Is a Paradigm Shift towards Early Endovascular Treatment of Type B Dissection justified?

Transcription

1 Is a Paradigm Shift towards Early Endovascular Treatment of Type B Dissection justified? Dittmar Böckler Department of Vascular and Endovascular Surgery University of Heidelberg, Germany

2 Disclosure Speaker name: Dittmar Böckler I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) x I do not have any potential conflict of interest

3 Adressing An Old Debate. Ref.: Nienaber C et al Eur H J 2005, Böckler D et al, JEVT 2009

4 Is Early Treatment in Type B dissections justifiable? YES - but under certain conditions : By identifying high riks patients performing TEVAR with low complication rate identifying the right time of intervention optimal device selection (sizing, conformability)

5 Type B Dissection Sub-Categories Acute Complicated Rupture Malperfusion Chronic Potential reasons for intervention Aneurysm degeneration Up to 30% become aneurysmal 1 Rupture Dissection extension Malperfusion or ischemic events Acute Uncomplicated 1 Fattori R, Montgomery D, Lovato L, et al. Survival after endovascular therapy in patients with type B aortic dissection: a report from the International Registry of Acute Aortic Dissection (IRAD). JACC: Cardiovascular Interventions 2013;6(8):

6 Acute Risks of TEVAR in Acute Dissections aneurysm related mortality 30 day mortality 19 % acute/ 0 % in chronic 22% complication rate

7 Abdominal expansion rate 88.9% after 36 mths. Growh rate 3mm /yr. Chronic Risks of TEVAR in Acute Dissections abdominal aneurysmal progression

8 Benefits and Risks of Endovascular vs BMT Benefit Risk Aortic Remodeling Patient management Long-term outcomes Procedural Complications Paraplegia Stroke

9 Acute/subacute Uncomplicated Type B-Dissection Can we Identify high risk patients that could benefit from early TEVAR than BMT alone?

10 Can MRCT answer this? INSTEAD INSTEAD XL ADSORB

11 Criticism & Downsides of RMCT ADSORB - primary endpoints definition - different defintion of FL thrombosis in both arms - underpowered, change in sample size Instead & Instead XL - early chronic phase (2-52 weeks after onset) - underpowered - 21 % crossover rate - 4 received TEVAR rather than being excluded

12 Endpoints of TEVAR Treatment Primary clinical endpoint All cause mortality Secondary end points Aorta-specific mortality Progression of disease

13 Endpoint: All cause -Mortality INSTEAD XL at 5 yrs ADSORB at 1 yr.

14 Endpoint: Aorta specific Mortality INSTEAD XL at 5 yrs ADSORB at 1 yr.

15 Endpoint: Progression & Adverse Event INSTEAD XL at 5 yrs ADSORB at 1 yr.

16 How to define the high risk patient? 56 year, male from Heidleberg Acute Type B-Dissection RR contolled under medication asymptomatic or uncomplicated randomized in BMT arm in ADSORB

17 Evangelista A, Salas A, Ribera A, et al Circulation 2012;125(25): Nienaber CA, Kische S, Rousseau H, et al; Circulation: Cardiovascular Interventions 2013;6(4): Loewe C, Czerny M, Sodeck GH, et al. Annals of Thoracic Surgery 2012;93(4): Weiss G, Wolner I, Folkmann S, et al. European Journal of Cardiothoracic Surgery 2012;42(3): Kato M, Bai H, Sato K, et al.. Circulation 1995;92(9)Supplement II: Kudo T, Mikamo A, Kurazumi H, et aljournal of Thoracic & Cardiovascular Surgery 2014;148(1): Onitsuka S, Akashi H, Tayama K, et al. Annals Thoracic Surgery 2004;78(4): Takahashi J, Wakamatsu Y, Okude J, et al.. Annals of Thoracic & Cardiovascular Surgery 2008;14(5): Song JM, Kim SD, Kim JH, et al. Long-term predictors of descending aorta aneurysmal change in patients with aortic dissection. Journal of the American College of Cardiology 2007;50(8): Tanaka A, Sakakibara M, Ishii H, et al.. Journal of Vascular Surgery 2014;59(2): Tsai TT, Evangelista A, Nienaber CA, et al;. New England Journal of Medicine 2007;357(4): Marui A, Mochizuki T, Koyama T, Mitsui N.. Journal of Thoracic & Cardiovascular Surgery 2007;134(5): High riks predictors in Retrospective Imaging Evaluation At initial presentation: 1) Primary entry tear diameter 10 mm 2) Primary entry tear location 3) Total aortic diameter 4 cm 4) False lumen diameter 22 mm 5) Partial false lumen thrombosis 6) Fusiform index.64

18 Primary Entry Tear > 10 mm 10 mm Evangelista A, Salas A, Ribera A, et al. Long-term outcome of aortic dissection with patent false lumen: predictive role of entry tear size and location. Circulation 2012;125(25):

19 Primary Tear Location Can be difficult to determine outer or inner curve on Axial slices Weiss G, Wolner I, Folkmann S, et al. The location of the primary entry tear in acute type B aortic dissection affects early outcome. European Journal of Cardiothoracic Surgery 2012;42(3):

20 Primary Tear Location Concavity Location higher Compication Rate FL on the Convexity Concavity Department of Weiss G, Wolner I, Folkmann S, et al. The location of the primary entry tear in acute type B aortic dissection affects early outcome. European Journal of Cardiothoracic Surgery 2012;42(3):

21 Initial Total Aortic Diameter 40 mm Takahashi J, Wakamatsu Y, Okude J, et al. Maximum aortic diameter as a simple predictor of acute type B aortic dissection. Annals of Thoracic & Cardiovascular Surgery 2008;14(5):

22 False Lumen Measurement Initial Presentation Measurement at Upper Thoracic (UT) or Distal to Arch Song J-M, Kim S-D, Kim J-H, et al. Long-term predictors of descending aorta aneurysmal change in patients with aortic dissection J Am Coll Cardiol 2007;50:

23 Partial False Lumen Thrombosis 1 year follow-up Tsai TT, Evangelista A, Nienaber CA, Myrmel T, Meinhardt G, Cooper JV et al. Partial thrombosis of the false lumen in patients with acute type B aortic dissection. N Engl J Med 2007;26;357:349-59

24 Fusiform Index Initial Presentation 42.5 mm/ ( )= 0.63 C Marui A, Mochizuki T, Koyama T, Mitsui N. Degree of fusiform dilatation of the proximal descending aorta in type B acute aortic dissection can predict late aortic events. Journal of Thoracic & Cardiovascular Surgery 2007;134(5):

25 Expanded False Lumen Distal Aorta 1 year follow-up

26 Right Timing for TEVAR in B Dissections

27 Right Timing for TEVAR in B Dissections Acute early N= 70 Acute delayed N= 44 Subacute N= 18

28 Ideal Stent Graft for Type B Dissections? HUMAN STUDY eissn Med Sci Monit Basic Res, 2015; 21: DOI: /MSMBR Received: Accepted: Published: Device Conformability and Morphological Assessment After TEVAR for Aortic Type B Dissection: A Single-Centre Experience with a Conformable Thoracic Stent-Graft Design Authors Contribution: Study Design A Data Collection B Statistical Analysis C Data Interpretation D Manuscript Preparation E Literature Search F Funds Collection G ABCDEF 1 BCD 2 BEF 1 EF 1 ACDE 1 Moritz S. Bischoff Matthias Müller-Eschner Katrin Meisenbacher Andreas S. Peters Dittmar Böckler 1 Department of Vascular and Endovascular Surgery, Heidelberg University Hospital, Heidelberg, Germany 2 Department of Radiodiagnostics and Interventional Radiology, Heidelberg University Hospital, Heidelberg, Germany Corresponding Author: Source of support: Dittmar Böckler, dittmar.boeckler@med.uni-heidelberg.de Departmental sources Background: Material/Methods: Results: Conclusions: MeSH Keywords: Full-text PDF: The aim of this study was to analyze device conformability in TEVARof acute and chronic (a/c) type B aortic dissections (TBAD) using the Gore Conformable Thoracic Aortic Stent-graft (CTAG). From January 1997 to February 2014, a total of 90 out of 405 patients in our center received TEVAR for TBAD. Since November 2009, 23 patients (16 men; median age: 62 years) were treated with the CTAG. Indications were complicated atbad in 15 (65%) and expanding ctbad in 8 (35%) patients. Primary endpoints were the assessment of device conformability by measuring the distance (D) from the radiopaque gold band marker (GM) at the proximal CTAG end to the inner curvature (IC) of the arch on parasagittal multiplanar reformations of CT angiography, as well as the evaluation of aortic diameter changes following TEVAR. Median follow-up was 13.3 months (range: 2 days to 35 months). Primary and secondary success rates were 91.3% (21/23) and 95.6% (22/23), respectively. There was 1 type Ia endoleak, retrograde dissection or primary conversion was not observed. Median GM-IC-D was 0 mm (range: 0 mm to 10 mm). GM-IC-D was associated with zone 2 placement compared to zone 3 (P=0.036). There was no association between GM-IC-D formation and arch type. In atbad cases the true lumen significantly increased after TEVAR(P=0.017) and the false lumen underwent shrinkage (P=0.025). In ctbad patients the false lumen decreased after TEVAR(P=0.036). The CTAG shows favorable conformability and wall apposition in challenging arch pathologies such as TBAD. Aneurysm, Dissecting Cardiovascular Diseases Endovascular Procedures

29 Summary Is Early Treatment in Type B Dissections justifiable? YES - under these conditions : Identification of high riks patients (CT based) High TEVAR performance (low complication rate) Delayed timing Optimal device selection

30 Conclusions There is a trend towards early treatment in selected patients at higher risk that could benefit from early TEVAR intervention Image-based high risk predictors may help identify uncomplicated Type B dissection patients

31 Is a Paradigm Shift towards Early Endovascular Treatment of Type B Dissection justified? Dittmar Böckler Department of Vascular and Endovascular Surgery University of Heidelberg, Germany