Neuromodulation : journal of the International Neuromodulation Society
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Multicenter Study
Can Cerebrospinal Fluid Pressure Detect Catheter Complications in Patients Who Experience Loss of Effectiveness With Intrathecal Baclofen Therapy?
The catheter status of patients who presented with loss of intrathecal baclofen (ITB) therapy effectiveness was investigated using measurements of cerebrospinal fluid (CSF) pressure transmitted through the catheter fluid path to the pump. The aim of the study was to estimate the appropriate threshold separating catheter complications from "normal" catheter function, and to compare catheter status based on CSF pressure with the clinical diagnosis. ⋯ In-clinic CSF pressure data acquisition is technically feasible. Overall, catheter status based on the algorithm demonstrated concordance with the clinical diagnosis in 29 of 37 patients (78.4%).
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Intrathecal (IT) drug infusion is an appropriate and necessary tool in the algorithm to treat refractory cancer and noncancer pain. The decision-making steps/methodology for selecting appropriate patients for implanted targeted drug delivery systems is controversial and complicated. Therefore, a consensus on best practices for determining appropriate use of IT drug infusion may involve testing/trialing this therapy before implantation. ⋯ The PACC provides consensus guidance on best practices of trialing for IDDS implants. In addition, the PACC recommends that no trial may be required in certain patient populations.
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Pain treatment is best performed when a patient-centric, safety-based philosophy is used to determine an algorithmic process to guide care. Since 2007, the International Neuromodulation Society has organized a group of experts to evaluate evidence and create a Polyanalgesic Consensus Conference (PACC) to guide practice. ⋯ New algorithms and guidance have been established to improve care with the use of intrathecal drug delivery.
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Intrathecal therapy is an important part of the pain treatment algorithm for chronic disease states. The use of this option is a viable treatment strategy, but it is inherent for pain physicians to understand risk assessment and mitigation. In this manuscript, we explore evidence and mitigating strategies to improve safety with intrathecal therapy. ⋯ Intrathecal therapy is a viable and relatively safe option for the treatment of cancer- and noncancer-related pain. Continued research and expert opinion are required to improve our current pharmacokinetic and pharmacodynamic model of intrathecal drug delivery, as this will undoubtedly improve safety and efficacy.
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This study aimed to utilize failure modes and effects analysis (FMEA) to transform clinical insights into a risk mitigation plan for intrathecal (IT) drug delivery in pain management. ⋯ The methodology of FMEA offers a systematic approach to prioritizing risks in a complex environment such as IT therapy. Unmet needs and information gaps are highlighted through the process. Risk mitigation and strategic planning to prevent and manage critical failure modes can contribute to therapeutic success.