Results of Thoracic Endografting

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Results of Thoracic Endografting

• John F Eidt MD
• University of Arkansas for Medical Sciences
• eidtjohnf_at_uams.edu

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No disclosures
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Results of Thoracic Endografting

• Thoracic aneurysm
• Type B dissection
• Complicated
• Uncomplicated
• Trauma disruption
• Acute
• Remote (chronic)
• Other penetrating aortic ulcers,
  pseudoaneurysm, IMH

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Results of Thoracic Endografting
Chronic Type B Dissection
Acute Type B Dissection
Acute aortic injury
Descending Thoracic Aneurysm
Pseudoaneurysm
Intramural hematoma
Penetrating aortic ulcer
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What is the natural history of thoracic aortic
aneurysm?

• Multiple disease entities
• Ascending, arch, descending, TAAA
• Surveillance dependent on imaging
• CXR, CT, CTA, MR
• Patients not offered surgery are typically
  highest risk and not representative of population
  as whole

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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
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Univariate predictors of rupture

• Initial aortic size gt6 cm (OR 3.7)
• Aortic size index gt4.25 cm/m2
• Female gender (OR 2.73)
• Aneurysm location in descending aorta (OR 3.2)
• 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
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N170
Unoperated 5 year survival 13-39 COD
Aneurysm- related 50
Perko MJ, Norgaard M, Herzog TM, Olsen PS,
Schroeder TV, Pettersson G. Unoperated aortic
aneurysms a survey of 170 patients. Ann Thorac
Surg 1995591204-9.
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What are the results of modern open repair of
thoracic aneurysm?
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Open thoracic aneurysm repair
n 30d Mort Para
Verdant Montreal 1995 351 35(10) 0
Galloway NYU 1996 62 4(6.5) 0
Ehrlich Vienna 1998 58 18(31) 6(10)
Biglioli Milan 1999 143 8(5.5) 7(5)
Cooley THI 2000 132 17(13) 11(8)
Coselli Baylor 2004 387 17(4.3) 10(2.6)
Estrera/Safi UT 2005 300 24(8) 7(2.3)
Glade Nether 2005 53 6(11) 4(8)
Makaroun TAG 2006 94 11(11.7) 13(13.8)
Stone MGH 2006 93 14(15.1) 8(8.6)
1673 154(9.2) 66(3.9)
30 d mortality 4.3-31 Paraplegia 0-13.8
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Endograft results

• No randomized trials (Level 1 or 2)
• Few case-control series
• Numerous case series and registries

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Thoracic endograft case series with gt20 patients
1999-2006 N36
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Thoracic endograft results (all indications)

• N3780 patients
• 30 day mortality
• 6.9 (0-19)
• Stroke
• 3.0 (0-18.6)
• Paraplegia
• 2.6 (0-12.5)

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Case SeriesOpen (n10) vs. Endograft (n37)
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Case Control Series

• Ehrlich et al 1998 (Vienna)
• Glade et al 2005 (Netherlands)
• TAG Pivotal Trial 2006 (USA)

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Glade et al Netherlands 2005Open n 53 Endo n42
pns
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 Vasc
Endovasc Surg 29 28-34, 2005.
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GORE TAG Thoracic Endograft
Two FDA Studies

• 99-01 Phase II trial
• Original Device
• Sept 99 May 01

Original w/ Spine

• 03-03 Confirmatory Study
• Modified Device
• Jan 04 Jun 04

Modified w/o Spine
FDA approval of the TAG device on March 23, 2005
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TAG Pivotal Peri-operative Comparative Results
TAG N 140 OPEN N 94 P
Operative Mortality 2 12 0.01
Paraplegia or Paraperesis 3 14 0.01
Stroke 4 4 1.0
Major Adverse Events _at_ 30 days 28 70 0.0001
Major Bleeding 11 54 0.001
Major Pulmonary Complications 13 38 0.001
Major Vascular Complications 18 6 0.01
Mean Blood Loss 250 ml 1850 ml 0.001
Mean Hospital Stay 3 d 10 d 0.001
Return to normal activities 30 d 78 d 0.001
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Major TAG related Long Term Complications

• 5 Years follow-up
• Rupture 0
• Migration 1
• Any Endoleak _at_ any time 17
• Endoleak _at_ 5 years 3
• Size Increase _at_ 5 Years 23

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TAG Freedom from Major Adverse Events
.48
.22
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TAG Aneurysm Related Mortality
.98
.90
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TAG All Cause Mortality
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European Registries

• Eurostar
• Talent thoracic registry

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Number of devices
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Eurostar (June 2006)

• n656
• Technical success 90
• 30 d Mortality 11.3
• Spinal cord injury 2.7
• Stroke 2.9
• Endoleak
• 7 Type I
• 2 Type II

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Eurostar Freedom from rupture
98
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Talent Thoracic Registry

• n457
• Technical success 97.8
• 30 d Mortality 5
• Spinal cord injury 1.8
• Stroke 3.7
• Endoleak 21 at end of case
• Persistent endoleak 9.6
• Type I gtgtgtType II (7.7 vs. 1.5)

Fattori et al, J Thor Cardiovasc Surg 132, 2006
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Talent Thoracic Registry
11 late deaths related to aorta 7 aortic
ruptures (all dissections) 2 aortoesophageal
fistulas 2 retrograde dissections (?bare stent)
90.2
74.1
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Effect of AAA on Risk of Spinal Cord Injury
(n125)
Baril et al, Ann Vasc Surg 20 188, 2006
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Spinal Cord Injury

• Number of devices
• Length of coverage
• lt205 mm
• Prior AAA
• Hypotension (MAP lt90)

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TX1 (Cook) Greenberg et alJVS 41 589, 2005
(mean f/u 14 m)
N100
Death 30 d 7
Stroke 2.5
Paraplegia 6.0
Prior AAA 55
Secondary intervention 15
Endoleak 12 mos 6.0
24 mos survival 77
Conduit 19
2 permanent)
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Valor I (Talent) HIGH RISKAll indications
N137
Death 30 d 7.3 (10)
Paraplegia 0.0 (0)
Paraparesis 2.2 (3)
Stroke 8.8 (12)
Endoleak 10.1 (11)
One year survival 74.6
One year rupture 2.2
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(No Transcript)
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RELAY (Bolton Medical, Sunrise, FLA)
N27
Death 30 d 4.8
Paraplegia 3.7
Paraparesis 0
Stroke 3.7
Endoleak 7.4
6 mos survival 95
6 mos rupture 0
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Long-term survival
Long-term survival is equivalent for open and
endovascular repair 50-70 _at_ 5 years
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Summary Thoracic Aneurysm

• Endograft associated with improved short-term
  outcomes (mortality, LOS, ICU, paraplegia)
• Long-term survival similar to open repair

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Natural History of Acute Type B Dissection IRAD
2006
Tsai et al, Circulation 1142226, 2006
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Natural History of Acute Type B Dissection IRAD
2006
77-82 3 yr survival after discharge
Tsai et al, Circulation 1142226, 2006
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Endovascular treatment of complicated type B
dissections

• Feasibility established by Nienaber classic 2003
  report
• n11 patients with no in-hospital mortality
• Meta-analysis 2006 (Eur Heart J 27 2006)
• Technical success 98
• 2 yr survival 90
• Stroke 2
• Paraplegia 1
• Major complication 11

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Endovascular treatment of uncomplicated type B
dissections

• Appeals to reason
• ??data??

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INvestigation of STEnt grafts in patients with
type B Aortic Dissection Design of the INSTEAD
triala prospective, multicenter, European
randomized trialChristoph A. Nienaber, MD et al,
Am Heart J 2005149592-9

• Prospective, randomized
• Best medical management vs endograft
• gt14 d uncomplicated type B dissection

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IRAD one year survival data used to support
INSTEAD
Medical 75
Endograftgt95
Based on IRAD data, INSTEAD is powered to detect
an 18 mortality difference at 12 months with
n136
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INSTEAD results

• 12 month all cause mortality
• Best medical management 3
• Endograft 10 (NS)
• Role of endograft in uncomplicated type B
  dissection remains uncertain

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Aortic Trauma

• Traumatic rupture of the aorta is usually fatal
  only 10-20 reach the hospital alive
• Of those reaching the hospital alive, an
  additional 5-10 die within a few hours due to
  massive, multi-system injury
• The appropriate treatment of the remaining 5-10
  remains controversial

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Open surgery for traumatic aortic injury

• Mortality 5-25
• Paraplegia 9-19

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Endograft repair of thoracic aortic injury

• 39 published case series (2001-2006)
• 352 patients
• 30 d mortality 11.2 (0-23.1)
• Paraplegia None

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Nonoperative management of traumatic aortic
injury, Hirose et al, J Trauma, Injury, Infection
and Critical Care, 2006, 60 597
1.5 aorta-related mortality in 133
patients treated non-operatively
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Avoid over-sizing Minimum aortic diameter 23 mm
with TAG
Steinbauer et al, JVS 43 609, 2006 Idu, MM.
Collapse of a stent-graft following treatment of
a traumatic thoracic aortic rupture. Journal of
Endovascular Therapy 12(4)503-7, 2005
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Problems to solve

• Natural history of varied pathology
• Etiology of stroke
• Paraplegia lack of uniform protection
• Endoleak - treatment
• Collapse apposition to inner curve
• Durability esp young patients
• Branch vessel coverage

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Summary Thoracic Endograft

• No randomized trials
• Open repair of thoracic aorta is associated with
  significant mortality and morbidity even in
  centers of excellence
• Endograft repair is feasible and safe
• Technical success in more than 98
• Long-term survival is equal for open and
  endograft and primarily related to co-morbidities
• Type I endoleak is more common than Type II

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Summary Thoracic Endograft

• 15-20 require iliac/aortic conduit
• Major vascular injury more common with endograft
• Coverage of LSCA is relatively benign and most
  avoid prophylactic bypass except
• Dominant L vertebral artery
• Incomplete Circle of Willis
• Patent LIMA
• Coverage of celiac has been associated with
  catastrophic visceral ischemia (?embolic?)

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Summary Thoracic Endograft

• Stroke is at least as common as Spinal Cord
  Injury
• SCI after endograft is less frequent than after
  open repair
• SCI linked to number of devices, length of
  coverage, previous AAA repair, hypotension
• Spinal cord protection strategies are not applied
  uniformly
• SCI very rare in traumatic aortic injury

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Summary Thoracic Endograft

• Endograft treatment of complicated type B
  dissections is superior to open surgery
• Endograft treatment of uncomplicated type B
  dissections may not be superior to best medical
  management
• Role of endograft in treatment of traumatic
  aortic injury is feasible but of unproven benefit
  No FDA-approved device
• Natural history of penetrating aortic ulcers,
  intramural hematoma and remote traumatic aortic
  injuries is poorly defined