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A 10-Year Single-Center Experience With the GORE TAG Conformable Thoracic Stent Graft in the Treatment of Thoracic Aortic Disease

OBJECTIVE: The aim of this study was to report 10-year real-world single-center experience with the GORE TAG conformable thoracic aortic graft (CTAG), focusing on rupture-free survival, aortic-related reintervention, and device-related complications during midterm and long-term follow-up (FU). METHO...

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Autores principales: Skrypnik, Denis, Bischoff, Moritz S., Meisenbacher, Katrin, Kronsteiner, Dorothea B., Böckler, Dittmar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9096584/
https://www.ncbi.nlm.nih.gov/pubmed/34632839
http://dx.doi.org/10.1177/15266028211049340
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author Skrypnik, Denis
Bischoff, Moritz S.
Meisenbacher, Katrin
Kronsteiner, Dorothea B.
Böckler, Dittmar
author_facet Skrypnik, Denis
Bischoff, Moritz S.
Meisenbacher, Katrin
Kronsteiner, Dorothea B.
Böckler, Dittmar
author_sort Skrypnik, Denis
collection PubMed
description OBJECTIVE: The aim of this study was to report 10-year real-world single-center experience with the GORE TAG conformable thoracic aortic graft (CTAG), focusing on rupture-free survival, aortic-related reintervention, and device-related complications during midterm and long-term follow-up (FU). METHODS: This retrospective study analyzes results of thoracic endovascular aortic repair (TEVAR) performed between January 2009 and December 2018. Out of 419 TEVAR procedures within this period, 194 patients (male 57.2%, 111/194), with a mean age of 65 ± 13 years, were treated with the CTAG device. Indication for TEVAR was a thoracic aortic aneurysm in 24.7% (48/194), type B aortic dissection in 32.5% (63/194), penetrating aortic ulcer 15.5% (30/194), and miscellaneous 27.3% (53/194). Emergently were operated 43.8% (85/194) patients. Median follow-up (FU) including computed tomography imaging was 43.5 months (Q1-Q3: 8.6–67.0) and was completed in 91.2% (177/194) of patients. RESULTS: Overall survival rates were 75.8% (95% confidence interval [CI] = [0.76–0.70]) and 56.6% (95% CI = [0.57–0.50]) at 12 and 60 months, respectively. Cumulative incidence for aortic rupture was 11.9% (95% CI = [0.07–0.17]) at 60 and 90 months, respectively. Cumulative incidence for aortic-related reintervention was 27.5% (95% CI = [0.21–0.34]) at 60 and 90 months. Cumulative incidence for migration was 2.8% (95% CI = [0.004–0.05]) and 3.9% (95% CI = [0.007–0.07]) at 60 and 90 months, respectively. New endograft infections or material fatigue were not observed. CONCLUSIONS: The herein reported 10-year real-world single-center experience with the CTAG observed favorable long-term outcome. Thus, the device demonstrates appropriate persistent safety, efficacy, and clinical durability up to long-term FU in the treatment of diverse thoracic aortic pathologies.
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spelling pubmed-90965842022-05-13 A 10-Year Single-Center Experience With the GORE TAG Conformable Thoracic Stent Graft in the Treatment of Thoracic Aortic Disease Skrypnik, Denis Bischoff, Moritz S. Meisenbacher, Katrin Kronsteiner, Dorothea B. Böckler, Dittmar J Endovasc Ther Clinical Investigation OBJECTIVE: The aim of this study was to report 10-year real-world single-center experience with the GORE TAG conformable thoracic aortic graft (CTAG), focusing on rupture-free survival, aortic-related reintervention, and device-related complications during midterm and long-term follow-up (FU). METHODS: This retrospective study analyzes results of thoracic endovascular aortic repair (TEVAR) performed between January 2009 and December 2018. Out of 419 TEVAR procedures within this period, 194 patients (male 57.2%, 111/194), with a mean age of 65 ± 13 years, were treated with the CTAG device. Indication for TEVAR was a thoracic aortic aneurysm in 24.7% (48/194), type B aortic dissection in 32.5% (63/194), penetrating aortic ulcer 15.5% (30/194), and miscellaneous 27.3% (53/194). Emergently were operated 43.8% (85/194) patients. Median follow-up (FU) including computed tomography imaging was 43.5 months (Q1-Q3: 8.6–67.0) and was completed in 91.2% (177/194) of patients. RESULTS: Overall survival rates were 75.8% (95% confidence interval [CI] = [0.76–0.70]) and 56.6% (95% CI = [0.57–0.50]) at 12 and 60 months, respectively. Cumulative incidence for aortic rupture was 11.9% (95% CI = [0.07–0.17]) at 60 and 90 months, respectively. Cumulative incidence for aortic-related reintervention was 27.5% (95% CI = [0.21–0.34]) at 60 and 90 months. Cumulative incidence for migration was 2.8% (95% CI = [0.004–0.05]) and 3.9% (95% CI = [0.007–0.07]) at 60 and 90 months, respectively. New endograft infections or material fatigue were not observed. CONCLUSIONS: The herein reported 10-year real-world single-center experience with the CTAG observed favorable long-term outcome. Thus, the device demonstrates appropriate persistent safety, efficacy, and clinical durability up to long-term FU in the treatment of diverse thoracic aortic pathologies. SAGE Publications 2021-10-11 2022-06 /pmc/articles/PMC9096584/ /pubmed/34632839 http://dx.doi.org/10.1177/15266028211049340 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage)
spellingShingle Clinical Investigation
Skrypnik, Denis
Bischoff, Moritz S.
Meisenbacher, Katrin
Kronsteiner, Dorothea B.
Böckler, Dittmar
A 10-Year Single-Center Experience With the GORE TAG Conformable Thoracic Stent Graft in the Treatment of Thoracic Aortic Disease
title A 10-Year Single-Center Experience With the GORE TAG Conformable Thoracic Stent Graft in the Treatment of Thoracic Aortic Disease
title_full A 10-Year Single-Center Experience With the GORE TAG Conformable Thoracic Stent Graft in the Treatment of Thoracic Aortic Disease
title_fullStr A 10-Year Single-Center Experience With the GORE TAG Conformable Thoracic Stent Graft in the Treatment of Thoracic Aortic Disease
title_full_unstemmed A 10-Year Single-Center Experience With the GORE TAG Conformable Thoracic Stent Graft in the Treatment of Thoracic Aortic Disease
title_short A 10-Year Single-Center Experience With the GORE TAG Conformable Thoracic Stent Graft in the Treatment of Thoracic Aortic Disease
title_sort 10-year single-center experience with the gore tag conformable thoracic stent graft in the treatment of thoracic aortic disease
topic Clinical Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9096584/
https://www.ncbi.nlm.nih.gov/pubmed/34632839
http://dx.doi.org/10.1177/15266028211049340
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