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Early outcomes associated with use of the Zenith TX2 Dissection Endovascular Graft for the treatment of Stanford type B aortic dissection

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Jayna J. Patel, Piotr Kasprzak, Karin Pfister, Nikolaos Tsilimparis, Tilo Kölbel, Carl Wahlgren, Sari Hammo, Kevin Mani, Anders Wanhainen, Giovanni Rossi, Enrico Leo, Ingeborg Böing, Hubert Schelzig, Alexander Oberhuber, Frode Aasgaard, Enrico Vecchiati, Antonio Fontana, Bijan Modarai

Original languageEnglish
Pages (from-to)547-555
Number of pages9
JournalJournal of Vascular Surgery
Volume74
Issue number2
DOIs
Accepted/In press2021
PublishedAug 2021

Bibliographical note

Funding Information: Author conflict of interest: B.M. is a proctor, speaker, and consultant for Cook Medical and receives travel-grants and research-grants. T.K. is a proctor, speaker, and consultant for Cook Medical and receives travel-grants, research-grants and royalties from Cook Medical. N.T. is proctor, speaker and receives research-grants from Cook Medical. K.M. is a proctor and receives research grant from Cook Medical. The remaining authors report no conflicts. Publisher Copyright: © 2021 Society for Vascular Surgery Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

King's Authors

Abstract

Objective: To evaluate short term outcomes related to the use of the Zenith TX2 Dissection Endovascular Graft (ZDEG) and the Zenith Dissection Bare stent (ZDES) for the treatment of Stanford type B aortic dissections. Methods: This retrospective multicenter case cohort study collated data from 10 European institutions for patients with both complicated and uncomplicated type B aortic dissection treated with ZDEG and ZDES between 2011 and 2018. The primary end point was mortality at 30 and 90 days. Secondary end points included complications related to TEVAR, such as, type Ia endoleak, stroke, paraparesis, paraplegia, and retrograde type A dissection (RTAD). Statistical analysis was carried out using the t test, or one-way analysis of variance and the χ2 or Fisher exact tests. Results: We treated 120 patients (87 male; mean age, 62.7 ± 12.2years) either in the acute 76 (63.3%), subacute 16 (13.3%), or chronic 28 (23.3%) phase. Seven patients (5.8%) died within 30 days after the index procedure and two (1.7%) between 30 and 90 days. There was one instance of postoperative RTAD in a patient treated for rupture. Stroke and paraplegia occurred in three (2.5%) and five (4.2%), patients, respectively. Eight patients (6.7%) had a type Ia endoleak in the perioperative period. There were no instances of paraplegia, no permanent dialysis, and no requirement for adjunctive superior mesenteric or celiac artery stenting in the 33 patients (27.5%) who were treated by concurrent placement of ZDES distal to the ZDEG. The length and distal oversizing of ZDEG components used was less in this group. Conclusions: The present series demonstrates a low (<1%) RTAD rate and favorable morbidity and mortality. The lower rate of paraplegia, dialysis, and visceral artery stenting in the cohort that had adjunctive use of ZDES is compelling and merits further assessment.

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