Aortic neck dilatation post EVAR - Vascular Disease Management€¦ · Aortic neck dilatation post...

Aortic neck dilatation post EVAR

Sonya S Noor, MD,FACSMEDICAL DIRECTOR, GATES VASCULAR INSTITUTE,BUFFALO

JAN 24 2020, ISET

Sonya S Noor, MD, FACSDirector, Endovascular services

GVI and BGMCBuffalo, NY

DisclosuresSpeaker’s Bureau:• Janssen• BSC• ELGX

Honorarium:• Janssen• BSC• ELGX

Consultant:• Janssen• BSC• ELGX

AAA repair by EVAR

• The goal is to prevent rupture• Minimally invasive treatment

• The rate limiting steps : • Hostile neck anatomy

• Difficult access

• Characteristics of Hostile Neck Anatomy

• Short Aortic Necks (<15mm)• Reverse Tapered Necks• Calcium • Thrombus• Severe Angulation • Large Diameter

Persistent EVAR Challenges

48% Patients < 15mm Necks*

M2S Database – 43,000 CT Scans

63% Women < 15mm Necks**

(CHAP) Collaborative effort – 1,063 CT Scans

Calcium/Thrombus lined Necks

Reverse Tapered Necks

At Inferior Renal Artery

At IR + 5

At IR + 13

* Derived from M2S Measurement Database of 43,000 AAA CT Scans

** New England Society for Vascular Surgery, Matthew P. Sweet, MD et all The influence of gender and aortic aneurysm size on eligibility for endovascular abdominal aortic aneurysm repair Clinician-FDA Collaborative effort, Characterization of Human Aortic Anatomy Project (CHAP), 1063 CT Scans

Ovation AFX2 Zenith Flex Excluder C3 Endurant II

Key Indications

Proximal Neck Length 13mm IR at Neck Dia ≥15mm ≥15mm ≥15mm ≥10mm

Proximal Neck Angle (°)

≤60 if neck length ≥10mm ≤45 if neck length <10mm ≤60 ≤60 for infrarenal neck

≤45 for suprarenal neck ≤ 60 ≤60

Neck Diameter 16-30mm at 13mm IR 18-32mm 18-32mm 19-32mm 19-32mm

Iliac Diameter 8-25mm 10-23mm 7.5-20mm 8-25mm 8-25mm

Device Features

Profile OD (main body) 14F-15F 19F 21F-23F 20F 18F-20F

Neck requirements in EVAR

*Device Indications from Company Instructions for Use1 In Ovation pivotal trial, neck length indication of ≥ 7mm

The Ovation® System is approved to treat infrarenal abdominal aortic aneurysms and is not approved for any other intended use in any geography.

Type I Endoleak is a Leading Cause for Open Conversion After EVAR 1,2,3

641 PatientsFrom 1991-2014

Review of 26 articles

Source: Kouvelos, et al, JVS, 2015

1Brinster, et al. Late Open Conversion and Explantation of Abdominal Aortic Stent Grafts, J Vasc Surg, 2011. 2Kelso, et al. Late Conversion of Aortic Stent Grafts, J Vasc Surg, 2009.3 Kouvelos et al. Late Open Conversion After Endovascular Abdominal Aortic Aneurysm Repair, J Vasc Surg, 2015.

Source: Rusius, et al, Vascular and Endovascular Surgery, 2011

Source: Steuer et al, European Heart Journal, 2016

The Ovation® System is approved to treat infrarenal abdominal aortic aneurysms and is not approved for any other intended use in any geography. The Ovation® Abdominal Stent Graft Platform and associated components are not available in all countries or regions. Please contact your Endologix representative for details regarding product availability. Prior to use, refer to the “Instructions for Use” for complete and specific indications, contraindications, all warnings and precautions. Rx only. MM1941 Rev 01

“Images for illustration only and do not imply the use of Ovation would result in a successful outcome.”

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Baseline 1 Year Growth 2 Year Growth 3 Year Growth 4 Year Growth 5 Year Growth

Prox

imal

Nec

k di

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ge e

xpan

sion

(mm

)

Aortic Neck Dilatation Over Time

1Monahan JVS 2010: 52: 303-7. N=46. Devices: Cook Zenith2Rodway EJVES 2008;35:685-93 EVAR: N=67, Open N=56. Data to 2 years.3Core Lab evaluation, Ovation Global Pivotal Trial. N=94. Data as of Aug 2, 20164Neck dilation = growth > 3mm at 10mm, 13mm, and 15mm below renals

Ovation System3,4

Self-Expanding Stents1

Open Repair2

Core lab results demonstratestable neck diameterand durable seal with Ovation through 5 years

Aortic Neck Dilatation(AND) after EVAR: Does Stent Design Matter?


8

Aortic neck seal with grafts

©2016 Endologix, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

REVERSE-TAPER REVERSE-TAPER ANATOMY TREATED WITH OVATION ® PLATFORM

HEAVY CALCIFICATION CALCIFIED ANATOMY TREATED WITH OVATION® PLATFORM

Chronic outward force from oversized stent, combined with blood pressure, can result in neck dilatation and may compromise seal. 1,2,3

Sealing ring creates no chronic outward force and insulates the neck from blood pressure, resulting in a stable neck diameter. 4

Conventional wire and fabric grafts may not be able to fully conform to an irregular luminal surface.

Polymer is injected in a low viscosity liquid state, allowing sealing ring to mold and conform to irregular luminal surfaces, creating a customized seal.

Self Expanding Stent Graft

Aortic Neck Pre and post EVAR with SE vs POLYMER

©2016 Endologix, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Blood Pressure + Stent Outward Radial Force

Contributes to Neck Dilatation

Minimal Blood Pressure+ NO Stent Outward Radial Force

No Neck Dilatation

Blood pressure results in a bulge in aortic wall where tissue is weak

Blood Pressure Aneurysm

Ovation iX™ Stent Graft

Untreated Aneurysm Oversized wire and fabric graft allows

transmission of blood pressure, and exerts pressure of its own

Polymer-filled O-ring insulates aortic neck from blood pressure

MM1312 Rev 02

SELF EXPANDING STENT GRAFTChronic outward force from stent, combined with blood pressure, can result in aortic neck dilatation. 1

Proximal Neck Dilatation after EVAR: Does Stent Design Matter?

Increased size

of aorta

24.6%Neck Dilation

incidence of clinical events with dilation Type 1a endoleak, migration, and reintervention

26%

over a 15 month to 9 year period

vs 2% Without dilation


• Graft Migration2,3

– 27% of patients with AND had graft migration >10mm– AND occurs in up to 30% of patients after EVAR and main risk factor for

migration

• Type Ia Endoleak2,4

– AND significantly influences incidence of late type I endoleaks (p=0.001)

• Sac Enlargement2

• 20% of Patients with AND Require Secondary Interventions3

Aortic Neck Dilatation (AND) after EVAREUROSTAR1

§ 25% and 35% of patients at 2 and 4 years had >15% increase in proximal neck diameter

1 Diehm et al. J Endovasc Ther 2007;14:122-1292 Cao et al. J Vasc Surg 2003;37:1200-5.3 Dillavou et al. Vasc Endovascular Surg 2005;39:47-54. 4 Napoli et al. EUR Radiol 2003,13:1962-71.

Updated, Contemporary (2016) Literature Review of AND

Limitations of the AND Evidence• Various endograft designs with different sealing mechanisms studied• Study cohorts ranged from 27 to 6383 patients • Limited mean follow-up• Significant Heterogeneity in Measurement Methods and AND Definition• Lack of association between clinical impact of AND

26 articles published between 1998 and 2015 that encompassed

9721 patients (median age 71.8 years; 9439 men)

Kouvelos et al. J Endovasc Ther 2017 Feb;24(1):59-67

Ovation Platform: IS THIS THE ANSWER TO AND?14F OD ultra-low profile system enables smooth aneurysm access

Staged deployment of suprarenal stent allows simple, precise placement

Polymer-filled sealing ring creates a custom seal and protects the aortic neck

Low permeability PTFE enables effective aneurysm exclusion and device patency

Conformable, kink resistant PTFE iliac limbs designed to reduce risk of occlusion


Aortic Neck Stability after Polymer Sealing with Ovation

The Ovation® Abdominal Stent Graft Platform has not been studied in a head-to-head clinical study against other EVAR devices.

Growth = > 3mm at 10mm, 13mm, and 15mm IR

The Ovation System Global Pivotal Core Lab Results

Demonstrate No Neck Dilatation

Monahan JVS 2010: 52:303-7. N=46 Ovation Global Pivotal Trial. N=94. Data cut Aug 2, 2016

Safety and Effectiveness

Safety20 to 30

daysN=161

31 to 365daysN=159

366 to 730daysN=154

731 to 1095 daysN=140

1096 to 1460 daysN=124

1461 to 1825 daysN=105

MAEs 2.5% 3.8% -- -- -- --

Device Related MAE

0% 0% -- -- -- --

Rupture 0% 0% 0% 0% 0% 1%

Conversion 0% 0% 0% 0% 0% 0%

Effectiveness3 30 Day 1 Year 2 Years 3 Years 4 Years 5 Years

Type I/III Endoleak 0% (0/153) 0% (0/143) 0% (0/120) 0% (0/109) 0% (0/87) 0% (0/66)

Migration Baseline 0% (0/150) 0% (0/133) 0% (0/117) 0% (0/96) 0% (0/78)

Occlusion 0% (0/159) 0% (0/151) 0.7% (1/135) 0% (0/120) 2% (2/98) 2.5% (2/79)

Technical Success1 AllN=161

Successful delivery and deployment of one aortic body and two iliac limbs

100%5 year results of the global pivotal clinical study to evaluate the safety and effectiveness of the Ovation Abdominal Stent Graft System.

Data extraction: August 2, 2016

1 Site reported2 MAE and Device Related MAE from CEC-adjudicated

data. Rupture and Conversion site reported.3 Endoleaks and Migration Core Lab reported;

Occlusion site reported.


95% primary clinical success through 2 yearsAbsence of aneurysm-related death, type I or type III endoleak, graft infection or

thrombosis, aneurysm expansion >5 mm, aneurysm rupture, or conversion to open repair

Aortic Neck Stability after Polymer Sealing with Ovation

De Donato et al. J Vasc Surg 2016;63(1):8–15

• ZONE A: Changes in diameters over time

Ovation

mean 0.18 ± 0.22mmmedian 0.1 mm (0,-0.3)

• ZONE B: Changes in diameters over time

Ovation

median 0.0 mm (0,-0.6mm)mean -0.32 ± 0.87mm

• ZONE C: Changes in diameters over time

Ovation

median 0.0 mm (+0.4,-0.3mm)mean -0.06 ± 0.97mm

Gates Vascular Institute Multispecialty facility:

Cardiology, Vascular SurgeryCardiac Surgery, NeurosurgeryIR

• Grafts used – most

• Teaching Institution - 10 Fellows or Residents trained on Ovation use

• Decision matrix: why select one AAA graft over another for each patient

Pre-case

Post-30 day

Post-30 day Post 2-year

Post 2-year

Pre-case

Pre-case

Straightforward

Reverse Tapered Neck

Heavy Calcification

No aortic neck growth at 4 years



Post-30 day Post 4-year

Ovation CustomSeal™ - Stability in a Variety of Anatomies


Thrombus Laden Neck

5 YearsPre-Op

Ovation Platform Custom Seal


Ovation Results at GVI

First Experience May 24, 2013

– 100% Technical Success, 6 adjunctive balloon expandable stents devices used

– No ruptures, 1 limb occlusions

– 2 secondary procedures

– No evidence of aneurysm enlargement– NO migration

# of Patients Follow up

107 12 month

150 6 month

200 30 days

215 total implants


Patients were treated at the disclosure of physician, not all may be on-IFU and results presented here do not indicate a claim of similar outcomes. Safety and effectiveness of Ovation when used off-IFU have not been established

• AND etiology remains controversial, inconsistently defined, and poorly understood

• Multiple attributions: natural disease progression, open repair, and EVAR with self-expanding stents.

– Clinically significant AND associated with endoleak, migration, secondary intervention

• AND presents surveillance following EVAR• Polymer EVAR with the Ovation System seems to have less AND • Further understanding of predictive risk factors needed

Conclusions: Aortic Neck Dilatation: AND

Thank you

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