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Core ICD Therapies Indications

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					                     Core ICD - Overview


Module 1: Rhythm Basics
Module 2: Therapies & Indications
Module 3: ICD Concepts
Module 4: ICD Automated Functions
Module 5: Troubleshooting
     MODULE 2

Therapies & Indications
             Module 2: Therapies & Indications
                                                    Overview

• Diagnosing Rhythm            • Indications for Device
  Disorders                      Therapy
   – Holter/Event Monitors        – Class I, II & III Definitions
   – Testing & EP Study           – Pacemaker Indications
• Therapeutic Options             – ICD Indications
   – Anti-arrhythmic Drugs
   – Ablation / Surgical Therapy
   – External Electric Therapy
   – Device Therapy
           Module 2: Therapies & Indications
                                       Objectives

• Explain how arrhythmias are diagnosed

• Describe therapies available for the various
  types of rhythm disorders

• Identify rhythm disorders and patient
  conditions that indicate device therapy
RHYTHM DISORDERS

Diagnosing Arrhythmias
                                Question?




How do you know when someone is having
arrhythmias?
                   Diagnosing Rhythm Disorders
                                         Medical History
• Symptoms
   – Palpitations/Pounding/Fluttering/
     Skipped Beats
   – Dizziness
   – Shortness of breath
   – Angina
• Circumstances
   – First and most recent episode
   – Frequency and duration
• Lifestyle Habits
• Family History
                            Diagnosing Arrhythmias
                                      EKG & Monitoring
• EKG
  – A 12-second snap shot of the heart’s electrical activity
• Holter Monitor
  – Short term, continuous recording – usually 24 hour
• Event Recorders
  – Records on-demand
  – Usually prescribed for up to 30 days
         ®
• Reveal Plus Insertable Loop Recorder
  – Automatic or on-demand episode storage
  – Up to 14 months recording
  – Leadless EKG
  – Episode retrieval in clinic
                        Diagnosing Arrhythmias
                    ®
             Reveal Plus Insertable Loop Recorder
Indicated for patients with:
 – Clinical syndromes/situations that increase risk of
   cardiac arrhythmias
 – Transient symptoms that may suggest cardiac
   arrhythmias
                          Diagnosing Arrhythmias
                                                                        ®
                                                       Reveal Plus




                           ®
Patient Activator    Reveal Plus ILR                  Programmer


• Minimally invasive outpatient procedure
• Patient and auto triggered to capture ECG
• Store up to 42 minutes of ECG
• High diagnostic yield (65-88%)1,2
                                1 Krahn, Am. J Card, 1998; 82:117-119
                                2 Reveal Syncope Validation Project Multi-center Study
                        Diagnosing Arrhythmias
                                               Testing
•Treadmill Test
 –For suspected exercise related arrhythmias
•Tilt Table Studies
 – For recurrent Syncope
 – Measures cardiac responses to change in position
•Echocardiogram
 – Uses sound waves (sonar) to measure heart motion
•Blood Tests
 – Evaluate blood sugar, electrolytes and hormone
   levels that could be possible causes of arrhythmias
                          Diagnosing Arrhythmias
                                               Testing

• Electrophysiological Study (EPS)
  – Measures electrical activity from inside the heart
  – Provokes arrhythmias

• Esophageal Electrophysiological Procedure
  –Taken from the esophagus (near the atrium)
  –Provokes arrhythmias
  –Also used for Cardioversion
                                  Question?




Once an arrhythmia is diagnosed, what
therapies are available?
RHYTHM DISORDERS

     Therapies
  Therapies for Rhythm Disorders


Antiarrhythmic Drugs
            Therapies for Rhythm Disorders


        Antiarrhythmic Drugs
• Often first line of treatment
• Can have side / adverse effects
                              Antiarrhythmic Drugs
                                                  Classes

• Class I – Sodium Channel Blockers
  – Reduce the ability of cell to depolarize
  – Slow conduction
    • 1A Agents: prolong refractory period
       – (ex: Procainamide, Quinidine, Disopyramide)
    • 1B Agents: shorten refractory period
    • 1C Agents: little effect on refractory period
       – (ex: Flecainide, Propafenone)
                              Antiarrhythmic Drugs
                                                Classes
• Class II – Beta Blockers
   – Mediated by the autonomic nervous system
      • Ex: Atenolol, Propranolol
• Class III – Potassium Channel Blockers
   – Prolong refractoriness
      • Ex: Amiodarone, Sotalol, Dofetilide
• Class IV – Calcium Channel Blockers
   – Reduces automaticity in SA & AV nodes
   – Prolong action potential
      • Ex: Verapamil
                       Antiarrhythmic Drugs
                                    Classes
• Class V – Cardiac glycoside
  – Effect via the vagus
     • Ex. Digoxin
• Class VI – Purinergic agonists
  – Act directly on the SA & AV nodes
  – Fast acting and rapidly metabolized
     • Ex. Adenosine
       Therapies for Rhythm Disorders


    Antiarrhythmic Drugs

Ablation or Surgical Procedure
            Therapies for Rhythm Disorders


   Ablation or Surgical Procedure
• Removes or destroys conductive tissue or
  the tissue responsible for arrhythmia onset
• Non reversible, permanent cure
                             Ablation Procedures


• AV Nodal Ablation (Ablate & Pace)
  – For ventricular rate control in patients with
    rapidly conducted atrial arrhythmias
  – Blocks conduction through the AV Node
  – Requires a pacemaker
            Ablation Procedures
AV Nodal Ablation: Ablate and Pace

      • Isolates atria from ventricles
      • Result: complete AV block
      • Requires permanent pacing

        * Note: does not cure AF *
                              Ablation Procedures
• AV Nodal Ablation (Ablate & Pace)
   – Alters conduction of the AV Nodal pathway
   – Requires a pacemaker

• Modification of the AV Junction
  – Alters conduction of the AV Nodal pathway
  – May require a pacemaker
• Focal Ablation (Pulmonary Vein Ablation)
  – Alters circuit or pathway of arrhythmia origination
  – Risk of pulmonary vein stenosis
• Linear Ablation
  – A linear lesion through a re-entry circuit
  – Can prevent re-entry tachycardias
                            Surgical Procedures

• MAZE Procedure
 – Open heart surgery for the treatment of AF
 – A ‘maze’ of electrically isolated incisions
   in the atrium
• Corridor Operation
  – An open heart operation for the treatment of AF
  – Creates a channel or ‘corridor’ for electrical
    impulses
  – Mimics normal conduction pathway
  – Blocks all AF waves from disturbing rhythm
  – Patient remains in AF with ventricular rhythm
    control
       Therapies for Rhythm Disorders


    Antiarrhythmic Drugs

Ablation or Surgical Procedure

  External Electric Therapy
                     External Electric Therapy




• Electrical current (shock) delivered through external
  paddles positioned on patient’s chest
• Used for emergency rescue of VT/VF or planned
  therapy for AF
• Usually painful or uncomfortable for patient
External Electric Therapy
      Electrode Placement


       Anterior-Lateral
                             External Electric Therapy
                                   Electrode Placement




Correct electrode position        Incorrect electrode position


• Correct electrode position optimizes the amount of
  current flowing through the ventricles
       Therapies for Rhythm Disorders


    Antiarrhythmic Drugs

Ablation or Surgical Procedure

  External Electric Therapy

     Implantable Devices
               Therapy: Implantable Devices

• Pacemaker
  – Delivers electric pulses that cause a heart to beat
  – Increases or regulates a rhythm

• Implantable Cardioverter Defibrillator (ICD)
  – Delivers electric shocks to terminate fast rhythms
  – Can deliver anti-tachycardia pacing (ATP) to
    overdrive a fast rhythm
  – Also functions as a pacemaker
            Therapy: Implantable Devices




Pacemaker                 Implantable Cardioverter
                                Defibrillator
                                   (ICD)

             (not to scale)
                  Therapy: Implantable Devices

     Arrhythmia Management Device for
              Co-Arrhythmias




Implantable Cardioverter             Pacemaker
      Defibrillator
         (ICD)
                    (not to scale)
    RHYTHM DISORDERS

Indications for Device Therapy
                Indications for Device Therapy
                                        Class I
• Evidence and/or general agreement that
  device therapy is:
 – Beneficial
 – Useful

 – Effective
               Indications for Device Therapy
                                           Class II
• Conflicting evidence and/or divergence of
  opinion as to the necessity of device therapy
 – Class IIa
    – Evidence is weighed in favor of device therapy
 – Class IIb
    – Usefulness less well established by evidence
              Indications for Device Therapy
                                     Class III

• Agreement that device therapy is
  unnecessary
                    Indications for Pacemakers
                                                 Class I
• Sinus node dysfunction
  – Sinus bradycardia
  – Sinus arrest
  – Sinus pause (SA exit block)
  – Brady-tachy syndrome
  – Atrial flutter or atrial fibrillation with symptomatic
    bradycardia
  – Chronotropic incompetence
                      Indications for Pacemakers
• Sinus node dysfunction                             Class I
• AV block
  – Advanced second degree AV block (Mobitz II)
  – Third degree AV block & Bi/Trifascicular Block
• Neurocardiogenic syncope
• Hypersensitive cardiac sinus syndrome
• Congenital heart disease and:
  – Advanced second or third degree AV Block
  – Symptomatic sinus node dysfunction
  – Long QT syndrome
• Specific Conditions of:
  – Hypertrophic obstructive cardiomyopathy (HOCM)
  – Idiopathic dilated cardiomyopathy
  – Post Cardiac Transplantation
                               Indications for ICD
                                                Class I
1. Cardiac Arrest
   – Due to VT or VF
   – Not due to transient or reversible cause
2. Spontaneous sustained VT
   – Structural heart disease must be present
3. Syncope of undetermined origin with:
   – Sustained VT that has clinical relevance and/or
     hemodynamic significance
   – VF induced during EP study when drug therapy to
     sustained VT is not preferred
                                   Indications for ICD
                                                    Class I
4. Nonsustained VT with:
   –   Coronary disease
   –   Prior MI
   –   LV Dysfunction
   –   Inducible VF or sustained VT
       (Non-suppressible by antiarrhythmic drugs)
5. Spontaneous sustained VT
   – Not amenable to other treatments
                              Indications for ICD
                                           Class IIa
1. LVEF <30% at:
   – 1 month post MI
   – 3 months post coronary revascularization
                              Indications for ICD
                                            Class IIb
1. Cardiac Arrest
   – Assumed due to VF
   – EP test precluded by other medical conditions
2. Symptomatic sustained VT while awaiting
   cardiac transplant
3. Conditions with life-threatening risk
   – Long QT Syndrome
   – Hypertrophic cardiomyopathy
                              Indications for ICD
                                            Class IIb
4. Nonsustained VT with:
   – Coronary disease
   – Prior MI
   – LV Dysfunction
   – Inducible VF or sustained VT
5. Syncope of undetermined origin with:
   – Ventricular dysfunction
   – Inducible ventricular arrhythmias
   – All other causes of syncope excluded
                              Indications for ICD
                                             Class IIb
6. RBBB and ST Segment Elevation with:
  – Syncope of unexplained origin, or
  – Family history of SCD
7. Syncope and:
  – Structural heart disease
  – Extensive testing failed to identify cause
                               Indications for ICD
                                                Class III
1. Syncope of undetermined origin
   – Without structural heart disease
   – No inducible VT or VF
2. Incessant VT or VF
3. VT or VF with an ablatable or
   surgically treatable cause
   – WPW, LVOT VT, ILVT, Fascicular VT
4. Transient or reversible VT
   – Due to AMI, electrolyte imbalance, drugs
     or trauma
                                Indications for ICD
                                               Class III
5. Psychiatric illness that may:
   – Be aggravated by device implantation
   – Preclude follow-up
6. Terminal illness
   – <6 month life expectancy
7. CAD and:
   – LV dysfunction and Prolonged QRS, or
   – Inducible VT in those undergoing bypass
8. NYHA Class IV Heart Failure in patients who
   are not candidates for transplant
              Trails & Indications




   How Clinical Trials
Support ICD Indications…
                                  Trials & Indications
                Secondary Prevention Clinical Trials

    AVID,
                1998 ACC/AHA Class I Indications
    CASH,       for ICD Therapy:
    CIDS
                1. Cardiac arrest due to VF or VT not due
                   to a transient or reversible cause.
                2. Spontaneous sustained VT.
                3. Syncope of undetermined origin with
CIDS and AVID      clinically relevant, hemodynamically
   Registry        significant sustained VT or VF induced
 Sub-studies       at electrophysiological study when drug
                   therapy is ineffective, not tolerated, or
                   not preferred.


                                     Gregoratos G. Circulation. 1998;97:1325-35.
                                   Trials & Indications
                               Post-MI Clinical Trials

          1998 ACC/AHA Class I Indications
          for ICD Therapy:

          4. Nonsustained VT with coronary disease, prior
• MADIT      MI, LV dysfunction, and inducible VF or
             sustained VT at EP study that is not
             suppressible by a Class I antiarrhythmic drug.
• MUSTT
          Class IIb Indications:
          4. Nonsustained VT with CAD, prior MI, and LV
             dysfunction, and inducible sustained VT or VF
             at EP study.




                                    Gregoratos G. Circulation. 1998;97:1325-35.
                          Trials & Indications
                                         MADIT-II

MADIT-II represents a broader patient
       group for ICD therapy:

     Patients with previous myocardial
         infarction (>4 weeks) and
          with low left-ventricular
          ejection fraction (< 30%)
                 - Class IIa -
                                      Disclosure

  This presentation is provided for general
 educational purposes only and should not be
 considered the exclusive source for this type
     of information. At all times, it is the
 professional responsibility of the practitioner
to exercise independent clinical judgment in a
              particular situation.
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                                                                           Disclosures
                                      Indications                  Reveal® Plus ILR
The Reveal Plus ILR is an implantable patient- and automatically-activated monitoring system that
records subcutaneous ECG and is indicated for:
  • patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
  • patients who experience transient symptoms that may suggest a cardiac arrhythmia
The 6191 Activator is intended for use in combination with the Model 9526 Reveal Plus Insertable
Loop Recorders.
                                   Contraindications
There are no known contraindications for the implantation of the Reveal Plus ILR. However, the
patient’s particular medical condition may dictate whether or not a subcutaneous, chronically
implanted device can be tolerated.
                                  Warnings/Precautions
Patients with the Reveal Plus ILR should avoid sources of magnetic resonance imaging, diathermy,
high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and
radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing.
Operation of the Model 6191 Activator near sources of electromagnetic interference, such as
cellular phones, computer monitors, etc., may adversely affect the performance of this device.
See the appropriate technical manuals for detailed information regarding indications,
contraindications, warnings and precautions.
                                        Caution
          Federal law (USA) restricts this device to sale by or on the order of a physician.
                                                                      Disclosures
                                                     External Defibrillators
                                       Indications
Defibrillation is indicated for terminating certain potentially fatal arrhythmias, such as
    ventricular fibrillation and symptomatic ventricular tachycardia.
Delivery of this energy in the synchronized mode is a method for treating atrial
    fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in
    relatively stable patients, ventricular tachycardia. The biphasic defibrillation
    waveform used in this device has only been clinically tested on adults; it has not
    been tested on pediatric patients.
The AED mode is to be used only on patients in cardiopulmonary arrest. The
   patient must be unconscious, pulseless, and not breathing spontaneously
   before using the defibrillator to analyze the patient's ECG rhythm. In AED
   mode, the defibrillator is not intended for use on pediatric patients less than
   eight years old.
                                  Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity
   (PEA) such as idioventricular or ventricular escape rhythms, and in the
   treatment of asystole
                                                                                   Disclosures
                                                               External Defibrillators
                                       Warnings/Precautions
Shock hazard.
•   The defibrillator delivers up to 360 joules of electrical energy. Unless properly used as described in these
    Operating Instructions, this electrical energy may cause serious injury or death. Do not attempt to operate
    this device unless thoroughly familiar with these Operating Instructions, and the function of all controls,
    indicators, connections, and accessories.
•   Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high
    voltages may be present. Contact authorized service personnel for repair.
Shock or fire hazard.
•   Do not immerse any portion of this device in water or other fluids. Avoid spilling any fluids on device or
    accessories. Do not clean with ketones or other flammable agents. Do not autoclave or sterilize this device
    or accessories unless otherwise specified.
Possible fire or explosion.
•   Do not use this device in the presence of flammable gases or anesthetics. Use care when operating this
    device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing). Turn off gas source
    or move source away from patient during defibrillation.
Possible electrical interference with device performance.
•   Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference
    (RFI), which could affect the performance of this device. RFI may result in distorted ECG and failure to
    detect a shockable rhythm. Avoid operating device near cauterizers, diathermy equipment, or cellular
    phones. Maintain equipment separation of at least four feet and do not rapidly key EMS radios on and off.
    Contact Technical Support if assistance is required.
                                                                                             Disclosures
                                                                       External Defibrillators
                                          Warnings/Precautions
Possible electrical interference.
•    This defibrillator may cause electromagnetic interference (EMI) especially during charge and energy transfers. EMI
     may affect the performance of equipment operating in close proximity. Verify the effects of defibrillator discharge on
     other equipment prior to using defibrillator in an emergency situation, if possible.
Possible device shutdown for the LIFEPAK 12 defibrillator/monitor.
•    Always have immediate access to a spare, fully charged, properly maintained battery. Replace the battery or
     connect the defibrillator to ac power when the device displays a low battery warning.
Possible defibrillator shutdown for the LIFEPAK 20 defibrillator/monitor.
•    When operating on battery power, the large current draw required for defibrillator changing may cause the
     defibrillator to reach shutdown voltage levels with no low battery warning. If the defibrillator shuts down without
     warning, or if a LOW BATTERY: CONNECT TO AC POWER message appears on the monitor screen, immediately
     connect the ac power cord to an outlet.
Possible improper device performance.
•    Using other manufacturers' cables, electrodes, or batteries may cause the device to perform improperly and
     invalidates the safety agency certification. Use only the accessories specified in these Operating Instructions.
     Possible failure to detect an out of range condition. Reselecting QUICK SET will reset the alarm limits around the
     patient's current vital sign values. This may be outside the safe range for the patient.
Safety risk and possible equipment damage.
•    Monitors, defibrillators, and their accessories (including electrodes and cables) contain ferromagnetic materials. As
     with all ferromagnetic equipment, these products must not be used in the presence of the high magnetic field
     created by a Magnetic Resonance Imaging (MRI) device. The high magnetic field created by an MRI device will
           attract the equipment with a force sufficient to cause death or serious personal injury to persons between the
               equipment and the MRI device. This magnetic attraction may also damage the equipment. Skin burns will
                     also occur due to heating of electrically conductive materials, such as patient leads and pulse oximeter
                          sensors. Consult the MRI manufacturer for more information.
                                                       Disclosures
                                           External Defibrillators
                                 Caution
Possible device damage.
• To help prevent component damage, do not mount device near vibration
  sources such as engine struts and landing gear.


                                  Note
Medtronic Emergency Response Systems devices, electrodes, and cables are
  latex-free. LIFEPAK external defibrillator/monitor/pacemaker systems are
  prescription devices.
                                                                                   Disclosures
                                                Indications                         Pacemakers
Medtronic pacemakers are indicated for rate adaptive pacing in patients who may benefit from increased
pacing rates concurrent with increases in activity and increases in activity and/or minute ventilation.
Medtronic pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may
benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for tretment of
conduction disorders that require restoration of both rate and AV synchrony, which include various degrees
of AV block to maintain the atrial contribution to cardiac output and VVI intolerance (e.g. pacemaker
syndrome) in the presence of persistent sinus rhythm.
                                            Contraindications
Medtronic pacemakers are contraindicated for the following applications:
  – Dual chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias
  – Asynchronous pacing in the presence (or likelihood) of competitive paced and intrinsic rhythms
  – Unipolar pacing for patients with an implanted cardioverter defibrillator because it may cause
      unwanted delivery or inhibition of ICD therapy
  – Medtronic Kappa 400 Series pacemakers are contraindicated for use with epicardial leads and with
      abdominal implantation.
                                          Warnings/Precautions
Pacemaker patients should avoid sources of magnetic resonance imaging, diathermy, high sources of
radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation to avoid
electrical reset of the device, inappropriate sensing and/or therapy.

                                                  Caution
             Federal law (US) restricts this device to sale by or on the order of a physician.
                                                                             Disclosures
                                            Indications                                       ICDs
    Medtronic implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular
    antitachycardia pacing and ventricular defibrillation for automated treatment of life-
    threatening ventricular arrhythmias.
                                        Contraindications
    Medtronic ICDs are contraindicated in Patients with transient or reversible ventricular
    tachyarrhythmia or as the sole treatment of atrial arrhythmia.
                                      Warnings/Precautions
•   Changes in patient’s disease and/or medications may alter the efficacy of the device’s
    programmed parameters.
•   Patients should stay away from sources of magnetic and electromagnetic radiation, including
    MRI, diathermy, and electrosurgical units, to avoid possible underdetection, inappropriate
    therapy delivery, and/or electrical reset of the device.
•   Do not place transthoracic defibrillation paddles directly over the device.
See the appropriate technical manuals for detailed information regarding instructions for use,
   indications, contraindications, warnings, precautions, and potential adverse events.
                                               Caution
          Federal law (US) restricts this device to sale by or on the order of a physician.
                                                                            Disclosures
                                       Indications                                      AT500
The Medtronic AT500 DDDRP pacing system is indicated for the following:
• Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent
    with increases in activity
• Accepted patient conditions warranting chronic cardiac pacing which include:
     –   Symptomatic paroxysmal or permanent second or third-degree AV block
     –   Symptomatic bilateral bundle branch block
     –   Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV
         conduction disorders
     –   Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of
         symptomatic tachyarrhythmias
The Medtronic AT500 system is also indicated for dual chamber and atrial tracking modes in
    patients who may benefit from maintenance of AV synchrony. Dual chamber modes are
    specifically indicated for treatment of conduction disorders that require restoration of
    both rate and AV synchrony, which include:
• Various degrees of AV block to maintain the atrial contribution to cardiac output
• VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm
Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in
    Bradycardia patients with one or more of the above pacing indications.
Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference
    Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the
    suppression of atrial tachyarrhythmias in bradycardia patients with atrial septal lead
    placement and one or more of the above pacing indications.
                                                                      Disclosures
                                       Contraindications                         AT500
The Medtronic AT500 DDDRP pacing system is contraindicated for:
• Implantation with unipolar pacing leads
• Concomitant implantation with another bradycardia device
• Concomitant implantation with an implantable cardioverter defibrillator
• There are no known contraindications for the use of pacing as a therapeutic modality to
    control heart rate. The patient’s age and medical condition, however, may dictate the
    particular pacing system, mode of operation, and implantation procedure used by the
    physician. Rate responsive modes may be contraindicated in those patients who cannot
    tolerate pacing rates above the programmed Lower Rate.
• Dual chamber sequential pacing is contraindicated in patients with chronic or persistent
    supraventricular tachycardias, including atrial fibrillation or flutter
• Single chamber atrial pacing is contraindicated in patients with an A-V conduction
    disturbance
• ATP therapy is contraindicated in patients with an accessory antegrade pathway
                                    Warnings/Precautions
Pacemaker patients should avoid sources of magnetic resonance imaging, diathermy, high
    sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and
    radiofrequency ablation to avoid electrical reset of the device, inappropriate sensing
    and/or therapy.
                                            Caution
       Federal law (US) restricts this device to sale by or on the order of a physician.
                                                                                   Disclosures
                                               Indications                             Gem III AT
The Medtronic Gem® III AT is indicated for use in ICD patients with atrial tachyarrhythmias, or who are at
significant risk of developing atrial tachyarrhythmias. The implantable cardioverter-defibrillator is intended
to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-
threatening ventricular arrhythmias. In addition, the GEM III AT is also intended to provide pacing,
cardioversion, and defibrillation for treatment of patient with symptomatic, drug refractory, atrial
fibrillation, and/or life-threatening ventricular tachyarrhythmias.
                                             Contraindications
Do not use Gem III AT in patients:
  – whose tachyarrhythmias may have transient or reversible causes
  – with incessant ventricular tachyarrhythmias or chronic atrial tachyarrhythmias
  – who have a unipolar pacemaker
  – Whose primary disorder is bradyarrhythmias
                                           Warnings/Precautions
Changes in the patient’s disease and/or medications may alter the efficacy of the device’s programmed
parameters. Patients should stay away from sources of magnetic and electromagnetic radiation, including
MRI, diathermy, and electrosurgical units, to avoid possible underdetection, inappropriate therapy deliver,
and/or electrical reset of the device. Do no place transthoracic defibrillation paddles directly over the
device. Use of the ICD system should not change the application of established anticoagulation protocols.
Following an ischemic or cerebrovascular accident, disable atrial defibrillation therapies until the patient
has stabilized. Potential complications include, but are not limited to, failure to detect and/or terminate
tachyarrhythmia episodes, acceleration of tachyarrhythmia episodes, and lead system complications. See
technical manual for detailed uses, contraindications, warning, precautions, and potential complications.
See warranty card for warranty information.

                                                  Caution
             Federal law (US) restricts this device to sale by or on the order of a physician.
                                                       Disclosures
                          Medtronic Carelink® Programmer
The Medtronic/Vitatron CareLink® programmer system is comprised of
   prescription devices indicated for use in the interrogation and
   programming implantable medical devices. Prior to use, refer to to
   the Programmer Reference Guide as well as the appropriate
   programmer software and implantable device technical manuals for
   more information related to specific implantable device models.
   Programming should be attempted only by appropriately trained
   personnel after careful study of the technical manual for the
   implantable device and after careful determination of appropriate
   parameter values based on the patient’s condition and pacing system
   used. The Medtronic CareLink programmer must be used only for
   programming implantable devices manufactured by Medtronic or
   Vitatron.
For additional information, please refer to the Medtronic CareLink®
   programmer technical manual or contact your sales representative.

				
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