1

1
Rob Leinders
Slides: TimJ ongen
Medtronic BakkenResearch Center
Bioelectronicaen Nanotechnologie
2008 - 2012
Module: Pacemaker Basics
2 Recommended Literature
Foundation of Cardiac Pacing. Sutton, Bourgeois, 1991, ISBN 0-
87993-337-2
Design of Cardiac Pacemakers. Webster 1993, ISBN 0-7803-
1134-5
Rapid Interpretation of EKGs. Dubin 1970, SBN 0-912912-00-6
The evolution of pacemakers: An electronics perspective, fromthe
hand crank to advanced wavelet analysis. Haddad AP, Houben
RP, Serdijn WA. IEEE Eng Med Biol Mag. 2006 May-J un;
25(3):38-48
3 Pacemaker Basics
EGM / ECG
Electrophysiology
MeasuringSignals
12LeadECG
Diseases
Bradycardia
Tachycardia
Pacemaker: Basics
ComponentsOverview
SimplifiedPacemaker
OutputPulse: Width/ Amplitude/ Capacitor
Sensing
WhySensing
Oversensing
Undersensing
SensingHardware
Frequency spectrum
Filters
Analog to Digital Conversion
Pacemaker: Current Devices
ICDs
Leads
Unipolar / Bipolar
Lowvoltage/ Highvoltage
Active/ PassiveFixation
LeadDesign
LeadImplantation
2
4 Practicum
Building a Pacemaker
Program a Pacemaker
Simulations with Patient Simulator
1
1 EGM / ECG
Measuring Signals
ECG
EGM
2
3 Cardiac Conduction - Sinus Node
The Hearts Natural
Pacemaker
Rate of 60-100 bpmat rest
Sinus Node
(SA Node)
2
4 Cardiac Conduction - AV Node
Receives impulses fromSA node
Delivers impulses to the His-
Purkinje System
Delivers rates between 40-60
bpmif SA node fails to
deliver impulses
Atrioventricular
Node (AV Node)
5 Cardiac Conduction - HIS Bundle
Begins conduction to the
ventricles
AV J unctional Tissue:
Rates between 40-60 bpm
Bundle of His
6 Cardiac Conduction - Purkinje Fibers
Bundle Branches and
Purkinje Fibers
Moves the impulse
through the ventricles
Provides Escape
Rhythm: 20-40 bpm
Purkinje Network
3
7 Normal Sinus Rhythm
8 Impulse Formation in SA Node
9 Atrial Depolarization
4
10 Delay at AV Node
11 Conduction through Bundle Branches
12 Conduction through Purkinje Fibers
5
13 Ventricular Depolarization
14 Plateau Phase of Repolarization
15 Final Rapid (Phase 3) Repolarization
6
16 Automaticity
Cardiac Cells are unique
because they spontaneously
depolarize
Upper (SA Node)
60-80 bpm
Middle (AV J unction)
40-60 bpm
Lower (Purkinje Network)
20-40 bpm
17 Measuring Signals
18 ECG
7
19 ECG
20 EGM / ECG
21 ECG
Precordial Leads: V1 V2 V3 V4 V5 V6
8
22 12 Lead ECG
23 EGM
Electrogram
Measure locally in Atria or Ventricles
Lead II and RV electrogram Lead II and HRA electrogram
1
1 Diseases
Bradycardia
Tachycardia
2 Bradycardia
Patient has a slow (Brady: slowness) heart rhythm:
Sinus Arrest
Brady/Tachy Syndrome
Sinus Bradycardia
Exit Block
Bi/Trifascicular Block
AV Block
3 Sinus Arrest
Failureof sinus nodedischarge
Absenceof atrial depolarization
Periods of ventricular asystole
May beepisodic as in vaso-vagal syncope, or carotid sinus hypersensitivity
May requireapacemaker
2
4 Sinus Bradycardia
Sinus Nodedepolarizes very slowly
If thepatient is symptomatic and therhythmis persistent and irreversible, may
requireapacemaker
5 Brady/Tachy Syndrome
Intermittent episodes of slow and fast rates fromtheSA nodeor atria
Brady <60 bpm
Tachy >100 bpm
AKA: Sinus NodeDisease
Patient may also haveperiods of AF and chronotropic incompetence
75-80% of pacemakers implanted for this diagnosis
6 Exit Block
Transient block of impulses fromtheSA node
Sinus Wenckebach is possible, but rare
Pacing is rareunless symptomatic, irreversible, and persistent
3
7 First-Degree AV Block
Standard PR interval 120 200 ms
Delayed conduction through theAV
In most casesno symptoms. No medicationsor PM therapy isneeded.
Correctingelectrolyteimbalancesisstandard therapy
8 Second-Degree AV Block
Type 1: Wenkebach prolongation of PR interval
Type 2: no prolongation
9 Third-Degree AV Block
No impulse conduction from the atria to the
ventricles
Atrial rate =130 bpm, Ventricular rate =37 bpm
Complete A V disassociation
Usually a wide QRS as ventricular rate is
idioventricular
4
10 Fascicular Block
Right bundle branch block
and left anterior hemiblock
Right bundle branch
block and left posterior
hemiblock
Complete left bundle
branch block
11 Trifascicular Block
Complete block in the right bundle branch, and
Complete or incomplete block in both divisions of
the left bundle branch
Identified by EP Study
12 Chronotopic Incompetence
CO =SV x HR
Healthy hearts are able to increase peak CO by
up to 5x baseline with exercise
Chronotopic Incompotence patients are only able
to increase CO x2 over baseline
5
13 Tachycardia
Sinus Tachycardia
Premature Contractions
Atrial Tachycardia
Accelerated Junctional Rhythm
Accelerated Idioventricular
Rhythm (AIVR)
Atrial Flutter
Atrial Fibrillation
AVRT/AVNRT
Ventricular Tachycardia
Ventricular Fibrillation
14 Sinus Tachycardia
Origin: Sinus Node
Rate: 100-180 bpm
Mechanism: Abnormal or Hyper Automaticity (for example, exercise)
15 Atrial Tachycardia
Origin: Atrium - Ectopic Focus
Rate: >100 bpm
Mechanism: Abnormal Automaticity
6
16 Premature Beats - PAC
Origin: Atrium (outside the Sinus Node)
Mechanism: Abnormal Automaticity
Characteristics: An abnormal P-wave occurring earlier than expected,
followed by compensatory pause
17
Origin: AV Node J unction
Mechanism: Abnormal Automaticity
Characteristics: A normally conducted complex with an absent P-wave,
followed by a compensatory pause
Premature Beats- PJ C
18
Origin: Ventricles
Mechanism: Abnormal Automaticity
Characteristics: A broad complex occurring earlier than expected,
followed by a compensatory pause
Premature Beats - PVC
7
19 PVC Patterns
Bigeminy
- Every other beat
Trigeminy
- Every third beat
Quadrigeminy
- Every fourth beat
20
Origin: Varies within the Ventricle
Mechanism: Abnormal Automaticity
Characteristics: Each premature beat changes axis; implies a different focus
of origin for each beat
Note: PVCs by themselves are not a predictor of VT/VF, nor do they imply
the need for a defibrillator
Multifocal PVC
21 Accelerated J unctional Rhythm
Origin: AV Node or J unctional Tissue
Mechanism: Abnormal Automaticity
Characteristics: Occurs when AV nodal cells depolarize at a rate
faster than the sinus node
8
22 Accelerated Idioventricular Rhythm
Origin: Ventricle
Mechanism: Abnormal Automaticity
Rate: Ventricular rate >sinus rate, but <VT
Characteristic: May dominate and take over the underlying rhythm
23 Accelerated Idioventricular Rhythm
Sinus Rhythm being taken over by an
Idioventricular Rhythm
24 Reentry
9
25 Reentry
26 Reentry
27 Atrial Flutter
Origin: Right and Left Atrium
Mechanism: Reentry, circus tachycardia
Rate: 250 400 bpm
Characteristics: Rapid, regular P-waves, regular R-waves
10
28
Origin: Right and/or left atrium, pulmonary veins
Mechanism: Multiple wavelets of reentry
Atrial Rate: >400 bpm
Characteristics: Random, chaotic rhythm; associated with irreg. ventricular rhythm
Atrial Fibrillation (AF)
29 Atrial Fibrillation (AF)
30 AF Mechanism
Paroxysmal: Sudden onset and spontaneous cessation
Persistent: Requires intervention to terminate, usually >24-48
hour duration
Permanent or Chronic: Unable to terminate
AF begets AF
The more frequent the AF the more frequently it will re-occur
and episodes tend to last longer
11
31
Mutifocal Atrial Tachycardia
Mechanism: Abnormal Automaticity (multi-
sites)
Characteristics: Many depolarization waves;
activation occurs asynchronously
Not commonly used terms anymore, usually
just called AF
Other AF Mechanisms
Single Foci
Mechanism: Abnormal Automaticity (single-
focus, usually in the Posterior Left Atrium)
Characteristics: Rapid discharge; single
ectopic site
Parasystole rare
32 Atrial Flutter vs. Atrial Fibrillation
Summary of Disease Characteristics
Atrial Flutter Atrial Fibrillation
Atrial Rate 250 to 400 bpm 400 bpm
Ventricular Rate/Rhythm Usually regular Varies with conduction
Grossly irregular
Pattern Saw tooth baseline Irregular or almost flat
baseline
Irregularly irregular
Underlying Mechanism Reentry viamacro re-
entrant circuit
Typically multiple
wavelet reentry
33 AVRT - AV Re-entrant Tachycardia
An SVT caused by the existence of an extra
pathway from the atria to the ventricles
Extra pathway +AV Node =reentry
Two Types
Orthodromic
Antidromic
12
34
Orthodromic
Mechanism: Reentry
Rate: 180 - 260 bpm+
Characteristics: Extra electrical pathway
to ventricles
AVRT
Accessory Pathway
Conduction to the ventricles via the AV node
(normal conduction) - then fromVentricles to the
Atria via the accessory pathway. Produces
narrow complex SVT.
35
Antidromic
Mechanism: Reentry
Rate: 180 - 260 bpm+
Characteristics: Extra electrical pathway to
ventricles. Wide-complex QRS.
AVRT
Accessory Pathway
Conduction to ventricles via the accessory
pathway. The impulse is then conducted
retrograde to atrial via the AV node. Produces
a wide-complex SVT.
36
Origin: A - V conduction outside the AV node (bundle of Kent). The Wolff
pathway conducts faster than the AV node
Characteristics: Short PR Interval (<120 ms), wide QRS (>110 ms), delta wave
Sudden cardiac death in these individuals is due to the propagation of an atrial
arrhythmia to the ventricles at a very high rate.
Wolff-Parkinson-White
13
37
Origin: AV Node
Mechanism: Reentry
Rate: 150 - 230 bpm, faster in teenagers
Characteristics: Normal QRS with absent P-waves
AVNRT - AV Node Re-entrant Tachycardia
38 AVRT vs. AVNRT
AVRT
180 260 bpm
Narrow QRS if
orthodromic
Wide QRS if antidromic
Delta wave +in SR
PR <120 msec
1:1 Conduction
AVNRT
150 230 bpm
Narrow QRS
Short RP
No delta waves
Initiating PR long
P-waves buried in QRS
Conduction 1:1, or 2:1
when distal block present
Treatment:
Ablation
Rarely is a ICD implanted
39 Monomorphic VT
Origin: Ventricles (Single Focus)
Mechanism: Reentry initiated by abnormal automaticity
or triggered activity
Characteristics: Rapid, wide and regular QRS. A-V
disassociation
14
40
Origin: Ventricles (Wandering Single Focus)
Mechanism: Reentry with movement in the circuit initiated by
abnormal automaticity or triggered activity
Characteristics: Wide and irregular QRS Complex that changes in axis
Polymorphic VT
41
Origin: Ventricle
Mechanism: Reentry (movement in focus)
Rate: 200 250 bpm
Characteristics: Associated with Long QT interval; QRS changes axis
and morphology with alternating positive/negative
complexes
Torsades de Pointes- Twisting of the points
42
Origin: Ventricle
Mechanism: Multiple wavelets of reentry
Characteristics: Irregular with no discrete QRS
Ventricular Fibrillation (VF)
1
1 Pacemaker Basics
Components Overview
Simplified Pacemaker
Output Pulse
Capacitor
Width
Amplitude
Strength Duration Curve+
2 Pacemaker Overview
Pulse Generator
Battery, sensing, pulse formation
Control (counter), telemetry
Wires (Leads)
3 Pacemaker Principle of Operation
2
4 Pacemaker Output
Output pulse
Anodal/Cathodal
Pulse width
Amplitude
5 Pacemaker Output
Delivered energy:
Strength duration curve
6 Pacemaker Output
1
1 Sensing
Why Sensing
Noise
Oversensing
Undersensing
Sensing Hardware
Frequency spectrum
Filters
Analog to Digital Conversion
2
Sensing
Sensing is the ability of the pacemaker to see
when a natural (intrinsic) depolarization is
occurring
Pacemakers sense cardiac depolarization by
measuring changes in electrical potential of
myocardial cells between the anode and cathode
3
EGM / ECG
Intrinsic deflection on
an EGM occurs when a
depolarization wave
passes directly under
the electrodes
Two characteristics of
the EGM are:
Signal amplitude
Slew rate
2
4 Slew Rate - Change in Voltage with Respect to the Change in Time
The longer the signal takes to
move frompeak to peak:
Thelower theslew rate
Theflatter thesignal
Higher slew rates (number in
mV) translate to greater sensing
Measured in volts per second V
o
l
t
a
g
e
Time
Slope
Slew rate=
Change in voltage
Time duration of
voltage change
5
Sense and Respond to Cardiac Rhythms
Accurate sensing enables the pacemaker to
determine whether or not the heart has created a
beat on its own
The pacemaker is usually programmed to respond
with a pacing impulse only when the heart fails to
produce an intrinsic beat
6
Accurate Sensing...
Ensures that undersensing will not occur
Ensures that oversensing will not occur
Provides for proper timing of the pacing pulse
3
7
Undersensing . . .
Pacemaker does not see the intrinsic beat, and
therefore does not respond appropriately
Intrinsic beat
not sensed
Scheduled pace
delivered
VVI / 60
8
Oversensing
An electrical signal other than the intended P or
R wave is detected
Marker channel
shows intrinsic
activity...
...though no
activity is present
VVI / 60
9
Sensitivity
The Greater the Number, the Less Sensitive the Device
to Intracardiac Events
4
10
Sensitivity
A
m
p
l
i
t
u
d
e

(
m
V
)
Time
5.0
2.5
1.25
11
Sensitivity
A
m
p
l
i
t
u
d
e

(
m
V
)
Time
5.0
2.5
1.25
12
Sensitivity
A
m
p
l
i
t
u
d
e

(
m
V
)
Time
5.0
2.5
1.25
5
13
Noise
Sensing amplifiers use filters that allow appropriate
sensing of P waves and R waves and reject
inappropriate signals
Unwanted signals most commonly sensed are:
T waves
Far-field events (R waves sensed by the atrial channel)
Skeletal myopotentials (e.g., pectoral muscle myopotentials)
14 Noise
Electrophysiological signals and interference
Myopotentials in unipolar EGM resulting
frompectoral muscles
=>Intermittent, baseline variations
Electromagnetic interference (main 50/60 Hz)
picked up by electrode tip- IPG can loop
=>Superimposed variations
RV current of injury, (artificial) ST-segment
shift. Disappears after approximately 30
min after lead implant
15
Accurate Sensing is Dependent on . . .
The electrophysiological properties of the
myocardium
The characteristics of the electrode and its
placement within the heart
The sensing amplifiers of the pacemaker
6
16
Factors That May Affect Sensing Are:
Lead polarity (unipolar vs. bipolar)
Lead integrity
Insulation break
Wire fracture
EMI Electromagnetic Interference
17
Unipolar Sensing
Produces a large
potential difference
due to:
A cathode and anode
that are further apart
than in a bipolar system
_
18
Bipolar Sensing
Produces a smaller
potential difference due to
the short interelectrode
distance
Electrical signals from
outside the heart such as
myopotentials are less likely
to be sensed
7
19
An Insulation Break
May Cause Both Undersensing or Oversensing
Undersensing occurs when inner and outer conductor
coils are in continuous contact
Signals fromintrinsic beats are reduced at the sense
amplifier and amplitude no longer meets the programmed
sensing value
Oversensing occurs when inner and outer conductor
coils make intermittent contact
Signals are incorrectly interpreted as P or R waves
20
A Wire Fracture
Can Cause Both Undersensing and
Oversensing
Undersensing occurs when the cardiac signal is
unable to get back to the pacemaker intrinsic
signals cannot cross the wire fracture
Oversensing occurs when the severed ends of the
wire intermittently make contact, which creates
potentials interpreted by the pacemaker as P or R
waves
21 Sensing Hardware
1
1
Pacemakers
2 Pacemaker Parts
Pacemaker
Can
Connector Block
Leads
Sensing
Circuit
Output
Stage
Battery
Battery
EOL circuit
Telemetry
System
Antenna
Sensor(s)
Sensor
Interface
Feed-throughs
Bonding wires
Mechanical Electronics
Timing/Control
Circuits
Telemetry
Protocol SW
Software
Algorithms
Memory
Microprocessor
AD Converter
Software Other
Hybrid
3
Telemetry
2
4 Pacemaker Telemetry
Pacemaker Telemetry
Voltage
regulators
Transceiver
Decoding Coding
Logic control unit Timebase
Telemetry front-end
Coupledcoils
175KHz AM, PModulated
MicroWatts power uplink
5
RF Telemetry products
TEL A/B/V, Used by CRDM
TEL N, used by Neuro
Range: Less then 50 cm
RF freq: 175 kHz
6
RF Telemetry products -2
TEL C Conexus currently in
use by CRDM
Later also by Neuro
Range: Up to 10 meters
RF band: 402 - 405 MHz
MICS: Medical Information
Communication Service
3
7
RAMware
8 RAMwhere?
Pacemaker
Can
Connector Block
Leads
Sensing
Circuit
Output
Stage
Battery
Battery
EOL circuit
Telemetry
System
Antenna
Sensor(s)
Sensor
Interface
Feed-throughs
Bondingwires
Mechanical Electronics
Timing/Control
Circuits
Telemetry
Protocol SW
Software
Algorithms
Memory
Microprocessor
ADConverter
Firmware Other
Hybrid
9 Device Memory
ROM
(ReadOnly Memory)
EEPROM
(ElectricallyErasable
Programmable ROM)
RAM
(RandomAccess Memory)
Firmware
Programmed Parameters
RAMware
Working data
Diagnostic data
RAMware
4
10 RAMware download
(1) RAMware download
(2) call RAMware
initialization
function
&
RAMware Media
11
Algorithms
12 Algorithms
Rate-Responsiveness
Based on activity (also possible on QT interval)
Day and night difference
Managed Ventricular Pacing
If not needed, pacing should be avoided
Switch between DDD(R) and AAI(R)
Mode Switch
What happens during AF when PM is programmed in DDD
mode
Switch between DDD(R) and DDIR
5
13 Algorithms (cont)
Additional chamber: LV pacing
Rate dependant AV interval
Rate-drop response
PVC response

1
1
ICD
2 ICD
Implantable Cardioverter Defibrillator
Whats the function
Sense
Detect
Therapy
Pace
3
CPU/Memory
The processor chip
analyses electrical
signals from the
heart and
determines whether
any shocks are
necessary. The chip
runs at less than 100
kHz
ICD Components ICD Components
GEM DR Dual Chamber, RateResponsiveImplantab
Defibrillator
Battery
The special batteries, made of
lithium silver vanadi um oxide, last
six years or more, even though
they have less energy than a
standard laptop battery
Transformer
For serious heart disturbances
requiring a higher shock, a
transformer converts low-
voltage battery power into a
higher voltage.
Casing
The I.C.D. is encased
in titanium. Scar
tissue grows around
it, locking it in place.
The device is sealed
shut to prevent
leakage, so when the
battery dies, the
entire device must
be replaced
Connectors
A lead with three
connecti ons provides
sensi ng capabiliti es and a
pathway for high-energy
shocks to one of the hearts
lower chambers. A second
lead with only one
connecti on provides
sensi ng and pacing to an
upper chamber.
Beeper
A warning beeper
indicates a low
battery or another
problem that a
doctor should check
out. There are no
warnings to signal a
large shock to the
patient.
Capacitors
Similar to the ones
used in camera
flashes, capacitors can
take up to 10 seconds
to draw enough energy
(30-40 J) from the
battery for a large
shock. Charge times
for smaller shocks are
much shorter.
Antenna
Communication
between the I.C.D. and
the programmer is
made through low-
frequency radio waves
sent from the unit' s
antenna to a doughnut-
shaped receiver held
over the patient' s chest
Leads
Flexible wires convey sensi ng
information to the I.C.D. and carry
electric shocks to the heart. A
patient may receive one or two
leads dependi ng on the nature of
the heart problem. They are
covered with silicone insulati on.
MarquisDR ImplantableDefibrillator
2
4 ICD Specs
Combined with:
Pacemaker
Cardiac Resynchronization
Longevity 7-10y
37 cc / 68 g
5 ICD Sensing
6 ICD Detection
Detection of VT/VF based on:
Rate
Duration
(Morphology)
3
7 ICD Therapy
8 ICD Settings
9 ICD - Shock
Shocking: 35 J charged in 8 s
Defibrillation (VF)
Cardioversion (VT)
Shock Delivery waveform
4
10 ICD Shock (cont)
11 ATP
1
1
Pacing Leads
2
Pacing Lead Lifetime Activity
70 bpm
100,000 beats/day
37,000,000 beats/year
500,000,000 beats/13.5 years
3
Conductor TipElectrode Insulation Connector Pin
Pacing Lead Components
Conductor
Connector Pin
Insulation
Electrode
Lead Assembly
2
4
Conductor
Purpose
Deliver electrical impulses fromIPG to electrode
Return sensed intracardiac signals to IPG
Conductor
5
Conductor -- Types
Types
Unifilar
Multifilar
Cable
6
Conductor -- Construction
Unipolar Construction
3
7
Conductor -- Unipolar Construction
Unipolar lead
1 pacing conductor
IPG case (can)
for sensing
8
Conductor -- Unipolar Construction
Unipolar Lead Characteristics
Larger pacing spikes on EKG
Small diameter lead body
Less rigid lead body
More susceptible to oversensing
May produce muscle and nerve stimulation
9
Conductor -- Construction
Bipolar Construction
Co-axial
Co-radial
Outer insulation
Tipelectrodecoil
Indifferent electrode
coil
Integral insulation
Tipelectrodecoil
Indifferent electrode
coil
4
10
Conductor -- Construction
Bipolar Construction
Parallel Coils
Coil/Cables
11
Conductor -- Bipolar Construction
Bipolar Lead Characteristics
Larger diameter lead body
Tend to be stiffer
Less susceptible to oversensing
Unipolar programmable
Less likely to produce muscle and nerve stimulation
12
Conductor -- Material
Typical Conductor Materials
MP35N (nickel alloy)
MP35N silver cored
5
13
Connector
Purpose
Connects lead to IPG, and provides a conduit to:
Deliver current from IPG to lead
Return sensed cardiac signals to IPG
Connector
14
Connector -- IS-1 Standard
IS-1 Standard Connectors
Sizes Prior to IS-1 Standard
3.2 mmlow-profile connectors
5/6 mmconnectors
15
Insulation
Purpose:
Contain electrical current
Prevent corrosion
Insulation
6
16
Insulation -- Properties
Properties of Insulation Materials
Tensile strength
Elongation
Tear strength
Abrasion
Compression set
Crush (cyclic compression)
Creep
17
Insulation -- Type
Insulation Types
Silicone
Polyurethane
Fluoropolymers (PTFE, ETFE)
18
Insulation -- Type
Silicone
Advantages
Inert
Biocompatible
Biostable
Disadvantages
High friction coefficient (sticky)
Handling damage
Size (for some types of silicone)
7
19
Insulation -- Type
Polyurethane
Advantages
Biocompatible
High tear strength
Low friction coefficient
Less fibrotic
Small lead diameter
Disadvantages
ESC MIO
20
Insulation -- Type
Fluoropolymers (PTFE, ETFE)
Advantages
Inert
Most biocompatible
High tensile strength
Small size
Disadvantages
Stiff when >0.003
More prone to creep
Difficult to manufacture without pinholes
21
Insulation -- Small Size
New Insulation Materials Facilitate the Benefits of
Smaller Lead Diameters
Smaller introducer size
Easier insertion/passage through smaller veins
More flexible lead bodies
Two leads through one introducer
Less intrusive
8
22
Electrodes
Purpose
Deliver a stimulus to myocardium
Detect (sense) intracardiac signals
Optimal Performance Factors
Low, Stable Thresholds
High Pacing Impedance
Low Source Impedance
Good Sensing
TipElectrode
RingElectrode
23
Electrodes
Characteristics and Design Factors that Impact
Electrical Performance
Fixation mechanism
Polarity
Surface material
Size
Surface structure
Steroid elution
24
Electrodes -- Fixation Mechanism
Passive Fixation Mechanism Endocardial
Tined
Canted/curved
9
25
Electrodes Fixation Mechanism
Active Fixation Mechanism Endocardial
Fixed screw
Extendible/retractable
26
Electrodes -- Fixation/Visualization
Fluoroscopic Image of Leads
CapSure
CapSure SP

Novus
CapSure Z

Novus
CapSureFix

Extended Retracted
FixedScrew
space
27
Electrodes -- Fixation Mechanism
Fixation Mechanism Myocardial/Epicardial
Stab-in
Screw-in
Suture-on
10
28
Electrodes -- Surface Material
Surface Material
Polished platinum
Activated carbon
Platinized metal
Surface Material Characteristics
Corrosion Resistant
Biocompatible
Reduced Polarization
29
Electrodes -- Size
Reducing Electrode Size
Increases Impedance
Reduces Current Drain
Increases Longevity
Disadvantage:
Increase polarization
30
Electrodes - Size/Polarization
Current Current Tissue
-
+
-
+
+
+
+ + -
+
-
-
+
+
+ +
+
- -
Polarization Layering Effect
11
31
Electrodes -- Surface Structure
Porous Electrode Surface
CapSure

8.0 mm
2
Porous Electrode
CapSure

SP Novus
5.8 mm
2
Platinized
Porous Electrode
CapSure

Z Novus
1.2 mm
2
Platinized
Porous Electrode
15KV x2500 12.0V MDT
32
Electrodes -- Surface Structure
Benefits of a Porous Electrode Surface
Reduces Polarization
Improves Sensing
Promotes Tissue In-Growth
33
Electrodes -- Steroid Elution
Tines for
Stable Fixation
Silicone Rubber Plug
Containing Steroid
Porous,
Platinized Tip
for Steroid
Elution
Type - Steroid in matrix
12
34
Electrodes Steroid Elution
IMPLANT CHRONIC
(8 weeks or longer)
Excitable
Cardiac
Tissue
Non-Excitable
Fibrotic
Tissue
Excitable
Cardiac
Tissue
35
Electrodes -- Steroid Elution
Benefits of Steroid Elution
Excellent Electrode-tissue Biocompatibility:
Fewer and less active inflammatory cells
Less fibrotic development
Improved Electrode Performance:
No significant threshold peaking nor chronic threshold
increases, virtually eliminating
exit block
Improved consistent sensing characteristics
36
Electrodes -- Steroid Elution
Effect of Steroid on Stimulation Thresholds
Pulse Width = 0.5 msec
0
3 6
Implant Time (Weeks)
Textured Metal Electrode
Smooth Metal Electrode
1
2
3
4
5
Steroid-Eluting Electrode
0 1 2 4 5 7 8 9 10 11 12
V
o
l
t
s
13
37 Leads - LV