2. DISCLOSURES
This presentation is provided for general educational purposes only and should not
be considered the exclusive source for this type of information. Patient information
(names, serial numbers, date, etc.) has been changed or removed to protect the
privacy of the patients used in this presentation.
At all times, it is the professional responsibility of the practitioner to exercise
independent clinical judgment in a particular situation. Changes in a patient’s
disease and/or medications may alter the efficacy of a device’s programmed
parameters or related features and results may vary. The device functionality and
programming described in this presentation are based on Medtronic products and
can be referenced in the published device manuals.
Important Reminder: This information is intended only for users in markets where
Medtronic products and therapies are approved or available for use. Content on
specific Medtronic products and therapies is not intended for users in markets that
do not have authorization for use.
3. OBJECTIVES
Explain the different types of pacemakers and the NBG Code
Identify the components of a pacemaker circuit
Describe the relationship between voltage, current, and
resistance
Describe the clinical significance of alterations in voltage,
current, and resistance
Recognize low and high impedance conditions and possible
causes
Identify a capture threshold and calculate safety margins
Understand sensing and sensitivity in a pacemaker
5. SINGLE CHAMBER SYSTEM
One lead
Atrium
Ventricle (most common)
May be used for patients in chronic
AF (VVI pacemaker) or patients
with sinus node dysfunction and no
history of AV block (AAI
pacemaker)
VVI Pacemaker AAI Pacemaker
6. DUAL CHAMBER SYSTEM
Two leads
One lead implanted in the atrium
One lead implanted in the
ventricle
Provides AV synchrony and pacing
support in both atrium and
ventricle if needed
DDD Pacemaker
8. TRIPLE CHAMBER SYSTEM
Three Leads:
Right Atrium
Right Ventricle
Left Ventricle (via the Coronary
Sinus vein)
Most commonly called a Bi-
Ventricular Pacemaker but also
called Cardiac Resynchronization
Therapy (CRT–P)
Paces both ventricles together to
“resynchronize” the beat
DDD BiV Pacemaker
9. NBG CODE – THE USUAL PACING MODES
Chamber(s)
Paced
Chamber(s)
Sensed
Response to
Sensing
Rate
Modulation
Multisite
Pacing
O = None
A = Atrium
V = Ventricle
D = Dual (A +V) + V)
S = Single (A or V)
O = None
A = Atrium
V = Ventricle
D = Dual (A + V)
S = Single (A or V)
O = None
T = Triggered
I = Inhibited
D = Dual (T + I)
O = None
R = Rate
modulation
O = None
A = Atrium
V = Ventricle
D = Dual (A + V)
Examples of pacing modes which are typically programmed:
DDD VVI DDIR
DDDR VVIR AAIR
10. What type of pacemaker is this?
KNOWLEDGE CHECKPOINT
12. KEY LEARNING POINTS
There are three types of pacemakers
Important to identify which one the patient has and why
The mode explains how the pacemaker should work
Very important to understanding the basic function of the device
15. THE PULSE GENERATOR
Common battery compositions
include:
Lithium-Iodine
Lithium silver vanadium oxide
with carbon monoflouride
Starting battery voltage will vary
depending on composition
Longevity
Dependent on impedance and
output
Commonly ranges from 6-12
years
Circuitry
Battery
16. LEADS ARE INSULATED WIRES
Deliver electrical impulses from the pulse generator to the heart
Sense cardiac depolarization
Lead
17. LEAD POLARITY
Unipolar leads
May have a smaller diameter
lead body than bipolar leads
May exhibit larger pacing
artifacts on the surface ECG
May cause pectoral muscle
stimulation
Bipolar leads
Usually less susceptible to
oversensing of non-cardiac
signals (i.e., myopotentials, EMI,
etc.)
Al-Ahmad, A, Ellenbogen KA, Natale A, Wang PJ. Pacemakersand ImplantableCardioverterDefibrillators:An Expert'sManual. Minneapolis, MN: Cardiotext Publishing;
2010.
To tip (cathode)
From ring (anode)
Unipolar lead
Bipolar coaxial lead
18. UNIPOLAR PACING SYSTEM
The lead has only one electrode
(the cathode) at the tip
The pacemaker can is the anode
When pacing, the impulse:
Flows through the tip electrode
(cathode)
Stimulates the heart
Returns through body fluid and
tissue to the IPG can (anode)
Why might this be important to
know during a procedure?
Cathode
-
Anode
+
19. Anode
BIPOLAR PACING SYSTEM
The lead has both an anode and
cathode
The pacing impulse:
Flows through the tip electrode
located at the end of the lead wire
Stimulates the heart
Returns to the ring electrode, the
anode, above the lead tip
Cathode
Anode +
Cathode -
20. TRANSVENOUS LEADS
Passive fixation (tined)
The tines become lodged in the
trabeculae of the apex or the
pectinate of the appendage
which are fibrous meshworks of
heart tissue
Active fixation (screw-in)
The helix, or screw, extends into
the endocardial tissue
Allows for lead positioning
anywhere in the heart’s chamber
The helix is extended using an
included tool
21. EPICARDIAL LEADS
Leads applied directly to the
surface of the heart
Utilized in pediatric patients
and patients contraindicated
for transvenous leads
Fixation mechanisms include:
Epicardial stab-in
Myocardial screw-in
Suture-on
Applied via sternotomy,
thoroscopy, or limited
thoracotomy
22. LEAD INSULATORS
Silicone insulated leads
Inert
Biocompatible
Biostable
Repairable with medical adhesive
Historically very reliable
Polyurethane insulated leads
Biocompatible
High tear strength
Low friction coefficient
Smaller lead diameter
Hayes, DL, Friedman P. Cardiac Pacing, Defibrillationand Resynchronization: A Clinical Approach. Hoboken, NJ: Wiley-Blackwell Publishing; 2008.
Newer bipolar lead insulation
SILICONE
POLYURETHANE
23. KNOWLEDGE CHECKPOINT
Where is the anode located in bipolar
pacing?
A.Tip Electrode
B.Ring Electrode
C.Device
D.Body Tissue
24. KEY LEARNING POINTS
The pacemaker circuit consists of the leads, device, and tissue
Modern leads are usually bipolar, endocardial, and active fixation but all
types of leads are available
Important to know what type of lead is implanted because it can be
helpful for diagnosing a problem and determining solutions
26. VOLTAGE
Voltage is the force, or “push,” that causes electrons to move through a
circuit
In a pacing system, voltage is:
Measured in volts (V)
Represented by the letter “V”
Provided by the pacemaker battery
Often referred to as amplitude or pulse amplitude
Note: The terms “amplitude” and “voltage” are often used interchangeably in pacing.
29. CURRENT
The flow of electrons through a completed circuit
In a pacing system, current is:
Measured in milliamps (mA)
Represented by the letter “I”
Determined by the amount of electrons that move through a circuit
Note: One ampere is a unit of electrical current produced by 1 volt acting through a resistance of 1 ohm. 1 Ampere = 1000milliamps
31. IMPEDANCE
The opposition to current flow
In a pacing system, impedance is:
Measured in ohms (W)
Represented by the letter “R”
The sum of all resistances to the flow of current
Lead conductor resistance
The resistance to current flow from the electrode to the myocardium
Polarization impedance (the accumulation of charges of opposite polarity in the
myocardium at the electrode-tissue interface)
34. SUMMARY
VOLTAGE, CURRENT, AND IMPEDANCE
Voltage: The force moving the current (V)
In pacemakers it is a function of the battery chemistry
Current: The actual continuing volume of flow of electricity (I)
This flow of electrons causes the myocardial cells to depolarize (to
“beat”)
Impedance: The sum of all resistance to current flow (R)
Impedance is a function of the characteristics of the conductor (wire),
the electrode (tip), and the myocardium (tissue).
35. OHM’S LAW
Describes the relationship
between voltage, current, and
resistance (impedance)
V
=
I X R
V
=I
R
V= I X R
I = V / R
R = V / I
V
=I R
V
I R
36. OHM’S LAW TELLS US:
1. If the impedance (R) remains constant, and the voltage decreases, the
current decreases
2. If the voltage is constant, and the impedance decreases, the current
increases
Why is this important to clinical management of pacemakers?
The relationship between voltage, current, and impedance provides the rationale for
decisions we make during evaluation of pacing systems and reprogramming. Proper
management of electrical characteristics is important for patient safety and device
longevity.
38. KEY LEARNING POINTS
Know where to find the voltage and impedance on the programmer and
report
Ohm’s law and the relationship between voltage, current, and impedance
Knowing how these factors relate to each other can help you
understand how the pacemaker paces the heart
40. TYPICAL LEAD IMPEDANCE RANGE
Most important that lead impedance is stable over the lifetime of the
device.
Generally, a 30% change or abrupt change is something to be concerned
about.
Hayes, DL, Friedman P. Cardiac Pacing, Defibrillation and Resynchronization: A Clinical Approach. Hoboken, NJ: Wiley-Blackwell Publishing; 2008.
Typical Impedance range = 200 to 1,000 Ohms.*
*Impedance is higher for specially designed high impedance leads.
41. LEAD IMPEDANCE VALUES
ELECTRICAL ANALOGIES
Normal resistance – friction caused by the hose and nozzle
Low resistance –leaks in the hose reduce the resistance
Similar to a pacemaker lead with an insulation breach which results in
low resistance and high current drain; may cause premature battery
depletion.
High resistance – a knot results in low total current flow
Similar to a pacemaker lead with a lead conductor break - impedance
will be high with little or no current reaching the myocardium.
42. KNOWLEDGE CHECKPOINT
What would you expect to happen if a lead was fractured?
A. Impedance would drop
B. Current would decrease
C. Impedance would rise
D. Both B and C
43. HIGH IMPEDANCE CONDITIONS
A FRACTURED CONDUCTOR
A fractured wire can cause
Impedance values to rise
Current flow from the battery
may be too low to be effective
Impedance values may exceed
3,000 W
Other reason for high impedance: Lead not seated properly in pacemaker
header (usually an acute problem).
44. CASE STUDY: CLINIC VISIT
85 year old male with h/o pacemaker implant in 1996. Generator change in
2005. Follow up visits in clinic have been normal. He now comes into your
office complaining of light-headedness and fatigue.
You interrogate his pacemaker and find the ventricular lead impedance is
1,867 ohms and it was usually trending around 700 ohms.
45. CHEST X RAY
Can you identify a problem?
1st Rib-Clavicle Crush (lead fracture)
47. SOLUTIONS FOR LEAD CRUSH
Unipolar configuration if the inner conductor is still intact
Lead replacement
48. KNOWLEDGE CHECKPOINT
What would you expect to happen if a lead has an insulation break?
Check all that apply.
Impedance would drop
Potential loss of capture
Current would increase
Battery longevity improves
49. LOW IMPEDANCE CONDITIONS
AN INSULATION BREAK
Insulation breaks can cause
impedance values to fall
Current drain is high and can
lead to more rapid battery
depletion
Current can drain through the
insulation break into the body or
other lead wire, not through
myocardium
Impedance values may be less than
300 W
Current will follow the path of LEAST
resistance
50. CASE STUDY: ROUTINE FOLLOW UP
A patient comes in for routine follow
up and you notice this on the initial
interrogation report:
51. LOOK AT THE EGM
What do you suspect?
Lead II
V EGM
Marker
Channel
52. INSULATION BREAK
A low impedance usually means an insulation break
Oversensing can be a result of an insulation break and the EGM shows
abnormal electrical signals
Now that we know what the problem is,
how do you fix it?
53. POLARITY SWITCH
The automatic “Polarity Switch” of the pacemaker can automatically notice
an issue with the lead impedance and switch to unipolar
54. REPLACE THE LEAD
Since the lead is still oversensing and has a low impedance in the unipolar
configuration, a lead replacement should be considered.
The compromised lead can be capped and a new ventricular pacing lead
can be placed at least 1 cm away to prevent lead-lead noise.
55. CAPTURE THRESHOLD
The minimum electrical stimulus needed to consistently capture the heart
outside of the heart’s own refractory period
Ventricular pacemaker 60 ppm
56. EFFECT OF LEAD DESIGN ON CAPTURE
Lead maturation
Fibrotic “capsule” develops around the electrode following lead
implantation
May gradually raise threshold
Usually no measurable effect on impedance
Ellenbogen, KA, Wood MA. Cardiac Pacing and ICDs. Hoboken, NJ: Blackwell Publishing; 2008.
57. STEROID ELUTING LEADS
Steroid eluting leads reduce the
inflammatory process
Exhibit little to no acute
stimulation threshold peaking
Leads maintain low chronic
thresholds
58. EFFECT OF STEROID ON STIMULATION THRESHOLDS
Ellenbogen, KA, Wood MA. Cardiac Pacing and ICDs. Hoboken, NJ: Blackwell Publishing; 1996.
59. FACTORS THAT CAN AFFECT THRESHOLDS
Pacemaker circuit (lead) integrity
Insulation break
Wire fracture
The characteristics of the electrode
Electrode placement within the heart
Drugs
Electrolytes
Sleeping/Eating
Hayes DL, Asirvatham SJ, Friedman PA. Cardiac Pacing, Defibrillation,and Resynchronization. Hoboken, NJ: Wiley-Blackwell; 2010.
60. MYOCARDIAL CAPTURE
Capture is a function of:
Amplitude—the strength of the impulse expressed in volts
The amplitude of the impulse must be large enough to cause depolarization (i.e.,
to “capture” the heart)
The amplitude of the impulse must be sufficient to provide an appropriate pacing
safety margin
Pulse width—the duration of the current flow expressed in
milliseconds
The pulse width must be long enough for depolarization to disperse to the
surrounding tissue
62. STRENGTH-DURATION CURVE
Strength-duration curve shows
relationship of amplitude and pulse
width
Adequate safety margins are
important because thresholds can
fluctuate slightly
63. STRENGTH DURATION CURVE EXAMPLE
Safety Margin = 2 x Amplitude Threshold
OR
3 x Pulse Width Threshold
64. PROGRAMMING OUTPUTS
Primary goal: Ensure patient safety and appropriate device performance
Secondary goal: Extend the service life of the battery
Typically program amplitude to < 2.5 V, but always maintain adequate
safety margins
Amplitude values greater than the cell capacity of the pacemaker
battery (usually about 2.8 V) require a voltage multiplier, resulting in
markedly decreased battery longevity
66. CASE STUDY: ER VISIT
A patient presented to the ER with the complaint that he felt just the way
he did when he first received his pacemaker. What is your interpretation?
67. ORDER A CHEST X-RAY
The chest x-ray revealed a dislodged lead
69. SENSING
Sensing is the ability of the pacemaker to “see” when a natural (intrinsic)
depolarization is occurring
Pacemakers sense cardiac depolarization by measuring changes in
electrical potential of myocardial cells between the anode and cathode
75. SENSING AMPLIFIERS/FILTERS
Accurate sensing requires that extraneous signals are filtered out
Because whatever a pacemaker senses is by definition a P- or an R-
wave
Sensing amplifiers use filters that allow appropriate sensing of P- and
R-waves, and reject inappropriate signals
Unwanted signals most commonly sensed are:
T-waves (which the pacemaker defines as an R-wave)
Far-field events (R-waves sensed by the atrial channel, which the
pacemaker thinks are P-waves)
Skeletal muscle myopotentials (e.g., from the pectoral muscle, which
the pacemaker may think are either P- or R-waves)
Signals from the pacemaker (e.g., a ventricular pacing spike sensed on
the atrial channel “crosstalk”)
76. VECTORS AND GRADIENTS
The wave of depolarization
produced by normal conduction
creates a gradient across the
cathode and anode. This changing
polarity creates the signal.
Once this signal exceeds the
programmed sensitivity – it is
sensed by the device.
77. CHANGING THE VECTOR
A PVC occurs, which is conducted
abnormally. Since the vector
relative to the lead has changed,
what effect might this have on
sensing?
In this case, the wave of
depolarization strikes the anode
and cathode almost
simultaneously. This will create a
smaller gradient and thus, a
smaller signal.
78. SENSING ACCURACY
Affected by:
Pacemaker circuit (lead) integrity
Insulation break
Wire fracture
The characteristics of the electrode
Electrode placement within the heart
The sensing amplifiers of the pacemaker
Lead polarity (unipolar vs. bipolar)
The electrophysiological properties of the myocardium
EMI – Electromagnetic Interference
79. UNDERSENSING . . .OVERPACING
Pacemaker does not “see” the intrinsic beat, and therefore does not
respond appropriately
82. CASE STUDY: TELEMETRY CALL
You are on call and the telemetry
nurse calls you because a patient’s
pacemaker is “malfunctioning.”
She saw that the lower rate was
programmed to 60 but at times the
patient is going 50 bpm.
You grab the programmer and
interrogate:
83. SOLUTION
Now that we know what the problem is,
How do we fix it?
Measure the size of the R waves
Make the ventricular lead less sensitive by increasing the ventricular
sensitivity
84. KEY LEARNING POINTS
• The NBG code indicates the pacing mode and whether the pacemaker is
pacing, sensing, and inhibiting in either the atrium and ventricle.
• There is a mathematical relationship between voltage, current, and
resistance. These variables should be considered for patient safety (to
ensure capture) and device longevity.
• Lead impedance is a key measure of lead integrity. Low or high
impedance may indicate a faulty lead.
• Appropriate safety margins should be applied to the capture threshold to
ensure patient safety.
• Proper sensing is vital to the operation of the pacemaker.
85. INDICATIONS, SAFETY, AND WARNINGS
If you are located in the United States, please refer to the brief statement(s) below to review
applicable indications, safety and warning information. See the device manual for detailed
information regarding the implant procedure, indications, contraindications, warnings,
precautions, and potential complications/adverse events. For further information, please call
Medtronic at 1.763.514.4000 and/or consult the Medtronic website at www.medtronic.com.
If you are located outside the United States, see the device manual for detailed information
regarding the implant procedure, indications, contraindications, warnings, precautions, and
potential adverse events. For further information, contact your local Medtronic representative
and/or consult the Medtronic website at www.medtronic.com.
Consult instructions for use at this website. Manuals can be viewed using a current version of any
major Internet browser. For best results, use Adobe Acrobat Reader® with the browser.
86. BRIEF STATEMENTS (USA): IPGS
Indications
Implantable Pulse Generators (IPGs) are indicated for rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in
activity. Pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber
modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include various degrees of AV
block to maintain the atrial contribution to cardiac output and VVI intolerance (e.g. pacemaker syndrome) in the presence of persistent sinus rhythm. See device
manuals for the accepted patient conditions warranting chronic cardiac pacing. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrythmias in
patients with one or more of the above pacing indications. For the MR Conditional IPGs, a complete SureScan® pacing system, which consists of an approved
combination (see http://www.mrisurescan.com/) MRI SureScan device with SureScan lead(s), is required for use in the MR environment.
Contraindications
IPGs are contraindicated for concomitant implant with another bradycardia device and concomitant implant with an implantable cardioverter defibrillator. There are no
known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient’s age and medical condition, however, may dictate the
particular pacing system, mode of operation, and implant procedure used by the physician. Rate-responsive modes may be contraindicated in those patients who
cannot tolerate pacing rates above the programmed Lower Rate. Dual chamber sequential pacing is contraindicated in patients with chronic or persistent
supraventricular tachycardias, including atrial fibrillation or flutter. Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between
paced and intrinsic rhythms. Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance. Anti-tachycardia pacing (ATP) therapy is
contraindicated in patients with an accessory antegrade pathway.
Warnings/Precautions
Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and
electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device
electrical reset or device damage. Do not place transthoracic defibrillation paddles directly over the device.
For MR Conditional IPG Systems, before performing an MRI scan, refer to the SureScan pacing system technical manual for additional information, patients and their
implanted systems must be screened to meet the MRI Conditions of Use. Do not scan patients who do not have a complete SureScan pacing system consisting of an
approved combination MRI SureScan device with SureScan lead(s); patients who have broken, abandonedor intermittent leads; or patients who have a lead impedance
value of < 200 Ω or > 1,500 Ω.
Potential complications
Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect
and/or terminate arrhythmia episodes, and surgical complications such as hematoma, infection, inflammation, and thrombosis.
SureScan systems have been designed to minimize potential complications in the MRI environment. Potential MRI complications include, but are not limited to, lead
electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF, and/or
hemodynamic collapse.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential
complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
AUGUST 25, 2015
87. BRIEF STATEMENT (USA): CRT PACEMAKERS (IPGS)
Indications
Cardiac Resynchronization Therapy (CRT) IPGs are indicated for NYHA Functional Class III and IV patients who remain symptomatic despite stable, optimal heart
failure medical therapy and have a LVEF ≤ 35% and a prolonged QRS duration and for NYHA Functional Class I, II, or III patients who have a LVEF ≤ 50%, are on stable,
optimal heart failure medical therapy if indicated and have atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that
cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent
need for pacing should be done post implant. Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased
pacing rates concurrent with increases in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV
synchrony. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in patients with one or more of the above pacing indications.
Contraindications
CRT IPGs are contraindicated for concomitant implant with another bradycardia device and concomitant implant with an implantable cardioverter defibrillator. There
are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient’s age and medical condition, however, may dictate the
particular pacing system, mode of operation, and implant procedure used by the physician. Rate-responsive modes may be contraindicated in those patients who
cannot tolerate pacing rates above the programmed Lower Rate. Dual chamber sequential pacing is contraindicated in patients with chronic or persistent
supraventricular tachycardias, including atrial fibrillation or flutter. Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between
paced and intrinsic rhythms. Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance. Anti-tachycardia pacing (ATP) therapy is
contraindicated in patients with an accessory antegrade pathway.
Warnings/Precautions
Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and
electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device
electrical reset or device damage. Do not place transthoracic defibrillation paddles directly over the device.
Additionally, for CRT ICDs and CRT IPGs, certain programming and device operations may not provide cardiac resynchronization. Also for CRT IPGs, Elective
Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm. In this mode, patients may experience loss of cardiac resynchronization therapy
and / or loss of AV synchrony. For this reason, the device should be replaced prior to ERI being set. Use of the device should not change the application of established
anticoagulation protocols.
Potential complications
Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect
and/or terminate arrhythmia episodes, and surgical complications such as hematoma, infection, inflammation, and thrombosis.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential
complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
AUGUST 25, 2015
88. BRIEF STATEMENTS (USA): PACING LEADS
Indications
Medtronic leads are used as part of a cardiac rhythm disease management system. Leads are intended for pacing and sensing
and/or defibrillation. Defibrillation leads have application for patients for whom implantable cardioverter defibrillation is indicated
Contraindications
Medtronic leads are contraindicated for the following:
ventricular use in patients with tricuspid valvular disease or a tricuspid mechanical heart valve.
patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate or dexamethasone acetate may be
contraindicated. (includes all leads which contain these steroids)
Epicardial leads should not be used on patients with a heavily infarcted or fibrotic myocardium.
The SelectSecure Model 3830 Lead is also contraindicated for the following:
patients for whom a single dose of 40.µg of beclomethasone dipropionate may be contraindicated.
patients with obstructed or inadequate vasculature for intravenous catheterization.
Warnings/Precautions
People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not
receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage
to the device components, which could result in serious injury, loss of therapy, or the need to reprogram or replace the device.
For the SelectSecureModel 3830 lead, total patient exposure to beclomethasone 17,21-dipropionateshould be considered when
implanting multiple leads. No drug interactions with inhaled beclomethasone17,21-dipropionatehave been described. Drug
interactions of beclomethasone17,21-dipropionate with the Model 3830 lead have not been studied.
89. BRIEF STATEMENTS (USA): PACING LEADS
CONTINUED
Potential Complications
Potential complications include, but are not limited to, valve damage, fibrillation and other arrhythmias, thrombosis, thrombotic and
air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, muscle or nerve stimulation, pericardial rub, infection,
myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead
conductor fracture, insulation failure, threshold elevation or exit block.
See the device manual for detailed informationregarding the implant procedure, indications, contraindications, warnings,precautions,
and potential complications/adverseevents. For further information,please call Medtronic at 1-800-328-2518 and/orconsult
Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings,
precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518and/or
consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
90. BRIEF STATEMENTS (USA): ATTAIN® PERFORMA™ 4298
LEAD
Indications
The Attain Performa 4298 steroid eluting, quadripolar electrode, IS4 transvenous lead is indicated for chronic pacing and sensing in the left
ventricle via the cardiac vein, when used with a compatible Medtronic Cardiac Resynchronization Therapy (CRT) system. Extended bipolar
pacing is available using this lead in combination with a compatible CRT-D system and RV defibrillation lead.
Contraindications
Coronary vasculature – This lead is contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as
indicated by venogram.
Steroid use – Do not use in patients for whom a single dose of 288 μg of dexamethasone acetate may be contraindicated.
Warnings and Precautions
Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
Output pulses, especially from unipolar devices, may adversely affect device sensing capabilities. If a patient requires a separate stimulation
device, either permanent or temporary, allow enough space between the leads of the separate systems to avoid interference in the sensing
capabilities of the devices. Previously implanted pulse generators and implantable cardioverter defibrillators should generally be explanted.
People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs) and accompanying leads should not receive
diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device
components, which could result in serious injury, loss of therapy, and/or the need to reprogram or replace the device.
Leads should be handled with great care at all times. Use an anchoring sleeve with all leads. Ensure the anchoring sleeve is positioned close to
the lead connector pin, to prevent inadvertent passage of the sleeve into the vein. Use care when handling stylets. Any severe bending
kinking, stretching, handling with surgical instruments, or excessive force when inserting a stylet may cause permanent damage to the lead.
Rust stylets are not recommended with this lead due to the risk of conductor coil or insulation perforation.
Use care when handling guide wires. Damage to the guide wire may prevent the guide wire from performing with accurate torque response
and may cause vessel damage. Do not use excessive force to retract the guide wire from the lead. Refer to the product documentation
packaged with the guide wire for additional information.
Do not use magnetic resonance imaging (MRI) on patients who have this device implanted. MRI can induce currents on implanted leads,
potentially causing tissue damage and the induction of tachyarrhythmias.
91. BRIEF STATEMENTS (USA): ATTAIN® PERFORMA™ 4298 LEAD
CONTINUED
For the Model 4298 lead, total patient exposure to dexamethasone acetate should be considered. Drug interactions of dexamethasone
acetate with this lead have not been studied. It has not been determined whether the warnings, precautions, or complications usually
associated with injectable dexamethasone acetate apply to the use of this highly localized, controlled-release device. For a list of potential
adverse effects, refer to the Physician’s Desk Reference.
Do not force the guide catheter or leads if significant resistance is encountered. Use of guide catheters and/or leads may cause trauma to the
heart.
Keep external defibrillation equipment nearby for immediate use during acute lead system testing, the implant procedure, or whenever
arrhythmias are possible or intentionally induced during the post-implant testing. Backup pacing should be readily available during implant.
Use of the delivery system or leads may cause heart block.
To minimize the likelihood of trauma to the vein and to maintain lead flexibility while advancing the lead through the vein, keep the stylet
withdrawn 1 to 2 cm or select a more flexible stylet.
Do not insert the proximal end of the guide wire through the lead tip seal without using the guide wire insertion tool. Inserting the guide wire
without the guide wire insertion tool may damage the lead.
During lead implant and testing, use only battery-powered equipment or line-powered equipment specifically designed for this purpose to
protect against fibrillation that may be caused by alternating currents.
Potential Complications
Potential complications related to the use of transvenous leads include, but are not limited to the following patient-related conditions: cardiac
dissection, cardiac perforation, cardiac tamponade, coronary sinus dissection, death, endocarditis, erosion through the skin, extracardiac
muscle or nerve stimulation, fibrillation or other arrhythmias, heart block, heart wall or vein wall rupture, hematoma/seroma, infection,
myocardial irritability, myopotential sensing, pericardial effusion, pericardial rub, pneumothorax, rejection phenomena, threshold elevation,
thrombosis, thrombotic or air embolism, and valve damage.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential
complications/adverse events. For further information, please call Medtronic at 1 (800) 723-4636 and/or consult Medtronic’s
website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
92. BRIEF STATEMENT (USA): MEDTRONIC ATTAIN ABILITY
MODEL 4196, ABILITY PLUS MODEL 4296, AND ABILITY
STRAIGHT MODEL 4396 LEADS
Steroid eluting, dual electrode, transvenous, over the wire, cardiac vein pacing leads. The Model 4396 lead has tined fixation.
Indications
The Attain Ability Models 4196, 4296, and 4396 steroid eluting, dual electrode, IS-1 transvenous leads are indicated for chronic pacing and
sensing in the left ventricle via the cardiac vein, when used in conjunction with a compatible Medtronic Cardiac Resynchronization Therapy
(CRT) system. Extended bipolar pacing is available using this lead in combination with a compatible CRT-D system and RV defibrillation lead or
with a compatible CRT-P system and RV pacing lead. Additionally, unipolar pacing is available using the leads in combination with a compatible
CRT-P system.
Contraindications
Coronary vasculature - The leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as
indicated by venogram.
Steroid use - Do not use in patients for whom a single dose of 232 µg of dexamethasone acetate cannot be tolerated.
Warnings and Precautions
The Model 4196, 4296, and 4396 were designed for optimal pacing when used in a unipolar or extended bipolar configuration. The standard
bipolar configuration may result in markedly elevated pacing thresholds or produce anodal stimulation.
Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development. The clinical studies for these leads were not
designed to evaluate the removal of left ventricular leads from the coronary venous vasculature.
Output pulses, especially from unipolar devices, may adversely affect device sensing capabilities. If a patient requires a separate stimulation
device, either permanent or temporary, allow enough space between the leads of the separate systems to avoid interference in the sensing
capabilities of the devices. Previously implanted pulse generators and implantable cardioverter defibrillators should generally be explanted.
People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs) and accompanying leads should not receive
diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device
components, which could result in serious injury, loss of therapy, and/or the need to reprogram or replace the device.
93. BRIEF STATEMENT (USA): MEDTRONIC ATTAIN ABILITY
MODEL 4196, ABILITY PLUS MODEL 4296, AND ABILITY
STRAIGHT MODEL 4396 LEADS
CONTINUED
Leads should be handled with great care at all times. Use an anchoring sleeve with all leads. Ensure the anchoring sleeve is positioned close to
the lead connector pin, to prevent inadvertent passage of the sleeve into the vein. Use care when handling stylets. Any severe bending
kinking, stretching, handling with surgical instruments, or excessive force when inserting a stylet may cause permanent damage to the lead.
When using Model 4196, 4296, or 4396 leads, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead
length). Other stylets may extend beyond the lead tip causing lead tip seal damage or injury or perforation of the cardiac vein or heart. Rust
stylets are not recommended with these leads due to the risk of conductor coil or insulation perforation.
Use care when handling guide wires. Damage to the guide wire may prevent the guide wire from performing accurate torque response control
and may cause vessel damage. Do not use excessive force to retract the guide wire from the lead. Refer to the literature packaged with the
guide wire for additional information on guide wires.
Do not use magnetic resonance imaging (MRI) on patients who have this device implanted. MRI can induce currents on implanted leads,
potentially causing tissue damage and the induction of tachyarrhythmias.
For the Model 4196, 4296, or 4396 leads, total patient exposure to dexamethasone acetate should be considered. Drug interactions of
dexamethasone acetate with this lead have not been studied. It has not been determined whether the warnings, precautions, or
complications usually associated with injectable dexamethasone acetate apply to the use of this highly localized, controlled-release lead. For a
list of potential adverse effects, refer to the Physicians' Desk Reference.
Do not force the guide catheter or leads if significant resistance is encountered. Use of guide catheters and/or leads may cause trauma to the
heart.
Keep external defibrillation equipment nearby for immediate use during acute lead system testing, the implant procedure, or whenever
arrhythmias are possible or intentionally induced during the post-implant testing. Backup pacing should be readily available during implant.
Use of the delivery system or leads may cause heart block.
To minimize the likelihood of trauma to the vein and to maintain lead flexibility while advancing the lead through the vein, keep the stylet
withdrawn 1 to 2 cm or select a more flexible stylet.
Do not insert the proximal end of the guide wire through the lead tip seal without using the guide wire insertion tool. Inserting the guide wire
without the guide wire insertion tool could cause damage to the lead tip seal or to the conductor core or insulation.
94. BRIEF STATEMENT (USA): MEDTRONIC ATTAIN ABILITY
MODEL 4196, ABILITY PLUS MODEL 4296, AND ABILITY
STRAIGHT MODEL 4396 LEADS
CONTINUED
During lead implant and testing, use only battery-powered equipment or line-powered equipment specifically designed for this purpose to
protect against fibrillation that may be caused by alternating currents.
Potential Complications
Potential complications related to the use of tranvenous leads include, but are not limited to the following patient-related conditions: cardiac
dissection, cardiac perforation, cardiac tamponade, coronary sinus dissection, death, endocarditis, erosion through the skin, extracardiac
muscle or nerve stimulation, fibrillation or other arrhythmias, heart block, heart wall or vein wall rupture, hematoma/seroma, infection,
myocardial irritability, myopotential sensing, pericardial effusion, pericardial rub, pneumothorax, rejection phenomena, threshold elevation,
thrombosis, thrombotic or air embolism, and valve damage.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential
complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website
at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
95. BRIEF STATEMENT (USA): MEDTRONIC ATTAIN BIPOLAR
OTW MODEL 4194 LEAD
Indications
The Attain Bipolar OTW Model 4194 steroid eluting, IS-1 transvenous lead is indicated for chronic pacing and sensing in the left ventricle via
the cardiac vein, when used in conjunction with a compatible Medtronic Cardiac Resynchronization Therapy (CRT) system. Extended bipolar
pacing is available using this lead in combination with a compatible CRT-D system and RV defibrillation lead or with a compatible CRT-P
system and RV pacing lead.
Contraindications
Coronary vasculature - The leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as
indicated by venogram.
Steroid use - Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate cannot be
tolerated.
Warnings/Precautions
The Model 4194 was designed for optimal pacing when used in a bipolar configuration. The standard bipolar configuration may result in
markedly elevated pacing thresholds or produce anodal stimulation.
Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development. The clinical studies were not designed to
evaluate the removal of left ventricular leads from the coronary venous vasculature.
Output pulses, especially from unipolar leads, may adversely affect device sensing capabilities. Previously implanted pulse generators,
implantable cardioverter defibrillators, and leads should generally be explanted.
People with metal implants such as pacemakers, Implantable Cardioverter Defibrillators (ICDs), and accompanying leads should not receive
diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device
components, which could result in serious injury, loss of therapy, and/or the need to reprogram or replace the device.
Leads should be handled with great care at all times. Use an anchoring sleeve with all leads. Ensure the anchoring sleeve is positioned close to
the lead connector pin, to prevent inadvertent passage of the sleeve into the vein. Use care when handling stylets. Any severe bending,
kinking, stretching, handling with surgical instruments, or excessive force when inserting a stylet, may cause permanent damage to the lead.
When using Model 4194 leads, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length). Other
stylets may extend beyond the lead tip causing lead tip seal damage or injury, or perforation of the cardiac vein or heart. Rust stylets are not
recommended with this lead due to the risk of conductor coil or insulation perforation.
96. BRIEF STATEMENT (USA): MEDTRONIC ATTAIN BIPOLAR
OTW MODEL 4194 LEAD
CONTINUED
Use care when handling guide wires. Damage to the guide wire may prevent the guide wire from performing accurate torque response control
and may cause vessel damage. Do not use excessive force to retract the guide wire from the lead. Refer to the literature packaged with the
guide wire for additional information on guide wires.
Do not use Magnetic Resonance Imaging (MRI) on patients who have this device implanted. MRI can induce currents on implanted leads,
potentially causing tissue damage and the induction of tachyarrhythmias.
For the Model 4194 lead, total patient exposure to dexamethasone sodium phosphate should be considered. Drug interactions of
dexamethasone sodium phosphate with this lead have not been studied. It has not been determined if whether the warnings, precautions, or
complications usually associated with injectable dexamethasone sodium phosphate apply to the use of this highly localized, controlled-
release lead. For a list of potential adverse effects, refer to the Physicians' Desk Reference.
Do not force the guide catheter and/or leads if significant resistance is encountered. Use of the guide catheters and/or leads may cause
trauma to the heart.
Keep external defibrillation equipment nearby for immediate use during the acute lead system testing, the implant procedure, or whenever
arrhythmias are possible or intentionally induced during the post-implant testing. Backup pacing should be readily available during implant.
Use of the delivery system or leads may cause heart block.
To minimize the likelihood of trauma to the vein and to maintain lead flexibility while advancing the lead through the vein keep the stylet
withdrawn 1-2 cm or select a more flexible stylet.
Do not insert the proximal end of the guide wire through the lead tip seal without using the guide wire insertion tool. Inserting the guide wire
without the guide wire insertion tool could cause damage to the lead tip seal or to the conductor core or insulation.
During lead implant and testing, use only battery powered equipment or line-powered equipment specifically designed for this purpose to
protect against fibrillation that may be caused by alternating currents.
97. BRIEF STATEMENT (USA): MEDTRONIC ATTAIN BIPOLAR
OTW MODEL 4194 LEAD
CONTINUED
Potential Complications
Potential complications related to the use of transvenous leads include, but are not limited to the following patient-related conditions: cardiac
dissection, cardiac perforation, cardiac tamponade, coronary sinus dissection, death, endocarditis, erosion through the skin, extracardiac
muscle or nerve stimulation, fibrillation or other arrhythmias, heart block, heart wall or vein wall rupture, hematoma/seroma, infection,
myocardial irritability, myopotential sensing, pericardial effusion, epicardial rub, pneumothorax, rejection phenomena, threshold elevation,
thrombosis, thrombotic or air embolism, and valve damage.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential
complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website
at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
98. BRIEF STATEMENT (USA): MEDTRONIC ATTAIN STARFIX
MODEL 4195 LEAD
Indications
The Attain StarFix Model 4195 steroid eluting, transvenous lead with deployable lobes is intended for chronic pacing and sensing of the left
ventricle via a cardiac vein, when used in conjunction with a compatible implantable pulse generator or implantable cardiac defibrillator.
Contraindications
Coronary vasculature - This lead is contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as
indicated by venogram.
Steroid use - Do not use in patients for whom a single dose of 30 μg (micrograms) of beclomethasone dipropionate (BDP) cannot be tolerated.
Warnings/Precautions
Leads, stylets, and guide wires should be handled with great care at all times. When using the Model 4195 lead, only use compatible stylets
(stylets with downsized knobs and are 3 cm shorter than the lead length). Verify that the stylet does not extend beyond the lead tip prior to
inserting the lead in the delivery system. Implanting the lead with the stylet extending beyond the lead tip could cause injury or perforation of
the cardiac vein or heart.
Output pulses, especially from unipolar leads, may adversely affect device sensing capabilities.
Backup pacing should be readily available during implant. Use of leads may cause heart block.
For the Attain StarFix Model 4195 lead, total patient exposure to beclomethasone 17,21-dipropionate should be considered when implanting
multiple leads. No drug interactions with inhaled beclomethasone 17,21-dipropionate have been described. Drug interactions of
beclomethasone 17,21-dipropionate with the Model 4195 lead have not been studied.
People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive
diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device
components, which could result in serious injury, loss of therapy, or the need to reprogram or replace the device.
Do not use magnetic resonance imaging (MRI) on patients who have this device. MRI can induce currents on implanted leads, potentially
causing tissue damage and the induction of tachyarrhythmias.
Always use an acute retention clip to reposition or remove the lead. Always attempt to undeploy the lobes before repositioning or removing
the lead. If a lead must be removed or repositioned, consider referring the case to an experienced extraction center. Do not implant the acute
retention clip.
Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
99. BRIEF STATEMENT (USA): MEDTRONIC ATTAIN STARFIX
MODEL 4195 LEAD
CONTINUED
Extraction Warning
The risk and difficulty of removing the Medtronic Attain StarFix Model 4195 lead after a long implant time has not been studied. In light of the
novel fixation mechanism of the Model 4195 lead, there may be unique risk and difficulty associated with chronic removal. If a lead must be
removed or repositioned, consider referring the case to an experienced extraction center. Do not implant the acute retention clip.
Potential Complications
Potential clinical complications resulting from the use of transvenous leads include, but are not limited to the following: air embolism, avulsion
of the endocardium, valve, or vein, cardiac dissection, cardiac perforation, cardiac tamponade, coronary sinus dissection, death, endocarditis
and pericarditis, erosion through the skin, extracardiac muscle or nerve stimulation, fibrillation or other arrhythmias, heart block, heart wall or
vein wall rupture, hematoma/seroma, infection, myocardial irritability, myopotential sensing, pericardial effusion, pericardial rub,
pneumothorax, rejection phenomena, threshold elevation, thrombosis, thrombotic embolism, and valve damage.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential
complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website
at www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Last updated:
01 Sep 2016
100. BRIEF STATEMENT (USA): MEDTRONIC CARELINK 2090
PROGRAMMER
The Medtronic CareLink programmer system is comprised of prescription devices indicated for use in the interrogation and
programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate
programmer software and implantable device technical manuals for more information related to specific implantable device
models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual
for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and
pacing system used. The Medtronic CareLink programmer must be used only for programming implantable devices
manufactured by Medtronic or Vitatron.
See the device manuals for detailed information regarding the instructionsfor use, indications, contraindications,warnings,
precautions,and potential adverse events. For further information, please call Medtronic at 1-800-328-2518 and/orconsult
Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
NOVEMBER 16, 2015
This presentation is provided for general educational purposes only and should not be considered the exclusive source for this type of information. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation. Changes in a patient’s disease and/or medications may alter the efficacy of a device’s programmed parameters or related features and results may vary. The device functionality and programming described in this presentation are based on Medtronic products and can be referenced in the published device manuals.
This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorization for use.
Important Reminder: This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorization for use.
Pacing systems are also generally described by the number of chambers paced by the device. A single chamber system paces EITHER the atrium or ventricle.
Dual chamber systems, as the name implies, consist of 2 leads, one in the atrium the other in the ventricle. Dual chamber systems may be used in cases of sinus node disease even without AV block. Many physicians recognize there is some risk to the patient later developing block, and would rather implant a dual chamber system to begin with. Going back and revising a single chamber system into a dual chamber is not easy, and involves some increased operative risks to patients, and there is a risk of damaging the previously implanted lead.
We see many patients with implanted devices and, unfortunately, patients do not always realize which device they have. Typically an ID card will be provided, but if one is not, or the patient does not have it, an easy way to recognize device types is by a chest x-ray (CXR). Look at the device, the types leads, the number of leads and their position, and you can often tell what system the patient has.
Identifying a particular device can also be done via other information provided on the CXR. The general shape can be a clue, as can the unique radiopaque identifier manufactures use on their devices. Match the identifier to information from the manufacturer (in a device encyclopedia or via a tech services department). We’ll talk more about this later.
In the pictures above, we have a dual chamber pacemaker with the atrial lead in the right atrial appendage, and the ventricular lead in the apex of the right ventricle.
Show the attendees a path model with the LV lead placed in the CS to demonstrate where the lead is placed.
Answer: Bi-Ventricular Pacemaker (note the 3 leads)
Answer:
Paces: Ventricle
Senses: Ventricle
Inhibits if it senses an intrinsic ventricular beat
Rate response sensor is on
In a pacing system, body tissue is part of the circuit in the sense that it transmits the electrical impulse cell-to-cell (at the electrode-tissue interface). When the lead impedance is measured it includes this portion of the circuit as well.
Lithium-iodine is the most commonly used power source for today’s pacemakers. Microprocessors (both ROM and RAM) control sensing, output, telemetry, and diagnostic circuits.
The average heart beats about 35 million times in a year, and a pacemaker lead must be able to survive this harsh environment. The lead is subject to mechanical torque, flexing, bending, and the body’s natural defenses and bio-chemicals produced in response to inflammation. Pacemaker leads are designed to withstand these forces.
18
19
Epicardial or myocardial leads are implanted to the outside of the heart. These implants represent less than 5% of leads implanted, and are used primarily in pediatric cases, or for patients in whom transvenous lead implant is contraindicated.
Silicone has proven to be a reliable insulating material for more than three decades of clinical experience. However, silicone is a relatively fragile material, which can tear more easily than urethane. Therefore, the silicone layer must be relatively thick to resist tears, or shearing at implant. Silicone also has a higher coefficient of friction, and the moving of two leads through a single vein may be difficult. Medtronic’s platinum-cured silicone rubber, characterized by improved mechanical strength, has partially alleviated the issues of low tear strength and friction (Silicure).
Answer: B. Ring Electrode
Current is not a programmed value. It is calculated from the voltage that you program and the impedance of the pacing system. We will see how the current can be calculated later when we cover Ohm’s Law.
Resistance is a term used to refer to simple electric circuits without capacitors, and with constant voltage and current. Impedance is a term used to describe more complex circuits with capacitors and with varying voltage and current. Therefore, the use of the term impedance is more appropriate than resistance when discussing pacing circuits, although both are used.
If any two values are known, the third may be calculated (cover the value you are seeking and the others appear in the appropriate format to calculate the unknown value).
Ohm’s Law provides the rationale for many of the decisions we will make when evaluating pacing systems and making programming decisions.
So, what is the CLINICAL significance to all this information?
Proper management of electrical characteristics is important for patient safety and device longevity
Answer:
I = V / R
Current = 1.5 V / 397 Ohms = 0.0037 A = 3.7 mA
Now, what if the impedance is half (274 W)?
Current = 1.5 V / 274 W = 0.0055 A = 5.5 mA
What are the clinical consequences of a higher current drain?
Allow participants to tell you what values to calculate (Voltage / Impedance) since calculators will probably not be available (or they can use their cell phones). Then continue to build the slide and see what happens when the impedance in the system goes down. Have the participants calculate the new current drain and list possible consequences of a higher current drain such as reduced battery longevity and capturing other surrounding tissue like the phrenic nerve. Most people realize that programming the voltage higher will reduce battery longevity but don’t realize that the impedance of the system can also affect battery longevity.
Testing the impedance, thresholds, and sensing can tell you about the integrity of the pacemaker circuit. If any of these values have changed significantly, they may be able to diagnose a problem in the circuit. Depending on the values, you may be able to identify what the problem is and how you can fix it.
A review of the clinical relevance of Ohm’s law. Since high impedance conditions ultimately conserve the battery, and device costs and longevity are a concern, does it necessarily follow that high impedance conditions are benign?
Resistance affects current flow. Leads with an insulation breach, such as the garden hose pictured in the middle, will measure a low resistance reading with a resultant high current drain, and possible premature battery depletion. Conversely, if there is a high resistance, such as a lead conductor break (represented by the knot), the current flow will be low or non-existent.
Answer: D. Both B and C.
An example of a high impedance condition is when the conductor coil fractures with the insulation remaining intact.
Impedance may exceed 3,000 Ohms and the current flow may be too low to be effective.
If a complete fracture of the wire occurs:
No current will flow
Impedance number will be “infinite,” or 9999 Ohms
When suspecting a wire break, look for a trend of increasing impedance values, rather than a single lead impedance value. The multifilar construction of the leads sometimes means that some of the small conductor filaments fail, while others remain intact. You’ll typically see a trend if increasing impedances over time.
Problem: Lead is pinched between the 1st Rib and Clavicle. X-ray shows visible stretching of the conductors with potential fracture.
Possible Symptoms: High or Intermittently High Resistance, Oversensing, loss of capture, Inappropriate Detection.
Acute/Chronic: Chronic. Generally within the first two years.
Definitive Diagnostic: X-Ray, Manipulation (Resistance/ECG)
Solution: Invasive procedure. Can cap old lead and implant a new lead. Possible lead extraction.
This close-up shows the possible effects of a 1st rib and clavicle crush (subclavian crush). Although not as common with the modern, smaller, pacing leads, crush still occurs, especially with subclavian sticks.
The unipolar configuration may be a solution, the lead could still continue to fail so it must be watched closely or only used as a temporary solution. Patient dependency, age, and risk factors should all be weighed to decide if the lead should be replaced immediately, at generator change (he has had this device in for 6 years), or if a unipolar configuration will be a permanent solution for him.
Answer:
- Impedance would drop
- Potential loss of capture
- Current would increase
An insulation break would cause a lower impedance, and higher current drain, therefore decrease the battery longevity. I = V/R
Insulation around the lead wire prevents current loss from the lead wire. Electrical current seeks the path of least resistance, which is normally the conductor coil. Insulation breaks are often marked by a trend of falling impedance values. An impedance reading that changes suddenly, or one that is >30% lower than previously recorded values for a given patient, is considered significant and should be watched closely.
Insulation break that exposes a conductor may cause any of the following:
Impedance values to fall
Current to drain through the insulation break into the body, or into the other wire
Potential for loss of capture
More rapid battery depletion
The ventricular lead impedance is low, and is unipolar. This may indicate a lead insulation issue.
To fix this issue you should consider implanting a new lead; the lead is not functioning even in the unipolar configuration. Lead extraction is not recommended because of the high risk associated with the procedure and should only be done if necessary.
Capture threshold is defined as the minimum electrical stimulus required to CONSISTENTLY capture the heart outside of the myocardial refractory period (i.e., outside of the absolute and effective refractory periods). In this example of simple ventricular pacing, we see the first 3 pacing “spikes” are followed by QRS complexes, but the fourth is not. This fourth complex is an example of non-capture.
Once a pacemaker and its leads are implanted into the body, a maturation process begins. For the leads, there are three phases that make up this process:
The acute phase, where thresholds immediately following implant are low
The peaking phase, where thresholds rise and reach their highest point, usually around one week post-implant. This is followed by a decline in the threshold over the next 6 to 8 weeks as the tissue reaction subsides.
The chronic phase, where thresholds assume a stable reading to a level somewhat higher than that at implantation, but less than the peak threshold
The lead maturation process occurs due to the trauma to cells surrounding the electrode, which causes edema, and subsequent development of a fibrotic capsule. The unexcitable capsule reduces the current at the electrode interface, requiring more energy to capture the heart.
Steroid eluting leads reduce inflammation by employing a capsule of dexamethasone sodium phosphate This steroid is gradually emitted over time, nearly eliminating the peaking phenomenon of the lead maturation process, and greatly reducing the formation of the fibrotic capsule around the cathode.
Medtronic first introduced steroid eluting leads in the mid 1980’s. Today we manufacture and sell steroid eluting leads with active and passive fixation, and even epicardial steroid eluting leads.
This graph compares the stimulation thresholds of contemporary pacing leads. Older, non-steroid electrodes exhibited higher threshold peaking than that of steroid leads shown on the slide.
The different types of electrodes exhibit a wide range of threshold peaking.
Steroid-eluting electrodes continue to show lower chronic stimulation thresholds and no significant peaking.
Threshold changes are shown here over a 12-week period post-implant, where a comparison is made between:
• Smooth metal electrode
• Textured metal electrode
• Steroid-eluting electrode
Traditionally, implant stimulation thresholds are relatively low. Non-steroid-eluting electrodes exhibit a peaking phase from week 1 to approximately week 6, due to the maturation process at the electrode-tissue interface. Steroid-eluting electrodes exhibit virtually no peaking.
The chronic phase of stimulation threshold occurs 8-12 weeks post-implant, which is characterized by a plateau. This plateau is higher than the acute phase, due to fibrotic encapsulation of the electrode. Steroid-eluting lead chronic thresholds remain close to implant values.
References: Pacing Reference Guide, Bakken Education Center, 1995, UC199601047aEN. Cardiac Pacing, Second Edition, Edited by Kenneth A. Ellenbogen. 1996.
Voltage has been describes as the force “drawing” the electrons out of the battery, and the size of the voltage certainly affects a pacemakers ability to capture. But another component is involved - the pulse width – or length of time the voltage is applied.
The pulse width, expressed in milliseconds, is the duration of time the pacemaker circuit is complete. Electricity flows from the battery down the lead, out the tip (cathode), and back to the anode.
The longer the pulse width, the shorter the battery longevity. An increase in pulse width leads to an increase in total energy delivered (reducing the battery longevity).
BUT
The longer the duration of the stimulus, the lower the amplitude required to capture the heart. So when thinking of myocardial capture, the pulse amplitude (voltage) and the pulse width (duration) are related.
Any combination of pulse width and voltage, on or above the strength duration curve, will result in capture
There are several ways to actually perform threshold tests – we’ll cover this a bit later, but the outcome is the same – once you’ve determined the threshold, you must make a programming recommendation.
When a threshold is determined by decrementing the pulse width at a fixed voltage, capture or pacing output safety margins have traditionally been selected as follows:
At a given voltage, where the pulse width value is < 0.30 ms: Tripling the pulse width is equivalent to providing a two-time voltage safety margin.
Pulse widths at a given voltage value, which are > 0.30 ms, are not typically selected because they are less efficient (expend more energy), while not providing further safety. In this case, the voltage should be doubled to provide a two-time safety margin.
Appropriate safety margins are programmed because of fluctuations in the capture threshold that can occur due to eating, sleeping, exercise, or other factors. Typically, we will program about a 2-times safety margin on a chronic system.
A patient with an acute (new) pacing system will typically be programmed to a setting allowing a higher safety margin, due to the lead maturation process, which can occur within the first 6-8 weeks following implant.
In most lithium-iodine batteries (those used most often in pacemakers today), the battery voltage is 2.8 V at the beginning of battery life. If an output is programmed above this setting (for example, to 5 V), a voltage multiplier must be used to achieve the higher amplitude. The impact on battery longevity is significant and can reduce longevity by as much as half.
The operating voltage of the pacemaker battery is only 2.5-2.8 V. In other words, when the battery reaches 2.5 volts it is almost time to replace the pacemaker. Despite this narrow range, typically, pacemakers can last for up to about 8 years.
When you learn about voltage multipliers causing significant battery drain (as when programming outputs to 5.0 V), you might think the reverse is also true—programming low outputs leads to significant gains in battery longevity. Unfortunately – not quite. While longevity can be improved by outputs less than 2.0 V at short pulse widths, most pacemakers also contain diagnostics that also require battery energy.
The take-away: When conditions and tests dictate, it is appropriate to program an output and safety margin that keeps the patient safe. When you can, try to program in the 2.0 V range. Less than that and you don’t realize much gain. More than 2.5 V and you start wasting energy, but always keep patient safety in mind.
Some clinics may have a pre-established minimum that they allow the output to be programmed down to.
Answer: D. 1.25 V
Interrogated Data
None available.
Interpretation
ECG shows loss of ventricular capture and a rate of 65 ppm, indicating pacemaker at end of service.
Conclusion
The patient was advised to come to the office for further evaluation, which revealed a real-time battery voltage of 1.64 V and “ERI: Replace Pacer” message confirming pacemaker at elective replacement. Lead impedance also showed an out-of-range value of 65,535 , indicating a lead conductor coil fracture. The patient was scheduled for lead and generator replacement, and was upgraded to a dual-chamber system.
He was also advised to comply with scheduled transtelephonic and clinic follow-ups.
Discussion
These leads have been damaged by a patient with twiddler’s syndrome who either consciously or not manipulated the generator, thereby putting undue stress on the leads. Both the atrial and ventricular leads have been radically displaced. Note the coil of leads around the generator!
If the system is sensing myopotentials, then raise the fence or increase the number of the sensitivity setting. The pacemaker will "see less" of the incoming signal.
If the pacing system is not “seeing” intrinsic cardiac events, set the fence lower or decrease the number of the sensitivity setting. The pacemaker will then "see” more of the incoming signal.
If the system is sensing myopotentials, then raise the fence or increase the number of the sensitivity setting. The pacemaker will "see less" of the incoming signal.
If the pacing system is not “seeing” intrinsic cardiac events, set the fence lower or decrease the number of the sensitivity setting. The pacemaker will then "see” more of the incoming signal.
If the system is sensing myopotentials, then raise the fence or increase the number of the sensitivity setting. The pacemaker will "see less" of the incoming signal.
If the pacing system is not “seeing” intrinsic cardiac events, set the fence lower or decrease the number of the sensitivity setting. The pacemaker will then "see” more of the incoming signal.
If the system is sensing myopotentials, then raise the fence or increase the number of the sensitivity setting. The pacemaker will "see less" of the incoming signal.
If the pacing system is not “seeing” intrinsic cardiac events, set the fence lower or decrease the number of the sensitivity setting. The pacemaker will then "see” more of the incoming signal.
The goal of programming sensing is to provide the pacemaker with accurate information for timing and diagnostics. This information lets the pacemaker know if it needs to pace, when to pace, and what the intrinsic rate is.
Keep in mind: Every signal sensed via the atrial lead is a P-wave (according to the pacemaker), just as every signal sensed via the ventricular lead is an R-wave (according to the pacemaker).
A gradient, or difference, is created as the cells around the cathode (and then anode) depolarize (become more negative), and then repolarize (return to baseline).
The direction, or vector, of the current as it passes the cathode and anode, creates a differential, or gradient. A large gradient produces a large signal.
The variance we see in signal amplitude explains why we program at least a 2-times sensing safety margin. For example, sometimes an intrinsic R-wave might measure > 22 mV, but we will program a ventricular sensitivity of 2.5 mV. As long as there is no evidence of oversensing, this programming is acceptable.
Sensing is evolving in pacing. Many modern pacemakers are using adaptive sensing algorithms, pioneered by Medtronic. These algorithms automatically change the programmed sensitivity in response to measured P- and R-waves.
ICDs use a unique sensing algorithm called Auto-Adjusting Sensitivity (also a Medtronic innovation). These are also being used in some pacemakers.
A loss of circuit integrity, for example lead fracture or lead insulation break, can result in appropriate sensing and inappropriate pacemaker operation.
Thus, we can see how the electrical concepts discussed earlier apply to sensing.
Oversensing will exhibit pauses in single chamber systems. In dual chamber systems, atrial oversensing may cause fast ventricular pacing without P waves preceding the paced ventricular events.
Answer: A
Pacemaker A is able to “see” signals as small as 0.5 mV. Thus, it is more sensitive.
The strip demonstrates T Wave oversensing after ventricular pacing. Oversensing results in under pacing, so the pacing rate is lower than it should be.
If the attendees have programmers have them go and run a sensing test and then program the sensitivity accordingly.