Applied Science and Technology

Pulse Generators

Basic Circuit Components

Resistor

‘resists’ or slows flow of electrical charge

Measured in ohms; interchanged w impedance

Series: current is same in each resistor

Parallel: voltage is the same across each resistor

Capacitor

Stores & discharges electrical charge

Measured in farad (F)

Used in to store pacing pulses & shocks

Defibrillator circuit capacitors are 100-160 uF

Capacitance = Charge on conductor / potential across conductor (C = Q/V)

Transistor

Electrical switch within circuit

Function as current regulators; allows small current to control larger current

Billions of transistors built into pulse generators

Diode

Allows electrical current to flow in only one direction; director of flow

Zener diode protects pulse generator circuitry from high external voltages

Ex: external defibrillation

Rectifier

Converts biphasic signal to one with only positive components

Used in pulse generator sensing circuits

Half wave: only output positive portion of signal

Full wave: convert negative portion to positive signal

CMOS
 Complementary Metal Oxide Semiconductor

Elements of microprocessors and electric circuitry susceptible to radiation

Transformer

Converts electrical flow to output of higher voltage and lower current

Defib: used to charge capacitor to 900V from 3V battery

Pacer: used to create pulse output of up to 7.5V from 3V battery

Battery Technology

Desirable characteristics

High energy density

Low self-discharge

Small size

Highly predictable discharge curve

Solid state chemistry

Major components of batteries

Anode (+) : furnishes electrons to external circuit & at which electrochemical

oxidation occurs

Cathode(-): receives electrons & at which electrochemical reduction occurs

Early Battery Technologies/Chemistries

Nickel-Cadmium: first electronic pacemaker was implanted in Stockholm,

Sweden in 1958

Plutonium: various power sources have been used for pacemakers, including
thermoelectric batteries containing 2-4 curies of plutonium-238 (88yr half-life)

Mercury Oxide-Zinc: this battery had a very flat discharge curve, delivered 1.35V
cell voltage, and was susceptible to fluid infiltration.

Small amounts of hydrogen gas created reaction by-product which

required venting in generator shell

Current Battery Technology

Lithium Iodine: 2.8V

Lithium Manganese Dioxide: 3.3V

Lithium Carbon Monofluoride: 3.1V

 Lithium Silver Vanadium Oxide: 3.2V

Used in most ICD today

Optimized to charge defibrillation capacitor quickly

‘high rate’ battery

Pacemaker Longevity

Longevity = implant to ERI

Consumption

Determined by the energy consumption of pulse generator

Depends on both fixed parameters and physiologic and programmable variables

Programming to minimize unnecessary pacing can help optimize battery drain

Capacity

Determined by the deliverable capacity of its power source

Programmable output parameters of the system (voltage & pulse width)

Lead impedance

Pacing rate

Leads and Electrodes

Leads and Electrode Materials

Ideal Lead Properties

Biologically inert

No degeneration w movement or blood exposure

Ideal capture thresholds

Adequate sensing; p waves > 2.0 mV r waves > 5.0 mV

Stable fixation

MRI compatible

Lead Materials

Electrode

Platinum w 10% iridium

Elgiloy
 Silver and stainless steel

Activated carbon

Insulation

Polyethylene

Silicone rubber
High biocompatibility, low tear strength, high coefficient of friction

Polyurethane
High tensile strength, high tear strength

Polymers of polyurethane and silicone

-Multiple forms of insulation in single lead-

*most use either silicone or polyurethane*

Conductor Cables

Formats: double helix, dual helices, straight cables, combination, coaxial,

unifilar, multifilar, cable, solid

Pacing Electrode Designs

Endocardial Fixation: tined fixation v active fixation

Epicardial Fixation: screw-in v suture-on

Fixation Variety: pre-shaped LV leads, passive fixation w texture

Lead connector configurations

Original connectors

5-6 mm unipolar leads

VS 1 Standard

VS-1A: no sealing rings

VS-1B: sealing rings

IS-1/DF-1 Standard

IS-1 Pacing leads

DF-1 Defibrillator leads

IS-4/DF-4 Standard

IS-4 pacing defibrillator leads

 DF-4 ‘in line’ high voltage defibrillator leads

Standardized Headers & Connector Pins

DF4 system

Singe set screw; low energy IS4 and high energy DF4 leads

Advantages:

Reduced pocket bulk, prevention of inadvertent reversal of high-

voltage connections

DF1 & IS1 system

Single set screw for DF1, occasionally two for IS1

Seal rings are part of lead, not connector

ICD Lead Connectors

Conductors Coating

PTFE or ETFE

Isolates electrical components and bloodstream

Central Coil

Conductor for pacing cathode (tip)

Allows for stylet insertion

Facilitates extension or retraction of fixation helix

Helix in active fixation leads

Parallel Cables

Conductors for pacing anode(ring) and high voltage coils

Arranged as parallel cables and distributed around the central

coil

Electric current to anode, high voltage RV coil & high voltage SVC coil

Quadripolar Pacing

Multiple Shape and Spacing Options

Enables greater pacing flexibility than unipolar or bipolar leads

Low profile, various shapes

Various electrode spacing options

 Offers additional options to prevent pacing complications

Technical Problems w Pacing Leads

Electrode Problems

Materials risk of failure

Deterioration of polymer in physiologic environment

Thromboembolism due to inadequate blood compatibility

Tissue reactions at electrode/tissued interface (exit block)

General foreign body rejection

Perforation of leads

Excessive stress from sutures and body structures

Macro and micro dislodgement

Myocardial perforation

Symptomatic perforations reported

0.1-1.2% for pacemakers leads, 0.6-5.2% for ICD leads

Asymptomatic perforations up to 15%

Phrenic nerve stimulation

Lead Problems

Infections (usually RA)

Fracturing of insulation

Metal-ion oxidation

Fracturing of conductor cables

External pressure causes break of insulation and fracture of conductors

PNS (commonly w leads in CS)

Phrenic nerve injury

Failure Rates of Defib Leads

Non recalled leads 0.29-0.45% per year

St jude Riata 1% increase

Medtronic sprint fidelis > 2% increase

Leads w Hazard Alerts

 Telectronics ‘accufix’

Cordis passive fixation atrial lead

Medtronic spring fidelis

St jude Riata

Sensing

Signal Acquisition

Unipolar: one electrode in the heart (negative cathode in heart, positive anode in chest)

More likely to have far-field signal

Multi-component discrete atrial signals

Differences in waveform polarity may indicate impulse directionality

Bipolar: two electrodes in heart (negative cathode in tissue, positive anode ring in heart)

Signal reflects local activation

Signal Processing

High-Pass Filters: allow frequencies higher than a specific cut-off to pass

Low-Pass Filters: allow frequencies lower than a specified frequency to pass

Notch Filters: 60hZ filter removes unwanted noise that is common in powered
equipment (clears baseline)

Sensing

Defined as ability of pacemaker to ‘see’ intrinsic depolarization

Achieved by measuring changes in electrical potential between anode (-) and cathode
(+)

Under sensing: failure to detect intrinsic signals (blue arrows)

Leads to over-pacing

Shows up as inappropriate pacing in presence of intrinsic activity

Oversensing: detection of non-physiologic artifact or noise, or large t-wave, making

device think intrinsic event present

Inappropriately withholds pacing

Shows up as long periods without pacing

Oversensing in ICDs could lead to inappropriate tachy therapies

Sample ECG
 Tips in ECG Analysis

Determine intrinsic underlying rhythm

What are the pacing configurations (DC v SC)

Confirm basic pacemaker functions – is sensing appropriate?

Consider AV timing

Is there oversensing? Under?

Stimulation

Guideline for device selection

Single Chamber Pacing

SC Ventricular Pacing

Primarily for patients are not candidates to restore AV synchrony

Provides hemodynamic support

VVIR mode for patients without functioning sinus node

Rate response to increase HR with exertion

Chronic AF w slow or irregular response

SC Atrial Pacing

Indicated for patients with SSS and intact AV conduction

Indicated for symptomatic sinus node dysfunction and intact AV node

conduction

Provide atrial pacing support in the absence of intrinsic p-waves

Determine risk factors for developing a need for ventricular pacing

PAVE Study

Post AV nodal ablation evaluation study

180 patients

SC ppm or BiV ppm

BiV group performed better compared to SC group

Results: physicians may opt to implant BiV ppm post AV node ablation rather
than SC ppm

Block HF Trial
 Evaluated whether BiV pacing might reduce mortality, morbidity, and adverse LV
remodeling

Evaluated 918 patients w pacing indication of AV block , NYHA class I, II, or III HF,
& EF < 50%

Randomized to dual chamber RV pacing of BiV pacemaker

Results: BiV pacing was superior to conventional right ventricular pacing in pts w
AV block and LV systolic dysfunction w NYHA class I, II, or III heart failures

Dual Chamber Pacing

Indications

Symptomatic heart block

Symptomatic sick sinus syndrome

Symptomatic chronotropic incompetence

Paroxysmal AF associated w bradycardia

BiV Pacing

Goal: resynchronize R & L ventricular contraction

Indications

QRS > 120 ms

EF < 35%

Symptomatic HF

RA, RV, CS leads; can be CRT-P or -D

His Bundle Pacing

Technique requires the physician to implant the ventricular lead just distal to the AV
node

The pacing pulse uses the hearts own bundle branches to conduct to the ventricles,
resulting in physiologic narrow-paced QRS

Patients are expected to have a high percentage of RV pacing

For patients w indication for BiV pacing and LBBB

Lead distal to area of block stimulated LB recreating narrow QRS

Images shown demonstrate morphological differences in cardiac activation

between LBBB, BiV improvement pacing, and correction

May have higher pacing threshold & prone to oversensing atrial activity
High Voltage Therapy & Anti-Tachy Pacing

Indications

Primary Prevention

Multiple risk factors for VT but never experienced documented VT/F

Prior MI (at least 40 days ago) & LV EF < 30%

Patients w cardiomyopathy, functional class II to III and LVEF < 35%

Secondary Prevention

Pt survived prior documented episode of VT or VF

Implant of ICD recommended for secondary prevention of SCD

ATP

Most effective on re-entrant arrhythmias

Deliver pacing pulses at a rate slightly faster than the tachycardia cycle length

Resets the depolarization patter before progressing to shock therapy

ATP for vast VF was safe, effective & significantly improved quality of life
(PAINFREE RX)

Atrial ATP

Most effective in reentrant atrial tachycardia or flutter, not AFib

Burst pace atrium at a rate faster than sensed rate

Device Features

Rate Response Pacing

Address chronotropic incompetence

Sensors in device to recognize changes in metabolic demand

Detects sitting, standing, walking, climbing stairs

Increases pacing rate

Types include: accelerometer, minute ventilation, CLS, Blended accelerometer

Mode Switch

Algorithm for paroxysmal atrial tachycardia, atrial flutter, or atrial fibrillation

Prevents inappropriate tracking of atrial arrhythmias resulting in ventricular

pacing at or near max rates
 Allows device to switch from tracking mode (DDD, DDDR) to non-tracking mode (
DDI, DDIR, VDIR)

AV Search Algorithms

Allows intrinsic atrioventricular conduction to occur when present, and

physiologic paced AVD when conduction is absent

Automatically extends AVD to search for intrinsic conduction

Heart block of AV node ablation may not benefit

Contraindicated in hypertrophic obstructive cardiomyopathy (HOCM) or BiV

pacing for HF

Managed Ventricular Pacing (MVP) AAIR to DDDR, same as Vp Supression

Rate Drop for Neurocardiogenic Syncope

Neurocardiogenic or vasovagal syncope occurs when a patient experiences a

sudden drop in heart rate associated with a drop in blood pressure

Device senses four consecutive paced beats at lower rate limit, feature
accelerates pacing rate for a programmable period

Faster pacing counteracts patient symptoms otherwise experienced by sudden

heart rate and blood pressure drop

Negative AVD in HOCM

Pts experience septal hypertrophy, can lead to LVOT obstruction & thus reduced
cardiac output; exacerbated by native conduction

Program shorter AVD to ensure ventricular pacing

Stimulation Considerations

Acute to chronic shift

Active fixation leads will produce large current of injury

Acute to chronic shift in capture threshold values occurs in subsequent weeks

Auto capture feature ensures reliable capture without need for large safety

Strength Duration curve

Relationship between strength and durations

Rheobase: minimum current required to depolarize

Chronaxie: duration of current required to depolarize at two times rheobase

Understanding of strength-duration curve optimizes pacing functions and

longevity
 Wedensky Effect

Defined as the prolonged lower threshold of excitability

Lost tissue capture will have different values from step-down version v step-up

Eliminate the Wedensky effect by performing threshold testing w step up

approach

More susceptible in certain conditions (higher rate, narrow pulse width)

Phrenic Nerve Stimulation

PNS frequently occurs with CIEDS

Impulses from leads produce inadvertent PNS and are more susceptible to CRT
devices

PNS reported in 24% of patients with CRT device

Symptoms include dyspnea, uncomfortable muscle twitching, hiccups, malaise

Vagus Nerve Stimulation

VNS – technique stimulates vagus nerve

Effective for treating HF in preclinical studies

Investigating VS treatments for epilepsy, depression, headaches

Phrenic Nerve Pacing

Transvenous phrenic nerve pacing restroes physiologic nocturnal breathing

Implanted by EP using similar skills for CRT device procedures

Resembles pacemaker, functions as neurostimulator

Timing Cycles

Basic Pacemaker Configuration & NBG Codes

Components of Successful Pacing

Pulse generators – provides energy source

Leads – conduct energy to tissue

Electrode tissue contact – propagates impulse to surrounding tissue

Functions:

Sense intrinsic cardiac activity

Discriminate artifact and noise from real cardiac activity

 Detect and analyze rhythm changes

Capture myocardium, deliver energy which propagates

NBG Codes

Position I: Chambers Paced: 0, A, V, D

Position II: Chambers Sensed: 0, A, V, D

Position III: Response to Sensing: 0, T, I, D

Position IV: Rate Modulation: 0, R

Position V: Multi Site Pacing: 0, A, V, D

Nominal Implant Parameters

Lower Rate Limit – Single Chamber

Maximum time allowed between one paced or sensed beat and the next

Nominally 60-70 bpm

SC pacing w intact sinus node function may cause pacemaker syndrome

ventricular blanking period prevents t-wave oversensing, nominally 250 ms

Rate Hysteresis

Hysteresis promotes intrinsic activity below programmed lower rate

Pacing is inhibited if intrinsic rate is above hysteresis rate

First occurrence of an escape pace at the rate hysteresis rate suspends

hysteresis operations and reestablishes the lower rate as the escape rate

Sleep or Rest Rate

Allows slower pacing rates at night or during periods of rate

Lower Rate limit – Dual Chamber

For ventricular based devices, max time between ventricular events

Atrial timing max time determined by LRL – AVD (in ms)

For atrial based devices, max time between atrial events

Atrial events initiate AVD,

ventricular pacing occurs
at expiration if no intrinsic
 If intrinsic atrial rate accelerates, device tracks p-waves; can occur in 1:1 ratio up
to max tracking rate

Upper Rate Limit

Aka Max Tracking Rate

Fastest rate the ventricle can be paced in response to intrinsic atrial activity

Factors that affect appropriate URL

Age, activity level, ejection fraction, presence of coronary artery disease

UTR = 220 – (80%*Age)

Refractory Periods

PVARP: Post Ventricular Atrial Refractory Period

Prevents sensing of retrograde p waves that can lead to PMT

Rate Responsive Behavior

Senses changes in the bodys need for adjustment of cardiac rate

Ex: body motion, changes in breathing, changes in contraction strength

Parameters to program

Max Sensor Rate

Activity Threshold

Slope or Response Factor

Acceleration Time

Deceleration Time

Uncommon Modes of Pacing

DDI: used in DDD pacemakers the exhibit frequent episodes of atrial tachycardias

No tracking of intrinsic atrial events

Sensed p waves inhibits but does not start AVD

VDD: used in pts with intact sinus function and high-grade AV block

Atrial sensing dipoles

Upper Rate Behavior

Pacemaker Wenckebach: as atrial rates increase past UTR, refractor p wave falls into
PVARP, exceeding MTR so no Vp delivered
 2:1 Block: atrial rate exceeding TARP, pacemaker exhibits 2:1 block & can become
symptomatic

TARP = AVD + PVARP; 2:1 = 60,000/TARP

Reduction of RV Pacing

Increasing awareness of harmful clinical affects of excessive RV pacing

RV pacing > 40% leads to an increase in death & HF hospitalization

SAVE-PACe

Decrease in RV pacing was associated with 40% relative reduction in incidence of

persistent AF

Strategy to minimize RV pacing led to a 40% reduction in relative risk of

developing persistent AF

Algorithms to Reduce RV Pacing

Managed Ventricular Pacing (MVP)

AV Search Hysteresis

Ventricular Intrinsic Preference

RhythmIQ

Vp Supression

I Opt

Algorithms

Algorithms in Brady Therapy

Algorithms: step by step procedure or formula for solving a problem

Sets rules and outcomes of computer programs

Make treatment more manageable, more efficient, and with higher degree of
specificity

Implant Detection

Automatic on most pacemakers

Prevents issues caused by inappropriate pre-implant settings

Enables device to be implanted without prior programming

Triggered with lead is introduced into header

 Confirms implantation and allows other pre programmed algorithms or settings
to begin (mode, rate limits, rate response, sensing)

Auto Sensing

Meet the need for pacing and prevent over-pacing

Adjust sensitivity (dynamically beat-to-beat)

Respond to intrinsic and paced activity

Traditional sensitivity relies on the size of measured p wave and r wave

Lead maturation, MI, antiarrhythmics, and meds may affect size of sensed
amplitudes

Usually at least 2:1 safety margin

Auto Threshold

Physiologic factors affecting thresholds: hydration, temperature, sleep,

electrolyte, medication

Automated capture algorithms may eliminate the risk of non-capture, and

benefit battery life greatly

3 main types

Evoked response

Ventricular capture management

Atrial capture management

Management of Atrial Arrhythmias

Unnecessary RV Pacing

Reduction of Ventricular Pacing

RV pacing may increase risk of hospitalization due to heart failure, AF

Compared to AAI, VVI also increases risk of mortality

Left atrial size increased by pacing in DDD w any AVD, & LV function reduced in
DDD short AVD group; DANISH 2

Possibility to under detect AF w long AVDs

AVD > 350 ms can be linked to increased risk of PMT

AV Hysteresis

Extension of standard programmed AVD to search for native conduction

 Pre-programmed extension & pre-set number of cycles

Can react to varying conduction throughout day

Improved hemodynamics during episodes of AV Block by pacing w more

appropriate AVD, while still searching for intrinsic events at appropriate intervals

Reverse Mode Switch (Vp Supression)

DDDR to AAIR can occur after successful conduction search is found,

programmed AVD allows for intrinsic conduction

Properly chart mode so that tele can be discerned

For frequent switching pts, consider DDD w long AVD

Management of Syncope

DC pacing is Class IIb indication most effective in cardio-inhibitory type of vasovagal

syncope

2 main types of algorithms

Sudden Rate Drop – react to pause

Signs of sudden drop in HR in 60-sec detection window

May be set to trigger w programmed drop size & detect rate

Closed Loop Stimulation – prevents pause by measuring contraction strength

During vasovagal syncope episodes, there is less blood in RV, heart

compensates by increasing contractility

Algorithms in Tachy Therapy

Autosensing

Must be sensitive enough to detect potentially low signals of VF without

oversensing t waves

Uses rectified signal where the negative deflections are made positive

Uses and auto sensitivity algorithm that sets the sensitivity as a percentage of
the presensed R wave

Sensitivity reduces on a programmable slope until max sensitivity is reached

Algorithm will rest and start again from the programmed percentage of any new
event

Ideally sensitivity opens back up just after T wave; set to 50% of R wave initially
nominally

SVT Discriminators
18% risk of inappropriate shock, those who got inappropriately shocked were at
higher risk of receiving a second and 60% increase in mortality; over to 70-80%
of these shocks were due to misdiagnosed SVT

Most common discriminator is ventricular rate

Number of arrhythmia mechanisms may be present in same pt

Discriminators look at the following

How did it the rhythm start? Sustained? Evidence of AV associate? Beat

to beat morphology recognition

Single Chamber Discriminators

Onset: differentiates sudden onset VT from gradual onset SVT

Programmable feature determines how quickly the arrhythmia

starts

Sudden onset indicates VT

Limitations: AF, AFl, AVNRT, AVRT, AT, VT

Stability: analyzes interval regularity

Monomorphic VT is usually very regular, whereas AF is irregular

Limitations

can be fooled by very common reentrant arrhythmias w

regular cycle lengths

AVNRT, AVRT, AFl w stable clock sinus node recovery

time

AF w faster ventricular rates, > 175 bpm, as cycle length

becomes more stable

Morphology: analyzes shape of ventricular events

Uses shape of native r wave as a template and compares any

tachycardia in therapy zone to his template

Therapy is delivered if template varies by preset amount

If morphology of tachycardia is similar to normal template,

therapy withheld

Most accurate of the single chamber discriminators & has

sensitivity of 99-100% and specificity of 78-97%
Dual Chamber Discriminators

Sensitivity v Specificity Mneumonic

SNOUT – sensitive test when negative rules OUT disease

SPIN – specific test when positive rules IN if tachycardia is VT

Rate Branch

A & V ratios, onset, stability, morphology

Rhythm ID

A &V rates, ratios, vector timing correlation, sability and AF threshold, atrial
fibrillation threshold measured at lowest current amplitude of rapid pacing to
induce

Smart Algorithm

A & V rates, ratios, A & V stability separately, onset, morphology

PR Logic

Atrial and ventricular rates, av dissociation, regularity, morphology

PARAD+

VV Stability, PR Association, Vetricular tachycardia long cycle, level of associate,

acceleration, acceleration origin

Anti-Tachycardia Pacing

Low voltage pacing pulses to terminate reentrant ventricular tachycardias

Low voltage pacing pulses delivered in ‘excitable gap’ of VT circuit

Burst: delivers drive train (commonly 8-10 beats) at percentage of VT cycle length

Ramp: delivers stimulus at decremental cycle length until pre defined cycle length is
reached
 Scan: delivers stimulus at programmed decremental cycle length from burst-to-burst
episodes

Limitations

Painless and asymptomatic

Shown to cause acceleration of some VT cycle lengths

Can turn stable monomorphic VT into polymorphic VT or even VF

Generally accepted risk of acceleration is low when applied to slower VT at cycle

lengths > 300-320 ms

Shown to have > 90% success rate

Cardiac Resynchronization Therapy

AdaptivCRT

Monitors AV/VV conduction status and level of activity every minute

Adaptive LV and adaptive BiV

Reducing RV pacing while in adaptive LV increases battery longevity

Monitors for intrinsic AV conduction

If AV conduction is normal, device paces on in LV

If AV conduction is prolonged, device paces RV & LV

Defibrillation Concepts

Defibrillator Threshold Testing

Evaluation process that involves checking functionality and effectiveness of defibrillator

device

Goal is to observe whether device can detect and correct arrhythmia

Steps

Implant device, sedate patient

Induce VF via shock on T

ICD detects and treats arrhythmia

If not successful after two shocks, external pads used

 Reposition, reverse shocking polarity, change shocking vector, add
additional hardware ( azygous vein defibrillation coil, subcutaneous
array, dual coil)

Risks

Myocardial injury, worsening HF, persistent hypotension, CNS injury,

thromboembolic events, respiratory depression

SIMPLE trial: largest randomized trial assessing affects of DFT on clinical outcomes

2500 pts, DFT well tolerated without signification increase in complications, did
not improve efficacy or reduce arrhythmic death

S-ICD

Designed to avoid venous access and complication of inserting transvenous leads

Lower risk of infection compared to ICD

Limitations:

Estimates that up to 7.4% of candidates are not suitable for implant

Not for patients w symptomatic brady, incessant VT, frequently occurring VT

reliably terminated w ATP

Wearble Cardioverter – Defibrillator

Vestlike device, monitors heart rhythm and automatically delivers electric shock when
VF or VT detected, worn continuously

Indications
 Removal of an ICD for period of time due to infection in SCA patients, discharged
from hospital w VT protection until ICD implant

Effectiveness

First shock efficacy 99%

Post shock survival 90%

Inappropriate shock 2%