0
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...
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...
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...
Pacing Lead
 Unipolar
•
•
•
•
•

 Bipolar

Large spike
More sensitive to interference
Pectoral muscle stimulation
More s...
Pacing Lead
 Passive lead
 Tined lead

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

 < 1 mg Dexamethasone
Sodium Phosphate

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

6V
I=6/3=2A

U=IXR
U = Voltage (Volt, V)
I = Current (Ampere, A)
R = Resistance (...
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), lo...
NBG Code
I

II

III

IV

V

Chamber(s)
Paced

Chamber(s)
Sensed

Response to
Sensing

Rate
Modulation

Multisite
Pacing

O...
Mode Selection Considerations
 Status of Atrial Rhythm
 Intrinsic
 Presence of Atrial

Tachyarrhythmias:
 Acute/Chroni...
ICD
History of the AICD
Milestones
 1969 - Dr. Mirowski and Dr. Morton Mower
begin collaborating and develop the first
experi...
History of AICD Therapy
Milestones
 1975 - The first device is implanted and tested in an
animal
 1980 - The first patie...
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 t...
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

Measurement...
Therapy
High Voltage shock
 Uses of High Voltage Therapy
 To terminate:
 Ventricular Tachycardia
 Ventricular Fibrilla...
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
+ ...
Defib with slow VT and Fast VT
No therapy

Non-Treatment

SVT discrimination, VT
therapy deliver when VT
indicated

VF the...
CRT (Cardiac Resynchronization
Therapy)
Ventricular Resynchronization with CRT
Pacing @ left lateral free wall in addition
to right side

Symmetric lateral and se...
Optimal LV Lead Placement

Coronary Sinus
approach
Right Atrial
Lead
Left Lateral Free wall
LV Lead
Right Ventricular Lead...
Venograms and LV Lead Placement
Anterior

Right

Lateral

Basal

Posterior

Align to CS
OS/ Middle
Vein

Mid

LAO

AP

Api...
Final LV Lead Position
Final LV Lead Position
Thanks for your
attention
心臟植入性電子儀器(CIED)之歷史"CIED Overview"_20131019南區
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心臟植入性電子儀器(CIED)之歷史"CIED Overview"_20131019南區

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  • The Electrical Management of Cardiac Rhythm Disorders, Bradycardia, Slide Presentation 02
    Lead Technology
  • 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
  • 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
  • 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.
  • EMI : electrical magnet interferrencecrosstalk means sensing the pacing of another chamber
  • 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.
  • 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.
  • 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!
  • Guidant logo in upper right corner/
  • DF1-unipolar config
    Frontier – LV for bottom
  • 830V per maximum
  • 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.
  • 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.
  • Notice sternal wires to confirm view
    Notice LV and RV leads are in parallel
  • Notice sternal wires to confirm view
    Notice LV and RV leads are in parallel
  • Notice LV and RV leads are as far apart as possible, separating Septal wall from LV free wall
  • Transcript of "心臟植入性電子儀器(CIED)之歷史"CIED Overview"_20131019南區"

    1. 1. History and Overview of Cardiac Implantable Electronic Devices 成大醫院心導管室 放射師 王亦聖
    2. 2. Contents     Brief of cardiac pacing Overview of battery and generator Lead technology Pacemaker Mode and NBG code
    3. 3. ECG history
    4. 4. Cardiac Pacing
    5. 5. History of Pacemaker Arne Larsson 1958, Siemens-Elema In 1994 Siemens sold its entire pacemaker business to the American company St. Jude Medical
    6. 6. History of Pacemaker
    7. 7. Indications and CIED Products
    8. 8. Pacemaker
    9. 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. 10. Pacing System +
    11. 11. Pacemaker Components Connector Electric component Battery
    12. 12. Battery Technology Mercury-Zinc Battery
    13. 13. 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]
    14. 14. 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
    15. 15. Pacing Lead  Passive lead  Tined lead  Active lead  Screwed lead
    16. 16. 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
    17. 17. Myocardial and Epicardial Leads  Leads applied directly to the heart  Fixation mechanisms include:  Epicardial stab-in  Myocardial screw-in  Suture-on
    18. 18. 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
    19. 19. Pacing Impedance Insulation Defect <250 Ohm Normal Pacing Impedance 300 Ohm~1500 Ohm Lead fracture >1500 Ohm
    20. 20. Battery Capacity and Longevity
    21. 21. How pacemaker works  Pacing : Amplitude (V), Pulse width (ms) Pulse Amplitude (V) Capture Noncapture Pulse Width (ms)
    22. 22. How Pacemaker Works  Sensing- Choosing sensitivity Sensitivity 10.0 mV Sensitivity 5.0 mV Sensitivity 1.0 mV 23
    23. 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
    24. 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)
    25. 25. 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?
    26. 26. ICD
    27. 27. History of the AICD Milestones  1969 - Dr. Mirowski and Dr. Morton Mower begin collaborating and develop the first experimental model
    28. 28. 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
    29. 29. Whats Inside an ICD?
    30. 30. ICD Leads-DF1 and IS-1 Two DF-1, One IS-1 IS-1 (Pace/ Sense) DF-1 (Shock)
    31. 31. DF4 Development History  Project began in 2004  First submissions September 2007 35
    32. 32. Dual Coil Lead Proximal Shock Electrode Distal Shock Electrode Single Coil Lead
    33. 33. Dual coil v.s. Single coil Dual Coil Single Coil Advantange Lower DFT May easier to remove Disadvantage Difficult to remove Higher DFT
    34. 34. 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
    35. 35. 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!
    36. 36. Therapy Anti-tachycardia pacing (ATP)
    37. 37. Detection - Fixed Gain/ Sensitivity NSR PVT
    38. 38. 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
    39. 39. 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)
    40. 40. CRT (Cardiac Resynchronization Therapy)
    41. 41. 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
    42. 42. Optimal LV Lead Placement Coronary Sinus approach Right Atrial Lead Left Lateral Free wall LV Lead Right Ventricular Lead 47
    43. 43. Venograms and LV Lead Placement Anterior Right Lateral Basal Posterior Align to CS OS/ Middle Vein Mid LAO AP Apical RAO
    44. 44. Final LV Lead Position
    45. 45. Final LV Lead Position
    46. 46. Thanks for your attention
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