ADSORB trial results: Is it enough to switch the paradigm?
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1 ADSORB trial results: Is it enough to switch the paradigm? Jan Brunkwall, MD, PhD Professor and Chairman
2 Complications to acute type B dissection Mortality Rupture Organ Ischemia Dilatation/Aneurysm Refractory Hypertension
3 Mortality Acute Dissection (IRAD) Tsai et al EJVES 2009
4 Acute Dissection
5 Endoluminal Treatment Balloning Fenestration Stenting Stentgrafts
6 Fenestration or branch vessel stenting Author Year No pat Patency Slonim /40 Patel /69 Park /20 Midulla /35 Total /164 97%
7 Fenestration or branch vessel stenting Author Year No pat Patency Mortality Slonim /40 10/40 Patel /69 12/69 Park /20 18/20 Midulla /35 12/35 Total /164 97% 52/129 32%
8 Post TEVAR
9 UNIVERSITY HOSPITAL Malperfusion in AD
10 UNIVERSITY HOSPITAL Angio intraoperatively post TEVAR
11 ADSORB: The aim Compare best medical treatment (BMT) with BMT and Gore TAG stent graft (BMT+TAG) in patients with an acute (<14 days) uncomplicated type B dissection.
12 PI P Kasprzak J Brunkwall R Heijmen P Alric E Verhoeven H Schumacher J Fabiani HH Eckstein P Taylor M Malina N Mangialardi T Larzon D Böckler L Lönn G DialeKo S Trimarchi J Lammer Site Trialists Regensburg Cologne Nieuwegein Montpellier Nürnberg Hanau Paris Munich London Malmö Rome Örebro Heidelberg Copenhagen Napoli Milan Vienna
13 Primary Endpoints Freedom from any of the following: Incomplete or no false lumen thrombosis, Aortic dilatation and Aortic rupture (descending thoracic or abdominal aorta).
14 Demographics TAG+BMT BMT N Male (%) Age (Mean years) (Std Dev) 60.1 (10.5) 60.7 (13.4)
15 Dissection Type BMT BMT+TAG Type IIIA 19% 27% Type IIIB 81% 73%
16 Symptom Onset to Randomization TAG+BMT BMT N (Days) Median Range (0.29, 13.25) (0.26, 14.27)
17 Symptom Onset to TAG Placement TAG+BMT N 28 (Days) Median 5.50 Range (0.79, 14.00)
18 LSA Coverage 14 (47%) complete 5 (17%) partial 9 (30%) none
19 LSA Treatment Transposition 4 Bypass 3
20 Device Data (Median and Range) Length % Oversize
21 Results No deaths in neither group No strokes No paraplegia
22 BMT to TAG Crossovers <4days Case 1. Aortic Dilatation Case 2. Mesenteric Ischemia Case 3. Difficult blood pressure control retrograde dissection
23 BMT Follow up 4. Expansion to over 6 cm 5. Fenestration (malperfusion)
24 Case 1: TAG to BMT Crossovers Patient withdrew consent prior to procedure Case 2: Secondary imaging performed indicated insufficient proximal landing zone
25 Maximum True Lumen <0.001
26 Maximum False Lumen <0.003 <0.001
27 Overall Diameter
28 False lumen thrombosis BMT BMT+TAG P-value Complete thrombosis Partial Thrombosis 3% 57% < % 13% <0.001
29 BMT vs TEVAR in uncomplicated AD Yong-Lin et al JACC 2013
30 Survival Yong-Lin et al JACC 2013
31 Conclusions TEVAR with a TAG device is safe in acute uncomplicated type B dissections Aortic remodeling after one year was in favor of TAG placement 5/31 BMT patients had aortic events within one year
32 Conclusion The results of the ADSORB trial alone are not enough for a paradigm shift but, there is nothing speaking against TAG use in acute dissections
33 UNIVERSITY HOSPITAL Thank you very much for your adeneon
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