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Cardiovascular and interventional radiology
Aug, 2022;45 (8): 1186-1197.

Drug loss from Paclitaxel-Coated Balloons During Preparation, Insertion and Inflation for Angioplasty: A Laboratory Investigation.

Bernd Faenger, Andreas Heinrich, Ingrid Hilger, Ulf Teichgräber
Author Information
  1. Bernd Faenger: Deaprtement of Radiology, Jena University Hospital, Friedrich Schiller University Jena, Jena, Germany.
  2. Andreas Heinrich: Deaprtement of Radiology, Jena University Hospital, Friedrich Schiller University Jena, Jena, Germany.
  3. Ingrid Hilger: Deaprtement of Radiology, Jena University Hospital, Friedrich Schiller University Jena, Jena, Germany.
  4. Ulf Teichgräber: Deaprtement of Radiology, Jena University Hospital, Friedrich Schiller University Jena, Jena, Germany. Ulf.teichgraeber@med.uni-jena.de. ORCID
PMID: 35689119 DOI: 10.1007/s00270-022-03164-5

Abstract

PURPOSE: To investigate drug contamination of the working environment with paclitaxel drug-coated balloon (DCB) angioplasty due to loss of paclitaxel containing particles from the coating during DCB preparation, insertion, and inflation.
MATERIAL AND METHODS: In an experimetal laboratory setting, drug loss during removal of the protective cover and insertion of the DCB through the hemostatic valve of the introducer sheath and after inflation was examined. In seven DCB types of different manufacturers, semi-quantitative image analysis was performed during five standardized tests cycles. Additionally, every DCB type passed one cycle of a wipe test and one cycle of air sampling.
RESULTS: By removing the protective cover, the paclitaxel-covered balloon surface was significantly reduced in 3 out of 7 products (P = 0.043). Overall, extend of decline ranged from 0.4 to 12%. In 6 of 7 products, powdered paclitaxel clusters dropped down upon removal of the protective cover (0.099 ng/cm up to approx. 22 ng/cm). Contamination of the air was detected in none of the DCB types. When pushed through the vascular sheath, none of the investigated DCB types showed a significant loss of paclitaxel from the coated balloon surface. After balloon inflation, the paclitaxel-coated surface area varied between manufacturers ranging from 25.9 to 97.8%.
CONCLUSION: In some DCB types, the removal of the protective cover already leads to a significant loss of paclitaxel and paclitaxel-coated surfaces. As a result, there will be a contamination of the workplace and a reduction in the therapeutic dose.
LEVEL OF EVIDENCE: No level of evidence.

Keywords

Angioplasty Catheter DCB Drug-coated balloons Paclitaxel Peripheral artery disease

References

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MeSH Term

Angioplasty
Angioplasty, Balloon
Coated Materials, Biocompatible
Femoral Artery
Humans
Paclitaxel
Peripheral Arterial Disease
Popliteal Artery
Treatment Outcome

Chemicals

Coated Materials, Biocompatible
Paclitaxel
Journal Article
Article has an altmetric score of 1

Word Cloud

Created with Highcharts 10.0.0DCBpaclitaxellossballoonprotectivecovertypesinflationremovalsurfacedrugcontaminationinsertionsheathmanufacturersonecycleair7products0nonesignificantpaclitaxel-coatedPURPOSE:investigateworkingenvironmentdrug-coatedangioplastyduecontainingparticlescoatingpreparationMATERIALANDMETHODS:experimetallaboratorysettinghemostaticvalveintroducerexaminedsevendifferentsemi-quantitativeimageanalysisperformedfivestandardizedtestscyclesAdditionallyeverytypepassedwipetestsamplingRESULTS:removingpaclitaxel-coveredsignificantlyreduced3P = 0043Overallextenddeclineranged412%6powderedclustersdroppedupon099 ng/cmapprox22 ng/cmContaminationdetectedpushedvascularinvestigatedshowedcoatedareavariedranging259978%CONCLUSION:alreadyleadssurfacesresultwillworkplacereductiontherapeuticdoseLEVELOFEVIDENCE:levelevidenceDrugPaclitaxel-CoatedBalloonsPreparationInsertionInflationAngioplasty:LaboratoryInvestigationAngioplastyCatheterDrug-coatedballoonsPaclitaxelPeripheralarterydisease

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