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Reduced nontarget embolization and increased targeted delivery with a reflux-control microcatheter in a swine model - 23/09/21

Doi : 10.1016/j.diii.2021.05.002 
Silvia Rizzitelli a, 1, , Nir Holtzman b, 1, Geert Maleux c, Thierry De Baere d, Fei Sun e, Pierre-Olivier Comby f, Michael Tal g, Gwenaelle Bazin a, Francois Montestruc h, Thomas Viel i, Philippe Robert a, Osnat Harbater b, Eran Miller b, Claire Corot a
a R&I, Guerbet, 95943 Roissy CdG Cedex, France 
b Guerbet Company, Accurate Medical Therapeutics LTD, 7670203 Rehovot, Israel 
c Radiology, University Hospitals Leuven, 3000 Leuven, Belgium 
d Interventional Radiology, Institut Gustave Roussy, 94800 Villejuif, France 
e Endoluminal Therapy and Diagnosis Unit, Jesús Usón Minimally Invasive Surgery Centre, 10071 Cáceres, Spain 
f Department of Neuroradiology, François-Mitterrand University Hospital, 21079 Dijon, France 
g Interventional Radiology, Hadassah Hospital, 9112001 Jerusalem, Israel 
h MSC, eXYSTAT, 92240 Malakoff, France 
i Life Imaging Facility (PIV), Université de Paris, PARCC-INSERM U970, 75015 Paris, France 

Corresponding author at: R&I, Guerbet, 95943 Roissy CdG Cedex, France.R&I, GuerbetRoissy CdG Cedex95943France

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Highlights

A reflux control microcatheter was compared to a standard end hole microcatheter in terms of non-target embolization in a swine model.
A reflux control microcatheter delivers 98% of microspheres in the target site of injection compared to 89% with a standard end-hole microcatheter.
Percentage of non-target embolization calculated by micro computed tomography analysis is greater with a standard end hole microcatheter that with a reflux control microcatheter.
Qualitative observation of micro computed tomography images demonstrates an overall superiority of the reflux-control microcatheter compared to a standard end-hole microcatheter for renal embolization with radiopaque microspheres in a swine model.

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Abstract

Purpose

To evaluate the potential differences in non-target embolization and vessel microsphere filling of a reflux-control microcatheter (RCM) compared to a standard end-hole microcatheter (SEHM) in a swine model.

Materials and methods

Radiopaque microspheres were injected with both RCM and SEHM (2.4-Fr and 2.7-Fr) in the kidneys of a preclinical swine model. Transarterial renal embolization procedures with RCM or SEHM were performed in both kidneys of 14 pigs. Renal arteries were selectively embolized with an automated injection protocol of radio-opaque microspheres. Ex-vivo X-ray microtomography images of the kidneys were utilized to evaluate the embolization by quantification of the deposition of injected microspheres in the target vs. the non-target area of injection. X-ray microtomography images were blindly analyzed by five interventional radiologists. The degree of vessel filling and the non-target embolization were quantified using a scale from 1 to 5 for each parameter. An analysis of variance was used to compare the paired scores.

Results

Total volumes of radio-opaque microspheres injected were similar for RCM (11.5±3.6 [SD] mL; range: 6–17mL) and SEHM (10.6±5.2 [SD] mL; range: 4–19mL) (P=0.38). The voxels enhanced ratio in the target (T) vs. non-target (NT) areas was greater with RCM (T=98.3% vs. NT=1.7%) than with SEHM (T=89% vs. NT=11%) but the difference was not significant (P=0.30). The total score blindly given by the five interventional radiologists was significantly different between RCM (12.3±2.1 [SD]; range: 6–15) and the standard catheter (11.3±2.5 [SD]; range: 4–15) (P=0.0073), with a significant decrease of non-target embolization for RCM (3.8±1.3 [SD]; range: 3.5–4.2) compared to SEHM (3.2±1.5 [SD]; range: 2.9–3.5) (P=0.014).

Conclusion

In an animal model, RCM microcatheters reduce the risk of non-target embolization from 11% to 1.7%, increasing the delivery of microspheres of 98% to the target vessels, compared to SEHM microcatheters.

Il testo completo di questo articolo è disponibile in PDF.

Keywords : Embolization, Therapeutic, Interventional radiology, Non-target embolization, X-ray microtomography, Preclinical evaluation

Abbreviations : CI, LS means, μCT, NTE, RCM, SEHM, SD, TACE


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© 2021  The Author(s). Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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Vol 102 - N° 10

P. 641-648 - ottobre 2021 Ritorno al numero
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