jf eidt, savs 2007 thoracic endograft results results of thoracic endografting john f eidt md...

JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults

Results of Thoracic EndograftingResults of Thoracic EndograftingResults of Thoracic EndograftingResults of Thoracic Endografting

John F Eidt MDJohn F Eidt MD

University of Arkansas for Medical University of Arkansas for Medical SciencesSciences

[email protected]@uams.edu

John F Eidt MDJohn F Eidt MD

University of Arkansas for Medical University of Arkansas for Medical SciencesSciences

[email protected]@uams.edu


No disclosuresNo disclosures


Results of Thoracic EndograftingResults of Thoracic Endografting

DescendingDescendingThoracic Thoracic

AneurysmAneurysm

Acute aortic injuryAcute aortic injury

PseudoaneurysmPseudoaneurysm

Penetrating aortic ulcerPenetrating aortic ulcer

Intramural hematomaIntramural hematoma

Acute Type B DissectionAcute Type B Dissection

Chronic Type B Chronic Type B DissectionDissection


What is the natural history of What is the natural history of thoracic aortic aneurysm?thoracic aortic aneurysm?

• Multiple disease entitiesMultiple disease entities

• Ascending, arch, descending, TAAAAscending, arch, descending, TAAA

• Surveillance dependent on imagingSurveillance dependent on imaging

• CXR, CT, CTA, MRCXR, CT, CTA, MR

• Patients not offered surgery are Patients not offered surgery are typically highest risk and not typically highest risk and not representative of population as representative of population as wholewhole


Cumulative risk of rupture of thoracic aneurysm

Davies et al, (Yale Center for Thoracic Aortic Disease), Yearly rupture or dissection rates for thoracic aortic aneurysms: simple prediction based on size. Ann Thoracic Surg 73, 17, 2002


Univariate predictors of ruptureUnivariate predictors of rupture

• Initial aortic size >6 cm (OR 3.7)Initial aortic size >6 cm (OR 3.7)

• Aortic size index >4.25 cm/m2Aortic size index >4.25 cm/m2

• Female gender (OR 2.73)Female gender (OR 2.73)

• Aneurysm location in descending Aneurysm location in descending aorta (OR 3.2)aorta (OR 3.2)

• Presence of AAA (OR 4.6)Presence of AAA (OR 4.6)

Davies et al, (Yale Center for Thoracic Aortic Disease), Yearly rupture or dissection rates for thoracic aortic aneurysms: simple prediction based on size. Ann Thoracic Surg 73, 17, 2002


Perko MJ, Norgaard M, Herzog TM, Olsen PS, Schroeder TV, Pettersson G. Unoperated aortic aneurysms: a survey of 170 patients. Ann Thorac Surg 1995;59:1204-9.

UnoperatedUnoperated5 year survival5 year survival

= 13-39%= 13-39%

COD COD Aneurysm-Aneurysm-

relatedrelated=50%=50%

N=170


What are the results of What are the results of modernmodern open repair of thoracic aneurysm?open repair of thoracic aneurysm?


Open thoracic aneurysm repairOpen thoracic aneurysm repairnn 30d Mort30d Mort ParaPara

VerdantVerdant MontrealMontreal 19951995 351351 35(10%)35(10%) 00

GallowayGalloway NYUNYU 19961996 6262 4(6.5%)4(6.5%) 00

EhrlichEhrlich ViennaVienna 19981998 5858 18(31%)18(31%) 6(10%)6(10%)

BiglioliBiglioli MilanMilan 19991999 143143 8(5.5%)8(5.5%) 7(5%)7(5%)

CooleyCooley THITHI 20002000 132132 17(13%)17(13%) 11(8%)11(8%)

CoselliCoselli BaylorBaylor 20042004 387387 17(4.3%)17(4.3%) 10(2.6%)10(2.6%)

Estrera/SafiEstrera/Safi UTUT 20052005 300300 24(8%)24(8%) 7(2.3%)7(2.3%)

GladeGlade NetherNether 20052005 5353 6(11%)6(11%) 4(8%)4(8%)

MakarounMakaroun TAGTAG 20062006 9494 11(11.7%)11(11.7%) 13(13.8%)13(13.8%)

StoneStone MGHMGH 20062006 9393 14(15.1%)14(15.1%) 8(8.6%)8(8.6%)

16731673 154(9.2%)154(9.2%) 66(3.9%)66(3.9%)

30 d mortality 4.3-31%Paraplegia 0-13.8%

30 d mortality 4.3-31%Paraplegia 0-13.8%


Endograft resultsEndograft results

• No randomized trials (Level 1 or 2)No randomized trials (Level 1 or 2)

• Few case-control seriesFew case-control series

• Numerous case series and Numerous case series and registriesregistries


Thoracic Thoracic endograft endograft case series case series with >20 with >20 patients patients 1999-2006 1999-2006 N=36N=36


Thoracic endograft results Thoracic endograft results (all indications)(all indications)

• N=3780 patientsN=3780 patients

• 30 day mortality30 day mortality

• 6.9% (0-19%)6.9% (0-19%)

• Stroke Stroke

• 3.0% (0-18.6%)3.0% (0-18.6%)

• ParaplegiaParaplegia

• 2.6% (0-12.5%)2.6% (0-12.5%)


Case – Control SeriesCase – Control Series

• Ehrlich et al 1998 (Vienna)Ehrlich et al 1998 (Vienna)

• Glade et al 2005 (Netherlands)Glade et al 2005 (Netherlands)

• TAG Pivotal Trial 2006 (USA)TAG Pivotal Trial 2006 (USA)


Glade et al Netherlands 2005Glade et al Netherlands 2005Open n= 53 Endo n=42Open n= 53 Endo n=42

8%

4%

11%

2%

5%

00

2

4

6

8

10

12

Death Stroke SCI

OpenEndo

Mid-term survival and costs of treatment of patients with descending thoracic aortic Mid-term survival and costs of treatment of patients with descending thoracic aortic aneurysms: endovascular vs. open repair: a case-control study. Glade et al, Eur J aneurysms: endovascular vs. open repair: a case-control study. Glade et al, Eur J Vasc Endovasc Surg 29; 28-34, 2005.Vasc Endovasc Surg 29; 28-34, 2005.

endoopenp=ns


• 99-0199-01 Phase II trial Phase II trial

Original Device Original Device

Sept 99 – May 01Sept 99 – May 01

GORE TAG Thoracic EndograftGORE TAG Thoracic Endograft

• 03-0303-03 Confirmatory Study Confirmatory Study

Modified DeviceModified Device

Jan 04 – Jun 04Jan 04 – Jun 04

Two FDA Studies

FDA approval of the TAG device on March 23, 2005

Original w/ Spine

Modified w/o

Spine


TAG Pivotal Peri-operative Comparative ResultsTAG Pivotal Peri-operative Comparative Results

TAGTAGN = 140N = 140

OPEN OPEN N = 94N = 94 PP

Operative MortalityOperative Mortality 2 %2 % 12 %12 % 0.010.01

Paraplegia or ParaperesisParaplegia or Paraperesis 3 %3 % 14 %14 % 0.010.01

StrokeStroke 4 %4 % 4 %4 % 1.01.0

Major* Adverse Events @ 30 daysMajor* Adverse Events @ 30 days 28 %28 % 70 %70 % 0.00010.0001

Major BleedingMajor Bleeding 11%11% 54 %54 % 0.0010.001

Major Pulmonary ComplicationsMajor Pulmonary Complications 13 %13 % 38 %38 % 0.0010.001

Major Vascular ComplicationsMajor Vascular Complications 18 %18 % 6 %6 % 0.010.01

Mean Blood LossMean Blood Loss 250 ml250 ml 1850 ml1850 ml 0.0010.001

Mean Hospital StayMean Hospital Stay 3 d3 d 10 d10 d 0.0010.001

Return to normal activitiesReturn to normal activities 30 d30 d 78 d78 d 0.0010.001


Major TAG related Long Term ComplicationsMajor TAG related Long Term Complications

5 Years follow-up5 Years follow-up

RuptureRupture 00

MigrationMigration 11

Any Endoleak @ any timeAny Endoleak @ any time 17% 17%

Endoleak @ 5 yearsEndoleak @ 5 years 3% 3%

Size Increase @ 5 YearsSize Increase @ 5 Years 23% 23%

TAG Freedom from Major Adverse Events

Endo Open

Years Since Treatment

0 1 2 3 4

Fre

edo

m f

rom

MA

E

1.0

0.8

0.6

0.4

0.2

0.0

Log Rank P = 0.001

.48.48

.22.22

TAG Aneurysm Related Mortality

Endo Open


0 1 2 3 4

Su

rviv

al

1.0

0.8

0.6

0.4

0.2

0.0

Log Rank P = 0.01

.98.98

.90.90

2201/16/2007

TAG All Cause Mortality

Endo Open


0 1 2 3 4

Su

rviv

al

1.0

0.8

0.6

0.4

0.2

0.0

Log Rank P = 0.40


European RegistriesEuropean Registries

• EurostarEurostar

• Talent thoracic registryTalent thoracic registry


0%

10%

20%

30%

40%

50%

60%

70%

1 2 3 4 5 6 7

Eurostar TTR

Number of devicesNumber of devices


Eurostar (June 2006)Eurostar (June 2006)

• n=656 n=656

• Technical success 90%Technical success 90%

• 30 d Mortality 11.3%30 d Mortality 11.3%

• Spinal cord injury 2.7%Spinal cord injury 2.7%

• Stroke 2.9%Stroke 2.9%

• Endoleak Endoleak

• 7% Type I7% Type I

• 2% Type II2% Type II


Eurostar Freedom from ruptureEurostar Freedom from rupture

98%


• n=457n=457

• Technical success 97.8%Technical success 97.8%

• 30 d Mortality 5%30 d Mortality 5%

• Spinal cord injury 1.8%Spinal cord injury 1.8%

• Stroke 3.7%Stroke 3.7%

• Endoleak 21% at end of caseEndoleak 21% at end of case

• Persistent endoleak 9.6%Persistent endoleak 9.6%

• Type I >>>Type II (7.7% vs. 1.5%)Type I >>>Type II (7.7% vs. 1.5%)

Fattori et al, J Thor Cardiovasc Surg 132, 2006Fattori et al, J Thor Cardiovasc Surg 132, 2006

Talent Thoracic RegistryTalent Thoracic Registry


Talent Thoracic RegistryTalent Thoracic Registry

90.2%

74.1%

11 late deaths related to aorta7 aortic ruptures (all dissections)2 aortoesophageal fistulas2 retrograde dissections

(?bare stent)

11 late deaths related to aorta7 aortic ruptures (all dissections)2 aortoesophageal fistulas2 retrograde dissections

(?bare stent)


Effect of AAA on Risk of Spinal Effect of AAA on Risk of Spinal Cord Injury (n=125)Cord Injury (n=125)

14.3%4 of 28

1.0%1of 97

0

2

4

6

8

10

12

14

16

No AAA AAABaril et al, Ann Vasc Surg 20: 188, 2006Baril et al, Ann Vasc Surg 20: 188, 2006


Spinal Cord InjurySpinal Cord Injury

• Number of devicesNumber of devices

• Length of coverageLength of coverage

• <205 mm<205 mm

• Prior AAAPrior AAA

• Hypotension (MAP <90)Hypotension (MAP <90)


TX1 (Cook) – Greenberg et alTX1 (Cook) – Greenberg et alJVS 41: 589, 2005 (mean f/u 14 m)JVS 41: 589, 2005 (mean f/u 14 m)

N=100N=100

Death 30 dDeath 30 d 7% 7%

StrokeStroke 2.5%2.5%

ParaplegiaParaplegia 6.0%*6.0%*

Prior AAAPrior AAA 55%55%

Secondary interventionSecondary intervention 15% 15%

Endoleak 12 mos Endoleak 12 mos 6.0%6.0%

24 mos survival24 mos survival 77%77%

ConduitConduit 19%19%*2 permanent)*2 permanent)


Valor I (Talent) HIGH RISKValor I (Talent) HIGH RISKAll indicationsAll indications

N=137N=137

Death 30 dDeath 30 d 7.3% (10)7.3% (10)

ParaplegiaParaplegia 0.0% (0)0.0% (0)

ParaparesisParaparesis 2.2% (3)2.2% (3)

StrokeStroke 8.8% (12)8.8% (12)

EndoleakEndoleak 10.1% (11)10.1% (11)

One year survivalOne year survival 74.6%74.6%

One year ruptureOne year rupture 2.2%2.2%


RELAY (RELAY (Bolton Medical, Sunrise, FLABolton Medical, Sunrise, FLA) )

N=27N=27

Death 30 dDeath 30 d 4.8%4.8%

ParaplegiaParaplegia 3.7%3.7%

ParaparesisParaparesis 00

StrokeStroke 3.7%3.7%

EndoleakEndoleak 7.4%7.4%

6 mos survival6 mos survival 95%95%

6 mos rupture6 mos rupture 00


Long-term survivalLong-term survival

0102030405060708090

100

open endo

TAG Open

MGH Open

Glade Open

TAG Endo

MGH Endo

Glade Endo

Brandt Endo

Demers Endo

Eurostar Endo

TTR Endo

AHI Endo

Long-term survivalis equivalent for

open and endovascular repair50-70% @ 5 years

Long-term survivalis equivalent for

open and endovascular repair50-70% @ 5 years


Summary: Thoracic AneurysmSummary: Thoracic Aneurysm

• Endograft associated with Endograft associated with improved short-term outcomes improved short-term outcomes (mortality, LOS, ICU, paraplegia)(mortality, LOS, ICU, paraplegia)

• Long-term survival similar to open Long-term survival similar to open repairrepair


N=317N=317

Medical RXMedical RX

78%78%EndograftEndograft

11%11%SurgerySurgery

11%11%

In-hospital mortalityIn-hospital mortality

10%10%In-hospital mortalityIn-hospital mortality

11%11%In-hospital mortalityIn-hospital mortality

29%29%

Tsai et al, Circulation 114:2226, 2006Tsai et al, Circulation 114:2226, 2006

Natural History of Acute Type Natural History of Acute Type B Dissection: IRAD 2006B Dissection: IRAD 2006


Tsai et al, Circulation 114:2226, 2006Tsai et al, Circulation 114:2226, 2006

Natural History of Acute Type Natural History of Acute Type B Dissection: IRAD 2006B Dissection: IRAD 2006

77-82%3 yr survival

after discharge

77-82%3 yr survival

after discharge


Endovascular treatment of Endovascular treatment of complicatedcomplicated type B dissections type B dissections

• Feasibility established by Nienaber classic Feasibility established by Nienaber classic 2003 report2003 report

• n=11 patients with no in-hospital mortalityn=11 patients with no in-hospital mortality

• Meta-analysis 2006 (Eur Heart J 27; 2006)Meta-analysis 2006 (Eur Heart J 27; 2006)

• Technical success 98%Technical success 98%

• 2 yr survival 90%2 yr survival 90%

• Stroke 2%Stroke 2%

• Paraplegia 1%Paraplegia 1%

• Major complication 11%Major complication 11%


Endovascular treatment of Endovascular treatment of uncomplicateduncomplicated type B dissections type B dissections

• Appeals to reasonAppeals to reason

• ??data????data??


INvestigation of STEnt grafts in patients with type B INvestigation of STEnt grafts in patients with type B Aortic Dissection: Design of the INSTEAD trial—a Aortic Dissection: Design of the INSTEAD trial—a prospective, multicenter, European randomized trialprospective, multicenter, European randomized trialChristoph A. Nienaber, MD et al, Am Heart J 2005;149:592-9Christoph A. Nienaber, MD et al, Am Heart J 2005;149:592-9

• Prospective, randomizedProspective, randomized

• Best medical management vs Best medical management vs endograft endograft

• >14 d “uncomplicated” type B >14 d “uncomplicated” type B dissectiondissection


Medical =75%Medical =75% Endograft>95%Endograft>95%

Based on IRAD data, INSTEAD is powered to detect Based on IRAD data, INSTEAD is powered to detect an 18% mortality difference at 12 months with an 18% mortality difference at 12 months with

n=136n=136

IRAD one year survival data used to support INSTEADIRAD one year survival data used to support INSTEAD


INSTEAD resultsINSTEAD results

• 12 month all cause mortality12 month all cause mortality

• Best medical management – 3%Best medical management – 3%

• Endograft – 10% (NS)Endograft – 10% (NS)

• Role of endograft in uncomplicated Role of endograft in uncomplicated type B dissection remains uncertaintype B dissection remains uncertain


Aortic TraumaAortic Trauma• Traumatic rupture of the aorta is Traumatic rupture of the aorta is

usually fatal; only 10%-20% reach usually fatal; only 10%-20% reach the hospital alivethe hospital alive

• Of those reaching the hospital Of those reaching the hospital alive, an additional 5-10% die alive, an additional 5-10% die within a few hours due to massive, within a few hours due to massive, multi-system injurymulti-system injury

• The appropriate treatment of the The appropriate treatment of the remaining 5-10% remains remaining 5-10% remains controversialcontroversial


Open surgery for traumatic aortic Open surgery for traumatic aortic injury injury

• Mortality 5-25%Mortality 5-25%

• Paraplegia 9-19%Paraplegia 9-19%


Endograft repair of thoracic Endograft repair of thoracic aortic injuryaortic injury

• 39 published case series (2001-39 published case series (2001-2006)2006)

• 352 patients352 patients

• 30 d mortality = 11.2% (0-23.1)30 d mortality = 11.2% (0-23.1)

• Paraplegia = NoneParaplegia = None


Nonoperative management of traumatic aortic injury, Nonoperative management of traumatic aortic injury, Hirose et al, J Trauma, Injury, Infection and Critical Care, Hirose et al, J Trauma, Injury, Infection and Critical Care, 2006, 60: 5972006, 60: 597

1.5% aorta-related mortalityin 133 patients

treated non-operatively

1.5% aorta-related mortalityin 133 patients

treated non-operatively


Steinbauer et al, JVS 43: 609, 2006Steinbauer et al, JVS 43: 609, 2006Idu, MM. Collapse of a stent-graft following treatment of Idu, MM. Collapse of a stent-graft following treatment of a traumatic thoracic aortic rupture. Journal of a traumatic thoracic aortic rupture. Journal of Endovascular Therapy: 12(4):503-7, 2005Endovascular Therapy: 12(4):503-7, 2005

Avoid over-sizingMinimum aortic diameter

=23 mm with TAG

Avoid over-sizingMinimum aortic diameter

=23 mm with TAG


Problems to solveProblems to solve

• Natural history of varied pathologyNatural history of varied pathology

• Etiology of strokeEtiology of stroke

• Paraplegia – lack of uniform protection Paraplegia – lack of uniform protection

• Endoleak - treatmentEndoleak - treatment

• Collapse – apposition to inner curveCollapse – apposition to inner curve

• Durability – esp young patientsDurability – esp young patients

• Branch vessel coverageBranch vessel coverage


Summary: Thoracic EndograftSummary: Thoracic Endograft

• No randomized trialsNo randomized trials

• Open repair of thoracic aorta is associated Open repair of thoracic aorta is associated with significant mortality and morbidity even in with significant mortality and morbidity even in centers of excellencecenters of excellence

• Endograft repair is feasible and safeEndograft repair is feasible and safe

• Technical success in more than 98%Technical success in more than 98%

• Long-term survival is equal for open and Long-term survival is equal for open and endograft and primarily related to co-endograft and primarily related to co-morbiditiesmorbidities

• Type I endoleak is more common than Type IIType I endoleak is more common than Type II



• 15-20% require iliac/aortic conduit15-20% require iliac/aortic conduit

• Major vascular injury more common with Major vascular injury more common with endograftendograft

• Coverage of LSCA is relatively benign and Coverage of LSCA is relatively benign and most avoid prophylactic bypass exceptmost avoid prophylactic bypass except• Dominant L vertebral arteryDominant L vertebral artery

• Incomplete Circle of WillisIncomplete Circle of Willis

• Patent LIMAPatent LIMA

• Coverage of celiac has been associated with Coverage of celiac has been associated with catastrophic visceral ischemia (?embolic?)catastrophic visceral ischemia (?embolic?)



• Stroke is at least as common as Spinal Cord Stroke is at least as common as Spinal Cord InjuryInjury

• SCI after endograft is less frequent than after SCI after endograft is less frequent than after open repairopen repair

• SCI linked to number of devices, length of SCI linked to number of devices, length of coverage, previous AAA repair, hypotensioncoverage, previous AAA repair, hypotension

• Spinal cord protection strategies are not Spinal cord protection strategies are not applied uniformly applied uniformly

• SCI SCI very rarevery rare in traumatic aortic injury in traumatic aortic injury


Summary: Thoracic EndograftSummary: Thoracic Endograft• Endograft treatment of Endograft treatment of complicatedcomplicated type B type B

dissections is superior to open surgerydissections is superior to open surgery

• Endograft treatment of uncomplicated type B Endograft treatment of uncomplicated type B dissections dissections may notmay not be superior to best medical be superior to best medical managementmanagement

• Role of endograft in treatment of traumatic Role of endograft in treatment of traumatic aortic injury is feasible but of unproven benefit – aortic injury is feasible but of unproven benefit – No FDA-approved deviceNo FDA-approved device

• Natural history of penetrating aortic ulcers, Natural history of penetrating aortic ulcers, intramural hematoma and “remote” traumatic intramural hematoma and “remote” traumatic aortic injuries is poorly definedaortic injuries is poorly defined

jf eidt, savs 2007 thoracic endograft results results of thoracic endografting john f eidt md...

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