History and Overview of Cardiac

Implantable Electronic Devices Allied Professional Training, THRS

07th, 14th, 21st, Sep, 2013

Contents

Brief of cardiac pacing

Overview of battery and generator

Lead technology

Pacemaker Mode and NBG code

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

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

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

History of Pacemaker

1958, Siemens-Elema

In 1994 Siemens sold its entire pacemaker business to the

American company St. Jude Medical

Arne Larsson

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

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

+

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

Pacing Impedance

Insulation Defect

<250 Ohm

Normal Pacing

Impedance

300 Ohm~1500

Ohm

Lead fracture

>1500 Ohm

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

Pacemaker Components

Connector

Electric

component

Battery

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

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

Battery Capacity and Longevity

How pacemaker works

Pacing : Amplitude (V), Pulse width (ms)

Capture

Noncapture

Pulse Width (ms)

Pu

lse A

mp

litud

e (V

)

How Pacemaker works

Sensing

T-wave P- or R-wave Myopotentials

8 mV

0,2 mV 1 mV

Band pass filter

How Pacemaker Works

Sensing- Choosing sensitivity

23

Sensitivity

5.0 mV

Sensitivity 1.0 mV

Sensitivity

10.0 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

Timing Cycles

Base rate (Lower rate limit)

Refractory

Absolute Refractory Period Relative or Noise Sampling Period Alert Period

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

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?

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

Pacing Lead

Passive lead

Tined lead

Active lead

Screwed lead

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

l l

l

l l

l

l l

l l l l l

l

l l l

l l

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

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

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

ICD

History of the AICD

1969 - Dr. Mirowski and Dr. Morton Mower

begin collaborating and develop the first

experimental model

Milestones

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

Whats Inside an ICD?

ICD Leads-DF1 and IS-1

Two DF-1, One IS-1

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

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

Dual Coil Lead

Proximal

Shock

Electrode

Distal

Shock

Electrode

Hot Can

Single Coil Lead

Cold Can

Dual coil v.s. Single coil

Dual Coil Single Coil

Pro Lower DFT Higher DFT

Con Difficult to

remove

May easier to

remove

ICD Modules

Special Functions

Measurements

Electrogram and Data Storage

Revers

ion

Cla

ssif

icati

on

Sen

sin

g

Induction

Th

era

py

PVT

Detection - Fixed Gain/ Sensitivity

NSR

Automatic Sensitivity Control (ASC)

Automatic Sensitivity Tracking

GAIN FILTER COMP

THRESHOLD

Sensed Event From Sense/Pace

Leads

Threshold adjusts

+ and - to adapt

to the signal

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

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

Therapy

Anti-tachycardia pacing (ATP)

Therapy

High Voltage shock

Uses of High Voltage Therapy

To terminate:

Ventricular Tachycardia

Ventricular Fibrillation

Thanks, I needed that!

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”

Magnet in ICD

Off Detection, No therapy will be delivered

CRT (Cardiac Resynchronization

Therapy)

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

54

Synchrony

More work done

with less effort &

increased efficiency!

55

Coronary Sinus

approach

Right Atrial

Lead

Right Ventricular Lead

Left Lateral Free wall

LV Lead

Optimal LV Lead Placement

Venograms and LV Lead Placement

LAO AP RAO

Align to CS OS/

Middle Vein

Anterior

Lateral

Posterior

Right

Basal

Mid Apical

Final LV Lead Position

RAO

Good

lateral

position

Final LV Lead Position

LAO

Good

lateral

position

CIED revolution

MRI

conditional

Device

Leadless

pacemaker

……