1. ONE STAGE REPAIR IN COMPLEX AORTIC DISEASE : SURGERY COMBINED WITH OPEN DISTAL STENT GRAFTING REQUIRES A NEW STENT GRAFT DESIGN U. Herold, M. Kamler, I. Aleksic, K. Tsagakis, J. Piotrowski, H. Jakob 34. Jahrestagung der Deutschen Gesellschaft für Herz-, Thorax- und Gefäßchirurgie Hamburg 13. - 16. Februar 2005

2. 2 Background In standard repair of complex thoracic aortic disease the descending aorta remains untreated Enlargement10 % Rupture 20 % Malperfusion Syndromes 2-5% Mortality 2nd stage10 % Kirsch M, et al. 2002; 123 : 318-25Safi HJ, et al. 2004; 240 : 677 - 685

3. 3 Objective The combined procedure (Surgery + Open Distal Stent Grafting) represents a new method towards one stage repair Commercially available standard stent graft devices are inappropriate due to their lay out for retrograde aortic delivery

4. 4 Patients & Methods 01/00 - 02/05 275 pts underwent surgery for aortic pathology -> 15 pts were treated with the combined procedure Mean age 56 yrs (range 39 – 76 yrs), male 58% Pathology : Acute Type A Diss.3(20%) Chron Type A Diss.5 (33%) Compl. Type B Diss.3 (20%) True Aneurysm4(27%)

5. 5 Surgical Technique Placement of the stent graft (after distal open anastomosis) in open antegrade fashion Control of false/true lumen flow by on-line TEE and on table angiography (Hybrid OR) SACP : Perfusion 10 ml/kg/BW; 18 C°, max. mean perfusion pressure 50 mmHg

6. 6 Hybrid OR

7. 7 Phase A (2001 n=3 ) Medtronic ® Talent Endoluminal Stent Graft Device Open distal and proximal bar ends Covered portion 13.5 cm (stent 15 cm) Introducer device 170 cm length Stent Graft release by pushing (standard device for retrograde aortic stenting) Herold et. al 2002, 22, 891-97

8. 8 Experience System too long Poor handling properties High resistance against bending High friction forces Limited steerability Sharp tip of the introducer critical Open bar ends potentially harmful Result 1 Stentgraft migration 1 Stentgraft protrusion to false lumen Phase A (2001 n=3)

9. 9 Phase B (2002, 3 Patients) Custom made Medtronic ® Talent Stent Graft Changes : Stent Graft with closed web design (no open distal bar ends) Reinforced circular spring distal Short abdominal introducer device (90 cm length) Stent Graft loaded in reversed mode

10. 10 Experience Improved control of stent graft placement Steerability and handling improved Rigid area at the border introducer tip/stent graft device High friction forces Sharp tip of the introducer Phase B (2002, 3 Patients)

11. 11 Program Interuppted 49 yrs female: M. Marfan, st.p. acute Type A dissection, st.p. conduit implantation 7/00, st.p. bilat. carotid bypass, st.p. stenting of abdominal aorta 7/01 prior to surgery (Malperfusion) Uneventful postoperative course : sudden death on 4 th pop. day (rupture of false lumen)

12. 12 Phase C (2003, 8 Patients) Custom made Medtronic ® Talent Stent 2nd Generation Changes Closed web design distal and proximal Reduction of introducer device (21 F) Oversizing stent – true lumen max. 2 mm Experience Rigidity reduced but still critical Enhanced by kinking of the delivery system Sharp tip of the introducer

13. 13 Phase D (2004 Complete New Prototyping) Custom designed JOTEC © Essen Stent Graft Device

14. 14 Phase D (Example) 42 yrs, male : chronic Type A dissection

15. 15 Phase D (Example : One Stage repair)

16. 16 Phase D (Example : One Stage repair) Post HLM12 min protamine20 min protamine

17. 17 Results n = 15Follow Up 24,6 ±13,2 mths (range 44 – 1mth) Exclusion / thrombosis of false lumen11/11100 % Hospital mortality * 2/15 14 % Late death 0/13 0 % Stent Graft migration * 1/15 7 % Reintervention* 1/1 7 % * Standard stent Graft era

18. 18 Conclusion Open distal stent grafting represents a new and promising tool to simplify complex thoracic aortic surgery The complete new design now meets the requirements of open distal antegrade stent grafting The new Jotec ® Essen stent graft device allows for true one stage repair of complex thoracic aortic disease The integrated vascular prosthesis offers a less time consuming method for replacement of the aortic arch and the ascending aorta

19. 19

20. 20 Evolutionary Steps