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Troubleshooting

ITB Therapy℠ with Lioresal® Intrathecal has a well-established safety and efficacy profile in the treatment of severe spasticity demonstrated in the 20+ years of clinical use.1 However, patients should be monitored and periodically reevaluated to ensure optimal therapy.

In general, patients with chronic, nonprogressive neurologic conditions, dosing of Lioresal® Intrathecal (baclofen injection) should be relatively stable during the maintenance phase of therapy. More frequent dose evaluations and

adjustments may be necessary in patients with progressive diseases (eg, multiple sclerosis). When patients present with previously well-controlled hypertonia or when they present with hypotonia, their spasticity should be reevaluated and their ITB therapy system should be reexamined. If no patient-related factors for change in spasticity are discovered, an investigation into their ITB therapy system should be undertaken. An algorithm for loss of efficacy has recently been developed. Learn more by clicking on each box in the image.2,3

Loss of Efficacy Troubleshooting Algorithm3

AP, anterior-posterior; CAP, catheter access port; CT, computed tomography; ITB, intrathecal; IV, intravenous; LP, lumbar puncture.

Adapted from Reference 3: Saulino M, Anderson DJ, Doble J, et al. Best practices for Intrathecal baclofen therapy: troubleshooting. Neuromodulation. 2016;19(6):632-641

 

Reservoir refilling must be performed by fully trained and qualified personnel following the directions provided by the pump manufacturer. Extreme caution must be used when filling an FDA approved implantable pump, following strict aseptic technique and ensuring refill directly into the reservoir and not the catheter access port. Following pump implantation, and for each adjustment of the dosing rate of the pump and/or concentration of Lioresal® Intrathecal, the patient should be monitored closely until it is certain the patient’s response to the infusion is acceptable and reasonably stable.

  1. Boster AL, Bennett SE, Bilsky GS, et al. Best practices for intrathecal baclofen therapy: screening test. Neuromodulation. 2016;19(6):616-622.
  2. Francisco GE, Saulino M. Chapter 19: Intrathecal baclofen for spasticity. In: Brashear A, Elovic E, eds. Spasticity: Diagnosis and Management. 2nd ed. New York, NY: Demos Medical Publishing, LLC, 2016.
  3. Saulino M, Anderson DJ, Doble J, et al. Best practices for intrathecal baclofen therapy: troubleshooting. Neuromodulation. 2016;19(6):632-641.
  4. Lioresal® Intrathecal (baclofen injection) for intrathecal injection [prescribing information]. Saol Therapeutics, Roswell, Georgia; January 2019.

Bolus Dose3

A single ITB pump bolus dose (in the amount of a test dose or higher) can be programmed. This serves as both a diagnostic tool and may improve therapeutic outcomes. A positive response to a lumbar puncture bolus rather than a pump bolus indicates there may be a system malfunction (eg, a malfunctioning pump or problem with the catheter).3

Catheter Access Port3

In addition to examining the patient and the pump, the catheter access port should be examined. A diagnostic aspiration may determine catheter patency or malfunction. Failure to aspirate fluid suggests catheter disruption or occlusion, and a catheter revision or replacement may be necessary. This should be performed after confirming the pump is functioning properly.3

History/Physical Exam3

When examining the potential causes of suboptimal ITB therapy, a targeted medical history and physical examination are warranted. History should include onset, duration, course, and exacerbating and relieving factors of the patient’s symptoms. If a patient presents with rapidly progressing hypertonia with autonomic instability or hyptonia with somnolence, emergent treatment and hospitalization should be considered. Symptoms such as mental status change, hypotonia, hypertonia, respiratory rate, blood pressure, and muscle activity can provide important clues suggestive of Lioresal® Intrathecal (baclofen injection) overdose or withdrawal.3 In addition, the pump should be interrogated, pump and catheter sites should be examined, and current medications should be evaluated as they have the potential to exacerbate or obscure symptoms.3 Physical examination should include a targeted neuromuscular examination and mental status evaluation. A laboratory assessment should evaluate infection and other noxious stimuli along with complete blood counts, serum electrolytes, hepatic and renal function, and coagulation status.

Pump Interrogation3

Active dosing parameters should be evaluated by interrogating the pump. If a programming error is detected, it should be corrected by returning to the previously determined appropriate dosing level. This may result in symptom reversal. If there is an audible pump alarm or the pump reservoir has extra/residual volume, there may be a pump-related malfunction. A low reservoir alarm indicates the pump is nearly empty and the patient needs an immediate refill. In rare cases, there may be a rotor stall and restart is needed or has been delayed.3

What Are the Potential Pump and Catheter Complications that Can Occur After Implant?4

Once the SynchroMed® II pump and catheter are implanted, device complications may occur that can require surgery (to remove or replace the pump, catheter, or catheter fragment). Device complications may impact the flow of medication delivered, which could lead to symptoms of overdose or withdrawal of Lioresal® Intrathecal (baclofen injection).4

Possible complications include an internal component failure that may result in loss of therapy or inability to program the pump.4 The pump, catheter, or catheter fragment could migrate within the body or erode through the skin. Tissue or an inflammatory mass may form at the tip of the catheter in the intrathecal space potentially causing a loss of therapy or neurological impairment, including paralysis. The catheter could leak, tear, or become disconnected resulting in delivery of medication into the area under the skin where the pump is implanted and/or along the catheter path. The catheter could kink or become blocked resulting in no delivery of medication. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. Errors in locating the pump during the refill procedure can result in symptoms of overdose that may be serious or life-threatening.

Imaging3

Both the pump and catheter can be evaluated through imaging. Contrast imaging can be used to visualize the catheter and verify the tip location. Extravasation of contrast from the catheter can diagnose breaks, tip locutions, or migration into the subdural or epidural space. MRI of the thoracic spine can determine if soft tissue abnormalities (eg, spinal hemorrhage, abscess) exist near the catheter tip. Contrast should be suitable for intrathecal use.3

Important Safety Information for Lioresal® Intrathecal (baclofen injection)

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).

Indications and Usage

Contraindications

Select Warnings and Precautions

Adverse Reactions

Common Adverse Reactions

Serious Adverse Reactions

Postmarketing Experience

Use in Specific Populations

For more information, including BOXED WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.