Pump Refill Research Articles

ID: 317289 Virtual Reality during Intrathecal Pump Refills in Children: a randomized controlled trial

ID: 317289 Virtual Reality during Intrathecal Pump Refills in Children: a randomized controlled trial

Traditional Lecture Versus Procedural Video Randomized Trial: Comparative Analysis of Instructional Methods for Teaching Baclofen Pump Management.

This study compared the effectiveness of traditional lectures and microvideos in teaching baclofen pump programming and refilling to physicians who have completed less than 10 refills for the previous 2 yrs. A mixed-method approach was used with 60 participating physicians specializing in physical medicine and rehabilitation or pain management. Preintervention and postintervention assessments were conducted using a rubric, and the participants' perceptions and preferences were gathered through focus group sessions. Two thirds of the participants specialized in physical medicine and rehabilitation. No significant differences in the preintervention, postintervention, or knowledge retention scores were found between the traditional lecture and microvideo groups. Both methods demonstrated comparable effectiveness in improving the baclofen pump refilling and programming skills. Qualitatively, participants perceived both approaches as equally helpful, but those in the microvideo group raised concerns because of instructors' unavailability and online platform navigation. Nevertheless, they preferred the convenience, accessibility, and time efficiency of the microvideos. The study concluded that microvideos are an effective alternative to traditional lectures for acquiring knowledge on baclofen pump programming and refilling. Further research should consider learners' characteristics and investigate the benefits of blended learning in medical education.

Baclofen Stability up to One Year in In Vivo Intrathecal Infusion Pumps

ObjectivesCommercial intrathecal baclofen treatment (ITBT) infusion pumps are recommended to be refilled within a maximum of 180 days, thus necessitating at least twice-yearly outpatient visits and refill injections. In particular, pumps with 40-mL reservoir volumes would allow much longer refill intervals. We investigated baclofen stability in active implanted ITBT infusion pumps in vivo with refill intervals up to 367 days to study the feasibility of lengthening refill intervals beyond six months. Materials and MethodsWe obtained 25 baclofen samples from 19 patients receiving ITBT with varying pump refill intervals. All patients had a baclofen infusion system delivering undiluted 2 mg/mL baclofen at continuous rates of 96.1 to 673.7 μg/d with a concentration of 2.002 mg/mL. Baclofen concentrations of the infusate samples acquired during the refill procedures were analyzed using a validated high-performance liquid chromatography with diode-array detection (HPLC-DAD) assay, later complemented with repeat assay with pH and physical measurements. We also present the validation data of the HPLC-DAD assay. ResultsDuring the mean refill interval of 247 days (SD 90, range 54–367 days), the mean change in baclofen concentration was −0.0156 mg/mL (−0.8%, SD 0.14, range −0.30 to 0.32 mg/mL, paired t-test p = 0.57, t24 = 0.57). Only a low negative correlation was found between the baclofen concentration and the refill interval (Pearson’s r = −0.32, p = 0.12). ConclusionsWe could not show a significant change in baclofen concentration over the time studied; 2 mg/mL baclofen ITBT refill intervals could be lengthened to up to one year—the theoretical maximum refill interval in our cohort would have been 489 days. Further studies with larger sample sizes and other baclofen brands are warranted.

ID: 217168 Intrathecal Pump Refill Leading to Altered Mental Status: Diagnosis and Management of a Pocket Fill

An 83 year-old male was admitted to the ICU from an outside hospital secondary to altered mental status in the setting of an intrathecal pump. The family reported the patient was in his usual state of health until four days prior when a home health nurse refilled his intrathecal pump with hydromorphone. At the time of pump refill, there was concern for drainage from the pump site and the usual difficulty of fill due to scar anterior to the device. The patient presented that evening to a local hospital due to being sluggish but was sent home with no clear etiology identified or trigger for admission. Three days later, he returned to the local hospital due to altered mental status felt to be medication overdose. Narcan was given causing severe agitation necessitating treatment with ketamine, morphine, and lorazepam. He was then transferred to Emory University for further critical care management and evaluation for possible intrathecal pump infection versus system failure.

Psychosocial and medical factors associated with intrathecal baclofen pump explants: A case series.

The goal of this retrospective chart review study was to explore factors that contributed to consideration of or actual pump explantation in pediatric patients with intrathecal baclofen (ITB) pumps. Medical records of 30 patients with ITB pumps were reviewed. Quantitative data, including demographic, clinical, psychosocial, and service utilization variables were culled from the records. Qualitative data were collected from clinic visit notes, pump-related follow-up phone calls, and any pump-related emergency room visits. Of those reviewed, six underwent ITB pump explantation, and two considered explantation. Factors contributing to pump explantation or consideration of explantation included the following: postoperative infection, pump malfunction, non-adherence, anxiety/behavioral factors impacting the patient's tolerance of the pump, distance to the medical provider, frequency of required pump refill appointments, lack or perceived lack of intrathecal baclofen effect, and difficulty transitioning to adult care providers. Due to the complex care regimen associated with ITB pumps and various psychosocial and logistical factors that impact treatment success, a standardized multidisciplinary pre-implantation education, screening, and assessment process should be developed. Such a process would ensure that patients/families receive appropriate education, including proactively identifying treatment barriers and potential complications, possibly minimizing dissatisfaction with treatment and the need for explantation.

A Clinical Evaluation of the Accuracy of an Intrathecal Drug Delivery Device

IntroductionImplantable intrathecal drug delivery (ITDD) devices are used to treat severe pain and spasticity refractory to conventional medical management. Although off-label medications and drug admixtures are commonly used in clinical practice and recommended by international guidelines, manufacturers state that this practice can result in device failure. The impact of off-label drugs and drug combinations on pump accuracy has hitherto never been assessed. Materials and MethodsA multinational, three-center, retrospective review of patient records was undertaken. The inclusion criterion was the presence of an ITDD device implantation in adult patients, with the pump in situ for the expected battery lifespan. Residual drug volumes at each refill, drug mixtures and concentrations, and rate and flow pattern of the pump (simple or flex) were recorded. A normalized flow rate ratio was calculated (actual to theoretical flow rate). The impact of nonapproved drugs, battery life, pump size, and flow program on drug delivery accuracy was assessed. ResultsData from 1402 pump refills were collected (73 patients). The overall mean accuracy ratio was 0.995 (95% CI = 0.986–1.004). The ratio for approved drug status was 0.990 vs 0.997 in nonapproved, with a difference of −0.007 (−0.032 to 0.017). At the tenth centile for remaining battery life (14 months), the ratio was 0.983 vs 1.009 for the 90th centile (69 months), with a difference of −0.026 (−0.038 to −0.014). The ratio for flex administration was 0.982 vs 1.006 for simple, with a difference of −0.024 (−0.040 to −0.008). For pump size of 40 mL, the ratio was 0.975 vs 1.010 for 20 mL, with a difference of −0.035 (−0.063 to −0.008). The 95% prediction interval for individual refill ratios was ±0.15. ConclusionIn a clinical setting, the ITDD pumps retained high levels of accuracy and acceptable precision across their lifespan despite using unapproved drugs or admixtures and under various flow modes and rates.

Virtual Reality during Intrathecal Pump Refills in Children: A Case Series.

Virtual reality has proven to be an effective approach to decrease pain in acute settings, both in adults and children. The aim of this study is to evaluate whether virtual reality (VR) could reduce pain during an intrathecal pump refill procedure in children receiving intrathecal drug delivery, compared to a standard refill procedure. This is a three-arm crossover randomized controlled trial, evaluating the effect of VR on pain in children with cerebral palsy undergoing an intrathecal pump refill compared to a standard refill and a refill with distraction (watching a video). Pain was evaluated using the Wong–Baker Faces Scale. Secondary outcomes were procedural pain, fear, state anxiety, the incidence of adverse events and satisfaction. Six children participated in this study, whereby all children underwent the three conditions. Five children indicated an equal of lower pain score during VR, compared to a standard refill. This finding of an equal or lower pain intensity score for the VR condition compared to the control condition was also revealed by the ratings of the parents, physician and the researcher. The influence of VR on anxiety and fear seem to be in line with the influence of watching a video. In terms of satisfaction, all children and parents agreed with the statement that they would like to use VR again for a next refill. Due to the lack of adverse events, the high degree of satisfaction of children with VR and the decreased pain levels after a refill with VR, physicians may aim to explore the implementation of VR during intrathecal pump refill procedures in children in a daily clinical routine care setting.

PO201 / #826 HOSPITAL@HOME FOR INTRATHECAL PUMP REFILLS: A PROSPECTIVE EFFECTIVENESS, SAFETY AND FEASIBILITY STUDY: E-POSTER VIEWING

Continuous Intrathecal Drug Delivery through an implanted pump is a well-known therapeutic option for the management of chronic pain and severe disabling spasticity. To have a successful therapy, pump refills need to be performed at regular time intervals after implantation. In line with the increased applications of Hospital@Home (i.e. the trend towards displacement of care from hospital to home setting), these refill procedures might be performed at the patient’s home instead of at the hospital.

Hospital at Home for Intrathecal Pump Refills: A Prospective Effectiveness, Safety and Feasibility Study.

Continuous Intrathecal Drug Delivery through an implanted pump is a well-known therapeutic option for the management of chronic pain and severe disabling spasticity. To have a successful therapy, pump refills need to be performed at regular time intervals after implantation. In line with the increased applications of Hospital at Home, these refill procedures might be performed at the patient’s home. The aim of this pilot study is to evaluate the feasibility, safety, and effectiveness of intrathecal pump refill procedures at home. Twenty patients were included whereby pump refill procedures were conducted at the patient’s home. To enable contact with the hospital, a video connection was set-up. Tele-ultrasound was used as post-refill verification. All procedures were successfully performed with complete patient satisfaction. Ninety-five percent of the patients felt safe during the procedure, and 95% of the procedures felt safe according to the physician. All patients indicated that they preferred their next refill at home. The median time consumption for the physician/nurse at the patient’s home was 26 min and for the researcher at the hospital 15 min. In light of quality enhancement programs and personalized care, it is important to continue urgent pain management procedures in a safe way, even during a pandemic.

First Evaluation Switching From Ropivacaine to Highly Concentrated Bupivacaine in Intrathecal Mixtures for Cancer Pain

Intrathecal drug delivery is widely used for intractable cancer pain treatment. A combination of drugs with morphine and bupivacaine is recommended in first line therapy. In France, we use ropivacaine 10mg/mL instead of bupivacaine 5mg/mL, the only concentration available. Bupivacaine 40 mg/mL has been available in France only since July 2020 under temporary authorization of use. The main objective of the study was to evaluate the safety, efficacy by pain assessment, to analyze drug dosage changes, to report adverse events (AEs) and conversion ratios switching from ropivacaine to bupivacaine. Secondary objective was to evaluate costs differences. We conducted this retrospective follow-up monocentric study within the Institut de Cancérologie de l'Ouest (ICO) Pain Department in Angers, France. We included 14 patients aged 18 years and above, implanted with an Intrathecal Drug Delivery Systems (IDDS) for cancer pain treatment and followed up at ICO from July 2020 to February 2021 after switching from ropivacaine to bupivacaine. We used a continuous infusion mode and Bolus could be added through Personal Therapy Manager (PTM). The median conversion ratio between ropivacaine and bupivacaine was 0.68 (0.65; 0.69) and resulted in no significant change in numeric rating scale evaluation (p=0.10). We observed moderate and rapidly reversible AEs such as clinical hypotension (29%) and motor block after bolus (21%). The estimated median hospital cost per day was significantly lower (p=0.05) for the bupivacaine refills than for the last ropivacaine pump refill, decreasing from US$ 61.7 (49.6; 70.5) to US$ 50.4 (45.9; 60.4). The median reimbursement per day from the National Health Insurance (NHI) was three times lower for bupivacaine pump refill when compared to the last ropivacaine pump refill (p < 0.01), decreasing from US$ 179.10 (156.79; 182.91) to US$ 64.59 (59.85; 71.89). Switching from ropivacaine to bupivacaine in IDDS appears more efficacious while remaining just as secure, and at lower cost.

Stability Study of Admixtures Combining Ziconotide With Morphine or Sufentanil in Polypropylene Syringes

The association of morphine ziconotide or sufentanil ziconotide was used to manage cancer 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. A stability indicating UPLC-DAD method was developed and validated according to the ICH guidelines. Fur mixtures of each association have been stored in 5 ± 3°C and 25 ± 2°C and were evaluated for seven days and compared to the initial observed concentrations. The stability of these associations was demonstrated at 5°C for seven days thanks to relative concentrations (95% confidence intervals of the mean of three samples) systematically positioned between 95% and 105%. No degradation product was observed during the stability study. This study shows the stability of these association morphine ziconotide or sufentanil ziconotide at 5°C for seven days in polypropylen syringes. This result will allow the transport of the preparation under optimal conditions. Advance preparations for intrathecal pump refills could also be feasible.

The Impact of a Music Video on Procedural Pain and State Anxiety

PurposePatients with chronic pain and/or spasticity who have an intrathecal targeted drug delivery (TDD) pump require frequent needle access procedures to refill the pump's medication reservoir. Some patients find the access procedure painful and/or anxiety provoking. The purpose of this study was to determine if a nursing intervention of providing a distraction with a music relaxation video during the pump access procedure would reduce patients’ pain and state anxiety. Design/MethodsIn this longitudinal, pre-test post-test, quasi-experimental design, patients watched a 13-minute calming music video while the nurse performed the needle access procedure. Data collection instruments included a combination of researcher-developed questionnaires, the Defense & Veterans Pain Rating Scale (DVPRS), and the State Trait Anxiety Inventory (STAI). Pain and anxiety were measured pre- and post-pump refill procedures at baseline with no intervention (T1) and at two subsequent pump refills with the music video intervention (T2 and T3). ResultsThe sample consisted of 31 adults with chronic pain (n = 28) or spasticity (n = 3). All participants had an implanted pump for at least six months. Specialty trained nurses refilled the participants’ pump in their home. The findings support the use of a music video as an effective intervention for reducing participants’ perception of pain and anxiety during the pump refill procedure. Neither pre-test pain nor pre-test anxiety scores differed across time. Post-test mean pain scores decreased consistently across time (T1 = 5.55, T2 = 4.42, T3 = 4.23; P = .002). Post-test anxiety scores showed a significant decrease (P <.05) between T1 (M = 37.87) and T2 (M = 30.94) which was not sustained at T3 (M = 35.68, P = .284). Overall, the majority of participants indicated liking the music video intervention. They also expressed interest in using the intervention for future refill procedures or other stressful situations. ConclusionsThe music video was effective in producing a sustained reduction over time of participants’ pain during the pump refill procedures; it was most effective in initially reducing participants’ state anxiety at the initial intervention visit; however, it did not demonstrate a progressively sustained effect. Participants’ opinions about the music video experience were positive.

Virtual reality to reduce pain intensity and anxiety during intrathecal pump refills in children with cerebral palsy

Virtual reality to reduce pain intensity and anxiety during intrathecal pump refills in children with cerebral palsy

Response to: Managing Intrathecal Drug Delivery Devices in a Global Pandemic

Response to: Managing Intrathecal Drug Delivery Devices in a Global Pandemic

Stability and Compatibility of Drug Mixtures from Intrathecal Pump Using High Performance Liquid Chromatography

Although management of intractable pain using long-term intrathecal analgesic administration by implantable infusion systems has become acceptable clinical practice, this method presents unique challenges regarding the stability of the pharmaceutical agent(s) delivered. The stability and compatibility of a single drug such as hydromorphone or bupivacaine, as well as mixtures of morphine-clonidine, have previously been reported, but only using implantable infusion systems and syringes under simulated clinical use conditions, not from implanted intrathecal pumps. The objective of this study was to assess the compatibility and stability of drug mixtures from intrathecal pumps placed in patients. For this case-series, 5 patients with intrathecal pumps who presented to the pain clinic for refill were randomly selected. An aliquot of sample extracted from the pump and an aliquot of new medicine used for pump refill were collected. High performance liquid chromatography (HPLC) was used to compare the 2 samples. Drug samples used were as follows: (A) hydromorphone only, (B) morphine and bupivacaine, (C) hydromorphone and ziconotide, (D) ziconotide and baclofen; and (E) hydromorphone, ziconotide, and baclofen. Samples B and E appeared to be stable when placed in situ in the SynchroMed II intrathecal pump based on the HPLC analysis. However, samples A, C, and D appeared to have undergone some degradation and/or byproduct formation as noted in the graphical display on HPLC. While sample A was a single-drug combination, the sample was in the pump for over 3 months; likewise, sample E was a 3-drug combination, however it was in the pump for only 30 days. Based on these results, it appears as though (a) when the length of time the drug stays in the intrathecal pump increases, or (b) when a combination of drugs is used in the intrathecal pump (as opposed to a single drug), some drug degradation and/or byproduct formation happens as seen on HPLC. This is the first reported study assessing the compatibility and stability of drug mixtures from intrathecal pumps. While the above reported HPLC data reveals quantitative differences, further qualitative analysis is required for confirmation and possible identification of possible degradation and/or byproducts. Key words: Degradation, high performance liquid chromatography, intrathecal pump

Preparing individuals with spinal cord injury for extreme storms in the era of climate change

Preparing individuals with spinal cord injury for extreme storms in the era of climate change

Usefulness of Imaging for Intrathecal Drug Delivery Systems: An update

Intrathecal Drug Delivery Systems are invasive pain treatment techniques that require bypassing the blood-brain barrier in order to implant a catheter inside the CSF. Imaging is a key element before and during implantation as well as in the diagnosis of complications. The understanding of delivery mechanisms has been greatly improved using MRI. Drug diffusion can now be modeled according to infusion level and flow rate for each individual patient. MRI and CT are useful in diagnosing the patient, targeting spinal level, and accurately evaluating implantation concerns or contraindications. Imaging is a key tool during the implantation of the device. Catheter positioning is essential as the treatment diffusion is limited, and the tip of the catheter must be set behind the spinal cord. Currently, fluoroscopy is the gold standard for catheter placement. Biplane Interventional Imaging and surgical CT scan will soon be able to help with more accurate positioning. An ultrasound-guided technique is helpful to localize a recessed septum in challenging pump refill procedures where pumps are deeply situated. Imaging is also essential for device malfunction diagnosis. Plain radiology is currently limited as new catheters have a poor opacity, but it remains useful for confirming motor stall of the peristaltic pump and is appropriate for the diagnosis of pump rotation. High-resolution three-dimensional Computer Tomography reconstruction allows accurate control of catheter positioning and the diagnosis of dislodgment, kinking, and breaking. MRI is the most accurate imagery to diagnose spinal cord injuries following implantation or as an adverse effect of IT treatment such as granuloma. Diffusion control requires dynamic imaging which can be performed by TC99 scintigraphy. This allows for the visualization of drug diffusion and velocity. In the near future, novel techniques such as PET- CT scan could be useful for testing the distribution of intrathecal drugs

Use of Color Flow Doppler Ultrasonography to Increase the Safety of Intrathecal Drug Delivery System Refills

Intrathecal drug delivery systems are effective tools in the treatment of chronic pain or spasticity. Using intrathecal drug delivery systems, drugs are directly infused into the cerebrospinal fluid and gain access to critical receptors in the central nervous system. This delivery method allows for the use of markedly reduced doses of medications to produce the same effects as seen with higher orally administered doses. Reduced dosing produces fewer side effects, creating a more favorable treatment course for patients already suffering from chronic pain or spasticity. Complications with intrathecal drug delivery systems can occur during both the implantation process and the postoperative maintenance of the device. The most common procedure carried out during postoperative maintenance of these devices is the intrathecal pump refill. This procedure must be performed by experienced practitioners in a systematic way in order to prevent complications. The most dreaded of these complications is inadvertent injection of medication into the subcutaneous space as opposed to into the device, commonly referred to as a “pocket fill.” This paper describes and recommends the routine use of color flow doppler ultrasonography as an easy, safe, and effective tool to reduce the chance of a catastrophic “pocket fill.” Routine utilization of live color flow ultrasound guidance during pump refills allows the practitioner to carefully document flow of medication into the pump under the silicone septum. It also allows for demonstration of no leakage from, or fluid increase superficial to, the septum. Additionally, 2 ultrasound images are obtained to document color flow deep to the septum and no color flow/leak/fluid superficial to the septum. Although this complication is rare, it can lead to severe complications including oversedation, respiratory depression, and death. As such, we believe that the utilization of color phase doppler ultrasonography could further reduce this incidence. Key words: Analgesics, opioids, chronic pain, drug overdose, infusion pumps, implantable, injections, spinal, medication errors, spasticity, ultrasonics, methods, ultrasonography, interventional

Long-term results of the DelIVery for Pulmonary Arterial Hypertension trial.

BackgroundThe DelIVery for Pulmonary Arterial Hypertension clinical trial was a multi-center, prospective, single arm, Investigational Device Exemption study utilizing a fully implantable, programmable intravascular delivery system consisting of a pump and a catheter for intravenous treprostinil. The study met its primary endpoint and demonstrated that the intravascular delivery system significantly reduced catheter related complications at 22,000 subject-days of follow-up compared with a predefined objective performance criterion. Here we summarize the results obtained during a 6.4-year follow-up period.MethodsThroughout study follow-up, participants had clinic visits and medication refills at least every 12 weeks (dependent on the subjects’ dose). All adverse events and intravascular delivery system complications were evaluated and recorded.ResultsSixty pulmonary arterial hypertension subjects were followed post device implantation for approximately 282 patient-years (range 87 days to 6.4 years). Of the 60 subjects, 14 died (1 related to intravascular delivery system pump failure), 2 withdrew after lung transplants, and 2 withdrew due to pump pocket infection. No catheter-related bloodstream infections, catheter thrombosis or occlusions, or catheter kinks occurred through 282 patient-years. Two participants had adverse events of abdominal pain, rash, due to subcutaneous treprostinil “leaks” after one catheter puncture and one catheter laceration during pump refill and replacement, respectively. Eight pump failure events occurred: seven pump motor stalls and one early replacement (faulty battery).ConclusionDelivery of treprostinil with an intravascular delivery system is a safe alternative to an external delivery system, while providing enhanced life experiences. To preserve the risk–benefit ratio, treatment at specialized pulmonary arterial hypertension centers is recommended until training is disseminated at other sites.

Accuracy and Precision of the SynchroMed II Pump

The objective of this study was to evaluate the accuracy and precision of SynchroMed II programmable infusion pumps for delivery of intrathecal baclofen to treat severe spasticity. Retrospective chart review study. Urban academic rehabilitation clinic. Patients with spasticity treated with intrathecal baclofen. A retrospective chart review of 149 patients inclusive of 755 individual patient encounters more than a 2.5-year span for baclofen pump refills was performed. Charts were reviewed to obtain data on the concentration and dose of intrathecal baclofen, aspirated and residual volumes, age of the pump, and reservoir volume of the pump. Flow rate (mL/day) was calculated for each chronological visit. Flow rates from clinical data were used to calculate the accuracy and precision based on the manufacturer's specifications for both the 20 mL and 40 mL pumps. The infused volume accuracy and precision of both the 20 mL pumps and 40 mL pumps remained within manufacturer's specifications while delivering drug at a rate slightly lower than predicted. There were no cases of pump over-infusion. There is a statistically significant decrease in flow rate accuracy over the lifespan of the pump. SynchroMed II pumps infuse at slightly less than their predicted rate while remaining within the manufacturer's specifications. No pump over-infusions were noted. Pump flow rate declines over time. Further study is warranted to assess the impact of this flow rate decrease on patient treatment and safety.