Lecture 9

Pacemakers and Artificial

Hearts

Dr. D. Saravanakumar,
Assistant Professor, SMBS,
VIT - Chennai Campus.
Email: [email protected]

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 Introduction to Pace Makers

• Modern day pacemakers serve the primary function

of either maintaining a minimum heart rate to avoid
symptomatic or potentially life-threatening brady or
tachyarrhythmias or offering resynchronization
between the left and right ventricles in the setting of
heart failure.
• Multiple advances in device design,
programming, sensor technology, and materials
science have afforded the ability to offer an ever-
widening range of devices with a variety of
specialized features.

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 Pacemaker Functions

• Stimulate cardiac depolarization

• Sense intrinsic cardiac function
• Respond to increased metabolic demand by
providing rate responsive pacing
• Provide diagnostic information stored by the
pacemaker

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 Basic Concepts of Pacing

• Cardiac myocytes may be “activated” by the delivery of an

electrical pacing stimulus.

• This stimulus creates an electrical field that allows for the

generation of a self- propagating wave front of action potentials
that may then advance from the stimulation site.

• The minimum amplitude and duration required to generate the

self-propagating wave front that results in cardiac activation is
referred to as the threshold.

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 Basic Concepts of Pacing
• In order to provide for consistent myocardial stimulation, there needs
to be a constant source of energy for pulse delivery, which is
provided by the pulse generator, a conductor that will deliver the
stimulus from the source, which is the lead itself, an electrode at the
end of the conductor that delivers the pulse, and underlying
myocardium that is excitable.

• Failure at any of these points (e.g. due to fracture in the lead or loss
of contact between the electrode and the underlying myocardium)
will result in failure of myocardial stimulation.

• Currently available pacing systems comprise a pulse generator and one

or more pacemaker leads with lead tips positioned in the cardiac
chamber of interest.

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 Basic Concepts of Pacing
• Sensing of local electrograms (EGMs) is essential to the
proper function of permanent pacemakers.
• Whether sensing takes place in a unipolar or bipolar system
and despite the differences between the two, the principles of
sensing remain the same.
• Two electrodes, a cathode and an anode, are required to
complete the electrical circuit between the body and the
pacemaker.
• In a bipolar system, both anode and cathode are located in
the heart, whereas in a unipolar system only the cathode is
located in the heart and the pacemaker generator can serve
as the anode.

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 Basic Concepts of Pacing
• As a wavefront of depolarization travels toward an
endocardial electrode in contact with resting
myocardium, the electrode becomes positively charged
relative to the depolarized region. This is manifest in the
intracardiac EGM as a positive deflection.
• As the wave front of depolarization passes under the
recording electrode, the outside of the cell suddenly
becomes negatively charged relative to resting
myocardium, and a brisk negative deflection is seen in the
intracardiac EGM.
• The positive and negative deflections that precede and
follow the intrinsic deflection represent activation in
neighbouring regions of myocardium relative to the
recording electrode.
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 Basic Concepts of Pacing

A typical bipolar ventricular electrogram

(EGM) in a normal individual. The sharp
downward deflection in the EGM represents
the intrinsic deflection and indicates the
moment of activation under the recording
electrode. The slope of the intrinsic deflection
(dV/dt) is expressed in volts per second and is
referred to as the slew rate. For an EGM to be
sensed by a sensing amplifier, the amplitude
and slew rate must exceed the sensing
thresholds.

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 Pacemaker Components
• A basic pacing system is made up
of:
• Implantable pulse generator that
contains:
• A power source—the
battery within the pulse generator that
generates the impulse
• Circuitry—controls pacemaker operations

• Leads—Insulated wires that deliver

electrical impulses from the pulse
generator to the heart. Leads also
transmit electrical signals from the heart
to the pulse generator.

• Electrode—a conductor located at the

end of the lead; delivers the impulse to
the heart

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 Schematic of Circuits in Pacemaker

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 Pulse Generator

• Contains a battery that provides

the energy for sending
electrical impulses to the heart

• Houses the circuitry that

controls pacemaker operations

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 Battery
• A battery converts chemical energy into electrical energy.
• The source of this energy is the electrochemical reactions that
occur within the
battery.
• During a spontaneous chemical reaction, substances react to form
more stable products.
• Redox reactions: types of reactions in which oxidation and
reduction occur. They are called redox reactions because electrons
are transferred from one reactant to another.
2Li + I2  2LiI

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 Implantable Battery Design Requirements
• The most important requirement in battery selection for
implantable devices is high reliability.
• Other significant factors include the desired longevity of the
device (directly related to battery energy density, circuit
design, and overall device size) and an appropriate
indication of impending battery depletion (end-of-service
warning).
• The basic considerations when designing a battery for an
implantable medical device include the current variations
that can be expected from the circuit as the device provides
its service for individual patients.
• Once the range of these application requirements are
defined, the current, voltage and capacity requirements of
the battery can be determined.
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 Microprocessors
• Microprocessors have become the standard control circuits of
implantable pacemakers and ICDs.
• Microprocessors have several advantages over older
integrated circuits, including a far greater circuit density and
greatly reduced current drain.
• Microprocessors also allow very sophisticated algorithms,
requiring multiple calculations, to be incorporated into
implantable devices, and have vastly increased data storage.
• The microprocessor can respond to changes in programming
instructions that allow functions to be added or changed after
implantation.
• The integrated circuit of pulse generators may contain both
read-only memory (ROM) and random access memory
(RAM).

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 Microprocessors
• ROM (typically 256 KB to 1 MB) is used to guide the
sensing and output circuits.
• In addition, RAM is used to store diagnostic information
regarding pacing rate, intrinsic heart rates, and sensor
output.
• The amount of RAM (1–16 MB) included in the pulse
generator varies between models and manufacturers, but has
rapidly increased in modern pulse generators, allowing for a
far greater amount of diagnostic information to be stored.
• The rapidly expanding diagnostic capabilities of pacemakers
has allowed for improved assessment of the physiological
condition of the patient, including stored information about
heart rate variability, respiration, intracardiac pressure,
patient activity, lung water, and arrhythmia logs.

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 Sensing Circuit
• The intracardiac EGM is conducted from the electrodes to
the sensing circuit of the PG, where it is amplified and
filtered.
• The intracardiac EGM is filtered to remove unwanted
frequencies, a process that markedly affects the amplitude of
the processed signal.
• Following filtering of the intracardiac signal, the processed
signal is compared with a reference voltage to determine if
the signal exceeds a threshold detection level (programmed
sensitivity).
• Signals with amplitudes greater than the sensitivity threshold
level are sensed as intracardiac events, whereas signals of
lower amplitude are discarded as noise.
• Signals that exceed the threshold level are sent to the timing
circuit and logic circuits.
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 Timing Circuit
• The pacing cycle length, sensing refractory and alert
periods, pulse duration and AV interval are precisely
regulated by the timing circuit of the pulse generator.
• The timing circuit of a pulse generator is a crystal
oscillator that generates a very accurate signal with a
frequency in the kilo Hertz range.
• The output of the crystal oscillator is sent to a digital
timing and logic control circuit that operates
internally generated clocks at divisions of the
oscillator frequency.
• The output of the logic control circuit is a logic pulse
that triggers the output pacing pulse, the blanking and
refractory intervals, and the AV delay.
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 Rate Responsive Pacing Sensors

• When the need for oxygenated blood increases, the

pacemaker ensures that the heart rate increases to
provide additional cardiac output
• There are several different types of sensors that may
be employed in pacemakers. Most commonly,
sensors work to augment heart rate in response to
physical activity, whether by detecting patient
movement or changes in respiratory rate.
• Those most accepted in the market place are:
• Activity sensors that detect physical movement and increase the
rate according to the level of activity
• Minute ventilation sensors that measure the change in respiration
rate and tidal volume via transthoracic impedance readings

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 Rate Responsive Pacing Sensors
• Using technology that detects changes in vibration,
acceleration, or minute ventilation, pacemakers may be pre-
programmed to induce concomitant changes in the paced
rate if the physiological heart rate does not meet those
parameters.

• Other sensors may use sensitivity to temperature, QT

interval, or local myocardial contractility to respond to
conditions under which increases in heart rate are desired,
but for which sensors that detect only changes in physical
activity would be inadequate.

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 Leads

Leads Are Insulated Wires That:

• Deliver electrical impulses

from the pulse generator to
the heart.

• Sense cardiac depolarization.

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 Leads

During Pacing, the Impulse:

• Begins in the pulse

generator

• Flows through the lead and

the cathode (–)

• Stimulates the heart

• Returns to the anode (+)

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 Components of Pace Maker Leads
1) Electrodes
2) Conductors
3) Insulation
4) Connector pin
5) Fixation mechanism

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 Types of Lead Design

A) Coaxial lead body design consists of two nested coil B) In coradial design, a single coil contains the
conductors to the tip and ring electrodes, each wrapped parallel conductor strands to the tip and ring
in a separate layer of insulation. The inner coil connects electrodes, with each strand covered by a
to the tip cathode and contains a central lumen for fluoropolymer(ETFE) insulator. A surrounding layer
stylet passage; the outer coil connects to the ring of outer insulation by polyurethane covers the lead
anode.can be attached to endocardium via active/passive body.Design can allow significantly smaller (<6F)
fixing mechanisms but limited by large diameters diameters but limits the fixation mechanism.

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 ICD Leads
• Defibrillator leads have greater complexity, with two,
three, or four conductors that connect to the
pacing/sensing electrodes as well as to the high-voltage
shocking coil(s), depending on the specific type of lead.
• Because of the prohibitive bulk that would result from a
coaxial design with more than two conductors, ICD
leads generally have a different type of structure,
known as a multilumen design.
• This type of ICD lead consists of a long cylinder of
insulating material, with separate internal channels
running down its length. Each conductor runs down an
individual channel, usually with its own additional
covering tube of insulation.

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 ICD Leads

Multilumen ICD lead design

consists of a single body of
insulation with several
internal channels that
contain the conductor
elements (central pace/sense
coil and outer high- voltage
cables), each covered by its
own layer of fluoropolymer
insulation. A surrounding
layer of outer polyurethane-
based insulation is present.
HP, High- performance.

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 Example: Micra Transcatheter Pacing System
• The miniaturized Micra™ transcatheter pacing system (TPS) is the world’s
smallest pacemaker, delivered percutaneously via a minimally invasive
approach, directly into the right ventricle and does not require the use of
leads.

• 99% implant success rate in 726-patient global trial

• 48% fewer major complications than traditional pacemakers

• 93% smaller than conventional pacemakers5

• Ultra low-power circuit design delivers an estimated average 12-year battery

longevity.

• MRI SureScan™ technology allows the patient to be safely scanned using either
a 1.5T or 3T full body MRI.

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 Linear one-step deployment facilitates consistent capsule
placement, no torque required.
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 The Artificial Heart: A
Design Example

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 The Human Heart

 Heart has four

chambers
 Right chambers
pump blood to lungs
to receive oxygen
 Left chambers pump
oxygenated blood
from lungs to rest of
the body

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 The Human Heart

• Right and left atria receive blood

• Right and left ventricles pump blood
• Valves produce one-way blood flow from atria
ventricles arteries
• Energy to pump blood comes from nutrients and
oxygen in blood
• The blood supply to the heart is provided by
coronary arteries

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 Heart Disease

• Heart attack:blockage of coronary artery damages

portion of heart muscle
• Congestive heart failure: gradual weakening of
heart
• Millions suffer from heart disease
• Many cases are treatable with lifestyle changes,
drugs and/or surgery
• Surviving patients suffering from most severe
• cases need new hearts!

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 The Need for a Heart Substitute

• 100,000 Americans/year suffering from severe heart

disease need new hearts
• Only 2,000 patients receive heart transplants
• Conclusion: many patients die waiting for a new
heart!
• A suitable alternative to donor hearts could prolong
thousands of lives

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 History of Heart Substitutes

 WWII: first open

heart surgeries
 1953: heart-lung
machine successfully used
during heart surgery
 1958: Drs. Willem Kolff
and Tetsuzo Akutsu sustain a
dog for 90 minutes with a
PVC artificial heart
 1967: Dr. Christian
Barnard transplants a donor
heart into a 59 year old man
(he survived 18 days)

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 History of Heart Substitutes

 1969: Dr. Denton Cooley

uses an artificial heart to
sustain a patient waiting for a
donor (survived 3 days)
 1972: Cyclosporine
introduced to suppress
immune responses of
transplant recipients
 1982: Dr. William DeVries
implants the Jarvik-7 artificial
heart into Dr. Barney Clark (he
Liotta heart (1969) Jarvik-7 (1982)
survived 112 days)

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 Why Heart Substitutes Fail

• Immune response “rejects” transplant or side effects

due to immune suppression
• Infection due to tubes and wires passing through
skin
• Formation of clots
• Damage to red blood cells
• Lack of pulsatile blood flow?

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 Design Process

• Identify the problem or need to address

• Specify details/criteria of an adequate solution to
your problem
• Implement various solutions that meet the criteria
you specified
• Test to determine which solution is most viable
• Further testing to refine the solution you chose

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 Design Refinement

 Identify Problem
Process is iterative
– You need to repeat
various steps after Specify Criteria
testing
– Make design
changes Implement Design
based on test results
 Failed designs
– Design didn’t meet Test Design
criteria
– Could be due to
Refine Design
inappropriate criteria

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 Criteria for a Heart Substitute
• Must fit into chest cavity and connect to atria, pulmonary artery and
aorta quickly
• Provide an adequate blood flow (8 – 10 liters/min)
• Send deoxygenated blood to the lungs and oxygenated blood to the
body
• Operate continuously for an indefinite period of time
• Provide adequate warning if something is wrong or if it is going to
fail
• Should increase/decrease blood flow based on patient activity level
• Should not evoke an immune response
• No wires or tubes that penetrate the skin
• Should not produce blood clots
• Should not damage red blood cells
• Ideally should have pulsatile blood flow
• Many others we haven’t thought of!

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 The AbioCor® Heart

 Implanted into 59 year

old Robert Tools on July
2, 2001 at Jewish
Hospital in Louisville KY
(96 days)
 Patient is able to walk
around, organs are
functioning normally,
undergoing daily
rehabilitation for
eventual release

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 How the AbioCor® Heart Works

 Hydraulic pump forces

blood to lungs and body
 Power is provided by an
internal rechargeable
battery
 Battery is recharged by
coils on surface and
below skin
 Internal controller
monitors system and
controls pump speed

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 Surgical Procedure

 Implant controller,
battery and coil
 Connect patient to
heart-lung machine
 Cut away ventricles
 Sew grafts onto atria
and arteries
 Connect implants to
grafts
 Remove patient from
heart-lung machine

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 AbioCor® Design Criteria
• Grapefruit size, weighs 2 lbs, requires a 7 hour surgery for
implantation
• Can provide up to 8 liters/min of blood to the lungs and body
• Has two chambers for pumping deoxygenated blood to the lungs and
oxygenated blood to the body
• Wireless energy transfer system allows for continuous operation
• Internal controller monitors operation
• Internal controller increases/decreases blood flow based on blood
oxygen levels
• Materials are inert to the immune system
• Completely contained within the chest – no wires or tubing through
skin!
• Made of special materials and special pump design to prevent clots and
RBC damage
• Pumping alternates between chambers, creating a pulsatile blood flow

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