Presentation on theme: "Pacemaker Patient Follow-up Module 8"— Presentation transcript:
1Pacemaker Patient Follow-up Module 8 Student NotesThis 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 NotesThis 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%.World HeadquartersMedtronic, Inc.710 Medtronic ParkwayMinneapolis, MNUSAInternet:Tel: (763)EuropeMedtronic International Trading SàrlRoute du MolliauCh TolochenazSwitzerlandTel: (41 21)Asia-PacificMedtronic International, Ltd.16/F Manulife PlazaThe Lee Gardens, 33 Hysan AvenueCauseway BayHong KongTel: (852)CanadaMedtronic of Canada Ltd.6733 Kitimat RoadMississauga, Ontario L5N 1W3Tel: (905)Toll-free: 1 (800)Medtronic USA, Inc.Toll-free: 1 (800)(24-hour technical support for physicians and medical professionals)Latin AmericaMedtronic USA, Inc.Doral Corporate Center II3750 NW 87th Avenue Suite 700Miami, FL 33178USATel: (305)UC d ENMedtronic, Inc.Minneapolis, MNJanuary 2008
2Objectives List the steps for performing a pacemaker follow-up Locate threshold, sensing and impedance data on a Quick Look™ screenIdentify broad trends in Cardiac Compass® and HF Management ReportsIdentify additional resources or information useful for performing patient follow-upStudent NotesInstructor Notes
3Pacemaker Patient Follow-up Routine device follow-upTypically 1 per year for chronic single chamber and 2 per year for chronic dual chamber pacemakersThese guidelines evolved because the primary purpose of the follow-up was to evaluate the deviceIncreasing 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 guidelinesStudent NotesInstructor Notes
4Pacemaker Patient Follow-up Steps Evaluating the deviceDetermine the battery voltageCheck the lead impedanceTest capture thresholdsTest sensing thresholdsPerform a magnet/non-magnet test (required by Medicare in some US states)Student NotesNote: 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
5Pacemaker Patient Follow-up Evaluating the Device Battery voltageTo verify the pacemaker’s ability to operate and estimate the remaining longevityLead impedanceTo verify that the leads are electrically intactCapture thresholdsTo verify an appropriate pacing safety marginSensing thresholdsTo verify an appropriate sensing safety marginTo observe the underlying rhythmMagnet/non-magnet testTo verify Recommended Replacement Time (RRT) has not been reachedStudent NotesRecommended replacement time is often abbreviated as RRT. Some older devices refer to this same time as early replacement indicator (ERI).Instructor NotesAsk: Why is battery voltage evaluated?To verify the pacemakers ability to operate and estimate the remaining longevityAsk: Why is lead impedance evaluated?To verify that the leads are electrically intactAsk: Why are capture thresholds evaluated?To verify an appropriate pacing safety marginAsk: Why are sensing thresholds evaluated?To verify an appropriate sensing safety marginTo observe the underlying rhythmAsk: Why is a magnet/non-magnet test evaluated?To verify the recommended replacement time (RRT) has not been reached
6Pacemaker Evolution for the Follow-up Clinic Battery voltageEstimate of remaining time to replacementMost modern devices provide this estimate in some fashionMost modern devices will also indicate impending elective or recommended replacementLead impedanceMeasured with interrogationLong-term trends, if available, are very usefulPacing thresholdsIn some devices this test is automatic and performed routinely (e.g., daily)Sensing thresholdsIn some devices this test is automatic and performed routinely (e.g., every intrinsic event)Magnet testFormerly only way to determine if Recommended Replacement Time (RRT) had been reachedLess of a need as devices now routinely report RRT conditionStudent NotesInstructor Notes
7Battery Voltage Estimating Remaining Longevity Max voltage in a pacemaker battery is typically 2.8 VRRT at 2.5 VoltsVoltage information is provided on the programmerMany devices estimate remaining longevity based on % pacing, lead impedances, and pacing outputsMagnet Test evolved as a way to evaluate if RRT criteria is met via a simple telephone or in-clinic checkWhen a magnet is applied, verify if the pacemaker shows normal magnet behavior or RRT magnet behaviorFor some pacemakers, a magnet initiates a Threshold Margin Test (TMT)Student NotesThe 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 msThe first two sequences of pulses are delivered at the programmed AmplitudeThe third sequence is delivered at a 20% reduction of the programmed AmplitudeAt the completion of the TMT, pacing is forced to a rate of 85 bpm in the magnet modeInstructor NotesAsk: Where can you find the magnet rates for various pacemakers?In the Pacemaker and ICD Encyclopedia
8Resource Pacemaker And ICD Encyclopedia All device manufactures share essential device informationAll publish encyclopediasMedtronic’s version is available on-line, as a download for both Palm and Pocket PCAll include information on leads, devices, model numbers, x-ray identification, etc.Includes Beginning-of-Life (BOL) magnet mode and ratesRRT magnet mode and ratesOther RRT indicators (e.g., pulse width “stretching”)Student NotesNote: Magnet rates for most new models of Medtronic pacemakers are:BOL: 85 ppmRRT: 65 ppmInstructor Notes
9Status CheckDetermine the magnet and non-magnet modes, and rates for a Kappa® 700, Model KDR731.Click for answerStudent NotesMany device manufactures maintain Technical Service Departments, which are usually an excellent resource:Medtronic’s phone: (U.S.)Instructor NotesDistribute 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 ppmMode: DOOAsk: Find the magnet rate and mode for a Kappa 700, Model KDR731, at Early Replacement Indicator (ERI).Magnet rate: 65 ppmMode: VOO
10Status Check Find the Estimated Longevity Click for answerBattery Voltage can be found by selecting “Battery and Lead Measurements” under the Data icon.Student NotesInstructor Notes
11Magnet Testing If required: Use a donut magnet (or the programming head)Record the ECG with and without the magnetMedicare guidelines call for a 30-second recording of eachObserve the ECG for asynchronous pacing with the magnetMeasure the pacing rateSome modern devices provide a specific magnet test as an option on their programmerStudent NotesInstructor Notes
12Lead ImpedanceCan 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 fractureAt implant, it could indicate a loose set screwCan you recall the expected range of lead impedances?Normally, Ω, although some specially designed leads may be higherClick for answerStudent NotesInstructor NotesClick for answer
13Status Check Find the lead impedances Click for answerThese trends show stable impedances. For more information, touch the chevron.Student NotesInstructor Notes
14Pacing ThresholdsCan you recall the pacing output safety margin on a chronic system?Multiply the amplitude threshold by twoCan 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 VPatient safety is paramountClick for answerClick for answerStudent NotesTwo 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, orWhile holding the amplitude constant, multiply the pulse width by threeInstructor NotesDiscuss the following example with the participants:Threshold testing results in 1.5 V at 0.2 msBattery voltage is 2.6 VChronic leadsThe clinic has established a minimum pacing amplitude of 2.0 VAsk: What would you program the outputs to?2.0 V at 0.6 msExplanation: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.
15Status Check Find the pacing thresholds Click for answerThese trends show stable thresholds. Note how the atrial threshold has decreased since implant.For more information, touch the chevron.Student NotesInstructor Notes
16Threshold Testing Manual Methods The device automatically performs threshold testsBut where would you find a manual threshold (or other) test?Student NotesSome different methods for performing threshold tests include:Capture ManagementMedtronic’s automatic atrial and ventricular capture verification algorithmRuns automatically at clinician determined intervalsAutomatically reprograms the pacemaker to 2X (or other) safety marginStrength DurationTests the amplitude at a fixed pulse widthThen, tests pulse width at twice the threshold amplitudeThe clinician determines capture/loss of captureUseful in guiding programming decisionsAuto decrementTest either the amplitude or the pulse widthOne value is held constant, the other is testedFast test, useful when system is chronic and thresholds stableInstructor NotesClick for answer
17Status 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 answerStudent NotesInstructor Notes
18Performing a Manual Pacing Threshold Test ProcessTell the patient what you are going to doForce pacingPeriodically lower the test value (amplitude or pulse width)Stop the test once Loss-of-Capture (LOC) is seen on the ECGThe value just above LOC is the threshold0.75 V1.25 V1.00 VStudent NotesThere 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 rateAtrial: Using DDD on a patient without AV conduction, increase the pacing rate to above the intrinsic rateVentricular: Using VVI, increase the pacing rate to above the intrinsic rateVentricular: Using DDD, decrease the AV to below the intrinsic AV intervalPeriodically lowering the test value is automatically accomplished if you utilize the Auto Decrement feature on the Threshold Test screen.Instructor NotesAsk: What is the threshold?1.25 VSet 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 captureLabel the capture thresholdsRecommend appropriate programming changes to pacing outputs, if necessary
19Status Check Find the P- and R-wave measurements Click for answerTo see the P- and R-wave trends, touch the chevron.Student NotesInstructor Notes
20Sensing Tests Manual Methods This device automatically measures P- and R-wavesBut where would you find a manual sensing (or other) test?Student NotesInstructor NotesClick for answer
21Status Check What is the definition of the sensing threshold? The minimum signal size required to inhibit (or trigger) the pacemakerClick for answerStudent NotesInstructor Notes
22Performing a Manual Sensing Test ProcessTell the patient what you are going to doReduce (if necessary) the pacing rate to allow the intrinsic events to occurPeriodically 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-waveStudent NotesThe periodic increase of the test value is automatic for most current pacemakers.Instructor NotesSet 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 sensingRecommend appropriate programming changes to sensitivity, if necessary
23Routine TestingWith almost all manufacturers, routine threshold and sensing tests can be performed on a programmer interface that guides you through the stepsObserve the patient carefully for symptoms or complaintsFollow the on-screen directions and closely observe the ECG for changesStudent NotesInstructor Notes
24Other Routine Tests Underlying rhythm Retrograde conduction Etc. Can frequently ascertain the underlying rhythm during the sensing testOptionally, you can perform this test with the programmerRetrograde conductionEtc.Done per clinic protocol, or only if neededStudent NotesInstructor Notes
25So 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 NotesActivities of daily living are often abbreviated as ADL.Accurate diagnostics depend on:The battery is within the normal operating rangeThe leads are electrically intactWhen the pacemaker paces – it capturesAll intrinsic cardiac events are sensed and no othersInstructor NotesFor each question:Ask: What other questions can be asked to uncover more information?
26Optimizing Pacemakers for Patients Always evaluate the rate histogramsLook for a “stair-case” distribution of ratesAsk about the patient’s ability to achieve their desired levels of activityStudent NotesLRL = Lower Rate LimitUTR = Upper Tracking RateUSR = Upper Sensor RateInstructor NotesRates 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 levelRates below the LRL may occur because of a timing anomaly.Rates above the UTR/USR may indicate an arrhythmia.
27Optimizing Pacemakers for Patients Always evaluate for the presence of arrhythmiaWhat type?Is the patient symptomatic?Student NotesInstructor NotesAsk: Why are these important?Information on atrial arrhythmias is important to physicians, so they can manage co-morbidities, such as risk for strokeCardiac 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.
28Episode Specific Diagnostics In pacemakers, stored EGMs can be useful:Confirming accuracy of other arrhythmia diagnosticsFor example – is oversensing triggering arrhythmia collection?Collecting arrhythmia triggersAn EGM is an ECG recorded via the pacemaker’s leads and stored in the deviceStudent NotesInstructor NotesStored EGM of an episode of AF
29Optimizing Pacemakers for Patients Always evaluate the percent pacingMany devices have a percent pacing counter, or look to the histograms for this informationDevice longevity is affected by pacing outputsHigh outputs decrease longevityLow outputs (below about 2.0 V) don’t have as dramatic of an affectSo reducing the percentage of unnecessary pacing will improve device longevity and there may be other benefits to patients (more later)Student NotesInstructor Notes
30Reducing the Pacing Percentage Managing AV delaysUse auto AV extension algorithms (e.g., Medtronic’s Search AV+) with Auto-PVARP options to:Reduce unnecessary right ventricular pacingAllow higher UTRGuard against retrograde conductionStudent NotesInstructor NotesAsk: 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
31Reducing the Pacing Percentage Search AV+ example:AV intervals are scannedIf the majority end in pacing (8/16) the AV delay is automatically increasedStudent NotesInstructor NotesNote: AV scanning algorithms will typically still result in ventricular pacing about 40-50% of the time.
32Using Other Diagnostics Some devices include indicators of HF status and can be very usefulFor example: HR variability, Average day/night rates, Activity trendsOtherwise be guided by:The patient’s diagnosis, complaints, symptomsStudent NotesInstructor Notes
33Clinic Evolution Taking Advantage of Pacemaker Automaticity Devices do not routinely require extensive testing to confirm they are operating correctlyBut 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 concernsIf 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 reprogrammingAllow the physician to determine if routine clinic visits are warranted?Student NotesThe 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
34Medtronic CareLink® Network Example Clinic A******Click to LoginStudent NotesSecurity measures, such as full username and password authentication, ensure data privacy and integrity.Instructor Notes
35CareLink™ Network Example Pick the patient transmissionStudent NotesHere we click on the “Last Sent” of the InSync Sentry® patient, to view his reports.Instructor NotesNote: the patient information is fictitious
36CareLink™ Network Example Student NotesThe CareLink™ report for a pacemaker is a pdf file. This slide shows the top half of the first page of the report.Instructor Notes
37Status Check Case 1 This patient has had a DDDR pacemaker for 6 years Functioning normallyOn a routine telephone check, the following strip is transmittedThe patient’s magnet is in placeWhat conclusions can you draw?Click for answerAsynchronous pacingStudent NotesInstructor NotesA-A interval 705msV-V interval 705msNormal magnet behavior, operating in DOO mode at 85 ppm
38Status Check Case 2This patient was implanted about 6 months ago for SNDHe 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 NotesInstructor NotesClick for answer
39Status Check Case 2 Results of pacemaker testing: Battery voltage: 2.78 VSensing:P-waves mVR-waves >22.8 mVUnderlying rhythm Sinus Brady at 50 bpmThresholdsAtrial 1.0 V tested at 0.4 msVentricular 0.8 V tested at 0.4 msStudent NotesInstructor Notes
40Status Check Case 2What 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 answerClick for answerStudent NotesInstructor Notes
41Status Check Case 3This elderly patient had a DDDR implanted for sinus node dysfunction 8 weeks agoDiscovered sinus node disease with pauses on routine physicalPast medical history includes hypertensionShe denies palpitationsTreatment: Hydrochlorothiazide (blood pressure medication)Patient comes to the clinic for her first routine checkAll values within normal and expected limitsAtrial and Ventricular outputs reduced to a 2.5x safety marginNo other changes madeStudent NotesInstructor Notes
42Status Check Case 3 Cardiac Compass Report Is she having AF? How much AF is she having?Student NotesInstructor NotesClick for answerEpisodes totaling 8 hours on one day, about 4 hours on two days, and several shorter episodes 1 min to 1 hour durations thereafter.
43Status Check Case 3 Cardiac Compass Report Is the ventricular response to AF well controlled?Click for answerStudent NotesInstructor NotesYes, as a very low percent of the ventricular response to AF is > 100 bpm.
44A Couple of QuestionsIn 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 answerAsymptomatic 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 NotesInstructor NotesClick for answer5-7% per year. The take-away: AF is silent and dangerous.
45Status Check Case 3Based on the Cardiac Compass® data, the MD decides to add Sotalol 160 bid and CoumadinThe patient returns 6 months laterIs her arrhythmia status improved?Click for answerStudent NotesInstructor NotesYes, it has improved. Her last episode was at the end of May.
46A Couple More Questions For this patient, how would you make the diagnosis of PAF without these kinds of diagnostics?She had no symptomsShe was not in AF on clinic visitsFor 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 AFStudent NotesInstructor Notes
47Brief 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.ContraindicationsIPGs 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.
48Brief Statements (continued) Warnings/PrecautionsChanges 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 complicationsPotential 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 atCaution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
49Brief Statement: Medtronic Leads IndicationsMedtronic 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 indicatedContraindicationsMedtronic 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.
50Brief Statement: Medtronic Leads (continued) Warnings/PrecautionsPeople 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 ComplicationsPotential 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 atCaution: Federal law (USA) restricts this device to sale by or on the order of a physician.
51DisclosureNOTE: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.