Restoration of rostral cerebrospinal fluid flow to solve treatment failure caused by obstruction in long-term intrathecal baclofen administration.

Objects: We describe five traumatic spinal cord injury (SCI) patients with an intrathecal baclofen administration (ITB) failure caused by a rostral CSF flow obstruction referred to our expert center between January 2014 and January 2019. We discuss the diagnostic workup, rostral CSF flow obstruction as the cause of the ITB failure and treatment.Methods: When we could not determine the cause of the ITB failure through the patient's history, physical spasticity examination, pump readout, absence of fluid in the pump reservoir during aspiration, or plain radiography, we performed pump catheter access port (computed tomography [CT]) myelography. When CT myelography did not reveal the diagnosis, we used scintigraphy. In an obstruction, we aimed for CSF flow restoration. In three cases, we conducted a laminectomy with microsurgical adhesiolysis. In two of these patients, we could not achieve CSF flow restoration; thus, we placed an intradural catheter bypass. Recently, in three patients, we applied a less invasive technique of percutaneous fenestration of the obstruction.Results: In one case, we performed a successful catheter replacement. In another case using surgical adhesiolysis, spasticity control was complete. In two cases, we could obtain improvement with an additional intradural bypass, followed by a percutaneous fenestration of the obstruction, resulting in further improved CSF flow restoration. In one case, percutaneous fenestration was the first line of treatment. In all cases with percutaneous fenestration, we experienced spasticity control.Conclusion: Preliminary results showed that the restoration of rostral CSF flow might result in an effective ITB treatment in patients with an intrathecal obstruction.

Isotopic Scintigraphy in Intrathecal Drug Delivery Failure: A Single-Institution Case Series.

BACKGROUND: The aim of this study was to assess the feasibility and diagnostic accuracy of an optimized 111 Indium-diethylenetriamine-penta-acetic-acid single-photon-emission computed tomography (CT) (111 In-DTPA SPECT-CT) examination in patients with suspected intrathecal drug delivery (ITDD) failure. MATERIALS AND METHODS: Retrospective analysis of routinely collected observational data from a case series of patients in the setting of the academic Center for Pain Medicine, Departments of Radiology and Nuclear Medicine and Neurosurgery. Twenty-seven patients participated between January 2014 and January 2019. Thirty-six optimized examinations including standardized pump flow rate with additional SPECT-CT imaging and a stepwise standardized analysis were performed. A 10 mL mixture of medication and 20 MBq 111In-DTPA was injected into the pump reservoir. Planar and SPECT-CT images were acquired at 24, 48, and 72 hours (h) after injection and at 96 hours and/or seven days, if needed. All images were reassessed by the first two authors using an optimized procedure. RESULTS AND CONCLUSIONS: Twenty-two abnormalities were identified in 21 examinations, with these abnormalities consisting of leakage (n = 7), spinal catheter obstruction (n = 7), and cerebrospinal fluid flow obstruction (n = 8). Interventions (n = 19) confirmed the cause of ITDD failure. A false-positive finding at follow-up (n = 1) and a false-negative finding (n = 1) were encountered. Sensitivity was 95% (20/21) and the specificity 93% (14/15). A significant difference (p < 0.001) was found between the accuracy of the conventical and the optimized analysis. The optimized 111 In-DTPA SPECT-CT examination is a powerful diagnostic tool for detecting the cause of ITDD failure.

Intrathecal baclofen as emergency treatment alleviates severe intractable autonomic dysreflexia in cervical spinal cord injury.

Context: Episodic attacks of autonomic dysreflexia (AD) are regularly experienced by patients with a spinal cord injury (SCI) on T6 or higher levels. The episodes can result in a pounding headache, flushing, blurred vision, anxiety, a stroke, posturing, hyperthermia, retinal bleeding, seizures, myocardial ischemia, cardiac arrhythmias, and death. The observed associated bradycardia is explained as a baroreceptor reflex response to the high blood pressure. Intrathecal baclofen (ITB) has been used to treat chronic AD. This case highlights the occurrence of intractable AD after removal of the ITB delivery system because of a pump pocket infection. We describe the benefit of ITB as an emergency treatment for intractable AD.Findings: A 53-year-old male suffered from spasticity and AD after a C5 ASI B SCI in 2002 was successfully treated with ITB for 14 years. He developed Staphylococcus aureus and Pseudomonas aeruginosa cellulitis at the orifice of his suprapubic catheter, which caused an abscess in the pump pocket. To prevent a withdrawal syndrome, the medication was reduced in three steps of 25%, and the pump was explanted. Postoperatively, he experienced severe AD and was treated with clonazepam, clonidine, and urapidil. The next day, the severely fluctuating blood pressure and pulse rate were no longer controllable with the medication. At L2-3, a temporary external intrathecal catheter for reinitiating ITB was inserted. With this treatment, the AD and the spasticity symptoms could be controlled.Conclusion/Clinical Relevance: The case demonstrated that refractory AD could be managed with ITB in an emergency.

Catheter Access Port (Computed Tomography) Myelography in Intrathecal Drug Delivery Troubleshooting: A Case Series of 70 Procedures.

OBJECTIVES: Intrathecal drug delivery is used for the treatment of intractable spasticity, dystonia, and pain. When the symptomatology fails to respond to therapy, the cause could be failure of the medication infusion. The purpose of this study is to assess pump catheter access port (CAP)-myelography and CAP-CT-myelography as advanced imaging methods in treatment failure. MATERIALS AND METHODS: We analyzed observational routinely collected data of 70 CAP procedures with 2D/3D reconstructions and additional imaging of 53 adult patients where the cause of treatment was unclear between November 2013 and November 2018. CAP-myelography and CAP-CT myelography were performed with postprocessing 2D/3D reconstructions. When myelography could not be obtained or when the result did not reveal the cause of the treatment failure, additional procedures, such as noncontrast CT, MRI, lumbar puncture CT, and 111Indium-DTPA SPECT-CT, were performed. RESULTS: CAP fluid aspiration prior to contrast medium injection was not possible (N = 17). In one case, contrast was injected into the pump pocket unintentionally (N = 1). Of 70 procedures, 24% were unaspiratable. The remaining CAP myelography examinations (N = 52) had limited value for the diagnosis. CAP-CT myelography (N = 50) was normal (N = 31). The abnormal results (N = 19) were dorsal dural leak (N = 5), subdural catheter position (N = 2), limited rostral flow of contrast material (N = 4), limited and abnormal contrast distribution (N = 3), obstruction of rostral flow (N = 2), a leak at the pump-catheter connection (N = 1), and a sheared catheter localized in the pump pocket (N = 2). Limited contrast distributions were found to be false positive findings (N = 2). Four normal CT-CAP myelographic procedures were false negatives, as the reference tests revealed a cause of intrathecal drug delivery (ITDD) failure. The CAP-CT procedures resulted in a sensitivity of 81% (17/21) and a specificity of 93% (27/29). CONCLUSIONS: CAP-CT myelography with 2D/3D reconstructions is an essential step in the diagnostic algorithm for cases involving ITDD failure.

Efficiency and Safety of Aftercare With Intrathecal Baclofen on Location.

OBJECTIVES: Patients with intractable spasticity treated with intrathecal baclofen (ITB) need regular evaluation and aftercare in an outpatient clinic or pain clinic setting. Logistically, this can be challenging. A solution could be to perform treatment at the patient's home setting. In the Netherlands, a project of the Dutch Healthcare Authority was initiated to deliver ambulatory ITB-related services via a home-based Ambulant Care Clinic. This aftercare is performed by nurse practitioners (NP) with support from a medical specialist. The scope of the study was to investigate the efficiency and safety of ITB-care for patients with severe disabling spasticity in their home setting. MATERIALS AND METHODS: A retrospective analysis of prospectively collected data. Patients with congenital or acquired spasticity were treated with ITB (1st April 2011 to January 1st 2016) using an implanted programmable pump system were referred to the home-based Ambulant Care Clinic by various neuromodulation centers in the Netherlands. All study parameters were a part of the standard intake and follow-up documentation. RESULTS: Of the 900 patients treated with ITB in the Netherlands, 239 were referred to the home-based Ambulant Care Clinic and included in this study. Mean age was 45.5 (range 7-82) years; 52% lived at home; the average satisfaction score was 9 (scale 0-10); and 0.29% had (serious) adverse events (60% of clinical manifestations were prevented by remote double-check control). Certifications for patient safety and quality standards were obtained. CONCLUSIONS: The concept of ITB aftercare on location demonstrated efficacy and safety in the described setting. For troubleshooting, close collaboration with a neuromodulation center is necessary and can be arranged in chain-based care.

Low-Dose Computed Tomography With Two- and Three-Dimensional Postprocessing as an Alternative to Plain Radiography for Intrathecal Catheter Visualization: A Phantom Pilot Study.

OBJECTIVES: In intrathecal drug delivery, visualization of the device has been performed with plain radiography. However, the visibility of the related structures can be problematic. In troubleshooting, after the contrast material injection via the catheter access port, a computed tomography (CT) scan has been used. In troubleshooting, we also used a non-contrast CT scan with 2D and 3D reconstructions. With the current phantom study, we aimed to obtain high-resolution imaging of a poor opaque catheter with the use of a low-dose single-energy 2D and 3D CT scan with limited radiation exposure as a substitute for plain radiography. MATERIALS AND METHODS: The catheter was placed into a fatty substance and mounted on an anthropomorphic abdomen phantom followed by CT with varying kVp settings and with added tin beam filtering. Dose levels corrected based on the spinal catheter tip on T8 would result in a calculated effective dose in the range of the mSv's calculated for the plain x-ray examination. RESULTS: Ultimately, Sn100 kVp has the best trade-off between visibility, artifacts, and noise for a fixed dose. Although 3D VRT imaging was challenging at this low dose level, we could make a full evaluation possible with complementary 2D projections. CONCLUSIONS: We could correctly identify the catheter and related structures, which supports the investigation of this in vivo and side-by-side evaluation with plain radiography. If found superior, then this technique may be able to replace plain radiography, while providing better visualization and acceptable radiation exposure. CONFLICT OF INTEREST: Dr. Delhaas reports personal fees from Medtronic Inc., as a previous consultant, outside the submitted work; Prof. van der Lugt reports grants from GE Healthcare, Siemens, Stryker, Medtronic, and Penumbra outside the submitted work.

Plain radiography in patients treated with intrathecal drug delivery using an implantable pump device.

OBJECTIVES: Intrathecal drug administration using an implanted pump system is well established in intractable spasticity and pain. However, despite continuous advancements in manufacturing technology, adverse events related to the pump and catheter still occur. Most of them, such as migration, damage, disconnection and occlusion, are related to the spinal catheter. The aim of this overview is to update radiologists on how plain radiography of the implanted delivery system for intrathecal drug administration should be interpreted and to increase awareness for the need of urgent and timely multidisciplinary troubleshooting. METHODS: Plain radiographic images of patients treated with intrathecal drug administration using an implantable drug delivery system were analysed in a multidisciplinary setting at our (university) referral centre for complications in intrathecal drug administration. RESULTS: Examples of catheter-related adverse events are described and a proposal is made for stepwise interpretation of standard plain radiographic images. CONCLUSIONS: Plain radiological images are the mainstay for the diagnosis of catheter-related adverse events in intrathecal drug delivery. Radiologists play an important role in an early diagnosis. An awareness of abnormal radiological findings seems important to avoid a life-threatening withdrawal syndrome. TEACHING POINTS: • Untimely cessation of intrathecal drug delivery can lead to a life-threatening withdrawal syndrome. • Initially mild symptoms can lead to an exacerbation of a withdrawal syndrome. • Most intrathecal catheter-related problems are visible on plain radiography. • Common causes of catheter problems are migration, lacerations, occlusion and disconnection. • Knowledge on implanted intrathecal catheters is crucial for interpretation of plain radiography.

Postdural puncture headache in complex regional pain syndrome: a retrospective observational study.

OBJECTIVE: To describe the unusual course of postdural puncture headache (PDPH) after pump implantation for intrathecal baclofen (ITB) administration in patients with complex regional pain syndrome (CRPS)-related dystonia. DESIGN: Case series based on data collected from 1996 to 2005. Setting. Movement disorders clinic, university hospital. PATIENTS: A total of 54 patients with CRPS-related dystonia who were treated with ITB. RESULTS: A high incidence (76%) and prolonged course (median 18 days, range 2 days to 36 months) of PDPH was found. Radionuclide studies performed in two patients with long-lasting symptoms (12-16 months) did not reveal cerebrospinal fluid (CSF) leakage. In patients without signs of CSF leakage (N = 38), epidural blood patches administered in 24 patients were effective in 54%, while ketamine infusions administered in six patients were effective in 67%. CONCLUSIONS: Our observations may suggest that other mechanisms besides intracranial hypotension play a role in the initiation and maintenance of PDPH in CRPS and stimulate new directions of research on this topic.

Long-term outcomes of continuous intrathecal baclofen infusion for treatment of spasticity: a prospective multicenter follow-up study.

Long-term outcomes of 115 patients treated with continuous intrathecal baclofen infusion are reported. A prospective follow-up study was conducted in eight centers. Patients were followed up over a 12-month period. The follow-up scores on the three spasticity scales (Ashworth, spasm, and clonus scales) were significantly lower at every follow-up visit in comparison to the intake score, except for the clonus scale scores at 12 months. Improvements in health-related quality of life (EQ-5D) and functionality (SIP-68, functional independence measure) were small and nonsignificant. A significant reduction in severity of self-reported personal problems rating scale was observed. Sixty-six patients had no adverse events. Types of adverse events reported were wound complications (22%), catheter problems (36%), cerebrospinal fluid leakage (25%), and other complications (17%). Intrathecal baclofen reduces spasticity and severity of patient-reported problems but its effect on quality of life and functionality is less apparent. Improvements are desired in selection criteria, design of spinal catheters, and outcome scales.

The "pain pen" for breakthrough cancer pain: a promising treatment.

Breakthrough pain has been recognized as a challenging pain phenomenon in cancer. Oral transmucosal fentanyl citrate (OTFC) recently has been recommended as treatment, but OTFC is not widely available. Therefore, alternatives are needed. In two separate pilot studies, 58 patients were instructed to self-administer subcutaneous (SC) rescue opioids (hydromorphone (n=43), morphine (n=11), or sufentanil (n=4), using a standard injection-pen for breakthrough pain. Patients were asked to rate the overall efficacy of SC rescue opioids on a 3-point scale (not noticeable, moderate, or good). The efficacy was rated as good in 49 patients (84%, 95% CI: 73-91%), moderate in 8 patients (14%), and not noticeable in 1 patient (2%). The median dose per injection was equianalgesic to 25 mg of SC morphine (range: 4-150 mg). Twenty-nine patients (50%) were treated until death (n=26) or were on ongoing treatment (n=3). Patients were treated for a median of 6 weeks (1 day-41 months).