Intrathecal Drug Delivery Systems Research Articles

Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS)

Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS)

Intrathecal Pump Exposure to Electromagnetic Interference: A Report of Device Interrogation following Multiple ECT Sessions

Intrathecal drug delivery systems represent an increasingly common treatment modality for patients with a variety of conditions, including chronic pain and spasticity. Pumps rely on electronic programming to properly control and administer highly concentrated medications. Electromagnetic interference (EMI) is a known exposure that may cause a potential patient safety issue stemming from direct patient injury, pump damage, or changes to pump operation or flow rate. The objective of our case report was to describe an approach to evaluating a patient with a pump prior to and following exposure to EMI from electroconvulsive therapy (ECT), as well as to document findings from device interrogations associated with this event. Case report. Academic university-based pain management center. We present the case of a patient with an intrathecal pump who underwent multiple exposures to EMI in the form of 42 ECT sessions. Interrogation of the intrathecal drug delivery system revealed no safety issues following ECT sessions. At no time were error messages, unintentional changes in event logs, unintentional changes in pump settings, or evidence of pump stall or over-infusion noted. Communication with multiple entities (patient, family, consulting physicians, and device manufacturer) and maintaining vigilance through device interrogation both before and after EMI exposure are appropriate safeguards to mitigate the risk and detect potential adverse events of EMI with intrathecal drug delivery systems. Given the infrequent reports of device exposure to ECT, best practices may be derived from experience with EMI exposure from magnetic resonance imaging (MRI). Although routine EMI exposure to intrathecal drug delivery systems should be avoided, we describe one patient with repeated exposure to ECT without apparent complication.

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

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). 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 4mm 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. The mean deviation from the RFP center was 4.9mm (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). 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.

Inadvertent Spinal Shock during an Intrathecal Drug Delivery System Refill – A Case Report and Troubleshooting Algorithm

Intrathecal drug delivery systems (IDDS) are used to treat patients with chronic refractory pain syndromes and spasticity. IDDS offer an effective therapy to control pain while offering the advantage of a decrease in the incidence of side effects from high-dose systemic opioid therapy. Serious outcomes including death or permanent brain damage may occur from medication administration errors, primarily during maintenance of IDDS. The pump refill and reprogramming procedures, although elemental in theory, are not bereft of serious and fatal side effects .The importance of understanding the IDDS and competency in performing pump refills and programming is of critical importance. To reduce the risk of drug-related errors, particular attention should be paid to the proper functioning of pump hardware, drug reservoir volume discrepancies and overdose symptoms reported by patients. Furthermore, the clinician should be prepared for drug errors and follow the risk mitigation flowchart mentioned in the clinician refill reference card provided by the IDDS manufacturer. We present a case report of a 62-year old male with a history of post-laminectomy syndrome, associated with chronic back pain for the last 4 years. The patient developed inadvertent total spinal shock during a refill procedure of the IDDS reservoir. The educational objective of this case report is to highlight troubleshooting options, plus some of the risks and complications that can occur when managing an intrathecal pump delivery system. Clinicians involved in the ongoing care of patients with IDDS should undergo periodic competency validations. Imaging modalities are useful adjuncts for intrathecal pump refills when a patient has a more difficult entry or previous complications at the time of refill. A rapid recognition of evolving complications and implementation of appropriate treatment are the cornerstones of successfully managing complications associated with refilling of IDDS. Key words: Intrathecal drug delivery system, drug refill, total spinal shock, seroma, catheter port study, rotor study

Neuromodulation in Pediatrics: Case Series.

Neuromodulation, particularly intrathecal drug delivery systems and spinal cord stimulators (SCSs), can be a valuable tool when treating chronic pain in adults. However, there is a paucity of literature with regard to its use in pediatrics. We present a series of 14 children and adolescents with intractable pain who received a SCS or a pump for the intrathecal delivery of medications between 2010 and 2016 at our institution. During the study period, we placed 10 intrathecal pumps and 4 SCSs with an average age of 17 years old. Pain scores significantly improved after the implant (P<0.007) and function improved in 79% of patients. Opioid use was also significantly reduced. Three patients eventually had their device removed due to psychiatric comorbidities. Four patients had complications that were treated without further sequelae. Neuromodulation can offer important options in treating some pediatric chronic pain patients. In-depth knowledge of primary disease and strict patient selection in the context of the patient's social situation is vital to successful treatment.

Retrospective Analysis of Intrathecal Drug Delivery: Outcomes, Efficacy, and Risk for Cancer-Related Pain at a High Volume Academic Medical Center

Cancer pain is common and difficult to treat, as conservative medical management fails in approximately 20% of patients for reasons such as intolerable side-effects or failure to control pain. Intrathecal drug delivery systems (IDDS), while underutilized, can be effective tools to treat intractable cancer pain. This study aims to determine the degree of pain relief, efficacy, and safety of patients who underwent IDDS implantation at a multidisciplinary pain clinic. A retrospective review was conducted of patients with an intrathecal pain pump implanted for malignant pain. Charts were reviewed for demographics, cancer type, pain scores before and after implantation, and intrathecal drugs utilized. A Wilcoxon Signed-Rank test was conducted on the paired differences of pain scores before and after implant. A regression analysis was conducted using a linear model to assess effects of demographic variables on change in pain scores. 160 patients were included in analysis. The median pain score was 7.1 at time of implantation and 5.0 at one-month postimplantation. For patients with both baseline and one-month pain scores available, the median decrease in pain was 2.5 (p < 0.0001). Pain scores three-month postimplantation did not significantly differ from one-month postimplantation. Median longevity was 65 days. Five patients had pumps explanted due to infection with a median time to pump extraction of 28 days. IDDS has the potential to improve cancer pain in a variety of patients and should be strongly considered as an option for those with cancer pain intractable to conservative medical management.

Removal of Intrathecal Catheters Used in Drug Delivery Systems

Implanted intrathecal drug delivery systems (IDDS) are increasingly used in the treatment of spasticity and in patients with refractory pain. Literature discussing complications associated with intrathecal pump placement is widely available. However, reports of complications following the removal of chronically placed catheters are scarce. We reviewed our series of patients who had surgery to remove the intrathecal catheter. Retrospective review was performed for all patients who underwent surgery to remove a catheter linked to an IDDS between 2010 and 2016. Patients older than 18 years were included in final analysis. Demographic (including age at removal, sex, BMI, and comorbidities) and etiologic characteristics (indications of IDDS implant and explant, interval between implant and explant, and concomitant surgery) were analyzed. Simple logistic regression was performed to seek any potential predictor of complications. Fifty-nine patients underwent removal of their intrathecal catheter after variable periods (mean interval of 189 months). On eight occasions, patients developed complications after catheter removal (mean interval between implant and explant was 76 months for these cases). Retained catheter was the cause of complications in half of these occasions. Persistent cerebrospinal fluid leak was the next most common complication, with requirement of an external ventricular drain and lumbar drain to facilitate wound healing on two separate occasions. Removal of an intrathecal catheter from IDDS systems may cause complications that in some cases require additional surgery.

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

The localization of the reservoir fill port of Intrathecal Drug Delivery Devices (IDDS) can be difficult. The purpose of this study was to assess the ease of fill port access during the ultrasound-guided refill technique compared to the blind refill technique in IDDSs with a raised septum on the pump surface. Written informed consent was obtained from 19 adult patients undergoing regular refills of their Raised Septum IDDSs (RS-IDDSs). The primary outcome of this single center prospective comparison study was the number of attempts to enter the reservoir fill port with the needle comparing the ultrasound-guided technique vs. the blind technique. The number of skin punctures per refill procedure and time to enter the reservoir fill port was secondary outcomes. For between group comparisons the Friedman test for repeated measures on ranks was used. One hundred and eleven refill procedures were assessed in 19 patients over a period of 24 months. The median number of attempts to enter the reservoir fill port with the needle differed significantly between the ultrasound-guided technique and the blind technique (4 [IQR: 1-6] vs. 1 [IQR: 1-3], p = 0.018), in favor of the blind technique. The median time to enter the reservoir fill port differed significantly between the ultrasound-guided technique and the blind technique (58 sec [IQR: 38-94] vs. 22 sec [IQR: 16-40], p < 0.001). The results of this study suggest that for a RS-IDDS the blind refill technique needs significantly less attempts to enter the reservoir fill port than the US-guided refill technique.

Title: Quantifying the change of spasticity after intrathecal baclofen administration: A descriptive retrospective analysis

ObjectivesExploratory research quantifying the change of spasticity among patients who underwent baclofen intrathecal drug delivery system (IDDS) implantation.Patients and Methods: 88 patients with a baclofen IDDS were identified. Patient characteristics, spasticity scores pre/post intrathecal baclofen test dose, and IDDS perioperative implantation records were collected. The primary outcome was to quantify the extent to which there was a change in Modified Ashworth Scores (MAS) pre/post-intrathecal baclofen test dose administration. Secondary outcomes included the prevalence of perioperative IDDS implantation complications. ResultsThe mean age at IDDS implant was 44.2 years (range, 19–71), and 62.5% were male. 45.5% had spasticity of spinal cord origin, 9% of cerebral origin, and 45.5% of other upper motor neuron dysfunction. Reduction of MAS in the spinal cord origin group was 2.6 (mean, 3.5 to 0.9), cerebral origin group was 2.9 (mean, 3.3 to 0.4), and other origin group was 2.5 (mean, 3.6 to 1.1). In all patients, post dural puncture headache was the most commonly reported complication at 22.7%. ConclusionThis report offers novel findings documenting a quantifiable change of at least two points on the MAS before and after intrathecal baclofen test dose as statistically significant and could prove to be useful information to enhance the decision making process to proceed with intrathecal baclofen beyond assessment of functional abilities.

Long-term Outcomes Using Intrathecal Drug Delivery Systems in Complex Regional Pain Syndrome.

Providing durable long-term pain control for patients with complex regional pain syndrome (CRPS) is challenging. A multidisciplinary approach focused on physical therapy is frequently prescribed, with opioids and invasive procedures reserved for those challenged by functional progression. In this study, we examined the long-term efficacy of intrathecal drug delivery systems (IDDS) in patients with CRPS at our institution. Patients with CRPS implanted with an IDDS between 2000 and 2013 who had four or more years of continuous follow-up were included in the analysis. The outcome variables of interest were pain intensity and oral opioid intake. The primary predictor of interest was dose of intrathecal opioids, with ziconotide, bupivacaine, and clonidine characterized as binary secondary predictors. Of the 1,653 IDDS identified, 62 were implanted primarily for CRPS-related pain. Of these, 26 had four or more years of complete follow-up data. Pain scores did not significantly decrease over time, and we observed no correlation between pain intensity and use of any intrathecal medication. Although oral opioid intake decreased over time, intrathecal opioid dose did not affect oral opioid consumption. Ziconotide was associated with a hastening of the decrease in oral opioid intake, whereas the presence of bupivacaine paradoxically increased oral opioid intake. Our study demonstrates that intrathecal opioid dose was not associated with long-term decreases in oral opioid intake. Additionally, ziconotide was associated with a decrease in oral opioid intake over the four-year follow-up, and bupivacaine was associated with an increase in oral opioid intake. Our study examines the long-term effectiveness of intrathecal medications in managing pain in patients with complex regional pain syndrome. We present a detailed follow-up over four years for 26 patients, tracking oral opiate intake, pain scores, and intrathecal pump settings. Our findings suggest that intrathecal opiates may not be effective in reducing oral opiate intake, ziconotide may hasten a decrease in intake, and bupivacaine may lead to an increase in intake.

Intrathecal Drug Delivery Systems for Refractory Pancreatic Cancer Pain: Observational Follow-up Study Over an 11-Year Period in a Comprehensive Cancer Center.

Pancreatic cancer is the fourth leading cause of cancer-related death in Europe and the United States. Studies have demonstrated that patients with pancreatic cancer have a high prevalence of pain, with rates varying from 47% to 82%. Analgesia using intrathecal drug delivery systems (IDDS) has been poorly studied specifically in this population. The IDDS for pancreatic cancer pain was a follow-up observational study designed to evaluate 11-year results of IDDS for refractory pancreatic cancer pain at the Institut de Cancérologie de L'Ouest, Paul Papin in France. Patients were followed from March 2006 to April 2017. Patients were selected for IDDS based on multidisciplinary meeting discussion. All IDDS-treated patients were prescribed a combined intrathecal analgesics regimen through a catheter placed according to painful metameric level. Postimplant assessment of pain was determined using a numerical rating scale (NRS). Patients were followed via day-hospital visits and telephone calls at least monthly until death. Pain scores were compared using the Wilcoxon signed rank test. Overall survival (OS) was estimated using the Kaplan-Meier method and compared between groups by log rank tests. Ninety-three patients received IDDS, and total therapy duration accounts for 10,300 IDDS days. Implanted patients suffered from severe pain before implantation (median presurgical NRS, 8 [interquartile range, 7-9]) despite a median 360 mg (260-600) oral morphine equivalent daily dose. Median OS in the whole cohort after intrathecal treatment start was 82 days (95% confidence interval, 59-95). Median OS after surgery for implantable pump was 91 days (83-111) and for external pump 27 days (20-49; P < .0001). IDDS was associated with pain relief with a significant statistical difference between preimplantation NRS pain score and 1 week (median, -6 [-7 to -4]; P < .001), 1 month (median, -5 [-6 to -3]; P < .001), and 3 months (median, -6 [-7 to -4]; P < .001). Severe pain (NRS score, ≥7) decreased from 89.2% before surgery to 4.5% after 1 week, 6.7% after 1 month, and 10.3% after 3 months of IDDS implant (P < .01). Global complications rate was low, consistent with published literature. Despite our study's limitations, results suggest that long-term IDDS for refractory malignant pain due to pancreatic cancer was both efficacious and safe in pancreatic cancer pain. We have demonstrated, in the largest series of IDDS for pancreatic cancer pain reported yet, a clinically and statistically significant pain reduction in patients receiving IDDS.

Management of a Cancer Patient with an Intrathecal Drug Delivery System and an Acute Brain Abscess

Surgical-site infection, spinal cord abscess, and catheter tip granuloma are known but rare complications of intrathecal drug delivery systems (IDDS). To date, there are no published cases of brain abscess in a patient with an IDDS. In this study, we report a case of a cancer patient with an IDDS for management of cancer pain who developed a brain abscess with profound mental status changes and clinical management challenges.

Intrathecal Drug Delivery and Spinal Cord Stimulation for the Treatment of Cancer Pain.

The purpose of the present investigation is to summarize the body and quality of evidence including the most recent studies in support of intrathecal drug delivery systems and spinal cord stimulation for the treatment of cancer-related pain. In the past 3years, a number of prospective studies have been published supporting intrathecal drug delivery systems for cancer pain. Additional investigation with adjuvants to morphine-based analgesia including dexmedetomidine and ziconotide support drug-induced benefits of patient-controlled intrathecal analgesia. A study has also been recently published regarding cost-savings for intrathecal drug delivery system compared to pharmacologic management, but an analysis in the Ontario, Canada healthcare system projects additional financial costs. Finally, the Polyanalgesic Consensus Committee has updated its recommendations regarding clinical guidelines for intrathecal drug delivery systems to include new information on dosing, trialing, safety, and systemic opioid reduction. There is still a paucity of clinical evidence for spinal cord stimulation in the treatment of cancer pain. There are new intrathecal drugs under investigation including various conopeptides and AYX1. Large, prospective, modern, randomized controlled studies are still needed to support the use of both intrathecal drug delivery systems as well as spinal cord stimulation for cancer pain populations. There are multiple prospective and small randomized controlled studies that highlight a potential promising future for these interventional modalities. Related to the challenge and urgency of cancer pain, the pain practitioner community is moving toward a multimodal approach that includes discussions regarding the role of intrathecal therapies and spinal cord stimulation to the individualized treatment of patients.

A case series discussing the intrathecal drug delivery system to improve the quality of life in terminal cancer patients

Cancer is a life changing diagnosis and chronic pain in these terminally ill patients is extremely debilitating. In the present case series, the feasibility of continuous infusion of low dose local anaesthetics and opioids through the intrathecal route has been discussed pertaining to patient selection, technique, drugs used and trouble shooting. The intrathecal catheters were connected through a subcutaneous port to an external ambulatory infusion device (CADD pump) and used on a home care basis.

Intrathecal Drug Delivery Systems for the Management of Chronic Noncancer Pain: A Systematic Review of Economic Evaluations.

Intrathecal drug delivery (ITDD) systems are one of a limited number of management options for chronic noncancer pain, cancer pain, and spasticity. Concerns over their effectiveness and high initial costs led National Health Service (NHS) England to decommission ITDD for patients with chronic noncancer pain. However, the extent to which this decision is in line with existing economic evidence is unclear. The aim of this systematic review was to identify and review the existing evidence on the cost effectiveness of ITDD for chronic noncancer pain. Full and partial economic evaluations on ITDD were identified through systematic searches in MEDLINE, Embase, Web of Science, and the NHS for Reviews and Dissemination databases. Database searches were complemented by hand searching of reference lists of relevant studies and searches of grey literature. Study selection was carried out by 2 assessors, independently. Study quality assessment was performed to inform critical appraisal of health economics studies. Data were extracted using a data extraction form developed for the purposes of this study. Four thousand four hundred and sixty-four unique studies were identified, of which 7 met the inclusion criteria. With the exception of 1 study, the studies found ITDD to be either cost saving or cost effective compared to conventional medical management. ITDD became cost ineffective in 1 further study following price year adjustment to 2016. Study findings showed ITDD to be not cost effective only in extremely conservative scenarios. There is limited evidence on the effectiveness of ITDD in noncancer pain; however, the available economic evidence controverts arguments to refute the treatment on economic grounds.

Intrathecal Pump Refills, Pocket Fills, and Symptoms of Drug Overdose: A Prospective, Observational Study Comparing the Injected Drug Volume vs. the Drug Volume Effectively Measured Inside the Pump

One complication associated with the refill procedure of intrathecal drug delivery systems (IDDSs) include a "pocket fill," which is the inadvertent injection of the drug into the subcutaneous space surrounding the pump. The purpose of our study was to assess the mean volume discrepancy between the injected and the effective drug volume inside the IDDS reservoir after refills that did not lead to signs of overdose and to record at which volume discrepancy symptoms of overdose were noticed. After 221 refill procedures performed in 19 adult patients, drug volume inside the reservoir was assessed with a fill level sensor, and the volume discrepancy between injected and measured volume was recorded. Symptoms of overdose were monitored. For between group comparisons the Mann-Whitney U test was used, using a p-value of <0.05 to indicate statistical significance. The median volume discrepancy in the 20 mL IDDSs was 0.40 mL (IQR: 0.18-0.61; 10th p: 0.0; 90th p: 0.74) whereas in the 40 mL IDDSs the median volume discrepancy was 1.3 mL (IQR: 1.06-1.74; 10th p: 0.81; 90th p: 2.2). Symptoms of overdose were observed after 6 out of the 221 refill procedures. Volumes at which the symptoms of overdose arose were between 1.15 and 4.5 mL in 20 mL IDDSs and between 2.08 and 4.88 mL in 40 mL IDDSs. A volume discrepancy of >1 mL in 20 mL IDDSs and of >2 mL in 40 mL IDDSs after refill should be regarded as potentially consequential with regard to risk of overdose possibly caused by a pocket fill. In case of potentially consequential volume discrepancies, hospitalization and monitoring is recommended to preclude late overdose symptoms outside the hospital.

A Contemporary Medicolegal Analysis of Implanted Devices for Chronic Pain Management.

Analysis of closed malpractice claims allows the study of rare but serious complications and likely results in improved patient safety by raising awareness of such complications. Clinical studies and closed claims analyses have previously reported on the common complications associated with intrathecal drug delivery systems (IDDS) and spinal cord stimulators (SCS). This study provides a contemporary analysis of claims from within the past 10 years. We performed a closed claims analysis for a period January 1, 2009 to December 31, 2013 for cases with pain medicine as the primary service. These cases were identified using the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS), a database containing more than 300,000 malpractice claims from more than 400 academic and community institutions, representing approximately 30% of malpractice cases in the United States. The clinical narratives, which included medical files, claims files, depositions, and expert witness testimony, were reviewed by the authors, as were the CRICO coded variables, which included algorithmically determined contributing factors to the patient injury. Intrathecal drug delivery systems represented 17 of the closed claims; spinal cord stimulators represented 11 of the closed claims. The most common chronic pain diagnoses for which a device was implanted included failed back surgery syndrome and spasticity. The average total incurred for pain medicine claims was $166,028. Damaging events included IDDS refill errors (eg, subcutaneous administration of medication, reprogramming errors), intraoperative nerve damage, and postoperative infection (eg, epidural abscess, meningitis). High-severity outcomes included nerve damage (eg, paraplegia) and death. Medium-severity outcomes included drug reactions (eg, respiratory arrest from opioid overdose) and the need for reoperation. For both IDDS and SCS, deficits in technical skill were the most common contributing factor to injury, followed by deficits in clinical judgment, communication, and documentation. Implanted devices used for pain management involve a significant risk of morbidity and mortality. Proper education of providers and patients is essential. Providers must acquire the technical skills required for the implantation and refilling of these devices and the clinical skills required for the identification and management of complications such as intrathecal granuloma. Proper patient selection and clear communication between the provider and the patient about these possible complications are of paramount importance.

A numerical investigation of intrathecal isobaric drug dispersion within the cervical subarachnoid space.

Intrathecal drug and gene vector delivery is a procedure to release a solute within the cerebrospinal fluid. This procedure is currently used in clinical practice and shows promise for treatment of several central nervous system pathologies. However, intrathecal delivery protocols and systems are not yet optimized. The aim of this study was to investigate the effects of injection parameters on solute distribution within the cervical subarachnoid space using a numerical platform. We developed a numerical model based on a patient-specific three dimensional geometry of the cervical subarachnoid space with idealized dorsal and ventral nerve roots and denticulate ligament anatomy. We considered the drug as massless particles within the flow field and with similar properties as the CSF, and we analyzed the effects of anatomy, catheter position, angle and injection flow rate on solute distribution within the cerebrospinal fluid by performing a series of numerical simulations. Results were compared quantitatively in terms of drug peak concentration, spread, accumulation rate and appearance instant over 15 seconds following the injection. Results indicated that solute distribution within the cervical spine was altered by all parameters investigated within the time range analyzed following the injection. The presence of spinal cord nerve roots and denticulate ligaments increased drug spread by 60% compared to simulations without these anatomical features. Catheter position and angle were both found to alter spread rate up to 86%, and catheter flow rate altered drug peak concentration up to 78%. The presented numerical platform fills a first gap towards the realization of a tool to parametrically assess and optimize intrathecal drug and gene vector delivery protocols and systems. Further investigation is needed to analyze drug spread over a longer clinically relevant time frame.

Bleeding Complications in Patients Undergoing Intrathecal Drug Delivery System Implantation.

Intrathecal drug delivery systems (IDDSs) have dramatically improved analgesia and the functional status of cancer patients and those with chronic pain states. However, given the close proximity to the neuraxis and frequent concomitant use of antiplatelet or anticoagulant medications, this intervention is not without risk. The goal of this investigation was to determine the incidence of bleeding complications following IDDS placement. This is a retrospective review from 2005 through 2014 of adult patients undergoing IDDS implantation or revision at a tertiary care center. The primary outcome was a bleeding-related neurological complication requiring emergency medicine, neurology, or neurosurgical evaluation within 31 days. A total of 247 procedures were performed on 216 unique patients. Patients received aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) within seven days of needle placement for 64 procedures (25.9%). A preprocedural platelet count or international normalized ratio (INR) was available within 30 days for 138 procedures (55.9%). Of these, two patients had a platelet count lower than 100 x 109/L and one patient had an INR of 1.5 or higher at the time of the procedure. One neurological complication was identified (0.4%) that was not related to procedural bleeding. Similarly, three patients (1.2%) received a periprocedural red blood cell transfusion, none of which were related to procedural bleeding. No cases of bleeding-related neurological complications were identified following IDDS placement or revision, including in those receiving aspirin or NSAIDs. Future investigations with larger numbers are needed to further explore the safety of antithrombotic therapy continuation or discontinuation periprocedurally.

Cerebrospinal Fluid Leak Presenting with Radiculitis and Delayed Onset Headache Following Intrathecal Pump Implantation

The issue of cerebrospinal fluid (CSF) leak due to catheter-related failure persists despite new approaches to surgical techniques. There is limited literature about atypical presentations of post dural puncture headaches post intrathecal drug delivery system (IDDS) implantation. A 59-year-old woman with a past medical history of lumbar postlaminectomy syndrome, chronic pain, and lower back pain underwent an intrathecal drug delivery system implantation after exhausting other modalities for pain relief. The patient presented to the office one-month postoperatively with symptoms of lower back pain, left lower extremity radiculopathy, and lower back subcutaneous fluid collection. A dye study using catheter access port access revealed a patent intrathecal catheter with no fluid leakage or collection after injecting contrast dye through the catheter access port. A fine needle aspiration performed under ultrasound guidance revealed a clear fluid. Using laboratory evaluation, this was confirmed to be CSF using laboratory evaluation. An epidural blood patch was performed, which provided minimal radicular pain relief. Several days after, she began experiencing fronto-occipital headaches and the lumbar fluid collection reaccumulated. An intrathecal dye study again was done and showed retrograde flow from the catheter causing a lumbar fluid collection. A catheter exchange was performed resolving the CSF leak and the patient’s symptoms. Post dural puncture headaches after IDDS implantation may have an atypical presentation. Providers should ensure the intrathecal catheter is well secured and firmly anchored to prevent migration. Patient symptoms after IDDS implantation may necessitate further investigation, including: patient evaluation, confirming catheter continuity, and minimally invasive or surgical management. Complications from IDDS may be reduced with further research on equipment and implantation techniques. Key words: Intrathecal drug delivery system, neuraxial analgesia, chronic pain, post dural puncture headache, post laminectomy syndrome, intrathecal catheters