2. Thoracic Stent Graft Zenith ® TX1

3. Thoracic Stent Graft The Zenith ® TAA One Piece Endovascular Graft is a customized graft with the H&L-BOne-Shot™ Introducer System designed for endovascular repair of Thoracic Aortic Aneurysms (TAA) in the descending aorta. It is intended for treatment of patients with atherosclerotic aneurysms, symptomatic acute or chronic dissections, contained ruptures, growing aneurysms and/or aneurysms resulting in distal ischemia.

4. Aneurismal disease Aortic dissection Traumatic Aortic Rupture Thoracic Stent Graft Indications

5. Thoracic Stent Graft Contraindications Insufficient flow to sustain stent graft patency Arterial vessels incompatible with the delivery system Aneurysm dimensions outside range of the graft system dimensions Lesions that cannot be crossed with a delivery system Systemic infection Allergic reaction to contrast media, device materials or anticoagulant therapy Congenital degenerative collagen disease (e.g. Marfan's syndrome) Pregnancy Thrombus in the proposed landing zones Risk of occlusion of the carotid artery, SMA or other vital vessels

6. The Thoracic Aorta is not the Abdominal Aorta High flow and pulsatility Different pathologies Different anatomy –larger diameter vessel –curved –different branch vessels to consider

7. Advantages: Tube Graft - simple Single groin access Disadvantages : Curve High flow The Thoracic Aorta is not the Abdominal Aorta

8. Device Design for Thoracic Aorta Accurate positioning Flexible and conforms to curve

9. Characteristics of the Stent Graft Bottom uncovered stent with barbs –Thickness is 16/1000 inch, length 26 mm Sealing stent (internal) –Thickness is 15/1000 inch, length 17 mm Body stents (external) –Thickness is 14/1000 inch, length 14 mm Top sealing stent with barbs (internal) –Thickness is 16/1000 inch, length 17 mm

10. Woven Polyester Mesh Thickness is 0.35 mm Porosity is 350 ml/min/cm 2 Suture material is –Green, polyester ethibond –Blue, polypropylene

11. Radiopaque Markers 4 gold markers at the top 4 gold markers at the bottom Longitudinal markers

12. Sizes Graft Diameter (REG. TRIAL) –22-34 mm proximal and distal –length: min 75 mm/max 150 mm (Larger diameters available only upon request) Graft Diameter (CLIN. INVEST) –22-42 mm proximal and distal –length: min 75 mm/max 225 mm Introducer Diameter –18 FR for a graft diameter:  -  26 mm –20 FR for a graft diameter:  28 -  34 mm –22 FR for a graft diameter: 36 - 42 mm

13. Internal/External Stents Inner stents for sealing –One or two top internal stents possible –Top inner stent with barbs penetrating the graft External stents –Smooth inner surface –Pressure from within the lumen; the polyester mesh is being pushed against the stents

14. Gaps 5 mm gaps –Diameter of the graft 22-26 mm 7 mm gaps –Diameter of the graft 28-34 mm 10 mm gaps –Diameter of the graft 36-42 mm

16. Top Inner Stent with Barbs 17 mm long (to facilitate the curve) Barbs are 5 mm long Inside for sealing Held by a release wire attached to the release bottom on the introducer handle

17. Bottom Uncovered Stent with Barbs 26 mm long Barbs are 5 mm long Secured at the bottom cap with a release wire Uncovered stent –For safe distal fixation of the stent

18. Introducer System Sheath with hemostatic valve with sideport Metal needle tubing with COONS dilator Pusher with bottom cap Two release wires

19. Sheath 18 FR (22-26 mm) 20 FR (28-34 mm) 22 FR (36-42 mm) 70 cm long Low friction PTFE

20. Metal Needle Tube with Coons Dilator Curved Straight 100 mm long 80 mm long No sideholes for angiography!

22. Pusher Made from PVC Attached to the handle with bottom caps Carrier of the two release wires

23. Handle Black release wire mechanism locking bottom uncovered stent White release wire mechanism locking covered top stent

24. Release Wires One to hold the proximal part closed One through the bottom cap to overcome accidental release of the bottom stent Both wires are connected with the black and white knobs on the handle

25. Sliding Handle To release bottom uncovered stent

26. Pin Vise Locking mechanism for metal tube to control tip movement

27. Metal Tube Stopper to avoid unintended release of graft Lumen for.035 inch wire guide

29. Procedure In theatre or in the vascular radiology suite C-arm - mobile or stationary X-ray unit Surgeon with radiologist

30. Preparation Artery selection for delivery system entry Tortuosity of the access vessels and aneurysm Quality of the landing zones Landing zone diameters distance between the proximal and distal landing zones

31. Preparation Unilateral femoral cut down 2500 units of heparin/systemic dose Prepare the device 10.000 units/100 ml Catheter through the SCA

32. Image showing the catheter through the SCA

33. Placement Always under fluoroscopy Over a 260 cm LES or AUS wire Never rotate the introduction system The dilator tip softens at body temp. Connect a heparin drip (1000u/500ml)

34. Deployment Lower patient’s blood pressure (if possible) Withdraw the sheath (verify position with angiography). You can push the graft up, but never pull it down.

35. Further Deployment Continue to withdraw sheath until the hemoreduction valve docks with the control handle Check position again and if ok release safety wire 1 Remove the security screw and withdraw the front part of the handle till it docks with the back part of the handle. The bottom cap is opened Remove security wire 2 and the top will be deployed

38. Finalizing Molding balloon Final angiography

39. New Areas Rupture Type B dissections

40. Thoracic Aortic Rupture A new indication for stent graft? Open repair - high morbidity/mortality Distance to left SCA - short prox. neck Optimal device design? Frequently other serious injuries Immediate or delayed treatment?

41. Traumatic thoracic aortic aneurysm: treatment with endovascular stent-grafts NH Kato, MD Dake, DC Miller, CP Semba, RS Mitchell, MK Razavi and ST Kee Radiology 1997; 205: 657-662 Delayed treatment of traumatic rupture of the thoracic aorta with endoluminal covered stent H Rousseau, P Soula, P Perreault, B Bui, et al Circulation. 1999; 99: 498-504

42. Thoracic Aortic Rupture

48. Stent Graft for Type B Dissection; Issues Continued perfusion of false lumen   mortality Medical R x still has risk of rupture and progression Surgery has high risk of death and paraplegia AIM: Aortic remodeling due to stent expansion of true lumen and thrombosis and retraction of false lumen

49. Nonsurgical reconstruction of thoracic aortic dissection by stent-graft placement Christoph A Nienaber, Rossella Fattori, Gunnar Lund et al N Engl J Med 340(20):1539-45, 1999 May 20 Conclusion: Preliminary observations suggest that elective, nonsurgical insertion of an endovascular stent graft is safe and efficacious in selected patients who have thoracic aortic dissection and for whom surgery is indicated. Endoluminal repair may be useful for interventional reconstruction of thoracic aortic dissection

50. Stent Graft for Type B Dissection; Issues Lumen 5.5 cm or greater Luminal expansion or pain Proximal entry point to false lumen Entry point  0.5 cm from LSCA 1 iliac without dissection

51. Thoracic Aorta - Conclusions Promising area No long term data Studies needed

52. Thoracic Aorta - Questions Which cases to treat? Acute or delayed treatment? Custom or standard grafts? Transpose LSCA? Stop the heart? Further improvements in design?

53. Thoracic Endovascular Graft

54. Anatomy