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History and Overview of Cardiac
Implantable Electronic Devices

成大醫院心導管室
放射師 王亦聖
Contents





Brief of cardiac pacing
Overview of battery and generator
Lead technology
Pacemaker Mode and NBG code
ECG history
Cardiac Pacing
History of Pacemaker

Arne Larsson

1958, Siemens-Elema
In 1994 Siemens sold its entire pacemaker business to the
American company St. Jude Medical
History of Pacemaker
Indications and CIED Products
Pacemaker
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




Pacing System

+
Pacemaker Components
Connector

Electric
component

Battery
Battery Technology

Mercury-Zinc
Battery
Battery Technology
Li-I battery Lithium Battery
[V]

Lithiumiodine

3,0

30 µA
2,0

1.8 V
Phase 1

Phase 2
Phase 3

1,0

0

1

2

3

4

[Ah]
Pacing Lead
 Unipolar
•
•
•
•
•

 Bipolar

Large spike
More sensitive to interference
Pectoral muscle stimulation
More susceptible to EMI
Smaller lead diameter

• Small spike
• More sensitive to intrinsic
cardiac signals
• No myopotential inhibition
• EMI protected
• Less crosstalk

Anode
“+”
Unipolar
Anode
“+”

Cathod
“-”

Cathod
“-”
Bipolar
Pacing Lead
 Passive lead
 Tined lead

 Active lead
 Screwed lead
Steroid Delivery
 MCRD steroid
 (Monolithic Controlled Release Delivery)

 < 1 mg Dexamethasone
Sodium Phosphate

mplitude (Volt)
3.5
3.0
2.5
 
2.0   
1.5
1.0 




0.5





0 4 8 12 16 20





With steroid




52

Weeks
Myocardial and Epicardial Leads
 Leads applied directly to the
heart
 Fixation mechanisms include:
 Epicardial stab-in
 Myocardial screw-in
 Suture-on
Fundamentals of Electricity
 Ohm’s Law

6V
I=6/3=2A

U=IXR
U = Voltage (Volt, V)
I = Current (Ampere, A)
R = Resistance ( Ohm, Ω)

3Ω

12 V

6Ω

I = 12 / 6 = 2 A
Pacing Impedance

Insulation Defect
<250 Ohm

Normal Pacing
Impedance
300 Ohm~1500
Ohm

Lead fracture
>1500 Ohm
Battery Capacity and Longevity
How pacemaker works
 Pacing : Amplitude (V), Pulse width (ms)
Pulse Amplitude (V)

Capture

Noncapture
Pulse Width (ms)
How Pacemaker Works
 Sensing- Choosing sensitivity

Sensitivity
10.0 mV
Sensitivity
5.0 mV
Sensitivity 1.0 mV

23
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 noncardiac signals), increase the mV setting
 Sensitivity should
 Pick up low-amplitude cardiac signals
 Avoid very low-amplitude non-cardiac signals

24
NBG Code
I

II

III

IV

V

Chamber(s)
Paced

Chamber(s)
Sensed

Response to
Sensing

Rate
Modulation

Multisite
Pacing

O = None
A = Atrium
V = Ventricle
D = Dual (A +

O = None
A = Atrium
V = Ventricle
D = Dual (A +

O = None
T = Triggered
I = Inhibited
D = Dual (T +

O = None
R = Rate

O = None
A = Atrium
V = Ventricle
D = Dual (A +

V)

V)

modulation

I)

NASPE/BPEG Generic
NASPE is the North American Society of Pacing and Electrophysiology
BPEG is the British Pacing and Electrophysiology Group

V)
Mode Selection Considerations
 Status of Atrial Rhythm
 Intrinsic
 Presence of Atrial

Tachyarrhythmias:
 Acute/Chronic
 Status of AV Conduction
 Normal Slowed Blocked
 Presence of Chronotropic
Incompetence
26

Single Chamber ?

Dual Chamber ?

Rate Modulation?
ICD
History of the AICD
Milestones
 1969 - Dr. Mirowski and Dr. Morton Mower
begin collaborating and develop the first
experimental model
History of AICD Therapy
Milestones
 1975 - The first device is implanted and tested in an
animal
 1980 - The first patient is implanted with an AICD
device
Whats Inside an ICD?
ICD Leads-DF1 and IS-1
Two DF-1, One IS-1

IS-1 (Pace/ Sense)

DF-1 (Shock)
DF4 Development History
 Project began in 2004
 First submissions September 2007

35
Dual Coil Lead

Proximal
Shock
Electrode

Distal
Shock
Electrode

Single Coil Lead
Dual coil v.s. Single coil

Dual Coil

Single Coil

Advantange

Lower DFT

May easier to
remove

Disadvantage

Difficult to
remove

Higher DFT
ICD Modules
Electrogram and Data Storage

Special Functions

no sr eve R
i

y par e hT

not ac fi ssa C
i i
l

Measurements

gn s ne S
i

Induction
Therapy
High Voltage shock
 Uses of High Voltage Therapy
 To terminate:
 Ventricular Tachycardia
 Ventricular Fibrillation
Ph
ase
1

se
Pha

2

Thanks, I needed that!
Therapy
Anti-tachycardia pacing (ATP)
Detection - Fixed Gain/ Sensitivity

NSR

PVT
Automatic Sensitivity Control (ASC)
Automatic Sensitivity Tracking
GAIN
From Sense/Pace
Leads

FILTER
Threshold adjusts
+ and - to adapt
to the signal
THRESHOLD

COMP
Sensed Event
Defib with slow VT and Fast VT
No therapy

Non-Treatment

SVT discrimination, VT
therapy deliver when VT
indicated

VF therapy
deliver

Treatment

Treatment

Treatment

Tach A
(Slow VT)

Tach B
(Fast VT)

(ATP and
CV Shocks)

(ATP and
CV Shocks)

500 ms
(120 bpm)

375 ms
(160 bpm)

Sinus

>500 ms
(<120 bpm)

Fib
(Shock)

300 ms
(200 bpm)
CRT (Cardiac Resynchronization
Therapy)
Ventricular Resynchronization with CRT
Pacing @ left lateral free wall in addition
to right side

Symmetric lateral and septal wall
conduction & contraction

More efficient pump

46
Optimal LV Lead Placement

Coronary Sinus
approach
Right Atrial
Lead
Left Lateral Free wall
LV Lead
Right Ventricular Lead

47
Venograms and LV Lead Placement
Anterior

Right

Lateral

Basal

Posterior

Align to CS
OS/ Middle
Vein

Mid

LAO

AP

Apical

RAO
Final LV Lead Position
Final LV Lead Position
Thanks for your
attention

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心臟植入性電子儀器(CIED)之歷史"CIED Overview"_20131019南區

Notes de l'éditeur

  1. The Electrical Management of Cardiac Rhythm Disorders, Bradycardia, Slide Presentation 02 Lead Technology
  2. 威廉·埃因托芬(Willem Einthoven,1860年5月21日-1927年9月29日)是一位荷蘭醫師與生理學家
  3. 1928: Mark Lidwell Lidwell&apos;s device ran on alternating current and required a needle to be inserted into the patient&apos;s ventricle. In 1928 he used intermittent electrical stimulation of the heart to save the life of a child born in cardiac arrest 1932Hyman&apos;s device, described in 1932 (Fig.​(Fig.40,40, ​,41),41), was powered by a spring-wound hand-cranked motor and called by Hyman himself an “artificial pacemaker”, a term still in current use. John Hopps (Fig. 48), an electrical engineer, was recruited on a part-time basis by the National Research Council of Canada and designed what was perhaps the first electronic device specifically built as a cardiac pacemaker. It was an external unit driven by vacuum tubes. The electrical impulses were transmitted via a bipolar catheter electrode to the atria using a transvenous approach. Atrial pacing was readily achieved and heart rate could be controlled with no uncomfortable chest wall contractions
  4. Mr Larrson, 1915-2001, 25 replacement in his lifetimeThe first clinical implantation into a human of a fully implantable pacemaker was in 1958 at the Karolinska Institute in Solna, Sweden, using a pacemaker designed by Rune Elmqvist and surgeon Åke Senning, connected to electrodes attached to the myocardium of the heart by thoracotomy. The device failed after three hours. A second device was then implanted which lasted for two days. The world&apos;s first implantable pacemaker patient, Arne Larsson, went on to receive 26 different pacemakers during his lifetime. He died in 2001, at the age of 86, outliving the inventor as well as the surgeon.
  5. EMI : electrical magnet interferrencecrosstalk means sensing the pacing of another chamber
  6. Epicardial or myocardial leads are implanted to the outside of the heart. These implants represent less than 5% of leads implanted, and are used primarily in pediatric cases or for patients in whom transvenous lead implant is contraindicated.
  7. The resulting signal, after filtering, will be compared to the programmed sensitivity. Any signal of less amplitude than the sensitivity level will be under sensed. This is again one way of avoiding over-sensing. A signal of good quality and amplitude will exceed the sensitivity level and thus be sensed.
  8. The diagram points out how much of a balancing act it can be to program sensitivity. Let’s say the little signal indicated is a true cardiac signal that just happens to be small. You want the sensitivity “bar” low enough that such signals are detected. On the other hand, if that little signal was muscle noise or something else you did not want to detect, you would want sensitivity programmed high enough to not sense it. This is why sensitivity must be programmed for each patient individually and evaluated (and possibly reprogrammed) at every follow-up session!
  9. Guidant logo in upper right corner/
  10. DF1-unipolar config Frontier – LV for bottom
  11. 830V per maximum
  12. In this configuration the device can deliver Tach A and B therapy (ATP and/or CV) and Fib therapy (HV Shocks). Any rate less than 500 ms or 120 bpm will be called sinus and no therapy will be delivered. Any rate above 500 ms or 120 bpm but less than 375 ms or 160 bpm will receive Tach A therapy. Any rate greater than 375 ms or 160 bpm but less than 300 ms or 200 bpm will receive Tach B therapy. Any rate greater than 300 ms or 200 bpm will receive Fib or shock therapy. This configuration would be used rarely. The patient would have to have 2 different VT’s one fast and one slow.
  13. An epicardial approach was used initially to attach a lead to the posterolateral wall of the LV via a thoracotomy. Although the transvenous approach is now used more widely because of reduced intraoperative complications and an easier postoperative recovery, the epicardial approach may still be considered when coronary access can not be achieved.
  14. Notice sternal wires to confirm view Notice LV and RV leads are in parallel
  15. Notice sternal wires to confirm view Notice LV and RV leads are in parallel
  16. Notice LV and RV leads are as far apart as possible, separating Septal wall from LV free wall