Pump Refill Research Articles

Pocket Fill During Intrathecal Pump Refill: Is it a Frequent Occurrence?

Pocket Fill During Intrathecal Pump Refill: Is it a Frequent Occurrence?

The Official Journal of ATTD Advanced Technologies & Treatments for Diabetes Conference Berlin, Germany—February 20–23, 2019

The Official Journal of ATTD Advanced Technologies &amp; Treatments for Diabetes Conference <i>Berlin, Germany—February 20–23, 2019</i>

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

Blessing or burden? Long-term maintenance, complications and clinical outcome of intrathecal baclofen pumps.

AimThe intrathecal baclofen pump is an effective treatment for spasticity. However, long‐term results have reported patients’ dissatisfaction and perception of disability. Potential causes include a frequent need for baclofen pump refill and risks of complications. The aim of the present study was to evaluate the long‐term maintenance, complications and clinical outcome of intrathecal baclofen pumps.Patients and MethodsWe conducted a 16‐year retrospective cohort study of patients with spasticity treated with an intrathecal baclofen pump at a university hospital from 2000 to 2016. The primary outcome was the rate of infection per puncture for baclofen pump refill. Secondary outcomes included the incidence of other complications, such as running out of baclofen causing symptomatic withdrawal symptoms, pump mechanical failure, pump battery end of life and the need for pump replacement. The clinical outcome was assessed by the Modified Ashworth Scale (mAS).ResultsIn total, 340 follow‐up episodes with pump refill procedures were recorded. The average interval between each pump refill was 57.3 days (±15.4 days). The average duration of admission for each pump refill was 4 h and 49 min (from 2 h 23 min to 10 h). There were two events with established infection after puncture for the refill, giving rise to an infection rate per puncture of 0.6 percent (2/340).For the long‐term clinical outcome, at an average follow‐up period of 7.6 years, the postoperative mAS for spasticity was 2.0 ± 0.756, which was significantly better than the preoperative mAS at 3.75 ± 0.462 (P = 0.001).ConclusionLong‐term aftercare with baclofen pump refill was safe, with an infection rate of 0.6 per cent per puncture for each refill. Long‐term intrathecal baclofen pump was effective in the treatment of spasticity with persistent significant improvement in the spasticity scale.

Stability of sufentanil and baclofen mixtures for intrathecal analgesia at different concentrations in polypropylene syringes

Intrathecal analgesia is a method using various molecules alone or in combination. Among these, the association sufentanil/ baclofen is widely used. Instead of moving patients to the few expert centers taking charge of these specific preparations, it could be better to transport syringes to peripheral centers managing pump refilling. That is why, it is interesting to demonstrate the stability of the mixture, and so to be able to ensure the best transport conditions of syringes. A stability indicating UPLC-DAD method was developed and validated according to the ICH guidelines. Four mixtures of sufentanil baclofen stored in 5±3°C and 25±2°C were evaluated for seven days and compared to the initial observed concentrations. The stability is demonstrated only for preparations stored at 5±3°C for seven days thanks to relative concentrations (95% confidence intervals of the mean of 3 samples) systematically positioned between 90% and 110%. On the other hand, after few days, degradation products of sufentanil appeared for all mixtures stored at 25°C±2°C. This study shows the stability of a weakly and a highly concentrated mixture of sufentanil and baclofen solutions in polypropylene syringes stored at 5±3°C for seven days. This result will allow the transport of the preparation under optimal conditions. Advance preparations for intrathecal pump refills could also be feasible.

Validated chromatographic method for the simultaneous determination of eight drugs (morphine, ropivacaine, bupivacaine, baclofen, clonidine, sufentanil, fentanyl and ziconotide) for intrathecal analgesia

Intrathecal analgesia has increased over the past two decades in various indications: chronic refractory pain from cancerous or non-cancerous origins, spasticity. These different indications involve the use of different molecules alone or in combination such as morphine, ropivacaine, bupivacaine, fentanyl, sufentanil, clonidine, baclofen and ziconotide. Pump refills are prepared at the pharmacy under a laminar flow hood. An analytical control should be carried out before release of the preparation. A new method of analytical control by chromatography has been developed and validated according to the International Conference on Harmonization guideline in order to secure the production process.

Stability Study of Morphine and Baclofen Solution in Polypropylene Syringes

AbstractBackgroundThe association of morphine and baclofen is used for the treatment of spasticity related pain. Moving these patients is sometimes difficult. In order to transport these syringes for pump refilling, it could be interesting to demonstrate the stability of the mixture, and so to be able to ensure the best transport conditions of syringes.MethodsA stability indicating UPLC-DAD method was developed and validated according to the ICH guidelines. Two mixtures of morphine and baclofen – a low concentration mixture (morphine 1 mg/mL – baclofen 0.08 mg/mL) and a high concentration mixture (morphine 10 mg/mL – baclofen 1.6 mg/mL) stored in 5±3 °C and 25±2 °C were evaluated for seven days and compared to the initial observed concentrations.ResultsThe stability of the low and high mixture is demonstrated for both storage conditions for seven days thanks to relative concentrations (95 % confidence intervals of the mean of 3 samples) systematically positioned between 95 % and 105 %. No degradation product was observed during the stability study.ConclusionThis study shows the stability of a weakly concentrated mixture and a highly concentrated mixture of morphine and baclofen. Extrapolation of these data to an intermediate mixture may be considered. Further studies will support this hypothesis. This result will allow the transport of the preparation under optimal conditions. Advance preparations for intrathecal pump refills could also be feasible.

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.

Poster 314: Challenging Cases of Ultrasound Guided Baclofen Pump Refills: A Case Series

Poster 314: Challenging Cases of Ultrasound Guided Baclofen Pump Refills: A Case Series

Investigation on the selection of pump refill mode in vasopressor among ICU nurses

Objective To investigate the current status and reasons of selecting pump refill mode in vasopressor among intensive care unit (ICU) nurses. Methods From October 1st to October 31st, 362 ICU nurses from 6 sub-professional areas of a tertiary hospital were investigated by self-designed questionnaire. Results The survey showed that, the common pump refill mode that ICU nurses used was empty needle for empty needle (97.2%) , pump for pump (59.8%) , and seamless change between pumps (79.5%) . 55.9% of nurses selected seamless change between pumps when patients were using vasopressor, and for patients who were sensitive to vasopressor, 77.5% of nurses would select seamless change between pumps. Selections were all chosed by nurses according to their experience and the condition of disease. Conclusions Among several pump refill modes that used in clinic, the seamless change between pumps was the most common mode that nurses selected when they use vasopressor, but most of them was based on the condition of disease, and we should look for more guidances based on evidence and standardize the clinical pump refill. Key words: Nurse; Intensive care unit; Vasopressor; Pump refill; Blood concentration

Primary Hydromorphone-Related Intrathecal Catheter Tip Granulomas: Is There a Role for Dose and Concentration?

Intrathecal drug delivery therapy has been used effectively in treating patients with intractable chronic pain. The development of an intrathecal catheter tip granuloma (ICTG) related to delivery of intrathecal opiates is a relatively infrequent, but potentially devastating complication. While there are many morphine-related ICTG cases described, reports of hydromorphone-related ICTG are limited. In addition, studies suggest a strong correlation between the use of higher doses and concentrations of intrathecal opiates and ICTG formation. The objective of this study is to determine the incidence and the association of intrathecal hydromorphone dose, concentration, duration of treatment and concomitant agents with ICTG formation. This is a retrospective analysis of 101 consecutive patients implanted with intrathecal infusion delivery devices. Data were collected from chart review, and records of pump refills from the division of Pain Medicine of University Hospitals or outsourced to a home pump refill service. From a cohort of 101 consecutively implanted patients, 69 were treated with intrathecal hydromorphone and followed up postimplant for an average of 33.5 ± 24 months (range 0-93 months; 95% CI of 27-39 months). The incidence of ICTG in our patient population was 8.7% during this period of time postimplant with mean time to granuloma detection 35.1 ± 7.9 months. Patients developing granuloma (n = 6) were treated with a combination of intrathecal hydromorphone and bupivacaine infusion. Exposure time to intrathecal agents was not different between the granuloma and nongranuloma group. Monthly dose increase of hydromorphone was higher in granuloma group vs. non-granuloma group (58 ± 34 mcg/month n = 6 vs. 25 ± 8 mcg/month n = 63). Four out of six granuloma cases occurred with low dose and concentration of IT hydromorphone (160-370 mcg/day; 0.75-1.0 mg/mL concentration). Intrathecal bupivacaine dose was not different between groups. A subset of patients was treated with intrathecal fentanyl and bupivacaine. No intrathecal granulomas occurred in this patient cohort. This is the first clinical report demonstrating an association of hydromorphone with intrathecal granulomas, particularly at low doses and concentrations of hydromorphone. This study supports the notion that using low dose of IT opioids might not protect against ICTG development but that the level of exposure and type of opioid used in IT space might be highly correlated with ICTG development. Further research and recommendations related to chronic intrathecal opioid infusions are necessary to raise awareness of significant incidence of ICTG and development of tests to isolate patient populations at high risk.

Poster 242 Ultrasound Guided and Doppler Verified Baclofen Pump Refill.

PM&RVolume 8, Issue 9S p. S239-S239 Neurological Rehabilitation Poster 242 Ultrasound Guided and Doppler Verified Baclofen Pump Refill Samuel T. Clanton MD, PhD, Samuel T. Clanton MD, PhD McGaw Medical Center of Northwestern University, Northwestern Medical School/RIC, Chicago, IL, United StatesSearch for more papers by this authorMithra Maneyapanda MD, Mithra Maneyapanda MD McGaw Medical Center of Northwestern University, Northwestern Medical School/RIC, Chicago, IL, United StatesSearch for more papers by this authorChristopher Reger MD, Christopher Reger MD McGaw Medical Center of Northwestern University, Northwestern Medical School/RIC, Chicago, IL, United StatesSearch for more papers by this author Samuel T. Clanton MD, PhD, Samuel T. Clanton MD, PhD McGaw Medical Center of Northwestern University, Northwestern Medical School/RIC, Chicago, IL, United StatesSearch for more papers by this authorMithra Maneyapanda MD, Mithra Maneyapanda MD McGaw Medical Center of Northwestern University, Northwestern Medical School/RIC, Chicago, IL, United StatesSearch for more papers by this authorChristopher Reger MD, Christopher Reger MD McGaw Medical Center of Northwestern University, Northwestern Medical School/RIC, Chicago, IL, United StatesSearch for more papers by this author First published: 24 September 2016 https://doi.org/10.1016/j.pmrj.2016.07.275Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume8, Issue9S2016 AAPM&R Annual Assembly AbstractsSeptember 2016Pages S239-S239 RelatedInformation

Ultrasound Guidance for Technically Challenging Intrathecal Baclofen Pump Refill: Three Cases and Procedure Description.

Intrathecal baclofen (ITB) therapy is a common treatment used to reduce spasticity due to neurologic disorders and injuries. A variety of factors can increase the difficulty of ITB pump refill. Excess subcutaneous fat overlying the pump, spasticity, suboptimal positioning, pump rotation or inversion, and scar formation over the reservoir fill port can create challenges during pump refill. As a result, multiple unsuccessful attempts at accessing the reservoir fill port can be painful and increase the risk of infection, particularly when repeat skin puncture is required. Blind attempts to refill a pump in challenging cases may also result in subcutaneous injection or pocket fill, resulting in a potentially fatal baclofen withdrawal syndrome. We describe 3 successful ITB pump refills in technically challenging cases when using ultrasound guidance. This represents an innovative approach to using ultrasound guidance to facilitate ITB refill in adults with intractable spasticity. We present these new clinical data with a literature review of potential complications related to inaccurate pump refill procedures and discuss the utility of ultrasound guidance for preventing such adverse events.

Baclofen overdose from possible intrinsic malfunction of SynchroMed II pump

This is a case report illustrating an overdose of baclofen in a 10-year-old boy due to a likely malfunction of a SynchroMed II pump. This ultimately necessitated a pump replacement. One-year follow-up showed no further incidents of baclofen overdose, with multiple pump refills.

Influence of pH and temperature on ziconotide stability in intrathecal analgesic admixtures in implantable pumps and syringes

PurposeThe aim of our study was to investigate the influence of pH and temperature on the stability of ziconotide in analgesic admixtures containing morphine and ropivacaine. MethodsAll admixtures were combined using a wide range of concentrations, in implantable pumps and syringes, using temperatures from 4°C to 37°C. Quantification was made thanks to a specific chromatographic technique. pH has also been measured throughout the study. ResultsAdmixtures confirm excellent stability for morphine and ropivacaine. Concerning ziconotide, an acid hydrolysis has been observed, reducing the time of use of our admixtures in a significant way, but producing non-toxic degradation products. The degradation was linear in all conditions. Inside the implantable pumps at body temperature turned out to be the best conditions for lower protein breakdown. Finally the degradation process showed a high correlation with the pH and the morphine concentration with a median loss of concentration delay due to degradation of 3.5 days [3; 5] when pH<4.5 and 13 days [13; 24] when pH≥4.5. ConclusionOur admixtures showed different stability depending on the drug concentrations, pH and temperature. The great majority of mixtures in real life in our institution have stability highly compatible with our practice and with the delay between two pump refilling.

(461) Exacerbation of spasticity-related pain after occlusion of intrathecal baclofen pump catheter in a patient with excessive pump movement: a case report

Patient is a 31-year-old woman with painful spastic cerebral palsy who underwent an intrathecal baclofen (ITB) pump placement in 11/2011. Initially, she appreciated an improvement in spasticity-related pain from ITB therapy. Within several months, she began to complain of “excessive” pump movement. Patient also believed the pump was occasionally flipping within the abdominal pocket. In 7/2014, patient presented for a scheduled ITB pump refill. Interrogation of the pump revealed an expected residual baclofen volume of 4.5 milliliters.

Sequential Injection Chromatography with post-column reaction/derivatization for the determination of transition metal cations in natural water samples

In this work, the applicability of Sequential Injection Chromatography for the determination of transition metals in water is evaluated for the separation of copper(II), zinc(II), and iron(II) cations.Separations were performed using a Dionex IonPACTM guard column (50mm×2mm i.d., 9 µm). Mobile phase composition and post-column reaction were optimized by modified SIMPLEX method with subsequent study of the concentration of each component. The mobile phase consisted of 2,6-pyridinedicarboxylic acid as analyte-selective compound, sodium sulfate, and formic acid/sodium formate buffer. Post-column addition of 4-(2-pyridylazo)resorcinol was carried out for spectrophotometric detection of the analytes׳ complexes at 530nm.Approaches to achieve higher robustness, baseline stability, and detection sensitivity by on-column stacking of the analytes and initial gradient implementation as well as air-cushion pressure damping for post-column reagent addition were studied.The method allowed the rapid separation of copper(II), zinc(II), and iron(II) within 6.5min including pump refilling and aspiration of sample and 1mmol HNO3 for analyte stacking on the separation column. High sensitivity was achieved applying an injection volume of up to 90µL. A signal repeatability of<2% RSD of peak height was found. Analyte recovery evaluated by spiking of different natural water samples was well suited for routine analysis with sub-micromolar limits of detection.

Longevity and cost of implantable intrathecal drug delivery systems for chronic pain management: a retrospective analysis of 365 patients.

Intrathecal drug delivery systems represent an important component of interventional strategies for refractory chronic pain syndromes. Continuous intrathecal administration of opioids results in higher subarachnoid drug concentrations, improved pain scores, and less frequent side effects when compared with systemic opioid administration. Substantial costs arise at the time of surgical implantation and at revision for battery depletion or treatment of a complication. Despite current widespread use, the real-world longevity and cost of implanted intrathecal pumps (ITP) has not been fully quantified. Patients with an ITP implanted at Cleveland Clinic Pain Management Center between January 1998 and December 2012 were included. ITP longevity was calculated as the time between implant and explant for depletion of the system's battery. Using the 2013 fee schedule of the Centers for Medicare & Medicaid Services, the daily cost of having a functioning ITP was calculated. The costs of office visits for pump refills and the cost of intrathecal medications were not included, nor were the possible savings due to decreased utilization of alternate medical services. Three hundred sixty-five patients had 559 pumps implanted. Postlaminectomy syndrome was the most common indication (40%). The median system longevity for all pumps was 5.4 years (97.5% confidence interval: [5.0, 5.8]), including pumps extracted prematurely, as well as those that reached the elective replacement interval. The median ITP longevity was 5.9 years (95% confidence interval: [5.6, 6.1]) for pumps explanted for end of battery life. The median system cost per day was $10.46. The median cost per day of pumps explanted for end of battery life was $9.26, versus $44.59 for pumps explanted prematurely due to complications. Overall, the cohort experienced an increased incidence of pump-related complications and a device longevity that was within the range of the manufacturer's anticipated lifespan. Increasing the lifespan of the ITP and improving patient selection have the potential to significantly improve the cost-effectiveness of intrathecal therapy.

The Accuracy of Template-Guided Refill Technique of Intrathecal Pumps Controlled by Fluoroscopy: An Observational Study.

Intrathecal drug therapy is being utilized increasingly for the treatment of chronic refractory pain. However, performing the regular pump refill procedures caries the potential risk of medication injection into the subcutaneous tissue. The aim of this study was to assess the accuracy of this template-guided refill technique by means of fluoroscopic evaluation. In 23 patients, the difference between the identification of the reservoir fill port center using the manufacturer's template and fluoroscopic guidance was assessed on four consecutive refill procedures by a two physicians. A distance surpassing that between the center and the margin of the port (3.5 mm) was considered a clinically relevant deviation. Analyses were performed with a one-sample t-test, with p < 0.05 indicating statistical significance. The mean difference distance between identification markings of the target with fluoroscopic guidance and with the template was 8.2 mm, with limited variance (2.7 mm). For all individual refill procedures, the port center identification accuracy differed significantly from zero (all p < 0.001) and from the clinically relevant cut-off point of 3.5 mm (all p < 0.001). Only seven attempts (6.4%) were within the margins of the fill port. Our results suggest poor accuracy of insertion point identification using the template. This highlights the potential risk of errors related to identification of the puncture site using the template-guided technique.

Silicone Septum Leakage at the Origin of a Drug Overdose in a Patient Implanted With an Intrathecal Pump

Intrathecal (IT) pump failures usually result in decreased drug administration and symptom reoccurrence with or without withdrawal syndrome. We report a case of a leaking silicone septum associated to a systemic drug overdose. An 84-year-old patient treated with IT clonidine for chronic back pain presented with a state of confusion, visual hallucinations, and hypertension two hours after an unremarkable pump (SynchroMed EL, Medtronic, Minneapolis, MN, USA) refill. The reservoir was emptied and 14 mL (8.4 mg of clonidine) was found to be missing (difference between retrieved and expected volumes). The pump was refilled and a check on the next day showed again a loss of 3.5 mL. A malfunction was suspected and the pump was replaced (SynchroMed II, Medtronic). The inspection of the external surface of the pump revealed severe damage to the silicone septum with multiple gouges due to needle scarring. A fluid leak also was clearly seen through the septum. The signs and symptoms presented by this patient are consistent with clonidine overdose that resulted from a combination of a possible accidental pocket fill and a definite septum leak into the subcutaneous tissue. The damage to the silicone could be due to the loss of the nontraumatic properties of the Huber needles that are rubbed against the metallic case in attempting to locate the injection port during refill procedures. This observation is the first description of a silicone septum damage contributing to a pump dysfunction and drug overdose despite the use of appropriate needles for refilling.