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

Maino, Paolo; Kuijk, Sander M. J. van; Pérez, Roberto; Koetsier, Eva

doi:10.1111/ner.12736

Cited by 10 publications

(17 citation statements)

References 13 publications

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“…Therefore, the needle has to pass less subcutaneous tissue before entering the RFP, reducing the risk for needle deviation and possibly rendering needle access more easy. This hypothesis is sustained by previous studies, results of which suggested that a more deeply located RFP leads to significantly more needle attempts and a higher procedural time to enter the RFP …”

Section: Discussionsupporting

confidence: 58%

“…Other factors related to the implanted pump or the patient, such as pump tilt, scar tissue, and the accumulation of fluid above the RFP, may also have an influence on refill accuracy . Because of the low occurrence rate of these factors, we did not formally test these associations.…”

Section: Discussionmentioning

confidence: 99%

“…The skin was disinfected, and with sterile gloves the tubing was attached to the syringe at one end and to the needle at the other end. The manual identification of the RFP consisted of palpating the raised RFP on the pump surface through the skin . The skin around the RFP was fixated with one hand, while the needle was inserted into the center of the raised RFP with the other hand.…”

Section: Methodsmentioning

confidence: 99%

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Refill Port Identification of Intrathecal Drug Delivery System Devices With a Raised Fill Port

2019

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Objectives The aim of this study was to assess the accuracy of the manual identification of the reservoir fill port (RFP) for refill of intrathecal drug delivery systems (IDDSs) with a raised RFP on the pump surface (raised‐RFP‐IDDSs), and compare this to previously reported data of patients with IDDSs with a recessed RFP (recessed‐RFP‐IDDSs). Methods Nineteen patients underwent 2 IDDS refills for the treatment of noncancer pain or spasticity. The primary endpoint of this prospective observational study was the deviation between the needle insertion point and the RFP center, quantified by fluoroscopic visualization. A distance surpassing that between the center and the margin of the RFP of 4 mm was considered a clinically relevant deviation. The results were compared with previously reported data of a patient cohort with recessed‐RFP‐IDDSs, and the differences were tested using Student's t‐test. Results The mean deviation from the RFP center was 4.9 mm (standard deviation = 3.7). The RFP identification accuracy deviated more than the clinically relevant difference in 17 out of 35 instances (48.6%). The number of attempts and median procedural time was significantly correlated to the needle deviation. The mean deviations in the raised‐RFP‐IDDS cohort were consistently lower compared to the recessed‐RFP‐IDDS cohort (first refill procedure 4.0 vs. 8.5, P < 0.001; second procedure 5.9 vs. 8.1, P = 0.074). Conclusion The results of this study suggest that the manual localization of the RFP for raised‐RFP‐IDDSs is moderately accurate, and more accurate if compared to previously published accuracy of the template‐guided technique for recessed‐RFP‐IDDSs.

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Section: Discussionsupporting

confidence: 58%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Refill Port Identification of Intrathecal Drug Delivery System Devices With a Raised Fill Port

2019

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“…Our study concerned superficially located IDDSs (mean 8.9 mm (SD 2.4 mm), which might have had a positive influence on the blind (palpation) technique. This accounts also for the previous study regarding Raised‐RFP‐IDDSs, which concerned IDDSs with a mean skin to RFP depth of 3.1 mm (SD 1.8 mm) . In deeper implanted IDDSs it might be more difficult to identify the outer borders and the RFP of the reservoir.…”

Section: Resultsmentioning

confidence: 60%

“…In conclusion, the study results suggest that there is no difference in RFP needle access efficiency between the US‐guided and the blind refill technique in superficially located Recessed‐RFP‐IDDSs, if performed by experienced practitioners. The results of the previous study regarding (also superficially located) Raised‐RFP‐IDDSs suggested that US guidance even slightly worsens efficiency of the RFP needle access in comparison to the blind refill technique . US guidance has the additional drawback of costs and requires training.…”

Section: Resultsmentioning

confidence: 99%