Best Practices for ITB Therapy: Patient Selection Cindy Ivanhoe, MD, John McGuire, MD Barbara...

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Best Practices Best Practices for for ITB Therapy: ITB Therapy: Patient Selection Patient Selection Cindy Ivanhoe, MD, John McGuire, Cindy Ivanhoe, MD, John McGuire, MD Barbara Ridley, MD Michael MD Barbara Ridley, MD Michael Saulino, MD PhD Jeff Shilt, MD Saulino, MD PhD Jeff Shilt, MD

Transcript of Best Practices for ITB Therapy: Patient Selection Cindy Ivanhoe, MD, John McGuire, MD Barbara...

Page 1: Best Practices for ITB Therapy: Patient Selection Cindy Ivanhoe, MD, John McGuire, MD Barbara Ridley, MD Michael Saulino, MD PhD Jeff Shilt, MD Best Practices.

Best Practices for Best Practices for ITB Therapy:ITB Therapy:

Patient SelectionPatient Selection

Cindy Ivanhoe, MD, John McGuire, MD Cindy Ivanhoe, MD, John McGuire, MD Barbara Ridley, MD Michael Saulino, MD PhD Barbara Ridley, MD Michael Saulino, MD PhD

Jeff Shilt, MDJeff Shilt, MD

Best Practices for Best Practices for ITB Therapy:ITB Therapy:

Patient SelectionPatient Selection

Cindy Ivanhoe, MD, John McGuire, MD Cindy Ivanhoe, MD, John McGuire, MD Barbara Ridley, MD Michael Saulino, MD PhD Barbara Ridley, MD Michael Saulino, MD PhD

Jeff Shilt, MDJeff Shilt, MD

Page 2: Best Practices for ITB Therapy: Patient Selection Cindy Ivanhoe, MD, John McGuire, MD Barbara Ridley, MD Michael Saulino, MD PhD Jeff Shilt, MD Best Practices.

DisclosuresDisclosures

• Consultant, Research and Educational Consultant, Research and Educational grants from Medtronic, Mallinckrodtgrants from Medtronic, Mallinckrodt

Page 3: Best Practices for ITB Therapy: Patient Selection Cindy Ivanhoe, MD, John McGuire, MD Barbara Ridley, MD Michael Saulino, MD PhD Jeff Shilt, MD Best Practices.

ITB FDA IndicationITB FDA Indication• Management of severe spasticity Management of severe spasticity

of spinal and cerebral origins. of spinal and cerebral origins. • Any patient who demonstrates Any patient who demonstrates

spasticity that interferes with spasticity that interferes with comfort, active or passive comfort, active or passive function, activities of daily living, function, activities of daily living, mobility, positioning, or caregiver mobility, positioning, or caregiver assistance should be considered assistance should be considered for interventions including ITB for interventions including ITB therapytherapy

Page 4: Best Practices for ITB Therapy: Patient Selection Cindy Ivanhoe, MD, John McGuire, MD Barbara Ridley, MD Michael Saulino, MD PhD Jeff Shilt, MD Best Practices.

Patient SelectionPatient Selection

• Define Severe Spasticity Define Severe Spasticity

• Timing Timing

• Influential FactorsInfluential Factors

• Patient/Family EducationPatient/Family Education

• Goal SettingGoal Setting

• FailureFailure

• ContraindicationsContraindications

• ConclusionsConclusions

Page 5: Best Practices for ITB Therapy: Patient Selection Cindy Ivanhoe, MD, John McGuire, MD Barbara Ridley, MD Michael Saulino, MD PhD Jeff Shilt, MD Best Practices.

SpasticitySpasticity• ““Disordered sensori-motor control, Disordered sensori-motor control,

resulting from an upper motor neuron resulting from an upper motor neuron lesion, presenting as intermittent or lesion, presenting as intermittent or sustained involuntary activation of sustained involuntary activation of muscles.” muscles.” (Pandyan, 2005, SPASM consortium)(Pandyan, 2005, SPASM consortium)

• Measure abnormal muscle activity not Measure abnormal muscle activity not “stiffness”“stiffness”

• Includes clonus, cocontraction, associated Includes clonus, cocontraction, associated reactions, dystonia, and spasmsreactions, dystonia, and spasms

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Severe SpasticitySevere Spasticity• Degree of functional limitation to the Degree of functional limitation to the

patient/caregiver.patient/caregiver.• How Problematic is it?How Problematic is it?• Resistance to passive stretch does not Resistance to passive stretch does not

always correlate with functional impactalways correlate with functional impact• Inability to perform basic ADL’s: hygiene, Inability to perform basic ADL’s: hygiene,

dressing, and toileting. dressing, and toileting. • Cause pain, interrupt sleep, negatively Cause pain, interrupt sleep, negatively

impact mood, and impair mobility.impact mood, and impair mobility.

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Timing of InterventionTiming of Intervention

• FDA label requires waiting one year after FDA label requires waiting one year after TBI before ITB therapy. “Too Restrictive”TBI before ITB therapy. “Too Restrictive”

• Earlier Treatment safe/effective in Earlier Treatment safe/effective in appropriate patients. appropriate patients. (Francois, 2001, Francisco, 2005, (Francois, 2001, Francisco, 2005, Meythaler, 1999)Meythaler, 1999)

• Musculoskeletal consequences in delayed or Musculoskeletal consequences in delayed or nonintervention, including contracture, nonintervention, including contracture, ankylosis, and skin breakdown. ankylosis, and skin breakdown. (Gerszten, 1998, Lai, (Gerszten, 1998, Lai, 2008, Berman, 2015)2008, Berman, 2015)

• Weigh risk vs benefits of early vs lateWeigh risk vs benefits of early vs late

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Complimentary TreatmentsComplimentary Treatments

• Rehabilitation treatmentsRehabilitation treatments• Focal/Segmental TreatmentsFocal/Segmental Treatments– Nerve/Motor point blocksNerve/Motor point blocks

– Tendon transfer/lengtheningTendon transfer/lengthening• Generalized Treatments:Generalized Treatments:– Oral/Intrathecal medicationsOral/Intrathecal medications– RhizotomyRhizotomy

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Ambulatory PatientsAmbulatory Patients

• ITB may improve the ITB may improve the ambulation status or gait ambulation status or gait performance with concurrent performance with concurrent intensive therapy. intensive therapy.

• Improvements in isolated cases Improvements in isolated cases (Meythaler, 1999, Dario, 2002, Horn, 2005)(Meythaler, 1999, Dario, 2002, Horn, 2005)

• Larger studies mixed results Larger studies mixed results (Zahavi, 2004, Plassat, 2004, Gerszten, 1997, (Zahavi, 2004, Plassat, 2004, Gerszten, 1997, Chow, 2015)Chow, 2015)

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Pediatric Patients Pediatric Patients

• Spasticity during rapid growth prevents Spasticity during rapid growth prevents normal bone and muscle development normal bone and muscle development causing muscle shortening, joint causing muscle shortening, joint dislocations, poor motor function. dislocations, poor motor function.

• Early treatment of spasticity reduces the Early treatment of spasticity reduces the need for orthopedic surgery for need for orthopedic surgery for contracture or torsion deformity in contracture or torsion deformity in children with severe spasticity from children with severe spasticity from cerebral palsy. cerebral palsy. (Gerszten, 1998)(Gerszten, 1998)

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Pediatric Patients Pediatric Patients

• Preoperative discussion should include Preoperative discussion should include baseline evaluations for scoliosis, hip baseline evaluations for scoliosis, hip status, hydrocephalus, and urodynamic status, hydrocephalus, and urodynamic status. status.

• Impact of ITB on scoliosis development Impact of ITB on scoliosis development or progression is controversial. or progression is controversial.

• No prospective, matched cohort studiesNo prospective, matched cohort studies

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Progressive Disease StatesProgressive Disease States

• MS or progressive muscular dystrophies, MS or progressive muscular dystrophies, who are implanted prior to significant who are implanted prior to significant joint contracture formation, weakness, or joint contracture formation, weakness, or muscle imbalance, might demonstrate muscle imbalance, might demonstrate maintenance of function for longer maintenance of function for longer periods. periods. (Guerrera, 2014, Bethoux, 2013, Erwin, 2011)(Guerrera, 2014, Bethoux, 2013, Erwin, 2011)

• Early exposure to ITB therapy is Early exposure to ITB therapy is warranted to prevent musculoskeletal warranted to prevent musculoskeletal ramifications of spasticity.ramifications of spasticity.

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Other ConsiderationsOther Considerations• ITB provides spasticity control while avoiding ITB provides spasticity control while avoiding

cognitive side effects of oral medications. cognitive side effects of oral medications. • Environmental infrastructure,Environmental infrastructure,• Individual desire and motivation to participate Individual desire and motivation to participate

in necessary therapy and lifestyle changes,in necessary therapy and lifestyle changes,• Appropriate level of residual neurologic ability Appropriate level of residual neurologic ability

following injury, and access to appropriate following injury, and access to appropriate care.care.

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Goal SettingGoal Setting

• Meaningful to patient/caregiver. Meaningful to patient/caregiver. • Use common language and approachUse common language and approach• Integrates the psychosocial, physical, Integrates the psychosocial, physical,

medical, biomechanical, and functional medical, biomechanical, and functional aspects of each patient.aspects of each patient.

• What matters most to the patient/caregiverWhat matters most to the patient/caregiver

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Goals: Improved Body Goals: Improved Body Function & StructureFunction & Structure

• Improved skin integrityImproved skin integrity• Improved standing capacityImproved standing capacity• Improved or maintained range of motionImproved or maintained range of motion• Improved orthotic toleranceImproved orthotic tolerance• Reduced startle responseReduced startle response• Reduced musculoskeletal painReduced musculoskeletal pain

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Goals Improved ParticipationGoals Improved Participation

• Improved enduranceImproved endurance• Improved standing capacityImproved standing capacity• Improved ambulation speedImproved ambulation speed• Improved sitting balance/toleranceImproved sitting balance/tolerance• Improved orthotic toleranceImproved orthotic tolerance• Improved cosmesisImproved cosmesis• Reduced need for oral anti-spasticity Reduced need for oral anti-spasticity

medications medications

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Goals: Improved ADL’sGoals: Improved ADL’s

• Improved ease of hygieneImproved ease of hygiene• Improved standing capacityImproved standing capacity• Improved ambulation speedImproved ambulation speed• Improved quality of ambulationImproved quality of ambulation• Improved sitting balance/toleranceImproved sitting balance/tolerance• Reduced fallsReduced falls

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Failure of Other TherapiesFailure of Other Therapies• Consider the least invasive options firstConsider the least invasive options first• Unresponsiveness to oral medications or failure Unresponsiveness to oral medications or failure

of less invasive options should not be mandated of less invasive options should not be mandated before exploring ITB therapy.before exploring ITB therapy.

• Many patients who could benefit from ITB have Many patients who could benefit from ITB have a suboptimal response or inadequate therapeutic a suboptimal response or inadequate therapeutic benefit from oral medications.benefit from oral medications.

• Combined therapies depict the most reasonable Combined therapies depict the most reasonable approach compared to hierarchical or approach compared to hierarchical or compartmentalized modelscompartmentalized models

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Synergistic Model of Spasticity Synergistic Model of Spasticity ManagementManagement

PatientPatient

IntrathecalBaclofen(ITB™)Therapy

OralMedications

OrthopedicSurgery

Neurosurgery

Non-Pharmaclogical

InjectionTherapy

Page 20: Best Practices for ITB Therapy: Patient Selection Cindy Ivanhoe, MD, John McGuire, MD Barbara Ridley, MD Michael Saulino, MD PhD Jeff Shilt, MD Best Practices.

Absolute ContraindicationsAbsolute Contraindications

• True allergy to baclofenTrue allergy to baclofen• Active infectionActive infection– Chronic colonization (bladder, decub Chronic colonization (bladder, decub

ulcer) can be implanted in selective ulcer) can be implanted in selective cases; consider ID consultation.cases; consider ID consultation.

Page 21: Best Practices for ITB Therapy: Patient Selection Cindy Ivanhoe, MD, John McGuire, MD Barbara Ridley, MD Michael Saulino, MD PhD Jeff Shilt, MD Best Practices.

Relative ContraindicationsRelative Contraindications• Unrealistic goals by the patient/caregiversUnrealistic goals by the patient/caregivers• Unmanageable mental health issues,Unmanageable mental health issues,• Psychosocial factors (i.e., unreliable Psychosocial factors (i.e., unreliable

transportation, inconsistency in keeping transportation, inconsistency in keeping appointments, frequently changing phone appointments, frequently changing phone numbers, etc.)numbers, etc.)

• Financial burdenFinancial burden• Modifiable with case manager or social workerModifiable with case manager or social worker

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Summary of Best PracticesSummary of Best Practices• Severe spasticity: unduly troublesome/problematic to patients Severe spasticity: unduly troublesome/problematic to patients

or caregivers.or caregivers.• ITB therapy should be considered in all patients with ITB therapy should be considered in all patients with

inadequately controlled, problematic spasticity, in all phases inadequately controlled, problematic spasticity, in all phases of disease processes.of disease processes.

• ITB therapy effective improving ambulatory function in ITB therapy effective improving ambulatory function in certain patients. Rehabilitative therapy should be applied certain patients. Rehabilitative therapy should be applied concomitantly.concomitantly.

• ITB therapy is a highly effective tool for spasticity reduction ITB therapy is a highly effective tool for spasticity reduction in the pediatric population. Baseline evaluations for scoliosis, in the pediatric population. Baseline evaluations for scoliosis, hip status, hydrocephalus, and urodynamic status.hip status, hydrocephalus, and urodynamic status.

Page 23: Best Practices for ITB Therapy: Patient Selection Cindy Ivanhoe, MD, John McGuire, MD Barbara Ridley, MD Michael Saulino, MD PhD Jeff Shilt, MD Best Practices.

Summary of Best PracticesSummary of Best Practices

• ITB should be considered early to potentially ITB should be considered early to potentially avoid or delay musculoskeletal and functional avoid or delay musculoskeletal and functional consequences of spasticity.consequences of spasticity.

• Patient/family/caregiver education is crucial Patient/family/caregiver education is crucial • Goal setting is necessary for patients and Goal setting is necessary for patients and

clinicians to approach the utilization of ITB clinicians to approach the utilization of ITB therapy in a meaningful and effective way.therapy in a meaningful and effective way.

• Must consider the absolute and relative Must consider the absolute and relative contraindications and develop appropriate contraindications and develop appropriate strategies for each issue. strategies for each issue.

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ReferencesReferences1. Lance JW. Symposium Synopsis. Spasticity: Disordered Motor Control. Chicago, IL: Year Book Medical Publishers; 1980:485-494.1. Lance JW. Symposium Synopsis. Spasticity: Disordered Motor Control. Chicago, IL: Year Book Medical Publishers; 1980:485-494.2. Denny-Brown D. The Cerebral Control of Movement. Springfield, IL: Thomas; 1966.2. Denny-Brown D. The Cerebral Control of Movement. Springfield, IL: Thomas; 1966.3. Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW, Task Force on Childhood Motor Disorders. Classification and definition of 3. Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW, Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics 2003;111(1):e89-97.disorders causing hypertonia in childhood. Pediatrics 2003;111(1):e89-97.4. Malhotra S, Pandyan AD, Day CR, Jones PW, Hermens H. Spasticity, an impairment that is poorly defined and poorly measured. Clin Rehabil 4. Malhotra S, Pandyan AD, Day CR, Jones PW, Hermens H. Spasticity, an impairment that is poorly defined and poorly measured. Clin Rehabil 2009;23(7):651-658.2009;23(7):651-658.5. Pandyan AD, Gregoric M, Barnes MP, et al. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil 5. Pandyan AD, Gregoric M, Barnes MP, et al. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil 2005;27(1-2):2-6.Rehabil 2005;27(1-2):2-6.6. Francois B, Vacher P, Roustan J, et al. Intrathecal baclofen after traumatic brain injury: early treatment using a new technique to prevent 6. Francois B, Vacher P, Roustan J, et al. Intrathecal baclofen after traumatic brain injury: early treatment using a new technique to prevent spasticity. J Trauma 2001;50(1):158-161.spasticity. J Trauma 2001;50(1):158-161.7. Francisco GE, Hu MM, Boake C, Ivanhoe CB. Efficacy of early use of intrathecal baclofen7. Francisco GE, Hu MM, Boake C, Ivanhoe CB. Efficacy of early use of intrathecal baclofentherapy for treating spastic hypertonia due to acquired brain injury. Brain Inj 2005;19(5):359-364.therapy for treating spastic hypertonia due to acquired brain injury. Brain Inj 2005;19(5):359-364.8. Meythaler JM, Guin-Renfroe S, Grabb P, Hadley MN. Long-term continuously infused8. Meythaler JM, Guin-Renfroe S, Grabb P, Hadley MN. Long-term continuously infusedintrathecal baclofen for spastic-dystonic hypertonia in traumatic brain injury: 1-year experience. Arch Phys Med Rehabil 1999;80(1):13-19.intrathecal baclofen for spastic-dystonic hypertonia in traumatic brain injury: 1-year experience. Arch Phys Med Rehabil 1999;80(1):13-19.9. Bose P, Hou J, Nelson R, et al. Effects of acute intrathecal baclofen in an animal model of TBIinduced spasticity, cognitive, and balance 9. Bose P, Hou J, Nelson R, et al. Effects of acute intrathecal baclofen in an animal model of TBIinduced spasticity, cognitive, and balance disabilities. J Neurotrauma 2013;30(13):1177-1191.disabilities. J Neurotrauma 2013;30(13):1177-1191.10. Gerszten PC, Albright AL, Johnstone GF. Intrathecal baclofen infusion and subsequent10. Gerszten PC, Albright AL, Johnstone GF. Intrathecal baclofen infusion and subsequentorthopedic surgery in patients with spastic cerebral palsy. J Neurosurg 1998;88(6):1009-1013.orthopedic surgery in patients with spastic cerebral palsy. J Neurosurg 1998;88(6):1009-1013.11. Lai LP, Reeves S, Smith BP, Kolaski K, Shilt JS. Use of intrathecal baclofen in a pediatric11. Lai LP, Reeves S, Smith BP, Kolaski K, Shilt JS. Use of intrathecal baclofen in a pediatriccerebral palsy patient with refractory hemiplegia to maintain orthopaedic surgery gains. J Pediatrcerebral palsy patient with refractory hemiplegia to maintain orthopaedic surgery gains. J PediatrRehabil Med 2008;1(3):263-268.Rehabil Med 2008;1(3):263-268.12. Berman CM, Eppinger MA, Mazzola CA. Understanding the reasons for delayed referral for12. Berman CM, Eppinger MA, Mazzola CA. Understanding the reasons for delayed referral forintrathecal baclofen therapy in pediatric patients with severe spasticity. Childs Nerv Systintrathecal baclofen therapy in pediatric patients with severe spasticity. Childs Nerv Syst2015;31(3):405-413.2015;31(3):405-413.

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