PACEMAKERS ARE NOT JUST FOR THE HEART! Ab Siadati MD

Transcription

1 PACEMAKERS ARE NOT JUST FOR THE HEART! Ab Siadati MD

2 WHAT IS DEEP BRAIN STIMULATION?

3 WHY SHOULD YOU CONSIDER DBS SURGERY FOR YOUR PATIENTS?

4 HOW DOES DBS WORK? DBS electrical stimulation overrides abnormal neuronal activity within the VIM, GPi, or STN brain regions to bring motor controlling circuits into a more normal state of function, thereby reducing movement disorder symptoms.

5 WHAT ARE THE CURRENT APPROVED INDICATIONS FOR DBS? Essential Tremor and Parkinsonian Tremor 1997 Indicated for unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) for the suppression of tremor in the upper extremity in patients diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where tremor constitutes a significant functional disability. Parkinson s Disease 2002 Indicated for bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson s disease that are not adequately controlled with medication Primary Dystonia 2003 HDE* Indicated for unilateral or bilateral stimulation of the GPi or the STN as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients seven years of age or older. Obsessive Compulsive Disorder 2009 HDE* 100,000+ patients worldwide have been treated with Medtronic DBS Therapy Indicated for the bilateral stimulation of the anterior limb of the internal capsule (AIC) as an adjunct to medications and as an alternative to anterior capsulotomy for the treatment of chronic, severe, treatment resistant Obsessive-Compulsive Disorder (OCD) in patients who have failed at least 3 selective serotonin reuptake inhibitors (SSRIs) * Humanitarian Device: The effectiveness of this device for the treatment of Dystonia or Obsessive-Compulsive Disorder has not been established.

6 History of DBS in the US and Europe 1st Medtronic DBS System Implant CE Mark for Parkinsonian Tremor CE Mark Advanced PD Motor Symptoms CE Mark / FDA Dystonia* HDE CE Mark Epilepsy CE Mark for Essential Tremor FDA Essential Tremor FDA Parkinson s Disease CE Mark / FDA OCD* HDE * Humanitarian Device: The effectiveness of this device for the treatment of Dystonia or Obsessive-Compulsive Disorder has not been established.

7 Implantable Components: 1. Leads DBS Therapy is delivered using a small 1.2 mm in diameter stimulating lead that is implanted into the intended brain target. Each lead has four electrodes on the distal end that can be activated by the neurostimulator in a variety of combinations to adjust the location and shape of the stimulation field. Connector End

8 Implantable Components: 2. Extension

9 Implantable Components: 3. Implantable Neurostimulators (INS) The INS contains the battery and electronics to generate and deliver the stimulation and is typically implanted in the subclavicular region Three different neurostimulators are available: Activa SC, Activa PC and Activa RC* *Activa RC Model is only approved for the essential tremor and Parkinson's disease indications.

10 EXTERNAL COMPONENTS: CLINICIAN PROGRAMMER Adjustments to stimulation parameters are made noninvasively using the Medtronic N Vision clinician programmer

11 EXTERNAL COMPONENTS: PATIENT PROGRAMMER Compatible with Activa SC, Activa PC and Activa RC* neurostimulators Patients can adjust parameters, and choose from up to 4 clinician defined stimulation groups Designed to reach optimized parameters more quickly LCD screen provides patient with information about their therapy settings *Activa RC Model is only approved for the essential tremor and Parkinson's disease indications.

12 RECHARGE SYSTEM COMPONENTS Representation of the Activa recharging system components The Activa RC* neurostimulator is powered by a rechargeable battery This battery charge must be maintained in order to continue to receive therapy over the service life of the neurostimulator (3) (1) (4) (2) *Activa RC Model is only approved for the essential tremor and Parkinson's disease indications.

13 RISKS AND ADVERSE EVENTS This therapy is NOT for everyone. DBS Therapy requires brain surgery which could have serious or even fatal complications. Other complications can occur and may require additional surgery. DBS Therapy may cause worsening of some symptoms.

14 HOW IS THE SURGERY DONE? Two day surgery usually separated by one week Stage I: Placement of the DBS leads during awake craniotomy targeting specific parts of Gpi, VIM, and STN (depending on the diagnosis and dominant symptoms) Stage II: placement of extension kits and pulse generators, patient is put to sleep for a short outpatient procedure

15 STEPS IN STAGE I : 1. Preoperative volumetric MRI 2. Targeting Vim, STN or GPi using Stealth station, using predetermined formulas, anatomical atlas. Avoiding ventricles and blood vessels, preserving the angles to get coverage in the appropriate part of the nucleus. $400,000

16 APPLICATION OF STEREOTACTIC FRAME TO THE HEAD OBTAINING A CT WITH THE FRAME ON THE HEAD MERGING OF THE MRI AND THE CT SCAN OF THE LEAD $125,000

17 Getting the exact coordinates for the target after the merge between CT and MRI

18 BURR HOLES, TARGETING

19 MICRO ELECTRODE RECORDING

20

21 MACRO ELECTRODE STIMULATION, IMPLANTATION