Contents

1 IMPLANTABLE PACEMAKERS ..............................................................................................................................3

1.1 Types of Implantable Pacemakers depend on chambers...........................................................................3
1.1.1 Single-Chamber Pacemakers ..............................................................................................................3
1.1.2 Dual-Chamber Pacemakers ................................................................................................................4
1.1.3 Trible-Chamber Pacemakers ..............................................................................................................4
1.2 Types of Implantable Pacemakers depend on clinical Requirements ........................................................5
1.2.1 Fixed Rate Pacemaker ........................................................................................................................5
1.2.2 Demand Pacemaker............................................................................................................................6
1.2.3 R wave Triggered Pacemaker .............................................................................................................6
1.2.4 Ventricular Inhibited or R Wave Blocked Pacemaker.........................................................................6
1.2.5 Atrial Triggered Pacemaker ................................................................................................................6
1.2.6 Ventricular Synchronous Demand Pacemaker ...................................................................................6
1.2.7 Programmable Pacemaker .................................................................................................................8
1.2.8 Asynchronous Pacemaker ............................................................................................................... 10
1.2.9 The Demand Pacemaker .................................................................................................................. 11
1.2.10 Rate-responsive Pacemakers........................................................................................................... 11
1.2.11 The Atrial-Synchronous Pacemaker ................................................................................................ 12
1.3 Classification code of pacemaker ............................................................................................................ 13
1.3.1 Modes of Cardiac Pacing ................................................................................................................. 14
1.4 Components of an implantable pacemaker ............................................................................................ 17
1.4.1 Implantable pulse generator (IPG) .................................................................................................. 18
1.4.2 Lead Wires and Electrodes .............................................................................................................. 20

Figure 1-1 The implantable pacemaker placed inside the human body ....................................................................3
Figure 1-2 Single-chamber pacemakers have one lead that goes either to the right ventricle (as shown below) or
to the right atrium. .....................................................................................................................................................4
Figure 1-3 Dual-chamber pacemakers have two leads. One goes to the right atrium and the other to the right
ventricle. .....................................................................................................................................................................4
Figure 1-4 Bi-ventricular pacemaker ..........................................................................................................................5
Figure 1-5 Various pacing modalities in demand pacemakers (a) ventricular demand inhibited: VVI (b) A-V
sequential DVI (c) atrial synchronous (ventricular inhibited), (VD T/I, (d) fully automatic DDD) ..............................5
Figure 1-6 Block diagram of a ventricular synchronous demand pacemaker ............................................................6
Figure 1-7 Functional block diagram of programming interface................................................................................8
Figure 1-8 Block diagram of a multi-programmable pacemaker ...............................................................................9
Figure 1-9 Block diagram of an asynchronous cardiac pacemaker ........................................................................ 10
Figure 1-10 A demand-type synchronous pacemaker Electrodes serve as a means of both applying the stimulus
pulse and detecting the electric signal from spontaneously occurring ventricular contractions that are used to
inhibit the pacemaker’s timing circuit. .................................................................................................................... 11
Figure 1-11 Block diagram of a rate-responsive pacemaker ................................................................................... 12
Figure 1-12 An atrial-synchronous cardiac pacemaker, which detects electric signals corresponding to the
contraction of the atria and uses appropriate delays to activate a stimulus pulse to the ventricles. .................... 12
Figure 1-13 Components of a pacemaker ............................................................................................................... 18
Figure 1-14 Constructional details of lithium iodine battery (Courtesy: Wilson Greatbatch, U.S.A.)..................... 18
Figure 1-15 the 555 oscillators ................................................................................................................................ 19
Figure 1-16 Unipolar vs. bipolar pacing ................................................................................................................... 21
Figure 1-17 Pacemaker leads and their inner conductor design............................................................................. 23

Table 1 The Naspe/Bpeg Generic (Nbg) Pacemaker Code ...................................................................................... 13

 pacemaker
1 IMPLANTABLE PACEMAKERS
The implantable pacemaker, along with its electrodes, is designed to be entirely implanted beneath the
skin. Its output leads are connected directly to the heart muscle (Fig. 1.1). The pacemaker is a
miniaturized pulse generator and is powered by small batteries. The circuit is so designed that the
batteries supply sufficient power for a long period. Since the pacemaker is located just beneath the skin,
the replacement of the pacemaker unit involving relatively minor surgery has become a routine
procedure.
For any implantable circuit, the basic requirements are:
• The components used in the circuit should be highly reliable;
• The power source should be in a position to supply sufficient power to the circuit over prolonged
periods;
• The circuit should be covered with a biologically inert material so that the implant is not rejected
by the body; and
• The unit should be covered in such a way that body fluids do not find a way inside the circuit and
thus short-circuit the batteries or result in another malfunctioning of the circuit.

Figure 11-1 The implantable pacemaker placed inside the human body

From 1968 to 1972, the average life of most pacemakers was 22 months and they were too large
(Furman, 1969). With important advances in many areas, particularly in power sources, miniaturization
of electronic circuits, and hermetic encapsulation, the average life of a pacemaker in 1974 was around
31 months. From 1975 onwards, the life of pacemakers was increased to more than five years. Some of
the present-day pacemaker manufacturers even provide a lifetime of pacing performance warranty,
though under certain conditions.
1.1 Types of Implantable Pacemakers depend on chambers
There are three basic types of implantable pacemakers which are designed to serve different purposes:

1.1.1 Single-Chamber Pacemakers

In a single-chamber pacemaker, only one wire (pacing lead) is placed into a chamber of the heart.
Sometimes it is the upper chamber or atrium. Other times it is the lower chamber or ventricle. (Fig 1.2)
 Figure 11-2 Single-chamber pacemakers have one lead that goes either to the right ventricle (as shown below) or to the right atrium.

1.1.2 Dual-Chamber Pacemakers

In dual-chamber pacemakers, wires are placed in two chambers of the heart. One lead pace the atrium
and one pace the ventricle. This approach more closely matches the natural pacing of the heart. This
type of pacemaker can coordinate function between the atria and ventricles. (Fig 1.3)

Figure 11-3 Dual-chamber pacemakers have two leads. One goes to the right atrium and the other to the right ventricle.

1.1.3 Trible-Chamber Pacemakers

Also known as bi-ventricular pacing. This treatment involves having a pacemaker with three leads, called
a bi-ventricular pacemaker. One lead goes to the right atrium (top right chamber of the heart), one to
the right ventricle (lower right chamber), and one to the side of the left ventricle. A bi-ventricular
pacemaker is only recommended for people with dyssynchrony (when the ventricles aren't beating in
time with each other) or those who have an ECG showing a very specific type of electrical pattern. as
shown in (Fig 1.4) and is divided into two types

• Cardiac resynchronization therapy with a pacemaker (CRT-P): CRT-P can help your heart to pump
more efficiently which can improve your symptoms. It won’t cure your heart failure, but it can
improve your overall outlook and slow down its progression. Although doctors choose those
patients who are suitable for resynchronization therapy very carefully, there are a small number
of people who find that this treatment doesn't help.
• Cardiac resynchronization therapy with a defibrillator (CRT-D): This treatment involves having a
single device that combines a bi-ventricular (three-lead) pacemaker and an ICD. It's used for
people with heart failure who might also be at risk of developing fast, life-threatening heart
rhythms. If you have one of these emergencies, the ICD can restore your normal rhythm by
delivering an electric shock to your heart.
 Figure 11-4 Bi-ventricular pacemaker

1.2 Types of Implantable Pacemakers depend on clinical Requirements

different types of implantable pacemakers as shown in (Fig. 1.5) are utilized. Besides the fixed rate units,
the most widely used (97%) implanted pacemakers are the R-wave controlled units (R-wave inhibited
and in some cases R-wave triggered). There has been extensive development of other types of
pacemakers such as atrial demand, bi-focal demand, and the programmable that enable external
programming of such parameters as impulse frequency, impulse duration, output current/voltage, and
refractory period.

Figure 11-5 Various pacing modalities in demand pacemakers (a) ventricular demand inhibited: VVI (b) A-V sequential DVI (c) atrial
synchronous (ventricular inhibited), (VD T/I, (d) fully automatic DDD)

1.2.1 Fixed Rate Pacemaker

This type of pacemaker is intended for patients having permanent heart blocks. The rate is pre-set, say
at 70 bpm. The rate can be varied externally in implanted units by magnetically actuating a built-in relay.
Since the fixed-rate pacemaker functions regardless of the patient’s natural heart rhythm, it poses a
potential danger because of competition between the patient’s rhythm and that of the pacemaker.
1.2.2 Demand Pacemaker
These pacemakers have gradually almost replaced the fixed rate pacemakers because they avoid
competition between the heart’s natural rhythm and the pacemaker rhythm. The demand unit functions
only when the R-R intervals of the natural rhythm exceed a pre-set limit.

1.2.3 R wave Triggered Pacemaker

The ventricular synchronized demand type (R wave triggered) pacemaker is meant for patients who are
generally in heart block with occasional sinus rhythm. The pacemaker detects ventricular activity (R wave
of ECG) and stimulates the ventricles after a very short delay time of some milliseconds. If there is sinus
rhythm, the stimulating impulse will occur in the ventricular de-polarization. If there is an asystole, the
unit will stimulate the heart after a pre-set time.

1.2.4 Ventricular Inhibited or R Wave Blocked Pacemaker

The ventricular inhibited type (R wave blocked) pacemaker is meant for patients who generally have
sinus rhythm with occasional heart block. The circuitry detects spontaneous R wave potentials at the
electrodes and the pacemaker provides a stimulus to the heart after pre-set asystole. However, in the
case of ventricular activity, the R-wave does not trigger the output circuit of the pacemaker but blocks
the output circuit and no stimulation impulse is given to the heart.

1.2.5 Atrial Triggered Pacemaker

This is an R wave-triggered or atrial-triggered pacemaker. The pacemaker detects the atrial de-
polarization and starts the pulse-forming circuits after a delay so that the impulse to the ventricles is
delivered after a suitable PR interval. The major advantage of this pacemaker is its ability to provide
maximum augmentation of cardiac output at changing atrial rates to meet various physiological
requirements.

1.2.6 Ventricular Synchronous Demand Pacemaker

Fig. 1.6 shows a functional block diagram of a ventricular synchronous demand pacemaker. The pulse
generator has two functions, viz., pacing and sensing. Sensing is accomplished by picking up the ECG
signal. In the case of dual-chamber pacing, the P wave is also sensed. Once the ECG signal enters the
sensing circuit, it is passed through a QRS bandpass filter. This filter is designed to pass signal
components in the frequency range of 5-100 Hz, with a center frequency of 30 Hz.

Figure 11-6 Block diagram of a ventricular synchronous demand pacemaker

This is followed by an amplifier and threshold detector which is designed to operate with a detection
sensitivity of 1–2 mV. The sensitivity of this order ensures reliable detection of cardiac signals sensed on
the electrodes which typically have amplitudes in the 1–30 mV range depending on the electrode surface
area and the sensing circuit loading impedance. A refractory period (T1) is necessarily incorporated to
limit the pulse delivery rate, particularly in the presence of electromagnetic interference. It is meant to
prevent multiple re-triggering of a stable multivibrator following a sensed or paced contraction. The free-
running multivibrator provides a fixed rate mode with an interval of T2 via the output driver circuit. The
output pulses of a length T3 synchronous with input signals that fall outside the sensing refractory period
T1 are thus delivered at the stimulating electrodes. Most commercial pacemakers employ a single
defibrillation protection diode, while others employ symmetrical two-diode type protection. The diodes
in this case are placed back-to-back. The symmetrical protectors minimize the detection of high-level,
high-frequency, pulsed electromagnetic interference artifacts, and thus raise the noise detection
threshold. Two types of stimuli are produced by the output circuit of the pacemaker. These are the
constant voltage and constant current types. Constant voltage amplitude pulses are typically in the range
of 5 V with a duration of 500 to 600 ms. The lithium-iodine cell voltage is 2.8 V, and therefore if pulses
of about 5 V are required at the output of the pacemaker, a voltage doubler circuit is employed. Constant
current amplitude pulses are typically in the range of 8 to 10 mA with a pulse duration ranging from 1.0
to 1.2 ms. Pulse rates range from 70 to 90 beats per minute in synchronous pacemakers whereas those
that are not the fixed rate type typically provide rates ranging from 60 to 150 beats per minute.
Pacemakers usually provide for a refractory period in the range of 400 to 500 ms. For most pulse
generators, the pacing circuit impedance is 5 k to 20 kW, whereas a demand pulse generator sensing
amplifier is generally a high input impedance device with a typical value of 5 MW. The amplifier must
detect intrinsic cardiac activity in the millivolt region and yet withstand pacing circuit output pulses that
are several volts in amplitude. Also, the input impedance of the sensing circuit and output impedance of
the pacing circuit appear in parallel, and the net impedance seen by the load is not more than the output
impedance of the pacing circuit. Sensing and pacing are achieved with one of two configurations: bipolar
and unipolar. In bipolar, the anode and cathode are close together, with the anode at the tip of the lead
and cathode, a ring electrode about 2 cm proximal to the tip. Both electrodes are located on or in the
heart tissue. In a unipolar system, only one pole (usually negative) is located on or in the heart tissue.
The positive electrode is located remotely, generally on the body of the pacemaker generator itself. The
atrial-synchronous pacemaker is a more complex device that is designed to replace the blocked
conduction system of the heart. As explained earlier, the heart’s intrinsic pacemaker located in the SA
node initiates the cardiac cycle by stimulating the atria to contract and then providing a stimulus to the
AV node which, after some delay, stimulates the ventricles. If the SA node can stimulate the atria, the P
wave of the ECG corresponding to atrial contraction can be detected by an electrode implanted in the
atrium and used to trigger the pacemaker in the same way that it triggers the AV node.
1.2.7 Programmable Pacemaker
A programmable pacemaker consists of two parts: the external unit which generates programmed
stimuli and is transferred to an internal unit by one of the several communication techniques. Fig. 1.7
shows a functional block diagram of the programming interface. The commonly used methods of
transmitting information are:

(i) magnetic—an electromagnet placed on the surface of the body establishes a magnetic field that
penetrates the skin and operates the pacemaker’s reed switch,
(ii) radio-frequency waves—the information can be transmitted over high-frequency
electromagnetic waves which are received inside the body by an antenna. The antenna is usually
in the shape of a coil housed within the pacemaker,
(iii) acoustic-ultrasonic pressure waves from a suitable transducer placed over the skin, can
penetrate the human body. They are received by a suitable receiver in the pacemaker which
carries out the desired function.

Figure 11-7 Functional block diagram of programming interface

Out of all these methods, the magnetic field method is the most widely used because of its simplicity
and minimal power requirements. An essential requirement of programmable pacemakers is that they
should be immune to accidental programming from naturally occurring energy sources. To meet this
requirement, the information is usually coded and the pacemaker contains a decoding mechanism to
recognize proper information. This programming security code method makes it practically impossible
to reprogram an implantable pacemaker through extraneous random magnetic fields.

Fig. 1.8 is a detailed block diagram of the multi-programmable pacemaker. It may be considered as being
comprised of the three systems. System 1 controls the main timing functions of the pulse generator and
carries the rate limiter, the pulse output circuit, and the stimulating function of the electrode. Operating
as directed by the programmable control circuit, this system generates output pulses at the programmed
rate, width, and amplitudes unless overridden by System 2. System 2 carries the sensing and signal-
discriminating function of the circuit. Comprising the sensing function of the electrode, an RF filter, a
signal amplifier, and a comparator, this system identifies signals of cardiac origin and, where appropriate,
sends an inhibit signal to System 1. System 3 carries the programmable control circuit, the data validate
circuit, the reed

Figure 11-8 Block diagram of a multi-programmable pacemaker

Switch, and the master timing crystal. This system affects program recognition, storage, and execution
as well as control of the battery and various test sequences. Under normal operating conditions, the
timing control circuit periodically triggers the output circuit causing the emission, at the programmed
rate, of stimulation pulses of programmed pulse width and amplitude. The period between each trigger
signal is scrutinized by the rate limiter and in the unlikely event of component failure causing a rate
increase, the limiter holds the rate of stimulation to less than 180 bpm. Upon receipt of inhibit signals
from System 2, the timing control circuit compares their time of arrival against the programmed
refractory period. Signals arriving within the refractory period are ignored. A signal detected by the
electrode is filtered of high-frequency components by the RF filter. The signal is then selectively
amplified by an amount determined by the programmed sensitivity level and the resultant signal is
compared with a preset level at the comparator. Signals of either polarity with a magnitude greater than
the preset level, enable an input signal to be fed to the timing control circuit of System 1. Signals below
the preset level are ignored. System 3, acting on programming signals transmitted to the reed switch,
directs the pulse generator to function as programmed. The reed switch by opening and closing in
sympathy with magnetic pulses emitted by the programmer feeds signals to the data validation circuit.
After first verifying that the reed switch was closed for a minimum period of 300 ms, the data validate
circuit checks and executes a code validation check. Only when all these checks are satisfied is the
programmable control circuit directed to store the new code. By activating appropriate electronic
switches, the programmable control circuit directs Systems 1 and 2 to implement the new program
conditions. The pulse generator is non-invasively programmable using a programmer which emits a
magnetic code, that enables the following parameters to be altered: rate, pulse width, pulse amplitude,
sensitivity, refractory period, and hysteresis. All measurements are taken at 37°C with 500W resistive
load. The programmer contains a microprocessor-based transmitter/receiver that operates by
inductively coupling pulse-position modulated, binary-coded data from the programmer via the
programming wand to the pulse generator. The programming information is contained in a 20-bit
command code specifying the desired rate, pulse width, pulse amplitude, sensitivity level, mode of
operation, a pulse generator model identification code, and check codes. If an attempt is made
intentionally or unintentionally to include in a programming command a parameter that is not a feature
of the pulse generator being used, that parameter will simply remain at its nominal value. All validly
reprogrammed parameters in the command will be implemented. Part of the command code is a check
code. If this check code is not correct, the command is rejected by the pulse generator, and no
programming occurs. The timing of the transmission is precise. Crystal oscillators in both the
programmer and the pulse generator control the frequency of data exchanges. Each data bit is
transmitted within approximately 1.0 ms. The entire command code and its complement are transmitted
within approximately 40 ms or 1/25th of a second. At present most manufacturers, are offering PC-based
programming units rather than dedicated proprietary instruments. These systems are more flexible and
more easily updated when new devices are released. Also, time-efficient programming plays an
important role in the productivity of pacing clinics which may provide follow-up for a very large number
of patients per year.

1.2.8 Asynchronous Pacemaker

An asynchronous pacemaker is free running. Its electric stimulus appears at a uniform rate regardless of
what is going on in the heart or the rest of the body. It, therefore, gives a fixed heart rate. It was the first
type of pacemaker that was developed in the mid-twentieth century

Figure 1-9 Block diagram of an asynchronous cardiac pacemaker

The power supply is necessary to supply energy to the pacemaker circuit. Primary battery sources are
used.
The oscillator establishes the pulse rate for the pacemaker; this, in turn, controls the pulse output circuit
that provides the stimulating pulse to the heart. This pulse is conducted along lead wires to the cardiac
electrodes.

Each of these blocks is important in the construction of the pacemaker, and each must be made highly
reliable because the faulty operation of this device can cost a patient’s life.
Another component of the overall construction of the pacemaker that is not included in Fig 1.9 is the
package itself. Not only must the package of an implanted pacemaker be compatible and well tolerated
by the body, but it must also provide the necessary protection to the circuit components to ensure their
reliable operation. The body is a corrosive environment, so the package must be designed to operate
well in this environment while occupying minimal volume and mass.
Today, cardiac pacemakers are contained in hermetically sealed metal packages. Titanium and stainless
steel are frequently used for the package. Special electron beam or laser welding techniques have been
developed to seal these packages without damaging the electronic circuit or the power source. These
metal packages take up less volume and are more reliable than the earlier, polymer-based packages.
1.2.9 The Demand Pacemaker
It consists of a timing circuit, an output circuit, and electrodes, just like those of the asynchronous
pacemaker, but it has a feedback loop as well. The timing circuit is set to run at a fixed rate, usually 60
to 80 beats/ min. After each stimulus, the stimulus, and then generates the next pulse. timing circuit
resets itself, and waits for the appropriate interval to provide the next However if, during this interval a
natural beat occurs in the ventricle, the feedback circuit detects the QRS complex of the ECG signal from
the electrodes and amplifies it. This signal is then used to reset the timing circuit. It awaits its assigned
interval before producing the next stimulus. If the heart beats again before this stimulus is produced,
the timing circuit is again reset and the process repeats itself. Thus, we see that, when the heart’s
conduction system is operating normally and the heart has a natural rate that is greater than the rate
set for the timing circuit, the pacemaker remains in standby mode, and the heart operates under its
pacing control. In this way, the heart can respond to changing demands of the organism by changing its
rate in the usual manner. If, on the other hand, a temporary heart block occurs, the pacemaker takes
over and stimulates the heart at the fixed rate of the timing circuit. (Fig 1.10)

Figure 1-10 A demand-type synchronous pacemaker Electrodes serve as a means of both applying the stimulus pulse and detecting the
electric signal from spontaneously occurring ventricular contractions that are used to inhibit the pacemaker’s timing circuit.

1.2.10 Rate-responsive Pacemakers

In some patients, due to the diseased condition of the sinus node, the heart’s natural pacemaker is not
able to increase its rate in response to metabolic demands. Although synchronous pacemakers can meet
some of the physiological demands for variation in heart rate, these devices cannot replicate the
functions of the heart or meet the demands of the body during stressful activities such as exercise. A
new type of pacemaker that makes use of a control system has been developed. A sensor is used to
convert a physiological variable in the patient to an electrical signal that serves as an input to the
controller circuit, which can determine whether any artificial pacing is required or not. Fig. 1.9 shows a
block diagram of a rate-responsive pacemaker. Several sensor-based rate-responsive systems were
developed during the late 1970s and 1980s, including blood pH, respiratory rate, vibration or motion,
blood temperature, and QT interval. Today, the majority of pacemakers are rate-responsive,
incorporating one or more sensors. The most common sensor is the activity sensor which uses piezo-
electric materials to detect vibrations caused by body movement. Some of the other sensors which are
under various stages of research and development are blood pH, blood temperature, stroke volume,
oxygen saturation, and minute ventilation. The sensor can be placed within the pacemaker itself or
located at some other place in the body. It may be noted that each of the physiological variables requires
a different control logarithm for the control circuit. Minute volume (tidal volume * the number of
respirations) is a fine physiological indicator because it responds to the rapid change in metabolic
demand via increases in tidal volume and respiratory rate. It provides better rate-responsive
characteristics and is used in many rate-responsive pacemakers.

Figure 11-11 Block diagram of a rate-responsive pacemaker

1.2.11 The Atrial-Synchronous Pacemaker

is a more complicated circuit, as shown in Fig 1. 10. In this case, the pacemaker is designed to replace
the blocked conduction system of the heart. The heart’s physiological pacemaker, located at the SA node,
initiates the cardiac cycle by stimulating the atria to contract and then providing a stimulus to the AV
node, which, after an appropriate delay, stimulates the ventricles. If the SA node can stimulate the atria,
the electric signal corresponding to atrial contraction (the P wave of the ECG) can be detected by an
electrode implanted in the atrium and used to trigger the pacemaker in the same way that it triggers the
AV node. (Fig 1. 10) shows the voltage v1 that is detected by the atrial electrodes.

Figure 11-12 An atrial-synchronous cardiac pacemaker, which detects electric signals corresponding to the contraction of the atria and
uses appropriate delays to activate a stimulus pulse to the ventricles.

This voltage is a pulse that corresponds to each beat. The atrial signal is then amplified and passed
through a gate to a monostable Multivibrator giving a pulse v2 of 120 ms duration, the approximate delay
of the AV node. Another monostable Multivibrator giving a pulse duration of 500 ms is also triggered by
the atrial pulse. It produces v4, which causes the gate to block any signals from the atrial electrodes for a
period of 500 ms following contraction. This eliminates any artifact caused by the ventricular contraction
from stimulating additional ventricular contractions. Thus, the pacemaker is refractory to any additional
stimulation for 500 ms following atrial contractions.
 The falling edge of the 120 ms-duration pulses, v2, is used to trigger a monostable multivibrator of 2
ms duration. Thus, pulse v2 acts as a delay, allowing the ventricular stimulus pulse v3 to be produced at
120 ms following atrial contraction. Then v3 controls an output circuit that applies the stimulus to
appropriate ventricular electrodes.
Often atrial-synchronous pacemakers have provisions to run at a fixed rate in case the atrial stimulus
is lost. This is achieved by combining the demand-pacemaker system with the atrial-stimulus pacemaker
system so that an atrial stimulus disables a fixed-rate timing circuit. If the stimulus is absent, the fixed-
rate timing circuit takes over and controls the output circuit in the same way as in the asynchronous
pacemaker.
1.3 Classification code of pacemaker
With rapid developments taking place in implantable pacemaker technology, it was felt necessary to
develop a standard nomenclature to facilitate the identification of the type and functions of the
pacemaker. The detailed nomenclature jointly adopted by the North American Society of Pacing and
Electrophysiology (NASPE) and the British Pacing and Electrophysiology Group (BPEG) is given in Table 1
as a 5-letter code. In the five-letter code, the first letter indicates the chamber or chambers that are
paced. The second letter shows those chambers in which sensing takes place. The third letter reveals
how the pacemaker will respond to a sensed event. For example; the pacemaker will ‘inhibit’ the pacing
output when intrinsic activity is sensed or will ‘trigger’ a pacing output based on a specific, previously
sensed event. The fourth letter describes the degree of programmability of the pacemaker but is typically
used to indicate that the device can provide a rate response. The fifth letter is reserved specifically for
anti-tachycardia functions.

IV
I II III Programmable In
Chamber Paced Chamber Sensed Response to Sensing Functions/Rate Antitachy Function(s)
Modulation

P: Simple
V: Ventricle V: Ventricle T: Triggered P: Pace
programmable

A: Atrium A: Atrium I: Inhibited Multi-programmable S: Shock

D: Dual (A+V) D: Dual (A+V) D: Dual (T+I) C: Communicating D: Dual (P+S)

O: None O: None O: None R: Rate modulating O: None

S: Single (A or V) S: Single (A or V) O: None

Table 1 The Naspe/Bpeg Generic (Nbg) Pacemaker Code
1.3.1 Modes of Cardiac Pacing
The modes of pacemakers are based on a generic code known as NBG (combined from NASPE/BPEG)
and typically consist of 5 letters.

Letter 1. In the area being paced, A stands for atria, V stands for Ventricle, D stands for Dual, O stands
for none

• Letter 2. For the area which is sensed, A stands for atria, V stands for Ventricle, D stands for Dual,
O stands for none

• Letter 3. The response of the pacemaker to sense: O stands for none, I stand for inhibiting, T
stands for triggering, and D stands for dual

• Letter 4. Rate adaptiveness. O stands for none, and R stands for rate adaptiveness.

The modes are explainable by dividing them into categories of a single chamber or dual chamber:

1.3.1.1 Single Chamber Modes

• VOO
V- Pacing in the ventricle

O- Sensing is OFF

O- Response to sensing is OFF

In this mode, the pacemaker paces at a programmed rate regardless of the intrinsic electrical activity of
the heart.

• VVI
V- Pacing in the ventricle

V- Sensing in the ventricle

I-Inhibit

In this mode, the pacemaker can sense the electrical activity and withhold pacing when not required.

• AOO
A- Pacing in the atrium

O- Sensing is OFF

O- Response to sensing is OFF

In this mode, the pacemaker paces at a programmed rate regardless of the intrinsic electrical activity of
the heart.
 • AAI
A- Pacing in the atrium

A- Sensing in the atrium

I- Inhibit

In this mode, the pacemaker can adapt to the intrinsic atrial rate and should be able to pace when needed
and inhibit when not required.

1.3.1.2 Dual Chamber Modes

Dual Chamber Modes can further subdivide into Tracking Modes and Non-Tracking modes.

Tracking Modes

• DDD

D- Pacing in the atrium and ventricle

D- Sensing in the atrium and ventricle

D- Inhibit and or trigger

Intrinsic P-wave and QRS can inhibit pacing, and intrinsic P-wave or atrial pace can trigger an AV delay.

This model is fully capable of adapting to intrinsic heart rhythm and mimicking normal conduction as
much as possible.

DDD has four distinct pacing patterns

1. AsVs (Atrial sensed ventricle sensed): Used when the patient has good sinus node function and
good AV node function

2. AsVp (Atrial sensed Ventricular paced): Used when the patient has a good sinus node function but
poor AV node conduction

3. ApVs (Atrial paced Ventricular sensed): Used when the patient has poor sinus node function but
has intact AV node conduction

4. ApVp (Atrial paced Ventricular paced): Used when the patient has a poor function in both the
sinus node and AV node.

• VDD

V- Pacing in the ventricle

D- Sensing in the atrium and ventricle

D- Inhibit and or trigger

Intrinsic QRS can inhibit ventricular pacing, and Intrinsic P-wave can trigger an AV delay.

In this mode, one cannot pace the atrium, but an intrinsic atrial activity can trigger an AV delay resulting
in P-wave tracking and possibly maintaining AV synchrony.

The primary issue with VDD programming mode is that if sinus node function drops below the pacemaker
programmed lower rate; then it will cause AV dissociation due to the inability to pace in the atrium.

VDD mode should only be used in patients with good SA node function. It might be used in a situation
where the patient has a high pacing threshold in the atrium. This way, the pacemaker will be able to sense
in the atrium, maintain AV synchrony, and not waste battery life by pacing in the high threshold atrium.

Non-Tracking Modes

• DDI

D - Pacing in the atrium and ventricle

D - Sensing in the atrium and ventricle

I - Response to that sensing will be to either pace or inhibit

This mode's primary use is in patients with atrial tachyarrhythmias and mode switch algorithms. DDI
mode will result in AV dissociation if the atrial rate goes high than the set rate. P wave tracking is excellent
for AV synchrony; however, if the patient goes into atrial fibrillation with a rapid heart rate, one does not
want to track the atrium and pace the ventricle at a high rate.

• DOO

D- Pacing in the atrium and ventricle

O- Sensing is OFF

O- Response to that sensing is OFF

This mode results in AV sequential pacing at the lower rate limit regardless of the heart's intrinsic activity.
DOO mode is asynchronous pacing and is usually used only in certain situations, such as when a magnet
is placed over a pacemaker or sometimes when a patient is having surgery.

R- Rate Response

Rate Response or Rate Adaptive Pacing is used in patients with chronotropic incompetence. Chronotropic
incompetence is defined as the inability of the heart to appropriately increase its rate with increased
activity or metabolic demand that leads to exercise intolerance. Usually, there is a problem with the SA
node function.

The pacemaker utilizes its sensing ability with the aid of sensors that can sense motion or minute
ventilation changes according to the activity and pace the heart at a required rate.
Choosing a Pacing Mode

While selecting a pacemaker mode, the clinician will want to ensure that the patient has viable atrial
activity. If the atrium is healthy, the clinician will want to maintain AV synchrony as much as possible.

The first important question is if the sinus node function is intact.

If sinus node function is not intact and the patient has atrial arrhythmias:

Chronic Atrial Arrhythmias, e.g., Atrial Fibrillation or Atrial Flutter:

• If the patient is chrono-tropically incompetent, the mode of choice will be VVIR.

• If the patient is chrono-tropically competent, the mode of choice will be VVI.

Paroxysmal Atrial Arrhythmias:

• If the patient is chrono-tropically incompetent, the mode of choice will be DDDR.

• If the patient is chrono-tropically competent, the mode of choice will be DDD.

If the sinus node is intact and the patient has normal sinus rhythm or sinus bradycardia:

Intact AV Node conduction

• If the patient is chrono-tropically incompetent, the mode of choice will be AAIR.

• If the patient is chrono-tropically competent, the mode of choice will be AAI.

AV Node conduction not Intact:

• If the patient is chrono-tropically incompetent, the mode of choice will be DDDR.

• If the patient is chronotropic ally competent, the mode of choice will be DDD.

1.4 Components of an implantable pacemaker

Pacemakers consist of an implantable pulse generator (IPG), which contains the electronics, a battery,
and one or two leads. The pulse generator generates the electric current needed to stimulate the
myocardium. The current is delivered to the myocardium via the leads, which are guided to the right
atrial and ventricular myocardium via a vein (Figure 1.11).
 Figure 11-13 Components of a pacemaker

The pacemaker is commonly implanted under the clavicle, between the skin and the pictorials major.
The pulse generator has a shell of titanium which is well tolerated by the surrounding tissues. The leads
are introduced into one of the larger veins (typically the subclavian vein) and guided further down to the
heart where they contact the endocardium.
1.4.1 Implantable pulse generator (IPG)
Implantable pulse generator consists of three main components:
1.4.1.1 Power supply
Lithium Cells: The long-life lithium-iodine battery-powered pacemaker represents a significant advance
in pacemaker technology. The lithium battery is solid-state and consists of an anode of metallic lithium
(Li) and a cathode of molecular iodine (I2) bonded in the complex form to an organic carrier. The solid
electrolyte consists of crystalline lithium-iodide (LiI). The following reaction takes place:

2Li + I2 = 2 LiI + e

The relative ease with which the single outer shell electron is lost from the atoms of the alkali metals
family makes them the most active of all metals. Lithium has the highest electrochemical equivalent of
any alkali metal. It is, therefore, the most energetic anode material and is ideal for use in high-energy-
density batteries. An anode current collecting screen is pressed between two layers of lithium, forming
the anode assembly (Fig. 1.12). The battery develops a voltage of 2.8 volts, which is stepped up to 5 V in
the circuitry. No gas is evolved from the simple cell reaction; therefore, the lithium cell can be
hermetically sealed in a welded stainless-steel enclosure.

Figure 11-14 Constructional details of lithium iodine battery (Courtesy: Wilson Greatbatch, U.S.A.)
The lithium iodide battery shows a continuous, but gradual drop in voltage over a period of years, due
to the slow increase in the internal resistance. Once the output voltage has fallen to 3.3 V, producing a
6-bpm decline in pulse rate, replacement of the pulse generator is indicated. This happens when internal
resistance becomes 35 to 40 kW. With the battery’s energy capacity at 4.14 Ah, a service of more than
10 years is expected. Pacemakers can last anywhere from 5 to 10 years or more - on average about seven
years. Device longevity depends upon how hard the battery inside the pacemaker has to work. This is
affected by how much energy is required to pace the heart and how the system is programmed. With
the ongoing research and development, the life of pacemakers continues to increase as their size
decreases, making them more comfortable for people. Replacing a pacemaker may be done on an
outpatient basis or may include an overnight stay in the hospital.

1.4.1.2 Timing circuit

The asynchronous pacemaker represents the simplest kind of pacemaker because it provides a train of
stimulus pulses at a constant rate regardless of the functioning of the heart. A free-running oscillator is
all that is required for the timing pulse in such a system. More advanced pacemakers, such as those used
today, still have timing circuits to determine when a stimulus should be applied to the heart, but complex
logic circuits, quartz crystal control, and even a microprocessor replace the simple, free-running
oscillator. for example, the 555 oscillators as shown in (Fig 1.13)

Figure 1-15 the 555 oscillators

Where T1 present ON time and T2 presents OFF time and we can control them by changing (Ra, Rb, and C). The fig.
above presents asynchronized pacemaker

1.4.1.3 Output circuit

The pulse output circuit of the pacemaker generator produces the actual electric stimulus that is applied
to the heart. At each trigger from the timing circuit, the output circuit generates an electric stimulus pulse
that has been optimized for stimulating the myocardium through the electrode system that is being applied
with the generator. Constant-voltage or constant-current amplitude pulses are the two usual types of
stimuli produced by the output circuit. Constant-voltage amplitude pulses are typically in the 5.0 to 5.5 V
range with a duration of 500 to 600 ps. Constant-current amplitude pulses are typically in the range of 8
to 10 mA with pulse durations ranging from 1.0 to 1.2 ms. Rates for asynchronous pacemakers range from
70 to 90 beats/min, whereas pacemakers that are not fixed rate typically achieve rates ranging from 60 to
150 beats/min.

1.4.2 Lead Wires and Electrodes

Because, in most pacemaker designs, the generator is located at some position remote from the heart
itself, there must be an appropriate conduit to carry the electric stimuli to the heart and to apply them in
the appropriate place.
1.4.2.1 Lead wires
The lead wires, in addition to being good electrical conductors, must be mechanically strong. Their
distal ends must not only withstand the constant motion of the beating heart, but as the individual in whom
the pacemaker is implanted moves about, these lead wires have to be able to withstand the stress of being
flexed in various positions. A second requirement of the lead-wire system is that it must be well insulated.
If this is not the case, wherever faults in the insulation occur, there is effectively another stimulating
electrode that, in addition to possibly stimulating the tissue in its vicinity, shunts important stimulating
current away from its intended point of application on the heart. To meet these requirements, the lead
wires presently used consist of interwound helical coils of spring-wire alloy molded in a silicone rubber
or polyurethane cylinder. The helical coiling of the wire minimizes stresses applied to it, and the multiple
strands serve as insurance against the failure of the pacemaker following the rupture of a single wire. The
soft compliant silicone-rubber or polyurethane encapsulation maintains the flexibility of the lead-wire
assembly and provides electrical insulation and biological compatibility.
1.4.2.2 Electrodes
The electrodes for delivering stimulating pulses can be connected either on the outside or inside the wall
of the heart. Electrodes connected to the outer wall of the heart muscle are called myocardial electrodes
connected to the inner side of the heart chamber and are known as endocardia electrodes. Endocardia
electrodes are inserted through a suitable vein, preferably the jugular vein, and pushed directly into the
heart. This method offers an advantage in that open heart surgery is not necessary for the replacement
of the myocardial electrode. Two types of electrode systems are commonly used, viz., bipolar and
unipolar.

1.4.2.2.1 Unipolar electrodes

Two types of electrode systems are commonly used, viz., bipolar and unipolar. In the unipolar system,
one electrode is inside or on the heart and is the stimulating electrode, and the second electrode
(indifferent electrode) is usually a large metal plate attached to the pulse generator. The indifferent
electrode is much larger in size than the pacing electrode. The current in this case flows between the
pacing electrode in the heart and the indifferent electrode via the body tissue. The batteries are so
arranged that the pacing electrode is negative (cathode) and the indifferent electrode is positive (anode).
1.4.2.2.2 Bipolar electrodes
In the bipolar electrode system, both electrodes are approximately the same size and both are placed
inside or on the heart so that the current flows between the two electrodes. The pulse generator is so
attached that the distal electrode, at the tip of the catheter, is negative and the proximal electrode ring
is positive. (Fig 1.14)

Figure 1-16 Unipolar vs. bipolar pacing

In bipolar pacing., the voltage difference is established at the lead tip, between the anode and cathode.
(Fig 1.14) With unipolar pacing, the voltage difference is established between the lead tip and the pulse
generator, such that electrons Flow between the pulse generator and the lead tip. (Fig 1.14)
Electrons travel a longer distance in unipolar pacing, which therefore requires slightly more energy to
successfully depolarize the myocardium. Moreover, currents flowing from the pulse generator and the
lead tip may stimulate excitable tissue between the can and the lead tip. Consequently, unipolar
pacemakers yield larger stimulation artifacts on ECG. In bipolar pacing, the anode and cathode are both
located within the heart and the resulting stimulation artifact becomes very discrete, or invisible .
1.4.2.3 Lead design
Pacing lead components include the electrode and fixation device, the conductor, the insulation, and the
connector pin. Leads function in the harsh environment of the human body and are subject to biological,
chemical, and mechanical repetitive stress. They must be constructed of materials that provide
mechanical longevity, stability, and flexibility; they must satisfy electrically conductive and resistive
requirements; they must be insulated with a material that is durable and that has a low friction
coefficient to facilitate implantation; and they must include an electrode that provides good mechanical
and electrical contact with the myocardium. The industry continues to improve lead design to achieve
these goals.

Conventional leads are composed of a metal conductor (‘coil’) enclosed by an insulation layer, which
minimizes the current leak and electromagnetic interference from the outside world (Fig1.15). The lead
conductors are arranged in coaxial or cordial designs (Fig1.15).
 • Coaxial leads have an inner conductor that extends down the length of the lead to the tip
electrode, the cathode, arranged in a coil configuration with a central lumen to allow for the
passage of a stylet at implantation. This coil is covered by a cylindrical length of inner insulation,
which, in turn, is wrapped by another coil conductor that also runs down the lead to the ring
electrode, the anode. A second outer insulation layer protects the ring conductor from the
outside environment (Fig1.15B).
• Cordial leads, a single coil extends down the length of the lead and it consists of two parallel,
alternating conductor strands, one of which connects to the cathode and the other to the anode.
Each conductor strand is individually coated with an inner insulation layer and the single two-
component coil is surrounded by another outer insulation layer (Fig1.15).

Although coaxial design leads have been the standard for many years, the resulting bulk and stiffness of
this four-layer design encouraged the development of the cordial design, which is less bulky (~1.7 mm)
and more flexible. The outer insulation in both designs is made of polyurethane or silicone. Polyurethane
is a synthetic segmented polymer with high tensile strength and resistance to mechanical abrasion. Thus,
a thin layer of insulation can be used to cover the lead conductors, enabling low-diameter leads.
However, polyurethane leads are stiff and not fully biostable, being subject to in vivo biological
degradation, due to environmental stress cracking and metal ion oxidation, resulting in insulation
defects. Silicone, in contrast, is more flexible and biostable over extended periods. Its main disadvantage
relates to its lower tensile strength, thus rendering it susceptible to abrasion and tears. Therefore, a
thicker insulation layer must be used to maintain lead reliability, which increases lead bulk. Pacemaker
leads conductors are typical of coaxial or cordial designs, surrounded by insulation layers (A, B). Coaxial
design conductors have an inner conductor that extends down the length of the lead to the tip with
another outer coil conductor that also runs down the lead to the ring electrode, the anode. Cordial
conductors are composed of a single coil conductor which extends down the length of the lead and
consists of two parallel, alternating conductor strands, one of which connects to the cathode and the
other to the anode. Each conductor strand is individually coated with an inner insulation layer, which
serves to insulate each strand from the other, despite being intertwined. The single two-component coil
is surrounded by another outer insulation layer. A magnified scheme of the inner and outer insulation
layers of a typical coaxial lead is shown (B). The conductors themselves are usually made of silver core
alloy wires, consisting of a central core of relatively soft, low-resistance silver surrounded by a thick
strong high-resistance MP-35N outer shell in the drawn-filled tube design (C), or by a few strands of high-
resistance MP-35N shells in the drawn brazed strand design (D).
 Figure 1-17 Pacemaker leads and their inner conductor design

MP-35N, an alloy of nickel, cobalt, chromium, and molybdenum, is the basic material that is used for
most modern conductors. The main advantage of MP-35N is its high strength and resistance to corrosion.
Its main disadvantage is its high electrical resistance, but this has been overcome with the development
of composite-wire conductors that incorporate low-resistance metals, such as silver (thus named silver-
cored alloy wires). In most pacing leads, these materials are generally incorporated into a drawn-filled
tube composite-wire conductor strand consisting of a thick strong body of MP-35N filled with a central
core of softer low-resistance silver metal, often encased in a further outer shell of platinum alloy. An
alternative conductor design is the drawn brazed strand design, consisting of a few strands of high-
resistance MP-35N material tightly molded over a central silver strand. Thus, the inner low-resistance
metal is forced between and around the strong outer strands. The functional purpose of these designs
is to create conductors that are both resistant to corrosion and have low electrical resistance (Fig1.15)

EXAMPLE 13.1 A cardiac pacemaker delivers 5 V pulses of 2 ms duration to bipolar electrodes, which can
be approximated as being a 2 kΩ-resistive load. The mean pulse rate of the pacemaker is 70 per min. The
pulses represent 25% of the energy consumed by the pacemaker. The pacemaker is powered by two
lithium cells connected in series to give a voltage of 5.6 V. As the designer of this circuit, you are called
upon to specify a battery capable of operating the pacemaker for 10 years. What is the minimum
acceptable capacity for each cell?

ANSWER The energy per stimulus pulse will be

𝑉2 5𝑣 2
𝐸𝑝 = 𝑇 = 2𝑘 ∗ 2𝑚𝑠 = 25𝜇𝐽 ---------------(1)
𝑅 Ω

The number of pulses in 10 years (including 2 leap years) will be

N = 70 min-1 x 60min/h x 24h/day x 365.25 day/year x 10year
= 3.68 x 108 pulses-------------------------(2)
Thus, the total energy will be
E t = N E p = 3.68 x 108 x 25 𝜇J = 9.2 kJ -----------(3)
The energy supplied by the battery must be four times as great

Eb = 4Et = 36.8 kJ----------------(4)

If, for the sake of argument (because it would be unwise to draw such a large current from these
cells due to polarization and source resistance effects), we draw a current of 1 A from the battery, it
would be supplying a power of 5.6 W. The period of time over which this power would have to be
supplied to give an energy Eb would then be

𝐸𝑏 3.6𝑘𝐽
𝑇 = 5.6𝑊 = = 6.57𝑘𝑠 = 1.83ℎ-------------(5)
5.6𝑊

Thus, the battery capacity must be at least 1.83 A-h, or rounding off, 2 A-h to operate this pacemaker.