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1.  Bladder stones – red herring for resurgence of spasticity in a spinal cord injury patient with implantation of Medtronic Synchromed pump for intrathecal delivery of baclofen – a case report 
BMC Urology  2003;3:3.
Background
Increased spasms in spinal cord injury (SCI) patients, whose spasticity was previously well controlled with intrathecal baclofen therapy, are due to (in order of frequency) drug tolerance, increased stimulus, low reservoir volume, catheter malfunction, disease progression, human error, and pump mechanical failure. We present a SCI patient, in whom bladder calculi acted as red herring for increased spasticity whereas the real cause was spontaneous extrusion of catheter from intrathecal space.
Case Presentation
A 44-year-old male sustained a fracture of C5/6 and incomplete tetraplegia at C-8 level. Medtronic Synchromed pump for intrathecal baclofen therapy was implanted 13 months later to control severe spasticity. The tip of catheter was placed at T-10 level. The initial dose of baclofen was 300 micrograms/day of baclofen, administered by a simple continuous infusion. During a nine-month period, he required increasing doses of baclofen (875 micrograms/day) to control spasticity. X-ray of abdomen showed multiple radio opaque shadows in the region of urinary bladder. No malfunction of the pump was detected. Therefore, increased spasticity was attributed to bladder stones. Electrohydraulic lithotripsy of bladder stones was carried out successfully. Even after removal of bladder stones, this patient required further increases in the dose of intrathecal baclofen (950, 1050, 1200 and then 1300 micrograms/day). Careful evaluation of pump-catheter system revealed that the catheter had extruded spontaneously and was lying in the paraspinal space at L-4, where the catheter had been anchored before it entered the subarachnoid space. A new catheter was passed into the subarachnoid space and the tip of catheter was located at T-8 level. The dose of intrathecal baclofen was decreased to 300 micrograms/day.
Conclusion
Vesical calculi acted as red herring for resurgence of spasticity. The real cause for increased spasms was spontaneous extrusion of whole length of catheter from subarachnoid space. Repeated bending forwards and straightening of torso for pressure relief and during transfers from wheel chair probably contributed to spontaneous extrusion of catheter from spinal canal in this patient.
doi:10.1186/1471-2490-3-3
PMCID: PMC155678  PMID: 12659647
2.  Complications of Intrathecal Baclofen Pump: Prevention and Cure 
ISRN Neurology  2012;2012:575168.
Increasingly, spasticity is managed with surgically implanted Intrathecal Baclofen pumps. Intrathecal Baclofen pump revision surgery unrelated to programmable pump end-of-life is not uncommon, requiring special attention during pre-, intra-, and postoperative management. We aimed to identify and describe complications of Intrathecal Baclofen pump as well as to report avoidance and management of complications. Methods and Materials. Through 2002–2006, at the department of neurosurgery, Henry Ford and Oakwood Health Systems, Intrathecal Baclofen pumps were implanted in 44 patients: 24 children versus 20 adults; 30 “primary-implant-patients”; 14 “revision-only patients”. We evaluated reasons for revision surgeries and diagnostic workup requirements. Results. Eight primary-implant-patients required 14 revisions and 7 of revision-only patients needed 13 procedures. Seven patients with slowly increasing baclofen-resistant spasticity had either (i) unsuspected pump-catheter connector defects, (ii) an X-ray-documented pump-catheter connector defect, (iii) X-ray-demonstrated fractured catheter with intrathecal fragment. Implant infections occurred in 4 cases. Scintigraphy revealed occult CSF leakage N=1 and intrinsic pump failure N=1. Conclusion. Intrathecal Baclofen pumps, although very gratifying, have a high, technique-related complication incidence during implant life. Meticulous technique, high clinical suspicion, appropriate workup, and timely surgical management can reduce surgical complications of Intrathecal Baclofen pump implantation.
doi:10.5402/2012/575168
PMCID: PMC3323842  PMID: 22548189
3.  Complications and salvage options after laser lithotripsy for a vesical calculus in a tetraplegic patient: a case report 
Background
Laser lithotripsy of vesical calculi in tetraplegic subjects with long-term urinary catheters is fraught with complications because of bladder wall oedema, infection, fragile urothelium, bladder spasms, and autonomic dysreflexia. Severe haematuria should be anticipated; failure to institute measures to minimise bleeding and prevent clot retention can be catastrophic. We present an illustrative case.
Case presentation
A tetraplegic patient underwent laser lithotripsy of vesical stone under general anaesthesia. During lithotripsy, severe bladder spasms and consequent rise in blood pressure occurred. Bleeding continued post-operatively resulting in clot retention. CT revealed clots within distended but intact bladder. Clots were sucked out and continuous bladder irrigation was commenced. Bleeding persisted; patient developed repeated clot retention. Cystoscopy was performed to remove clots. Patient developed abdominal distension. Bladder rupture was suspected; bed-side ultrasound scan revealed diffuse small bowel dilatation with mild peritoneal effusion; under-filled bladder containing small clot. Patient developed massive abdominal distension and ileus. Two days later, CT with oral positive contrast revealed intra-peritoneal haematoma at the dome of bladder with perforation at the site of haematoma. Free fluid was noted within the peritoneal cavity. This patient was managed by gastric drainage and intravenous fluids. Patient's condition improved gradually with urethral catheter drainage. Follow-up CT revealed resolution of bladder rupture, perivesical haematoma, and intra-peritoneal free fluid.
Conclusion
If bleeding occurs, bladder irrigation should be commenced immediately after surgery to prevent clot retention. When bladder rupture is suspected, CT of abdomen should be done instead of ultrasound scan, which may not reveal bladder perforation. It is debatable whether laparotomy and repair of bladder rupture is preferable to nonoperative management in tetraplegics. Anti-muscarinic drugs should be prescribed prior to lithotripsy to control bladder spasms; aspirin and ibuprofen should be omitted. If significant bleeding occurs during lithotripsy, procedure should be stopped and rescheduled. Percutaneous cystolithotripsy using a wide channel could be quicker to clear stones, as larger fragments could be retrieved; lesser stimulant for triggering autonomic dysreflexia, as it avoids urethral manipulation. But in patients with small, contracted bladder, and protuberant abdomen, percutaneous access to urinary bladder may be difficult and can result in injury to bowels.
doi:10.1186/s13037-014-0052-3
PMCID: PMC4304632  PMID: 25621008
Spinal cord injury; Tetraplegia; Neuropathic urinary bladder; Vesical calculus; Laser lithotripsy; Complications; Bladder perforation
4.  Intrathecal Baclofen Pump for Spasticity 
Executive Summary
Objective
To conduct an evidence-based analysis of the effectiveness and cost-effectiveness of intrathecal baclofen for spasticity.
The Technology
Spasticity is a motor disorder characterized by tight or stiff muscles that may interfere with voluntary muscle movements and is a problem for many patients with multiple sclerosis (MS), spinal cord injury (SCI), cerebral palsy (CP), and acquired brain injury (ABI).(1). Increased tone and spasm reduces mobility and independence, and interferes with activities of daily living, continence and sleep patterns. Spasticity may also be associated with significant pain or discomfort (e.g., due to poor fit in braces, footwear, or wheelchairs), skin breakdown, contractures, sleep disorders and difficulty in transfer.
Goals of treatment are to decrease spasticity in order to improve range of motion, facilitate movement, reduce energy expenditure and reduce risk of contractures. Existing treatments include physical therapy, oral medications, injections of phenol or botulinum toxin, or surgical intervention.
Baclofen is the oral drug most frequently prescribed for spasticity in cases of SCI and MS.(1) Baclofen is a muscle relaxant and antispasticity drug. In the brain, baclofen delivered orally has some supraspinal activity that may contribute to clinical side effects. The main adverse effects of oral baclofen include sedation, excessive weakness, dizziness, mental confusion, and somnolence.(2) The incidence of adverse effects is reported to range from 10% to 75%.(2) Ochs et al. estimated that approximately 25-30% of SCI and MS patients fail to respond to oral baclofen.(3;4)
Adverse effects appear to be dose-related and may be minimized by initiating treatment at a low dose and gradually titrating upwards.(2) Adverse effects usually appear at doses >60 mg/day.(2) The rate of treatment discontinuation due to intolerable adverse effects has generally been reported to range from 4% to 27%.(2)
When baclofen is administered orally, only a small portion of the original dose crosses the blood brain barrier and enters the central nervous system (CNS) fluid, which is the site of drug action. In order to bypass the oral route, baclofen may be administered intrathecally by infusion directly to the CNS.
Candidates for intrathecal baclofen infusion are patients with spasticity who have intractable spasticity uncontrolled by drug therapy, or who experience intolerable side effects from oral baclofen.
Advantages of intrathecal baclofen infusion are:
Direct drug administration to the cerebrospinal fluid (CSF)
The central side effects of oral baclofen, such as drowsiness or confusion, appear to be minimized with intrathecal administration.
The intrathecal delivery of baclofen concentrates the drug in the CSF at higher levels than those attainable via the oral route.
Intrathecal administration can use concentrations of baclofen of less than one hundredth of those used orally.(5)
Adjustable/programmable continuous infusion makes it possible to finely titrate patients’ doses and to vary the doses over the hours of the day. For example, the dose can be relatively low to give the patients the extensor tone needed for ambulation during the day and increased at night, thereby improving quality of sleep.
Reversible (in contrast to surgery).
A patient who is a candidate for intrathecal baclofen infusion must have no contraindications to the insertion of an intrathecal catheter (e.g., anticoagulant therapy, coagulopathy, local or systemic infection, anatomical abnormality of the spine).
Review Strategy
The Medical Advisory Secretariat reviewed the literature to assess the effectiveness, safety, and cost-effectiveness of intrathecal baclofen to treat patients who have intractable spasticity uncontrolled by drug therapy, or who experience intolerable side effects to oral baclofen.
The Medical Advisory Secretariat used its standard search strategy to retrieve international health technology assessments and English-language journal articles from selected databases.
Summary of Findings
Level 2 evidence supports the effectiveness of intrathecal baclofen infusion for the short-term reduction of severe spasticity in patients who are unresponsive or cannot tolerate oral baclofen
Level 3 evidence supports the effectiveness of intrathecal baclofen for the long-term reduction of severe spasticity in patients who are unresponsive or cannot tolerate oral baclofen
Level 4 qualitative evidence demonstrates functional improvement for patients who are unresponsive or cannot tolerate oral baclofen
Intrathecal baclofen is cost-effective with costs which may or may not be avoided in the Ontario health system
True functional use remains to be determined
PMCID: PMC3382401  PMID: 23074476
5.  Intrathecal baclofen withdrawal syndrome- a life-threatening complication of baclofen pump: A case report 
Background
Intrathecal baclofen pump has been used effectively with increasing frequency in patients with severe spasticity, particularly for those patients who are unresponsive to conservative pharmacotherapy or develop intolerable side effects at therapeutic doses of oral baclofen. Drowsiness, nausea, headache, muscle weakness, light-headedness and return of pretreatment spasticity can be caused by intrathecal pump delivering an incorrect dose of baclofen. Intrathecal baclofen withdrawal syndrome is a very rare, potentially life-threatening complication of baclofen pump caused by an abrupt cessation of intrathecal baclofen.
Case presentation
A 24-year-old man with a past medical history of cerebral palsy and spastic quadriparesis developed hyperthermia, disseminated intravascular coagulation, rhabdomyolysis, acute renal failure and multisystem organ failure leading to a full-blown intrathecal baclofen withdrawal syndrome. Intrathecal baclofen pump analysis revealed that it was stopped due to some programming error. He was treated effectively with supportive care, high-dose benzodiazepines and reinstitution of baclofen pump.
Conclusion
The episodes of intrathecal baclofen withdrawal syndrome are mostly caused by preventable human errors or pump malfunction. Educating patients and their caregivers about the syndrome, and regular check-up of baclofen pump may decrease the incidence of intrathecal baclofen withdrawal syndrome. Oral baclofen replacement may not be an effective method to treat or prevent intrathecal baclofen withdrawal syndrome. Management includes an early recognition of syndrome, proper intensive care management, high-dose benzodiazepines and prompt analysis of intrathecal pump with reinstitution of baclofen.
doi:10.1186/1472-6904-4-6
PMCID: PMC514562  PMID: 15301690
6.  Status dystonicus resembling the intrathecal baclofen withdrawal syndrome: a case report and review of the literature 
Introduction
Status dystonicus is a rare but life-threatening disorder characterized by increasingly frequent and severe episodes of generalized dystonia that may occur in patients with primary or secondary dystonia. Painful and repetitive spasms interfere with respiration and may cause metabolic disturbances such as hyperpyrexia, dehydration, respiratory insufficiency, and acute renal failure secondary to rhabdomyolysis. Intrathecally administered baclofen, delivered by an implantable pump system, is widely used for the treatment of refractory spasticity. Abrupt cessation of intrathecal baclofen infusion has been associated with a severe withdrawal syndrome comprised of dystonia, autonomic dysfunction, hyperthermia, end-organ failure and sometimes death. The aetiology of this syndrome is not well understood. Status dystonicus describes the episodes of acute and life-threatening generalized dystonia, which occasionally manifest themselves in patients with dystonic syndromes.
Case presentation
We present the case of a nine-year-old Caucasian boy who experienced a severe episode of status dystonicus with no known cause and clinical features resembling those described in intrathecal baclofen withdrawal. Our patient subsequently underwent the placement of an intrathecal baclofen pump without incident.
Conclusion
The similarity between the clinical features of the case we present and those reported in connection to abrupt withdrawal of intrathecal baclofen is emphasized. Several drugs, although not intrathecal baclofen withdrawal, have previously been associated with status dystonicus. The similarity between the life-threatening dystonic episode experienced by our patient, and those reported in intrathecal baclofen withdrawal, highlights the possibility that, rather than representing a true physiological withdrawal syndrome, abrupt withdrawal of intrathecal baclofen may simply precipitate an episode of status dystonicus in susceptible individuals. The clinical similarities between the intrathecal baclofen withdrawal syndrome and status dystonicus have not previously been highlighted.
doi:10.1186/1752-1947-4-294
PMCID: PMC2939556  PMID: 20807402
7.  Candida Glabrata Perinephric Abscess 
Perinephric abscess is a rare complication of urinary tract infections, and the etiology is usually a gram negative bacillus. We report a case of Candida glabrata perinephric abscess in a patient with diabetes mellitus who had a recent episode of pyelonephritis that was treated with antibiotics. Percutaneous drainage and fluconazole treatment led to resolution of the infection. Yeast perinephric abscess should be considered when symptoms of acute or chronic urinary tract infection occur in elderly and diabetic patients, especially patients who are unresponsive to antibacterial therapy. The clinical course is sometimes insidious. Imaging (contrast-enhanced CT or MRI) is required for diagnosis, and drainage is indicated for successful therapy. Adjuvant antifungal treatment is recommended based on the results of antifungal susceptibility tests.
doi:10.5152/eajm.2011.14
PMCID: PMC4261371  PMID: 25610164
Candida glabrata; Perinephric abscess; Fluconazole; Percutaneous drainage
8.  Case of emphysematous pyelonephritis in kidney allograft: Conservative treatment 
Emphysematous pyelonephritis is an acute necrotizing infection with gas in the kidney and perinephric space that carries a bad prognosis. Apart from its predisposing clinical entities, diabetes mellitus and immune-incompetence are quite common in patients with this infection. We report a case of a 53-year-old kidney transplant recipient diabetic male, suffering from recurrent fever, abdominal pain and nausea episodes. Immediate broad-spectrum antibiotics were administered and percutaneous drainage was performed after the diagnosis. The bacteria involved were Stahpylococcus epidermidis and Escherichia coli. After 4 weeks of antibiotic treatment and abscesses drainage, the case was resolved. Consecutives urine cultures and ultrasonographies confirm the complete resolution of the disease. We discuss the predisposing factors, clinical presentation and management.
doi:10.5489/cuaj.1555
PMCID: PMC4001655  PMID: 24839494
9.  Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity 
OBJECTIVES—To compare clinical effectiveness and health related quality of life in patients with severe spasticity who received intrathecal baclofen or a placebo.
METHODS—In a double blind, randomised, multicentre trial 22 patients were followed up during 13 weeks and subsequently included in a 52 week observational longitudinal study. Patients were those with chronic, disabling spasticity who did not respond to maximum doses of oral baclofen, dantrolene, and tizanidine. After implantation of a programmable pump patients were randomly assigned to placebo or baclofen infusion for 13 weeks. After 13 weeks all patients received baclofen. Clinical efficacy was assessed by the Ashworth scale, spasm score, and self reported pain, and health related quality of life by the sickness impact profile (SIP) and the Hopkins symptom checklist (HSCL).
RESULTS—At three months the scores of the placebo and baclofen group differed slightly for the spasm score (effect size=0.20) and substantially for the Ashworth scale (effect size=1.40) and pain score (effect size=0.94); health related quality of life showed no significant differences. Three months after implantation the baclofen group showed a significant, substantial improvement on the SIP "physical health", "mental health", "mobility", and "sleep and rest" subscales and on the HSCL mental health scale; patients receiving placebo showed no change. After one year of baclofen treatment significant (P<0.05) improvement was found on the SIP dimensions "mobility" and "body care and movement" with moderate effect sizes. Improvement on the SIP subscale "physical health" (P<0.05; effect size 0.86), the SIP overall score (without "ambulation"), and the "physical health" and overall scale of the HSCL was also significant, with effect sizes >0.80. Changes in health related behaviour were noted for "sleep and rest" and "recreation and pastimes" (P<0.01, P<0.05; effect size 0.95 and 0.63, respectively). Psychosocial behaviour showed no improvement.
CONCLUSIONS—Intrathecal baclofen delivered by an implanted, programmable pump resulted in improved self reported quality of life as assessed by the SIP, and HSCL physical health dimensions also suggest improvement.


PMCID: PMC2169658  PMID: 9285459
10.  A case with fistula formation between a perinephric retroperitoneal abscess, a ureter and a descending colon: Successful outcome after conservative management 
Canadian Urological Association Journal  2014;8(9-10):E644-E646.
A 72-year-old man diagnosed with hydronephrosis and perinephric abscess because of an impacted urinary stone in the left uretero-pelvic junction was admitted to hospital with high-grade fever. The insertion of a percutaneous drain improved his general condition. Then, imaging from the percutaneous drainage tube revealed a fistula formation between the cavity of the perinephric retroperitoneal abscess, the descending colon, and the left renal pelvis. The patient received conservative management, including insertion of a percutaneous drain, discontinuation of oral intake and antimicrobial chemotherapy. Three days after the percutaneous drainage and discontinuation of oral intake, imaging revealed no apparent fistula. Fistula formation between a perinephric abscess and the descending colon is very rare; this is the first case of a long-term favourable outcome by conservative management.
doi:10.5489/cuaj.1789
PMCID: PMC4164555  PMID: 25295138
11.  Intrathecal baclofen: Its effect on symptoms and activities of daily living in severe spasticity due to spinal cord injuries: A pilot study 
Indian Journal of Orthopaedics  2009;43(1):46-49.
Background:
Spasticity is a major problem related to spinal cord injuries. Use of intrathecal baclofen with an implanted pump seems a very useful mode of therapy in patients in whom oral antispasmodic agents are either not effective or produce intolerable side-effects.
Materials and Methods:
Twenty-four patients with mean age 50 years (range 32-72 years) had intrathecal baclofen pump implanted for the severe spasticity of spinal origin. One patient died following implantation of pump due to natural causes and was not included in the study. The patients were followed up for mean 22 months (range, one to five years).
Results:
All 24 patients showed improvement in their spasm following the procedure. Improvement was noted in pain (12), sleep disturbance (20) and sphincter control (14). Patients had improvement in activities of daily living such as feeding ability (10), self care (10), indoor and outdoor mobility (19), and driving (4). One patient had catheter leakage immediately after the surgery and required change of catheter. The radio telemetry allows very good adjustment of the dose according the individual patients needs.
Conclusion:
Intrathecal baclofen pump improves the symptoms of spasm and also the quality of life. It helps the patient to live more independently. It is not an irreversible surgery for the patient and hence it is very useful in the changing the dynamics in this group of patients.
doi:10.4103/0019-5413.45323
PMCID: PMC2739492  PMID: 19753179
Activities of daily living; intrathecal baclofen; spasticity; spinal cord injury
12.  Examining the effectiveness of intrathecal baclofen on spasticity in individuals with chronic spinal cord injury: A systematic review 
Objective
To review the available evidence on the effectiveness of intrathecal baclofen in the treatment of spasticity in individuals with spinal cord injuries (SCIs) at least 6 months post-injury or diagnosis.
Data sources
A literature search of multiple databases (Pub Med, CINAHL, EMBASE) was conducted to identify articles published in the English language.
Study selection
Studies were included for review if: (1) more than 50% of the sample size had suffered a traumatic or non-traumatic SCI; (2) there were more than three subjects; (3) subjects received continuous intrathecal baclofen via an implantable pump aimed at improving spasticity; and (4) all subjects were ≥6 months post-SCI, at the time of the intervention.
Data extraction
Data extracted from the studies included patient and treatment characteristics, study design, method of assessment, and outcomes of the intervention.
Data synthesis
Methodological quality was assessed using the PEDro for randomized-controlled trials (RCTs) and the Downs and Black (D&B) tool for non-RCTs. A level of evidence was assigned to each intervention using a modified Sackett scale.
Conclusion
The literature search resulted in 677 articles. No RCTs and eight non-RCTs (D&B scores 13–24) met criteria for inclusion, providing a pooled sample size of 162 individuals. There was substantial level 4 evidence that intrathecal baclofen is effective in reducing spasticity. Mean Ashworth scores reduced from 3.1–4.5 at baseline to 1.0–2.0 (P < 0.005) at follow-up (range 2–41 months). Average dosing increased from 57–187 µg/day at baseline to 218.7–535.9 µg/day at follow-up. Several complications from the use of intrathecal baclofen or pump and catheter malfunction were reported.
doi:10.1179/2045772313Y.0000000102
PMCID: PMC4066544  PMID: 24089997
Baclofen; Muscle spasticity; Spinal cord injuries; Activities of daily living; Ashworth scale
13.  Intrathecal baclofen therapy in severe head injury, first time in Nepal, a technique suitable for underdeveloped countries 
Asian Journal of Neurosurgery  2011;6(1):49-51.
Intrathecal baclofen (ITB) has been found to be helpful not only for spasticity but also for unconsciousness in a vegetative patient. This is the first case of ITB in Nepal, and here we discuss the effectiveness of ITB for spasticity in a patient in vegetative state. We also discuss about a simple technique for ITB used in Nepal where baclofen pump is not available. Here, we present a case of a 40-year-old male patient who had severe head injury with diffuse axonal injury treated conservatively. He went on to a vegetative state and subsequently developed severe spasticity of all the limbs. ITB was started under the guidance of one of the authors , Prof. Taira. Baclofen was injected to the spinal intrathecal space through a catheter which is used for spinal anesthesia. Spasticity improved significantly and his higher mental function also showed signs of improvement. He finally became fully conscious and well oriented. ITB is very useful in cases of severe spasticity and vegetative condition, a state of unconsciousness lasting longer than a few weeks. Even with a simple technique in the absence of baclofen pump, ITB can be used with its optimum effect.
doi:10.4103/1793-5482.85638
PMCID: PMC3205552  PMID: 22059105
Intrathecal baclofen; Nepal; spasticity; vegetative state
14.  Intrathecal baclofen treatment in dystonic cerebral palsy: a randomized clinical trial: the IDYS trial 
BMC Pediatrics  2013;13:175.
Background
Dystonic cerebral palsy is primarily caused by damage to the basal ganglia and central cortex. The daily care of these patients can be difficult due to dystonic movements. Intrathecal baclofen treatment is a potential treatment option for dystonia and has become common practice. Despite this widespread adoption, high quality evidence on the effects of intrathecal baclofen treatment on daily activities is lacking and prospective data are needed to judge the usefulness and indications for dystonic cerebral palsy. The primary aim of this study is to provide level one clinical evidence for the effects of intrathecal baclofen treatment on the level of activities and participation in dystonic cerebral palsy patients. Furthermore, we hope to identify clinical characteristics that will predict a beneficial effect of intrathecal baclofen in an individual patient.
Methods/Design
A double blind placebo-controlled multi-center randomized clinical trial will be performed in 30 children with dystonic cerebral palsy. Patients aged between 4 and 25 years old with a confirmed diagnosis of dystonic cerebral palsy, Gross Motor Functioning Classification System level IV or V, with lesions in the cerebral white matter, basal ganglia or central cortex and who are eligible for intrathecal baclofen treatment will be included. Group A will receive three months of continuous intrathecal baclofen treatment and group B will receive three months of placebo treatment, both via an implanted pump. After this three month period, all patients will receive intrathecal baclofen treatment, with a follow-up after nine months. The primary outcome measurement will be the effect on activities of and participation in daily life measured by Goal Attainment Scaling. Secondary outcome measurements on the level of body functions include dystonia, spasticity, pain, comfort and sleep-related breathing disorders. Side effects will be monitored and we will study whether patient characteristics influence outcome.
Discussion
The results of this study will provide data for evidence-based use of intrathecal baclofen in dystonic cerebral palsy.
Trial registration
Nederlands Trial Register, NTR3642
doi:10.1186/1471-2431-13-175
PMCID: PMC3840690  PMID: 24165282
Cerebral palsy; Dystonia; Dyskinesia; Goal attainment scaling; Intrathecal baclofen; Randomized controlled trial
15.  Effect of Intrathecal Baclofen Concentration on Spasticity Control: Case Series 
Background/Objective:
Intrathecal baclofen (ITB) has been shown to be an effective treatment for severe spasticity of spinal or cerebral origin. Although most patients respond well to an ITB trial, there are often difficulties in achieving and/or maintaining such effectiveness with ITB pump treatment. There are few published guidelines for dosing efficacy and no studies looking at the effect of concentration of ITB on spasticity management.
Methods:
Case series of 3 adults with severe spasticity treated with ITB pump: a 44-year-old man with C7 tetraplegia using a 40-mL Medtronic SynchroMed II pump with 500-μg/mL concentration; a 35-year-old woman with traumatic brain injury with right spastic hemiplegia using a 18-mL Medtronic SynchroMed EL pump with 2,000-μg/mL concentration; and a 43-year-old woman with spastic diplegic cerebral palsy using a 40-mL Medtronic SynchroMed II pump with 2,000-μg/mL concentration.
Results:
After reducing ITB concentrations in the pump, either as part of a standard protocol for dye study to assess the integrity of pump and catheter system or secondary to plateau in therapeutic efficacy, patients experienced temporary, significant reduction in spasticity based on range of motion, Modified Ashworth scores, and verbal feedback.
Conclusions:
Decreasing the concentration of ITB seems to affect spasticity control. Further research in this area is needed for those patients with refractory spasticity to optimize efficacy of ITB therapy.
PMCID: PMC2582431  PMID: 18959357
Spasticity; Baclofen; Intrathecal; Tetraplegia; Hemiplegia; Cerebral palsy; Traumatic brain injury
16.  Endoscopic ultrasound-guided drainage of pancreatic fluid collections 
Pancreatic fluid collections (PFCs) develop secondary to either fluid leakage or liquefaction of pancreatic necrosis following acute pancreatitis, chronic pancreatitis, surgery or abdominal trauma. Pancreatic fluid collections include acute fluid collections, acute and chronic pancreatic pseudocysts, pancreatic abscesses and pancreatic necrosis. Before the introduction of linear endoscopic ultrasound (EUS) in the 1990s and the subsequent development of endoscopic ultrasound-guided drainage (EUS-GD) procedures, the available options for drainage in symptomatic PFCs included surgical drainage, percutaneous drainage using radiological guidance and conventional endoscopic transmural drainage. In recent years, it has gradually been recognized that, due to its lower morbidity rate compared to the surgical and percutaneous approaches, endoscopic treatment may be the preferred first-line approach for managing symptomatic PFCs. Endoscopic ultrasound-guided drainage has the following advantages, when compared to other alternatives such as surgical, percutaneous and non-EUS-guided endoscopic drainage. EUS-GD is less invasive than surgery and therefore does not require general anesthesia. The morbidity rate is lower, recovery is faster and the costs are lower. EUS-GD can avoid local complications related to percutaneous drainage. Because the endoscope is placed adjacent to the fluid collection, it can have direct access to the fluid cavity, unlike percutaneous drainage which traverses the abdominal wall. Complications such as bleeding, inadvertent puncture of adjacent viscera, secondary infection and prolonged periods of drainage with resultant pancreatico-cutaneous fistulae may be avoided. The only difference between EUS and non-EUS drainage is the initial step, namely, gaining access to the pancreatic fluid collection. All the subsequent steps are similar, i.e., insertion of guide-wires with fluoroscopic guidance, balloon dilatation of the cystogastrostomy and insertion of transmural stents or nasocystic catheters. With the introduction of the EUS-scope equipped with a large operative channel which permits drainage of the PFCs in “one step”, EUS-GD has been increasingly carried out in many tertiary care centers and has expanded the safety and efficacy of this modality, allowing access to and drainage of overly challenging fluid collections. However, the nature of the PFCs determines the outcome of this procedure. The technique and review of current literature regarding EUS-GD of PFCs will be discussed.
doi:10.4253/wjge.v4.i11.479
PMCID: PMC3506965  PMID: 23189219
Endoscopic ultrasound-guided drainage; Pancreatic fluid collections; Pseudocysts; Pancreatic abscesses; Infected necrosis
17.  Evaluation of usefulness of scintigraphic imaging in diagnosis of intrathecal drug delivery system malfunction – a preliminary report 
Polish Journal of Radiology  2013;78(3):21-27.
Summary
Background:
Implantable intrathecal drug delivery systems (IDDS) are basic tool enabling chronic intrathecal pharmacotherapy. Lack of expected clinical results of IDDS therapy necessitates search for the cause with the help of diagnostic imaging methods among other things. Beside radiological techniques, it is also possible to visually assess IDDS systems by nuclear medicine methods. In this study we assess utility of radioisotopic methods in differential diagnosis of failure of therapy with IDDS systems.
Material/Methods:
Scintigraphic studies were performed in selected patients with neurological diseases associated with spasticity, who had IDDS system implanted and were unable to maintain satisfying clinical effect of inrathecally infused baclofen. After emptying the IDDS system of the drug, radiotracer (99mTc-DTPA) solution was injected into the pump reservoir. Subsequently, a series of scintigraphic images was registered, demonstrating passage and distribution of the infused radiotracer.
Results:
In all investigated cases, scintigraphic study resulted in acquiring relevant additional diagnostic information. Normal or disrupted distribution of radiotracer in spinal canal allowed for a diagnosis drug resistance or demonstrated presence of arachnoid adhesions respectively. Early appearance of radiotracer in blood was considered a proof of leak. Our examinations had decisive influence on further patient treatment, allowing for diagnosis of drug resistance in one patient or complication related to IDDS system in three other cases including breakage of a catheter, pump malfunction and arachnoid adhesions.
Conclusions:
Scintigraphic methods carry significant amount of information facilitating final diagnosis of the cause of IDDS therapy failure. They should become an important element complementing the diagnostic strategy in patients with suspected failure of intrathecal drug administration systems. Interpretation of radioisotopic studies, since they are purely functional, must be performed in strict relation to clinical data and radiological examinations as they carry indispensable, basic information regarding morphology.
doi:10.12659/PJR.889130
PMCID: PMC3789929  PMID: 24115956
intrathecal drug delivery system; intrathecal baclofen; intrathecal; baclofen; scintigraphy; 99mTc-DTPA
18.  Unpredicted spontaneous extrusion of a renal calculus in an adult male with spina bifida and paraplegia: report of a misdiagnosis. Measures to be taken to reduce urological errors in spinal cord injury patients 
BMC Urology  2001;1:3.
Background
A delay in diagnosis or a misdiagnosis may occur in patients with spinal cord injury (SCI) or spinal bifida as typical symptoms of a clinical condition may be absent because of their neurological impairment.
Case presentation
A 29-year old male, who was born with spina bifida and hydrocephalus, became unwell and developed a swelling and large red mark in his left loin eighteen months ago. Pyonephrosis or perinephric abscess was suspected. X-ray of the abdomen showed left-sided staghorn calculus. Since ultrasound scan showed no features of pyonephrosis or perinephric abscess, he was prescribed a prolonged course of antibiotics for infection presumed to arise from the site of metal implant in spine. He developed a discharging sinus, following which the loin swelling and red mark subsided. About three months ago, he again developed a red mark and minimal swelling in the left loin. Ultrasound scan detected no abnormality in the renal or perinephric region. Therefore, the red mark and swelling were attributed to pressure from the backrest of his chair. Five weeks later, the swelling in the left loin burst open and a large stone was extruded spontaneously. An X-ray of the abdomen showed that he had extruded the central portion of the staghorn calculus from left kidney. With hindsight, the extruded renal calculus could be seen lying in the subcutaneous tissue of left loin lateral to the 10th rib in the X-ray of abdomen, which was taken when he presented with red mark and minimal swelling.
Conclusion
This case illustrates how mistakes in diagnosis could occur in spinal cord injury patients, and highlights the need for corrective measures to reduce urological errors in these patients. Voluntary reporting of urological errors is recommended to facilitate learning from our mistakes. In the patients who have marked spinal curvature, ultrasonography of kidneys and perinephric region may not be entirely reliable. As clinical symptoms and signs may be non-specific in SCI patients, they require prompt, detailed and occasionally, repeated investigations. A joint team approach by health professionals belonging to various medical disciplines, which is strengthened by frequent, informal and honest discussions of a patient's clinical condition, is likely to reduce urological errors in SCI patients.
doi:10.1186/1471-2490-1-3
PMCID: PMC64578  PMID: 11801198
19.  Empyema and Respiratory Failure Secondary to Nephropleural Fistula Caused by Chronic Urinary Tract Infection: A Case Report 
Case Reports in Pulmonology  2012;2012:595402.
We report a case of nephropleural fistula causing empyema and respiratory failure in a 68-year-old gentleman with a long history of urological problems including recurrent nephrolithiasis and urinary tract infections. He was admitted with sepsis, a productive cough, pyuria, and reduced breath sounds over the left hemithorax. Radiological imaging revealed a fistulous connection between a left-sided perinephric abscess and the pleural space. He was commenced on broad spectrum intravenous antibiotics but developed progressive respiratory failure requiring intensive care admission. Urinary and pleural aspirates cultured facultative anaerobic pathogens with identical resistance patterns. Drainage of thoracic and perinephric collections was carried out, allowing him to be extubated after 24 hours and discharged home after 18 days on an extended course of oral antibiotics. Left nephrectomy is now planned after a period of convalescence. Empyema developing in patients with known urolithiasis should alert the treating physician to the possibility that a pathological communication has formed especially if typical urinary tract pathogens are cultured from respiratory sampling.
doi:10.1155/2012/595402
PMCID: PMC3504369  PMID: 23198240
20.  Failure of Urological Implants in Spinal Cord Injury Patients due to Infection, Malfunction, and Implants Becoming Obsolete due to Medical Progress and Age-Related Changes in Human Body Making Implant Futile: Report of Three Cases 
Case Reports in Urology  2013;2013:826748.
Any new clinical data, whether positive or negative, generated about a medical device should be published because health professionals should know which devices do not work, as well as those which do. We report three spinal cord injury patients in whom urological implants failed to work. In the first, paraplegic, patient, a sacral anterior root stimulator failed to produce erection, and a drug delivery system for intracavernosal administration of vasoactive drugs was therefore implanted; however, this implant never functioned (and, furthermore, such penile drug delivery systems to produce erection had effectively become obsolete following the advent of phosphodiesterase type 5 inhibitors). Subsequently, the sacral anterior root stimulator developed a malfunction and the patient therefore learned to perform self-catheterisation. In the second patient, also paraplegic, an artificial urinary sphincter was implanted but the patient developed a postoperative sacral pressure sore. Eight months later, a suprapubic cystostomy was performed as urethral catheterisation was very difficult. The pressure sore had not healed completely even after five years. In the third case, a sacral anterior root stimulator was implanted in a tetraplegic patient in whom, after five years, a penile sheath could not be fitted because of penile retraction. This patient was therefore established on urethral catheter drainage. Later, infection with Staphylococcus aureus around the receiver block necessitated its removal. In conclusion, spinal cord injury patients are at risk of developing pressure sores, wound infections, malfunction of implants, and the inability to use implants because of age-related changes, as well as running the risk of their implants becoming obsolete due to advances in medicine. Some surgical procedures such as dorsal rhizotomy are irreversible. Alternative treatments such as intermittent catheterisations may be less damaging than bladder stimulator in the long term.
doi:10.1155/2013/826748
PMCID: PMC3705782  PMID: 23864980
21.  Management of severe spasticity with intrathecal baclofen delivered by a manually operated pump. 
Intrathecal baclofen abolishes spasticity in many patients with neurological diseases but there are few studies on its long-term effectiveness. Since 1986 a manually operated subcutaneous pump has been used to deliver baclofen intrathecally in 21 patients with a follow up of at least one year. Most patients had multiple sclerosis and all were wheelchair-bound. Sixteen patients had a complete and sustained benefit. In four other patients the treatment was effective in the short term but not in the long term. In the remaining patient the pump never worked. Complications included meningitis, pump failure, erosion through the skin, and baclofen overdose. Nevertheless, only three patients have asked to discontinue the treatment. We conclude that intrathecal baclofen, delivered by a manually operated implanted pump, is an effective treatment for severe spasticity in most patients.
PMCID: PMC1072919  PMID: 8201328
22.  Intra-arterial hepatic chemotherapy for unresectable colorectal liver metastases: a review of medical devices complications in 3172 patients 
Background
Hepatic artery infusion (HAI) is indicated to treat unresectable colorectal hepatic metastases, with recent applications as a neoadjuvant or adjuvant treatment. Traditionally performed with the infusion of fluoropyrimidine-based chemotherapy, it has been now tested with oxaliplatin or irinotecan and associated with systemic chemotherapy.
Methods
To evaluate the impact of medical devices complications we carried out a search of the published studies on HAI in unresectable colorectal liver metastases. Complications were pooled according to the applied medical system: 1) surgical catheter, 2) radiological catheter, and 3) fully implantable pump. The surgical catheter is inserted into the hepatic artery from the gastro-duodenal artery. The radiological catheter is inserted into the hepatic artery through a percutaneous transfemoral or transaxillar access. The fully implantable pump is a totally internal medical device connected to the arterial hepatic catheter during laparotomy.
Results
The selection criteria were met in 47/319 studies. The complications of surgical and radiological medical devices connected to a port were found in 16 and 14 studies respectively. Meanwhile, complications with a fully implantable pump were reported in 17 studies. The total number of complications reported in studies evaluating patients with surgical or radiological catheter were 322 (322/948, 34%) and 261 (261/722, 36.1%) respectively. In studies evaluating patients with a fully implantable pump, the total number of complications was 237 (237/1502, 15.8%). In 18/319 studies the number of cycles was reported. The median number of cycles with surgically and radiologically implanted catheters was 8 and 6 respectively. The fully implantable pump allows a median number of 12 cycles.
Conclusions
The fully implantable pump, maintaining a continuous infusion through the system, allows the lowest risk for thrombosis and infection and the best median number of cycles of loco-regional chemotherapy in HAI.
PMCID: PMC3417858  PMID: 22915912
liver metastases; colorectal cancer; medical devices; loco-regional treatments; intra-arterial hepatic chemotherapy
23.  Intrathecal Baclofen for Spasticity Management: A Comparative Analysis of Spasticity of Spinal vs Cortical Origin 
Background/Objective:
To examine the differences in intrathecal baclofen management of individuals with spasticity of cortical vs spinal etiologies.
Design:
Retrospective chart review of 57 individuals with the diagnoses of severe cortical and spinal spasticity requiring an intrathecal baclofen pump.
Methods:
Parameters evaluated included daily dosage of medication required, flex vs simple continuous delivery modes, dosing changes, need for other local spasticity treatment, and catheter complications.
Results:
There were no statistically significant differences between individuals with cortical spasticity and spinal spasticity when comparing daily dosage, number of contacts, and mode of delivery. At 6 months, there was a statistically significant difference in dosing between individuals with multiple sclerosis and those without. Within groups, there was a significant difference in average daily dosing over 3 years. A significant difference was found comparing the use of botulinum toxin type A for upper extremity spasticity within the cortical group. Nine individuals had catheter complications.
Conclusions:
Cortical and spinal spasticity appear to parallel each other with no significant differences in daily dosing, dosing changes, and mode of delivery of intrathecal baclofen. This did not hold true at all time points for the multiple sclerosis subgroup. The significant difference noted within groups for daily dosing over the first 3 years challenges the notion of stable dosing over time. Focal injections of Botox/phenol in the upper extremities are an important adjunct therapy for patients with cortical spasticity, even after the placement of an intrathecal baclofen pump. Our complication rate was slightly lower than that reported in the literature.
PMCID: PMC2853324  PMID: 20397440
Spinal cord injuries; Multiple sclerosis; Cerebral palsy; Stroke; Brain injury, traumatic; Baclofen, intrathecal; Botulinum toxin type A; Phenol; Spasticity, cortical, spinal; Intrathecal pump
24.  Ultrasound-guided percutaneous drainage of infected pancreatic necrosis 
Surgical Endoscopy  2013;27(8):2841-2848.
Background
The role of percutaneous drainage in the management of infected pancreatic necrosis remains controversial, and ultrasound-guided technique is rarely used for this indication. The purpose of this study was to evaluate the safety and efficacy of sonographically guided percutaneous catheter drainage for infected pancreatic necrosis.
Methods
The patient group consisted of 16 men and 2 women. The mean age of the patients was 47 years. The median computed tomography severity index of acute pancreatitis was 10 points. Percutaneous catheter drainage was performed under sonographic guidance using preferably retroperitoneal approach, and transperitoneal access in selected cases. The medical records and imaging scans were reviewed retrospectively for each patient.
Results
Percutaneous catheter drainage resulted in a complete resolution of infected pancreatic necrosis in 6 of 18 patients (33 %). Twelve of 18 patients who were initially managed with PCD required eventually necrosectomy (67 %). The most common reason for crossover to surgical intervention was persistent sepsis (n = 7). Open necrosectomy was performed in 4 of these patients, and 3 patients underwent successful minimally invasive retroperitoneal necrosectomy. Five patients required conversion to open surgery because of procedure-related complications. In 3 cases, there was leakage of the necrotic material into the peritoneal cavity. Two other patients experienced hemorrhagic complications. Overall mortality rate was 17 %. The size of the largest necrotic collection in patients who were successfully treated with percutaneous drainage decreased by a median of 76 % shortly after the procedure, whereas it decreased only by a median of 16 % in cases of failure of percutaneous drainage.
Conclusions
Ultrasound-guided percutaneous catheter drainage used in infected pancreatic necrosis is a technique with acceptably low morbidity and mortality that may be the definitive treatment or a bridge management to necrosectomy. A negligible decrease in size of the necrotic collection predicts failure of percutaneous drainage.
doi:10.1007/s00464-013-2831-9
PMCID: PMC3710405  PMID: 23404151
Acute pancreatitis; Infected necrosis; Pancreatic necrosectomy; Pancreatic necrosis; Percutaneous catheter drainage
25.  Baclofen Pump Intervention for Spasticity Affecting Pulmonary Function 
Introduction:
Muscle spasticity may adversely affect pulmonary function after spinal cord injury (SCI). However, there is limited information regarding the treatment of spasticity as a determinant of pulmonary function. This study presents the case of a man with C4 tetraplegia who had severe spasticity and difficulty weaning from ventilatory support.
Methods:
Case presentation.
Results:
Severe spasticity likely contributed to respiratory compromise in this patient. Successful and rapid weaning from the ventilator occurred within 3 weeks of baclofen pump placement.
Conclusions:
Randomized clinical trials among SCI patients with significant spasticity are needed to determine whether intervention with a baclofen pump facilitates earlier ventilatory weaning.
PMCID: PMC1864906  PMID: 16396387
Spinal cord injuries; Spasticity; Ventilator weaning; Baclofen pump; Respiratory impairment; Tetraplegia

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