Abstract
Objective
study aims to assess the clinical efficacy, technical features, and early follow-up outcomes of aortic arch dissection (AD) requiring left subclavian artery (LSA) reconstruction using the aorta arch stent-graft system combined with the endovascular needle system for in situ fenestration.
Methods and Results
Eight patients with AD were enrolled in this clinical trial after rigorous screening between July 2021 and August 2022. The 8 patients who participated in this trial were male, with a mean age of 62.0 ± 8.3 years. The total operative time was 148.38 ± 35.06 minutes, and the mean hospitalization time was 11.4 ± 4.4 days. A total of 12 aortic stents were implanted in the 8 patients, and branching stents were implanted in the LSA in all patients. No cases of delayed endoleak occurred. There were no stent- or aorta-related deaths. The 2 deaths that did occur were confirmed to have been due to causes outside of the aorta and were unrelated to the thoracic endovascular aortic repair procedure, with a 1-year stent patency rate of 100%.
Conclusions
We believe that this trial of in situ fenestration achieved satisfactory early results, with reasonable postprocedural stent patency and patient survival, and there were no endoleaks requiring intervention during follow-up. However, long-term follow-up is needed to validate the findings of this trial.
Trial registration
ClinicalTrials.gov PRS Protocol Registration and Results System (URL: Home - ClinicalTrials.gov, NCT05126446).
Keywords
Get full access to this article
View all access options for this article.
References
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
