Dissection de type B: l étude Instead et corollaire stratégique

Transcription

1 Dissection de type B: l étude Instead et corollaire stratégique Christoph A. Nienaber, MD, FACC University Rostock Heartcenter Med. Clinic I Cardiology christoph.nienaber@med.uni-rostock.de

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

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4 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)

5 TEVAR: Complicated acute type B Dissection - midterm F/U Actuarial Survival in KM format Actuarial freedom from RX failure 16 acute complicated Type B (contained rupture, malperfusion) Early mortality 25% Stable F/U over 8 years Verhoye JP et al., J Thorac Cardiovasc Surg Aug;136(2):424-30

6 Outcomes in complicated type B dissections (TTR) MAD-REDEEM cases Type B dissection Kische S, Nienaber CA, Ehrlich M et al. J Thorac Cardiovasc Surg. 2009;138:

7 Outcome after Isolation of false lumen Stabilization of complicated type B aortic dissection Lombardi et al., J Vasc Surg 2012;55:

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

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

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

11 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

12 INSTEAD: Endpoints Primary endpoint All-cause mortality at 2 years Secondary endpoints Thrombosis of False Lumen Degree of Aortic Expansion Cardiovascular morbidity Quality of life Lenght of ICU and hospital stay Crossover Nienaber CA et al. Circulation 2009;120:

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

14 INSTEAD: Time from Impact to Randomization

15 ADSORB / 1 year Mortality ADSORB trial No need for SG in first 2 weeks of uncomplicated type B dissection

16 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):

17 STEP I: Induced aortic remodeling after TEVAR + F/U STEP I Completely reconstructed acute dissection A B C Progressive shrinkage of false lumen thrombus mass Relief of infrarenal true lumen collapse Sealing and healing! 90% Remodeling after TEVAR Nienaber etal. Circulation 2009: 120:

18 Step II: Petticoat for Aortic Remodeling Complete false lumen thrombosis in the descending thoracic aorta Pre-procedure Post-procedure 24 months

19 Evolution of TEVAR III: Isolation of FL by STABLE concept Staged Thoracoabdominal And Branch vessel Endoluminal repair for improved Remodeling Mossop PJ et al., Nat Clin Pract Cardiovasc Med. 2005;2:

20 INSTEAD-XL Landmark analysis Mortality (1st EP) Nienaber CA et al, Circ Cardiovasc Interv. 2013

21 INSTEAD-XL Landmark analysis CV death (2nd EP) Nienaber CA et al, Circ Cardiovasc Interv. 2013

22 INSTEAD-XL / Landmark analysis Progression (2nd EP) Nienaber CA et al, Circ Cardiovasc Interv. 2013

23 Longterm outcomes in IRAD TEVAR vs. medical management of type B dissection Fattori R et al. JACC Card. Intervention 2013

24 Uncomplicated type B dissection: does it exist?

25 Subacute type B dissection -TEVAR for uncomplicated?- 90 % remodeling 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:

26 Remodeling and Outcomes Watanabe etal., J Endovasc Ther 2014; 21:

27 New risk group: False Lumen diameter: FL > 22 mm Two patients with a small initial false lumen diameter at the upper descending thoracic aorta showed a complete resorption of the false lumen (left) or did not show an aneurysm for approximately 3 years (middle), while another patient with a large initial false lumen diameter developed an aorta aneurysm after approximately 2.5 years (right). Song JM, et al. JACC 2007; 50:

28 New risk group: Partial false lumen thrombosis? 31.6% 3 years 22.6% 3 years Tsai T, Evangelista A, Nienaber C et al., N Engl J Med Jul 26;357(4):349-59

29 New risk group: Local Inflammation, Partial FL thrombosis, rupture? Partial FL thrombosis Expanding FL Ongoing metabolic activity on FDG-PET Rupture? Nienaber C et al. Circ Cardiovas Imaging 2009; 2:

30 Aortic inflammation & TEVAR Baseline After TEVAR Biology CT PET-CT TEVAR Sakalihasan N, Nienaber CA et al, EHJ 2014 (submitted)

31 New risk group: Entry size and long-term outcome? 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:

32 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:

33 Long-term outcome of aortic dissection (repair) Cumulative survival free from sudden death and surgical/endovascular treatment by entry tear pattern (size and location) Evangelista et al, Circulation 2012;125:

34 INSTEAD at high risk! Primary endpoint All-cause mortality at 2 years Secondary endpoints Thrombosis of False Lumen Degree of Aortic Expansion Complication Cardiovascular according morbidity to Quality of life recent criteria Lenght of ICU and hospital stay Crossover Nienaber CA et al. Circulation 2009;120:

35 Risk profiles of type B aortic dissection (update 2013) 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

36 Rethinking TEVAR for Dissection Long-term follow-up of INSTEAD-XL and IRAD in 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 will become a therapeutic option for all candidates with a reasonable life expectancy

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

38 Vorgehen 2014 Divchev D, Nienaber C, etal., Chirurg 2014; 85:

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

40 or rupture FL open and no Isolation FL expansion TL compression Impending rupture

41 Facts Dissection TEVAR is effective and safe in complicated type B TEVAR did not improve 2-years survival in stable type B Favourable aortic remodelling INSTEAD Trial 5-years encouraging for pre-emptive TEVAR Courtesy of Dr. FJ Criado Courtesy of M.M.Thompson Mother registry

42 Rethinking TEVAR for Dissection Are there patients that should not be treated with TEVAR?...may be a few! - Stable chronic patients with complete False Lumen thrombosis (IRAD; NEJM 2007) - Stable chronic patients with tiny entry tears (<10mm) and no FL expansion (Evangelista et al., Circulation 2012; Song et al., JACC 2007) - Stable patients with a life expectancy of less than 2 years (INSTEAD-XL, Circulation CVInt 2013) - Stable chronic dissection without FDG-uptake on PET imaging LIEGE/Rostock project (under review) - Need for proximal arch/zone 0 debranching/consider open surgery or branched TEVAR (Bünger et al., JVS 2013)

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44 IRAD experience with TEVAR Fattori R et al. JACC Card. Intervention 2013