Abstract
Purpose
To prospectively evaluate the new Flexor©Parallel™ Rapid Release™ (Cook®, Bloomington, IN, USA) access sheath (UAS) which allows the use of a single wire to serve as both safety and working guide.
Materials and methods
Between June and September 2014, adult patients from five European centers who underwent flexible ureteroscopy (fURS) for therapeutic and diagnostic purposes were included. The 12/14Fr Flexor©Parallel™ UAS was evaluated. Data were collected and examined by both univariate and multivariate analyses. The UAS material and usage characteristics were rated per case by the surgeons on a scale from very bad to very good.
Results
In total, 134 UASs were used in 67 male and 67 female patients. Fifty percent of ureters (67 patients) were pre-stented. Ninety percent of the procedures were therapeutic. The overall successful insertion rate was 94 %. Pre-stenting status was the only independent factor for a successful access sheath insertion: 98.5 % of the pre-stented patients had a successful UAS placement vs. 82 % of non-pre-stented (p = 0.001, C.I. 95 %: 1.2). Evaluation of the material and radiopacity was considered very good in over 90 % of cases. Release of the guidewire, hydrophilic coating, gliding of the endoscope and repeatability were considered very good in over 80 %. There were two (1.4 %) UAS malfunctions and one submucosal lesion reported.
Conclusions
The use of the Flexor©Parallel™ Rapid Release™ (Cook®, Bloomington, IN, USA) with usage of a single guidewire in a prospective multicentric scenario was clinically applicable in the majority of cases. Pre-stenting increased the chance of a successful insertion from 82 to 98.5 %.
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Acknowledgments
Authors’ contribution
Alberto Breda MD: Protocol/project development, Data collection or management, Manuscript writing/editing. Esteban Emiliani MD: Data collection or management, Manuscript writing/editing. Felix Millán MD Ph.D…: Data analysis. Cesare Marco Scoffone MD: Protocol/project development, Data collection or management, Manuscript writing/editing. Thomas Knoll MD Ph.D. MSc: Protocol/project development, Data collection or management, Manuscript writing/editing. Palle J. S. Osther MD Ph.D.: Protocol/project development, Data collection or management, Manuscript writing/editing. Evangelos Liatsikos MD Ph.D.: Protocol/project development, Data collection or management, Manuscript writing/editing.
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The study was financially supported by COOK®. Alberto Breda is advisor for Karl Storz and Cook Medical, Esteban Emiliani has no competing financial interests, Felix Millán is advisor for Cook Medical, Cesare Marco Scoffone is advisor for Karl Storz, Boston Scientific, Porges Coloplst, Cook Medical and Lumenid, Thomas Knoll is advisor for Cook Medical, Palle J. S. Osther is advisor for Cook Medical, Karl Storz Endoskope, Olympus Boston Scientific, Porges Coloplast and Storz Medical, and Evangelos Liatsikos is advisor for Cook Medical.
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Breda, A., Emiliani, E., Millán, F. et al. The new concept of ureteral access sheath with guidewire disengagement: One wire does it all. World J Urol 34, 603–606 (2016). https://doi.org/10.1007/s00345-015-1638-9
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DOI: https://doi.org/10.1007/s00345-015-1638-9