INSTEAD at 5-year follow-up shifts the expectations for endovascular treatment

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1 INSTEAD at 5-year follow-up shifts the expectations for endovascular treatment Christoph A. Nienaber, MD, FACC University Heart Center Rostock Department of Medicine I - Cardiology

2 Type B aortic dissection: Survival and predictors Hypotension/Shock Malperfusion Tsai T, Nienaber C, et al. Circulation 2006, 114:

3 High risk group: Complicated type B dissection Malperfusion syndrome treated with endovascular stent-graft and PETTICOAT; a) angiography of lower body malperfusion; b) reperfusion after proximal stent-graft; c) 3D CT reconstruction of acute complicated dissection with malperfusion; d) reconstructed aorta and abolished malperfusion after stent-graft and PETTICOAT. Nienaber et al; JVS 2011 (in press)

4 TEVAR Best choice in complicated dissection C. Nienaber et al J Vasc Surg 2011;54:

5 Type B aortic dissection: Survival and predictors Hypotension/Shock Malperfusion Tsai T, Nienaber C, et al. Circulation 2006, 114:

6 Medical: Survival after acute type B aortic dissection UNIVERSITÄT 09/06/13 ROSTOCK UNIVERSITÄT MEDIZINISCHE ROSTOCK FAKULTÄT MEDIZINISCHE FAKULTÄT Acosta S, et al., Annals of Vascular Surgery 2007; 21:

7 Prospective RCT: Chronic type B dissection Stable type B Dissection: INvestigation of... instead...? STEnt-grafts in Aortic Dissection pre post Optimal medical treatment versus stent-graft + OMT UNIVERSITÄT 09/06/13 ROSTOCK UNIVERSITÄT MEDIZINISCHE ROSTOCK FAKULTÄT MEDIZINISCHE FAKULTÄT 7

8 INSTEAD: Investigation of Stent-grafts in Aortic Dissection Objective: 1yr outcomes of uncomplicated type B aortic dissection treated by Talent Stentgraft in addition to best medical tx versus best medical tx alone (tailored/monitored) l Initial Centers l l l l l l l Rostock Berlin Bologna Essen Leipzig Vienna Bordeaux complicated resection ACADEMIC stentgraft ± peripheral stents ± fenestration uncomplicated INSTEAD OMT + stentgraft

9 INSTEAD: Patient flow Nienaber CA et al. Circulation 2009;120:

10 INSTEAD: Endpoints Primary endpoint q All-cause mortality at 2 years Secondary endpoints q Thrombosis of False Lumen q Degree of Aortic Expansion q Cardiovascular morbidity q Quality of life q Lenght of ICU and hospital stay q Crossover Nienaber CA et al. Circulation 2009;120: UNIVERSITÄT 09/06/13 ROSTOCK MEDIZINISCHE FAKULTÄT 10

11 INSTEAD: Time from Impact to Randomization

12 INSTEAD: 2 years-outcomes after TEVAR in stable I year crossover 2 years crossover rate 14% (p=0.02) 20% (p=0,02) Nienaber C, Rousseau H, et al. Circulation Dec 22;120(25):

13 Landmark analysis Mortality (1st EP) 13

14 Landmark analysis CV death (2nd EP) 14

15 Landmark analysis Progression (2nd EP) 15

16 Medical: Survival after acute type B aortic dissection --- INSTEAD SG INSTEAD Medical Acosta S, et al., Annals of Vascular Surgery 2007; 21:

17 Longterm outcomes in IRAD TEVAR vs. medical management of type B dissection JACC (in press)

18 Remodeling after Stentgraft 90% remodeling with TEVAR (p 0.001) after 2 years Nienaber CA et al. Circulation 2009;120:

19 INSTEAD-XL: Predictive Factors for death (MV-analysis) Type B aortic dissection: Complete FL thrombosis - Incomplete FL thrombosis - Thoracoabdominal extent of dissection - Persistant Hypertension - Entry size 13 mm + Medical management +

20 Entry size: Long-term outcome of aortic dissection? Entry tear of aortic dissection visualized by 2- dimensional (left) and color-doppler (right) TEE Type B dissection with an entry tear located in the proximal part of the descending aorta (arrow) by tranverse view Type A dissection with an entry tear in the proximal part of the residual dissection (arrow) in the upper ascending aorta by longitudinal view Evangelista et al, Circulation 2012;125:

21 Long-term outcome of aortic dissection (Large, >15 mm) Cumulative survival free from sudden death and surgical/ endovascular treatment by entry tear size Evangelista et al, Circulation 2012;125:

22 Risk profiles of type B aortic dissection (update 2012) Classic Criteria for complicated type B dissection: Total aortic diameter 5.5 mm Elefteriade 2002, Ann Thoracic Surgery Malperfusion Syndromes Nienaber 2011, JVS Impending rupture (extraaortic blood) Davies 2002, Annals of thoracic surgery Early false lumen expansion Song 2007, JACC Recent Criteria Partial false lumen thrombosis Tsai T, NEJM 2007 Focal FDG-uptake (inflammation) Sakalihasan N, p.c. Ongoing episodes of pain Trimarchi S, Circ 2010 Intractable hypertension Evangelista A, Circ 2012 Large entry size (> 15 mm) IRAD, Circ 2010 What is left as uncomplicated dissection? Current Literature 2012

23 INSTEAD-XL (Extended length of F/U) Long-term Follow up of INSTEAD and type B Aortic Dissection reveals: - Uncomplicated type B dissection is a misnomer, is not stable and medical management is not safe - Isolation of the false lumen leads to remodeling to avoid new (late) acute scenarios - Successful remodeling (usually completed after 2 years) ensures longterm stability - Preemptive TEVAR in type B dissection sets the stage for remodeling and may become a therapeutic option.

24 INSTEAD-XL and IRAD-LT encourages stent-graft induced remodeling in any type B aortic dissection Ann Thorac Surg 2008

25

26 Survival in type B dissection IRAD unpublished

27 Subacute type B dissection -TEVAR for uncomplicated?- 90 % remodelin g after TEVAR Contrast-enhanced MRA of chronic type B dissection originating from the aortic arch region in MIP (A) and as volume-rendered 3D reconstruction (B). Follow-up MRA at 7 days after stent-graft placement shows a completely sealed proximal entry to the thrombosed false lumen. The diameter of the true lumen is normalized and the descending aorta is reconstructed (C). Nienaber et al; Circ 2009; 120:

28 INSTEAD: TEVAR in chronic uncomplicated type B dissection? pre pre post 4 m 12 m post Typical INSTEAD-patient initial para-graft perfusion delayed closure of FL aortic remodeling 69 y, male, acute type B 12/98, SG 9/99, uneventful F/U 28

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