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Management of Endoleaks after EVAR Michel Makaroun MD Co-Director UPMC Heart and Vascular Institute Professor and Chief, Division of Vascular Surgery University of Pittsburgh School of Medicine

Management of endoleaks after evar asvs 2013

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Page 1: Management of endoleaks after evar asvs 2013

Management of Endoleaks after EVAR

Michel Makaroun MDCo-Director UPMC Heart and Vascular Institute

Professor and Chief, Division of Vascular Surgery University of Pittsburgh School of Medicine

Page 2: Management of endoleaks after evar asvs 2013

Disclosures

Consultant:

WL Gore, Cordis, Medtronic

Research Grants:

WL Gore, Cook, CordisMedtronic, Boston Scientific, Abbott

Bolton, Lombard, Trivascular

Page 3: Management of endoleaks after evar asvs 2013

Type IAttachment leak

Type IIBranch flow

Type IIIDefect in graft ormodular disconnection

Type IVFabric porosity

The Different Types of Endoleaks

Page 4: Management of endoleaks after evar asvs 2013

There is almost uniform consensus about

Type I and III Endoleaks

They are serious and associated with a significant risk of rupture!

Should be treated whenever feasible:

either with

Endovascular Salvage or Open Conversion

Page 5: Management of endoleaks after evar asvs 2013

6 Ruptures All from Type I or Type III

Page 6: Management of endoleaks after evar asvs 2013

TYPE I + III

J Vasc Surg 2002;35:461-73

Page 7: Management of endoleaks after evar asvs 2013

Type I Endoleaks

Page 8: Management of endoleaks after evar asvs 2013

World Review of Ruptures after EVAR55% (129/235) of All Ruptures

are due to Type I endoleaks 38 of the ruptures in the first 30 days

Page 9: Management of endoleaks after evar asvs 2013

Intrasac Pressure Measurements

Before Exclusion

Mean Pressure: 75 mmHg

After EVAR with Type I

Mean Pressure: 111 mmHgBefore Implantation Type I endoleak

Page 10: Management of endoleaks after evar asvs 2013

Earliest EVAR Tube Experience

Parodi first 50 patients (1995)

5 Type I endoleaks (10%) : 3 proximal 2 distal

4 died by 8 months, one from Rupture @2 months

20% Mortality from Rupture 1st year !

Page 11: Management of endoleaks after evar asvs 2013

Earliest EVAR Bifurcated Experience

Chuter first 41 patients (1996)

9 Type I endoleaks (22%)

2 Type I died within 3 days from rupture

22% Mortality from Rupture!

Page 12: Management of endoleaks after evar asvs 2013

Early Experience proved Type I Endoleaks to be serious. ALL Type I Endoleaks have since been treated when feasible

at original procedure or when discovered!!

1. Incidence has decreased significantly2. Very few type I endoleaks are monitored conservatively

Small endoleaks missed at completion angiography Endoleaks difficult to manage by endovascular means

in sick patients with limited life expectancy

Page 13: Management of endoleaks after evar asvs 2013

Endovascular Rx of Type I Endoleaks Extensions with Stent Grafts

High pressure balloons Increase Radial Force by Palmaz Stents

Endostapling

Extension Simple and effective but can be limited by

1. Renals close to the proximal end2. Essential internal iliac artery

In those situationsCoiling of the track may work

Or Coverage of the Renals with chimneys

Rarely Open Conversion is required

Higher Mortality and morbidity

Page 14: Management of endoleaks after evar asvs 2013

Procedural Type I Endoleak Treated by Ballooning

Pre deployment Type I Endoleak Ballooning No more endoleak

Page 15: Management of endoleaks after evar asvs 2013

Procedural Type I Endoleak Treated by Extension

Pre deployment Type I Endoleak Extension No more endoleak

Page 16: Management of endoleaks after evar asvs 2013

Procedural Type I Endoleak Treated with Palmaz

Type I Endoleak Palmaz Stent No Endoleak

Page 17: Management of endoleaks after evar asvs 2013

Procedural Type I Endoleak Treated by Endostaples

Courtesy of Jim Joye DO

Page 18: Management of endoleaks after evar asvs 2013

Late Type I Endoleaks

Can be due to Migration

Aneurysmal degeneration of neck

Enlargement of Iliac arteries

Angulation

Page 19: Management of endoleaks after evar asvs 2013

Treated with New Endograft inside first one

Endovascular Rx of Proximal Type I Endoleakafter Proximal Migration

Page 20: Management of endoleaks after evar asvs 2013

Endovascular Rx of Distal Type I from Iliac Degeneration

7 years post Ancure:

Distal Type I Endoleak

Right Limb

Endoleak

Excluder 14.5 x 7cm Extension

No moreEndoleaks

Treated by Extension

Page 21: Management of endoleaks after evar asvs 2013

Endovascular Rx of Proximal Type I Endoleakafter Proximal Migration

3 years post AneuRx:

Migration and Proximal Type I

No More Endoleaks

Treated by Extension and Palmaz Stent

Page 22: Management of endoleaks after evar asvs 2013

Endovascular Rx of Proximal Type I Endoleakafter Proximal Migration

Treated by Extension and Left renal stent

Type I

Old Type II coiled

NO Type I

No RoomTo extend

Page 23: Management of endoleaks after evar asvs 2013

Endovascular Rx of Proximal Type I Endoleakwith renal coverage and chimneys

Aneurysm neck wall

Poor deployment and Type I Treated with suprarenal Extension and 2 chimneys

FailedExtension

Palmaz

Staples

Page 24: Management of endoleaks after evar asvs 2013

Coiling of Distal Type I

6 months post Tube Ancure

Distal Type I

Graft

Endoleak

Coils1 Month Post Coiling 5.8 cm

Page 25: Management of endoleaks after evar asvs 2013

Coiling of Distal Type I1 year post coiling 4.6 cm 2 years post coiling 3.4 cm

5 year post coiling 2.8 cm4 year post coiling 2.8 cm

Page 26: Management of endoleaks after evar asvs 2013

Type I

Open Conversion

Does not always require complete ExplantationOperative Mortality: 5-10%

High Morbididty

Conversion To Open Repair

Page 27: Management of endoleaks after evar asvs 2013

Type III Endoleaks

Page 28: Management of endoleaks after evar asvs 2013

Fabric Tear and Type III Endoleak

Fabric Tear from Wall stent in Ancure Rx with Excluder Limb6 years after Implantation

Page 29: Management of endoleaks after evar asvs 2013

Limb Disconnection and Type III endoleak

Rt Limb Disconnection in a Lifepath Rx with Excluder Limb 6 years after Implantation

Page 30: Management of endoleaks after evar asvs 2013

How about Type II Endoleaks?

The opinions here are much more divided !

Page 31: Management of endoleaks after evar asvs 2013

The Majority of Endoleaks are Type II

0

20

40

60

80

100

None Type I Type II Type III Type IV TypeIndet

% s

ub

ject

s ev

alu

ated

12 Mos

24 Mos

36 Mos

48 Mos

60 Mos

Excluder Regulatory Trial: 5 year Chart

Page 32: Management of endoleaks after evar asvs 2013

12 MosType II Total % Type II Total % Type II Total %

Talent 10 159 6.2%* 1 118 0.80% 0 113 0.00%Lifepath 4 57 7.00%Excluder 13 86 15.10% 8 55 14.50% 5 36 13.90%Zenith 19 124 15.30% 3 43 7.00%AneuRx 34 327 10.40% 29 210 13.80% 13 92 14.10%Ancure 27 295 9.20% 15 213 7.00% 2 121 1.60%Total 107 1048 10.20% 56 639 8.80% 20 362 5.50%

24 Mos 36 Mos

Occurs with all Grafts in 14% (10-20%) of patients Prevalence decreases to 5-10% between 1-3 years

Sheehan MK, Makaroun MS et al J Vasc Surg 2006;43:657-61

Incidence Similar for ALL Endografts

Page 33: Management of endoleaks after evar asvs 2013

Diagnosis of Type II Endoleaks

CT and Duplex agree in many cases on Endoleak.

Source of Endoleak ???

Page 34: Management of endoleaks after evar asvs 2013

Diagnosis of Type II Endoleaks

Page 35: Management of endoleaks after evar asvs 2013

Source can be difficult to determine Some endoleaks are very complex

90 x 91 mm AAA

MB Nov 2003

MB Dec 2003

Type I Endoleak ??

Or is it IMA Type II ??

CT Diagnosis of Type II Endoleaks

Page 36: Management of endoleaks after evar asvs 2013

SMA Injection

Large Patent IMA

Type II IMA Endoleak

Page 37: Management of endoleaks after evar asvs 2013

MB February 2004

5 Fr Glide cath

RenegadeMicrocath

Transcend .014 wire

Page 38: Management of endoleaks after evar asvs 2013

1. WHEN TO TREAT?

The answer has changed steadily over the years gradually favoring a more conservative approach

The current recommendation: Rx confirmed Type II Endoleaks ONLY when

associated with AAA sac Enlargement !

Also eliminates many unnecessary re-interventions

Page 39: Management of endoleaks after evar asvs 2013

Evidence suggests that Type II endoleaks have a relatively Benign Natural History !

0

10

20

30

40

50

60

70

80

90

OP D/C 3m 6m 12m 24m 36m

Excluded

Endoleaks

No Interventions until 6 Months

2/3 resolve spontaneouslyby 6 months

Makaroun et al Eur J Vasc Endovasc Surg 1999;18:185-90

UPMC 1999

Page 40: Management of endoleaks after evar asvs 2013

Spontaneous resolution can occur Late

Year 1. May 2003

Type II Endoleak

Year 2. May 2004

Type II Endoleak

Year 3. May 2005

No Endoleak

Late Spontaneous Resolution (3 Years)

Page 41: Management of endoleaks after evar asvs 2013

PersistentType II Endoleak

Lumbars

September 2006

+ AAA can shrink despite Type II Endoleak

September 200553 x 55 mm

September 200643 x 45 mm

10 mm Decrease

Page 42: Management of endoleaks after evar asvs 2013

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

Page 43: Management of endoleaks after evar asvs 2013

965 Patients with 154 Type II Endoleaks (16%) 75% seal spontaneously in 5 years (KM analysis) Only 8.4% experienced enlargement > 5mm

J Vasc Surg 2006;44:453-59

Page 44: Management of endoleaks after evar asvs 2013

So Should we Ignore Type II Endoleaks?

Probably not!

Page 45: Management of endoleaks after evar asvs 2013

Review of 270 Aneurysm Ruptures after EVAR Endoleaks the cause of rupture in 160 patients

Type I or III in 114 Patients Type II in 23 Patients

Eur J Vasc Endovasc Surg 2009;37:15-22

Page 46: Management of endoleaks after evar asvs 2013

Type II Endoleaks Usually run a benign course

But can rarely result in rupture

Should ONLY be treated when associated with AAA enlargement!

Caveat: Increasing Sac Size is an unproven surrogate for the potential of future rupture but quite likely

Page 47: Management of endoleaks after evar asvs 2013

2. How to do it?

There is no consensus as to the best way to treat Type II Endoleaks, as they can be very different

from each other and can be very complex to treat.

Page 48: Management of endoleaks after evar asvs 2013

Approaches to Type II Endoleaks

Observation

Laparoscopic clipping of branches

Open Surgical Conversion

Partial or Complete

Endovascular Approaches !!

Page 49: Management of endoleaks after evar asvs 2013

Endovascular Rx of Type II Endoleaks

Multiple Branch Vessels involved IMA Multiple sets of Lumbars Other branches Large Nidus

Diagnosis is usually suspected by Duplex or CT but has to be confirmed at angiography!

Principle of Endo RX

Obliterate the feeding vessels and if possible the nidus

Three Different Approaches Trans-Arterial catheterization:

More technically demanding but potentially more effective

Translumbar puncture Transcaval direct access

Rx Nidus. Difficult to get vessels

Occluding Agents Glue Onyx Thrombin Coils

Page 50: Management of endoleaks after evar asvs 2013

Onyx and Glue are liquid agents that help fill nidus but very expensive and complicate FU

ONYX

18 m later size increased from 9 to 14 cmand presented with a leaking AAA

Page 51: Management of endoleaks after evar asvs 2013

Onyx and Glue are liquid agents that help fill nidus but very expensive and complicate FU

Type III Disconnection

Type IBEndoleak

UnrecognizedType IIEndoleak

Poorly coiled

Page 52: Management of endoleaks after evar asvs 2013

2. How I do itTechnical Notes

Trans-arterial Coaxial System Micro-catheters Coils

Can deliver very long coils if needed (Interlocks) Use Saline flush for short ones instead of coil pushers Make sure it is occluded

Proximal lumbars (L1-L3) near impossible to reach

Page 53: Management of endoleaks after evar asvs 2013

Int Iliac coils

6 Fr Sheath in Internal Iliac5 Fr angled Catheter

Microcatheter

Page 54: Management of endoleaks after evar asvs 2013

Lumbar EndoleakCoils at origin of Lumbar

Page 55: Management of endoleaks after evar asvs 2013

Lumbar Endoleak Coils in LumbarOne month later

Treatment of Type II Endoleaks

Page 56: Management of endoleaks after evar asvs 2013

Coiling of Type II IMA Endoleak

IMA endoleak treated by coiling

Page 57: Management of endoleaks after evar asvs 2013

Type II Endoleaks Can be Complex: Case AH

June 07: Lumbar Type II endoleak

Microcatheter Access

Lumbars CoiledNo endoleak

Page 58: Management of endoleaks after evar asvs 2013

AH Oct 07: Endoleak still present/ AAA larger

Oct 07

PersistentEndoleak

MoreFeeders

RenegadeMicroCatheter Access to AAA Sac

Complex Endoleak

Nidus and Branches Coiled

Some endoleaks are complex and

require multiple interventions

Page 59: Management of endoleaks after evar asvs 2013

Trans-Arterial Access Not Always AvailableOW March 2012

PersistentEndoleak

67x70 mm

Type II EndoleakNo Transarterial Access Right

No Transarterial Access left

Page 60: Management of endoleaks after evar asvs 2013

Trans-Lumbar Approach Reasonable AlternativeOW March 2012

Patient prone Shiba needle/ .018 wire Puncture endoleak Exchange for Stiff wire 6 Fr 30 cm sheath Catheter Eliminate Nidus

Page 61: Management of endoleaks after evar asvs 2013

Trans-Lumbar Approach Reasonable AlternativeOW March 2012

6 Fr Sheath5 Fr angled Catheter

Microcatheter

Page 62: Management of endoleaks after evar asvs 2013

Trans-Caval Approach Useful in Some Patients

Patient Supine Trans-Caval approach

with a Rosch-Uchida catheter

Angiogram Direct embolization of

Nidus and branches Removal of catheter

and completion cavogram

Page 63: Management of endoleaks after evar asvs 2013

3. Does it Work?

A qualified YES! Of course conversions (both partial and complete) do

work but associated morbidity is high

Endovascular interventions are tedious and will work in most, if operator is experienced and persistent

Page 64: Management of endoleaks after evar asvs 2013

3. Does it Work?Unfortunately, Very little long term data exists!

It is easy to make claims of effectiveness since:

a) Many interventions were carried too early when most endoleaks would have resolved spontaneously

b) Many techniques obstruct future imagingc) No clear endpoint of effectiveness: Size of AAA

Page 65: Management of endoleaks after evar asvs 2013

UPMC experience 1995- 2003 All Trans-Arterial coiling

Endoleaks only treated if persistent > 6 months Success: No leaks and stable or shrinking AAA sac

FU: Mean 18 months

J Vasc Surg 2004;40:430-4

Page 66: Management of endoleaks after evar asvs 2013

Results of Coiling

28 patients Follow-up 1-60mos Clinical Success (82%)

15/19 (79%) Type II 8/9 (89%) Type I

Procedural Morbidity 0% Procedural Mortality 0%

Page 67: Management of endoleaks after evar asvs 2013

Type II Endoleaks: Results of Coiling

19 patients 21 attempts

2 patients required more than one intervention

Can be very complex 15 successful

1 IMA 7 pure lumbar 7 combined

Page 68: Management of endoleaks after evar asvs 2013

3 Lumbar CoilsTwo years laterTwo interventions laterCoils Not Occlusive

MultipleCoils addedTill Occlusion

Page 69: Management of endoleaks after evar asvs 2013

Several sources coexist in some complex cases

Type IILumbar

1 Year Year 2

Type IDistal

Year 3

Type IIIMA

Page 70: Management of endoleaks after evar asvs 2013

Endovascular techniques can be used safely and

effectively to Treat Endoleaks after EVAR Type I and Type III should almost always be treated

when discovered Treatment of Type II should be reserved to patients

with sac enlargement Open Conversions may be necessary but carry a

higher morbidity and mortality

Summary

Page 71: Management of endoleaks after evar asvs 2013