1. History and Overview of Cardiac
Implantable Electronic Devices
Allied Professional Training, THRS
07th, 14th, 21st, Sep, 2013

2. Contents
 Brief of cardiac pacing
 Overview of battery and generator
 Lead technology
 Pacemaker Mode and NBG code

3. ECG history
王叔和 (201-
280BC) : 脈經
Hippocrates (460
– 375 BC): “Those
who suffer from
frequent and
strong faints
without any
manifest cause die
suddenly”
Dr. William Harvey
(1578-1657)
1774AD : first external
electric stimulation of
heart
1882AD :Dr.Von Ziemssen
decscribed 42 (46) y/o female
with chest tumor,
Stimulated her heart using
electric current and could
change her heart rate at will

4. 1887AD : The
physiologist Augustus
Desire’ recorded the
first human surface
electrocardiogram
Willem Einthoven
(1860 – 1927),He
initially indicated the
four observed
deflections with the
characters A, B, C, D
but later adopted the
middle characters of
the alphabeth: P, Q, R,
S and T
1942:The extremity bipolar electrode
system (the standard
electrocardiogram lead system) was
expanded in 1933 by F. N. Wilson who
introduced the unipolar chest wall
electrode
ECG history

5. Cardiac Pacing
1928: Mark Lidwell:
Pacing to save life of a
infant in cardiac arrest
1932: Hyman
Pacemaker
“artificial pacemaker”
1940 Hoop
pacemaker
1950
Zoll
Pacemaker :
1st catheter
electrode
1957
Bakken’s
Pacemaker

6. History of Pacemaker
1958, Siemens-Elema
In 1994 Siemens sold its entire pacemaker business to the
American company St. Jude Medical
Arne Larsson

7. Indications and CIED Products
• Pacemaker
• Single chamber pacemaker
• Dual chamber pacemaker
Bradycardia
• ICD (Implantable cardiovertor
defibrillator)
• Single chamber ICD
• Dual Chamber ICD
Ventricular
Tachycardia/Ventricular
Fibrillation
• CRT-P
• CRT-D
Congestive Heart Failure

8. Pacemaker

9. Modern Pacemaker
 Fully programmable dual chamber pacing
 Rate response to activity and metabolic changes
 Telemetry of pacer function
 Incorporated algorithms to respond to change in
intrinsic rhythms
 Store patients arrhythmic events

10. Pacing System
+

11. Fundamentals of Electricity
 Ohm’s Law
U = I X R
U = Voltage (Volt, V)
I = Current (Ampere, A)
R = Resistance ( Ohm, )
6 V
I = 6 / 3 = 2 A
12 V
I = 12 / 6 = 2 A
3 6

12. Pacing Impedance
Insulation Defect
<250 Ohm
Normal Pacing
Impedance
300 Ohm~1500
Ohm
Lead fracture
>1500 Ohm

13. Battery Energy
 Energy, W= U X I X t
W = U x I x t
W=
U2 x t
R
I =
U
R
2X output voltage
4X Energy

15. Pacemaker Components
Connector
Electric
component
Battery

16. Lithium Battery
Battery Technology
Li-I battery
3,0
[V]
[Ah]
Lithiumiodine
Phase 1 Phase 2
Phase 3
30 µA
2,0 1.8 V
1,0
0 1 2 3 4

17. A Specialized Battery – Quasar (QMR)
 Uses Lithium on the anode and both Silver Vanadium Oxide (SVO)
and polycarbonmonofluoride (CFx) on the cathode
 SVO for fast movement of ions
 Lithium and CFx to approximate pacer battery characteristic
 Current collector- collect ions formed by chemical reaction & transport them to
battery terminal & to the device

18. Battery Capacity and Longevity

19. How pacemaker works
 Pacing : Amplitude (V), Pulse width (ms)
Capture
Noncapture
Pulse Width (ms)
PulseAmplitude(V)

20. How Pacemaker works
 Sensing
T-wave P- or R-wave Myopotentials
8 mV
0,2 mV1 mV
Band pass filter

21. How Pacemaker Works
 Sensing- Choosing sensitivity
23
Sensitivity
5.0 mV
Sensitivity 1.0 mV
Sensitivity
10.0 mV

22. 24
Considerations in Sensitivity Programming
 To make the device more sensitive (to pick up signals it
might be missing), lower the mV setting
 To make the device less sensitive (to avoid detecting non-
cardiac signals), increase the mV setting
 Sensitivity should
 Pick up low-amplitude cardiac signals
 Avoid very low-amplitude non-cardiac signals

23. Timing Cycles
 Base rate (Lower rate limit)
 Refractory
Absolute Refractory Period Relative or Noise Sampling Period Alert Period

24. I II III IV V
Chamber(s)
Paced
Chamber(S)
Sensed
Mode(s) of
Response
Progammable
Functions
Antitachyca
rdia
Functions
V=Ventricle V=Ventricle T=Triggered R=Rate
Modulable
O=None
A=Atrium A=Atrium I=Inhibited C=Cpmmunicating P=Paced
D=Dual (A&V) D=Dual (A&V) D=Dual M=Multiprogramm
able
S=Shocks
O=None O=None O=None P=Simple
Programmable
D=Dual
O= None
THE NBG CODE

25. 27
Mode Selection Considerations
 Status of Atrial Rhythm
 Intrinsic vs. Paced
 Presence of Atrial
Tachyarrhythmias:
 Acute/Chronic
 Status of AV Conduction
 Normal Slowed Blocked
 Presence of Chronotropic
Incompetence
Single Chamber ?
Dual Chamber ?
Rate Modulation?

27. Pacing Lead
 Unipolar-Large Antenna
• Large spike
• More sensitive to interference
• Pectoral muscle stimulation
• More susceptible to EMI
• Smaller lead diameter
 Bipolar
• Small spike
• More sensitive to intrinsic
cardiac signals
• No myopotential inhibition
• EMI protected
• Less crosstalk
Cathod “-”
Anode “+”
Anode “+”
Cathod “-”
Unipolar
Bipolar

28. Pacing Lead
 Passive lead
 Tined lead
 Active lead
 Screwed lead

29. 31SJM internal use ONLY
Steroid Delivery
 MCRD steroid
 (Monolithic Controlled Release Delivery)
 < 1 mg Dexamethasone
Sodium Phosphate
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0 4 8 12 16 20 52
l
l
l
ll
l
l
l
l
l l
lll ll
l
ll l
l
l
Amplitude (Volt)
Weeks
With steroid

30. Myocardial and Epicardial Leads
 Leads applied directly to the
heart
 Fixation mechanisms include:
 Epicardial stab-in
 Myocardial screw-in
 Suture-on

31. Magnet Reed Switch
Magnet are need for test:
Asynchronous mode
DOO/AOO/VOO
Magnet rate could indicate
battery longevity, eg. Magnet
rate is 99 at BOL, 85 at ERI

32. SJM internal use ONLY
Magnet for Troubleshooting
 When a magnet is applied:
 Pacing rate increases
 Newer device 98.5 ppm (5000 series devices)
 Older SJM devices (pre Affinity) programmed rate
 BOL = magnet rate = 98.6 ppm / 2.75 volts
 ERI = magnet rate = 86.3 ppm / 2.5 volts
 EOL = magnet rate = 68.0 ppm / 2.2 volts
 Device reverts to asynchronous mode
 DDD >> DOO
 VVI >> VOO
 AAI >> AOO
 AV delay decreases 125
 If you don’t get any pacing?
 Could be an ICD or the pacer is at EOS
 Check CXR for ID

33. ICD

34. History of the AICD
 1969 - Dr. Mirowski and Dr. Morton Mower
begin collaborating and develop the first
experimental model
Milestones

35. History of AICD Therapy
 1975 - The first device is implanted and tested in an
animal
 1980 - The first patient is implanted with an AICD
device
Milestones

36. Whats Inside an ICD?

37. ICD Leads-DF1 and IS-1
Two DF-1, One IS-1
DF-1 (Shock)IS-1 (Pace/ Sense)

38. 40
DF4 Development History
 Project began in 2004
 Originally designed on Epic+ device
 Built on Atlas II+ HF, Promote (non-RF), and Riata ST for
testing
 Extensive testing done on this system
 No failures at two times maximum voltage (1500V)
 First submissions September 2007

39. Dual Coil Lead
Proximal
Shock
Electrode
Distal
Shock
Electrode
Hot Can
Single Coil Lead
Cold Can

40. Dual coil v.s. Single coil
Dual Coil Single Coil
Pro Lower DFT Higher DFT
Con Difficult to
remove
May easier to
remove

41. ICD Modules
Special Functions
Measurements
Electrogram and Data Storage
Reversion
Classification
Sensing
Induction
Therapy

42. PVT
Detection - Fixed Gain/ Sensitivity
NSR

43. Automatic Sensitivity Control (ASC)
Automatic Sensitivity Tracking
GAIN
FILTER COMP
THRESHOLD
Sensed EventFrom Sense/Pace
Leads
Threshold adjusts
+ and - to adapt
to the signal

44. Defib with slow VT and Fast VT
Tach B
(Fast VT)
(ATP and
CV Shocks)
Treatment
375 ms
(160 bpm)
Sinus
Tach A
(Slow VT)
(ATP and
CV Shocks)
Fib
(Shock)
Non-Treatment Treatment Treatment
500 ms
(120 bpm)
300 ms
(200 bpm)
>500 ms
(<120 bpm)
No therapy
SVT discrimination, VT
therapy deliver when VT
indicated
VF therapy
deliver

45. AF/AFl
+
Morphology,
Stability ( AVA)
VT/ VF
Treat
VT w/ 1:1
retro
AF + VT
AFl + VT
Treat
AF/AFl
Inhibit
ST, AT,
1:1 SVT
Inhibit Treat
Isolated
VT
+
Morphology
Onset
Sinus Tach
AV Int
Atrial CL
Ventricular CL
Dual Chamber Sensing:
Rate Branch + Additional SVT Criteria

46. Therapy
Anti-tachycardia pacing (ATP)

47. Therapy
High Voltage shock
 Uses of High Voltage Therapy
 To terminate:
 Ventricular Tachycardia
 Ventricular Fibrillation
Thanks, I needed that!

48. Q: How do you manage a patient with multiple
shocks?
 Appropriate therapy
 Ischemia
 CHF
 Electrolytes
 Beta blockers
 Procainamide
 Amiodarone
 Inappropriate Therapy
 Noise
 EMI
 Inappropriate programming
 Increased rate cutoff settings for 1 zone,
2 zone and 3 zone programming
 Longer detection intervals for 2 zone and
3 zone programming
 Optimized SVT discriminator settings for
VR, DR and CRT-D
 ATP as the first therapy in all zones
(including ATP while charging in VF zone)
 VT and SVT override settings
programmed to off
epoisodes of sustained VT/VF in 24 hrs = “Storm”

49. Magnet in ICD
 Off Detection, No therapy will be delivered

50. CRT (Cardiac Resynchronization
Therapy)

51. 53
Ventricular Resynchronization with CRT
Pacing @ left lateral free wall in addition
to right side
Symmetric lateral and septal wall
conduction & contraction
More efficient pump

52. 54
Synchrony
More work done
with less effort &
increased efficiency!

53. 55
Coronary Sinus
approach
Right Atrial
Lead
Right Ventricular Lead
Left Lateral Free wall
LV Lead
Optimal LV Lead Placement

54. Venograms and LV Lead Placement
LAO AP RAO
Align to CS OS/
Middle Vein
Anterior
Lateral
Posterior
Right
Basal
Mid
Apical

55. Final LV Lead Position
RAO
Good
lateral
position

56. Final LV Lead Position
LAO
Good
lateral
position

57. CIED revolution
MRI
conditional
Device
Leadless
pacemaker
……