JF Eidt, SAVS 2007 Thoracic Endograft Results Results of Thoracic Endografting John F Eidt MD University of Arkansas for Medical Sciences John F Eidt MD University of Arkansas for Medical Sciences

JF Eidt, SAVS 2007 Thoracic Endograft Results No disclosures

JF Eidt, SAVS 2007 Thoracic Endograft Results Results of Thoracic Endografting Thoracic aneurysm Thoracic aneurysm Type B dissection Type B dissection Complicated Complicated Uncomplicated Uncomplicated Trauma disruption Trauma disruption Acute Acute Remote (chronic) Remote (chronic) Other – penetrating aortic ulcers, pseudoaneurysm, IMH Other – penetrating aortic ulcers, pseudoaneurysm, IMH

JF Eidt, SAVS 2007 Thoracic Endograft Results Results of Thoracic Endografting Descending Thoracic Aneurysm Acute aortic injury Pseudoaneurysm Penetrating aortic ulcer Intramural hematoma Acute Type B Dissection Chronic Type B Dissection

JF Eidt, SAVS 2007 Thoracic Endograft Results What is the natural history of thoracic aortic aneurysm? Multiple disease entities Multiple disease entities Ascending, arch, descending, TAAA Ascending, arch, descending, TAAA Surveillance dependent on imaging Surveillance dependent on imaging CXR, CT, CTA, MR CXR, CT, CTA, MR Patients not offered surgery are typically highest risk and not representative of population as whole Patients not offered surgery are typically highest risk and not representative of population as whole

JF Eidt, SAVS 2007 Thoracic Endograft Results 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 2007 Thoracic Endograft Results Univariate 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/m2 Aortic size index >4.25 cm/m2 Female gender (OR 2.73) Female gender (OR 2.73) Aneurysm location in descending aorta (OR 3.2) Aneurysm location in descending 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 2007 Thoracic Endograft Results 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: Unoperated 5 year survival = 13-39% CODAneurysm-related=50% N=170

JF Eidt, SAVS 2007 Thoracic Endograft Results What are the results of modern open repair of thoracic aneurysm?

JF Eidt, SAVS 2007 Thoracic Endograft Results Open thoracic aneurysm repair n 30d Mort ParaVerdantMontreal (10%)0 GallowayNYU (6.5%)0 EhrlichVienna (31%)6(10%) BiglioliMilan (5.5%)7(5%) CooleyTHI (13%)11(8%) CoselliBaylor (4.3%)10(2.6%) Estrera/SafiUT (8%)7(2.3%) GladeNether (11%)4(8%) MakarounTAG (11.7%)13(13.8%) StoneMGH (15.1%)8(8.6%) (9.2%)66(3.9%) 30 d mortality % Paraplegia % 30 d mortality % Paraplegia %

JF Eidt, SAVS 2007 Thoracic Endograft Results Endograft results No randomized trials (Level 1 or 2) No randomized trials (Level 1 or 2) Few case-control series Few case-control series Numerous case series and registries Numerous case series and registries

JF Eidt, SAVS 2007 Thoracic Endograft Results Thoracic endograft case series with >20 patients N=36

JF Eidt, SAVS 2007 Thoracic Endograft Results Thoracic endograft results (all indications) N=3780 patients N=3780 patients 30 day mortality 30 day mortality 6.9% (0-19%) 6.9% (0-19%) Stroke Stroke 3.0% (0-18.6%) 3.0% (0-18.6%) Paraplegia Paraplegia 2.6% (0-12.5%) 2.6% (0-12.5%)

JF Eidt, SAVS 2007 Thoracic Endograft Results Case Series Open (n=10) vs. Endograft (n=37)

JF Eidt, SAVS 2007 Thoracic Endograft Results Case – 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 2007 Thoracic Endograft Results Glade et al Netherlands 2005 Open n= 53 Endo n=42 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; , endo open p=ns

JF Eidt, SAVS 2007 Thoracic Endograft Results Phase II trial Phase II trial Original Device Sept 99 – May 01 GORE TAG Thoracic Endograft Confirmatory Study Confirmatory Study Modified Device Jan 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 2007 Thoracic Endograft Results 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 % 1.0 Major* Adverse 30 days 28 % 70 % Major Bleeding Major Bleeding11% 54 % Major Pulmonary Complications Major Pulmonary Complications 13 % 38 % Major Vascular Complications Major Vascular Complications 18 % 6 % 0.01 Mean Blood Loss 250 ml 1850 ml Mean Hospital Stay 3 d 10 d Return to normal activities 30 d 78 d 0.001

JF Eidt, SAVS 2007 Thoracic Endograft Results Major TAG related Long Term Complications 5 Years follow-up 5 Years follow-up  Rupture0  Migration1  Any any time 17%  5 years 3%  Size 5 Years 23%

TAG Freedom from Major Adverse Events Endo Open Years Since Treatment Freedom from MAE Log Rank P =

TAG Aneurysm Related Mortality Endo Open Years Since Treatment Survival Log Rank P =

22 01/16/2007 TAG All Cause Mortality Endo Open Years Since Treatment Survival Log Rank P = 0.40

JF Eidt, SAVS 2007 Thoracic Endograft Results European Registries Eurostar Eurostar Talent thoracic registry Talent thoracic registry

JF Eidt, SAVS 2007 Thoracic Endograft Results Number of devices

JF Eidt, SAVS 2007 Thoracic Endograft Results 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 I 7% Type I 2% Type II 2% Type II

JF Eidt, SAVS 2007 Thoracic Endograft Results Eurostar Freedom from rupture 98%

JF Eidt, SAVS 2007 Thoracic Endograft Results n=457 n=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 case Endoleak 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, 2006 Talent Thoracic Registry

JF Eidt, SAVS 2007 Thoracic Endograft Results Talent Thoracic Registry 90.2% 74.1% 11 late deaths related to aorta 7 aortic ruptures (all dissections) 2 aortoesophageal fistulas 2 retrograde dissections (?bare stent) 11 late deaths related to aorta 7 aortic ruptures (all dissections) 2 aortoesophageal fistulas 2 retrograde dissections (?bare stent)

JF Eidt, SAVS 2007 Thoracic Endograft Results Effect of AAA on Risk of Spinal Cord Injury (n=125) Baril et al, Ann Vasc Surg 20: 188, 2006

JF Eidt, SAVS 2007 Thoracic Endograft Results Spinal Cord Injury Number of devices Number of devices Length of coverage Length of coverage <205 mm <205 mm Prior AAA Prior AAA Hypotension (MAP <90) Hypotension (MAP <90)

JF Eidt, SAVS 2007 Thoracic Endograft Results

JF Eidt, SAVS 2007 Thoracic Endograft Results TX1 (Cook) – Greenberg et al JVS 41: 589, 2005 (mean f/u 14 m) N=100 Death 30 d 7% Stroke 2.5% 2.5% Paraplegia 6.0%* 6.0%* Prior AAA 55% Secondary intervention 15% Endoleak 12 mos 6.0% 24 mos survival 77% Conduit19% *2 permanent)

JF Eidt, SAVS 2007 Thoracic Endograft Results Valor I (Talent) HIGH RISK All indications N=137 Death 30 d 7.3% (10) 7.3% (10) Paraplegia 0.0% (0) 0.0% (0) Paraparesis 2.2% (3) 2.2% (3) Stroke 8.8% (12) 8.8% (12) Endoleak 10.1% (11) One year survival 74.6% One year rupture 2.2%

JF Eidt, SAVS 2007 Thoracic Endograft Results

JF Eidt, SAVS 2007 Thoracic Endograft Results RELAY ( Bolton Medical, Sunrise, FLA ) N=27 Death 30 d 4.8% 4.8% Paraplegia 3.7% 3.7% Paraparesis 0 Stroke Endoleak7.4% 6 mos survival 95% 6 mos rupture 0

JF Eidt, SAVS 2007 Thoracic Endograft Results Long-term survival is equivalent for open and endovascular repair 5 years Long-term survival is equivalent for open and endovascular repair 5 years

JF Eidt, SAVS 2007 Thoracic Endograft Results Summary: Thoracic Aneurysm Endograft associated with improved short-term outcomes (mortality, LOS, ICU, paraplegia) Endograft associated with improved short-term outcomes (mortality, LOS, ICU, paraplegia) Long-term survival similar to open repair Long-term survival similar to open repair

JF Eidt, SAVS 2007 Thoracic Endograft Results N=317 Medical RX 78% In-hospital mortality 10% Endograft11% 11% Surgery11% 29% Tsai et al, Circulation 114:2226, 2006 Natural History of Acute Type B Dissection: IRAD 2006

JF Eidt, SAVS 2007 Thoracic Endograft Results Tsai et al, Circulation 114:2226, 2006 Natural History of Acute Type B Dissection: IRAD % 3 yr survival after discharge 77-82% 3 yr survival after discharge

JF Eidt, SAVS 2007 Thoracic Endograft Results Endovascular treatment of complicated type B dissections Feasibility established by Nienaber classic 2003 report Feasibility established by Nienaber classic 2003 report n=11 patients with no in-hospital mortality n=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%

JF Eidt, SAVS 2007 Thoracic Endograft Results Endovascular treatment of uncomplicated type B dissections Appeals to reason Appeals to reason ??data?? ??data??

JF Eidt, SAVS 2007 Thoracic Endograft Results INvestigation of STEnt grafts in patients with type B Aortic Dissection: Design of the INSTEAD trial—a prospective, multicenter, European randomized trial Christoph A. Nienaber, MD et al, Am Heart J 2005;149:592-9 Prospective, randomized Prospective, randomized Best medical management vs endograft Best medical management vs endograft >14 d “uncomplicated” type B dissection >14 d “uncomplicated” type B dissection

JF Eidt, SAVS 2007 Thoracic Endograft Results Medical =75% Endograft>95% Based on IRAD data, INSTEAD is powered to detect an 18% mortality difference at 12 months with n=136 IRAD one year survival data used to support INSTEAD

JF Eidt, SAVS 2007 Thoracic Endograft Results INSTEAD results 12 month all cause mortality 12 month all cause mortality Best medical management – 3% Best medical management – 3% Endograft – 10% (NS) Endograft – 10% (NS) Role of endograft in uncomplicated type B dissection remains uncertain Role of endograft in uncomplicated type B dissection remains uncertain

JF Eidt, SAVS 2007 Thoracic Endograft Results Aortic Trauma Traumatic rupture of the aorta is usually fatal; only 10%-20% reach the hospital alive 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 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 The appropriate treatment of the remaining 5-10% remains controversial

JF Eidt, SAVS 2007 Thoracic Endograft Results Open surgery for traumatic aortic injury Mortality 5-25% Mortality 5-25% Paraplegia 9-19% Paraplegia 9-19%

JF Eidt, SAVS 2007 Thoracic Endograft Results Endograft repair of thoracic aortic injury 39 published case series ( ) 39 published case series ( ) 352 patients 352 patients 30 d mortality = 11.2% (0-23.1) 30 d mortality = 11.2% (0-23.1) Paraplegia = None Paraplegia = None

JF Eidt, SAVS 2007 Thoracic Endograft Results Nonoperative management of traumatic aortic injury, Hirose et al, J Trauma, Injury, Infection and Critical Care, 2006, 60: % aorta-related mortality in 133 patients treated non-operatively 1.5% aorta-related mortality in 133 patients treated non-operatively

JF Eidt, SAVS 2007 Thoracic Endograft Results 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 Avoid over-sizing Minimum aortic diameter =23 mm with TAG Avoid over-sizing Minimum aortic diameter =23 mm with TAG

JF Eidt, SAVS 2007 Thoracic Endograft Results Problems to solve Natural history of varied pathology Natural history of varied pathology Etiology of stroke Etiology of stroke Paraplegia – lack of uniform protection Paraplegia – lack of uniform protection Endoleak - treatment Endoleak - treatment Collapse – apposition to inner curve Collapse – apposition to inner curve Durability – esp young patients Durability – esp young patients Branch vessel coverage Branch vessel coverage

JF Eidt, SAVS 2007 Thoracic Endograft Results Summary: Thoracic Endograft No randomized trials No randomized trials Open repair of thoracic aorta is associated with significant mortality and morbidity even in centers of excellence Open repair of thoracic aorta is associated with significant mortality and morbidity even in centers of excellence Endograft repair is feasible and safe Endograft 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 endograft and primarily related to co- morbidities Long-term survival is equal for open and endograft and primarily related to co- morbidities Type I endoleak is more common than Type II Type I endoleak is more common than Type II

JF Eidt, SAVS 2007 Thoracic Endograft Results Summary: Thoracic Endograft 15-20% require iliac/aortic conduit 15-20% require iliac/aortic conduit Major vascular injury more common with endograft Major vascular injury more common with endograft Coverage of LSCA is relatively benign and most avoid prophylactic bypass except Coverage of LSCA is relatively benign and most avoid prophylactic bypass except Dominant L vertebral artery Dominant L vertebral artery Incomplete Circle of Willis Incomplete Circle of Willis Patent LIMA Patent LIMA Coverage of celiac has been associated with catastrophic visceral ischemia (?embolic?) Coverage of celiac has been associated with catastrophic visceral ischemia (?embolic?)

JF Eidt, SAVS 2007 Thoracic Endograft Results Summary: Thoracic Endograft Stroke is at least as common as Spinal Cord Injury Stroke is at least as common as Spinal Cord Injury SCI after endograft is less frequent than after open repair SCI after endograft is less frequent than after open repair SCI linked to number of devices, length of coverage, previous AAA repair, hypotension SCI linked to number of devices, length of coverage, previous AAA repair, hypotension Spinal cord protection strategies are not applied uniformly Spinal cord protection strategies are not applied uniformly SCI very rare in traumatic aortic injury SCI very rare in traumatic aortic injury

JF Eidt, SAVS 2007 Thoracic Endograft Results Summary: Thoracic Endograft Endograft treatment of complicated type B dissections is superior to open surgery 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 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 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 Natural history of penetrating aortic ulcers, intramural hematoma and “remote” traumatic aortic injuries is poorly defined