Initial single-center experience using Fiber Optic RealShape guidance in complex endovascular aortic repair

J Vasc Surg. 2023 Apr;77(4):975-981. doi: 10.1016/j.jvs.2022.11.041. Epub 2022 Nov 13.

Abstract

Objective: In the present study, we have described the technical success using Fiber Optic RealShape (FORS) endovascular guidance and its effects on the overall procedural time and radiation usage during complex endovascular aortic repair (EVAR).

Methods: Fenestrated and branched EVARs performed at a single center from 2017 to 2022 were prospectively studied. FORS-guided procedures were matched retrospectively 1:3 to non-FORS-guided procedures by the incorporated target arteries and body mass index. Technical success was defined as successful target vessel cannulation using FORS for the entirety of navigation (wire insertion to exchange for a stiff wire). The predictors of technical success were evaluated via logistic regression. The procedural times and radiation doses were compared between the matched cohorts using the Wilcoxon rank sum test.

Results: A total of 21 FORS-guided procedures were matched to 61 non-FORS-guided procedures. A total of 95 FORS cannulations were attempted (87 for the visceral target artery and 8 for the bifurcate gate). Technical success was achieved in 81 cannulations (85%); 15 (16%) were completed without the use of live fluoroscopy. The univariate predictors of FORS technical success included <50% target artery stenosis, <50% target artery calcification, and the target vessel attempted (P < .05 for each). FORS failures were attributed to device material properties in six cases, device failure in two cases, and the wire/catheter combination in six. The use of FORS guidance was associated with shorter median procedural and fluoroscopy times and a lower dose area product and air kerma (P ≤ .0001 for each).

Conclusions: The results from our initial experience with FORS during complex EVAR, including our learning curve, has shown promise, with acceptable technical success and reductions in procedural times and radiation usage.

Trial registration: ClinicalTrials.gov NCT02050113.

Keywords: EVAR; Endovascular guidance; FORS; Fiber optics; Three-dimensional.

MeSH terms

  • Aortic Aneurysm, Abdominal* / surgery
  • Aortography / methods
  • Blood Vessel Prosthesis
  • Blood Vessel Prosthesis Implantation*
  • Endovascular Aneurysm Repair
  • Endovascular Procedures*
  • Humans
  • Prosthesis Design
  • Retrospective Studies
  • Risk Factors
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT02050113