COREPACE MODULE #6 PACEMAKER FOLLOW-UP Disclosures 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. The device functionality and programming described in this module are based on Medtronic products and can be referenced in the device manuals. Updated: August 2012 Objectives • Identify key features of 2090 programmer. • Provide a technique for you to complete a successful device follow-up, company independent • Locate threshold, sensing and impedance data on a Quick Look™ screen • Identify diagnostics available to aid in the management of a device patient • Describe the information available from the arrhythmia episode log that aids in the analysis of a patient’s rhythm and the device’s response Pacing System: Programmer On/Off Replace Paper Programmer Basics Emergency Buttons When maximum outputs are required, press Emergency Programmer Basics Head Touch Pen Programmer Basics Printer Buttons What’s in it for you? • What do you need to feel comfortable with a pacemaker follow-up? “PBL STOP” P B L Presenting Rhythm and Rate S T O P Sensing Battery Status Lead Status Threshold Observation, Data, and Events Program & Print “P” PRESENTING RHYTHM AND RATE Evaluating Patient’s Presenting Rhythm • What is the presenting rhythm? • What is the patient’s indication? – Does it correlate with the presenting rhythm? • What is the rhythm? – Normal sinus rhythm, Atrial fibrillation, Paced? • What is the rate? – Is the intrinsic rate fast, slow or normal? • Is the sensor or the Lower Rate limit in control? • Are we pacing or sensing? – What is the percentage of atrial pacing? – What is the percentage of ventricular pacing? • Has anything changed since last follow-up session? Paced Rhythm Recognition Single Chamber Device: Ventricular Pacing Single Chamber Device: Atrial Pacing (AAI) Rhythm Recognition Atrial Fibrillation: No Pacing VVI / 60 Atrial Flutter: No Pacing DDDR / 60 Rate Recognition Programming: DDD / 60 / 120 Why do we only see pacing? What is the patient’s intrinsic rate? DDD Pacing • If you know that a patient is programmed to a tracking mode of DDD, it may give you an idea of what the patients indication and underline rhythm is. • DDD mode has 4 different faces of pacing. Paced Rhythm Recognition Sensing in the Atrium & Sensing in the Ventricle (AS-VS) Pacing in the Atrium & Sensing in the Ventricle (AP-VS) Paced Rhythm Recognition Sensing in the Atrium & Pacing in the Ventricle (AS-VP) Pacing in the Atrium & Ventricle (AP-VP) Troubleshooting VVI / 60 Loss of Capture Why? Troubleshooting Loss of Atrial Sensing “B” BATTERY STATUS Battery Status • Determine battery voltage status • Calculated and displayed longevity (min and max) • Measured in volts; battery impedance used to determine replacement time. • RRT – Recommended Replacement Time • ERI – Elective Replacement Indicator • If RRT/ERI is approaching, the battery voltage may help determine when to schedule next patient visit. Assessing Battery Status Assessing Battery Status Determining Battery Status Without Programmer • Apply a magnet over a Medtronic pacemaker to determine battery status (not function) – Asynchronous rate of 85bpm (705ms), either DOO or VOO Normal battery status – Asynchronous rate of 65bpm (923ms), VOO or sometimes DOO Elective replacement/Recommended replacement time • Note that the pacemaker is not programmable to a rate of 65 • When magnet is removed, pacemaker goes back to normally programmed mode, or if at ERI/RRT, to VVI 65bpm Knowledge Checkpoint What is the beginning of life magnet rate and mode of a Medtronic Pacemaker? a. b. c. d. Depends on the device Programmed Upper Rate and Mode Programmed Lower Rate and Mode 85 bpm; Asynchronous Pacing (DOO, VOO) Knowledge Checkpoint What is the end of life magnet rate of a Medtronic Pacemaker? a. b. c. d. 65 bpm No pacing Programmed Lower Rate Depends on the device “L” LEAD IMPEDANCE (ohms) Resistance and current flow • Resistance affects current flow. Use a the garden hose as an analogy. • There’s normal resistance when the garden hose is intact. “Normal” resistance • Leads with an insulation breach, will measure a low resistance reading with a resultant high current flow, and possible premature battery depletion. “Low” resistance High current flow • If there is a high resistance, such as a lead conductor break, the current flow will be low or non-existent. “High” resistance Low current flow Lead Insulation Break – Insulation around the lead wire prevents current loss from the lead wire. – Electrical current seeks the path of least resistance. – An insulation break that exposes wire to body fluids, which have low resistance, causes: • Lead impedance to fall • Current to drain into the body • Battery depletion • Impedance values below 300W. – Insulation breaks are often marked by a trend of falling impedance values. Decreased resistance < 300 W – An impedance reading that changes suddenly or one that is >30% is considered significant and should be watched closely.1 1 Hayes, David L., et. al. (2000). Cardiac pacing and defibrillation: a clinical approach . New York: Blackwell Publishing. (pg. 398). Lead Wire Fracture – A wire fracture within the insulating sheath may cause impedance values to rise. – Impedance values across any break in the wire will increase and may exceed 2,000 W. – Often such increases will be quite gradual, representing a continuing increase in lead degradation. • Look for a trend in an increase in impedance values rather than a single lead impedance value. – Current flow may become too low to be effective in generating capture of the heart – If a complete fracture of the wire occurs: • No current will flow • Impedance number will be “infinite” Increased resistance > 2000 W Checking Lead Impedances • Medtronic pacemakers takes a lead impedance measurement – At 2:00am daily – During interrogation – Can be initiated manually • A single lead impedance reading is not enough! – Trends are the best indicators of the significance of those single readings—a 30% variation is regarded as a “deviation” worth investigation (though it may prove inconclusive)1 – Note that trends may be stable, but lead still may not be functioning correctly • Use lead measurements as another piece of the puzzle when troubleshooting • Checking with Technical Services will sometimes help confirm the “normalcy” of out-of-range readings 1 Hayes, David L., et. al. (2000). Cardiac pacing and defibrillation: a clinical approach . New York: Blackwell Publishing. (pg. 398). Lead Impedance Trends Recent Single Measurement Lead Impedance Trends (Detail) Click the chevron button to get more detailed impedance information. Knowledge Checkpoint What is the expected range of lead impedances? a. b. c. d. 500 – 5000 ohms 200 – 2000 ohms 100 – 4000 ohms Depends on the pacemaker Knowledge Checkpoint Why is knowing the lead impedance is important? Check all that apply. It provides detail on longevity. It may warn you of a lead insulation failure or a lead conductor fracture. At implant, it may indicate a loose set screw. It is not as important as battery status. Knowledge Checkpoint What are the lead impedances in this example. “S” SENSING (millivolts mV) Normal Sensing Values in Sinus Rhythm • Acute Phase (within 3 months of implant) – P-waves = > 1.5mV – R-waves = > 6mV • Chronic Phase (>3 months post-implant) – P-waves = > 1.0mV – R-waves = > 5mV • Note that pathologic rhythms, such as AF, will cause low amplitude P-waves.1 1 Ellenbogen, Kenneth A. and Mark A. Wood. (2005). Cardiac Pacing and ICDs. Massachusetts: Blackwell Publishing. (pg. 342). Sensitivity: Not Sensitive Enough As You Lower The Number, You Make The Pacemaker More Sensitive Amplitude (mV) 5 mV 5.0 2 mV 2.5 1.25 Time 1mV (Can’t see well!) Sensitivity: Too Sensitive 5 mV (Sees too much!) 2 mV Amplitude (mV) 1mV 5.0 2.5 1.25 Time Sensitivity: Just Right 5 mV 2 mV Amplitude (mV) 1mV 5.0 2.5 1.25 Time Why is sensing so important? Oversensing vs. Undersensing Intrinsic beat not sensed Scheduled pace delivered Undersensing leads to overpacing (symptoms?)! Marker Channel™ shows intrinsic activity... ...though no activity is present Oversensing leads to underpacing (and possible asystole)! Knowledge Checkpoint You are presented with the ECG strip with the programmed device parameters below. What area of the strip looks abnormal, A, B, C, or D? B. A. Device is programmed as follows: DDD 60–130 bpm PAV: 150 ms SAV: 120 ms PVARP: 310 ms C. D. Knowledge Checkpoint Hypothesis What explains this atrial pace? – Intermittent atrial undersensing. The P-wave was not “seen” and the lower rate (LRL) timed out, resulting in an atrial pace Why did this atrial pace NOT capture? – Atrial pacing occurred in the absolute refractory period of the atrial muscle tissue Knowledge Checkpoint Confirming Your Hypothesis What would you do? • Interrogate and observe the rhythm What would you expect to see? • P-waves without markers Knowledge Checkpoint Testing Your Hypothesis What would you do to test your hypothesis? • Perform a sensing test – Is the device programmed correctly? – P/R- wave amplitudes can change • Check lead impedances – Undersensing can be a symptom of a lead fracture or lead insulation failure – Undersensing can be a symptom of lead dislodgement Knowledge Checkpoint Considerations • Suppose device was programmed with an Atrial Sensitivity of 4.0 mV • P-waves measure 4.0- 5.0 mV Would programming a sensing value of 2.0 mV make it more or less sensitive? • 2.0 mV is more sensitive than 4.0 mV How would you program the sensitivity if you wanted to sense fine AF, for example? • Program sensitivity to a more sensitive value (~2.0 mV) to make sure device can sense AF. Knowledge Checkpoint What area on the strip looks abnormal, A, B, C, or D? C. A. B. Device is programmed as follows: DDD 60–130 bpm PAV: 150 ms SAV: 120 ms PVARP: 320 ms D. Knowledge Checkpoint Hypothesis What is your hypotheses? – Atrial undersensing – Ventricular oversensing Knowledge Checkpoint Hypothesis: Atrial Undersensing X • If this P-wave is not sensed, and not tracked, then determine when the next atrial event should occur in the timing sequence. • DDD 60 (1000 ms) minus the SAV (120 ms) = 880 ms from the last QRS to the next atrial pace (the V-A interval). We should see an atrial pace at the X. • Thus, this cannot be atrial undersensing Knowledge Checkpoint Hypothesis: Ventricular Oversensing • Remember the information – A-A = 1000 ms – A-V = 120 ms – PVARP 320 ms – Calculated the V-A = 880 ms A P A R V S • Measure V-A interval backward from the atrial pace, and assume the pacemaker senses a ventricular “event” here (VS). • The VS starts a 400 ms refractory period in the atrium (PVC Response). • The atrial event then falls in the PVARP of this “event” – and cannot be used for timing, and thus it does not start an SAV. Knowledge Checkpoint Confirming the Hypothesis: Ventricular Oversensing What would you do? Interrogate and observe the rhythm What would you expect to see? VS/VR markers without QRS complexes Knowledge Checkpoint Confirming the Hypothesis: Ventricular Oversensing • Suppose you interrogate and see this on the strip: – Run a sensing test – Try to provoke oversensing • Arm/shoulder movement • Have patient reach across his/her body – Program to non-RR mode Observe Marker Channel for VS without a QRS Knowledge Checkpoint Review Questions What patient complains, what might you suspect with this strip? • C/O syncope, presyncope, vertigo, weakness What pacemaker telemetry data might indicate the cause? • Ventricular lead impedance What long-term effect will this condition have on device diagnostics? • Ventricular rate diagnostics will be inaccurate because oversensing may be recorded and interpreted as an arrhythmia Considerations • When there is evidence of “overpacing,” or pacing despite intrinsic activity, consider undersensing • When there is evidence of “under-pacing,” or pauses without pacing, consider oversensing ** Please note, these rules are NOT absolute “T” THRESHOLD Conduction System: Pacing During pacing, the impulse travels via the myocardium, not the native cardiac conduction system, therefore, the QRS is wide. Normal QRS Paced QRS Is there capture of the heart? 2 Settings Used to Ensure Capture 1. Pulse amplitude – the amount of voltage delivered to the heart by the pacemaker to ensure capture of the heart (strength of an output pulse) 2. Pulse width – time (duration) of the pacing pulse GOAL Find the minimum amount of energy needed to consistently capture the heart (stimulation threshold). Automatic Threshold Measurements Conducting a Threshold Test Threshold Test Type Change between Amplitude and Pulse Width and which chamber to pace. Amplitude Threshold Testing • Keeping pulse width stable, decrement voltage until loss of capture Pulse Width Setting: 0.5ms (fixed) 1.5V 1.0V .5V Loss of capture: 0.5V @ 0.5ms Threshold value: 1.0V @ 0.5ms Pulse Width Threshold Testing • Keeping voltage stable, decrement in pulse width Voltage setting: 2.0 Volts (fixed) .30ms .20ms .1ms Loss of capture: 2.0V @ 0.1ms Threshold value: 2.0V @ 0.2ms .06ms Test Results via Programmer Final Adjusted Threshold Final Output Programming • Primary goal: Ensure patient safety & appropriate device performance Recommended safety margin: – Acute phase (< 3 months post implant): 3 times the amplitude of the threshold value • Example: Threshold 1V @ 0.4ms Final Programming: 3V @ 0.4ms – Chronic phase (approx > 3 months post implant): 2 times the amplitude of the threshold value • Example: Threshold 1V @ 0.4ms Final Programming: 2V @ 0.4ms • Secondary goal: Extend the service life of the battery – 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 – Typically program amplitude to < 2.5 V, while ALWAYS maintaining adequate safety margins • Example: A common output value might be 2.0 V at 0.4 ms *Note: Particular care should be given to safety margins for pacemaker dependent patient Knowledge Checkpoint Define pacing threshold. Pacing Thresholds • What is the pacing output safety margin on a chronic system? – Multiply the amplitude threshold by two • What is 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 “O” OBSERVATIONS, DATA, & EVENTS What else should be checked? • What have we checked already? – Presenting Rhythm – Battery Status and Lead impedances – Sensing and Threshold testing • Other questions to consider: – 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? • The device’s diagnostic and observation recordings can help answer some of these questions Quick Look™ II Arrhythmia Observations Many pacemaker patients will develop atrial tachyarrhythmias over the life of their device. Observations alert the clinician to situations that may require further investigation. Printed Reports-Initial Interrogation Page 1: Device/lead status, histograms, episode summary Page 2: Episode logs, V rate during AT/AF histogram, and Cardiac Compass® trend Initial Interrogation Report Device Status Automatically generated upon interrogation. This report page contains most of the device and lead status documentation needed for routine follow-up. Initial Interrogation Report Clinical Status Assess rate response, percent pacing and sensing, and occurrences of A or V high rate episodes. Initial Interrogation Report Arrhythmia Status Management of atrial tachyarrhythmias may be simplified through use of the Cardiac Compass® trends and arrhythmia summary diagnostics. Combined with the QuickLook™ II “Observations,” this information may help with assessment of: • Rate-control therapy • Rhythm-control therapy • Risk for stroke Optimizing Pacemakers for Patients • Always evaluate for the presence of arrhythmia – What type? – Is the patient symptomatic? Cardiac Compass is a simple way to stay informed of trends in the patient’s atrial arrhythmia burden, to monitoring effectiveness of new drugs, or possible concern with anticoagulants. Cardiac Compass also provides trends on the ventricular response to these arrhythmia. Arrhythmia Management Rate-Control Assessment* V Rate During AT/AF Details • Available on-screen or in initial interrogation report • Histogram displays percent of V-beats paced or sensed that fall into each rate bin • Only V-beats during mode switch included Printed Report Version Clinical Questions/Concerns • Do ventricular rates recorded during atrial tachyarrhythmias suggest that medications need to be modified to control ventricular response? • Is modification of the AV node an alternative option? On-Screen Display • Is conducted AF response ON? If not, would it be useful to try? Arrhythmia Management Rhythm-Control Assessment Cardiac Compass Details • Lists AT/AF observations (if any) • Vertical lines reflect cumulative daily burden levels (hrs/day) • Includes MS episodes (or, if MS = OFF, AHR episodes) regardless of duration Printed Report Version On-Screen Display Clinical Questions/Concerns? • Are previously undiagnosed episodes present? • Do episode date/times correlate to patient symptoms? • Has rhythm-control therapy increased the amount of time spent in sinus rhythm? • Are pharmacologic or other therapy adjustments needed? • Are atrial tachyarrhythmias affecting HF status or frequency of VT/VF? Arrhythmia Management Risk for Stroke Assessment* Clinical Questions/Concerns • Is there an increased risk for stroke due to episodes of long duration? • Do daily burden levels suggest that the patient may be at a higher risk for stroke? • Does patient have other contributing risk factors? • Should anticoagulation therapy be modified or initiated? * The information collected may help with assessment of rate-control, rhythmcontrol, and risk for stroke in patients with atrial tachyarrhythmias. Diagnostics, Monitoring, and Trending Summary • Device status, clinical status, and arrhythmia status can all be assessed through Medtronic’s pacemaker monitoring and trending capabilities • Comprehensive monitoring and diagnostic information may help to confirm correct operation of device features and assess therapy efficacies 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) Optimizing Pacemakers for Patients • Always evaluate the rate histograms – Look for a “staircase” distribution of rates – Ask about the patient’s ability to achieve their desired levels of activity Rates below the LRL may occur because of a timing anomaly. Rates above the UTR/USR may indicate an arrhythmia. 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 Stored EGM of an episode of AF 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 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 Note: AV scanning algorithms will typically still result in ventricular pacing about 40-50% of the time. “P” PROGRAMMING & PRINTING FINAL REPORTS Programmed Parameters • Prior to printing have we made all the appropriate changes? • Are there any features that could be utilized to promote intrinsic conduction? • Do we need to make any changes based on testing? • What feature is available to clinicians to get initial parameters? Parameter Screen Review Print Reports • Print Final Reports – Sensing test results – Threshold test results – Key observations – Any changes this session noted on final report “PBL STOP” P B L Presenting Rhythm and Rate S T O P Sensing Battery Status Lead Status Threshold Observation, Data, and Events Program & Print Device Follow-Up: “PBL STOP” GOALS: – PBL - to obtain device status before checking anything else, including diagnostics, since some of the collected data may be incorrect if the device / lead has an issue. – STOP is to complete testing, make your assessments, program, and print final reports. – PBL STOP allows you to create a device follow-up routine and focus on the important information in a repeatable order. Case Study #1 One of the Nurse Practitioners in the pacemaker clinic has asked you to take a look at the interrogation report for one of their patients. • 28 year old male with intermittent complete heart block • 10 yr old single chamber pacemaker • Patient has been experiencing episodes of light headedness and was seen by his primary care physician with no findings. • As episodes continued over a week, he experienced near syncope several times and called the pacemaker clinic to be seen. • You are given the interrogation report. Utilize the “PBL STOP” methodology to assess the situation Case Study #1: Interrogation Report Case Study #1 (cont’d) “P” – Presenting Rhythm – Unfortunately, there is no EKG strip of the current rhythm at interrogation. “B” – Battery Status – What is the battery longevity? “L” – Lead Impedances – Is the lead impedance in the normal range? Case Study #1 (cont’d) “S” – Sensing Test – You are unable to find a sensing test print-out in the chart “T” – Threshold Test – You do find a recorded threshold strip What do you see? What is going on with this patient? Can you name two possible solutions? Case Study #1 (cont’d) undersensing oversensing escape escape escape LOC escape V escape interval=820ms/73 bpm • There is intermittent oversensing, and failure to capture with normal lead impedance. • Sense markers do not match any cardiac activity on the surface ECG. This could be an intermittent lead issue or a connection issue in the header. Case Study #1 (cont’d) Possible Causes • Header connection would be a possible source of problems • Occurs when IS-1 pin is not fully inserted into header when set screw is tightened. Set screw barely engages the distal edge of the IS-1 pin. With time, pin may move out of the header. • Typically see the impedance trending higher over time (in this case it is normal). • Higher probability if device was a recent implant. • Incomplete Fracture • Leads to intermittent contact between the broken ends of the lead wire or conductor, or an insulation break that allows intermittent shorting of the two conductors. • High impedance would indicate a fracture, and low impedance would indicate an insulation break. Case Study #1 (cont’d) What are some options for next steps? • Urgent/emergent revision with new lead implant • Program pacing and/or sensing of the lead to unipolar • In event of a cardiac emergency, use transcutaneous pacing function with Lifepak to provide backup pacing until a new lead can be placed. What are the considerations to programming lead to Unipolar? • Bipolar pacing is unreliable in this case, suggesting one of the conductors or the insulation is compromised. • Programming the polarity to unipolar simply turns off the lead’s ring electrode and the insulation between the tip and ring conductors. • If the tip conductor is the one with the intermittent fracture, the patient still has the same limitations on his pacing system. If the ring conductor or insulation is the issue, unipolar pacing resolves the safety issue of noncapture. • Reliability of unipolar pacing would need to be established and may only be a temporary fix. Case Study #1 (cont’d) Lead Monitor • Feature that automatically detects and counts the number of changes in impedance values. • Device produces an observation on the Quick Look screen when impedance is abnormal. • May be programmed to switch polarity from bipolar to unipolar if there is such a change and provide continued pacing. Case Study #2 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? Asynchronous pacing A-A interval 705ms V-V interval 705ms Normal magnet behavior, operating in DOO mode at 85 ppm Case Study #3 • • • • Patient implanted about 6 months ago for SND He comes to clinic for first 3 month pacemaker follow-up. Testing will need to be conducted How is the device currently programmed? Case Study #3 Results of pacemaker testing: – Battery voltage: 2.78 V – Sensing: • P-waves 2.0-2.5 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 Case Study #3 • What programming changes (if any) would you recommend? – Re-programming 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 unnecessary 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. Case Study #4 • 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 • Patient follow-up check: Presenting rhythm, Battery Status, Lead Impedance Measurements, Sensing and Threshold test All values within normal and expected limits Atrial and Ventricular outputs reduced to a 2.5x safety margin • What Step is next? – Review Observations, Data and Events Case Study #4 Cardiac Compass Report Is patient having AF? If so, how much? Episodes totaling 8 hours on one day, about 4 hours on two days, and several shorter episodes 1 min to 1 hour durations thereafter. It is noteworthy that she has not had any more AF in 1.5 months. Case Study #4 Cardiac Compass Report Is the ventricular response to AF well controlled? Yes, as a very low percent of the ventricular response to AF is > 100 bpm. A Couple of Questions • In patients with paroxysmal AF (PAF), how likely are they to experience symptoms of AF? 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 54:207-211, 1996] • What is the risk of stroke or CVA to someone with untreated AF? 5% per year for nonvalvular AF. The take-away: AF is silent and dangerous. [Baker, Daryll M. (2008). Stroke Prevention in Clinical Practice. London: Springer-Verlag. (pg. 27).] Case Study #4 • 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? Yes, it has improved. Her last episode was at the end of May. A Couple More Questions • For this patient, how would you make the diagnosis of PAF without these kinds of diagnostics? – Evaluate the patient for symptoms – Check for AF during clinic visits, routine EKGs – Holter monitor • For this patient, how would you evaluate the effectiveness of your treatment without these kind of diagnostics? – Continue routine EKGs and monitor for increase/decrease in reported symptoms. Key Learning Points • PBL STOP is a methodical way to perform a device followup. Following a routine each time you interrogate a device will increase your efficiency and thoroughness. • The Quick Look™ screen provides and overview of key parameters including percent pacing, impedance, sensing, and thresholds. • Device diagnostics aid in patient management and allow you to maximize patient follow-up Brief Statement: IPGs and ICDs 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 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 prolonged QRS duration. • 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 prolonged QRS duration. Brief Statement: IPGs and ICDs 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. 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. Brief Statement: IPGs and ICDs 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 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. Brief Statement: 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. The Attain Leads have application as part of a Medtronic biventricular pacing system. 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. The Attain leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram. For the Model 4193 and 4194 leads, do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated Brief Statement: Leads 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 17,21dipropionate 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. • Attain leads, stylets, and guidewires should be handled with great care at all times. When using a Model 4193 or 4194 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length). Output pulses, especially from unipolar leads, may adversely affect device sensing capabilities. Back-up pacing should be readily available during implant. Use of leads may cause heart block. For the Model 4193 and 4194 leads, it has not been determined if the warnings, precautions, or complications usually associated with injectable dexamethasone sodium phosphate 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. Patients should avoid diathermy. Previously implanted pulse generators, implantable cardioverterdefibrillators, and leads should generally be explanted. Brief Statement: 2090 Programmer Intended Use 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 manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential 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. Brief Statement: Leads Potential Complications • Potential complications related to the use of 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, hemoatoma/seroma, infection, myocardial irritability, myopotential sensing, pericardial effusion, epicardial or pericardial rub, pneumothorax, rejection phenomena, threshold elevation, thrombosis, thrombotic or air embolism, and valve damage. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation or exit block. • See the 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 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. World Headquarters Contact Information World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879 www.medtronic.com Medtronic USA, Inc. Toll-free: 1(800) 328-2518 (24-hour technical support for physicians and medical professionals) ©Medtronic, Inc. 2012 Minneapolis, MN http://www.medtronic.com All Rights Reserved April 2012
