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Results of Thoracic Endografting

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Title: Results of Thoracic Endografting


1
Results of Thoracic Endografting
  • John F Eidt MD
  • University of Arkansas for Medical Sciences
  • eidtjohnf_at_uams.edu

2
No disclosures
3
Results of Thoracic Endografting
  • Thoracic aneurysm
  • Type B dissection
  • Complicated
  • Uncomplicated
  • Trauma disruption
  • Acute
  • Remote (chronic)
  • Other penetrating aortic ulcers,
    pseudoaneurysm, IMH

4
Results of Thoracic Endografting
Chronic Type B Dissection
Acute Type B Dissection
Acute aortic injury
Descending Thoracic Aneurysm
Pseudoaneurysm
Intramural hematoma
Penetrating aortic ulcer
5
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

6
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
7
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
8
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.
9
What are the results of modern open repair of
thoracic aneurysm?
10
Open thoracic aneurysm repair
30 d mortality 4.3-31 Paraplegia 0-13.8
11
Endograft results
  • No randomized trials (Level 1 or 2)
  • Few case-control series
  • Numerous case series and registries

12
Thoracic endograft case series with gt20 patients
1999-2006 N36
13
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)

14
Case SeriesOpen (n10) vs. Endograft (n37)
15
Case Control Series
  • Ehrlich et al 1998 (Vienna)
  • Glade et al 2005 (Netherlands)
  • TAG Pivotal Trial 2006 (USA)

16
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.
17
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
18
TAG Pivotal Peri-operative Comparative Results
19
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

20
TAG Freedom from Major Adverse Events
.48
.22
21
TAG Aneurysm Related Mortality
.98
.90
22
TAG All Cause Mortality
23
European Registries
  • Eurostar
  • Talent thoracic registry

24
Number of devices
25
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

26
Eurostar Freedom from rupture
98
27
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
28
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
29
Effect of AAA on Risk of Spinal Cord Injury
(n125)
Baril et al, Ann Vasc Surg 20 188, 2006
30
Spinal Cord Injury
  • Number of devices
  • Length of coverage
  • lt205 mm
  • Prior AAA
  • Hypotension (MAP lt90)

31
(No Transcript)
32
TX1 (Cook) Greenberg et alJVS 41 589, 2005
(mean f/u 14 m)
2 permanent)
33
Valor I (Talent) HIGH RISKAll indications
34
(No Transcript)
35
RELAY (Bolton Medical, Sunrise, FLA)
36
Long-term survival
Long-term survival is equivalent for open and
endovascular repair 50-70 _at_ 5 years
37
Summary Thoracic Aneurysm
  • Endograft associated with improved short-term
    outcomes (mortality, LOS, ICU, paraplegia)
  • Long-term survival similar to open repair

38
Natural History of Acute Type B Dissection IRAD
2006
Tsai et al, Circulation 1142226, 2006
39
Natural History of Acute Type B Dissection IRAD
2006
77-82 3 yr survival after discharge
Tsai et al, Circulation 1142226, 2006
40
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

41
Endovascular treatment of uncomplicated type B
dissections
  • Appeals to reason
  • ??data??

42
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

43
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
44
INSTEAD results
  • 12 month all cause mortality
  • Best medical management 3
  • Endograft 10 (NS)
  • Role of endograft in uncomplicated type B
    dissection remains uncertain

45
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

46
Open surgery for traumatic aortic injury
  • Mortality 5-25
  • Paraplegia 9-19

47
Endograft repair of thoracic aortic injury
  • 39 published case series (2001-2006)
  • 352 patients
  • 30 d mortality 11.2 (0-23.1)
  • Paraplegia None

48
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
49
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
50
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

51
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

52
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?)

53
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

54
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
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