fundamentals of cardiac devices

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    1

    Welcome

    Chris Stamper

    Technical Field Engineer

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    2

    The Fundamentals of Cardiac DevicesModule 2

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    3

    Objectives

    After completing this introduction to Cardiac Devices, you ill!e a!le to"

    # $dentify the various cardiac device systems

    #$dentify the !asic indications for implantation for eachdevice

    # %ecogni&e each device type on a chest '(ray

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    )

    Cardiac Devices

    # Designed to"* %estore or maintain a rhythm and rate sufficient to meet

    meta!olic needs

    * +rovide diagnostic information a!out

    # Device operation

    # The patient

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    Cardiac Devices

    # +acema-ers or $mplanta!le +ulse .enerators /$+.0* +rovide a rate to support meta!olic needs

    * +rovide various diagnostics

    * Single and dual cham!er

    *A!out 1( years longevity

    * Some of the neer pacema-ers include therapies hich

    pace(terminate AT4AF

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    5

    Cardiac Devices

    # $mplanta!le Cardioverter Defi!rillators /$CDs0* %estore sinus rhythm in the presence of tachycardia

    # Defi!rillate

    # Cardiovert

    # Anti(Tachy +ace /AT+0

    * +rovide a rate to support meta!olic needs

    # $ncludes single or dual cham!er pacing

    * +rovide various diagnostics

    *A!out 5(6 years longevity

    * There are also devices designed to terminate AF via

    cardioversion4AT+ in addition to standard $CD therapies

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    7

    Cardiac Devices

    # Cardiac %esynchroni&ation Therapy /C%T0* $+. ith C%T, or an $+. 8 $CD ith C%T

    * %estore ventricular synchrony

    # 9ses a specially designed lead placed usually on the posterior(lateral

    all of the :; via the Coronary Sinus circulation

    # :; epicardial lead placement is an option

    # +rovides %; and :; synchronous pacing

    * May restore rhythms in presence of lethal tachycardia

    # C%T pacing 8$CD /

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    1

    Cardiac Devices

    # $mplanta!le :oop%ecorders /$:%0

    * +rovides rate(!ased monitoring

    # Fast rates

    # Slo rates

    * +rovides E.M during patient

    triggered events

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    6

    IndicationsPacemakers

    # The A

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    IndicationsDefibrillators

    # +rimary vs Secondary +revention for SCA* +rimary

    # +atients ho have e'perienced a previous SCA or ventricular arrhythmia

    # Studies such as A;$D, C$DS2, CAS

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    IndicationsDefibrillators (cont.)

    Bell defined !y

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    IndicationsDefibrillators (cont.)

    # $CD Class $ %ecommendation

    # +atients at least ) days post(M$

    # :;EF 3 * )

    # =

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    IndicationsCardiac Resynchronization hera!y

    # =

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    Indications"oo! Recorders

    # Transient, infreLuent !ut recurrent syncope

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    Reco#nizin# $ystemsPacemakers

    Dual Cham!er +acema-er

    %; :ead at the Ape'

    %A :ead in Appendage

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    Reco#nizin# $ystemsICD or %i#h Po&er

    %ight Atrial :ead

    Appro'imate position outlined

    %ight ;entricular :ead

    Bith %; and S;C coils

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    Reco#nizin# $ystemsCR "o&'Po&er

    %ight Atrial :ead

    :eft ;entricular :ead

    +laced on the surface of the

    :; via the Coronary Sinus

    %ight ;entricular :ead

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    Reco#nizin# $ystemsCR %i#h'Po&er

    %ight Atrial :ead

    :eft ;entricular :ead

    +laced on the surface of the

    :; via the Coronary Sinus

    %ight ;entricular :ead

    =ote the 2 high voltage defi!

    coils

    Surface EC. leads

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    Pacin# hera!y

    #Senses underlying heart rate* Delivers lo energy electrical

    pulses hen rate falls !elo

    programmed limit

    # :o energy pulses capture and

    depolari&e the heart musclecausing it to contract

    * Dual Cham!er $+.s provide

    A(; synchrony

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    # Atrium and ;entricle

    * Sensing

    * +acing

    # ;entricle

    * Antitachycardia pacing /AT+0

    ICD Pacin# hera!y

    Atrial :ead

    ;entricular :ead

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    %i#h'olta#e hera!y

    Cardioversion and

    Defi!rillation are delivered in

    !iphasic avesFor e'ample" First, from the S;C

    coil and the Can to the %; coil,

    and then reverse

    The device must detect * charge

    * confirm * and deliver the shoc-

    Fast, accurate detection, and fast

    charge times are critical

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    ICD hera!y

    Brady and

    Anti-Tachypacing (ATP)

    # The $CD lead is

    designed to carry !oth

    high voltage and

    pacing therapies

    * >rady

    * AT+

    * Cardioversion

    * Defi!rillation

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    Im!lant vol*tion

    +acema-ersesterday

    # First $mplants in early 65s

    # Single Cham!er, non

    programma!le

    # A!out 2 year longevity

    # A!out 2 cc

    # A!dominal implants, sternotomy

    for epicardial leads

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    Im!lant vol*tion

    +acema-ersToday

    # +ectoral implants

    # 5(7 F transvenous lead

    placement

    * Hutpatient4overnight stay

    # J 3 cc

    # 1( years longevity

    # Dual cham!er, multi(

    programma!le

    # Advanced diagnostics and

    trending information

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    Im!lant vol*tion

    $CD +ast" N(2 years ago $CDs

    # %eLuired maGor surgery

    * A!dominal implants

    * Median sternotomy to suturedefi! patches on heart

    * :ength of hospital stay I ee-

    # =onprogramma!le

    #

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    Im!lant vol*tion

    $CDs Today

    # Similar to a pacema-er implant

    # Transvenous, single incision

    * +ectoral implant

    * Hvernight stay

    # :ocal anesthesia, conscious

    sedation

    # +rogramma!le therapy options

    # Single, dual and triple cham!er

    /C%T0

    # 9p to 6 years longevity

    # A!out 3 cc

    # I N, implants4year

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    $tat*s Check

    # .iven the folloing patient

    * 57 H male patient, had an anterior M$ 2 years ago

    * EF 2

    * loc-er0

    * C4H

    # Severe shortness of !reath at rest, fatigue, una!le to perform AD:, vertigo, rare

    syncope

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    26

    $tat*s Check

    # +atientPs EC."

    =S%

    %ate 71

    :>>

    Bhat device

    system /if

    any0 is the

    patient li-ely

    to getKClic- for Anser

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    3

    $tat*s Check

    # Could this !e the previous

    patientPs chest '(rayK

    * $s it C%TK

    * $s it

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    3

    $tat*s Check

    # Consider the folloing patient* Elderly female patient

    * Medical history includes

    # E'(smo-er * Luit years ago

    # Mild e'ertional angina

    * Cardiac cath shos mild disease right coronary artery

    # 3 adult children

    *Medications# =itroglycerine +%= # Aspirin 1 mg 4day

    * C4H

    # Fatigue, una!le to perform normal activities

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    $tat*s Check

    # +atientPs stress test indicates"

    * Stopped after ) minutes for fatigue

    * EC. immediately after stress test" Clic- for Anser

    :i-ely a pacema-er, as the patient has chronotropic

    incompetence * her heart rate does not increase ith e'ercise

    Bhat device

    system ould you

    recommendK

    =S%, %ate 7

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    3333

    +asic Conce!ts,lectricity andPacemakers

    -od*le

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    3)3)

    Objectives

    9pon completion you ill !e a!le to"# Descri!e the relationship !eteen voltage, current, and

    resistance

    # Descri!e the clinical significance of alterations in voltage,

    current, and resistance

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    33

    Characteristics of an electrical circ*it/Incl*din# a !acemaker circ*it

    # ;oltage# Current

    # $mpedance

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    olta#e

    # ;oltage is the force, or ?push,@ that causes electrons tomove through a circuit

    # $n a pacing system, voltage is"

    * Measured in volts /;0

    * %epresented !y the letter ?;@

    * +rovided !y the pacema-er !attery

    * Hften referred to as amplitude or pulse amplitude

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    C*rrent

    # The flo of electrons in a completed circuit# $n a pacing system, current is"

    * Measured in milliamps /mA0

    * %epresented !y the letter ?$@

    * Determined !y the amount of electrons that move through a circuit

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    Im!edance

    # The opposition to current flo# $n a pacing system, impedance is"

    * Measured in ohms /)

    * %epresented !y the letter ?%@

    * The measurement of the sum of all resistance to the flo of current

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    olta#e0 C*rrent0 and Im!edance are Interde!endent

    # The interrelationship of the three components is analogousto the flo of ater through a hose

    * ;oltage represents the force ith hich

    * Current /ater0 is delivered through

    *A hose, here each component represents the total impedance"

    # The no&&le, representing the electrode

    # The tu!ing, representing the lead ire

    lt C t d I d

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    ))

    olta#e0 C*rrent0 and Im!edanceReca!

    # ;oltage" The force moving the current /;0* $n pacema-ers it is a function of the !attery chemistry

    # Current" The actual continuing volume of flo of electricity /$0

    * This flo of electrons causes the myocardial cells to depolari&e /to

    ?!eat@0

    # $mpedance" The sum of all resistance to current flo /% or

    or sometimes )

    * $mpedance is a function of the characteristics of the conductor /ire0,the electrode /tip0, and the myocardium

    lt d C t 1l

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    )

    olta#e and C*rrent 1lo&lectrical 2nalo#ies

    Spigot /voltage0 turned up, lots of

    ater flos /high current drain0

    Spigot /voltage0 turned lo, little flo

    /lo current drain0

    Bater pressure in system

    is analogous to voltage *

    providing the force to

    move the current

    R i t d C t 1l

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    )2

    Resistance and C*rrent 1lo&lectrical 2nalo#ies

    # =ormal resistance* friction caused !y the hose and no&&le

    More ater discharges, !ut is all of it going to

    the no&&leK

    #

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    )3

    Ohm3s "a&

    # Descri!es the relationship

    !eteen voltage, current,

    and resistance

    #; Q $ %

    # $ Q ; 4 %

    # % Q ; 4 $

    II

    R

    I

    R

    I

    R

    I Q

    Q

    Q

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    ))

    Ohm3s la& tells *s/

    $f the impedance remains constant, and the voltagedecreases, the current decreases

    2 $f the voltage is constant, and the impedance decreases,

    the current increases

    So BhatK

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    ))

    $tat*s Check

    # Start ith"

    * ;oltage Q ;

    * $mpedance Q

    * Current Q mA

    # Solve for Current /$0"

    * $ Q ;4%

    * $ Q ; U Q Amps

    * Current is mA

    # %educe the voltage to 2 ;

    * ;oltage Q ;

    * $mpedance Q

    * Current Q K

    # $s the current increased4

    decreased or unchangedK

    * $ Q ;4%

    * ; Q 2 ; U Q

    Amps or mA

    # he c*rrent is red*ced

    Bhat happens to current if the voltage is reduced !ut the

    impedance is unchangedK

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    )5)5

    $tat*s Check

    # Start ith"

    * ;oltage Q ;

    * $mpedance Q

    * Current Q mA

    # Solve for Current /$0"

    * $ Q ;4%

    * $ Q ; U Q Amps

    * Current is mA

    # %educe impedance to 2

    * ;oltage Q ;

    * $mpedance Q 2

    * Current Q K

    # $s the current increased4

    decreased or unchangedK

    * $ Q ;4%

    * ; Q 2 ; U 2 Q

    2 Amps or 2 mA

    # he c*rrent is increased

    Bhat happens to current if the impedance is reduced

    !ut the voltage is unchangedK

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    )7)7

    Other terms

    #Cathode" A negativelycharged electrode

    * For e'ample, the electrode on

    the tip of a pacing lead

    # Anode" A positivelycharged electrode

    * E'amples"

    # The ?ring@ electrode on a !ipolar lead

    # The $+. case on a unipolar system

    * More on this later /see"

    +acema-er >asics0

    2node

    Cathode

    +attery +asics

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    )1)1

    +attery +asics$o &here does the c*rrent come from4

    #A !attery produces electricity as a result of a chemicalreaction $n its simplest form, a !attery consists of"

    *A negative electrode /anode0

    *An electrolyte, /hich conducts ions0

    *A separator, /also an ion conductor0 and

    *A positive electrode /cathode0

    =egative terminal

    Anode

    Separator

    Cathode

    +ositive terminal

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    )6)6

    2!!lyin# lectrical Conce!ts toPacemakers

    -od*le 5

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    Objectives

    # 9pon completion you ill !e a!le to"* %ecogni&e a high impedance condition

    * %ecogni&e a lo impedance condition

    * %ecogni&e capture threshold

    * Determine hich sensitivity value is more

    /or less0 sensitive

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    lectrical Information

    # Bhy is this electrical information relevantK

    # A pacema-er is implanted to"

    * +rovide a heart rate to meet meta!olic needs

    # $n order to pace the heart, it must capturethe myocardium

    # $n order to pace the heart, it must -no hen to pace, ie, it must !e a!le to

    sense

    # A pacema-er reLuires an intact electrical circuit

    Ohm3s "a&

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    2

    Ohm s "a&Relevance to Pacemaker Patients

    #

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    33

    e ect o ead e o a ce o

    -yocardial Ca!t*re

    Bhat ould you e'pect to happen if a lead as partially

    fracturedK

    # $mpedance /or %esistance0 ould rise

    # Current ould decrease and !attery energy conserved

    ( !ut (

    Could you guarantee that enough current /$0 can flo

    through this fractured lead so that each time the

    pacema-er fired the myocardium ould !eatK

    %i#h Im!edance Conditions

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    )

    Lead wire fracture

    Increased resistance

    %i#h Im!edance Conditions2 1ract*red Cond*ctor

    # A fractured ire can cause

    $mpedance values to rise

    * Current flo from the !attery

    may !e too lo to !e effective

    # $mpedance values maye'ceed 3,

    Hther reason for high

    impedance" :ead not seated

    properly in pacema-er header

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    "ead Im!edance al*es Chan#e as a Res*lt of/

    # Bire fractures

    # $nsulation !rea-s

    Typically, normal impedance reading values range from 3to ,

    * Some leads are high impedance !y design These leads ill

    normally sho impedance reading values greater than , ohms

    # Medtronic

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    5

    "o& Im!edance Conditions

    # $nsulation !rea-s e'pose the

    lead ire to the folloing* >ody fluids, hich have a lo

    resistance, or

    * Another lead ire /in a !ipolar

    lead0

    # $nsulation !rea- that e'poses a

    conductor causes the folloing

    * $mpedance values to fall

    * Current to drain through the

    insulation !rea- into the !ody, or

    into the other ire

    * +otential for loss of capture

    * More rapid !attery depletion

    Current ill follo the path of

    :EAST resistance

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    7

    Ca!t*re hreshold

    # The minimum electrical stimulus needed to consistently capture the

    heart outside of the heartPs on refractory period

    ;entricular pacema-er 5 ppm

    Capture Non-Capture

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    1

    ffect of "ead Desi#n on Ca!t*re

    # :ead maturation

    * Fi!rotic ?capsule@ develops around the electrode folloing lead

    implantation

    * May gradually raise threshold

    * 9sually no measura!le effect on impedance

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    6

    $teroid l*tin# "eads

    # Steroid eluting leads

    reduce the inflammatory

    process

    * E'hi!it little to no acute

    stimulation threshold pea-ing

    * :eads maintain lo chronic

    thresholds

    Silicone ru!!er plugcontaining steroid

    Tines for

    sta!lefi'ation

    +orous, platini&ed tip

    for steroid elution

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    5

    ffect of $teroid on $tim*lation hresholds

    +ulse Bidth Q msec

    $mplant Time /Bee-s0

    Te'tured Metal Electrode

    Smooth Metal Electrode

    Steroid(Eluting Electrode

    2

    ;olts

    References/ +acing %eference .uide, >a--en Education Center, 66, 9C665)7aE= Cardiac +acing,2nd Edition, Edited !y Wenneth A Ellen!ogen 665

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    5

    -yocardial Ca!t*re

    # Capture is a function of"

    *Amplitudethe strength of the impulse e'pressed in volts

    # The amplitude of the impulse must !e large enough to cause depolari&ation /ie, to ?capture@

    the heart0

    # The amplitude of the impulse must !e sufficient to provide an appropriate pacing safety

    margin

    * +ulse idththe duration of the current flo e'pressed in

    milliseconds

    # The pulse idth must !e long enough for depolari&ation to disperse to the surrounding tissue

    Com!arison

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    52

    Com!arison6.7 olt 2m!lit*de at Different P*lse Widths

    Amplitude

    ;

    2 ms ms ms

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    53

    he $tren#th'D*ration C*rve

    # The strength(duration

    curve illustrates the

    relationship of

    amplitude and pulse

    idth

    *Any com!ination of

    pulse idth and voltage,

    on or a!ove the curve,

    ill result in capture

    +ulse Bidth

    .67

    8.7

    8.6

    9.7

    .96

    ;olts

    7.6 8.7 8.6

    Capture

    =o Capture

    %heo!ase

    Chrona'ie

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    5)

    D*ration

    P*lse Width (ms)

    Clinical :tility of the $tren#th'D*ration C*rve

    # >y accurately determining

    capture threshold, e canassure adeLuate safety margins

    !ecause"

    * Thresholds may differ in acute or

    chronic pacing systems

    * Thresholds fluctuate slightly daily

    * Thresholds can change due to

    meta!olic conditions or

    medications

    7.6 8.7 8.6

    .67

    8.7

    8.6

    9.7

    .96$tim

    *lationhresh

    old(olts)

    +rogrammed Hutput

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    5

    Pro#rammin# O*t!*ts

    # +rimary goal" Ensure patient safety and appropriate device

    performance

    # Secondary goal" E'tend the service life of the !attery

    * Typically program amplitude to J 2 ;, !ut alays maintain

    adeLuate safety margins# A common output value might !e 2 ; at ) ms

    *Amplitude values greater than the cell capacity of the pacema-er

    !attery /usually a!out 21 ;0 reLuire a voltage multiplier, resulting in

    mar-edly decreased !attery longevity

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    5555

    Pacemaker $ensin#

    # %efers to the a!ility of the pacema-er to ?see@ signals

    * E'pressed in millivolts /m;0

    # The millivolts /m;0 refers to the si&e of the signal the

    pacema-er is a!le to ?see@

    m; signal

    2 m; signal

    $ensitivity

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    57

    yhe al*e Pro#rammed into the IP;

    ime

    6.7 m

    9.6 m

    8.96 m

    $ensitivity

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    51

    Time

    m;

    2 m;

    2 m;

    m; sensitivity

    At this value the pacema-er ill not

    see the 3 m; signal

    yhe al*e Pro#rammed into the IP;

    $ensitivity

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    56

    yhe al*e Pro#rammed into the IP;

    At this value, the pacema-er can see !oth the 3 m; and the

    3 m; signal So, is ?more sensitive@ !etter, !ecause the

    pacema-er sees smaller signalsK

    2 m; Sensitivity

    Time

    m;

    2 m;

    2 m

    >ut hat

    a!out thisK

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    7

    $ensin# 2m!lifiers

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    7

    $ensin# 2cc*racy

    # Affected !y"

    * +acema-er circuit /lead0 integrity

    # $nsulation !rea-

    # Bire fracture

    * The characteristics of the electrode

    * Electrode placement ithin the heart

    * The sensing amplifiers of the pacema-er

    * :ead polarity /unipolar vs !ipolar0

    * The electrophysiological properties of the myocardium

    * EM$ * Electromagnetic $nterference

    "ead Cond*ctor Coil Inte#rity

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    72

    2ffect on $ensin#

    # 9ndersensing occurs hen the cardiac signal is una!le to

    get !ac- to the pacema-er

    * $ntrinsic signals cannot cross the ire fracture

    # Hversensing occurs hen the severed ends of the ire

    intermittently ma-e contact* Creates signals interpreted !y the pacema-er as +( or %(aves

    "ead Ins*lation Inte#rity

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    73

    2ffect on $ensin#

    # 9ndersensing occurs hen inner and outer conductor coils

    are in continuous contact

    * Signals from intrinsic !eats are reduced at the sense amplifier, and

    amplitude no longer meets the programmed sensing value

    # Hversensing occurs hen inner and outer conductor coilsma-e intermittent contact

    * Signals are incorrectly interpreted as +( or %(aves

    : i l P k

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    7)

    :ni!olar Pacemaker

    #Bhere is the sensing circuitK

    _

    Cathode

    Anode

    :ead tip to canThis can produce a large potential

    difference /signal0 !ecause the cathode

    and anode are far apart

    Clic- for Anser

    +i l P k

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    7

    +i!olar Pacemaker

    # Bhere is the sensing

    circuitK

    Anode and

    Cathode

    Clic- for Anser

    :ead tip to ring on the lead

    This usually produces a smaller potential

    difference due to the short inter(electrode

    distance#>ut, electrical signals from outside the

    heart /such as myopotentials0 are less

    li-ely to !e sensed

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    t d ; di t

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    7777

    ectors and ;radients

    Sense

    The ave of depolari&ation produced !y

    normal conduction creates a gradient

    across the cathode and anode This

    changing polarity creates the signal

    Hnce this signal e'ceeds the

    programmed sensitivity * it is

    sensed !y the device

    Clic- for More

    2 m;

    Ch i th t

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    7171

    Chan#in# the ector

    Sense

    2 m;

    A +;C occurs, hich is conducted

    a!normally Since the vector relative

    to the lead has changed, hat effect

    might this have on sensingK

    Clic- for More

    $n this case, the ave of

    depolari&ation stri-es the anode and

    cathode almost simultaneously This

    ill create a smaller gradient and

    thus, a smaller signal

    P*ttin# It 2ll o#ether

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    7676

    P*ttin# It 2ll o#ether

    # Appropriate output programming can improve device longevity

    * >ut, do not compromise patient safetyX# :ead design can improve device longevity via

    * Steroid eluting leads

    # Can help -eep chronic pacing thresholds lo !y reducing inflammation and scarring

    *atteries, circuit !oards, capacitors, etc, specificto needs, can lead to

    improved efficiencies and loered static current drain

    *

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    11

    P*ttin# It 2ll o#ether

    # +acema-er :ongevity is"

    *A function of programmed parameters /rate, output, time pacing0

    *A function of useful !attery capacity

    *A function of

    # Static current drain

    # Circuit efficiency

    # Hutput $mpedance

    # The loer the programmed sensitivity the MH%E sensitive

    the device

    * :ead integrity also affects sensing

    $tat*s Check

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    11

    $tat*s Check

    # Determine the threshold amplitude

    Capture threshold Q loest value ith consist capture

    This is at 2 ;

    Clic- for Anser

    2 ; ;7 ; ;

    $tat*s Check

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    1212

    $tat*s Check

    H%

    Clic- for Anser

    +acema-er A is a!le to ?see@ signals as small as m; Thus, it is

    more sensitive

    +rogrammed

    Sensitivity m;

    +acema-er

    A

    +rogrammed

    Sensitivity 2 m;

    +acema-er

    >

    # Bhich of these pacema-ers is more sensitiveK

    $tat*s Check

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    1313

    $tat*s Check

    # A pacema-er lead must fle' and move as the heart !eats

    Hn average, ho many times does a heart !eat in yearK

    Clic- for Anser

    3 M$::$H= times $t is not a simple tas- to design a

    lead that is small, relia!le, and lasts a lifetime

    $tat*s Check

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    1)1)

    $tat*s Check

    Clic- for Anser

    :ead Fracture"

    #

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    11

    What &o*ld yo* e=!ect4

    # Bhich value is out of rangeK

    # Bhat could have caused thisK

    +acema-er $nterrogation %eport

    Mode" DDD%

    :oer" %ate 5 ppm

    9T%" 3 ppm

    9S%" 3 ppm

    Atrial :ead $mpedance" )7 Hhms

    ;entricular :ead $mpedance" 6 Hhms

    $nsulation failure

    Clic- for Anser

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    hank >o*