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Endovascular Repair of Acute Uncomplicated Aortic Type B Dissection Promotes Aortic Remodelling: 1 Year Results of the ADSORB Trial

Brunkwall, J. ; Kasprzak, P. ; Verhoeven, E. ; Heijmen, R. ; Taylor, P. ; Alric, P. ; Canaud, L. ; Janotta, M. ; Raithel, D. and Malina, Martin LU , et al. (2014) In European Journal of Vascular and Endovascular Surgery 48(3). p.285-291
Abstract
Objectives: Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year. Methods: The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB. Results: Thirty-one patients were randomised to the BMT... (More)
Objectives: Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year. Methods: The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB. Results: Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation (p = .056 for all). One death occurred in the BMT TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only (p < .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group (p < .001). The false lumen reduced in size in the BMT+TAG group (p < .001) whereas in the BMT group it increased. The true lumen increased in the BMT TAG (p < .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062). Conclusions: Uncomplicated AD can be safely treated with the Gore TAG device. Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft, but long term results are needed. (C) 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Acute type B dissection, Uncomplicated, Stent graft, Thrombosis, Remodelling
in
European Journal of Vascular and Endovascular Surgery
volume
48
issue
3
pages
285 - 291
publisher
Elsevier
external identifiers
  • wos:000341554000011
  • scopus:84907669379
  • pmid:24962744
ISSN
1532-2165
DOI
10.1016/j.ejvs.2014.05.012
language
English
LU publication?
yes
id
683abecc-2f97-4bd2-866c-adc8efe8bc71 (old id 4709982)
date added to LUP
2016-04-01 14:58:57
date last changed
2022-04-22 05:52:50
@article{683abecc-2f97-4bd2-866c-adc8efe8bc71,
  abstract     = {{Objectives: Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year. Methods: The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB. Results: Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation (p = .056 for all). One death occurred in the BMT TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only (p &lt; .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group (p &lt; .001). The false lumen reduced in size in the BMT+TAG group (p &lt; .001) whereas in the BMT group it increased. The true lumen increased in the BMT TAG (p &lt; .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062). Conclusions: Uncomplicated AD can be safely treated with the Gore TAG device. Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft, but long term results are needed. (C) 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.}},
  author       = {{Brunkwall, J. and Kasprzak, P. and Verhoeven, E. and Heijmen, R. and Taylor, P. and Alric, P. and Canaud, L. and Janotta, M. and Raithel, D. and Malina, Martin and Resch, Tim and Eckstein, H. -H. and Ockert, S. and Larzon, T. and Carlsson, F. and Schumacher, H. and Classen, S. and Schaub, P. and Lammer, J. and Lonn, L. and Clough, R. E. and Rampoldi, V. and Trimarchi, S. and Fabiani, J. -N. and Boeckler, D. and Kotelis, D. and Boeckler, D. and Kotelis, D. and von Tenng-Kobligk, H. and Mangialardi, N. and Ronchey, S. and Dialetto, G. and Matoussevitch, V.}},
  issn         = {{1532-2165}},
  keywords     = {{Acute type B dissection; Uncomplicated; Stent graft; Thrombosis; Remodelling}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{285--291}},
  publisher    = {{Elsevier}},
  series       = {{European Journal of Vascular and Endovascular Surgery}},
  title        = {{Endovascular Repair of Acute Uncomplicated Aortic Type B Dissection Promotes Aortic Remodelling: 1 Year Results of the ADSORB Trial}},
  url          = {{http://dx.doi.org/10.1016/j.ejvs.2014.05.012}},
  doi          = {{10.1016/j.ejvs.2014.05.012}},
  volume       = {{48}},
  year         = {{2014}},
}