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陽明大學附設醫院
心臟內科 黃嵩豪
First External Stimulation
Catharina Serafin
Increase in heart rate (140 bpm)
Hugo von Ziemssen (1882)
Stimulation: ON OFF
Right Ventricle
Left Ventricle
1827/46 Bradycardia as cause of syncope
(Adams, Stokes)
1882 First external stimulation (von Ziemssen)
1932 First external pacemaker (Hyman)
1952 External stimulation via surface electrodes
(Zoll)
1958 External stimulator with transvenous lead
(Furman, Robinson)
1958 First implantable PM with transvenous lead
(Elmquist, Senning)
Historical Milestones
First External Pacemaker
Hyman (1932)
- Clockwork generator with manual power
- Transthoracic stimulation needle
- Handle turn to provide induction stimulus
Cardiac standstill
Stimulation 120 ppm
Transvenous External PM
Furman and Robinson (1958)
Wearable
Pulse
Generator -
Around
Waist (1958 )
First Implantable Pacemaker
Senning and Elmquist (1958)
Rune Elmquist
Engineer at Siemens-Elema
Ake Senning, Cardiac Surgeon
Karolinska Hospital Stockholm
First Implantable Pacemaker
Senning and Elmquist (1958)
• 2 Transistors
• Pulse 2 V / 1.5 ms
• Rate 80 ppm
55 mm Ø , 16 mm thick
First Pacemaker Patient: Arne Larsson
1986
First Implantable Pacemaker
First Battery Powered PM
Chardack, Greatbatch (1960)
10 Zinc-Mercury Batteries
First Programmable PM
Chardack, Greatbatch (1963)
with a screwdriver
Founded in 1949 as a
medical equipment
service company
History and Background History
• First external wearable
pacemaker
Success With Implantable Pacemakers
 In the United States, the first successful attempts at designing a totally implantable
pacemaker were reported by Drs. William Chardack and Andrew Gage at the Veterans
Administration Hospital in Buffalo, New York, and Wilson Greatbatch, an electrical
engineer. The three men carried out more than two years of experimental work and
testing, then published a paper about their work in 1960.
 Medtronic's founders read the article with interest and soon contacted the New York
researchers. Palmer Hermundslie flew his own plane to Buffalo to meet Dr. Chardack and
Greatbatch, and signed a contract giving Medtronic exclusive rights to produce and
market the Chardack-Greatbatch implantable pulse generator. Within two months of
beginning production in late 1960, Medtronic had received orders for 50 of the $375
implantable units.
 Co-founder Palmer Hermundslie often piloted his own plane to make emergency
deliveries of pacemakers.
 At the same time, Medtronic appointed Picker International Corporation of White
Plains, New York, as its sole distributor outside the United States, exclusive of Canada.
Picker's 72 foreign sales offices greatly expanded the marketing efforts of Medtronic,
which had 14 sales representatives covering the United States and Canada.
 In addition to the implantable pacemaker, the representatives sold seven other
Medtronic products, including the Telecor, which visibly and audibly monitored heart
activity; the Cardiac Sentinel, an automatic alarm that summoned aid when the patient's
heart activity became critical and stimulated the heart with an electronically regulated
pulse; and a Coagulation Generator, used to control bleeding during surgery without
damaging nearby tissue.
Dr. C. Walton Lillehei with a child who received
one of the early Medtronic external pacemakers
Atomic Pacemaker
Plutonium powered PM (1967)
Implantable Electronic Cardiac Devices
Historical Aspects
1932 1958 1964 1970 1980’s 1994
Hyman
Senning and
Elmquist
1st implant of
an electronic
PM
Mirowski
Development
of the 1st ICD –
implant in dogs
1st report of
CRT
RECENTLY
Furman
1st endocardiac
PM
Heart Failure
control
Home
Monitoring
Basic Concept of Pacemaker
Over view
- Pacemaker System
- Pacemaker Function
- NBG Code
- Lead Impedance
- The magnet Mode & Electromagnetic Interference
- Information for patient ‘s pacemaker
What is a pacemaker ?
 A device for increaseing a slow HR
 A device used primarily to correct some types of
bradycardia, or slow heart rhythms.
Who need it ?
 Indications for Pacing
 Sick Sinus Syndrome
 Heart Block
 Post RF Ablation
How does it work ?
 Attach the pacemaker system
 Pulse generator
 Sensing and Pacing leads
 Make it into a circuit
 Put the system into the body / under the skin and join to the
heart by pacing wire
 Program it’s function by the programmer
Pacing Systems
Pulse
generator
Sensing and
Pacing lead
The Pacemaker System
 Patient
 Lead
 Pacemaker
 Programmer
Lead
Pacemaker
Leads
 Epicardial
 Endocardial
Connection to Pacemaker
Just a Simple Lead
Lead System
 A lead is the insulated wire used to connect the pulse
generator to the cardiac tissue
 The lead transmits the energy to the myocardium and
relays intrinsic cardiac signals back to the sensing
circuit
Components of a Pacing Lead
Connector
Proximal Ring
Electrode
Lead
Body
Active Fixation
Mechanism
Suture
Sleeve
Distal Tip
Electrode
Fixation Mechanisms
Active fixation
Screw-in lead
Passive fixation
Tined tip
Passive fixation
Finned tip
Suture On
Sutureless
Epicardial Leads
Pacemaker Circuit
Unipolar VS Bipolar
Bipolar
Unipolar
Unipolar Vs. Bipolar
++-
Unipolar Configuration
Lead
Pacemaker
Unipolar Pathway
-
+
Bipolar Configuration
Lead
Pacemaker
-
+
Bipolar Pathway
Unipolar Versus Bipolar
UNIPOLAR vs BIPOLAR
Unipolar Leads
 Advantage
 Smaller size
 Easier to
implant?
 Larger spike on
surface ECG
 Theoretically
more reliable
 Disadvantages
 Possibility of
pocket stimulation
 Possibility of
myopotential
inhibition
 Susceptible to EMI
 Susceptible to
cross-talk
Bipolar Leads
 Advantages
 Torque control
 Noise Rejection
 Programming
flexibility
 No Pocket
stimulation
 Disadvantages
 Larger Diameter
 Stiffer
 Small ECG Artifact
in surface ECG
Lead Placement
 Ventricular Lead
 Right Ventricular Apex (RVA) or Right
Ventricular Outflow Tract (RVOT)
 Ventricular Bradycardia Pacing
 Sensing Intrinsic Rhythm
 Atrial Lead
 Right Atrial Appendage or Atrial Septal Wall
 Atrial Pacing
 Atrial Sensing
Ventricular Lead Placement
Atrial Lead Placement
 The atrial lead should be implanted on the septal wall
of the atrial appendage
 Once the lead is in the proper position it will have a
“wagging” appearance
Atrial Endocardial Placement
Single Chamber Pacing
 One Lead
 One Circuit / Pacemaker
 One Patient
Dual-Chamber Pacing
Basic Function
 Energy
 Output Parameters
 Cardiac Stimulation Threshold
 Impedance
Energy
 Ohm's Law
 Voltage
 Current
 Resistance
How to stimulate?
Ohm´s Law: V = R x I
R =
V
I
Voltage
Current
= =
[V]
[A]
The higher the voltage and the lower the resulting current
the higher is the resistance.
 V = Voltage, I = Current , R = Resistance
Voltage
The difference in potential energy
between two points
Unit of measure = volt (V)
Current
The rate of transfer or flow of
electricity
Unit of measure – milliampere
(mA)
Resistance
The opposition to the flow of
electrical current through a material
Unit of measure = ohm (Ω)
V = IR
V = IR
CONSTANT VOLTAGE
t (ms)
How to stimulate?
Pulse
Amplitude
Pulse Duration
U (V)
Pacemaker Pulse
Pacing Technology “Secret”
Pacemakers do only 2 things:
Pace
Sense
Capture
Definition : Cardiac depolarization and resultant
contraction caused by pacemaker stimulus
Pacing (Stimulation) threshold
 The lowest amount of energy to capture the
myocardium 100 % of the time
How to stimulate?
Pulse Duration (ms)
Pulse
Ampli-
tude
(V)
Pulse Duration (ms)
Pulse
Ampli-
tude
(V)
How to stimulate?
Rheobase - Chronaxie
How to stimulate?
Pulse Duration (ms)
Pulse
Ampli-
tude (V)
Energy
(mJ)
How to stimulate?
E = R x I x t
E = x t (Joule)
V2
R
Energy
V = R x I
V
R
I =
E = V x x tV
R
How to stimulate?
E = x t (J)
V2
R
Energy
How to save energy?
- lower pulse amplitude (V²)
- lower pulse duration
- high impedance
Strength Duration Curve
pulse width (msec)
Voltagethreshold(V)
Chronaxie
Rheobase
2 x Rheobase
Most efficient pulse width
• The rheobase is the least voltage needed to
depolarise the heart at an infinite pulse duration.
• The chronaxie is the shortest pulse duration
required to depolarise the heart at a voltage twice
the rheobase.
Pacing Thresholds
 Suggested Intraoperative Values
 Atrium
 Less than 1.5 Volts
 Ventricular
 Less than 1.0 Volts
 Pacing Impedance
 300-1500 Ω Depending on lead type
Acute To Chronic Threshold Change
 Historically reported to occur between
2-8 weeks post implant
 Thresholds may increase 2-5 times
 Virtual Electrode - Myocardial Interface
Excitable Tissue
Non-Excitable Tissue
Virtual Electrode
Electrode
Chronic Electrode
Pacing Thresholds
Hayes, D. et. al. Cardiac Pacing and Defibrillation: A Clinical Approach.
Futura. Armonk, NY. 2000:7.
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
1 2 3 4 5 6 7 13 26 52
Time After Implant
ChronicPacingThreshold,PulseWidth(ms)
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
1 2 3 4 5 6 7 13 26 52
Time After Implant
ChronicPacingThreshold,PulseWidth(ms)
Steroid
No Steriod
Sensing
Definition: The ability of the pacemaker to sense an
intrinsic electrical signal
Sensing
 When programming
sensitivity, as you lower the
number you make the
pacemaker more sensitive,
(allow it “see” more).
1 mV
2 mV
5 mV
Sensing
Sensing
 Sensing Threshold: indicates the minimum
intracardiac signal that will be sensed by the
pacemaker to initiate the pacemaker response
(inhibited or triggered)
Sensing
X
= programmed
sensitivity
Amplifier
and Filter
Signal
processing
Signal
recording
How to sense?
0
5
10
15
20
25
1 3 5 10 30 50 100 300 1000
VES
R-wave
T-wave
Amplitude
Frequency (Hz)
P-wave
Myopotentials
(mV)
How to sense?
Filtering of Intracardiac Signals
How to sense?
Sensitivity: 2.5 mV
Vs Vs
0
5
5
Intra-
cardiac
Signal
(mV)
Vs Vs Vs Vs
PM Marker
How to sense?
Sensitivity: 5.0 mV
Intra-
cardiac
Signal
(mV)
PM Marker
0
5
5
Vs Vs
 Undersensing
Sensing Thresholds
 Suggested Intraoperative Values
 Atrium
 Greater than 2.0 mV
 Ventricular
 Greater than 5.0 mV
The NASPE/BPEG Generic (NBG) Code
Position
Category
Letters
Used
Manufac-
turer’s
Designation
Only
I II III
Chamber(s)
Paced
Chamber(s)
Sensed
Response
to Sensing
Rate modulation Multisite
pacing
O-None
P-Simple
Programmable
M-Multi-
Programmable
C-Communicating
R-Rate
modulation
O-None
A-Atrium
V-Ventricle
D-Dual
(A+V)
S- Single
(A or V)
S- Single
(A or V)
O-None
A-Atrium
V-Ventricle
D-Dual
(A+V)
O-None
T-Triggered
I-Inhibited
D-Dual
(T+I)
O-None
A-Atrium
V-Ventricle
D-Dual
(A+V)
IV V
Version 2001
Insulation Break
Current is escaping
Decreased Resistance
Increased Current Drain
Pacing and sensing problems
Lead Fracture
Current cannot reach heart
Increased Resistance
Decreased Current Drain
Pacing and sensing problems
LiJ - Battery
Hybrid
Connectors
Titanium
housing
Components of the PM
Pacemaker Programming
Telemetry
Antenna
Pacemaker Power Source
Zinc-Mercury Lithium-Iodine
Pacemaker Power Source
Zinc-Mercury Lithium-Iodine
Time Time
Pacemaker Power Source
Pacemaker Power Source
Pulse Amplitude and Device Longevity
Battery 1.1 Ah
Mode VVI VVI DDD DDD
Amplitude (V) 5 2.5 5 2.5
Inhibited (µA) 11 11 12 12
Pacing V (µA) + 10 + 2,5 + 10 + 2,5
Pacing A (µA) - - + 10 + 2,5
Total (µA) 21 13,5 32 17
Longevity (yrs) 6,2 9,6 4,1 8,0
Lead Resistance/Impedance
Changes
 High Resistance
 > 2500 ohms
 Also called an “Open Circuit”
 Chronic lead system
 Fractured lead conductor coil
 Acute lead system
 Loss of contact between the terminal pin of the lead and the
pacemaker header set screw
 Low Resistance
 < 250 ohms
 Also called “Shorted Circuit”
 Insulation Break-Down
 Insulation cut by suture
 Degradation of the insulation
 Subclavian Crush Syndrome
Lead Resistance/Impedance
Changes
Implantable
Cardioverter
Defibrillator
Anti-tachycardia
Devices
First graphic documentation of ventricular fibrillation
ICD Evolution: 1850
Carl Ludwig (1816-1895)
 1st documented termination of VF with elevated current
 Their work went largely unnoticed for 30 years
ICD Evolution: 1899
• Reproduced electric current
termination of VF
• Done at the request of Bell
telephone to address
electrocution of line workers
(occurring at the rate of 1000/yr)
ICD Evolution: 1930
William Kouwenhoven (1886-1975)
What is ICD Therapy?
• ICD therapy consists of
pacing, cardioversion, and
defibrillation therapies to
treat tachyarrhythmias. ICDs
also have programmable
diagnostic functions.
• An ICD system includes the
device, and the pacing,
sensing and defibrillation
lead(s).
1947
• First successful
defibrillation of
exposed human
heart
• Required
thoracotomy
ICD Evolution:
Early Medtronic Defibrillator 1950’s
Used in open
heart surgeries
Applied directly
to the heart
ICD Evolution
1970
• Patent granted for
first totally
implantable
defibrillator
• System used an
intracardiac catheter
and SQ patch with
detection via RV
pressure transducer
ICD Evolution
Michael Mirowski (1924-1990)
ICD Evolution
NEJM 1997;337;1576-83
Secondary Prevention of Sudden Arrhythmic Death
AVID Study
N of Patients at Risk
ICD 742 502 (0.91) 274 (0.84) 110 (0.78) 9
Conventional 490 329 (0.90) 170 (0.78) 65 (0.69) 3
Moss AJ. N Engl J Med 2002;346:877-883
ICD
ConventionalP = 0.007
1.0
0.9
0.8
0.7
0.6
0.0
SurvivalProbability
0 1 2 3 4
Years
0.78
0.69
-31%
Primary Prevention of Sudden Arrhythmic Death
MADIT II Study
Cardiac Resynchronization
Therapy for Heart Failure
Ventricular Dysynchrony and Cardiac
Resynchronization
• Ventricular Dysynchrony1
– Electrical: Inter- or
Intraventricular conduction delays typically manifested as left bundle
branch block
– Structural: disruption of myocardial collagen matrix impairing electrical
conduction and mechanical efficiency
– Mechanical: Regional wall motion abnormalities with increased workload
and stress—compromising ventricular mechanics
• Cardiac Resynchronization
– Therapeutic intent of atrial synchronized biventricular pacing
• Modification of interventricular, intraventricular, and atrial-ventricular
activation sequences in patients with ventricular dysynchrony
• Complement to optimal medical therapy
1 Tavazzi L. Eur Heart J 2000;21:1211-1214
Prevalence of Inter- or Intraventricular
Conduction Delay
1 Havranek E, Masoudi F, Westfall K, et al. Am Heart J 2002;143:412-417
2 Shenkman H, McKinnon J, Khandelwal A, et al. Circulation 2000;102(18 Suppl II): abstract 2293
3 Schoeller R, Andersen D, Buttner P, et al. Am J Cardiol. 1993;71:720-726
4 Aaronson K, Schwartz J, Chen T, et al. Circulation 1997;95:2660-2667
5 Farwell D, Patel N, Hall A, et al. Eur Heart J 2000;21:1246-1250
IVCD 15%
IVCD >30%
General HF Population1,2
Moderate to Severe
HF Population3,4,5
60%
70%
80%
90%
100%
0 60 120 180 240 300 360
Days in Trial
CumulativeSurvival
QRS
Duration
(msec)
<90
90-120
120-170
170-220
>220
Wide QRS – Proportional Mortality Increase
• NYHA Class II-IV patients
• 3,654 ECGs digitally
scanned
• Age, creatinine, LVEF,
heart rate, and QRS duration
found to be independent
predictors
of mortality
• Relative risk of widest
QRS group 5x greater
than narrowest
1 Gottipaty V, Krelis S, Lu F, et al. JACC 1999;33(2) :145 [Abstr847-4].
Vesnarinone Study1
(VEST study analysis)
Clinical Consequences of
Ventricular Dysynchrony
• Abnormal
interventricular
septal wall motion1
• Reduced dP/dt3,4
• Reduced pulse
pressure4
• Reduced EF and
CO4
• Reduced diastolic
filling time1,2,4
• Prolonged MR
duration1,2,4
1 Grines CL, Bashore TM, Boudoulas H, et al. Circulation 1989;79:845-853.
2 Xiao, HB, Lee CH, Gibson DG. Br Heart J 1991;66:443-447.
3 Xiao HB, Brecker SJD, Gibson DG. Br Heart J 1992;68:403-407.
4 Yu C-M, Chau E, Sanderson JE, et al. Circulation. 2002;105:438-445.
Click to Start/Stop
Longer
Shorter
Relaxed
Courtesy of Dr Kass, MD, Johns Hopkins University, Maryland.
SEPTUM
BASE
APEX
SEPTUM
BASE
Normal Dilated Cardiomyopathy
APEX
Left Ventricular Dysfunction
Electromechanical Dyssynchrony
Summary of Proposed Mechanisms
Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445
Intraventricular
Synchrony
Atrioventricular
Synchrony
Interventricular
Synchrony
 LA
Pressure
 LV Diastolic
Filling
 RV Stroke
Volume
 LVESV  LVEDV
Reverse Remodeling
Cardiac Resynchronization
 MR dP/dt,  EF,  CO
( Pulse Pressure)
Proposed Mechanisms: Improved
Intraventricular Synchrony
Kass D Chen-Huan C, Curry C, et al. Circulation 1999;99:1567-73
PV loop tracings at right illustrate BiV/LV
pacing produces: greater stroke work
(area) and increased stroke volume
(width), and a reduced systolic volume
0
40
80
120
0 100 200 300
0
40
80
120
0 100 200 300
0
40
80
120
0 100 200 300
0
40
80
120
0 100 200 300
LVPressure(mmHg)LVPressure(mmHg)
LV Volume (mL) LV Volume (mL)
RV Apex RV Septum
LV Free Wall Biventricular
----- NSR Control - - - VDD Pacing
Adapted from Kass et al.
Proposed Mechanisms: Improved
Intraventricular Synchrony
Click to Start/Stop
 dP/dt 1,3,4 EF1,5
 Pulse Pressure 3,4  SV&CO1, 2
Improved Intraventricular
Synchrony1,2
 MR1
 LVESV1  LA
Pressure1
1 Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445
2 Søgaard P, Kim W, Jensen H, et al. Cardiology 2001;95:173-182
3 Kass D Chen-Huan C, Curry C, et al. Circulation 1999;99:1567-73
4 Auricchio A, Ding J, Spinelli J, et al. J Am Coll Cardiol 2002;39:1163-1169
5 Stellbrink C, Breithardt O, Franke A, et al. J Am Coll Cardiol 2001;38:1957- 65
Proposed Mechanisms: Improved
Atrioventricular Synchrony
Click to Start/Stop
1 Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445
2 Kindermann M, Frohlig G, Doerr T, et al. Pacing Clin Electrophysiol 1997; 20(I):2453-2462
3 Breithardt O, Stellbrink C, Franke A, et al. Am Heart J 2002;143:34-44
4 Søgaard P, Kim W, Jensen H, et al. Cardiology 2001;95:173-182
Improved Atrioventricular
Synchrony
 LA1
Pressure
 LV Diastolic
Filling1,3
 LVEDV1,4
Optimized AV Delay:
 Isovolumic Contraction Time1,2
 MR1,4
1 Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445
2 Kerwin W, Botvinick E, O’Connel W, et al. JACC 2000;35:1221-7
Improved Interventricular
Synchrony1,2
 LV Diastolic
Filling1
 RV Stroke
Volume1
Courtesy of Ottawa Heart Institute
LV Wall
Endocardium
RV
Septum
LV
Proposed Mechanisms: Improved
Interventricular Synchrony
Achieving Cardiac Resynchronization
Mechanical Goal: Atrial-synchronized bi-ventricular pacing
• Transvenous Approach
– Standard pacing lead in RA
– Standard pacing or defibrillation lead in RV
– Specially designed left heart lead placed in a left ventricular
cardiac vein via the coronary sinus
Right Atrial
Lead
Right Ventricular
Lead
Left Ventricular
Lead
Cardiac Resynchronization
Atrio-biventricular Pacing
LVRV
Cleland et al, Eur Heart J 2006;27(16):1928-32
0 500 1000 1500
0
25
50
75
Days
P<0.0001
Event-freeSurvival
571192321365404
889213351376409
Control
CRT
N of Patients at Risk
Medical Therapy
CRT
100
HF CF III/IV
EF<0.35
QRS>130ms
Cardiac Resynchronization
CARE-HF Study: Overall Mortality
Cardiac Resynchronization
CARE-HF Study: Sudden Mortality
Cleland et al, Eur Heart J 2006;27(16):1928-32
CRT
Medical
Therapy
Survival
Time (days)
Hazard ratio 0.54
(95% CI 0.35-0.84. P = 0.006)
CRT = 32 sudden deaths (7.8%)
Medical therapy = 54 sudden deaths (13.4%)
1.00
0.75
0.50
0.25
0.00
0 400 800 1200 1600
Cardiac Resynchronization + ICD
COMPANION Study: Overall Mortality
N Engl J Med 2005
CRT-D
CRT
TMO
Sobrevidalivredeeventos(%)
19%
12%
15%
N:1520
心臟植入性電子儀器(CIED )之歷史”CIED Overview “_20130907北區
心臟植入性電子儀器(CIED )之歷史”CIED Overview “_20130907北區

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心臟植入性電子儀器(CIED )之歷史”CIED Overview “_20130907北區

  • 2.
  • 3. First External Stimulation Catharina Serafin Increase in heart rate (140 bpm) Hugo von Ziemssen (1882) Stimulation: ON OFF Right Ventricle Left Ventricle
  • 4. 1827/46 Bradycardia as cause of syncope (Adams, Stokes) 1882 First external stimulation (von Ziemssen) 1932 First external pacemaker (Hyman) 1952 External stimulation via surface electrodes (Zoll) 1958 External stimulator with transvenous lead (Furman, Robinson) 1958 First implantable PM with transvenous lead (Elmquist, Senning) Historical Milestones
  • 5. First External Pacemaker Hyman (1932) - Clockwork generator with manual power - Transthoracic stimulation needle - Handle turn to provide induction stimulus Cardiac standstill Stimulation 120 ppm
  • 6. Transvenous External PM Furman and Robinson (1958)
  • 8. First Implantable Pacemaker Senning and Elmquist (1958) Rune Elmquist Engineer at Siemens-Elema Ake Senning, Cardiac Surgeon Karolinska Hospital Stockholm
  • 9. First Implantable Pacemaker Senning and Elmquist (1958) • 2 Transistors • Pulse 2 V / 1.5 ms • Rate 80 ppm 55 mm Ø , 16 mm thick
  • 10. First Pacemaker Patient: Arne Larsson 1986 First Implantable Pacemaker
  • 11. First Battery Powered PM Chardack, Greatbatch (1960) 10 Zinc-Mercury Batteries
  • 12. First Programmable PM Chardack, Greatbatch (1963) with a screwdriver
  • 13. Founded in 1949 as a medical equipment service company History and Background History • First external wearable pacemaker
  • 14. Success With Implantable Pacemakers  In the United States, the first successful attempts at designing a totally implantable pacemaker were reported by Drs. William Chardack and Andrew Gage at the Veterans Administration Hospital in Buffalo, New York, and Wilson Greatbatch, an electrical engineer. The three men carried out more than two years of experimental work and testing, then published a paper about their work in 1960.  Medtronic's founders read the article with interest and soon contacted the New York researchers. Palmer Hermundslie flew his own plane to Buffalo to meet Dr. Chardack and Greatbatch, and signed a contract giving Medtronic exclusive rights to produce and market the Chardack-Greatbatch implantable pulse generator. Within two months of beginning production in late 1960, Medtronic had received orders for 50 of the $375 implantable units.  Co-founder Palmer Hermundslie often piloted his own plane to make emergency deliveries of pacemakers.  At the same time, Medtronic appointed Picker International Corporation of White Plains, New York, as its sole distributor outside the United States, exclusive of Canada. Picker's 72 foreign sales offices greatly expanded the marketing efforts of Medtronic, which had 14 sales representatives covering the United States and Canada.  In addition to the implantable pacemaker, the representatives sold seven other Medtronic products, including the Telecor, which visibly and audibly monitored heart activity; the Cardiac Sentinel, an automatic alarm that summoned aid when the patient's heart activity became critical and stimulated the heart with an electronically regulated pulse; and a Coagulation Generator, used to control bleeding during surgery without damaging nearby tissue. Dr. C. Walton Lillehei with a child who received one of the early Medtronic external pacemakers
  • 16. Implantable Electronic Cardiac Devices Historical Aspects 1932 1958 1964 1970 1980’s 1994 Hyman Senning and Elmquist 1st implant of an electronic PM Mirowski Development of the 1st ICD – implant in dogs 1st report of CRT RECENTLY Furman 1st endocardiac PM Heart Failure control Home Monitoring
  • 17. Basic Concept of Pacemaker Over view - Pacemaker System - Pacemaker Function - NBG Code - Lead Impedance - The magnet Mode & Electromagnetic Interference - Information for patient ‘s pacemaker
  • 18. What is a pacemaker ?  A device for increaseing a slow HR  A device used primarily to correct some types of bradycardia, or slow heart rhythms.
  • 19. Who need it ?  Indications for Pacing  Sick Sinus Syndrome  Heart Block  Post RF Ablation
  • 20. How does it work ?  Attach the pacemaker system  Pulse generator  Sensing and Pacing leads  Make it into a circuit  Put the system into the body / under the skin and join to the heart by pacing wire  Program it’s function by the programmer
  • 22. The Pacemaker System  Patient  Lead  Pacemaker  Programmer Lead Pacemaker
  • 26. Lead System  A lead is the insulated wire used to connect the pulse generator to the cardiac tissue  The lead transmits the energy to the myocardium and relays intrinsic cardiac signals back to the sensing circuit
  • 27. Components of a Pacing Lead Connector Proximal Ring Electrode Lead Body Active Fixation Mechanism Suture Sleeve Distal Tip Electrode
  • 28. Fixation Mechanisms Active fixation Screw-in lead Passive fixation Tined tip Passive fixation Finned tip
  • 36. Unipolar Leads  Advantage  Smaller size  Easier to implant?  Larger spike on surface ECG  Theoretically more reliable  Disadvantages  Possibility of pocket stimulation  Possibility of myopotential inhibition  Susceptible to EMI  Susceptible to cross-talk
  • 37. Bipolar Leads  Advantages  Torque control  Noise Rejection  Programming flexibility  No Pocket stimulation  Disadvantages  Larger Diameter  Stiffer  Small ECG Artifact in surface ECG
  • 38. Lead Placement  Ventricular Lead  Right Ventricular Apex (RVA) or Right Ventricular Outflow Tract (RVOT)  Ventricular Bradycardia Pacing  Sensing Intrinsic Rhythm  Atrial Lead  Right Atrial Appendage or Atrial Septal Wall  Atrial Pacing  Atrial Sensing
  • 40. Atrial Lead Placement  The atrial lead should be implanted on the septal wall of the atrial appendage  Once the lead is in the proper position it will have a “wagging” appearance
  • 42. Single Chamber Pacing  One Lead  One Circuit / Pacemaker  One Patient
  • 44. Basic Function  Energy  Output Parameters  Cardiac Stimulation Threshold  Impedance
  • 45. Energy  Ohm's Law  Voltage  Current  Resistance
  • 46. How to stimulate? Ohm´s Law: V = R x I R = V I Voltage Current = = [V] [A] The higher the voltage and the lower the resulting current the higher is the resistance.  V = Voltage, I = Current , R = Resistance
  • 47. Voltage The difference in potential energy between two points Unit of measure = volt (V)
  • 48. Current The rate of transfer or flow of electricity Unit of measure – milliampere (mA)
  • 49. Resistance The opposition to the flow of electrical current through a material Unit of measure = ohm (Ω)
  • 50. V = IR V = IR CONSTANT VOLTAGE
  • 51. t (ms) How to stimulate? Pulse Amplitude Pulse Duration U (V) Pacemaker Pulse
  • 52. Pacing Technology “Secret” Pacemakers do only 2 things: Pace Sense
  • 53. Capture Definition : Cardiac depolarization and resultant contraction caused by pacemaker stimulus
  • 54. Pacing (Stimulation) threshold  The lowest amount of energy to capture the myocardium 100 % of the time
  • 55. How to stimulate? Pulse Duration (ms) Pulse Ampli- tude (V)
  • 56. Pulse Duration (ms) Pulse Ampli- tude (V) How to stimulate? Rheobase - Chronaxie
  • 57. How to stimulate? Pulse Duration (ms) Pulse Ampli- tude (V) Energy (mJ)
  • 58. How to stimulate? E = R x I x t E = x t (Joule) V2 R Energy V = R x I V R I = E = V x x tV R
  • 59. How to stimulate? E = x t (J) V2 R Energy How to save energy? - lower pulse amplitude (V²) - lower pulse duration - high impedance
  • 60. Strength Duration Curve pulse width (msec) Voltagethreshold(V) Chronaxie Rheobase 2 x Rheobase Most efficient pulse width • The rheobase is the least voltage needed to depolarise the heart at an infinite pulse duration. • The chronaxie is the shortest pulse duration required to depolarise the heart at a voltage twice the rheobase.
  • 61. Pacing Thresholds  Suggested Intraoperative Values  Atrium  Less than 1.5 Volts  Ventricular  Less than 1.0 Volts  Pacing Impedance  300-1500 Ω Depending on lead type
  • 62. Acute To Chronic Threshold Change  Historically reported to occur between 2-8 weeks post implant  Thresholds may increase 2-5 times  Virtual Electrode - Myocardial Interface
  • 63. Excitable Tissue Non-Excitable Tissue Virtual Electrode Electrode Chronic Electrode
  • 64. Pacing Thresholds Hayes, D. et. al. Cardiac Pacing and Defibrillation: A Clinical Approach. Futura. Armonk, NY. 2000:7. 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 1 2 3 4 5 6 7 13 26 52 Time After Implant ChronicPacingThreshold,PulseWidth(ms) 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 1 2 3 4 5 6 7 13 26 52 Time After Implant ChronicPacingThreshold,PulseWidth(ms) Steroid No Steriod
  • 65. Sensing Definition: The ability of the pacemaker to sense an intrinsic electrical signal
  • 66. Sensing  When programming sensitivity, as you lower the number you make the pacemaker more sensitive, (allow it “see” more). 1 mV 2 mV 5 mV Sensing
  • 67. Sensing  Sensing Threshold: indicates the minimum intracardiac signal that will be sensed by the pacemaker to initiate the pacemaker response (inhibited or triggered) Sensing
  • 69. 0 5 10 15 20 25 1 3 5 10 30 50 100 300 1000 VES R-wave T-wave Amplitude Frequency (Hz) P-wave Myopotentials (mV) How to sense? Filtering of Intracardiac Signals
  • 70. How to sense? Sensitivity: 2.5 mV Vs Vs 0 5 5 Intra- cardiac Signal (mV) Vs Vs Vs Vs PM Marker
  • 71. How to sense? Sensitivity: 5.0 mV Intra- cardiac Signal (mV) PM Marker 0 5 5 Vs Vs  Undersensing
  • 72. Sensing Thresholds  Suggested Intraoperative Values  Atrium  Greater than 2.0 mV  Ventricular  Greater than 5.0 mV
  • 73. The NASPE/BPEG Generic (NBG) Code Position Category Letters Used Manufac- turer’s Designation Only I II III Chamber(s) Paced Chamber(s) Sensed Response to Sensing Rate modulation Multisite pacing O-None P-Simple Programmable M-Multi- Programmable C-Communicating R-Rate modulation O-None A-Atrium V-Ventricle D-Dual (A+V) S- Single (A or V) S- Single (A or V) O-None A-Atrium V-Ventricle D-Dual (A+V) O-None T-Triggered I-Inhibited D-Dual (T+I) O-None A-Atrium V-Ventricle D-Dual (A+V) IV V Version 2001
  • 74. Insulation Break Current is escaping Decreased Resistance Increased Current Drain Pacing and sensing problems
  • 75. Lead Fracture Current cannot reach heart Increased Resistance Decreased Current Drain Pacing and sensing problems
  • 79. Pacemaker Power Source Zinc-Mercury Lithium-Iodine Time Time
  • 81. Pacemaker Power Source Pulse Amplitude and Device Longevity Battery 1.1 Ah Mode VVI VVI DDD DDD Amplitude (V) 5 2.5 5 2.5 Inhibited (µA) 11 11 12 12 Pacing V (µA) + 10 + 2,5 + 10 + 2,5 Pacing A (µA) - - + 10 + 2,5 Total (µA) 21 13,5 32 17 Longevity (yrs) 6,2 9,6 4,1 8,0
  • 82. Lead Resistance/Impedance Changes  High Resistance  > 2500 ohms  Also called an “Open Circuit”  Chronic lead system  Fractured lead conductor coil  Acute lead system  Loss of contact between the terminal pin of the lead and the pacemaker header set screw
  • 83.  Low Resistance  < 250 ohms  Also called “Shorted Circuit”  Insulation Break-Down  Insulation cut by suture  Degradation of the insulation  Subclavian Crush Syndrome Lead Resistance/Impedance Changes
  • 85. First graphic documentation of ventricular fibrillation ICD Evolution: 1850 Carl Ludwig (1816-1895)
  • 86.  1st documented termination of VF with elevated current  Their work went largely unnoticed for 30 years ICD Evolution: 1899
  • 87. • Reproduced electric current termination of VF • Done at the request of Bell telephone to address electrocution of line workers (occurring at the rate of 1000/yr) ICD Evolution: 1930 William Kouwenhoven (1886-1975)
  • 88. What is ICD Therapy? • ICD therapy consists of pacing, cardioversion, and defibrillation therapies to treat tachyarrhythmias. ICDs also have programmable diagnostic functions. • An ICD system includes the device, and the pacing, sensing and defibrillation lead(s).
  • 89. 1947 • First successful defibrillation of exposed human heart • Required thoracotomy ICD Evolution:
  • 90. Early Medtronic Defibrillator 1950’s Used in open heart surgeries Applied directly to the heart ICD Evolution
  • 91. 1970 • Patent granted for first totally implantable defibrillator • System used an intracardiac catheter and SQ patch with detection via RV pressure transducer ICD Evolution Michael Mirowski (1924-1990)
  • 93. NEJM 1997;337;1576-83 Secondary Prevention of Sudden Arrhythmic Death AVID Study
  • 94. N of Patients at Risk ICD 742 502 (0.91) 274 (0.84) 110 (0.78) 9 Conventional 490 329 (0.90) 170 (0.78) 65 (0.69) 3 Moss AJ. N Engl J Med 2002;346:877-883 ICD ConventionalP = 0.007 1.0 0.9 0.8 0.7 0.6 0.0 SurvivalProbability 0 1 2 3 4 Years 0.78 0.69 -31% Primary Prevention of Sudden Arrhythmic Death MADIT II Study
  • 95.
  • 97. Ventricular Dysynchrony and Cardiac Resynchronization • Ventricular Dysynchrony1 – Electrical: Inter- or Intraventricular conduction delays typically manifested as left bundle branch block – Structural: disruption of myocardial collagen matrix impairing electrical conduction and mechanical efficiency – Mechanical: Regional wall motion abnormalities with increased workload and stress—compromising ventricular mechanics • Cardiac Resynchronization – Therapeutic intent of atrial synchronized biventricular pacing • Modification of interventricular, intraventricular, and atrial-ventricular activation sequences in patients with ventricular dysynchrony • Complement to optimal medical therapy 1 Tavazzi L. Eur Heart J 2000;21:1211-1214
  • 98. Prevalence of Inter- or Intraventricular Conduction Delay 1 Havranek E, Masoudi F, Westfall K, et al. Am Heart J 2002;143:412-417 2 Shenkman H, McKinnon J, Khandelwal A, et al. Circulation 2000;102(18 Suppl II): abstract 2293 3 Schoeller R, Andersen D, Buttner P, et al. Am J Cardiol. 1993;71:720-726 4 Aaronson K, Schwartz J, Chen T, et al. Circulation 1997;95:2660-2667 5 Farwell D, Patel N, Hall A, et al. Eur Heart J 2000;21:1246-1250 IVCD 15% IVCD >30% General HF Population1,2 Moderate to Severe HF Population3,4,5
  • 99. 60% 70% 80% 90% 100% 0 60 120 180 240 300 360 Days in Trial CumulativeSurvival QRS Duration (msec) <90 90-120 120-170 170-220 >220 Wide QRS – Proportional Mortality Increase • NYHA Class II-IV patients • 3,654 ECGs digitally scanned • Age, creatinine, LVEF, heart rate, and QRS duration found to be independent predictors of mortality • Relative risk of widest QRS group 5x greater than narrowest 1 Gottipaty V, Krelis S, Lu F, et al. JACC 1999;33(2) :145 [Abstr847-4]. Vesnarinone Study1 (VEST study analysis)
  • 100. Clinical Consequences of Ventricular Dysynchrony • Abnormal interventricular septal wall motion1 • Reduced dP/dt3,4 • Reduced pulse pressure4 • Reduced EF and CO4 • Reduced diastolic filling time1,2,4 • Prolonged MR duration1,2,4 1 Grines CL, Bashore TM, Boudoulas H, et al. Circulation 1989;79:845-853. 2 Xiao, HB, Lee CH, Gibson DG. Br Heart J 1991;66:443-447. 3 Xiao HB, Brecker SJD, Gibson DG. Br Heart J 1992;68:403-407. 4 Yu C-M, Chau E, Sanderson JE, et al. Circulation. 2002;105:438-445. Click to Start/Stop
  • 101. Longer Shorter Relaxed Courtesy of Dr Kass, MD, Johns Hopkins University, Maryland. SEPTUM BASE APEX SEPTUM BASE Normal Dilated Cardiomyopathy APEX Left Ventricular Dysfunction Electromechanical Dyssynchrony
  • 102. Summary of Proposed Mechanisms Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445 Intraventricular Synchrony Atrioventricular Synchrony Interventricular Synchrony  LA Pressure  LV Diastolic Filling  RV Stroke Volume  LVESV  LVEDV Reverse Remodeling Cardiac Resynchronization  MR dP/dt,  EF,  CO ( Pulse Pressure)
  • 103. Proposed Mechanisms: Improved Intraventricular Synchrony Kass D Chen-Huan C, Curry C, et al. Circulation 1999;99:1567-73 PV loop tracings at right illustrate BiV/LV pacing produces: greater stroke work (area) and increased stroke volume (width), and a reduced systolic volume 0 40 80 120 0 100 200 300 0 40 80 120 0 100 200 300 0 40 80 120 0 100 200 300 0 40 80 120 0 100 200 300 LVPressure(mmHg)LVPressure(mmHg) LV Volume (mL) LV Volume (mL) RV Apex RV Septum LV Free Wall Biventricular ----- NSR Control - - - VDD Pacing Adapted from Kass et al.
  • 104. Proposed Mechanisms: Improved Intraventricular Synchrony Click to Start/Stop  dP/dt 1,3,4 EF1,5  Pulse Pressure 3,4  SV&CO1, 2 Improved Intraventricular Synchrony1,2  MR1  LVESV1  LA Pressure1 1 Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445 2 Søgaard P, Kim W, Jensen H, et al. Cardiology 2001;95:173-182 3 Kass D Chen-Huan C, Curry C, et al. Circulation 1999;99:1567-73 4 Auricchio A, Ding J, Spinelli J, et al. J Am Coll Cardiol 2002;39:1163-1169 5 Stellbrink C, Breithardt O, Franke A, et al. J Am Coll Cardiol 2001;38:1957- 65
  • 105. Proposed Mechanisms: Improved Atrioventricular Synchrony Click to Start/Stop 1 Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445 2 Kindermann M, Frohlig G, Doerr T, et al. Pacing Clin Electrophysiol 1997; 20(I):2453-2462 3 Breithardt O, Stellbrink C, Franke A, et al. Am Heart J 2002;143:34-44 4 Søgaard P, Kim W, Jensen H, et al. Cardiology 2001;95:173-182 Improved Atrioventricular Synchrony  LA1 Pressure  LV Diastolic Filling1,3  LVEDV1,4 Optimized AV Delay:  Isovolumic Contraction Time1,2  MR1,4
  • 106. 1 Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445 2 Kerwin W, Botvinick E, O’Connel W, et al. JACC 2000;35:1221-7 Improved Interventricular Synchrony1,2  LV Diastolic Filling1  RV Stroke Volume1 Courtesy of Ottawa Heart Institute LV Wall Endocardium RV Septum LV Proposed Mechanisms: Improved Interventricular Synchrony
  • 107. Achieving Cardiac Resynchronization Mechanical Goal: Atrial-synchronized bi-ventricular pacing • Transvenous Approach – Standard pacing lead in RA – Standard pacing or defibrillation lead in RV – Specially designed left heart lead placed in a left ventricular cardiac vein via the coronary sinus Right Atrial Lead Right Ventricular Lead Left Ventricular Lead
  • 109. Cleland et al, Eur Heart J 2006;27(16):1928-32 0 500 1000 1500 0 25 50 75 Days P<0.0001 Event-freeSurvival 571192321365404 889213351376409 Control CRT N of Patients at Risk Medical Therapy CRT 100 HF CF III/IV EF<0.35 QRS>130ms Cardiac Resynchronization CARE-HF Study: Overall Mortality
  • 110. Cardiac Resynchronization CARE-HF Study: Sudden Mortality Cleland et al, Eur Heart J 2006;27(16):1928-32 CRT Medical Therapy Survival Time (days) Hazard ratio 0.54 (95% CI 0.35-0.84. P = 0.006) CRT = 32 sudden deaths (7.8%) Medical therapy = 54 sudden deaths (13.4%) 1.00 0.75 0.50 0.25 0.00 0 400 800 1200 1600
  • 111. Cardiac Resynchronization + ICD COMPANION Study: Overall Mortality N Engl J Med 2005 CRT-D CRT TMO Sobrevidalivredeeventos(%) 19% 12% 15% N:1520