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

1958, Siemens-Elema In 1994 Siemens sold its entire pacemaker business to the American company St. Jude Medical

Arne Larsson

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

Mercury-ZincBattery

Battery Technology

Lithium BatteryBattery TechnologyLi-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

Pacing Lead Unipolar

• 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

Pacing Lead

Passive lead Tined lead

Active lead Screwed lead

Steroid Delivery MCRD steroid

(Monolithic Controlled Release Delivery) < 1 mg Dexamethasone

Sodium Phosphate

3.53.02.52.01.51.00.5

0 4 8 12 16 20 52

Amplitude (Volt)

Weeks

With steroid

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

U = I X RU = 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

Pacing Impedance

Insulation Defect

<250 Ohm

Normal Pacing Impedance300 Ohm~1500 Ohm

Lead fracture

>1500 Ohm

Battery Capacity and Longevity

How pacemaker works Pacing : Amplitude (V), Pulse width (ms)

Capture

Noncapture

Pulse Width (ms)

Pu

lse Am

plitu

de (V

)

How Pacemaker Works Sensing- Choosing sensitivity

23

Sensitivity5.0 mV

Sensitivity 1.0 mV

Sensitivity10.0 mV

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

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 + V)

O = None

A = Atrium

V = Ventricle

D = Dual (A + V)

O = None

T = Triggered

I = Inhibited

D = Dual (T + I)

O = None

R = Rate modulation

O = None

A = Atrium

V = Ventricle

D = Dual (A + V)

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

BPEG is the British Pacing and Electrophysiology Group

26

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

Single Chamber ?

Dual Chamber ?

Rate Modulation?

ICD

History of the AICD

1969 - Dr. Mirowski and Dr. Morton Mower begin collaborating and develop the first experimental model

MilestonesMilestones

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

MilestonesMilestones

Whats Inside an ICD?

ICD Leads-DF1 and IS-1

Two DF-1, One IS-1

DF-1 (Shock)IS-1 (Pace/ Sense)

35

DF4 Development History Project began in 2004 First submissions September 2007

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

Special Functions

Measurements

Electrogram and Data Storage

Rev

ersi

on

Cla

ssif

icat

ion

Sen

sin

gInduction

Th

erap

y

TherapyHigh Voltage shock

Uses of High Voltage Therapy To terminate:

Ventricular Tachycardia Ventricular Fibrillation

Thanks, I needed that!

Phase 1

Phase 2

TherapyAnti-tachycardia pacing (ATP)

PVT

Detection - Fixed Gain/ Sensitivity

NSR

Automatic Sensitivity Control (ASC)

Automatic Sensitivity Tracking

GAINFILTER COMP

THRESHOLD

Sensed EventFrom Sense/Pace Leads

Threshold adjusts+ and - to adapt

to the signal

Defib with slow VT and Fast VT

Tach B(Fast VT)

(ATP andCV Shocks)

Treatment

375 ms(160 bpm)

Sinus

Tach A(Slow VT)

(ATP andCV Shocks)

Fib

(Shock)

Non-Treatment Treatment Treatment

500 ms(120 bpm)

300 ms(200 bpm)

>500 ms(<120 bpm)

No therapySVT discrimination, VT therapy deliver when VT indicated

VF therapy deliver

CRT (Cardiac Resynchronization Therapy)

46

Ventricular Resynchronization with CRT

Pacing @ left lateral free wall in addition to right side

Symmetric lateral and septal wall conduction & contraction

More efficient pump

47

Coronary Sinus approach

Right Atrial Lead

Right Ventricular Lead

Left Lateral Free wallLV Lead

Optimal LV Lead Placement

Venograms and LV Lead Placement

LAO AP RAO

Align to CS OS/ Middle Vein

Anterior

Lateral

Posterior

Right

Basal

MidApical

Final LV Lead Position

Final LV Lead Position

Thanks for your attention