Intrathecal Drug Delivery Systems Research Articles

Risk Factors Associated with Postoperative Cerebrospinal Fluid Leaks After Intrathecal Drug Delivery System and an External Pump Implantation in Cancer Patients: A Retrospective Study.

To determine risk factors associated with postoperative cerebrospinal fluid leaks (CSFLs) after intrathecal drug delivery system (IDDS) and external pump implantation. The clinical data of 248 patients with advanced cancer who underwent IDDS implantation from January 2021 to December 2022 at the Department of Pain Medicine at the Hunan Cancer Hospital were retrospectively reviewed. Information regarding age, gender, height, weight, body mass index (BMI), tumour type, albumin levels, haemoglobin levels, history of diabetes and pre- and postoperative anti-tumour therapy was collected and analysed. Postoperative CSFLs occurred in 7 of 231 patients (3.30%). Statistical analysis indicated that gender, age, height, weight, BMI, tumour type, albumin levels, haemoglobin levels, history of diabetes, pre- and postoperative chemotherapy, pre- and postoperative radiotherapy, preoperative immunotherapy and postoperative targeted therapy were not independent factors for CSFLs. Preoperative targeted therapy [odds ratio (OR): 16.64; 95% confidence interval (CI): 1.42, 195.56; P = 0.01] and postoperative immunotherapy (OR: 13.38; 95% CI: 1.60, 111.65; P = 0.017) were factors associated with an increased postoperative CSFL rate. Of the two locations where CSFLs can occur, the back (puncture site of catheter, n = 4) and the hypochondriac region (location of infusion port implanted, n = 3), back CSFLs occurred earlier than in the hypochondriac region (18.25 ± 6.45 vs 115 ± 62.02 days, P = 0.032). Based on the data from our study, the timing of preoperative targeted therapy and postoperative immunotherapy should be considered to prevent the occurrence of CSFLs in cancer pain patients who have an IDDS and external pump.

Epidural and Intrathecal Drug Delivery Systems for Chronic Pain Management: Progress, Promises, and Challenges

Millions of people worldwide suffer from chronic pain, which significantly impacts their quality of life. Managing chronic pain is often complex and time-consuming. In this narrative review, we explore the use of epidural and intrathecal drug delivery systems (EIDDS) as a solution for chronic pain management. The purpose of this review is to provide an overview of recent approaches in targeted implantable drug delivery systems for chronic pain management, including their long-term safety, efficacy, cost-effectiveness, risks, and future opportunities and challenges. The data was gathered through extensive research using MEDLINE, PubMed, and Google Scholar databases, including studies published until June 13, 2023. The visual analogue scale, Karnofsky Performance Status (KPS), respiration, and oxygen saturation in the group receiving drugs through a targeted implantable drug delivery system were significantly better than those in the group receiving conventionally administered analgesia in a study on patients with advanced cancer. Whereas in comparison to conventional treatment alone, the targeted implantable drug delivery system alone or in combination therapy exhibited some advantages or similar effects in reducing chronic pain during a 1-year follow-up in patients with chronic non-cancer pain. Implantable drug delivery systems are a promising new treatment option for chronic pain treatment. All forms of pain, including those that are still challenging to treat with traditional methods, can now be targeted with devices and treatments.

Post-mastectomy Pain Syndrome: A Review Article and Emerging Treatment Modalities.

Post-mastectomy pain syndrome (PMPS) is a syndrome broadly applied to the development of chronic pain after surgical breast intervention (i.e., lumpectomy and mastectomy). The incidence of PMPS is likely underreported, and this has contributed to a paucity of high-level evidence related to the treatment of the aforementioned condition. A drive to reduce the burden of opioid use has led to pain management physicians trialing a variety of strategies to help patients manage PMPS. This review discusses the latest evidence behind treatment options for PMPS, exploring medications as well as interventional techniques (e.g., nerve blocks, radiofrequency ablation, neuromodulation, and intrathecal drug delivery systems). Recent advances in neuromodulation technology are of particular interest heredue to the well-localized nature of PMPS-related pain and the specificity with which modern neuromodulation techniques can generate an effect. Finally, the review proposes a framework with which to approach the care of patients with PMPS, with a specific emphasis on the early consideration of neuromodulation techniques along with functional and physical therapy to reduce patient medication burden and improve overall quality of life.

Education and Experience in Intrathecal Drug Delivery Systems (IDDS) During Pain Medicine Fellowships.

Targeted drug delivery (TDD) via intrathecal drug delivery systems (IDDS) exposure and clinical adoption remains low despite multiple well-designed trials that demonstrate safety, efficacy, reliability, and cost-saving benefits. This study aims to understand the possible contributing factors starting with Pain Medicine fellowship training. An internet-based, anonymous pilot survey was distributed to pain medicine fellows enrolled in an Accreditation Council for Graduate Medical Education (ACGME) accredited pain medicine training program during the 2021-2022 academic year. Fellowship programs were identified using published online ACGME accreditation data. The survey was distributed via email to fellowship program directors and coordinators and was made available through pain medicine societies. Seventy-one of four hundred and twenty-three pain medicine fellows (17% response rate) completed the survey. Nine percent of respondents evidence-informed opinion coincided with the most recent Polyanalgesic Consensus Conference (PACC) guidelines recommendations for IDDS treatment indications. Fifty-one percent of respondents felt there was an unmet need for IDDS training. About one-third of respondents felt that lack of curriculum, faculty, and cases were barriers to IDDS use, respectively. Thirty-one percent of fellows reported sufficient training for IDDS in their fellowship programs. The majority (70%) of respondents somewhat or strongly support direct training by IDDS manufacturers. A wide variability exists surrounding IDDS training during ACGME accredited pain medicine fellowship. Insufficient case exposure and lack of a standardized curriculum may play a role in future therapy adoption. The results from this study call for a more standardized training approach with an emphasis on adequate clinical exposure, utilization of peer reviewed educational curriculum and supplemental material to aid pain medicine fellows' education.

Intrathecal cervical analgesia for cancer pain: a 12-year follow-up study in a comprehensive cancer center

BackgroundIntrathecal analgesia plays a key role for patients suffering refractory cancer pain. Nevertheless, intrathecal drug delivery systems (IDDS), requiring a cervical catheter tip implantation, have been poorly described in medical...

The need of a comprehensive approach in a condition of poorly opioid-responsive cancer pain.

Spinal analgesia is often claimed as an effective strategy for patients with a poor response to systemic opioids. Despite the optimistic data reported in literature with intrathecal drug delivery systems (IDDS) for cancer pain, a critical analysis showed modest benefit. Indeed, intrathecal therapy may be potent means to be used in a very selected population. However, ability to manage spinal therapy combined with the use of opioids and other drugs in the general perspective of a comprehensive palliative care treatment may allow to resolve refractory cancer pain in a patient with a clinical profile of poor pain prognosis, according to the Edmonton staging system. A long-term management of patient who underwent different therapeuthic approaches, including multiple opioid lines, intrathecal analgesia, and a comprehensive palliative care treatment, is described. The case reported describes how the management of cancer pain may be complex, requiring a high level of expertise on using opioids, conversion ratios, different routes, particularly the intrathecal one, as well as providing a comprehensive palliative care treatment. No evidence-based treatment can be taken into consideration for such extreme conditions, where only experience and knowledge can guide to an effective course of treament along a period of about six months. Timely therapeutic strategies are needed to be performed in each challenging clinical situation along the course of disease.

Implanted intrathecal drug delivery systems may be associated with improved survival in patients with cancer.

Intrathecal Drug Delivery Systems (IDDS) are underused in the management of cancer-related pain despite evidence of both efficacy and survival benefit. There is currently limited evidence to indicate which patients might benefit most from IDDS. The aim of the study was to describe the baseline characteristics and survival outcomes of patients who accepted IDDS, patients who declined IDDS and patients who wished to go ahead with IDDS but whose condition deteriorated before they could do so. The survival data for 75 consecutive patients who had been offered intrathecal drug delivery were examined as part of a retrospective cohort study. Survival data was compared between three groups: those who accepted intrathecal drug delivery and went on to receive it (n = 41), those who accepted it but whose condition deteriorated before it commenced (n = 17) and those who declined this treatment modality (n = 17). Patients who received IDDS survived significantly longer after assessment compared to those who declined IDDS (hazard ratio (HR) for the IDDS group relative to the declined group 0.29 (95% CI 0.16 to 0.53), and 0.23 (95% CI 0.12 to 0.44) after adjustment for gender and baseline functional status. In patients who accepted IDDS but who were unable to commence treatment, survival after assessment was not significantly different from those who declined the IDDS (HR for the deteriorated group relative to the declined group 1.28 (95% CI 0.65 to 2.53), and 0.80 (95% CI 0.65 to 2.53) after adjustment for gender and baseline functional status). In this retrospective analysis, an improvement in survival may be associated with patients who accept ongoing pain management with an implanted intrathecal drug delivery system compared to those patients who either declined intrathecal drug delivery or deteriorated before it could be commenced.

More time in a community setting: A service evaluation of the impact of intrathecal drug delivery systems on place of care of patients with cancer pain.

Intrathecal Drug Delivery Systems are underutilised in the management of refractory cancer pain despite evidence of their efficacy. Not all patients who are offered this treatment modality accept it. There is no current evidence that indicates if the use of intrathecal drug delivery systems impacts on place of care for patients with cancer related pain. This service evaluation compared place of care, place of death and morphine equivalent daily dose at end of life for patients in whom Intrathecal Drug Delivery was successfully established versus those who chose comprehensive medical management. A retrospective longitudinal cohort study of 45 patients with cancer pain comparing those who had ongoing analgesia successfully delivered via an implanted Intrathecal Drug Delivery System (n = 28) with those who continued to receive comprehensive medical management (n = 17). There was a markedly greater time spent in the community in the intrathecal group than the medical management group (median 126.5vs 25.5 days; p = 0.002) and a lower morphine equivalent daily dose at end of life (median 127.5vs 440.0 p = 0.022). In patients with advanced cancer, the successful establishment of intrathecal analgesia is associated with more time in the community and a lower morphine equivalent daily dose at end of life. The study has low numbers, and the sample was retrospectively selected. Nevertheless, these findings suggest the initial investment of time in an inpatient setting may be beneficial. Further research is required, using larger, prospective studies of patient outcomes in this setting.

CURRENT ADVANCEMENTS AND COMPLICATIONS IN INTRATHECAL DRUG DELIVERY SYSTEM

Intrathecal drug delivery systems (IDDS) have emerged as a valuable treatment option for patients with chronic pain who have failed to achieve adequate relief with conventional therapies. These systems provide targeted delivery of medications directly to the cerebrospinal fluid, resulting in improved pain control and reduced systemic side effects. However, the use of IDDS is not without potential complications and considerations that must be addressed to ensure optimal patient outcomes. This comprehensive review examines the various complications associated with IDDS and the considerations that healthcare providers and patients need to be aware of. Surgical complications, such as infection, bleeding, spinal fluid leaks, and nerve damage, are discussed, along with strategies to minimize these risks. Device malfunctions, including pump failure, catheter issues, and electronic problems, are explored, highlighting the importance of regular monitoring and maintenance. Medication-related side effects, such as nausea, sedation, and respiratory depression, are addressed, emphasizing the need for close monitoring and appropriate dosage adjustments. Long-term considerations, including tolerance to medication, physical dependence, and withdrawal symptoms, are also examined, emphasizing the significance of gradual tapering and proper discontinuation protocols. The review underscores the importance of regular follow-up appointments to assess the system's functionality, medication dosages, and patient response to treatment. By proactively managing and addressing complications, healthcare providers can optimize pain relief and minimize adverse effects, ensuring the long-term effectiveness and safety of IDDS.

How I do it: weaning strategy for intrathecal drug delivery systems for chronic non-cancer pain: sublingual buprenorphine-naloxone microdosing schedule

How I do it: weaning strategy for intrathecal drug delivery systems for chronic non-cancer pain: sublingual buprenorphine-naloxone microdosing schedule

Intrathecal Drug Delivery Systems for Cancer Pain Control: Insights on Current Contemporary Practices in the US

ObjectivesAmong patients with cancer with moderate to severe, intractable pain, intrathecal drug delivery using an intrathecal drug delivery system (IDDS) offers effective pain control. In this study, we evaluate the trends of IDDS therapy among patients with cancer, associated comorbidities, complications, and outcomes, using a large representative US administrative inpatient data base. Materials and MethodsThe Nationwide Inpatient Sample (NIS) data base contains data from 48 states and the District of Columbia. The NIS was used to identify patients with cancer who underwent IDDS implantation between 2016 and 2019. Patients with cancer with intrathecal pumps for the treatment of chronic pain were identified using administrative codes. Baseline demographics, hospital characteristics, type of cancer associated with IDDS implantation, palliative care encounters, hospitalization costs, length of stay, and prevalence of bone pain were evaluated in the study. ResultsA total of 22,895 (0.32%) individuals with hospital admission for IDDS surgery were included for analysis among 7.06 million individuals with cancer in the final cohort. The IDDS cohort consisted of patients predominantly in the 65-to-79 years age group (40.49%), female sex (50.42%), and Caucasian ethnicity (75.82%). The top five cancers in patients receiving IDDS were lung (27.15%), colorectal (24.9%), liver (16.44%), bone (8.01%), and liver (7.99%) cancer. In addition, the length of stay was six days (interquartile range [IQR] four–nine days) and the median cost of hospital admission was $29,062 (IQR $19,413–$42,261) in the patients who received an IDDS. These factors were greater than those in patients without IDDS. ConclusionsA very few patients with cancer received IDDS in the US during the study period. Despite recommendations supporting its use, there are significant racial and socioeconomic disparities in IDDS use.

Role of Interventional Techniques in the Management of Cancer Pain

Pain is the major cause of morbidity in cancer patients. Interventional techniques should be considered for the management of pain that is refractory to traditional analgesics or when patients are unable to tolerate opioids. Interventional techniques are intended to stop pain signals through neural pathways from the periphery to the brain. This article deals with major interventional pain management techniques such as central neuraxial block, sympathetic block, peripheral nerve block, percutaneous cordotomy, percutaneous vertebroplasty and kyphoplasty, radiofrequency ablation, and cryoablation. Besides this, the role of radiotherapy and radionuclides in cancer pain have also been discussed. Central neuraxial block can effectively reduce pain while preventing opioid toxicity. It involves a percutaneous epidural or intrathecal catheter, an external syringe pump, or a fully implanted intrathecal drug delivery system to give medication. Sympathetic blocks such as celiac plexus and superior hypogastric block have role in patients with visceral abdominal pain. Peripheral nerve blocks may be employed when the distribution of somatic pain is restricted to a single nerve or plexus. Percutaneous cordotomy could be useful for any unilateral cancer pain below C4 dermatome. Percutaneous vertebroplasty (PV) treatment is used to alleviate axial back pain due to osteoporotic wedge fracture or malignant vertebral body disease. RFA and cryoablation techniques are now widely used for back pain due to osteoporotic and malignant vertebral collapse that are resistant to conservative treatment. External beam radiotherapy and radionuclides are useful in relieving cancer pain due to bone metastasis. This article aims at summarizing the indications, mechanisms, drug agents, contraindications, and complications of interventional pain management techniques that may offer benefits to patients coping with cancer and its terrible symptoms. Even though there is some risk involved with the techniques discussed in this article, the advantages of reduced pain and enhanced quality of life usually outweigh the risk.

Intrathecal drug delivery systems for cancer pain control: Insights on current contemporary practices in the US.

6605 Background: About a third of cancer survivors report moderate to severe pain. Intrathecal drug delivery system (IDDS) is an implantable pain control option for treating intractable chronic pain not responsive to systemic opioid therapy. Studies on the current practices in the US around the utilization of IDDS for cancer pain are lacking. Methods: The Nationwide inpatient sample (NIS) dataset is funded by the Agency for healthcare research and quality (AHRQ) for multistate healthcare research & decision-making. Adult patients admitted to hospitals with a primary or secondary cancer diagnosis between 2016-19 were included. Patients undergoing IDDS implantation were identified using the validated International Classification of Diseases, 10th Revision, Procedure Coding System codes (00HU33Z Insertion of infusion device into spinal canal, percutaneous approach and 0JH80VZ Insertion of infusion pump into abdomen subcutaneous tissue and fascia, open). Baseline demographics, hospital characteristics, and type of cancer associated with IDDS implantation were evaluated in the study. Results: 22,895 patients underwent IDDS surgery amongst 7.06 million hospitalizations from 2016-19. The IDDS cohort consisted of patients in the 65-79 years age group (40.49%), female sex (50.42%), and Caucasian ethnicity (75.82%). Most IDDS surgeries were performed in large, urban teaching hospitals. Conclusions: Despite recommendations supporting IDDS use, a small minority received the treatment with significant racial & socioeconomic disparities in IDDS use. [Table: see text]

ID: 213347 Intrathecal Bupivacaine Slows Opioid Dose Escalation in a Low-Dose Intrathecal Opioid Pump Population

Intrathecal drug delivery systems (IDDS) utilizing a low dose opioid strategy have proven durable in relieving pain without significant dose escalation (1). However, in a subset of patients, dose escalation is needed to maintain pain relief. Adjuvants such as bupivacaine are often used to augment pain relief in IDDS (2). We present a case series where bupivacaine was added to a low dose opioid strategy to slow the opioid escalation.

ID: 219049 Intrathecal Drug Delivery System (IDDS) Safety and Clinical Accuracy: 2-Year Registry Data

IDDS utilization in the treatment of chronic pain and severe spasticity involves intrathecal delivery of minute volumes of drug. System reliability and accuracy are key factors in patient safety and therapy effectiveness. Published clinical accuracy for available IDDS is currently limited to 1 year1,2,3, whereas available systems have implant lives of 7 years or more. To address this gap, a planned 4-year study of clinical accuracy and product performance events, initiated in 2017 at 15 European (EU) sites, is in progress. Results presented here are from a 2-year analysis.

ID: 215569 Updated Longitudinal Data From IDDS Product Surveillance Registry: Effect of Pump Durable Design Changes

TDD with programmable intrathecal drug delivery systems (IDDS) has been approved for malignant and chronic nonmalignant pain treatment since 1991 and severe spasticity since 1992. Identification of rare product performance events within IDDS becomes possible with expanded clinical use, necessitating product modifications to mitigate patient risk. Presented here is real-world evaluation of product performance updated with the most recent data following release of an enhanced IDDS.

ID: 212667 The Analysis of Personal Therapy Manager Setting After Intrathecal Morphine Pump Implantation: Case Series

Intrathecal drug delivery systems (IDDS) are used for long-term management of persistent, severe pain despite a multimodal approach with conventional pain treatment options. Several studies showed that the safety and effectiveness of IDDS in the management of patients with nonmalignant pain. However, the appropriate alleviation of breakthrough pain remains challenging. A patient-controlled analgesia (PCA) by a specific device—Personal Therapy Manager (PTM)—designed to be used with implanted programmable pumps. The usage patterns and settings of the devices in our center were analyzed.

ID: 215295 Targeted Drug Delivery Pump Failure Post MRI - A Sentinel Event

Intrathecal drug delivery systems (IDDS) are commonly utilized for many refractory chronic pain conditions and cancer associated pain. Manufacturer recommendations are available for physicians and MRI facilities to review prior to obtaining a scan1. We discuss a case in which IDDS malfunction occurred following MRI, despite following manufacturer instructions prior to and after MRI, resulting in profound medication overdose.

ID: 217145 Intrathecal Pump for the Treatment of Complex Regional Pain Syndrome After Failed Interventional Modalities

Intrathecal drug delivery systems have been utilized for decades. Although techniques may vary among providers, intrathecal pump placement is commonly used for cancer and chronic pain patients. At this time its utilization still lags behind other pain control modalities. Intrathecal infusion pumps may offer an excellent alternative for patients receiving poor analgesia with alternative interventional or pharmacological techniques, as well as reduce overall opioid requirements and reduce side effects. We provide a case in which a patient diagnosed with chronic cervical pain in the form of complex regional pain syndrome in unilateral extremity who previously received minimal relief with alternative modalities found significant pain reduction after both intrathecal pump trial and permanent pump placement.

ID: 207897 Neuromodulative Therapy and Reintegration Into Employment - A 10-Year Analysis of a Single Occupational-Health Surgery

There is only few data available how neuromodulative (spinal cord stimulation, intrathecal drug delivery systems) pain therapy effects the quality of life in patients with chronic pain1. So far, the ability to return to work after neuromodulative pain therapy has never been assessed. Surprisingly, the importance of employment to the quality of life is rather underestimated i.e., unemployment seems not only to have an effect on illness, but also seems to be the cause of it2.