Initial Experience Reported With Viabahn VBX as Bridging Stent Graft for Branched and Fenestrated EVAR
May 9, 2019—Online in Vascular and Endovascular Surgery, Sebastian Mafeld, MBBS, et al published findings from the initial experience with the balloon-expandable, heparin-bonded Viabahn VBX endoprosthesis (Gore & Associates) as a bridging stent graft (BSG) for branch and fenestrated endovascular aneurysm repair (FB-EVAR). The background of the study is that FB-EVAR and BSGs increase repair complexity with the potential for endoleak formation, stenosis, thrombosis, and graft migration.
According to the investigators, the mechanical construction of the Viabahn VBX endoprosthesis and its antithrombogenic properties may provide an advantage for FB-EVAR over existing BSGs. Therefore, they assessed the feasibility of Viabahn VBX to be used as a BSG with FB-EVAR in terms of efficacy, safety, and clinical outcomes.
As summarized in Vascular and Endovascular Surgery, this is a research ethics board–approved, prospective, single-arm cohort, pilot study of patients undergoing FB-EVAR between February 2017 and January 2018. FB-EVAR was performed per the standard institutional protocol by a team composed of vascular surgeons and interventional radiologists led by senior investigator Kong-Teng Tan, MD, at Toronto General Hospital in Toronto, Ontario, Canada. Viabahn VBX endografts were used for all intended visceral branches, as long as appropriately sized devices were available (under investigational testing authorization from Health Canada).
The investigators reviewed and summarized patient characteristics, procedural details, and technical and clinical outcomes.
FB-EVAR was performed in 13 patients (nine men, four women) who were mean age of 74 years (range, 61–83 years). A total of 41 Viabahn VBX devices were implanted. Mean maximum aneurysm size was 6.7 cm (range, 5.5–9.0 cm) and included five juxtarenal abdominal aortic and eight thoracoabdominal (three type V, three type IV, and two type III [Crawford Classification]) aneurysms.
The investigators reported that the Viabahn VBX device was successfully deployed in 40 (98%) of 41 cases. At a median follow-up of 223 days (range, 2–462 days), there was a 100% Viabahn VBX patency rate. Seven endoleaks were identified intra- or postprocedurally in six (46%) of 13 cases, including one type IB, three type II, two type III, and one unclassified. Nine complications occurred among the included patients.
The Viabahn VBX endoprosthesis is a safe and effective BSG for FB-EVAR, with no early stent thrombosis; however, further evaluation is required to determine longer-term stent efficacy, concluded the investigators in Vascular and Endovascular Surgery.