopolymer fill

TM: Reverse Taper Neck with Thrombus

Must Understand Behavior of particular Devices

Diam@ Renals: 22mm

13 mm lower: 31 mm

Allows Extension over Branches

The Zenith Fenestrated GraftCustom Made

Fenestrated Endografts: Concept

� 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

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MV 85 year old F: Very Short Neck

Type II endoleak treated at 3 years / well at 6 years (92y)

1 month:51 x 55 mm

1 year : 38 x 46 mm

Allows Extension over Branches off the shelf

The Ventana Endograft (Endologix)Based on a movable fenestration

**Caution : Investigational Device / Limited by United States Law to Investigational Use

JT 84 year old F: Very Short Neck

Doing well at 3 months

How should we pick an Endograft?

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How NOT to Choose An Endograft: I like the Rep! How to pick an Endograft

� Clinical data� Familiarity and expertise� Ease of use� Stock and availability� Price

2013

� Anatomy: Match Anatomy to device

How to pick an Endograft� Standard grafts may be used successfully for

many cases but new devices have special characteristics to handles difficult anatomy better� Necks 10-15 mm: New more accurate deployment

systems: C3 Excluder, Endurant..

� Very Short Necks: Fenestrated grafts

� Non Cylindrical necks: Ovation

� Severely Angulated necks: Aorfix

� Poor access and diseased iliacs: Ovation

� Occluded Iliac/narrow distal aorta…: AUI (Endurant or Zenith Renu)

Outcomes and Anatomy: A word of caution

� Late Outcomes may be negatively Impacted by Poor Anatomy

� Should Balance the decision of EVAR between Life expectancy, Risk of Rupture and Anatomic Challenge

� Close Long Term FU is needed even with newer endografts designed for challenging anatomy

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Any Room left for Open Repair?