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Original research
Virtual simulation with Sim&Size software for Pipeline Flex Embolization: evaluation of the technical and clinical impact
  1. Lorenzo Piergallini1,2,
  2. Federico Cagnazzo2,
  3. Giorgio Conte3,
  4. Cyril Dargazanli2,
  5. Imad Derraz2,
  6. Pierre-Henri Lefevre2,
  7. Gregory Gascou2,
  8. Daniel Mantilla2,
  9. Carlos Riquelme2,
  10. Alain Bonafe2,
  11. Vincent Costalat2
  1. 1Neuroradiology, Hospices Civils de Lyon, Lyon, France
  2. 2Neuroradiology, CHU Montpellier, Montpellier, France
  3. 3Neuroradiology, La Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano Policlinico, Milano, Italy
  1. Correspondence to Dr Lorenzo Piergallini, Neuroradiology, Hospices Civils de Lyon, Lyon 69002, France; lorenzo.piergallini{at}gmail.com

Abstract

Introduction During flow diversion, the choice of the length, diameter, and location of the deployed stent are critical for the success of the procedure. Sim&Size software, based on the three-dimensional rotational angiography (3D-RA) acquisition, simulates the release of the stent, suggesting optimal sizing, and displaying the degree of the wall apposition.

Objective To demonstrate technical and clinical impacts of the Sim&Size simulation during treatment with the Pipeline Flex Embolization Device.

Methods Consecutive patients who underwent aneurysm embolization with Pipeline at our department were retrospectively enrolled (January 2015–December 2017) and divided into two groups: treated with and without simulation. Through univariate and multivariate models, we evaluated: (1) rate of corrective intervention for non-optimal stent placement, (2) duration of intervention, (3) radiation dose, and (4) stent length.

Results 189 patients, 95 (50.2%) without and 94 (49.7%) with software assistance were analyzed. Age, sex, comorbidities, aneurysm characteristics, and operator’s experience were comparable among the two groups. Procedures performed with the software had a lower rate of corrective intervention (9% vs 20%, p=0.036), a shorter intervention duration (46 min vs 52 min, p=0.002), a lower median radiation dose (1150 mGy vs 1558 mGy, p<0.001), and a shorter stent length (14 mm vs 16 mm, p<0.001).

Conclusions In our experience, the use of the virtual simulation during Pipeline treatment significantly reduced the need for corrective intervention, the procedural time, the radiation dose, and the length of the stent.

  • aneurysm
  • flow diverter
  • device
  • brain
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Footnotes

  • Contributors LP: conceptualization, methodology, statistical analysis, writing-original draft preparation. FC: methodology, writing-reviewing and editing. GC: statistical analysis, methodology. CD: data curation, methodology. PHL: data curation, methodology. GG: data curation, methodology. ID: data curation, methodology. CR: data curation, methodology. AB: data curation, methodology. VC: reviewing and editing, methodology, supervision.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests VC declares having stocks of Sim&Cure.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request to the corresponding author.

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