Download DBS Therapy for Parkinson`s Disease

DBS Therapy for Parkinson’s Disease
HELP YOUR PATIENTS
ACHIEVE
Daily
Victories
Perry C.
Benefiting from DBS Therapy since 2006
Motor fluctuations and dyskinesias decrease
quality of life for people with Parkinson’s disease1
• In the United States, there are more than 1 million people living with Parkinson’s disease (PD). 2
• Levodopa generally provides smooth and stable benefits for up to 5 years after therapy introduction.3
• After this period, patients may experience increasingly troublesome and unpredictable motor fluctuations
and dyskinesias.3
Treating motor fluctuations and dyskinesias requires moving
beyond standard dopamine replacement therapy3
• The delayed “on,” wearing off, and dose failure of levodopa may be due to its impaired absorption, short
half-life, and the loss of striatal dopamine storage capacity.3
• When drugs become less reliable, Medtronic DBS Therapy (Deep Brain Stimulation) should be considered
to achieve PD treatment goals.
Benefits of Adding Medtronic DBS Therapy
Medications Alone Medtronic DBS Therapy
0 hours of additional “on” time4
Unpredictable
Dyskinesias and nonmotor
side effects
Pulsatile delivery
GI absorption required
5.1 hours additional “on” time
without troubling dyskinesias*
More predictable
Medication reduction may lead to
fewer drug-induced side effects
Continuous delivery
No GI absorption
Must cross blood-brain barrier
Targeted and direct
Dosing compliance challenges
Simplified medication regimen
may be possible
*Mean results; DBS is adjunctive to medications.
2
Deep Brain Stimulation Therapy for Movement Disorders
Iris C.
Benefiting from DBS Therapy since 2008
When drugs become less reliable,
Medtronic DBS Therapy should be considered
How Medtronic DBS Therapy Works
• One or more leads are implanted to deliver electrical
stimulation to parts of the brain involved in
movement control, including the globus pallidus
or subthalamic nucleus.
More than 75,000 patients
globally have been treated
with Medtronic DBS Therapy.
• Current delivered by the lead is believed to disrupt
and modulate abnormal motor circuit activity in the
brain caused by PD, thereby smoothing out motor
function. However, the exact mechanism of action
isn’t completely understood.
DBS Therapy with Medications Provides an Additional 5.1 Hours
of “On” Time to Smooth Out Motor Function Throughout the Day4
Dyskinesias
“On” time without
dyskinesias
“Off” time
Without DBS Therapy
Time (daily)
With DBS Therapy
* This chart is for illustrative purposes and
does not reflect actual “on” or “off” time.
“Medicine and surgery are not separate
disciplines. Surgery is not the failure
of neurology, but rather the extension
of neurology.”
— George Plotkin, MD, PhD
Help Your Patients Achieve Daily Victories 3
5.1 hours of additional “on” time without dyskinesias
compared to Best Medical Therapy (BMT) alone4
Additional “On” Time Without Dyskinesias4
DBS Therapy
+ BMT
(n = 108)
5.1 hours
BMT Alone
(n = 118)
0 hours
• Results from prospective multicenter randomized control trial
of patients with advanced PD4
• Medications were reduced 25%
on average for patients receiving
DBS Therapy4
0123 456
Mean Additional Hours of “On” Time Without Dyskinesias
p < 0.001
* Results were at 6 months post implant versus baseline.4
In a Separate Clinical Study, Medtronic DBS Therapy
Was Shown to Maintain Symptom Improvements After 5 Years6
Percent Improvement in “Off” Medication UPDRS
Motor Scores Compared with Pre-DBS Therapy Baseline6
Improvement in Motor Scores After 5 Years
100
1 Year (n = 43)
3 Years (n = 42)
83%
80
73% 74% 71%
75%
5 Years (n = 42)
75%
63%
60
52%
49%
40
20
0
Rigidity
Tremor
Akinesia
p < 0.001 5 years after surgery versus baseline
Best Medical Therapy Defined
Patients who received BMT were managed actively by movement disorder neurologists.
Patients received state-of-the-art care, including the active management of medications and nonpharmacological
therapy (e.g., physical occupational, and speech therapy) as needed to achieve best symptom control.
4
Deep Brain Stimulation Therapy for Movement Disorders
Proven safety profile
The majority of serious adverse events* with Medtronic DBS Therapy are
procedure-related and temporary4
• Although there was a significantly higher incidence of serious adverse events observed in patients
receiving DBS Therapy, 99% of serious adverse events were resolved by 6 months.4
• Improvements in MRI imaging, stereotactic equipment and software, and patient selection
have all helped advance DBS Therapy since the FDA first approved it in 1997.
Surgical risks include:
• Infection
• Cerebral hemorrhage
Hardware related risks include:
Additional risks and side effects:
• Speech may get worse after DBS Therapy,
requiring speech therapy.
• Some risks associated with DBS Therapy may be
due to improved function and greater activity.5
• Lead fractures
Unlike thalamotomy:
Stimulation related side
effects include:
•Paresthesia
• DBS Therapy preserves brain structures for
future therapies and treatments.
• DBS Therapy is safely performed bilaterally.4
•Speech
•Dystonia
Note: Stimulation-related side effects typically
can be reduced or resolved noninvasively through
fine-tuning of programming settings.
Note: Adverse events vary depending on implanting centers. Consult with the implanting center you refer patients to in order to determine risks and
adverse events.
* A serious adverse event was defined according to FDA regulations as any event that: results in death, is life-threatening, results in prolonged or new hospitalization,
results in disability or congenital anomaly/birth defect, or requires medical or surgical intervention to prevent one of the above outcomes.
Help Your Patients Achieve Daily Victories 5
Medtronic DBS Therapy in the PD continuum of care
In order to obtain maximum benefits from DBS Therapy, patients with idiopathic Parkinson’s disease must be
referred at the optimal time, or during a “window of opportunity” when the therapy may be most effective.
Window of Opportunity
Patient is experiencing troubling motor
symptoms not effectively controlled
by medications.
• “On” time characterized by disabling dyskinesias
(or other nonmotor side effects)
OR
• “Off” time characterized by disabling tremor,
rigidity, or akinesia/bradykinesia
OR
• Unpredictable “on/off” motor fluctuations
OR
• Medication-resistant tremor
DBS Therapy Exclusion Criteria
• No longer responsive to dopaminergic medication
• Severely disabled even in the best “on” state
• Medical conditions that prevent surgery
• Onset of frank dementia
According to the American Academy of Neurology (AAN), “10% to 20%
of people with PD may be eligible for surgical treatments.”7
6
Deep Brain Stimulation Therapy for Movement Disorders
When is Medtronic DBS Therapy appropriate?
DBS Therapy should be considered when the patient, despite optimal medical therapy, reaches a
stage where the daily burden of PD begins to cause significant interference with:
• Daily function
• Occupational activities
• Important leisure time pursuits
• Basic activities of daily living
Medtronic DBS Patient Referral Advisor
The Patient Referral Advisor is a software tool that creates a patient “appropriateness” profile for DBS
Therapy based on 5 absolute criteria and 7 relative criteria.
To download the Patient Referral Advisor software visit: www.medtronic.com/dbsreferraladvisor.
Discuss each patient’s goals and expectations
to determine whether DBS Therapy is right for
him or her. It’s important to set realistic goals
about the benefits of Medtronic DBS Therapy.
Help Your Patients Achieve Daily Victories 7
Patient management
Establish a partnership with your Medtronic DBS Therapy implant
center to manage postimplant patient care, which involves
programming and medical management.
• Initial Device Programming—Identifying and programing
optimal stimulation parameters during the first several months
• Maintenance Device Programming—Titrating stimulation as
needed over time
Patient programming is reimbursed.
Medtronic provides
comprehensive education,
training, and clinical and
technical support to help
manage patients with
DBS Therapy.
Innovative programming software
Medtronic has developed technology to make device programming easier, including:
• A step-by-step process that provides a systematic approach to programming
• The ability to capture, store and sort patient data in the device
• Features that maximize therapeutic response and device longevity
8
Deep Brain Stimulation Therapy for Movement Disorders
Present and future neuromodulation therapies
A paradigm shift
• Today, more than 500,000 patients globally have received
Medtronic neuromodulation devices.9
• The future of neurology will include the integration of
device-based neuromodulation treatment into the
management of the most common neurological disorders.
DBS Therapy continues
to be the fastest growing
treatment option for
people suffering from
movement disorders.
Medtronic neuromodulation therapies
Present
Parkinson’s Disease
Essential Tremor
Dystonia*
Obsessive-Compulsive Disorder*
Chronic Pain (Opioid)
Future
Intracerebroventricular
(ICV) Applications
Depression
Chronic Migraine (ONS)
Chronic Pain
(Nonopioid)
Malignant Pain
Chronic Pain
Spasticity
Urinary Incontinence
and Retention
* Humanitarian Device:
The effectiveness of this device
for the treatment of dystonia or
obsessive-compulsive disorder
has not been demonstrated.
Help Your Patients Achieve Daily Victories 9
Medtronic: The leader in DBS Therapy
Medtronic is committed to advancing the science of neuromodulation through:
Product innovation
• Providing new products such as Activa® PC—the next generation primary cell neurostimulator—and
Activa® RC—the first rechargeable neurostimulator for DBS Therapy
•New programming platform provides step-by-step guidance and advanced device programming options
Education
• Customized courses for clinicians designed to make DBS Therapy successful in your practice
Procedure support
• Medtronic Procedure Solutions provides a complete system to plan, record, place and manage with success
Innovative clinical research
• Medtronic has sponsored numerous studies to evaluate the safety and efficacy of DBS for current and
future indications
Indications for DBS Therapy
Parkinson’s Disease
Essential Tremor
• AAN Guidelines concluded that unilateral deep
brain stimulation resulted in a significant (60%
to 90%) reduction of contralateral limb tremor.8
• DBS Therapy improves activities of daily living
in patients with ET.4
Dystonia
• Approved in 2003 under Humanitarian Device
Exemption (HDE) for the treatment of
dystonia.*
Obsessive-Compulsive Disorder
• Approved in 2009 under HDE for the treatment
of obsessive-compulsive disorder.*
Kristin E.
Benefiting from DBS Therapy since 2003
* Humanitarian Device: The effectiveness
of this device for the treatment of dystonia
or obsessive-compulsive disorder has not
been demonstrated.
Medtronic DBS Therapy for Parkinson’s Disease, Tremor and Dystonia: Patients should always discuss the potential risks and benefits with a physician.
Indications:
Medtronic DBS Therapy for Parkinson’s Disease: Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson’s Disease is indicated for adjunctive
therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson’s disease that are not adequately controlled with medication.
Medtronic DBS Therapy for Tremor: Unilateral thalamic stimulation using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who
are diagnosed with Essential Tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. The safety or effectiveness of this therapy has not
been established for bilateral stimulation.
Medtronic DBS Therapy for Dystonia: Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Dystonia is indicated as an aid in the
management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older.
Contraindications: Contraindications include patients who will be exposed to MRI using a full body radio-frequency (RF) coil or a head transmit coil that extends over the chest area, patients who are unable to properly
operate the neurostimulator, or for Parkinson’s disease and Essential Tremor, patients for whom test stimulation is unsuccessful. Also, diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound
diathermy) is contraindicated because diathermy’s energy can be transferred through the implanted system (or any of the separate implanted components), which can cause neurostimulation system or tissue damage and
can result in severe injury or death. Transcranial Magnetic Stimulation (TMS) is contraindicated for patients with an implanted DBS System.
Warnings/ Precautions/Adverse Events: There is a potential risk of tissue damage using stimulation parameter settings of high amplitudes and wide pulse widths. Extreme care should be used with lead implantation in
patients with a heightened risk of intracranial hemorrhage. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Theft detectors and security
screening devices may cause stimulation to switch ON or OFF, and may cause some patients to experience a momentary increase in perceived stimulation. Although some MRI procedures can be performed safely with an
implanted DBS System, clinicians should carefully weigh the decision to use MRI in patients with an implanted DBS System. MRI can cause induced voltages in the neurostimulator and/or lead possibly causing
uncomfortable, jolting, or shocking levels of stimulation.
The DBS System may be affected by or adversely affect medical equipment such as cardiac pacemakers or therapies, cardioverter/ defibrillators, external defibrillators, ultrasonic equipment, electrocautery, or radiation
therapy. Safety and effectiveness has not been established for patients with neurological disease other than Parkinson’s disease or Essential Tremor, previous surgical ablation procedures, dementia, coagulopathies, or
moderate to severe depression; or for patients who are pregnant, under 18 years, over 75 years of age (Parkinson’s Control Therapy) or over 80 years of age (Tremor Control Therapy). For patients with Dystonia, age of implant
is suggested to be that at which brain growth is approximately 90% complete or above. Depression, suicidal ideations and suicide have been reported in patients receiving Medtronic DBS Therapy for Movement Disorders,
although no direct cause and effect relationship has been established.
Abrupt cessation of stimulation should be avoided as it may cause a return of disease symptoms, in some cases with an intensity greater than was experienced prior to system implant (“rebound” effect). Adverse events
related to the therapy, device, or procedure can include: stimulation not effective, cognitive disorders, pain, dyskinesia, dystonia, speech disorders including dysarthria, infection, paresthesia, intracranial hemorrhage,
electromagnetic interference, cardiovascular events, visual disturbances, sensory disturbances, device migration, paresis/asthenia, abnormal gait, incoordination, headaches, lead repositioning, thinking abnormal, device
explant, hemiplegia, lead fracture, seizures, respiratory events, and shocking or jolting stimulation.
Humanitarian Device (Dystonia): Authorized by Federal Law for the use as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia,
and cervical dystonia (torticollis), for individuals 7 years of age and older. The effectiveness of this device for this use has not been demonstrated. USA Rx only Rev 0311
Reclaim™ Deep Brain Stimulation Therapy for Obsessive-Compulsive Disorder: Product labeling must be reviewed prior to use for detailed disclosure of risks.
Indications: The Medtronic Reclaim DBS Therapy is indicated for bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment
of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).
Contraindications: Contraindications include patients who will be exposed to MRI using a full body radio-frequency (RF) coil or a head transmit coil that extends over the chest area, and for patients who are unable to
properly operate the neurostimulator. Also, diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) is contraindicated because diathermy’s energy can be transferred through the
implanted system (or any of the separate implanted components), which can cause tissue damage and can result in severe injury or death. Diathermy can damage parts of the neurostimulation system. Transcranial Magnetic
Stimulation (TMS) is contraindicated for patients with an implanted DBS System.
Warnings/precautions/adverse events:
Electroconvulsive Therapy (ECT) – The safety of ECT in patients who have an implanted deep brain stimulation (DBS) system has not been established. Induced electrical currents may interfere with the intended stimulation or
damage the neurostimulation system components resulting in loss of therapeutic effect, clinically significant undesirable stimulation effects, additional surgery for system explantation and replacement, or neurological injury.
There is a potential risk of tissue damage using stimulation parameter settings of high amplitudes and wide pulse widths. Extreme care should be used with lead implantation in patients with a heightened risk of intracranial
hemorrhage. Do not place the lead-extension connector in the soft tissues of the neck. Placement in this location has been associated with an increased incidence of lead fracture. Theft detectors and security screening
devices may cause stimulation to switch ON or OFF, and may cause some patients to experience a momentary increase in perceived stimulation. Severe burns could result if the neurostimulator case is ruptured or pierced.
The safety of somatic psychiatric therapies using equipment that generates electromagnetic interference (e.g., vagus nerve stimulation) has not been established. The Reclaim DBS System may be affected by or adversely
affect medical equipment such as cardiac pacemakers or therapies, cardioverter/ defibrillators, external defibrillators, ultrasonic equipment, electrocautery, or radiation therapy. Patients should be monitored for at least 30
minutes after a programming session, for side effects, including: autonomic effects (e.g., facial flushing, facial muscle contractions, or increased heart rate), hypomania, increased disease symptoms, sensations such as tingling,
smell, or taste. In addition, during treatment, patients should be monitored closely for increased depression, anxiety, suicidality, and worsening of obsessive-compulsive symptoms. The safety and probable benefit of this
therapy has not been established for patients with: Tourette’s syndrome, OCD with a subclassification of hoarding, previous surgical ablation (e.g., capsulotomy), dementia, coagulopathies or who are on anticoagulant
therapy, neurological disorders, and other serious medical illness including cardiovascular disease, renal or hepatic failure, and diabetes mellitus. In addition, the safety and probable benefit has not been established for these
patients: those whose diagnosis of OCD is documented to be less than 5 years duration or whose YBOCS score is less then 30, who have not completed a minimum of 3 adequate trials of first and/or second line medications
with augmentation, who have not attempted to complete an adequate trial of cognitive behavior therapy (CBT), who are pregnant, under the age of 18 years, and who do not have comorbid depression and anxiety.
Physicians should carefully consider the potential risks of implanting the Reclaim DBS System in patients with comorbid psychiatric disorders (e.g., bipolar, body dysmorphic, psychotic) as the Reclaim DBS System may
aggravate the symptoms. Additionally, the abrupt cessation of stimulation for any reason should be avoided as it may cause a return or worsening (i.e., “rebound” effect) of disease symptoms. Serious adverse events related to
the therapy, device, or procedure can include: suicidality/increased depression, increased OCD/fluctuating results, intracranial hemorrhage, lead/extension failure, aggression/violent behavior, accident proneness, irritability,
death, hypomania, infection, pyelonephritis, and post-operative seizure. Adverse events related to the therapy, device, or procedure can include: coma, paralysis, pain or discomfort at incision/implant sites, general post-op
discomfort, GI symptom (post op), increased anxiety, insomnia, cognitive disturbance (clouding), induced muscle contraction, restlessness, stimulation induced paresthesia, device migration, shocking or jolting stimulation,
induced sensation of taste/smell, weight gain, increased fatigue, upper respiratory infection, headaches, dizziness, dry mouth, itching at surgical site(s), nausea, sedation, and weight loss.
Humanitarian Device: Authorized by Federal (U.S.A) law for use as an adjunct to medications and as alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder
(OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). The effectiveness of this device for this use has not been demonstrated. USA Rx Only Rev 1009
References
1. Adler, CH. Relevance of motor complications in Parkinson’s disesae. Neurology. 2002;58(Suppl 1):S51-S56.
2. National Parkinson’s Foundation (www.parkinson.org/Page.aspx?pid=225) accessed site, Dec. 3, 2009.
3. Melamed E, Ziv I, Djaldetti R. Management of Motor Control Complications in Advanced Parkinson’s Disease. Movement Disorders. 2007;22(Suppl. 17)S379-S384.
4. Activa Therapy Clinical Summary, 2009.
5.Weaver FM, Follett K, Stern M, Hur K, Harris C, Marks WJ Jr, et al. Bilateral deep brain stimulation vs best medical therapy for patients with advanced Parkinson’s
disease: a randomized controlled trial. JAMA. 2009;301(1):63-73.
6. Krack R, Batir A, Van Blercom N, et al. Five-Year Follow-up of Bilateral Stimulation of the Subthalamic Nucleus in Advanced Parkinson’s Disease. N Engl J Med.
2003;349:1925-34.
7. AAN Guidelines Summary for patients and their families: medical and surgical treatment for motor fluctuations and dyskinesia in Parkinson’s disease, April 2006.
8.Zesiewicz TA, Elble R, Louis ED, et al. Practice paramater: therapies for essential tremor: Report of the Quality Standards Subcommittee of the AAN. Neurology.
2005;64:2008-2020.
9. Medtronic, Inc. data on file.
Help Your Patients Achieve Daily Victories 11
Ensure that Medtronic DBS Therapy
is a successful part of your practice
Step 1.Partner with your local implanting team.
• Establish referral processes and communications.
• Establish postimplant patient management roles.
Step 2. Identify appropriate patients.
• Attend a Medtronic education program to learn more about appropriate patient selection.
• Use the DBS Therapy Patient Referral Advisor to confirm appropriateness for patient referral.
Step 3. Discuss DBS Therapy with patients and their caregivers.
• Discuss patients’ goals with them.
• Educate patients about the benefits and risks of DBS Therapy.
• Set appropriate expectations.
Step 4. Refer appropriate patients for DBS Therapy.
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Medtronic Neuromodulation
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Minneapolis, MN 55432-5604
USA
Tel. 763-505-5000
Toll-free 1-800-328-0810
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Europe
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Australia
Medtronic Australasia Pty. Ltd.
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NSW 2113
Australia
Tel. +61-2-9857-9000
www.medtronicneuro.com.au
Canada
Medtronic of Canada Ltd.
6733 Kitimat Road
Mississauga, Ontario L5N 1W3
Canada
Tel. 1-905-826-6020
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