Refill Procedures of Intrathecal Drug Delivery Systems With a Recessed Fill Port on the Pump Surface: A Prospective Comparison Study of Ultrasound-Guided vs. Blind Refill Technique.
chronic pain
intrathecal drug delivery
intrathecal pump
spasticity
ultrasound guidance
Journal
Neuromodulation : journal of the International Neuromodulation Society
ISSN: 1525-1403
Titre abrégé: Neuromodulation
Pays: United States
ID NLM: 9804159
Informations de publication
Date de publication:
Oct 2019
Oct 2019
Historique:
received:
16
01
2018
revised:
14
06
2018
accepted:
15
07
2018
pubmed:
22
9
2018
medline:
21
3
2020
entrez:
22
9
2018
Statut:
ppublish
Résumé
Structural differences of implantable drug delivery systems (IDDSs) might have an impact on the efficiency of needle access to the reservoir fill port (RFP). The aim of this study was to assess the efficiency of RFP needle access with an ultrasound (US)-guided vs. a blind refill technique in IDDSs with a Recessed RFP (Recessed-RFP-IDDS). The primary outcome was the number of attempts needed to enter the RFP with a needle comparing the US-guided technique vs. the blind refill technique. The time to enter the RFP with the needle was a secondary outcome. We compared the amount of attempts between both techniques with the non-parametric Wilcoxon rank sum test. Fourteen adult patients underwent a total of 75 refills of their Recessed-RFP-IDDS during a period of 24 months. The median number of attempts to enter the RFP did not differ significantly between the US-guided technique and the blind refill technique (2.0 (IQR: 1-5) vs. 1.5 (IQR: 1-5.0), p = 0.572). The median time to enter the RFP with the needle did not differ significantly between both techniques (35.0 sec (IQR: 26.0-58.0) vs. 41.0 sec (IQR: 25.5-46.8), p = 0.878). The results of this study suggest that there is no difference in the RFP needle access efficiency between the US-guided and the blind refill technique in superficially located Recessed-RFP-IDDSs, if performed by experienced practitioners. However, the study did not address efficiency of the RFP needle access in IDDSs with aberrancy in pump location or refills performed by inexperienced staff.
Identifiants
pubmed: 30238550
doi: 10.1111/ner.12849
pii: S1094-7159(21)02015-8
doi:
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
799-804Informations de copyright
© 2018 International Neuromodulation Society.
Références
Deer TR, Pope JE, Hayek SM et al. The Polyanalgesic Consensus Conference (PACC): recommendations on intrathecal drug infusion systems best practices and guidelines. Neuromodulation 2017;20:96-132.
Falco FJ, Patel VB, Hayek S et al. Intrathecal infusion systems for long-term management of chronic cancer pain: an update of assessment of evidence. Pain Physician 2013;16:SE185-SE216.
Hayek SM, Deer TR, Pope JE, Panchal SJ, Patel VB. Intrathecal therapy for cancer and non-cancer pain. Pain Physician 2011;14:219-248.
Staats PS, Yearwood T, Charapata SG et al. Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS: a randomized control trial. JAMA 2004;291:63-70.
Francisco GE, Saulino MF, Yablon SA, Turner M. Intrathecal baclofen therapy: an update. PM R 2009;1:852-858.
Deer TR, Pope JE, Hayek SM et al. The Polyanalgesic Consensus Conference (PACC): recommendations for intrathecal drug delivery: guidance for improving safety and mitigating risks. Neuromodulation 2017;20:155-176.
Dario A, Scamoni C, Picano M, Fortini G, Cuffari S, Tomei G. The infection risk of intrathecal drug infusion pumps after multiple refill procedures. Neuromodulation 2005;8:36-39.
Rathmell JP, Miller MJ. Death after initiation of intrathecal drug therapy for chronic pain: assessing risk and designing prevention. Anesthesiology 2009;111:706-708.
Perruchoud C, Bovy M, Rutschmann B, Durrer A, Buchser E. Silicone septum leakage at the origin of a drug overdose in a patient implanted with an intrathecal pump. Neuromodulation 2013;16:467-463.
Prager J, Deer T, Levy R et al. Best practices for intrathecal drug delivery for pain. Neuromodulation 2014;17:354-372.
Shankar H. Ultrasound-guided localization of difficult-to-access refill port of the intrathecal pump reservoir. Neuromodulation 2009;12:215-218.
Hurdle MFB, Locketz AJ, Smith J. A technique for US-guided intrathecal drug delivery system refills. Am J Phys Med Rehabil 2007;86:250-251.
Maino P, van Kuijk SMJ, Perez RSGM, Koetsier E. Ease of fill port access during the ultrasound-guided vs. the blind refill technique of intrathecal drug delivery systems with a raised septum, a prospective comparison study. Neuromodulation 2017; e-pub ahead of print. https://doi.org/10.1111/ner.12736.
Maino P, Koetsier E, Perez RSGM. The accuracy of template-guided refill technique of intrathecal pumps controlled by fluoroscopy: an observational study. Neuromodulation 2015;18:428-432.
Maneyapanda MB, Chang Chien GC, Mattie R, Amorapanth P, Reger C, McCormick ZL. Ultrasound guidance for technically challenging intrathecal baclofen pump refill: three cases and procedure description. Am J Phys Med Rehabil 2016;95:692-697.
Saulino M, Gofeld M. “Sonology” of programmable intrathecal pumps. Neuromodulation 2014;17:696-698.
Gofeld M, McQueen CK. Ultrasound-guided intrathecal pump access and prevention of the pocket fill. Pain Med 2011;12:607-611.
Deer TR, Levy R, Prager J et al. Polyanalgesic consensus conference 2012: recommendations to reduce morbidity and mortality in intrathecal drug delivery in the treatment of chronic pain. Neuromodulation 2012;15:467-482.
Datta S, Satten GA. Rank-sum tests for clustered data. J Am Stat Assoc 2005;100:908-915.
McGlothlen GL, Rodriguez L. Training for the intraspinal drug delivery system reservoir refill procedure highly variable: a nationwide survey of health care professionals. Neuromodulation 2017;20:727-732.
Peccora CD, Ross EL, Hanna GM. Aberrant intrathecal pump refill: ultrasound guided aspiration of a substantial quantity of subcutaneous hydromorphone. Reg Anesth Pain Med 2013;38:544-546.
Hanlon JG, Gofeld M. Comparing ultrasound-guided and landmark-based intrathecal pump refill skills by trainees. Pain Medicine News, December 13-17, 2013. https://www.painmedicinenews.com/
Samper JM, Pérez VV, Alarcón MD, Ibáñez JA. Ultrasound imaging during filling of an internal infusion pump: a case report. Rev Esp Anestesiol Reanim 2008;55:316-317.
Greher M, Eichenberger U, Gustorff B. Sonographic localization of an implanted infusion pump injection port: another useful application of ultrasound in pain medicine. Anesthesiology 2005;102:243.