One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair

Marco V Usai; Mauro Gargiulo; Stéphan Haulon; Ignace Tielliu; Dittmar Boeckler; Hence Verhagen; Alba Méndez Fernández; Martin J Austermann

doi:10.1016/j.jvs.2023.07.061

One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair

J Vasc Surg. 2023 Dec;78(6):1376-1382.e2. doi: 10.1016/j.jvs.2023.07.061. Epub 2023 Aug 11.

Authors

Marco V Usai¹, Mauro Gargiulo², Stéphan Haulon³, Ignace Tielliu⁴, Dittmar Boeckler⁵, Hence Verhagen⁶, Alba Méndez Fernández⁷, Martin J Austermann⁸

Affiliations

¹ Department of Vascular Surgery, St. Franziskus Hospital, Münster, Germany. Electronic address: marcov.usai@hotmail.it.
² Department of Vascular Surgery, Azienda Ospedaliera Policlinico Sant'Orsola Malpighi, Bologna, Italy.
³ Department of Vascular Surgery, Hôpital Marie Lannelongue, GHPSJ, Université Paris Saclay, Le Plessis-Robinson, France.
⁴ Department of Vascular Surgery, University Medical Center Groningen, Groningen, the Netherlands.
⁵ Department of Vascular Surgery, University of Heidelberg, Heidelberg, Germany.
⁶ Department of Vascular Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.
⁷ Department of Vascular Surgery, University Hospital of Santiago de Compostela, A Coruña, Spain.
⁸ Department of Vascular Surgery, St. Franziskus Hospital, Münster, Germany.

PMID: 37572891
DOI: 10.1016/j.jvs.2023.07.061

Abstract

Objective: This post-market multicenter registry aimed to evaluate the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. In this subgroup analysis, we assessed the outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair at 1 year.

Methods: A single cohort from a prospective, multicenter, observational, 16-site European registry. Patients were enrolled from November 2018 to March 2022. Endpoints included 1-year primary patency (PP), primary assisted patency (PAP), and secondary patency (SP), stent graft-related death and serious adverse events through 30 days.

Results: Seventy-three patients were enrolled in this registry sub-cohort, 57 (78.1%) were male, and the mean age was 73 ± 8.1 years. Thoracoabdominal aneurysms predominated the cohort with 68 patients (93.2%), followed by five patients (6.8%) with pararenal and infrarenal aneurysms. Overall, 233 target vessels were treated with the index bridging graft. The overall per stent graft analysis demonstrated a PP of 95.8% at 1 year; PAP was 95.8%, and SP reached 97.9%. The per-target vessel analysis demonstrated a PP, PAP, and SP in the celiac trunk of 100%, 100%, and 100%; in the superior mesenteric artery of 96.0%, 96.0%, and 100%, and in the renal arteries of 94.2%, 94.2%, and 95.1%, respectively. Four patients (5%) died at 1 year; none of the deaths were device-related. The composite endpoint of target vessel technical success and freedom from VBX stent-related serious adverse events through 30 days was achieved in 98.6% of patients.

Conclusions: In this prospective post-market multicenter registry, the VBX stent demonstrated excellent results at 1 year, with almost 96% primary patency and 98% secondary patency. Patency in the renal arteries seems to be lower. Nevertheless, the VBX stent appears to be a reliable bridging stent for branched endovascular aortic repair.

Trial registration: ClinicalTrials.gov NCT03720704.

Keywords: BEVAR; Balloon-expandable stent; Bridging stent graft.

Publication types

Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Aneurysm*
Celiac Artery
Endovascular Aneurysm Repair*
Female
Humans
Male
Middle Aged
Prospective Studies
Stents

Associated data

ClinicalTrials.gov/NCT03720704