TY - JOUR
T1 - Endovascular Repair of Acute Uncomplicated Aortic Type B Dissection Promotes Aortic Remodelling
T2 - 1 Year Results of the ADSORB Trial
AU - Brunkwall, J
AU - Kasprzak, P
AU - Verhoeven, E
AU - Heijmen, R
AU - Taylor, P
AU - Alric, P
AU - Canaud, L
AU - Janotta, M
AU - Raithel, D
AU - Malina, W
AU - Resch, Ti
AU - Eckstein, H-H
AU - Ockert, S
AU - Larzon, T
AU - Carlsson, F
AU - Schumacher, H
AU - Classen, S
AU - Schaub, P
AU - Lammer, J
AU - Lönn, Lars Birger
AU - Clough, R E
AU - Rampoldi, V
AU - Trimarchi, S
AU - Fabiani, J-N
AU - Böckler, D
AU - Kotelis, D
AU - Böckler, D
AU - Kotelis, D
AU - von Tenng-Kobligk, H
AU - Mangialardi, N
AU - Ronchey, S
AU - Dialetto, G
AU - Matoussevitch, V
AU - ADSORB Trialists
N1 - Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
PY - 2014/9
Y1 - 2014/9
N2 - 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.
AB - 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.
KW - Acute Disease
KW - Aneurysm, Dissecting
KW - Blood Vessel Prosthesis Implantation
KW - Endovascular Procedures
KW - Europe
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Prospective Studies
KW - Stents
KW - Treatment Outcome
U2 - 10.1016/j.ejvs.2014.05.012
DO - 10.1016/j.ejvs.2014.05.012
M3 - Journal article
C2 - 24962744
SN - 1078-5884
VL - 48
SP - 285
EP - 291
JO - European Journal of Vascular and Endovascular Surgery
JF - European Journal of Vascular and Endovascular Surgery
IS - 3
ER -