JF Eidt, SAVS 2007 JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft Results Results Results of Thoracic Results of Thoracic Endografting Endografting John F Eidt MD John F Eidt MD University of Arkansas for University of Arkansas for Medical Sciences Medical Sciences [email protected][email protected]
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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
• 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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
What are the results of What are the results of modernmodern open repair of thoracic aneurysm?open repair of thoracic aneurysm?
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
Open thoracic aneurysm repairOpen thoracic aneurysm repairnn 30d Mort30d Mort ParaPara
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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)
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
• 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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
TAG Pivotal Peri-operative Comparative ResultsTAG Pivotal Peri-operative Comparative Results
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
Endovascular treatment of Endovascular treatment of uncomplicateduncomplicated type B dissections type B dissections
• Appeals to reasonAppeals to reason
• ??data????data??
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
Open surgery for traumatic aortic Open surgery for traumatic aortic injury injury
• Mortality 5-25%Mortality 5-25%
• Paraplegia 9-19%Paraplegia 9-19%
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
• 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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
• 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?)
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
• 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
JF Eidt, SAVS 2007JF Eidt, SAVS 2007 Thoracic Endograft Thoracic Endograft ResultsResults
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