Initial Experience With Viabahn VBX as the Bridging Stent Graft for Branched and Fenestrated Endovascular Aneurysm Repair

Vasc Endovascular Surg. 2019 Jul;53(5):395-400. doi: 10.1177/1538574419840880. Epub 2019 Apr 24.

Abstract

Purpose: To evaluate the feasibility and safety of a novel balloon-expandable, heparin-bonded endoprosthesis (Viabahn VBX, W. L. Gore and Associates) when used as a bridging stent graft (BSG) with fenestrated and branched endovascular aneurysm repair (FB-EVAR). FB-EVAR and BSGs increase repair complexity with the potential for endoleak formation, stenosis, thrombosis, and graft migration. The mechanical construction of the Viabahn VBX and its antithrombogenic properties may provide an advantage for FB-EVAR over existing BSGs. The efficacy, safety, and clinical outcomes were assessed.

Materials and methods: Research ethics board approved, prospective, single arm cohort, pilot study of patients undergoing FB-EVAR between February 2017 and January 2018. Fenestrated and branched endovascular aneurysm repair was performed per the standard institutional protocol by a team composed of vascular surgeons and interventional radiologists. 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). Patient characteristics, procedural details, and technical and clinical outcomes were reviewed and summarized.

Results: FB-EVAR was performed in 13 patients (9 male and 4 female) mean age of 74 (range: 61-83) with a total of 41 Viabahn VBXs stents implanted. Mean maximum aneurysm size was 6.7 cm (range: 5.5-9.0 cm) and included 5 juxtarenal abdominal aortic aneurysms and 8 thoracoabdominal; 3 type V, 3 type IV, and 2 type III (Crawford Classification). The Viabahn VBX was successfully deployed in 40 (98%) of 41 of cases. At median follow-up of 223 days (range: 2-462), there was a (40/40) 100% Viabahn VBX patency rate. Seven endoleaks were identified intra- or post procedurally in 6 (46%) of 13 cases, including 1 type IB, 3 type II, 2 type III, and 1 unclassified. Nine complications occurred in 6 patients.

Conclusion: The Viabahn VBX stent is a safe and effective BSG for FB-EVAR with no early stent thrombosis. Further evaluation is required to determine longer term stent efficacy.

Keywords: Viabahn VBX; aneurysm; bridging stent graft; endovascular.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anticoagulants / administration & dosage*
  • Anticoagulants / adverse effects
  • Aortic Aneurysm, Abdominal / diagnostic imaging
  • Aortic Aneurysm, Abdominal / physiopathology
  • Aortic Aneurysm, Abdominal / surgery*
  • Aortic Aneurysm, Thoracic / diagnostic imaging
  • Aortic Aneurysm, Thoracic / physiopathology
  • Aortic Aneurysm, Thoracic / surgery*
  • Aortography / methods
  • Blood Vessel Prosthesis Implantation / adverse effects
  • Blood Vessel Prosthesis Implantation / instrumentation*
  • Blood Vessel Prosthesis*
  • Coated Materials, Biocompatible*
  • Computed Tomography Angiography
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation*
  • Feasibility Studies
  • Female
  • Graft Occlusion, Vascular / etiology
  • Graft Occlusion, Vascular / physiopathology
  • Graft Occlusion, Vascular / prevention & control
  • Heparin / administration & dosage*
  • Heparin / adverse effects
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Prospective Studies
  • Prosthesis Design
  • Risk Factors
  • Stents*
  • Thrombosis / etiology
  • Thrombosis / physiopathology
  • Thrombosis / prevention & control
  • Time Factors
  • Treatment Outcome
  • Vascular Patency / drug effects

Substances

  • Anticoagulants
  • Coated Materials, Biocompatible
  • Heparin