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Advance EP Training
April/24/2011



         Basic ICD Treatment

                      張坤正 醫師
                中國醫藥大學 內科副教授
         中國醫藥大學附設醫院 心臟內科主任
ICD Concepts

ICD Automated Functions


Troubleshooting
ICD Concepts
                                           Overview
• Evolution of ICDs
• The ICD System
• Components
  – Device
     • Battery, Capacitors & Voltage
     • Circuitry
     • Connector Blocks
  – Leads
     • Transvenous & Epicardial
     • Electrical Design
     • Connectors: IS-1 & DF-1
  – Programmer
The Evolution of ICDs
ICD Evolution
                                                        1970
                               • Patent granted for first
                                 totally implantable
                                 defibrillator
                               • System used an
                                 intracardiac catheter and
                                 SQ patch with detection
                                 via RV pressure transducer




Michael Mirowski (1924-1990)
ICD Evolution



• 1947 First human internal defibrillation
• 1956 First human external defibrillation
• 1969 First external canine prototype tested
• 1970 First implantable prototype (895 g)
• 1975 First implantable Defib in canines (250 g)
• 1980 First human implant @ Johns Hopkins
• 1985 ICD market released (350 units)
ICD Evolution



• 1991 Non thoracotomy lead systems
• 1995 Pectoral ICD systems
• 1997 ICD & DDD
• 1998 ICD & DR
• 1999 ICD & Atrial Defibrillation
• 2001 ICD & Resynchronization Therapy
THE ICD SYSTEM
The ICD System
                   How it Works
*   Animation
The ICD System
                                 How it Works




                              Atrium & Ventricle
Ventricle                     • Bradycardia sensing
•   VT prevention             • Bradycardia pacing
•   Antitachycardia pacing    • Antitachycardia
                               pacing
•   Cardioversion
•   Defibrillation
ICD
Device Components
ICD
Device Components
ICD
           How High Voltage Is Created

Battery – Provides low voltage energy
                c

Transformer – Multiplies Voltage
                 c
Capacitor – Stores high energy for use
                 c
High Voltage Shock – Delivered on
demand
ICD
                             How High Voltage Is Created



   For Pacing                                  Pacing
                       Voltage                 Voltages
       Battery        Multiplier
          3.2            and
         Volts                       High      High Energy
                     Transformer
                                    Voltage    Shocks
For Defibrillation
                                   Capacitor   (Up to 800 Volts)
ICD
Battery Depletion
Battery & Charge Time Relationship


   Battery DOWN


                     Both can Indicate
                   Elective Replacement
                            (ERI)


  Charge Time UP
Battery & Charge Time Relationship
Battery & Charge Time Relationship

Battery Voltage & Charge Time in an optimized ICD battery
The Importance of Charge Time


    10 Seconds of VF




The longer the charge time, the
 longer this rhythm continues.
ICD
Connector Block
ICD
Connector Block
Components
ICD Connector Blocks
Today’s Current® DR RF Header (6 set screws)




     New DF4 DR Header (2 set screws)




23
COMPONENTS

High Voltage Leads
High Voltage Leads



                 Epicardial
Placed directly on the epicardium of the heart.



               Transvenous
  Introduced into the heart through a vein.
High Voltage Leads
High Voltage Leads
              Types of Transvenous Leads

Transvenous

                          Passive



                          Active



                          No
                          Fixation
Endocardial Lead Systems




 Passive Fixation (Tines)




Active Fixation (Screw)
Transvenous Leads
                       Placement

Single Coil      Dual Coil
Distal Coil




                          Proximal Coil

              Connector
              Pins
High Voltage Leads
Typical Transvenous Lead
Transvenous Lead
               Steroid Tip




*Steroid not available in all leads
Transvenous Lead
                    Steroid Tip
Benefits of Steroid:
• Reduces acute Trauma and
  Inflammation
• Rapid Tissue Damage Repair
• Reduced Fibrosis




      *Steroid not available in all leads
Transvenous Lead
             Lead Design




    Optimal Tissue
    Contact




*Steroid not available in all leads
Electrical Design
Lead Electrical Design
                                    Circuits

• High Voltage Leads can have 2 Circuits:


             PACING & SENSING


                SHOCKING
Lead Electrical Design
                       Circuits


PACING & SENSING


    Bipolar
Lead Electrical Design
           Pacing/Sensing Circuit

      • The electrical circuit for
        pacing and sensing
        includes:
        •Cathode – negative
         electrode (Tip)
        •Anode: positive electrode
         (Ring or Coil)




   Bipolar
Configuration
Lead Electrical Design
                               Circuits

PACING & SENSING



    Bipolar        True vs. Integrated
Polarity
      Pacing/Sensing Circuit



Bipolar
uses dedicated ring can as anode




Integrated Bipolar
uses RV Coil can as anode
Polarity
Pacing/Sensing Circuit
Lead Electrical Design
                               Circuits

PACING & SENSING



    Bipolar        True vs. Integrated

   SHOCKING



 High Voltage
     Coils
Polarity
               Shocking Circuit

Single Coil
• 1 high voltage coil per lead:
  - RV (Right Ventricle)
  - Other extra HV Coils/Patches
• 1 or 2 Connector Pins
 - (HV only or P/S + HV)

Dual Coil
• 2 High Voltage coils per lead:
  - RV + SVC
• 3 Connector Pins (P/S + 2 HV)
High Voltage Leads
                                          Connector Pins
    Pace / Sense Connection = IS-1
          (International Standard)




High Voltage Defibrillation Connections = DF-1
          (Defibrillation Standard)
Shocking Circuit
                                              Vectors
• The pathway in which high energy is delivered
• Determined by electrodes used:
  – HVA = active device
  – HVB = RV Coil
  – HVX = optional HV electrode (such as an SVC Coil)


Example: A > B                            A
                                    (Active Can)




           B
      (RV HV Coil)
Shocking Circuit
                                     Vectors
Example: A > B
(Active Can > RV HV Coil)
Shocking Circuit
                                          Vectors
Example of Dual Coil: AX > B
(Active Can + SVC HV Coil > RV HV Coil)
Shocking Circuit
                 Vectors

A>B     AX > B
COMPONENTS

Programmer
ICD Automated Functions
ICD Automated Functions
                                                       Overview

• Sensing                 • Therapy
   –The EGM Signal          –Tachyarrhythmia
   –The Sensing Circuit
                             • Anti-tachycardia Pacing      Low

   –Marker Channels            (ATP)                        Power



• Detection                  • Cardioversion (Non-
                               committed)
   –Suspension (Magnet)
                             • Defibrillation (Committed)
   –Rate & Duration
   (NID)                    –Bradyarrhythmia
   –Detection Zones          • Pacing Modes
   –SVT Discrimination       • Parameters
     • Single Chamber        • Other Brady Therapies
     • Dual Chamber
   –Redetection
ICD Automated Functions

        Sensing
Sensing


• Sensing - what the device “sees”



• Electrical Activity - what the
device is looking for



• Lead – contains the ‘eyeball’ of
  the device
Sensing
                                           True vs. Integrated Bipolar


• Range of ‘eyeball’ is determined by
  polarity
 True Bipolar Sensing        Integrated Bipolar Sensing




  Tip-to-ring                 Tip-to-coil
  Smaller surface area        Larger surface area
  More “localized” sensing    Broader sensing area
Sensing

•The ‘eye’ of the device
  – Constantly watches for
    electrical activity
  – Sees or Senses all
    electrical signals that pass
  – Signal produced by a
    passing electrical wave is
    called an Intracardiac
    Electrogram (EGM)
SENSING


The Intracardiac Electrogram EGM
Sensing

• Sensing is:
  –The process of identifying cardiac
   depolarizations from an intracardiac
   electrogram
Sensing
                                                                The EGM Signal



• The signal from a depolarization wave passing between sensing electrodes




                                                            Processed by
 Depolarization Wave                                              Device
The EGM Signal


• Measured by:
  – Amplitude
    • Peak-to-peak measurement (height)
     of deflection
    • Measured in Millivolts (mV)
  – Slew Rate
    • Speed of deflection change over time
    • Measured in volts per second (V/s)
The EGM Signal
                                                    Amplitude




• Measured Peak-to-Peak




                          Typical Ventricular EGM




     • >5 mV for optimal sensing
The EGM Signal
                                                           Slew Rate




• Measures Peak-to-Peak
  change in voltage over time

• R >.75 volts/sec for optimal
  sensing

                  dV
      Slew Rate =
      [V/s]       dt


                                 Typical Ventricular EGM
The EGM Signal
                                                   Fields




• Nearfield
  – Electrodes are close in range
     • EGM Source = Tip-to-Ring / Tip-to-Coil
  – Commonly a narrow signal (less myocardium in range)
  – Used for arrhythmia detection
     • Devices are hardwired to nearfield for detection
The EGM Signal
                                     Nearfield




EGM Source = Tip-to-Ring / Tip-to-Coil




  Tip-to-Ring          Tip-to-Coil
  (Bipolar)            (Integrated
                       Bipolar)
The EGM Signal
                                                  Nearfield




              Morphology
               Comparison




                  SINUS
                    RHYTHM               VT
EGM Source = Tip-to-Ring / Tip-to-Coil
The EGM Signal
                                               Fields




•Nearfield
  – Electrodes are close in range
     •EGM Source = Tip-to-Ring / Tip-to-Coil
  – Narrow signal – less myocardium in range
  – Used for arrhythmia detection


•Farfield
  –Electrodes are further in range
    •EGM Source = Variable
  –More myocardium covered in range
  –Can resemble surface EKG
The EGM Signal
                                   Farfield



     EGM Source = Variable




Can-to-RV Coil    RV Coil-to-SVC
(HVA to HVB)      Coil
                  (HVB to HVX)
The EGM Signal
                                  Farfield



Morphology
 Comparison




  SINUS
    RHYTHM               VT

EGM Source = Variable
SENSING

The Sensing Circuit
The Sensing Circuit

• Upon being ‘seen,’ a signal is transported through
  the sensing circuit
The Sensing Circuit
            The Amplifier
The Sensing Circuit
         The Bandpass Filter
The Sensing Circuit
               Rectifier
The Sensing Circuit
            Level Detector
The Sensing Circuit
            Level Detector
The Sensing Circuit
The Sensing Circuit
Sensitivity

• Minimum amplitude of electrical signal that
  registers as a sensed event
  – Set in Millivolts (mV)
  – Programmable Setting
Sensitivity
                       Programmed




If set at .15 mV
Sensitivity
                                   Programmed




If set at .3 mV
                  T-wave Not
                  Sensed
Sensitivity
   Auto-Adjusting
Sensitivity
                                                  Auto-Adjusting




• Allows sensing of fine VF waves
• Prevents sensing of T-waves, cross-chamber
   events, and pacing artifacts
Auto-Adjusting Sensitivity
                 Decay Constant
Threshold Start

                                                           Max R- wave
                    Max R-wave                             amplitude
                    amplitude                              measured at 7
                    measured at 4
                                                           mV
                    mV
                                                              Threshold Start
                              R- wave is                      set to 50% of
                              Sensed                          measured R-
                                                              wave or 3 mV

                2 mV                                   3 mV
                                                                              Maximum
                                                                              Sensitivity




                                                                Ventricular

Sensed Refractory                      Sensed Refractory
Decay Delay



• The Decay Delay holds the sensitivity
  threshold at the starting value for a
  programmable amount of time
                60 ms

                0 ms



         R-             T-
         wave           wave
Question?




What are the consequences of
undersensing?

• Failure to sense VF, therefore, no therapy
initiated
• Failure to treat VT that can accelerate to VF
• Can be fatal
Question?




What are the consequences of
oversensing?
• Inappropriate therapies
• Potential for inducing fatal arrhythmias
• Patient suffering due to inappropriate
therapy
SENSING


Marker Channels™
Marker Channel™


• Display:
  – Pace/Sense annotations
  – ICD functional annotations:
    • Sensing
    • Detection
    • Therapy
    • Other information



                                  * in Medtronic devices
ICD Automated Functions

       Detection
Question?




What does “Detection” mean?
A device defined arrhythmia is present
based on what is sensed.
Detection


• Confirms a sensed rhythm as an
  arrhythmia based on:
  – Rate
  – Duration
Detection
                                     Detection Rate


• Measured in:
  –Beat-to-beat intervals (milliseconds), or
  –Beats-per-minute (BPM)
• Classifies rhythm by detection zone:
  –VT = Ventricular Tachycardia
  –VF = Ventricular Fibrillation
• Programmable in ranges of rates
  Example:       VT = 162 bpm – 188 bpm
                 VF = 188 bpm and faster
Detection
                                                        Detect Duration




• Measured in:
     – Number of intervals to detect (NID), or
     – Length of time to detect
• Programmable by:
 –       Beat or interval counters

         • Consecutive
                  ex: 16 beats within the detect zone
         • Probabilistic (percentage or fraction)
                  ex: 12 out of 16 beats within the detect zone
     –   Time in seconds
Detection
                           Consecutive Counter




Used for detection of VT
Detection
        Probabilistic Counter




NID =
12/16
Detection
                                                   Detect Duration




Non-Sustained: Duration not met / No Detection




 Sustained: Duration met / Detection Occurs
Question?




What if the fast, sustained ventricular
rhythm is the result of an SVT?
SVT Discriminators


•SVT Discriminators:
  – Prevent detection of tachyarrhythmias
    caused by the presence of an SVT
  – Prevent inappropriate, unnecessary therapy
    due to rapid SVT conduction
  – Are present in some form in most ICDs
SVT Discriminators

•Discriminate based on:
  – Waveform morphology
     • EGM Width (single chamber)
     • Wavelet
  – Onset of arrhythmia
  – Stability of arrhythmia
  – Relationship between P- and R-waves
   (dual chamber / requires an atrial lead)
SVT Discriminators
                              Waveform Morphology




•Measures and stores the QRS
 characteristics of a normal sinus beat
•Identifies SVT vs. VT based on the QRS
 changes that occur in most VTs




    SINUS                VT
      RHYTHM
Classification: MD   Morphology
                                        Discrimination
 Sinus
 Supra-Ventricular




                                             Ventricular




Electrical wavefronts generated by focus approach electrodes from
different directions depending on the focus location.
SVT Discriminators
                                                                   Wavelet

•Match Threshold Programming
  – Lower %
    • More likely to withhold appropriately; less likely to detect true VT
  – Higher %
    • Less likely to appropriately withhold; more likely to detect true VT
SVT Discriminators
                                   Onset



•Based on the premise that most VTs
 are characterized by a sudden onset
•Evaluates the acceleration of the
 ventricular rate
•Discriminates between:
  –Gradual rate increase
  –Abrupt rate increase
•Determines VT present if rate
  increase is abrupt
SVT Discriminators
                                      Onset




• When On:
  – Averages 4 beats and compares with an
    average of previous 4 (multiplied by
    programmed Onset Percentage)
• Onset met if recent average is less
  than previous
SVT Discriminators
                                               Onset


• Onset Percentage = 81%




   530ms X 81% =      430ms ≠ 460ms = Onset
   430ms              Not Met
                                 * in Medtronic devices
SVT Discriminators
                                                 Stability




•Based on the premise that AF conducts
 irregularly to the ventricles
 (and VT is a stable, regular rhythm)


•Discriminates regular from irregular
 intervals within a detect zone
SVT Discriminators
                                      Stability

Stability = 50 ms




   Varies >50 ms from               Unstable
   previous 3
SVT Discriminators
                                               Dual Chamber




• Considers P and R relationship to
  discriminate SVT from VT
• Dual Chamber (requires an atrial and ventricular lead)
• Can be used in conjunction with other
  discriminators
Optimized DR Discriminators
                             Bigeminal Avoidance

                            Ventricular frequency >
                                 VT detection


                               Compare atrial &
                             ventricular frequency




        V<A                         V=A               V>A
                                                            SVT
                                                            On
              Stability                                     VT
Morphology     40 ms
                                                            Off
    45%                   Morphology
                                      Onset
 5 out of 8     AVA        45%, 5/8
                                     Passive
                80 ms      ATU On

        Any
SVT Discriminators
                                              PR Logic™




•What it looks for:
  – Atrial Fibrillation / Flutter
  – Sinus Tachycardia
  – Other 1:1 SVTs (such as AVNRT)
•How it works:
  – Analyzes:
    •   Pattern (P:R wave relationship)
    •   AV Association
    •   Rate
    •   Regularity (R waves)
PR Logic™
                                                                             Pattern



•Distinguishes SVTs by analyzing P and R-wave:
   – Pattern: number and position of atrial events relative to ventricular events
PR Logic™
Example: Sinus Tachycardia
PR Logic™
Example: Atrial Fibrillation
PR Logic™
   Example: AVNRT (Other 1:1 SVTs)




Junctional
Zone
Question?




What about far-field R-wave sensing
in the atrial channel?
PR Logic™
                                     Far-field R-wave Sensing



•Algorithm identifies and withholds
 therapy for:
  – Consistent, short-long pattern
Question?




What happens when a magnet is
applied over an ICD?
Tachy Detection
                                          Magnet Mode



• ICDs of different manufacturers respond to
  magnets differently

• Use when:
  – EMI is present (surgery, TENS, etc.)
  – Temporary suspension is preferred over permanent
    programming
  – Therapy is temporarily not desired
ICD Automated Functions

        Therapy
Question?




Can you name some therapies delivered
by an ICD?
ICD Therapies

• ICD Therapy
  – Low Power (Pacing Therapies)
    • Anti-tachycardia Pacing (ATP)
    • Bradyarrhythmia Pacing


  – High Power (Shock Therapies)
    • Cardioversion
    • Defibrillation
Anti-Tachycardia Pacing
Anti-Tachycardia Pacing




Re-entry        ATP delivered at a rate   Subsequent Pulse:
initiated       faster than               Wavefronts collide
                tachyarrhythmia.          closer to re-entry
                Wavefronts collide.       circuit




            Subsequent Pulses:                Arrhythmia
            Wavefronts collide                terminated
            even closer to re-
            entry circuit
Anti-Tachycardia Pacing

•Has programmable:
 – Sequences – the number of times ATP will be
   applied upon re-detection
Anti-Tachycardia Pacing

•Has programmable:


 –Pulses – the number of pulses per sequence
Anti-Tachycardia Pacing

•Has programmable:
  – Sequences – the number of times ATP will be applied
    upon re-detection (max = 10 in most)
  –Pulses – the number of pulses per sequence
    (1-15)
  –Rate of pulses delivered (percent or ms)
Anti-Tachycardia Pacing


• Types:
–Burst
  •A series of pacing pulses delivered at
   equal intervals
  •Interval decrement per sequence
Anti-Tachycardia Pacing
                    Burst
Anti-Tachycardia Pacing


•Types:
 –Burst
   •A series of pacing pulses delivered at equal
    intervals
   •Interval decrement per sequence
  –Ramp
     • A series of pacing pulses delivered at ever
       decreasing intervals
     • Adds a pulse per sequence
Anti-Tachycardia Pacing
                    Ramp
Anti-Tachycardia Pacing
                                           Burst and Ramp Comparison




Programmed Values:               Programmed Values:

       Number of S1 Pulses = 4          Number of S1 Pulses = 4
       Number of Sequences =            Number of Sequences = 4
4                                       R-S1% = 91%
       R- S1% = 91%                     Decrement* = 10 ms
       Decrement* = 10 ms        * Decrement between pulses
* Decrement between sequences * Adds a pulse per sequence
ICD Therapies

•Tachyarrhythmia Therapy
 –Anti-Tachycardia Pacing (ATP)
                           Low
                           Power

   •Pacing pulses delivered at a rate faster
    than the rhythm detected
   •Can successfully terminate re-entrant
    tachycardias
 –Cardioversion (CV)
                  High
                  Power

   •Non-committed shock therapy
    (must synchronize to an R-wave to be
    delivered)
   •Designed to treat re-entrant
    tachycardias
Cardioversion

•Delivers shock on an R-wave
•Aborts if synchronization cannot be
 obtained due to arrhythmia termination
Cardioversion
       Programming
ICD Therapies

    •Tachyarrhythmia Therapy
–Anti-Tachycardia Pacing (ATP)               Low
                                             Power
  •Pacing pulses delivered at a rate faster than the
   rhythm detected
  •Can successfully terminate re-entrant tachycardias
–Cardioversion (CV)          High
                             Power

 •A non-committed shock (must synchronize to an
  R-wave to be delivered)
 •Designed to treat organized tachyarrhythmias
–Defibrillation Shock       High Power


  •A shock delivered to the heart to terminate a
   tachyarrhythmia
ICD Therapy
      Benefits of Tiered Therapy




VT



FVT



VF
Defibrillation
                                Programming




*Medtronic Programming
Screen
Question?




When does the device call a therapy
a success?
ICD Therapies
                             Termination/Redetection




•“8 to terminate” rule
 –8 sinus and/or paced beats outside the
  slowed programmed detection zone




                            * in Medtronic devices
ICD System Troubleshooting
Troubleshooting
                            Overview



•ICD System Issues
 –Lead System & Connections
 –Device
 –Other Issues (Patient, EMI)
ICD SYSTEM ISSUES

Lead Systems & Connections
Question?




In an ICD System, what
component is generally known to
be the source of most issues?
 a. device
b. lead
ICD System Issues
                                               Leads



• Points of Failure
  – Acute (common suspects)
     • Connector
     • Lead Dislodgement/Perforation
ICD System Issues
                                                                Leads



Points of Failure
  – Chronic   (common suspects: High points of stress/pressure)
       Lead fracture   (commonly exhibits HIGH impedance/resistance)

       Lead insulation break     (commonly exhibits LOW
         impedance/resistance)
ICD System Issues


Points of Failure
  – Acute   (common suspects)
      Connector


        What kinds of things can go wrong here?
ICD System Issues
                                     Connector



Can you identify a problem?




              Set screw is obstructing the bore
ICD System Issues
                                 Connector



What might happen if a lead is
  connected?
ICD System Issues
                                 Connector


What is going on here?




                           Set Screw Noise
ICD System Issues


• Points of Failure
  – Acute   (common suspects)
     • Connector
     Lead dislodgement/perforation

            How do we know when this occurs?
ICD System Issues
                                               Lead Dislodgement



Common signs
  – Intermittent or loss of capture
  – Intermittent or loss or sensing
  – Inappropriate therapy during SVT
         (in this example due to atrial lead dislodgement)




         Atrial Dislodgement
ICD System Issues
                          Lead Dislodgement



Can you identify the dislodged
            lead(s)?
ICD System Issues
                                          Lead Dislodgement



• Avoiding dislodgements
  – Ensure sufficient slack in lead
  – Use suture sleeves
  – Check lead tip stability during implant
ICD System Issues
                                      Lead Perforation



• Occurs when:
  – Lead tip exits the heart, through the heart
ICD System Issues
                                                   Lead Perforation


•Diagnosing
  – Can be seen on x-ray
  – Definitive by Echo
  – Threshold and lead impedance may remain
    unchanged (due to possible continuous contact with tissue
   outside the heart)

•Possible patient symptoms
  – Change in pressure
  – Cardiac tamponade
  – Dyspnea
ICD System Issues

• Points of Failure
  – Acute (common suspects)
       • Connector
       • Lead dislodgement/perforation

   – Chronic   (common suspects: High points of stress/pressure)
           Lead fracture (commonly exhibits HIGH impedance)
ICD System Issues


Can you identify a problem?




    1st Rib-Clavicle Crush (lead fracture)
ICD System Issues
                              Lead Fracture




  Lead Crush




1st Rib & Clavicle Crush
ICD System Issues
                                 Lead Fracture



Can you identify the fracture?
ICD System Issues
                                                Lead Fracture

• Common behavior
  – Erratic sensing
  – Intermittent or loss of capture
  – High lead impedance
ICD System Issues
                    Lead Fracture




Example
ICD System Issues


• Points of Failure
  – Acute (common suspects)
      • Connector
      • Lead dislodgement/perforation
          (common suspects: high points
  – Chronic

        of stress/pressure)

         Lead fracture (commonly exhibits HIGH impedance)
         Lead insulation break (commonly exhibits
              LOW impedance)
ICD System Issues
                                        Insulation Break



• Common Behavior
  – Lead impedance
    • Low
    • Can be intermittent
  – Capture threshold
    • Sudden rise or loss
    • Can be intermittent
  – Sensing
    • Over/undersensing
    • Can be intermittent        Coaxial Inner
                               Insulation Breach
ICD System Issues
                   Insulation Break




Example
ICD SYSTEM ISSUES

      Device
ICD System Issues
                                         Device




• Common device issues:
  – Long charge times
  – Battery depletion
     • Elective Replacement (ERI)
     • End of Life (EOL)


  – Inappropriate programming
    Acceleration
    Over/Undersensing
    Output
ICD System Issues
                                            Device

Can you identify a problem?




                              T-wave oversensing
ICD System Issues
Can you identify the problem?
                                        Device




*Medtronic Programming          Undersensing
ICD System Issues
                                        Device

Can you identify the problem?




                                Undersensing
Infection/Erosion/Allergy
Allergy/Infection/Allergy
Infection/Erosion/Allergy
                                                      Allergy Testing


Allergy Test Metals
  (included in kits)

                        Allergy Test Kit Contents:

                                   Polyurethane
                                   Silicone
                                   Titanium
                                   Platinum Iridium
                                   Polysulfone
                                   Epoxy
                        Gold-sputtered devices
Abandoned Leads

• Chatter between active and abandoned leads
  may cause inappropriate therapy
Electromagnetic Interference
                                                    (EMI)


• The sensing of electrical signals other than
  those produced by the heart




                                   60 Hz (oversensing)
Test Your Skills


What might you suspect from this EGM?
Case Study (Noise)



• Male 62 years
• ICD Implant for VT/VF
• Patient got 11 shocks
Fast Path Summary
Trends: Signal Amplitude
Trends: Lead Impedance




          Impedance Decrease
Appropriate or Inappropriate Therapy?
Episode 52
A/V lead 皆有
noise
Case study (Morphology Change)



• Female 72 years old
• ICD for VT episodes
• Standard follow-up patient didn’t feel
  anything.
FastPath Summary
Episode Directory
Episode 1: Appropriate or Inappropriate Therapy?




                  Morphology score low
Diagnostics
Therapy
MD Auto Update




Morphology auto update score increase to 100
Episode 3: Correct Diagnosis?




                  SVT Diagnosis
Diagnostics




After morphology update Correct Discreamation is SVT
CMUH
CMUH
Indications for ICD Therapy
Implantable Cardioverter-Defibrillators

        I IIa IIb III
              IIb III             ICD therapy is indicated in patients who are survivors of
                                  cardiac arrest due to ventricular fibrillation or
                                  hemodynamically unstable sustained VT after evaluation
                                  to define the cause of the event and to exclude any
                                  completely reversible causes.
        I IIa IIb III
                                  ICD therapy is indicated in patients with structural heart
                                  disease and spontaneous sustained VT, whether
                                  hemodynamically stable or unstable.
        I IIa IIb III
                                  ICD therapy is indicated in patients with syncope of
                                  undetermined origin with clinically relevant,
                                  hemodynamically significant sustained VT or VF induced
                                  at electrophysiological study.

All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of
survival with good functional capacity for more than 1 year.
Implantable Cardioverter-Defibrillators
        I IIa IIb III
              IIb III             ICD therapy is indicated in patients with LVEF less than or
                                  equal to 35% due to prior MI who are at least 40 days
                                  post-MI and are in NYHA functional Class II or III.

        I IIa IIb III             ICD therapy is indicated in patients with nonischemic DCM
                                  who have an LVEF less than or equal to 35% and who are
                                  in NYHA functional Class II or III.

        I IIa IIb III
              IIb III             ICD therapy is indicated in patients with LV dysfunction
                                  due to prior MI who are at least 40 days post-MI, have an
                                  LVEF less than or equal to 30%, and are in NYHA
                                  functional Class I.

        I IIa IIb III             ICD therapy is indicated in patients with nonsustained VT
                                  due to prior MI, LVEF less than or equal to 40%, and
                                  inducible VF or sustained VT at electrophysiological study.

All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of
survival with good functional capacity for more than 1 year.
Implantable Cardioverter-Defibrillators
         I IIaIIbIII
                             ICD implantation is reasonable for patients with unexplained
                             syncope, significant LV dysfunction, and nonischemic DCM.
         I IIaIIbIII ICD implantation is reasonable for patients with sustained VT and
                     normal or near-normal ventricular function.

         I IIaIIbIII ICD implantation is reasonable for patients with HCM who have 1
                     or more major† risk factors for SCD.

                     ICD implantation is reasonable for the prevention of SCD in
         I IIaIIbIII patients with arrhythmogenic right ventricular
                     dysplasia/cardiomyopathy (ARVD/C) who have 1 or more risk
                     factors for SCD.
         I IIaIIbIII ICD implantation is reasonable to reduce SCD in patients with long-
                     QT syndrome who are experiencing syncope and/or VT while
                     receiving beta blockers.
All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of
survival with good functional capacity for more than 1 year.

† See Section 3.2.4, “Hypertrophic Cardiomyopathy,” in the full-text guidelines for definition of major risk factors.
Implantable Cardioverter-Defibrillators
        I IIaIIbIII           ICD implantation is reasonable for nonhospitalized
                              patients awaiting transplantation.
        I IIaIIbIII           ICD implantation is reasonable for patients with Brugada
                              syndrome who have had syncope.

        I IIaIIbIII           ICD implantation is reasonable for patients with Brugada
                              syndrome who have documented VT that has not resulted
                              in cardiac arrest.

        I IIaIIbIII           ICD implantation is reasonable for patients with
                              catecholaminergic polymorphic VT who have syncope
                              and/or documented sustained VT while receiving beta
                              blockers.
        I IIaIIbIII
                              ICD implantation is reasonable for patients with cardiac
                              sarcoidosis, giant cell myocarditis, or Chagas disease.
All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of
survival with good functional capacity for more than 1 year.
Implantable Cardioverter-Defibrillators
        I IIaIIbIII           ICD therapy may be considered in patients with nonischemic
                              heart disease who have an LVEF of less than or equal to
                              35% and who are in NYHA functional Class I.
        I IIa IIbIII
              IIbIII          ICD therapy may be considered for patients with long-QT
                              syndrome and risk factors for SCD.

        I IIaIIbIII           ICD therapy may be considered in patients with syncope
                              and advanced structural heart disease in whom thorough
                              invasive and noninvasive investigations have failed to define
                              a cause.
        I IIaIIbIII
                              ICD therapy may be considered in patients with a familial
                              cardiomyopathy associated with sudden death.
        I IIaIIbIII
                              ICD therapy may be considered in patients with LV
                              noncompaction.
All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of
survival with good functional capacity for more than 1 year.
Implantable Cardioverter-Defibrillators
        I IIa IIb III             ICD therapy is not indicated for patients who do not have
                                  a reasonable expectation of survival with an acceptable
                                  functional status for at least 1 year, even if they meet ICD
                                  implantation criteria specified in the Class I, IIa, and IIb
        I IIa IIb III             recommendations above.
                                  ICD therapy is not indicated for patients with incessant
                                  VT or VF.
        I IIa IIb III             ICD therapy is not indicated in patients with significant
                                  psychiatric illnesses that may be aggravated by device
                                  implantation or that may preclude systematic follow-up.
        I IIa IIb III             ICD therapy is not indicated for NYHA Class IV patients
                                  with drug-refractory congestive heart failure who are not
                                  candidates for cardiac transplantation or cardiac
                                  resynchronization therapy defibrillators (CRT-D).
All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of
survival with good functional capacity for more than 1 year.
Implantable Cardioverter-Defibrillators
        I IIa IIb III             ICD therapy is not indicated for syncope of undetermined
                                  cause in a patient without inducible ventricular
                                  tachyarrhythmias and without structural heart disease.
                                  ICD therapy is not indicated when VF or VT is amenable
        I IIa IIb III
                                  to surgical or catheter ablation (e.g., atrial arrhythmias
                                  associated with the Wolff-Parkinson-White syndrome, RV
                                  or LV outflow tract VT, idiopathic VT, or fascicular VT in
                                  the absence of structural heart disease).
        I IIa IIb III             ICD therapy is not indicated for patients with ventricular
                                  tachyarrhythmias due to a completely reversible disorder
                                  in the absence of structural heart disease (e.g., electrolyte
                                  imbalance, drugs, or trauma).


All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of
survival with good functional capacity for more than 1 year.
ICDs in Pediatric Patients and Patients With
             Congenital Heart Disease
        I IIa IIb III             ICD implantation is indicated in the survivor of
                                  cardiac arrest after evaluation to define the cause of
                                  the event and exclusion of any reversible causes.
        I IIa IIb III
                                  ICD implantation is indicated for patients with
                                  symptomatic sustained VT in association with
                                  congenital heart disease who have undergone
                                  hemodynamic and electrophysiological evaluation.
                                  Catheter ablation or surgical repair may offer
                                  possible alternatives in carefully selected patients.




All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of
survival with good functional capacity for more than 1 year.
ICDs in Pediatric Patients and Patients With
             Congenital Heart Disease
        I IIa IIb III
              IIb III             ICD implantation is reasonable for patients with congenital
                                  heart disease with recurrent syncope of undetermined origin
                                  in the presence of either ventricular dysfunction or inducible
                                  ventricular arrhythmias at electrophysiological study.

        I IIa IIb III             ICD implantation may be considered for patients with
                                  recurrent syncope associated with complex congenital heart
                                  disease and advanced systemic ventricular dysfunction
                                  when thorough invasive and noninvasive investigations have
                                  failed to define a cause.

        I IIa IIb III             All Class III recommendations found in Section 3 of the full-
                                  text guidelines, “Indications for Implantable Cardioverter-
                                  Defibrillator Therapy,” apply to pediatric patients and
                                  patients with congenital heart disease, and ICD implantation
                                  is not indicated in these patient populations.

All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of
survival with good functional capacity for more than 1 year.
Major Implantable Cardioverter-Defibrillator
 Trials for Prevention of Sudden Cardiac Death
       Trial            Year       Patients               LVEF                    Additional Study               Hazard            95% CI                 p
                                     (n)                                             Features                    Ratio*
 MADIT I              1996         196            < 35%                     NSVT and EP+                        0.46           (0.26-0.82)           p=0.009

 MADIT II             2002         1232           < 30%                     Prior MI                            0.69           (0.51-0.93)           p=0.016

 CABG-Patch           1997         900            < 36%                     +SAECG and CABG                     1.07           (0.81-1.42)           p=0.63

 DEFINITE             2004         485            < 35%                     NICM, PVCs or NSVT                  0.65           (0.40-1.06)           p=0.08

 DINAMIT              2004         674            < 35%                     6-40 days post-MI                   1.08           (0.76-1.55)           p=0.66
                                                                            and Impaired HRV

 SCD-HeFT             2006         1676           < 35%                     Prior MI of NICM                    0.77           (0.62-0.96)           p=0.007

 AVID                 1997         1016           Prior cardiac             NA                                  0.62           (0.43-0.82)           NS
                                                  arrest
 CASH†                2000         191            Prior cardiac             NA                                  0.766          ‡                     1-sided
                                                  arrest                                                                                             p=0.081
 CIDS                 2000         659            Prior cardiac             NA                                  0.82           (0.60-1.1)            NS
                                                  arrest, syncope

* Hazard ratios for death from any cause in the ICD group compared with the non-ICD group. Includes only ICD and amiodarone patients from CASH.
‡CI Upper Bound 1.112 CI indicates Confidence Interval, NS = Not statistically significant, NSVT = nonsustained ventricular tachycardia, SAECG = signal-averaged
electrocardiogram.
Epstein A, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. J Am Coll Cardiol 2008; 51:e1–62. Table 5.
Comparison of Medical Therapy, Pacing, and Defibrillation in
           Heart Failure (COMPANION) Trial


• 1520 patients with NYHA Class III or IV HF, ischemic
  cardiomyopathy (ICM) or nonischemic cardiomyopathy
  (NICM) and QRS ≥ 120 ms
• Randomized 1:2:2 to optimal pharmacological therapy
  (OPT) alone or in combination with cardiac
  resynchronization therapy with either a pacemaker (CRT-P)
  or pacemaker-defibrillator (CRT-D)
• Both device arms significantly ↓ combined risk of all-cause
  hospitalization and all-cause mortality by ~20% compared
  with OPT
• CRT-D ↓ mortality by 36% compared with OPT (p=0.003)
• Insufficient evidence to conclude that CRT-P inferior to
  CRT-D

  Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced
  chronic heart failure. N Engl J Med 2004;350:2140-50.
Implantable Cardioverter-Defibrillators and Prevention of
  Sudden Cardiac Death in Hypertrophic Cardiomyopathy


• Multicenter registry study of implanted ICDs in 506
  unrelated patients with HCM @ high risk for SCD (family
  hx of SCD, [septal thickness ≥ 30 mm], NSVT, syncope)
• Mean patient age 42 years (SD=17) and 87% had no or
  only mildly limiting symptoms
• Appropriate ICD discharge rates were 11% per year for
  2o prevention and 4% per year for 1o prevention
• For 1o prevention, 35% of patients with appropriate ICD
  interventions had undergone implantation for only 1 risk
  factor

 Maron BJ, Spirito P, Shen WK, et al. Implantable cardioverter-defibrillators and prevention of sudden cardiac death in hypertrophic
 cardiomyopathy. JAMA 2007;298:405-12.
Multicenter Automatic Defibrillator Implantation Trial
                  II (MADIT II)

• 1232 patients ≥ 1 month post-MI and LVEF ≤ 30%
• Randomized to ICD (n=742) or medical therapy (n=490)
• No spontaneous or induced arrhythmia required for
  enrollment
• 6% absolute and 31% relative risk ↓ in all-cause mortality
  with ICD therapy (p=0.016)




  Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced
  ejection fraction. N Engl J Med 2002;346:877-83.
Sudden Death in Heart Failure
                               (SCD-HeFT) Trial

• 2521 patients with NYHA Class II or III HF, ICM, or
  NICM and LVEF ≤ 35%
• Randomized to
  1) conventional rx for HF + placebo;
  2) conventional rx + amiodarone; or
  3) conventional rx + conservatively programmed shock-
  only single lead ICD
• No survival benefit for amiodarone
• 23% ↓ in overall mortality with ICD therapy
• Absolute ↓ in mortality of 7.2% after 5 y in the overall
  population
 Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med
 2005;352:225-37.
Defibrillator in Acute Myocardial Infarction
                         (DINAMIT) Trial

• 674 patients 6 to 40 days post-MI with LVEF ≤ 35% and
  impaired cardiac autonomic function
• Randomized to ICD therapy (n=332) or no ICD therapy
  (n=342)
• Arrhythmic death ↓ in ICD group, but ↑ in nonarrhythmic
  death (6.1% per year vs. 3.5% per year, HR 1.75 (95%
  CI 1.11 to 2.76; p=0.016)
• No difference in total mortality




 Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction.
 N Engl J Med 2004;351:2481-8.
Defibrillators in Nonischemic Cardiomyopathy
        Treatment Evaluation (DEFINITE) Trial

• 458 patients with NYHA Class I to III, NICM, LVEF ≤
  35% and premature ventricular contractions (> 10/h) or
  NSVT
• Randomized to standard medical rx alone or in
  combination with single-chamber ICD
• Strong trend toward ↓ all-cause mortality with ICD
  therapy, although not statistically significant (p=0.08)




 Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J
 Med 2004;350:2151-8.
Notable Changes in 2008 ACC/AHA/HRS Guidelines
1.  ICD recommendations are combined into a single list because of overlap between primary
    and secondary indications.
2. Primary prevention ICD indications in nonischemic cardiomyopathy are clarified using data
    from SCD-HeFT (i.e., ischemic and nonischemic cardiomyopathies and LVEF ≤35%, NYHA
    II-III) for support.
3. Indications for ICD therapy in inherited arrhythmia syndromes and selected nonischemic
    cardiomyopathies are listed.
4. MADIT II indication (i.e., ischemic cardiomypathy and LVEF ≤30%, NYHA I) is now Class I,
    elevated from Class IIa.
5. EF criteria for primary prevention ICD indications are based on entry criteria for trials on
    which the recommendations are based.
6. Emphasized primary SCD prevention ICD recommendations apply only to patients
    receiving optimal medical therapy and reasonable expectation of survival with good
    functional capacity for >1 year.
7. Independent risk assessment preceding ICD implantation is emphasized, including
    consideration of patient preference.
8. Optimization of pacemaker programming to minimize unneeded RV pacing is encouraged.
9. Pacemaker insertion is discouraged for asymptomatic bradycardia, particularly at night.
10. A section has been added that addresses ICD and pacemaker programming at end of life.

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Icd basic 042411(dr chang)

  • 1. Advance EP Training April/24/2011 Basic ICD Treatment 張坤正 醫師 中國醫藥大學 內科副教授 中國醫藥大學附設醫院 心臟內科主任
  • 2. ICD Concepts ICD Automated Functions Troubleshooting
  • 3. ICD Concepts Overview • Evolution of ICDs • The ICD System • Components – Device • Battery, Capacitors & Voltage • Circuitry • Connector Blocks – Leads • Transvenous & Epicardial • Electrical Design • Connectors: IS-1 & DF-1 – Programmer
  • 5. ICD Evolution 1970 • Patent granted for first totally implantable defibrillator • System used an intracardiac catheter and SQ patch with detection via RV pressure transducer Michael Mirowski (1924-1990)
  • 6. ICD Evolution • 1947 First human internal defibrillation • 1956 First human external defibrillation • 1969 First external canine prototype tested • 1970 First implantable prototype (895 g) • 1975 First implantable Defib in canines (250 g) • 1980 First human implant @ Johns Hopkins • 1985 ICD market released (350 units)
  • 7. ICD Evolution • 1991 Non thoracotomy lead systems • 1995 Pectoral ICD systems • 1997 ICD & DDD • 1998 ICD & DR • 1999 ICD & Atrial Defibrillation • 2001 ICD & Resynchronization Therapy
  • 9. The ICD System How it Works * Animation
  • 10. The ICD System How it Works Atrium & Ventricle Ventricle • Bradycardia sensing • VT prevention • Bradycardia pacing • Antitachycardia pacing • Antitachycardia pacing • Cardioversion • Defibrillation
  • 13. ICD How High Voltage Is Created Battery – Provides low voltage energy c Transformer – Multiplies Voltage c Capacitor – Stores high energy for use c High Voltage Shock – Delivered on demand
  • 14. ICD How High Voltage Is Created For Pacing Pacing Voltage Voltages Battery Multiplier 3.2 and Volts High High Energy Transformer Voltage Shocks For Defibrillation Capacitor (Up to 800 Volts)
  • 16. Battery & Charge Time Relationship Battery DOWN Both can Indicate Elective Replacement (ERI) Charge Time UP
  • 17. Battery & Charge Time Relationship
  • 18. Battery & Charge Time Relationship Battery Voltage & Charge Time in an optimized ICD battery
  • 19. The Importance of Charge Time 10 Seconds of VF The longer the charge time, the longer this rhythm continues.
  • 23. Today’s Current® DR RF Header (6 set screws) New DF4 DR Header (2 set screws) 23
  • 25. High Voltage Leads Epicardial Placed directly on the epicardium of the heart. Transvenous Introduced into the heart through a vein.
  • 27. High Voltage Leads Types of Transvenous Leads Transvenous Passive Active No Fixation
  • 28. Endocardial Lead Systems Passive Fixation (Tines) Active Fixation (Screw)
  • 29. Transvenous Leads Placement Single Coil Dual Coil
  • 30. Distal Coil Proximal Coil Connector Pins
  • 31. High Voltage Leads Typical Transvenous Lead
  • 32. Transvenous Lead Steroid Tip *Steroid not available in all leads
  • 33. Transvenous Lead Steroid Tip Benefits of Steroid: • Reduces acute Trauma and Inflammation • Rapid Tissue Damage Repair • Reduced Fibrosis *Steroid not available in all leads
  • 34. Transvenous Lead Lead Design Optimal Tissue Contact *Steroid not available in all leads
  • 36. Lead Electrical Design Circuits • High Voltage Leads can have 2 Circuits: PACING & SENSING SHOCKING
  • 37. Lead Electrical Design Circuits PACING & SENSING Bipolar
  • 38. Lead Electrical Design Pacing/Sensing Circuit • The electrical circuit for pacing and sensing includes: •Cathode – negative electrode (Tip) •Anode: positive electrode (Ring or Coil) Bipolar Configuration
  • 39. Lead Electrical Design Circuits PACING & SENSING Bipolar True vs. Integrated
  • 40. Polarity Pacing/Sensing Circuit Bipolar uses dedicated ring can as anode Integrated Bipolar uses RV Coil can as anode
  • 42. Lead Electrical Design Circuits PACING & SENSING Bipolar True vs. Integrated SHOCKING High Voltage Coils
  • 43. Polarity Shocking Circuit Single Coil • 1 high voltage coil per lead: - RV (Right Ventricle) - Other extra HV Coils/Patches • 1 or 2 Connector Pins - (HV only or P/S + HV) Dual Coil • 2 High Voltage coils per lead: - RV + SVC • 3 Connector Pins (P/S + 2 HV)
  • 44. High Voltage Leads Connector Pins Pace / Sense Connection = IS-1 (International Standard) High Voltage Defibrillation Connections = DF-1 (Defibrillation Standard)
  • 45. Shocking Circuit Vectors • The pathway in which high energy is delivered • Determined by electrodes used: – HVA = active device – HVB = RV Coil – HVX = optional HV electrode (such as an SVC Coil) Example: A > B A (Active Can) B (RV HV Coil)
  • 46. Shocking Circuit Vectors Example: A > B (Active Can > RV HV Coil)
  • 47. Shocking Circuit Vectors Example of Dual Coil: AX > B (Active Can + SVC HV Coil > RV HV Coil)
  • 48. Shocking Circuit Vectors A>B AX > B
  • 51. ICD Automated Functions Overview • Sensing • Therapy –The EGM Signal –Tachyarrhythmia –The Sensing Circuit • Anti-tachycardia Pacing Low –Marker Channels (ATP) Power • Detection • Cardioversion (Non- committed) –Suspension (Magnet) • Defibrillation (Committed) –Rate & Duration (NID) –Bradyarrhythmia –Detection Zones • Pacing Modes –SVT Discrimination • Parameters • Single Chamber • Other Brady Therapies • Dual Chamber –Redetection
  • 53. Sensing • Sensing - what the device “sees” • Electrical Activity - what the device is looking for • Lead – contains the ‘eyeball’ of the device
  • 54. Sensing True vs. Integrated Bipolar • Range of ‘eyeball’ is determined by polarity True Bipolar Sensing Integrated Bipolar Sensing Tip-to-ring Tip-to-coil Smaller surface area Larger surface area More “localized” sensing Broader sensing area
  • 55. Sensing •The ‘eye’ of the device – Constantly watches for electrical activity – Sees or Senses all electrical signals that pass – Signal produced by a passing electrical wave is called an Intracardiac Electrogram (EGM)
  • 57. Sensing • Sensing is: –The process of identifying cardiac depolarizations from an intracardiac electrogram
  • 58. Sensing The EGM Signal • The signal from a depolarization wave passing between sensing electrodes Processed by Depolarization Wave Device
  • 59. The EGM Signal • Measured by: – Amplitude • Peak-to-peak measurement (height) of deflection • Measured in Millivolts (mV) – Slew Rate • Speed of deflection change over time • Measured in volts per second (V/s)
  • 60. The EGM Signal Amplitude • Measured Peak-to-Peak Typical Ventricular EGM • >5 mV for optimal sensing
  • 61. The EGM Signal Slew Rate • Measures Peak-to-Peak change in voltage over time • R >.75 volts/sec for optimal sensing dV Slew Rate = [V/s] dt Typical Ventricular EGM
  • 62. The EGM Signal Fields • Nearfield – Electrodes are close in range • EGM Source = Tip-to-Ring / Tip-to-Coil – Commonly a narrow signal (less myocardium in range) – Used for arrhythmia detection • Devices are hardwired to nearfield for detection
  • 63. The EGM Signal Nearfield EGM Source = Tip-to-Ring / Tip-to-Coil Tip-to-Ring Tip-to-Coil (Bipolar) (Integrated Bipolar)
  • 64. The EGM Signal Nearfield Morphology Comparison SINUS RHYTHM VT EGM Source = Tip-to-Ring / Tip-to-Coil
  • 65. The EGM Signal Fields •Nearfield – Electrodes are close in range •EGM Source = Tip-to-Ring / Tip-to-Coil – Narrow signal – less myocardium in range – Used for arrhythmia detection •Farfield –Electrodes are further in range •EGM Source = Variable –More myocardium covered in range –Can resemble surface EKG
  • 66. The EGM Signal Farfield EGM Source = Variable Can-to-RV Coil RV Coil-to-SVC (HVA to HVB) Coil (HVB to HVX)
  • 67. The EGM Signal Farfield Morphology Comparison SINUS RHYTHM VT EGM Source = Variable
  • 69. The Sensing Circuit • Upon being ‘seen,’ a signal is transported through the sensing circuit
  • 70. The Sensing Circuit The Amplifier
  • 71. The Sensing Circuit The Bandpass Filter
  • 72. The Sensing Circuit Rectifier
  • 73. The Sensing Circuit Level Detector
  • 74. The Sensing Circuit Level Detector
  • 77. Sensitivity • Minimum amplitude of electrical signal that registers as a sensed event – Set in Millivolts (mV) – Programmable Setting
  • 78. Sensitivity Programmed If set at .15 mV
  • 79. Sensitivity Programmed If set at .3 mV T-wave Not Sensed
  • 80. Sensitivity Auto-Adjusting
  • 81. Sensitivity Auto-Adjusting • Allows sensing of fine VF waves • Prevents sensing of T-waves, cross-chamber events, and pacing artifacts
  • 82. Auto-Adjusting Sensitivity Decay Constant
  • 83. Threshold Start Max R- wave Max R-wave amplitude amplitude measured at 7 measured at 4 mV mV Threshold Start R- wave is set to 50% of Sensed measured R- wave or 3 mV 2 mV 3 mV Maximum Sensitivity Ventricular Sensed Refractory Sensed Refractory
  • 84. Decay Delay • The Decay Delay holds the sensitivity threshold at the starting value for a programmable amount of time 60 ms 0 ms R- T- wave wave
  • 85. Question? What are the consequences of undersensing? • Failure to sense VF, therefore, no therapy initiated • Failure to treat VT that can accelerate to VF • Can be fatal
  • 86. Question? What are the consequences of oversensing? • Inappropriate therapies • Potential for inducing fatal arrhythmias • Patient suffering due to inappropriate therapy
  • 88. Marker Channel™ • Display: – Pace/Sense annotations – ICD functional annotations: • Sensing • Detection • Therapy • Other information * in Medtronic devices
  • 90. Question? What does “Detection” mean? A device defined arrhythmia is present based on what is sensed.
  • 91. Detection • Confirms a sensed rhythm as an arrhythmia based on: – Rate – Duration
  • 92. Detection Detection Rate • Measured in: –Beat-to-beat intervals (milliseconds), or –Beats-per-minute (BPM) • Classifies rhythm by detection zone: –VT = Ventricular Tachycardia –VF = Ventricular Fibrillation • Programmable in ranges of rates Example: VT = 162 bpm – 188 bpm VF = 188 bpm and faster
  • 93. Detection Detect Duration • Measured in: – Number of intervals to detect (NID), or – Length of time to detect • Programmable by: – Beat or interval counters • Consecutive ex: 16 beats within the detect zone • Probabilistic (percentage or fraction) ex: 12 out of 16 beats within the detect zone – Time in seconds
  • 94. Detection Consecutive Counter Used for detection of VT
  • 95. Detection Probabilistic Counter NID = 12/16
  • 96. Detection Detect Duration Non-Sustained: Duration not met / No Detection Sustained: Duration met / Detection Occurs
  • 97. Question? What if the fast, sustained ventricular rhythm is the result of an SVT?
  • 98. SVT Discriminators •SVT Discriminators: – Prevent detection of tachyarrhythmias caused by the presence of an SVT – Prevent inappropriate, unnecessary therapy due to rapid SVT conduction – Are present in some form in most ICDs
  • 99. SVT Discriminators •Discriminate based on: – Waveform morphology • EGM Width (single chamber) • Wavelet – Onset of arrhythmia – Stability of arrhythmia – Relationship between P- and R-waves (dual chamber / requires an atrial lead)
  • 100. SVT Discriminators Waveform Morphology •Measures and stores the QRS characteristics of a normal sinus beat •Identifies SVT vs. VT based on the QRS changes that occur in most VTs SINUS VT RHYTHM
  • 101. Classification: MD Morphology Discrimination Sinus Supra-Ventricular Ventricular Electrical wavefronts generated by focus approach electrodes from different directions depending on the focus location.
  • 102. SVT Discriminators Wavelet •Match Threshold Programming – Lower % • More likely to withhold appropriately; less likely to detect true VT – Higher % • Less likely to appropriately withhold; more likely to detect true VT
  • 103. SVT Discriminators Onset •Based on the premise that most VTs are characterized by a sudden onset •Evaluates the acceleration of the ventricular rate •Discriminates between: –Gradual rate increase –Abrupt rate increase •Determines VT present if rate increase is abrupt
  • 104. SVT Discriminators Onset • When On: – Averages 4 beats and compares with an average of previous 4 (multiplied by programmed Onset Percentage) • Onset met if recent average is less than previous
  • 105. SVT Discriminators Onset • Onset Percentage = 81% 530ms X 81% = 430ms ≠ 460ms = Onset 430ms Not Met * in Medtronic devices
  • 106. SVT Discriminators Stability •Based on the premise that AF conducts irregularly to the ventricles (and VT is a stable, regular rhythm) •Discriminates regular from irregular intervals within a detect zone
  • 107. SVT Discriminators Stability Stability = 50 ms Varies >50 ms from Unstable previous 3
  • 108. SVT Discriminators Dual Chamber • Considers P and R relationship to discriminate SVT from VT • Dual Chamber (requires an atrial and ventricular lead) • Can be used in conjunction with other discriminators
  • 109. Optimized DR Discriminators Bigeminal Avoidance Ventricular frequency > VT detection Compare atrial & ventricular frequency V<A V=A V>A SVT On Stability VT Morphology 40 ms Off 45% Morphology Onset 5 out of 8 AVA 45%, 5/8 Passive 80 ms ATU On Any
  • 110. SVT Discriminators PR Logic™ •What it looks for: – Atrial Fibrillation / Flutter – Sinus Tachycardia – Other 1:1 SVTs (such as AVNRT) •How it works: – Analyzes: • Pattern (P:R wave relationship) • AV Association • Rate • Regularity (R waves)
  • 111. PR Logic™ Pattern •Distinguishes SVTs by analyzing P and R-wave: – Pattern: number and position of atrial events relative to ventricular events
  • 114. PR Logic™ Example: AVNRT (Other 1:1 SVTs) Junctional Zone
  • 115. Question? What about far-field R-wave sensing in the atrial channel?
  • 116. PR Logic™ Far-field R-wave Sensing •Algorithm identifies and withholds therapy for: – Consistent, short-long pattern
  • 117. Question? What happens when a magnet is applied over an ICD?
  • 118. Tachy Detection Magnet Mode • ICDs of different manufacturers respond to magnets differently • Use when: – EMI is present (surgery, TENS, etc.) – Temporary suspension is preferred over permanent programming – Therapy is temporarily not desired
  • 120. Question? Can you name some therapies delivered by an ICD?
  • 121. ICD Therapies • ICD Therapy – Low Power (Pacing Therapies) • Anti-tachycardia Pacing (ATP) • Bradyarrhythmia Pacing – High Power (Shock Therapies) • Cardioversion • Defibrillation
  • 123. Anti-Tachycardia Pacing Re-entry ATP delivered at a rate Subsequent Pulse: initiated faster than Wavefronts collide tachyarrhythmia. closer to re-entry Wavefronts collide. circuit Subsequent Pulses: Arrhythmia Wavefronts collide terminated even closer to re- entry circuit
  • 124. Anti-Tachycardia Pacing •Has programmable: – Sequences – the number of times ATP will be applied upon re-detection
  • 125. Anti-Tachycardia Pacing •Has programmable: –Pulses – the number of pulses per sequence
  • 126. Anti-Tachycardia Pacing •Has programmable: – Sequences – the number of times ATP will be applied upon re-detection (max = 10 in most) –Pulses – the number of pulses per sequence (1-15) –Rate of pulses delivered (percent or ms)
  • 127. Anti-Tachycardia Pacing • Types: –Burst •A series of pacing pulses delivered at equal intervals •Interval decrement per sequence
  • 129. Anti-Tachycardia Pacing •Types: –Burst •A series of pacing pulses delivered at equal intervals •Interval decrement per sequence –Ramp • A series of pacing pulses delivered at ever decreasing intervals • Adds a pulse per sequence
  • 131. Anti-Tachycardia Pacing Burst and Ramp Comparison Programmed Values: Programmed Values: Number of S1 Pulses = 4 Number of S1 Pulses = 4 Number of Sequences = Number of Sequences = 4 4 R-S1% = 91% R- S1% = 91% Decrement* = 10 ms Decrement* = 10 ms * Decrement between pulses * Decrement between sequences * Adds a pulse per sequence
  • 132. ICD Therapies •Tachyarrhythmia Therapy –Anti-Tachycardia Pacing (ATP) Low Power •Pacing pulses delivered at a rate faster than the rhythm detected •Can successfully terminate re-entrant tachycardias –Cardioversion (CV) High Power •Non-committed shock therapy (must synchronize to an R-wave to be delivered) •Designed to treat re-entrant tachycardias
  • 133. Cardioversion •Delivers shock on an R-wave •Aborts if synchronization cannot be obtained due to arrhythmia termination
  • 134. Cardioversion Programming
  • 135. ICD Therapies •Tachyarrhythmia Therapy –Anti-Tachycardia Pacing (ATP) Low Power •Pacing pulses delivered at a rate faster than the rhythm detected •Can successfully terminate re-entrant tachycardias –Cardioversion (CV) High Power •A non-committed shock (must synchronize to an R-wave to be delivered) •Designed to treat organized tachyarrhythmias –Defibrillation Shock High Power •A shock delivered to the heart to terminate a tachyarrhythmia
  • 136. ICD Therapy Benefits of Tiered Therapy VT FVT VF
  • 137. Defibrillation Programming *Medtronic Programming Screen
  • 138. Question? When does the device call a therapy a success?
  • 139. ICD Therapies Termination/Redetection •“8 to terminate” rule –8 sinus and/or paced beats outside the slowed programmed detection zone * in Medtronic devices
  • 141. Troubleshooting Overview •ICD System Issues –Lead System & Connections –Device –Other Issues (Patient, EMI)
  • 142. ICD SYSTEM ISSUES Lead Systems & Connections
  • 143. Question? In an ICD System, what component is generally known to be the source of most issues? a. device b. lead
  • 144. ICD System Issues Leads • Points of Failure – Acute (common suspects) • Connector • Lead Dislodgement/Perforation
  • 145. ICD System Issues Leads Points of Failure – Chronic (common suspects: High points of stress/pressure) Lead fracture (commonly exhibits HIGH impedance/resistance) Lead insulation break (commonly exhibits LOW impedance/resistance)
  • 146. ICD System Issues Points of Failure – Acute (common suspects) Connector What kinds of things can go wrong here?
  • 147. ICD System Issues Connector Can you identify a problem? Set screw is obstructing the bore
  • 148. ICD System Issues Connector What might happen if a lead is connected?
  • 149. ICD System Issues Connector What is going on here? Set Screw Noise
  • 150. ICD System Issues • Points of Failure – Acute (common suspects) • Connector Lead dislodgement/perforation How do we know when this occurs?
  • 151. ICD System Issues Lead Dislodgement Common signs – Intermittent or loss of capture – Intermittent or loss or sensing – Inappropriate therapy during SVT (in this example due to atrial lead dislodgement) Atrial Dislodgement
  • 152. ICD System Issues Lead Dislodgement Can you identify the dislodged lead(s)?
  • 153. ICD System Issues Lead Dislodgement • Avoiding dislodgements – Ensure sufficient slack in lead – Use suture sleeves – Check lead tip stability during implant
  • 154. ICD System Issues Lead Perforation • Occurs when: – Lead tip exits the heart, through the heart
  • 155. ICD System Issues Lead Perforation •Diagnosing – Can be seen on x-ray – Definitive by Echo – Threshold and lead impedance may remain unchanged (due to possible continuous contact with tissue outside the heart) •Possible patient symptoms – Change in pressure – Cardiac tamponade – Dyspnea
  • 156. ICD System Issues • Points of Failure – Acute (common suspects) • Connector • Lead dislodgement/perforation – Chronic (common suspects: High points of stress/pressure) Lead fracture (commonly exhibits HIGH impedance)
  • 157. ICD System Issues Can you identify a problem? 1st Rib-Clavicle Crush (lead fracture)
  • 158. ICD System Issues Lead Fracture Lead Crush 1st Rib & Clavicle Crush
  • 159. ICD System Issues Lead Fracture Can you identify the fracture?
  • 160. ICD System Issues Lead Fracture • Common behavior – Erratic sensing – Intermittent or loss of capture – High lead impedance
  • 161. ICD System Issues Lead Fracture Example
  • 162. ICD System Issues • Points of Failure – Acute (common suspects) • Connector • Lead dislodgement/perforation (common suspects: high points – Chronic of stress/pressure) Lead fracture (commonly exhibits HIGH impedance) Lead insulation break (commonly exhibits LOW impedance)
  • 163. ICD System Issues Insulation Break • Common Behavior – Lead impedance • Low • Can be intermittent – Capture threshold • Sudden rise or loss • Can be intermittent – Sensing • Over/undersensing • Can be intermittent Coaxial Inner Insulation Breach
  • 164. ICD System Issues Insulation Break Example
  • 165. ICD SYSTEM ISSUES Device
  • 166. ICD System Issues Device • Common device issues: – Long charge times – Battery depletion • Elective Replacement (ERI) • End of Life (EOL) – Inappropriate programming Acceleration Over/Undersensing Output
  • 167. ICD System Issues Device Can you identify a problem? T-wave oversensing
  • 168. ICD System Issues Can you identify the problem? Device *Medtronic Programming Undersensing
  • 169. ICD System Issues Device Can you identify the problem? Undersensing
  • 172. Infection/Erosion/Allergy Allergy Testing Allergy Test Metals (included in kits) Allergy Test Kit Contents: Polyurethane Silicone Titanium Platinum Iridium Polysulfone Epoxy Gold-sputtered devices
  • 173. Abandoned Leads • Chatter between active and abandoned leads may cause inappropriate therapy
  • 174. Electromagnetic Interference (EMI) • The sensing of electrical signals other than those produced by the heart 60 Hz (oversensing)
  • 175. Test Your Skills What might you suspect from this EGM?
  • 176. Case Study (Noise) • Male 62 years • ICD Implant for VT/VF • Patient got 11 shocks
  • 179. Trends: Lead Impedance Impedance Decrease
  • 181. Episode 52 A/V lead 皆有 noise
  • 182. Case study (Morphology Change) • Female 72 years old • ICD for VT episodes • Standard follow-up patient didn’t feel anything.
  • 185. Episode 1: Appropriate or Inappropriate Therapy? Morphology score low
  • 188. MD Auto Update Morphology auto update score increase to 100
  • 189. Episode 3: Correct Diagnosis? SVT Diagnosis
  • 190. Diagnostics After morphology update Correct Discreamation is SVT
  • 191. CMUH
  • 192. CMUH
  • 194. Implantable Cardioverter-Defibrillators I IIa IIb III IIb III ICD therapy is indicated in patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes. I IIa IIb III ICD therapy is indicated in patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable. I IIa IIb III ICD therapy is indicated in patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at electrophysiological study. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.
  • 195. Implantable Cardioverter-Defibrillators I IIa IIb III IIb III ICD therapy is indicated in patients with LVEF less than or equal to 35% due to prior MI who are at least 40 days post-MI and are in NYHA functional Class II or III. I IIa IIb III ICD therapy is indicated in patients with nonischemic DCM who have an LVEF less than or equal to 35% and who are in NYHA functional Class II or III. I IIa IIb III IIb III ICD therapy is indicated in patients with LV dysfunction due to prior MI who are at least 40 days post-MI, have an LVEF less than or equal to 30%, and are in NYHA functional Class I. I IIa IIb III ICD therapy is indicated in patients with nonsustained VT due to prior MI, LVEF less than or equal to 40%, and inducible VF or sustained VT at electrophysiological study. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.
  • 196. Implantable Cardioverter-Defibrillators I IIaIIbIII ICD implantation is reasonable for patients with unexplained syncope, significant LV dysfunction, and nonischemic DCM. I IIaIIbIII ICD implantation is reasonable for patients with sustained VT and normal or near-normal ventricular function. I IIaIIbIII ICD implantation is reasonable for patients with HCM who have 1 or more major† risk factors for SCD. ICD implantation is reasonable for the prevention of SCD in I IIaIIbIII patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C) who have 1 or more risk factors for SCD. I IIaIIbIII ICD implantation is reasonable to reduce SCD in patients with long- QT syndrome who are experiencing syncope and/or VT while receiving beta blockers. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year. † See Section 3.2.4, “Hypertrophic Cardiomyopathy,” in the full-text guidelines for definition of major risk factors.
  • 197. Implantable Cardioverter-Defibrillators I IIaIIbIII ICD implantation is reasonable for nonhospitalized patients awaiting transplantation. I IIaIIbIII ICD implantation is reasonable for patients with Brugada syndrome who have had syncope. I IIaIIbIII ICD implantation is reasonable for patients with Brugada syndrome who have documented VT that has not resulted in cardiac arrest. I IIaIIbIII ICD implantation is reasonable for patients with catecholaminergic polymorphic VT who have syncope and/or documented sustained VT while receiving beta blockers. I IIaIIbIII ICD implantation is reasonable for patients with cardiac sarcoidosis, giant cell myocarditis, or Chagas disease. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.
  • 198. Implantable Cardioverter-Defibrillators I IIaIIbIII ICD therapy may be considered in patients with nonischemic heart disease who have an LVEF of less than or equal to 35% and who are in NYHA functional Class I. I IIa IIbIII IIbIII ICD therapy may be considered for patients with long-QT syndrome and risk factors for SCD. I IIaIIbIII ICD therapy may be considered in patients with syncope and advanced structural heart disease in whom thorough invasive and noninvasive investigations have failed to define a cause. I IIaIIbIII ICD therapy may be considered in patients with a familial cardiomyopathy associated with sudden death. I IIaIIbIII ICD therapy may be considered in patients with LV noncompaction. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.
  • 199. Implantable Cardioverter-Defibrillators I IIa IIb III ICD therapy is not indicated for patients who do not have a reasonable expectation of survival with an acceptable functional status for at least 1 year, even if they meet ICD implantation criteria specified in the Class I, IIa, and IIb I IIa IIb III recommendations above. ICD therapy is not indicated for patients with incessant VT or VF. I IIa IIb III ICD therapy is not indicated in patients with significant psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up. I IIa IIb III ICD therapy is not indicated for NYHA Class IV patients with drug-refractory congestive heart failure who are not candidates for cardiac transplantation or cardiac resynchronization therapy defibrillators (CRT-D). All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.
  • 200. Implantable Cardioverter-Defibrillators I IIa IIb III ICD therapy is not indicated for syncope of undetermined cause in a patient without inducible ventricular tachyarrhythmias and without structural heart disease. ICD therapy is not indicated when VF or VT is amenable I IIa IIb III to surgical or catheter ablation (e.g., atrial arrhythmias associated with the Wolff-Parkinson-White syndrome, RV or LV outflow tract VT, idiopathic VT, or fascicular VT in the absence of structural heart disease). I IIa IIb III ICD therapy is not indicated for patients with ventricular tachyarrhythmias due to a completely reversible disorder in the absence of structural heart disease (e.g., electrolyte imbalance, drugs, or trauma). All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.
  • 201. ICDs in Pediatric Patients and Patients With Congenital Heart Disease I IIa IIb III ICD implantation is indicated in the survivor of cardiac arrest after evaluation to define the cause of the event and exclusion of any reversible causes. I IIa IIb III ICD implantation is indicated for patients with symptomatic sustained VT in association with congenital heart disease who have undergone hemodynamic and electrophysiological evaluation. Catheter ablation or surgical repair may offer possible alternatives in carefully selected patients. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.
  • 202. ICDs in Pediatric Patients and Patients With Congenital Heart Disease I IIa IIb III IIb III ICD implantation is reasonable for patients with congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias at electrophysiological study. I IIa IIb III ICD implantation may be considered for patients with recurrent syncope associated with complex congenital heart disease and advanced systemic ventricular dysfunction when thorough invasive and noninvasive investigations have failed to define a cause. I IIa IIb III All Class III recommendations found in Section 3 of the full- text guidelines, “Indications for Implantable Cardioverter- Defibrillator Therapy,” apply to pediatric patients and patients with congenital heart disease, and ICD implantation is not indicated in these patient populations. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.
  • 203. Major Implantable Cardioverter-Defibrillator Trials for Prevention of Sudden Cardiac Death Trial Year Patients LVEF Additional Study Hazard 95% CI p (n) Features Ratio* MADIT I 1996 196 < 35% NSVT and EP+ 0.46 (0.26-0.82) p=0.009 MADIT II 2002 1232 < 30% Prior MI 0.69 (0.51-0.93) p=0.016 CABG-Patch 1997 900 < 36% +SAECG and CABG 1.07 (0.81-1.42) p=0.63 DEFINITE 2004 485 < 35% NICM, PVCs or NSVT 0.65 (0.40-1.06) p=0.08 DINAMIT 2004 674 < 35% 6-40 days post-MI 1.08 (0.76-1.55) p=0.66 and Impaired HRV SCD-HeFT 2006 1676 < 35% Prior MI of NICM 0.77 (0.62-0.96) p=0.007 AVID 1997 1016 Prior cardiac NA 0.62 (0.43-0.82) NS arrest CASH† 2000 191 Prior cardiac NA 0.766 ‡ 1-sided arrest p=0.081 CIDS 2000 659 Prior cardiac NA 0.82 (0.60-1.1) NS arrest, syncope * Hazard ratios for death from any cause in the ICD group compared with the non-ICD group. Includes only ICD and amiodarone patients from CASH. ‡CI Upper Bound 1.112 CI indicates Confidence Interval, NS = Not statistically significant, NSVT = nonsustained ventricular tachycardia, SAECG = signal-averaged electrocardiogram. Epstein A, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. J Am Coll Cardiol 2008; 51:e1–62. Table 5.
  • 204. Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Trial • 1520 patients with NYHA Class III or IV HF, ischemic cardiomyopathy (ICM) or nonischemic cardiomyopathy (NICM) and QRS ≥ 120 ms • Randomized 1:2:2 to optimal pharmacological therapy (OPT) alone or in combination with cardiac resynchronization therapy with either a pacemaker (CRT-P) or pacemaker-defibrillator (CRT-D) • Both device arms significantly ↓ combined risk of all-cause hospitalization and all-cause mortality by ~20% compared with OPT • CRT-D ↓ mortality by 36% compared with OPT (p=0.003) • Insufficient evidence to conclude that CRT-P inferior to CRT-D Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 2004;350:2140-50.
  • 205. Implantable Cardioverter-Defibrillators and Prevention of Sudden Cardiac Death in Hypertrophic Cardiomyopathy • Multicenter registry study of implanted ICDs in 506 unrelated patients with HCM @ high risk for SCD (family hx of SCD, [septal thickness ≥ 30 mm], NSVT, syncope) • Mean patient age 42 years (SD=17) and 87% had no or only mildly limiting symptoms • Appropriate ICD discharge rates were 11% per year for 2o prevention and 4% per year for 1o prevention • For 1o prevention, 35% of patients with appropriate ICD interventions had undergone implantation for only 1 risk factor Maron BJ, Spirito P, Shen WK, et al. Implantable cardioverter-defibrillators and prevention of sudden cardiac death in hypertrophic cardiomyopathy. JAMA 2007;298:405-12.
  • 206. Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) • 1232 patients ≥ 1 month post-MI and LVEF ≤ 30% • Randomized to ICD (n=742) or medical therapy (n=490) • No spontaneous or induced arrhythmia required for enrollment • 6% absolute and 31% relative risk ↓ in all-cause mortality with ICD therapy (p=0.016) Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346:877-83.
  • 207. Sudden Death in Heart Failure (SCD-HeFT) Trial • 2521 patients with NYHA Class II or III HF, ICM, or NICM and LVEF ≤ 35% • Randomized to 1) conventional rx for HF + placebo; 2) conventional rx + amiodarone; or 3) conventional rx + conservatively programmed shock- only single lead ICD • No survival benefit for amiodarone • 23% ↓ in overall mortality with ICD therapy • Absolute ↓ in mortality of 7.2% after 5 y in the overall population Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:225-37.
  • 208. Defibrillator in Acute Myocardial Infarction (DINAMIT) Trial • 674 patients 6 to 40 days post-MI with LVEF ≤ 35% and impaired cardiac autonomic function • Randomized to ICD therapy (n=332) or no ICD therapy (n=342) • Arrhythmic death ↓ in ICD group, but ↑ in nonarrhythmic death (6.1% per year vs. 3.5% per year, HR 1.75 (95% CI 1.11 to 2.76; p=0.016) • No difference in total mortality Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med 2004;351:2481-8.
  • 209. Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Trial • 458 patients with NYHA Class I to III, NICM, LVEF ≤ 35% and premature ventricular contractions (> 10/h) or NSVT • Randomized to standard medical rx alone or in combination with single-chamber ICD • Strong trend toward ↓ all-cause mortality with ICD therapy, although not statistically significant (p=0.08) Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 2004;350:2151-8.
  • 210. Notable Changes in 2008 ACC/AHA/HRS Guidelines 1. ICD recommendations are combined into a single list because of overlap between primary and secondary indications. 2. Primary prevention ICD indications in nonischemic cardiomyopathy are clarified using data from SCD-HeFT (i.e., ischemic and nonischemic cardiomyopathies and LVEF ≤35%, NYHA II-III) for support. 3. Indications for ICD therapy in inherited arrhythmia syndromes and selected nonischemic cardiomyopathies are listed. 4. MADIT II indication (i.e., ischemic cardiomypathy and LVEF ≤30%, NYHA I) is now Class I, elevated from Class IIa. 5. EF criteria for primary prevention ICD indications are based on entry criteria for trials on which the recommendations are based. 6. Emphasized primary SCD prevention ICD recommendations apply only to patients receiving optimal medical therapy and reasonable expectation of survival with good functional capacity for >1 year. 7. Independent risk assessment preceding ICD implantation is emphasized, including consideration of patient preference. 8. Optimization of pacemaker programming to minimize unneeded RV pacing is encouraged. 9. Pacemaker insertion is discouraged for asymptomatic bradycardia, particularly at night. 10. A section has been added that addresses ICD and pacemaker programming at end of life.