Twenty years of evar in the us the procedure that changed a specialty

Twenty Years of EVAR in the USThe Procedure that changed a Specialty

Michel Makaroun MD

Co-Director UPMC Heart and Vascular Institute

Professor and Chief, Division of Vascular Surgery

University of Pittsburgh School of Medicine

Consultant in AAA field: WLGore, Medtronic, Cordis

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

Faculty Disclosure

The Transformation of Vascular Surgery:Published Articles with “Endovascular” in Title

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 281985 1990 1995 2000 2005 2010

Nov 23,1992 First EVAR in North America

Montefiore Hospital, Bronx, New York

Juan Parodi, Michael Marin, Frank Veith…

Juan Carlos Parodi MDBuenos Aires, Argentina

First EVAR in a human Sept 7, 1990

Reported the first 5 cases in 1991 in the

Annals of Vascular Surgery 5:491-499

The First EVAR Devices

Nicholas Volodos (Kiev, Ukraine) performed a similar

procedure for a thoracic traumatic aneurysm in 1987.

Reported in Russian only in 1988

Harrison Lazarus filed for a patent on an “Intraluminal graft

device, system and method” in December 1986

Granted US Patent number 4,787,899 on Nov 29,1988

Endovascular Technologies Inc.

The first study of a commercial device

Alexander Balko 1986

Animal work on Sheep

Precursor of the Talent Device

Michael Dake started working on Thoracic endografts

in 1992 and reported on 13 patients in 1994

In 1993 Timothy Chuter (as a fellow) started

promoting bifurcated grafts as a more viable solution

Lancet 1994;343:413

J Vasc Surg 1994;20:855-60

….But what if these devices do work ..?…. My present best guess is

that 35% to 70% of current vascular prosthetic grafts could be

replaced by TPEGs. That potential and the fact that insertion of

these devices requires catheter-guidewire-imaging skills, which we

generally do not have, in addition to our vascular surgical skills,

explains why vascular surgeons are so interested in and yet agitated

by TPEGs. These devices could make vascular surgeons as we

currently know them largely obsolete…

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

EVAR: Many Early Advantages

Local or Regional Anesthesia

Lower Morbidity and Mortality

Lower Blood Loss

Shorter Hospital and ICU Stays

Feasible in Higher-Risk patients

Patient Comfort

EVAR for AAA

first approved in 1999

86 year old

Significant CAD

Large 6 cm AAA

16 hours post procedure

The Far Reaching Impact of EVAR

Forced Retraining of the Vascular Workforce

Blurred Traditional Specialty Relationships

Changed our Operating Rooms and our Practice

Doubled the length of our Training Requirements

Promoted the Special Identity of Vascular Surgery

Prompted the Formation of a Vascular Surgery Board

Primary Specialty: Integrated Vascular Residencies

Increased the demand for Vascular Surgeons

Increased Compensation for our Specialty

J Vasc Surg 1999;29:177-86

70%

31%

34%

Steppacher R et al. J Vasc Surg 2009;49:1379-86

Vogel TR et al. J Vasc Surg 2009;49:1166-71

Annual Market Share by Provider Specialty

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2005 2006 2007 2008 2009

Vascular Surgery

Interventional Radiology

Interventional Cardiology

EVAR

Florida Inpatient Database (unpublished)

-10%

0%

10%

20%

30%

40%

50%

60%

2005 2006 2007 2008 2009

Pro

po

rtio

n

Year

Vascular Surgery




LE Int.


0%

10%

20%

30%

40%

50%

60%

70%

2005 2006 2007 2008 2009

Vascular Surgery




CAS



Blurred traditional Specialty Relationships



















J Vasc Surg 2009;49:1339-44

2008 2009 2010

Endovascular Diagnostic131 132 124

Endovascular Therapeutic355 440 307

EVARs and TEVARs 55 83 73

UPMC Average Caseload per Graduating Fellow 2008-2010

Endovascular Cases











J Vasc Surg 1998;27:195-202











Semin Vasc Surg 19:165-67

The Integrated Vascular Training Program

Directly from Medical School

5 Years: 24 months Core Surgery

36 months Vascular Surgery

Integrated Vascular Positions in match / Year

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1 2 3 4 5 6 7

2007 2008 2009 2010 2011 2012 2013

Integrated

Programs in

Vascular

Surgery:

April 2013

46 programs

50 positions

5 new

programs

approved in

February

2013 Match:

39 Programs participated

46 Positions offered

mailto:[email protected]

mailto:[email protected]











Vascular Surgery has quickly become one of the most difficult

recruitment efforts among all specialties.

60% increase in recruitment efforts the last 5 years


Stimulated Investments in Endovascular Technology

Far Beyond AAA affecting ALL Vascular Procedures

Thoracic and Thoraco-Abdominal Aneurysms

Thoracic Dissections

Vascular Trauma and Thoracic Aortic Transection

Popliteal Aneurysms

Aorto-Iliac and Lower Extremity Revascularization

Mesenteric Revascularization

Carotid Stenting

Abdominal EVAR

devices

Peripheral devices Thoracic

devices

Single Branch Device


Stimulated Investments in Endovascular Technology

Far Beyond AAA to affect ALL Vascular Procedures

Thoracic and Thoraco-Abdominal Aneurysms

Thoracic Dissections

Vascular Trauma and Thoracic Aortic Transection

Popliteal Aneurysms

Aorto-Iliac and Lower Extremity Revascularization

Mesenteric Revascularization

Carotid Stenting

EVAR

Two Decades later

Good Results and Improving!

Br J Surg 2001;88:1281-1282

August 25 2004

Initial Report of the UK EVAR Trial

October 14, 2004

Initial Report of the Dutch DREAM Trial

June 12, 2009

Initial Report of the VA OVER Trial

Randomized Trials EVAR vs OSR

Unequivocal Proof : EVAR HAS SUPERIOR EARLY RESULTS

UK EVAR 1 Trial

Randomized comparison of EVAR vs Open Repair

GOOD RISK CANDIDATES Suitable for both

From 1999 to 2003

1082 patients

41 Hospitals

AAA > 5.5 cm

> 60 Years old

Greenhalgh et al. EVAR 1 Trial. Lancet 2004;364:843-48

UK EVAR 1 Trial

EVAR Open p

30 day Mortality 1.7% 4.7% 0.01

Secondary Procedures 9.8% 5.8% 0.02

Greenhalgh et al. EVAR 1 Trial. Lancet 2004;364:843-48

EVAR OPENPer ProtocolIn Hospital Mortality 1.6% 6.0%

OVER Trial

Randomized comparison of EVAR vs Open Repair

GOOD RISK CANDIDATES Suitable for both

From 2002 to 2007

881 patients

42 VA Hospitals in the US

AAA > 5.0 cm

Mean age : 70 Years old

JAMA 2009;302:1535-1542

EVAR Open p

30 day Mortality 0.2% 2.3% 0.006

2 Yr Mortality 7.0% 9.4% 0.19

OVER Trial

NEJM 2012;367:1988-97

EVAR Open p

Initial Costs $37,068 $42,970 .04

@ 2 Years $75,325 $80,344 .35

EVAR is a cost effective alternative to open repair in the

US VA Health Care System for at least the first two years

Eur J Vasc Endovasc Surg 2012;44:543-8

1. Enthusiastic Adoption

of EVAR in the US

# 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

EARLY 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%*

2.47%

1.46%

5.19% 5.20%

5.02%

4.00% 4.28% 3.67%

0.00%

1.00%

2.00%

3.00%

4.00%

5.00%

6.00%

2000 2001 2002 2003

Year

Perc

ent

Mort

ality

EVAROpenAll elective AAA Repairs

*

* = P .05, 2000 vs 2003

*

Mortality of Elective AAA Repair

2001 2002 2003

Open 79.2% 78.5% 75.4%*

EVAR 90.7% 92.2% 90.9%

Overall 82.8% 83.4% 81.7%

* = P .05 2001 vs 2003

Discharge to Home

J Vasc Surg 2009;50:722-9

J Vasc Surg 2009;50:722-9

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 50.2

complications, % 8.8 27.3 11 34.1 15.7 41 17.9 48.9

J Vasc Surg 2009;50:722-9

Mortality is reduced by EVAR in ALL AGE GROUPS

Strong Patient’s Preference for EVAR

J Vasc Surg 2009;49:576-81

Preference

EVAR Open Surgery Undecided

84% 13% 3%

Many Factors Impact the Decision To Use

EVAR in Hostile Anatomy

Individual patient

factors

impact the decision

to offer EVAR in

challenging

Anatomy

99

26

EVAR

79.2%

Open

Personal UPMC Experience 2002

How Applicable is EVAR Anatomically?

Br J Surg 2001;88:77-81

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

EVAR”

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

Anatomic challenges that cause Exclusion

1997-2000

2000-2003

Change over time

10228 patients (1999-2008)

59% <5.5 cm

41% had Sac enlargement @ 5 years

ONLY 42% of EVAR’s had anatomy that fit guidelines

Circulation 2011;123;2848-2855

2. Widespread application of EVAR resulted in

Many Operators being Less experienced !

Personal volume

2000-2004: 250 EVAR / year

2012-2013: 70 EVAR / year

Severe Oversizing !

32 mm

Zenith

1 month

later

Neck

Rupture

19 mm

Narrowing

Open Conversion

Cause of Complication: Severe Oversizing

Poor planning and Inexperience

Poor Planning: Multiple Complications

Bilateral Accessory

Renal Arteries

Small

Distal

Aorta

Coiled

Accesories

Covered

R Renal

Early Renal

Bifurcation

Multiple Complications

Rt Hepato-Renal

Bypass for renal

salvage

Recovery Room: Paraplegia and No femoral Pulses

Complete Thrombosis and Severe Ischemia


Narrow Distal Aorta


Ax Bifem Bypass

Wound breakdown

exposed Graft

6th Operation:

Conversion with Aorto-BiIliac bypass

and

removal of Ax-Bifem

3. Increasing Application of EVAR to

Rupture AAA

EVAR for Ruptured AAA

MP 87 yr old woman Hypotensive

Home in 4 days

J Vasc Surg 2008

6%7%

8%

11%

0%

2%

4%

6%

8%

10%

12%

2001 2002 2003 2004

NIS

Percent of

Ruptured

AAA Rx with

EVAR in NIS

40%43%45%

35%

41%

31%

43%

29%

0%

10%

20%

30%

40%

50%

60%

2001 2002 2003 2004

Open

EVAR

39%

21%

46%

55%

0%

10%

20%

30%

40%

50%

60%

Teaching Non Teaching

Open

EVAR

Ann Surg 2012;256:651-658

Medicare Results

2008 rates of EVAR

Intact AAA 77 %

Rupture AAA 31%

4. Revision of Surveillance Regimens

With more reliance on Ultrasound

EVAR has Possible Late Complications

Endoleaks

Migration

Material Fatigue

Endoleak

Life Long Surveillance

Migration

J Vasc Surg 2009;50:1538

29 Ruptures

After EVAR

22 (76%)

were lost to

Follow-Up

after the

initial EVAR

The issue of life long surveillance

and repeated CT scans

especially in young patients

is a significant consideration:

Radiation + Costs

There is plenty of evidence however

this can be simplified with the use of Duplex US

J Vasc Surg 2009;49:845-50

Can Duplex Ultrasound Completely Replace

CT in Certain Patients?

No Ruptures

No Graft Occlusions

No diagnosed Migrations

7 non aneurysm related deaths

1 Graft Infection and explantation Death

Results of New Policy in 2007 (187 Patients)

It IS SAFE to replace CT with a Duplex

Ultrasound after 1 yr if AAA is stable!

5. Decreasing Secondary Intervention Rate

Increased Experience

Improving Endograft Technology

Less interventions on Type II Endoleaks

Ann Surg 2009;250:383-389

11% of patients Undergo Reinterventions

Majority for endoleaks mostly Type II

76% of Reinterventions endovascular

>80% successful reinterventions except for type II

Low Mortality and Morbidity

486 Patients with 90 Type II Endoleaks (18.5%)

61% sealed spontaneously in 6 months

Only 6% experienced enlargement > 5mm

J Vasc Surg 2004;39:306-13

More Appreciation of Reinterventions for

Open Repair

Small bowel obstruction

Impotence and Retrograde Ejaculation

False aneurysms

Incisional Hernias

Graft Infection

Aortoduodenal fistulas

And Yes Endoleaks !!!

Open Repair Complications

Incisional

Hernias

Incisional Hernias after Open AAA Repair:

Quite common!

Author Year Incidence

Liapis 2004 16.2%

Raffetto 2003 28.2%

Papadirmitriou 2002 11.1%

Musella 2001 31.4%

Adye 1998 31%

Holland 1996 38.2%

Hall 1995 10.2%

Combined 21%

Takagi et al Eur J Vasc Endovasc Surg 2007 33;177-181

Anastomotic

or

New Aneurysms


Aorto-duodenal Fistulas



Surgical Graft

Endoleak:

Reperfused aneurysm

Endoleak !!

After Open

Repair

Open Repair Complications: ENDOLEAK !!!

Perfused lumen 6 year old graft

N Engl J Med 2008;358:464-74.

2830 matched patients in each group @ 4 Years

EVAR Open Surgery p

Reintervention 9.0% 1.7% <0.001

AAA related

Laparotomy related

Procedures 4.1% 9.7% <0.001

Hospitalization for

SBO or Inc Hernia 8.1% 14.2% <0.001

6. New Device Development

Focused on Tailoring Graft to Anatomy !

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

Zenith

FenestratedEndurant AUI

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

Biggest Effort: Reducing Profile

Talent AneuRx Zenith Excluder Powerlink Endurant Ovation Aorfix

2013 Ovation

Sheath 14 F OD1999 Ancure

Sheath 27 F OD

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

Excluder: Thinner constraining Sleeve

Reduced profile 2-4 Fr size

31 and 35 mm Main body down to 18 Fr Profile ID

16,18 and 20 mm contra leg down to 12 Fr ID

23 contra leg down to 14 Fr / 27 mm down to 15 FR ID

23-28.5 Aortic Extenders down to 16 Fr ID

32 mm Aortic Extender 17 Fr and 36 mm down to 18 Fr ID

Same Implant but ePTFE

sleeve made stronger,

denser and thinner to

constrain components at

smaller diameter

Future Design Target includes much lower profile

Released early 2013

Zenith LP: Nitinol Replaces Stainless Steel

Nitinol instead of Stainless

New suprarenal stent design

New capless constraint

New Stent configuration

Woven polyester fabric

New Dilator tip and Cannula

Mostly New Device Still in Trials in US

18-22 Fr ID 16 Fr ID


MC:82 y woman with AAA + severe iliac disease

6mm Balloons

14 Fr Device

MC:82 y woman with AAA + severe iliac disease

Increased Adoption of 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


Aorfix

Incraft**

Zenith ExcluderOvation

Aptus HeliFX

Flexible Construction: Accommodate Anatomy

Excluder Endurant Zenith-flex Aorfix

Most Flexible is the Aorfix: Both Iliacs and Necks

Circular Concentric Rings Designed to

Accommodate Tortuous and Angulated Anatomy

The Aorfix (Lombard)

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

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 Graft

Custom Made

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

How to pick an Endograft

Clinical data

Familiarity and expertise

Ease of use

Stock and availability

Price

2013

Anatomy: Match Device to Anatomy

How to pick an Endograft

Workhorse Standard graft for most: Excluder

New devices have special characteristics to handle

difficult anatomy better

Short Necks 10-14 mm: New more accurate

deployment systems: C3 Excluder, Endurant..

Very Short Necks: Fenestrated Zenith graft

Non Cylindrical necks or small <17 mm: Ovation

Very poor Iliac access: ovation

Severe Neck angulation: Aorfix

Occluded Iliac or very complex iliac aneurysms: AUI

Narrow distal aorta: Endologix or AUI

Branched Grafts on the Horizon

Courtesy of R Greenberg

Branched TAAA Grafts

Courtesy of J Anderson

Branched Arch Grafts

Caution: Investigational device

Summary

EVAR has Excellent early results and good late

outcomes that continue to improve with new devices

that are also expanding its applicability

EVAR has largely replaced Open Repair in the US

in anatomically suitable candidates. This has been

associated with a decrease in total AAA mortality

EVAR had a profound effect on our specialty and

changed the face of Vascular Surgery as we knew it

Presentations & Public Speaking

Twenty years of evar in the us the procedure that changed a specialty