1. Pacemaker Patient Follow-up Module 8
Student Notes
This is Module 8 in the CorePace series and covers the basics of performing pacemaker follow-up.
This module will discuss the baseline information necessary for working toward more advanced knowledge in pacemaker operation.
It is possible that you may require additional supplemental materials to enhance your knowledge, or provide more practice. If you feel this is necessary for you, ask your instructor for suggestions on books or other tools.
Instructor Notes
This module should take approximately 2 hours to cover.
While delivering the module, engage the learners by asking questions and getting them to talk based on their previous knowledge.
Evaluate the learners by delivering the knowledge check at the end of this module. An acceptable score is 90%.
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Medtronic, Inc.
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January 2008

2. Objectives List the steps for performing a pacemaker follow-up
Locate threshold, sensing and impedance data on a Quick Look™ screen
Identify broad trends in Cardiac Compass® and HF Management Reports
Identify additional resources or information useful for performing patient follow-up
Student Notes
Instructor Notes

3. Pacemaker Patient Follow-up
Routine device follow-up
Typically 1 per year for chronic single chamber and 2 per year for chronic dual chamber pacemakers
These guidelines evolved because the primary purpose of the follow-up was to evaluate the device
Increasing sophistication of follow-up tools and the diagnostics the devices provide, may be changing the purpose of the follow-up, but have not affected the guidelines
Student Notes
Instructor Notes

4. Pacemaker Patient Follow-up Steps
Evaluating the device
Determine the battery voltage
Check the lead impedance
Test capture thresholds
Test sensing thresholds
Perform a magnet/non-magnet test (required by Medicare in some US states)
Student Notes
Note: The order you execute these steps is irrelevant – just be sure all steps are executed and the data recorded per the clinic protocol.
Instructor Notes

5. Pacemaker Patient Follow-up Evaluating the Device
Battery voltage
To verify the pacemaker’s ability to operate and estimate the remaining longevity
Lead impedance
To verify that the leads are electrically intact
Capture thresholds
To verify an appropriate pacing safety margin
Sensing thresholds
To verify an appropriate sensing safety margin
To observe the underlying rhythm
Magnet/non-magnet test
To verify Recommended Replacement Time (RRT) has not been reached
Student Notes
Recommended replacement time is often abbreviated as RRT. Some older devices refer to this same time as early replacement indicator (ERI).
Instructor Notes
Ask: Why is battery voltage evaluated?
To verify the pacemakers ability to operate and estimate the remaining longevity
Ask: Why is lead impedance evaluated?
To verify that the leads are electrically intact
Ask: Why are capture thresholds evaluated?
To verify an appropriate pacing safety margin
Ask: Why are sensing thresholds evaluated?
To verify an appropriate sensing safety margin
To observe the underlying rhythm
Ask: Why is a magnet/non-magnet test evaluated?
To verify the recommended replacement time (RRT) has not been reached

6. Pacemaker Evolution for the Follow-up Clinic
Battery voltage
Estimate of remaining time to replacement
Most modern devices provide this estimate in some fashion
Most modern devices will also indicate impending elective or recommended replacement
Lead impedance
Measured with interrogation
Long-term trends, if available, are very useful
Pacing thresholds
In some devices this test is automatic and performed routinely (e.g., daily)
Sensing thresholds
In some devices this test is automatic and performed routinely (e.g., every intrinsic event)
Magnet test
Formerly only way to determine if Recommended Replacement Time (RRT) had been reached
Less of a need as devices now routinely report RRT condition
Student Notes
Instructor Notes

7. Battery Voltage Estimating Remaining Longevity
Max voltage in a pacemaker battery is typically 2.8 V
RRT at 2.5 Volts
Voltage information is provided on the programmer
Many devices estimate remaining longevity based on % pacing, lead impedances, and pacing outputs
Magnet Test evolved as a way to evaluate if RRT criteria is met via a simple telephone or in-clinic check
When a magnet is applied, verify if the pacemaker shows normal magnet behavior or RRT magnet behavior
For some pacemakers, a magnet initiates a Threshold Margin Test (TMT)
Student Notes
The Threshold Margin Test assists with verifying capture thresholds. The TMT may indicate that loss-of-capture is possible but cannot verify that the safety margin is adequate. For Medtronic pacemakers that have TMT:
A dual chamber pacemaker delivers three asynchronous AV sequential pulses at a rate of 100 ppm, with a paced AV interval of 100 ms
The first two sequences of pulses are delivered at the programmed Amplitude
The third sequence is delivered at a 20% reduction of the programmed Amplitude
At the completion of the TMT, pacing is forced to a rate of 85 bpm in the magnet mode
Instructor Notes
Ask: Where can you find the magnet rates for various pacemakers?
In the Pacemaker and ICD Encyclopedia

8. Resource Pacemaker And ICD Encyclopedia
All device manufactures share essential device information
All publish encyclopedias
Medtronic’s version is available on-line, as a download for both Palm and Pocket PC
All include information on leads, devices, model numbers, x-ray identification, etc.
Includes Beginning-of-Life (BOL) magnet mode and rates
RRT magnet mode and rates
Other RRT indicators (e.g., pulse width “stretching”)
Student Notes
Note: Magnet rates for most new models of Medtronic pacemakers are:
BOL: 85 ppm
RRT: 65 ppm
Instructor Notes

9. Status Check
Determine the magnet and non-magnet modes, and rates for a Kappa® 700, Model KDR731.
Click for answer
Student Notes
Many device manufactures maintain Technical Service Departments, which are usually an excellent resource:
Medtronic’s phone: (U.S.)
Instructor Notes
Distribute the Pacemaker and ICD Encyclopedias (can be found on Medtronic Connect website)
Ask: Find the magnet rate and mode for a Kappa 700, Model KDR731, at Beginning-of-Life (BOL).
Magnet rate: 85 ppm
Mode: DOO
Ask: Find the magnet rate and mode for a Kappa 700, Model KDR731, at Early Replacement Indicator (ERI).
Magnet rate: 65 ppm
Mode: VOO

10. Status Check Find the Estimated Longevity
Click for answer
Battery Voltage can be found by selecting “Battery and Lead Measurements” under the Data icon.
Student Notes
Instructor Notes

11. Magnet Testing If required:
Use a donut magnet (or the programming head)
Record the ECG with and without the magnet
Medicare guidelines call for a 30-second recording of each
Observe the ECG for asynchronous pacing with the magnet
Measure the pacing rate
Some modern devices provide a specific magnet test as an option on their programmer
Student Notes
Instructor Notes

12. Lead Impedance
Can you recall why knowing the lead impedance is important?
Because the lead impedance can warn you of a lead insulation failure or a lead conductor fracture
At implant, it could indicate a loose set screw
Can you recall the expected range of lead impedances?
Normally, Ω, although some specially designed leads may be higher
Click for answer
Student Notes
Instructor Notes
Click for answer

13. Status Check Find the lead impedances
Click for answer
These trends show stable impedances. For more information, touch the chevron.
Student Notes
Instructor Notes

14. Pacing Thresholds
Can you recall the pacing output safety margin on a chronic system?
Multiply the amplitude threshold by two
Can you recall the maximum you would want to program the amplitude, assuming a threshold of < 1.0 V?
Normally, try to keep the output amplitude at < 2.5 V
Patient safety is paramount
Click for answer
Click for answer
Student Notes
Two of the ways to maintain an adequate pacing safety margin for chronic leads are:
While holding the pulse width constant, multiply the amplitude threshold by two, or
While holding the amplitude constant, multiply the pulse width by three
Instructor Notes
Discuss the following example with the participants:
Threshold testing results in 1.5 V at 0.2 ms
Battery voltage is 2.6 V
Chronic leads
The clinic has established a minimum pacing amplitude of 2.0 V
Ask: What would you program the outputs to?
2.0 V at 0.6 ms
Explanation:
Multiplying the amplitude by two and achieving an output of 3.0 V would be an appropriate safety margin. However, the voltage output exceeds the battery voltage.
Multiplying the pulse width by three and holding the voltage at 1.5 would also be an adequate safety margin. However, the clinic established minimum output of 2.0 V would be inappropriate.
Therefore, an output of 2.0 V at 0.6 ms maintains an adequate safety margin, while keeping the voltage above the clinic established minimum.
Another option would be to retest the threshold at a higher pulse width.

15. Status Check Find the pacing thresholds
Click for answer
These trends show stable thresholds. Note how the atrial threshold has decreased since implant.
For more information, touch the chevron.
Student Notes
Instructor Notes

16. Threshold Testing Manual Methods
The device automatically performs threshold tests
But where would you find a manual threshold (or other) test?
Student Notes
Some different methods for performing threshold tests include:
Capture Management
Medtronic’s automatic atrial and ventricular capture verification algorithm
Runs automatically at clinician determined intervals
Automatically reprograms the pacemaker to 2X (or other) safety margin
Strength Duration
Tests the amplitude at a fixed pulse width
Then, tests pulse width at twice the threshold amplitude
The clinician determines capture/loss of capture
Useful in guiding programming decisions
Auto decrement
Test either the amplitude or the pulse width
One value is held constant, the other is tested
Fast test, useful when system is chronic and thresholds stable
Instructor Notes
Click for answer

17. Status Check Recall the definition of the pacing threshold…
The minimum output at which the myocardium is consistently captured, outside of its refractory period.
Click for answer
Student Notes
Instructor Notes

18. Performing a Manual Pacing Threshold Test
Process
Tell the patient what you are going to do
Force pacing
Periodically lower the test value (amplitude or pulse width)
Stop the test once Loss-of-Capture (LOC) is seen on the ECG
The value just above LOC is the threshold
0.75 V
1.25 V
1.00 V
Student Notes
There are many acceptable ways to force pacing. Here are few for the given chamber:
Atrial: Using AAI on a patient with AV conduction, increase the pacing rate to above the intrinsic rate
Atrial: Using DDD on a patient without AV conduction, increase the pacing rate to above the intrinsic rate
Ventricular: Using VVI, increase the pacing rate to above the intrinsic rate
Ventricular: Using DDD, decrease the AV to below the intrinsic AV interval
Periodically lowering the test value is automatically accomplished if you utilize the Auto Decrement feature on the Threshold Test screen.
Instructor Notes
Ask: What is the threshold?
1.25 V
Set up a VIP-II and demo device with varying degrees of inappropriate outputs (i.e., an atrial pacing output of ms, with an atrial threshold of ms).
Have each student perform an atrial and ventricular threshold test. Make sure that each participant can appropriately:
Identify loss of atrial and ventricular capture
Label the capture thresholds
Recommend appropriate programming changes to pacing outputs, if necessary

19. Status Check Find the P- and R-wave measurements
Click for answer
To see the P- and R-wave trends, touch the chevron.
Student Notes
Instructor Notes

20. Sensing Tests Manual Methods
This device automatically measures P- and R-waves
But where would you find a manual sensing (or other) test?
Student Notes
Instructor Notes
Click for answer

21. Status Check What is the definition of the sensing threshold?
The minimum signal size required to inhibit (or trigger) the pacemaker
Click for answer
Student Notes
Instructor Notes

22. Performing a Manual Sensing Test
Process
Tell the patient what you are going to do
Reduce (if necessary) the pacing rate to allow the intrinsic events to occur
Periodically increase the test value (e.g., for 0.5 mV to 1.0 mV)
Observe the ECG for loss of inhibition (pacing despite the presence of P- or R-waves)
The value, just lower than when pacing occurs, is the size of the P- or R-wave
Student Notes
The periodic increase of the test value is automatic for most current pacemakers.
Instructor Notes
Set up a VIP-II and demo device with varying degrees of inappropriate sensitivity settings (i.e., an R-wave of 3 mV, with a ventricular sensitivity setting of 2.5 mV).
Have each student perform a P- and R-wave sensing test. Make sure that each participant can appropriately:
Identify loss of atrial and ventricular sensing
Recommend appropriate programming changes to sensitivity, if necessary

23. Routine Testing
With almost all manufacturers, routine threshold and sensing tests can be performed on a programmer interface that guides you through the steps
Observe the patient carefully for symptoms or complaints
Follow the on-screen directions and closely observe the ECG for changes
Student Notes
Instructor Notes

24. Other Routine Tests Underlying rhythm Retrograde conduction Etc.
Can frequently ascertain the underlying rhythm during the sensing test
Optionally, you can perform this test with the programmer
Retrograde conduction
Etc.
Done per clinic protocol, or only if needed
Student Notes
Instructor Notes

25. So We’ve Checked the Pacemaker
Is that all there is to it?
Well…
Is Rate Response programmed appropriately?
Can the patient achieve rates to support activities of daily living?
Is the patient having any arrhythmias?
What kind of arrhythmias, what rates, what triggers?
Can we program the device to extend its longevity?
Can we encourage intrinsic events?
…are just some of the questions we can answer by looking at the device diagnostics.
Student Notes
Activities of daily living are often abbreviated as ADL.
Accurate diagnostics depend on:
The battery is within the normal operating range
The leads are electrically intact
When the pacemaker paces – it captures
All intrinsic cardiac events are sensed and no others
Instructor Notes
For each question:
Ask: What other questions can be asked to uncover more information?

26. Optimizing Pacemakers for Patients
Always evaluate the rate histograms
Look for a “stair-case” distribution of rates
Ask about the patient’s ability to achieve their desired levels of activity
Student Notes
LRL = Lower Rate Limit
UTR = Upper Tracking Rate
USR = Upper Sensor Rate
Instructor Notes
Rates occurring below the LRL are explained in “CorePace Module 9: Troubleshooting,” in case 9.
Ask: What do you think about this distribution of rates?
This distribution is ok, but it depends on the patient’s symptoms and desired activity level
Rates below the LRL may occur because of a timing anomaly.
Rates above the UTR/USR may indicate an arrhythmia.

27. Optimizing Pacemakers for Patients
Always evaluate for the presence of arrhythmia
What type?
Is the patient symptomatic?
Student Notes
Instructor Notes
Ask: Why are these important?
Information on atrial arrhythmias is important to physicians, so they can manage co-morbidities, such as risk for stroke
Cardiac Compass is a simple way to stay informed of trends in the patient’s atrial arrhythmia burden.
Cardiac Compass also provides trends on the ventricular response to these arrhythmia.

28. Episode Specific Diagnostics
In pacemakers, stored EGMs can be useful:
Confirming accuracy of other arrhythmia diagnostics
For example – is oversensing triggering arrhythmia collection?
Collecting arrhythmia triggers
An EGM is an ECG recorded via the pacemaker’s leads and stored in the device
Student Notes
Instructor Notes
Stored EGM of an episode of AF

29. Optimizing Pacemakers for Patients
Always evaluate the percent pacing
Many devices have a percent pacing counter, or look to the histograms for this information
Device longevity is affected by pacing outputs
High outputs decrease longevity
Low outputs (below about 2.0 V) don’t have as dramatic of an affect
So reducing the percentage of unnecessary pacing will improve device longevity and there may be other benefits to patients (more later)
Student Notes
Instructor Notes

30. Reducing the Pacing Percentage
Managing AV delays
Use auto AV extension algorithms (e.g., Medtronic’s Search AV+) with Auto-PVARP options to:
Reduce unnecessary right ventricular pacing
Allow higher UTR
Guard against retrograde conduction
Student Notes
Instructor Notes
Ask: In patients with a CRT device – designed to restore ventricular synchrony via bi-ventricular pacing – what percent ventricular pacing is appropriate?
The goal for CRT is 100% ventricular pacing

31. Reducing the Pacing Percentage
Search AV+ example:
AV intervals are scanned
If the majority end in pacing (8/16) the AV delay is automatically increased
Student Notes
Instructor Notes
Note: AV scanning algorithms will typically still result in ventricular pacing about 40-50% of the time.

32. Using Other Diagnostics
Some devices include indicators of HF status and can be very useful
For example: HR variability, Average day/night rates, Activity trends
Otherwise be guided by:
The patient’s diagnosis, complaints, symptoms
Student Notes
Instructor Notes

33. Clinic Evolution Taking Advantage of Pacemaker Automaticity
Devices do not routinely require extensive testing to confirm they are operating correctly
But when troubleshooting a particular problem is required, most devices today offer detailed data that may help assist with analysis of device, lead and disease progression concerns
If all tests can be performed automatically, and if we could view all device diagnostics remotely, why not:
Use the pacemaker clinic only when a device has a problem or requires reprogramming
Allow the physician to determine if routine clinic visits are warranted?
Student Notes
The point is not to avoid patients – the point is to use your limited resources most efficiently and to the most benefit.
Remote monitoring, e.g., the Medtronic CareLink®, permits patients to download to a secure site, which the clinic can visit at their convenience.
This may eventually evolve to wireless downloads and automatic alerts, requiring no patient initiation.
What would you do with the time saved? How could you use this time to better manage all of your patients?
Instructor Notes

34. Medtronic CareLink® Network Example
Clinic A
******
Click to Login
Student Notes
Security measures, such as full username and password authentication, ensure data privacy and integrity.
Instructor Notes

35. CareLink™ Network Example
Pick the patient transmission
Student Notes
Here we click on the “Last Sent” of the InSync Sentry® patient, to view his reports.
Instructor Notes
Note: the patient information is fictitious

36. CareLink™ Network Example
Student Notes
The CareLink™ report for a pacemaker is a pdf file. This slide shows the top half of the first page of the report.
Instructor Notes

37. Status Check Case 1 This patient has had a DDDR pacemaker for 6 years
Functioning normally
On a routine telephone check, the following strip is transmitted
The patient’s magnet is in place
What conclusions can you draw?
Click for answer
Asynchronous pacing
Student Notes
Instructor Notes
A-A interval 705ms
V-V interval 705ms
Normal magnet behavior, operating in DOO mode at 85 ppm

38. Status Check Case 2
This patient was implanted about 6 months ago for SND
He came to the clinic for a wound check 2 weeks post op. This is first IPG clinic visit.
This (hypothetical) pacemaker requires that you do all the testing.
How is the device currently programmed?
Student Notes
Instructor Notes
Click for answer

39. Status Check Case 2 Results of pacemaker testing:
Battery voltage: 2.78 V
Sensing:
P-waves mV
R-waves >22.8 mV
Underlying rhythm Sinus Brady at 50 bpm
Thresholds
Atrial 1.0 V tested at 0.4 ms
Ventricular 0.8 V tested at 0.4 ms
Student Notes
Instructor Notes

40. Status Check Case 2
What programming changes (if any) would you recommend?
Re-program the A and V outputs to 2.0 V at 0.4 ms is reasonable. The leads should be stable at 6 months post implant.
Would you run any other tests or investigate any further?
The underlying rhythm indicates intact conduction. Consider programming a Search AV algorithm to reduce unncessary ventricular pacing.
Check the rate histograms and question the patient for the adequacy of his rate response.
Check other diagnostics for the presence of arrhythmia.
Click for answer
Click for answer
Student Notes
Instructor Notes

41. Status Check Case 3
This elderly patient had a DDDR implanted for sinus node dysfunction 8 weeks ago
Discovered sinus node disease with pauses on routine physical
Past medical history includes hypertension
She denies palpitations
Treatment: Hydrochlorothiazide (blood pressure medication)
Patient comes to the clinic for her first routine check
All values within normal and expected limits
Atrial and Ventricular outputs reduced to a 2.5x safety margin
No other changes made
Student Notes
Instructor Notes

42. Status Check Case 3 Cardiac Compass Report Is she having AF?
How much AF is she having?
Student Notes
Instructor Notes
Click for answer
Episodes totaling 8 hours on one day, about 4 hours on two days, and several shorter episodes 1 min to 1 hour durations thereafter.

43. Status Check Case 3 Cardiac Compass Report
Is the ventricular response to AF well controlled?
Click for answer
Student Notes
Instructor Notes
Yes, as a very low percent of the ventricular response to AF is > 100 bpm.

44. A Couple of Questions
In patients with paroxysmal AF (PAF), how likely are they to experience symptoms of AF?
What is the risk of stroke or CVA to someone with untreated AF?
Click for answer
Asymptomatic PAF occurs 12.1 times as often as symptomatic PAF in symptomatic patients [Page et al, Circulation 89(1):224-7, 1994]
Asymptomatic PAF occurs in 22-27% of patients with clinical improvement [ Wolk et al, Int J Cardiol 54: , 1996]
Student Notes
Instructor Notes
Click for answer
5-7% per year. The take-away: AF is silent and dangerous.

45. Status Check Case 3
Based on the Cardiac Compass® data, the MD decides to add Sotalol 160 bid and Coumadin
The patient returns 6 months later
Is her arrhythmia status improved?
Click for answer
Student Notes
Instructor Notes
Yes, it has improved. Her last episode was at the end of May.

46. A Couple More Questions
For this patient, how would you make the diagnosis of PAF without these kinds of diagnostics?
She had no symptoms
She was not in AF on clinic visits
For this patient, how would you evaluate the effectiveness of your treatment without these kind of diagnostics?
Her Medication regimen was not that effective in suppressing her AF
Student Notes
Instructor Notes

47. Brief Statements Indications
Implantable Pulse Generators (IPGs) are indicated for rate adaptive pacing in patients who ay benefit from increased pacing rates concurrent with increases in activity and increases in activity and/or minute ventilation. 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.
Implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Cardiac Resynchronization Therapy (CRT) ICDs are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration of ≥130 ms.
CRT IPGs are indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration of ≥130 ms.
Contraindications
IPGs and CRT IPGs are contraindicated for dual chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias; asynchronous pacing in the presence (or likelihood) of competitive paced and intrinsic rhythms; unipolar pacing for patients with an implanted cardioverter defibrillator because it may cause unwanted delivery or inhibition of ICD therapy; and certain IPGs are contraindicated for use with epicardial leads and with abdominal implantation.
ICDs and CRT ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, patients with incessant VT or VF, and for patients who have a unipolar pacemaker. ICDs are also contraindicated for patients whose primary disorder is bradyarrhythmia.

48. Brief Statements (continued)
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.
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. An additional complication for ICDs and CRT ICDs is the acceleration of ventricular tachycardia.
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 and/or consult Medtronic’s website at
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

49. Brief Statement: Medtronic 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 infracted 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.

50. Brief Statement: Medtronic Leads (continued)
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 SelectSecure Model 3830 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 3830 lead have not been studied.
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 specific 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 and/or consult Medtronic’s website at
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

51. Disclosure
NOTE:
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.