Results of Thoracic Endografting

1. Results of Thoracic Endografting John F Eidt MD University of Arkansas for Medical Sciences eidtjohnf@uams.edu

2. No disclosures

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

4. 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

5. 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

6. Univariate predictors of rupture • Initial aortic size >6 cm (OR 3.7) • Aortic size index >4.25 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

7. N=170 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 1995;59:1204-9.

8. What are the results of modern open repair of thoracic aneurysm?

9. Open thoracic aneurysm repair 30 d mortality 4.3-31% Paraplegia 0-13.8%

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

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

12. Thoracic endograft results (all indications) • N=3780 patients • 30 day mortality • 6.9% (0-19%) • Stroke • 3.0% (0-18.6%) • Paraplegia • 2.6% (0-12.5%)

13. Case – Control Series • Ehrlich et al 1998 (Vienna) • Glade et al 2005 (Netherlands) • TAG Pivotal Trial 2006 (USA)

14. endo open Glade et al Netherlands 2005Open n= 53 Endo n=42 p=ns 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.

15. 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

16. TAG Pivotal Peri-operative Comparative Results

17. Major TAG related Long Term Complications 5 Years follow-up • Rupture 0 • Migration 1 • Any Endoleak @ any time 17% • Endoleak @ 5 years 3% • Size Increase @ 5 Years 23%

18. 1.0 0.8 0.6 0.4 0.2 0.0 Log Rank P = 0.001 Freedom from MAE Endo Open 0 1 2 3 4 Years Since Treatment TAG Freedom from Major Adverse Events .48 .22

19. 1.0 0.8 0.6 0.4 0.2 0.0 Log Rank P = 0.01 Survival Endo Open 0 1 2 3 4 Years Since Treatment TAG Aneurysm Related Mortality .98 .90

20. 1.0 0.8 0.6 0.4 0.2 0.0 Log Rank P = 0.40 Survival Endo Open 0 1 2 3 4 Years Since Treatment TAG All Cause Mortality

21. European Registries • Eurostar • Talent thoracic registry

22. Number of devices

23. Eurostar (June 2006) • n=656 • Technical success 90% • 30 d Mortality 11.3% • Spinal cord injury 2.7% • Stroke 2.9% • Endoleak • 7% Type I • 2% Type II

24. Eurostar Freedom from rupture 98%

25. Talent Thoracic Registry • n=457 • 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 >>>Type II (7.7% vs. 1.5%) Fattori et al, J Thor Cardiovasc Surg 132, 2006

26. 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%

27. Effect of AAA on Risk of Spinal Cord Injury (n=125) Baril et al, Ann Vasc Surg 20: 188, 2006

28. Spinal Cord Injury • Number of devices • Length of coverage • <205 mm • Prior AAA • Hypotension (MAP <90)

30. TX1 (Cook) – Greenberg et alJVS 41: 589, 2005 (mean f/u 14 m) *2 permanent)

31. Valor I (Talent) HIGH RISKAll indications

33. RELAY (Bolton Medical, Sunrise, FLA)

34. Long-term survival Long-term survival is equivalent for open and endovascular repair 50-70% @ 5 years

35. Summary: Thoracic Aneurysm • Endograft associated with improved short-term outcomes (mortality, LOS, ICU, paraplegia) • Long-term survival similar to open repair

36. Natural History of Acute Type B Dissection: IRAD 2006 Tsai et al, Circulation 114:2226, 2006

37. Natural History of Acute Type B Dissection: IRAD 2006 77-82% 3 yr survival after discharge Tsai et al, Circulation 114:2226, 2006

38. Endovascular treatment of complicated type B dissections • Feasibility established by Nienaber classic 2003 report • n=11 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%

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

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

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

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

43. 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

44. Open surgery for traumatic aortic injury • Mortality 5-25% • Paraplegia 9-19%

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

46. 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

47. 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

48. 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

49. 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

50. 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?)