JMIR Publications

ABSTRACT

Background:

Extensive aortic pathologies are currently managed mainly by employing fenestrated or branched endovascular repair (F/B-EVAR) with high rates of technical success and reproducible mid-term results and supported by international societies guidelines2Despite the wide use of different CS during F/B-EVAR, none of them were specifically approved for use as bridging stents in combination with the different aortic stent-grafts available on the market4 at the time this study was designed.

Objective:

Study of the safety and mid-term clinical performance of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX stent graft) when used as a bridging stent with branched and fenestrated aortic endografts in treating complex abdominal aortic and thoraco-abdominal aneurysms.

Methods:

A retrospective and prospective, multicenter, single-arm study in the European Union (Clinical Trial.gov: NCT05143138) enrolled patients treated with the VBX stent graft as a bridging stent in branched endovascular repair (BEVAR) and fenestrated endovascular repair (FEVAR) to allow endovascular aneurysm repair between January 2017 and December 2021. Up to 15 sites in Europe were required to enroll a minimum of 220 patients. Subjects’ medical records were reviewed by the investigator and specific data were collected ambispectively for up to 5 years of follow-up from the index procedure. The primary endpoint is Target Vessel (TV) patency (patient level) through 12 months. The registry was designed to statistically test TV patency at 12 months in both FEVAR and BEVAR populations. The hypothesis will be tested separately in the two cohorts (F/B-EVAR), using subjects with core lab imaging results available annually through 5-years. The binomial exact test will be used with a one-sided 2.5% level of significance to test the null hypothesis.

Results:

In total, 259 patients were retrospectively enrolled for a prospective follow-up of 5 years: 136 patients (72.8% male, mean age: 73 years) in the BEVAR cohort, 92 patients (87.0% male, mean age: 72.7 years) in the FEVAR cohort, 31 patients (54.8% male; mean age: 70.9 years) in the mixed F/B-EVAR cohort. Overall, 662 TV were stented with the investigational covered stents: 163 (24.6%) celiac trunk, 192 (29.0%) superior mesenteric artery, 307 (46.4%) renal arteries. The VBX stent grafts were paired with branches in 451 cases (68.1%) or fenestrations in 211 cases (31.9%) of Cook Medical stent-graft in all cases.

Conclusions:

This study will investigate the VBX stent graft performance in combination with fenestrated and branched aortic grafts to corroborate its use in complex aortic endovascular procedures and support the modification of current device Instructions For Use (IFU). Clinical Trial: : ClinicalTrials.gov; NCT05143138; https://clinicaltrials.gov/study/NCT05143138