Boston Scientific CRMN11906 Implantable Defibrillator User Manual Cognis Part 3 Manual

Boston Scientific Corporation Implantable Defibrillator Cognis Part 3 Manual

Cognis Part 3 Manual

PACING THERAPIESVENTRICULAR TACHY SENSING INTERACTIONS 5-65When the programming interaction described in this scenario is present, amessage will describe the interaction of Tachy Rate Threshold with LRL andAV Delay. Similar messages may describe the interaction of V-Blank AfterA-Pace with MTR, MPR, or LRL. Along with each message, the pertinentprogrammable parameters are displayed to assist you in resolving theinteraction. Programming Dynamic VRP can be useful in resolving thesetypes of interactions.Programming ConsiderationsCertain programmed combinations of pacing parameters are known to interferewith ventricular tachy detection. The risk of ventricular tachy undersensingdue to device refractory periods is indicated by the interactive warnings onthe parameter screen.As with all device programming, you should evaluate the benefits and therisks of the programmed features for each patient (for example, the benefitof Rate Smoothing with a long AV Delay versus the risk of ventricular tachyundersensing).The following programming recommendations are provided to reduce the riskof ventricular undersensing due to the refractory period caused by an atrialpace (V-Blank after A-Pace):• If a dual-chamber pacing mode with Rate Smoothing or Rate AdaptivePacing is necessary:– Reduce the LRL– Shorten the AV Delay or use Dynamic AV Delay and reduce theminimum Dynamic AV Delay setting– Increase the Down Rate Smoothing percentage to the largest possiblevalue– Decrease the recovery time for Rate Adaptive Pacing modes– Reduce the MTR or MPR if Down Rate Smoothing is on– Reduce the MSR if the pacing mode is rate adaptive- DRAFT -
5-66 PACING THERAPIESVENTRICULAR TACHY SENSING INTERACTIONS• If Rate Smoothing or Rate Adaptive Pacing are not required for the patient,consider programming these features Off. Programming these features Offcan reduce the likelihood of atrial pacing at elevated rates.• If atrial pacing is not required for the patient, consider using VDD ratherthan DDD pacing mode.• In certain usage scenarios, you may elect to program long AV Delays toreduce ventricular pacing for patients with long PR intervals, while providingsensor pacing or rate smoothing to address other patient needs.• In certain usage scenarios, if a pattern of atrial pacing and VT beats isdetected, the AV delay is automatically adjusted to facilitate confirmationof a suspected VT. If no VT is present, the AV delay is returned to theprogrammed value. For programming scenarios where the automatic AVdelay adjustment may occur, a specific Parameter Interaction Attentionwill not be displayed.For discussion of details and additional information regarding these or otherprogrammed settings, please contact Technical Services at the 24-HourConsultation phone number on the back of this manual.In summary, when programming the pulse generator pacing and tachydetection parameters, it is useful to consider the possible interactions of thesefeatures in light of the expected arrhythmias of a particular patient. In general,the interactions will be brought to your attention through Parameter InteractionAttention messages on the PRM screen and can be resolved by reprogrammingthe pacing rate, AV delay, and/or refractory/blanking periods.- DRAFT -
6-1SYSTEM DIAGNOSTICSCHAPTER 6This chapter contains the following topics:• "Battery Status" on page 6-2• "Lead Tests" on page 6-6- DRAFT -
6-2 SYSTEM DIAGNOSTICSBATTERY STATUSBATTERY STATUSPulse generator battery summary information is displayed on the Summaryscreen. The Summary screen contains the following components:• Time Remaining—screen area with the following items:– Battery status gauge—displays a visual indication of the batterycapacity status, from BOL to explant recommendation– Approximate Time To Explant––displays the approximate time at whichexplant is recommended based on the pulse generator’s programmedparameters and recent usage history• Charge Time––displays the amount of time it took the pulse generatorto charge for the most recent maximum-energy shock or capacitorre-formation• Battery Detail icon—when selected, this icon displays the Battery DetailscreenBattery Status IndicatorsThe following battery status indicators appear in the battery status gauge. Allindicated longevity projections are calculated based on the pulse generator’sprogrammed parameters.• BOL—the pulse generator’s battery is at full capacity.• One Year Remaining—the pulse generator’s battery has approximatelyone year of full function remaining.- DRAFT -
SYSTEM DIAGNOSTICSBATTERY STATUS 6-3• Explant—the pulse generator’s battery is nearing depletion and the pulsegenerator has reached the point at which explant is recommended. Thisstatus indicates that pulse generator replacement must be scheduled.Once Explant status is reached there is sufficient battery capacity tomonitor and pace 100% under existing conditions for three months and todeliver six maximum-energy shocks. Once the battery capacity is depleted,pulse generator functionality is degraded.Once the battery capacity is depleted, the following occurs:– Number of zones reverts to one ventricular zone (VF) with a ratethreshold of 165 bpm– ATP therapy and low-energy shocks are unavailable– The programmed mode reverts to VVI/BiV– LRL defaults to 50 ppm– The following features are disabled:– RF telemetry– Daily measurement trends– Brady enhancement features– Episode storage– Diagnostic and EP tests– Device programming (Brady Mode and Ventricular Tachy Mode canbe programmed to Off)– Telemetry interrogation (using a wand) is still available and manualcapacitor re-formation can be selected.If the device reaches a point where insufficient battery capacity is availablefor continued operation, the device will revert to Storage Mode.NOTE: The device uses the programmed parameters and recent usagehistory to predict time to Explant. Greater than normal battery usage mayresult in the subsequent day’s approximate time to Explant to appear lessthan expected.- DRAFT -
6-4 SYSTEM DIAGNOSTICSBATTERY STATUSBattery Detail Summary ScreenThe Battery Detail summary screen provides the following information aboutpulse generator battery status (Figure 6-1 on page 6-5):• Last Delivered Shock––date, energy, charge time, and shock impedancedata• Beep When Explant Is Indicated––if this feature is programmed to On, thepulse generator emits 16 beeping tones every six hours after it reaches theExplant indicator. The tone can then be programmed to Off. Once thebattery capacity is depleted, Beep When Explant Is Indicated is enabled bythe device.CAUTION: Patients should be advised to contact their physicianimmediately if they hear tones coming from their device.• Last Capacitor Re-form––date and charge time• Manual Re-form Capacitor––this feature is used to command a capacitorre-formation when needed.• Charge Remaining (measured in ampere-hours)––the amount of chargeremaining based on the pulse generator’s programmed parameters untilthe battery is depleted.• Power Consumption (measured in microwatts)––the amount of power beingconsumed by the battery based on the pulse generator’s programmedparameters.• Power Consumption longevity impact––compares the power consumptionat the pulse generator’s currently programmed parameters with the powerconsumption of the parameters used to quote device longevity.- DRAFT -
SYSTEM DIAGNOSTICSBATTERY STATUS 6-5Figure 6-1. Battery Detail summary screenCapacitor Re-formationAutomatic Capacitor Re-form. Capacitor deformation may occur duringperiods when no shocks are delivered, resulting in longer charge times. Toreduce the effect of capacitor deformation on charge time, the capacitors areautomatically re-formed. Tones will not be emitted from the pulse generatorduring automatic capacitor re-formations (even if the Beep During CapacitorCharge feature is programmed to On). During a capacitor re-formation, theCharge Time is measured and stored for later retrieval.Manual Capacitor Re-form. Manual capacitor re-forms are not necessary, butmay be commanded via the PRM as follows:1. Select the Manual Re-form Capacitor button on the Battery Detail screenand ensure that telemetry communication is established. A messagewill appear indicating that the capacitors are charging. Warbling tonesfrom the pulse generator (if the Beep During Capacitor Charge feature isprogrammed to On) will sound while the capacitors are charging.2. The entire re-form cycle typically takes less than 15 seconds. Aftercompletion of the cycle, the capacitor energy is delivered to the pulsegenerator’s internal test load. The initial Charge Time is displayed on theBattery Detail screen.Charge Time MeasurementThe pulse generator measures the Charge Time whenever its capacitorscharge. The last measured value is stored in pulse generator memory anddisplayed by the PRM system on the Battery Detail screen.- DRAFT -
6-6 SYSTEM DIAGNOSTICSLEAD TESTSLast Delivered Ventricular ShockWhen a shock has been delivered to the patient, the following informationfrom the last shock delivered is stored in the pulse generator’s memory anddisplayed on the Battery Detail screen:•Date• Energy level•Chargetime• Shocking lead impedanceThis does not include auto capacitor re-forms or shocks that may have beendiverted. If a fault condition is encountered (i.e., high or low impedance), thefault will be indicated so that corrective action may be taken.NOTE: For shocks of 1.0 J or less, the accuracy of the impedancemeasurement decreases.LEAD TESTSThe following lead tests are available (Figure 6-2 on page 6-6):• Pace Impedance• Shock Impedance• Intrinsic Amplitude• Pace ThresholdFigure 6-2. Lead Tests screenLead tests can be accessed by using the following steps:- DRAFT -
SYSTEM DIAGNOSTICSLEAD TESTS 6-71. From the main screen, select the Tests tab2. From the Tests screen, select the Lead Tests tabAll lead tests may be performed following two different processes:• ViatheLeadTestsscreen––allowsyoutoperformthesameleadtestsacross all chambers• By selecting the desired chamber button––allows you to perform all testsonthesameleadIntrinsic Amplitude TestThe intrinsic amplitude test measures the intrinsic P- and R-wave amplitudesfor the respective chambers.An intrinsic amplitude test can be performed from the Lead Tests screen bycompleting the following steps:1. You may change the following preselected values as necessary to elicitintrinsic activity in the chamber(s) being tested:• Programmed Normal Brady Mode• LRL at 30 ppm• AV Delay at 300 ms2. Select the Intrinsic Amplitude button. During the test, a window will displaythe test’s progress. Selecting and holding the Intrinsic Amplitude Button willcause measurements to be repeated for up to 10 seconds until the button isreleased. When the window closes, the same test can be performed againby selecting the Intrinsic Amplitude button. To cancel the test, select theCancel button or press the DIVERT THERAPY key on the PRM.3. When the test is complete, the intrinsic amplitude measurement will bedisplayed. If the test is repeated, the measurements from the previoussession’s test and the current test will be displayed.NOTE: The test results from the last measurement are stored in pulsegenerator memory, retrieved during the initial interrogation, and displayed onthe Lead Tests screen. The measurements are also provided on the QuickNotes report.- DRAFT -
6-8 SYSTEM DIAGNOSTICSLEAD TESTSLead Impedance TestA lead impedance test can be performed and used as a relative measure oflead integrity over time.A shock impedance test is a useful tool in detecting shocking lead integritychanges over time. Evaluating this information together with the Last DeliveredShock impedance (displayed on the Battery Detail screen) or a subsequenthigh-energy shock impedance and other non-invasive diagnostic techniquesmay help troubleshoot potential lead system conditions.Pace and Shock lead impedance tests can be performed from the Lead Testsscreen by completing the following steps:1. Select the desired lead impedance test button. Selecting and holding abutton will cause measurements to be repeated for up to 10 seconds untilthe button is released.2. During the test, a window will display the test progress. When the windowcloses, the same test can be performed by once again selecting the desiredlead impedance test button. To cancel the test, select the Cancel button orpress the DIVERT THERAPY key on the PRM.3. When the test is complete, the impedance measurement will be displayed.If the test is repeated, the impedance measurements from the previoussession’s test and the current test will be displayed.NOTE: The test results from the last measurement are stored in pulsegenerator memory, retrieved during the initial interrogation, and displayed onthe Lead Tests screen. The measurements are also provided on the QuickNotes report.Pace Threshold TestThe Pace Threshold Test determines the minimum pace amplitude and/orpulse width needed for capture in a specific chamber. The minimum 2x voltageor 3x pulse width safety margin is recommended for each chamber basedon the capture thresholds, which should provide an adequate safety marginand help preserve battery longevity.Manual Pace Threshold Test- DRAFT -
SYSTEM DIAGNOSTICSLEAD TESTS 6-9Thetestbeginsataspecified starting value and steps that value down(amplitude or pulse width) as the test progresses. The PRM beeps with eachdecrement. The values used during the threshold test are programmable.The parameters are only in effect during the test. Testing for a chamber isallowed only when pacing is active for that chamber in the mode specified inthe start column.NOTE: The starting values for Amplitude and Pulse Width values areautomatically calculated. The device retrieves the stored results for theprevious pace threshold measurement (for the parameter being tested) andsets the parameter at three steps above the previous threshold measurement.The LRL is preselected at 90 ppm. For DDD mode, the LRL is further limitedto 10 ppm below the MTR.NOTE: If DDD mode is chosen, selecting either the atrial or ventricular testwill cause the pacing output to decrease only in the chamber selected.CAUTION: During the LV threshold test, RV backup pacing is unavailable.NOTE: When VVI mode and a ventricular test are selected, only the pacingoutput of the selected ventricular chamber decreases; the other ventricularchamber is not affected.NOTE: When DDD mode and a ventricular test are selected, only the pacingoutput of the selected ventricular chamber decreases; the atrium is paced at acontinuous amplitude, and the other ventricular chamber is not paced.Once the test is started, the device operates with the specified bradyparameters. Using the programmed number of cycles per step, the devicethen decrements (steps down) the selected test type parameter (Amplitude orPulse Width) until the test is complete. Real-time electrograms and annotatedevent markers, which include the values being tested, continue to be availableduring threshold testing. The display will automatically adjust to reflect thechamber being tested.During the threshold test, the programmer displays the test parameters in awindow while the test is in progress. To pause the test or perform a manualadjustment, select the Hold button on the window. Select the + or −button tomanually increase or decrease the value being tested. To continue the test,select the Continue button.- DRAFT -
6-10 SYSTEM DIAGNOSTICSLEAD TESTSThe threshold test is complete and all parameters are returned to the normalprogrammed values when any of the following occur:• The test is terminated via a command from the PRM (e.g., pressing the EndTest button or DIVERT THERAPY key)• The lowest available setting for Amplitude or Pulse Width is reached andthe programmed number of cycles has completed• Telemetry communication is interruptedA pace threshold test can be performed from the Lead Tests screen usingthe following steps:1. Select the desired chamber to be tested2. Select the Pace Threshold details button3. Select the test type4. Change the following parameter values as desired to elicit pacing in thechamber(s) being tested:• Mode•LRL• Paced AV Delay• Pacing Lead Config (programmable only for LV threshold test)• Amplitude• Pulse Width• Cycles per Step• LVPP (programmable only for LV threshold test)For DDD mode, the normal Brady MTR is used.NOTE: A long LVPP may inhibit left ventricular pacing at higher pacing rates.LVPP can be temporarily programmed (for example, to a shorter LVPP or Off)through the Pace Threshold Test screen.5. Watch the ECG display and stop the test by selecting the End Test buttonor pressing the DIVERT THERAPY key when loss of capture is observed.If the test continues until the programmed number of cycles at the lowest- DRAFT -
SYSTEM DIAGNOSTICSLEAD TESTS 6-11setting have occurred, the test is automatically terminated. The finalthresholdtestvaluewillbedisplayed(thevalueisonestepabovethevaluewhen the test was terminated).NOTE: The threshold test result can be edited by selecting the Edit Today’sTest button on the Threshold Test screen6. To perform another test, make changes to the test parameter values ifdesired, then begin again. Results of the new test will be displayed.NOTE: The test results from the most recent measurement are stored inpulse generator memory, retrieved during initial interrogation, and displayed onthe Lead Tests screen and on the Lead Status screen. The measurements arealso provided on the Quick Notes report.- DRAFT -
6-12 SYSTEM DIAGNOSTICSLEAD TESTS- DRAFT -
7-1PATIENT DIAGNOSTICSCHAPTER 7This chapter contains the following topics:• "Therapy History" on page 7-2• "Trends" on page 7-3• "Arrhythmia Logbook" on page 7-5• "Patient Triggered Monitor" on page 7-17- DRAFT -
7-2 PATIENT DIAGNOSTICSTHERAPY HISTORYTHERAPY HISTORYThe pulse generator automatically records detection and therapy informationfor each detected episode. This data can be reviewed at various levels ofdetail using the PRM.History data storage includes the following information for each episode:• Episode detail• Electrograms with annotated markers• IntervalsThe data includes information from all active electrodes. The devicecompresses the history data to store a maximum of 17 minutes of electrogramdata (13 minutes with Patient Triggered Monitor enabled). However, theamount of time actually stored may vary based on the data being compressed(e.g., noise on the EGM or an episode of VF).The priority, maximum number, and minimum number of episodes to be storedby the device for each episode type under normal conditions are specified(Table 7-1 on page 7-3). The device stores up to the maximum number ofepisodes for a specific episode type, unless the device memory is filled up first.The minimum number of episodes for each episode type protects a few lowpriority episodes from high priority episodes when device memory is full.Once the device memory available for episode data is filled, the device attemptsto prioritize the types of stored episodes and overwrite the stored episodesaccording to the following rules:• If the device memory is full, and there are episode types that have morethan the minimum number of episodes listed in the table, then the oldestof the lowest priority episodes from these episode types will be deleted.In this case, the low priority episodes are not deleted if their number ofepisodes is less than the minimum number listed in the table.• If the device memory is full, and there are no episode types that have morethan the minimum number of episodes listed in the table, then the oldest ofthe lowest priority episodes of all episode types will be deleted.• For non-commanded episodes, the episode type for VT-1, VT, and VFepisodes is determined according to the zone Duration that expiresfirst. If no zone Duration expires during an episode, the episode typeis nonsustained.- DRAFT -
PATIENT DIAGNOSTICSTRENDS 7-3• An episode in progress has the highest priority until its type can bedetermined.Table 7-1. Episode PriorityEpisode Type Priority Minimum number ofepisodes storedMaximum numberof episodes storedVF 1 510Patient TriggeredMonitor111VT/VT-1 235Cmd V 302NonSustV 312ATR 4 1 3PMT 4 1 3Once the history data is saved to a disk, it can be accessed at any time withoutdevice interrogation.TRENDSTrends provide a graphical view of specific patient and device data. This datacan be useful when evaluating your patient’s condition and the effectiveness ofprogrammed parameters. The following trends are available:• Events––displays both atrial and ventricular events.• Heart Rate––displays a trend of the patient’s heart rate. Intervals used inthis calculation must be valid sinus rhythm intervals. The validity of aninterval and the Heart Rate Trend data for the 24-hour collection period isdetermined by the HRV collection criteria.• Activity Level––displays a measure of the patient’s daily activity.• Atrial Burden––the amount of time spent in an ATR mode switch.• Respiratory Rate ––provides a trend of the patient’s daily respiratory rate.• SDANN––Standard Deviation of Averaged Normal R to R intervals. TheHRV collection period comprises 288 5-minute segments (24 hours). TheSDANN is the standard deviation of the averages of intrinsic intervals in the288 5-minute segments. Only intervals that meet the HRV collection criteriaare considered valid. If the HRV data for the collection period is invalid,then a value of “N/R” is displayed.- DRAFT -
7-4 PATIENT DIAGNOSTICSTRENDS• HRV Footprint––displays the percentage of the graph area used by theHRV plot. The graph area portrays an “at-a-glance snapshot” of thedistribution of variability versus heart rate over a 24-hour period. Thetrended percentage is a normalized score based on the footprint in thegraph. If an HRV plot was not obtained for the 24-hour period, then theHRV Footprint is not calculated and a value of “N/R” is displayed.• ABM (Autonomic Balance Monitor)––a device calculation based onR–R interval measurements; it mathematically functions as a surrogatemeasurement for LF/HF ratio.1Intervalsusedinthecalculationmustbevalid sinus rhythm intervals as determined by the HRV collection criteria. Ifthe HRV data is invalid for the 24-hour collection period, then the ABM isnot calculated for that collection period and a value of "N/R" is displayed.• Amplitude––provides amplitude measurements• Impedance––provides impedance measurementsFollow the steps below to access Trends:1. From the Events screen, select the Trends Tab2. Choose the Select Trends button to specify the trends you want to view.You can choose from the following categories:• Heart Failure––includes Heart Rate, SDANN, and HRV Footprint trends• Atrial Arrhythmia––includes Events, Heart Rate, and Atrial Burdentrends• Activity––includes Heart Rate, Activity Level, and Respiratory Ratetrends• Custom––allows you to select three trends to customize the informationdisplayed on the Trends screenThedisplayonthescreencanbeviewedinthefollowingmanners:• Select the desired time on the View button to choose the length of visibletrend data.1. Parasympathetic tone is primarily reflected in the high-frequency (HF) component ofspectral analysis. The low-frequency (LF) component is influenced by both the sympatheticand parasympathetic nervous systems. The LF/HF ratio is considered a measure ofsympathovagal balance and reflects sympathetic modulations. (Source: ACC/AHA Guidelinesfor Ambulatory Electrocardiography—Part III, JACC VOL. 34, No. 3, September 1999:912–48)- DRAFT -
PATIENT DIAGNOSTICSARRHYTHMIA LOGBOOK 7-5• Adjust the start and end dates by moving the slider bar at the top ofthe window. You can also adjust these dates by selecting the left- andright-arrow buttons.• Move the vertical axis across the graph by moving the slider bar at thebottom of the display window.Valid Heart Rate Trend Events Invalid Heart Rate Trend EventsAS with an interval not faster thanMTR, followed by a VSAPAS followed by VP at the programmedAV DelayAS with an interval faster than MTRNon-tracked VP eventsConsecutive AS events (nointervening V event)VP-NsRate Smoothing events (e.g., RVP↑)PVCHeart Rate Trend data may not be reported for a variety of reasons; the mostcommon are as follows:• Less than 67% of the 24-hour collection period (approximately 16 hours)contains valid Heart Rate Trend events• Brady parameters were programmed within the last 24 hoursARRHYTHMIA LOGBOOKThe Arrhythmia Logbook screen provides the following information about eachevent (Figure 7-1 on page 7-6):• The number, date, and time of the event• The type of event with zone• A summary of therapy delivered or attempted (if applicable)• Whether or not intervals and EGMs are stored as indicated by the presenceof details button- DRAFT -
7-6 PATIENT DIAGNOSTICSARRHYTHMIA LOGBOOK• Duration of the eventFigure 7-1. Arrhythmia Logbook screenTo display Arrhythmia Logbook data, use the following steps:1. From the Events tab, select Arrhythmia Logbook. If necessary, the pulsegenerator will be automatically interrogated and current data will bedisplayed. Data from a patient disk also can be displayed:a. Select the Utilities button on the toolbar.b. From the Utilities screen, select the Disk tab. Choose the Read Diskoption.2. While retrieving the data, the programmer will display a window indicatingthe progress of the interrogation. No information will be displayed if youselect the Cancel button before all of the stored data are retrieved.3. Use the slider and View button to control the range of dates for the eventsyouwanttodisplayinthetable.4. Select the Details button of an event in the table to display the eventdetails. Event details, available if the details button is present, are useful inevaluating each detection or therapy sequence.5. To sort events by date, type, therapy, or duration, select the correspondingcolumn header button. To reverse the order, select the column headeragain.6. To save specific events, select the event and choose the Save to Diskbutton. To print specific events, select the event and choose Reports from- DRAFT -
PATIENT DIAGNOSTICSARRHYTHMIA LOGBOOK 7-7the toolbar. Choose the selected Episodes Report and select the Printbutton.NOTE: An “in-progress” episode will not be saved; an episode must becomplete before it will be saved by the application.Events SummaryThe Events Summary screen displays additional details about the selectedepisode corresponding to the Arrhythmia Logbook.The summary data include the following:Episode Details• Episode number, date, time, type (VF, VT, VT-1, spontaneous/induced, orPTM indicating a Patient Triggered Monitor episode)• Average atrial and ventricular rates• Type of therapy delivered• For ATP therapy, the time of therapy delivery and the number of bursts• For shock therapy, the start time of charging, charge time, impedance,energy level• Time the episode endedATR Episodes• Episode number, date, time, and type (ATR)• Average atrial and ventricular rate during ATR mode switch• DurationPMT Episodes• Episode number, date, time, and type (PMT)• Atrial rate at PMT start• Average atrial and ventricular ratesFollow the steps below to view episode detail:- DRAFT -
7-8 PATIENT DIAGNOSTICSARRHYTHMIA LOGBOOK1. Select the desired episode on the Arrhythmia Logbook screen. The StoredEvent screen will appear.2. From the Stored Event screen, select the EGM tab to view the detailedinformation for this episode.3. Select the Previous Event or the Next Event button to display a previousor more current episode, one episode at a time.4. Select the Print Event button to print the episode detail being viewed.5. Select the Save to Disk button to save the episode detail to a patient datadisk.Stored ElectrogramsThe pulse generator can store annotated electrograms sensed from thefollowing leads prior to the onset of an episode around duration met, andaround therapy start and end:• Shock lead• RV pace/sense lead• LV pace/sense lead• Atrial pace/sense leadThe particular electrograms stored depend upon the episode type. The EGMstorage capacity varies depending on EGM signal condition and heart rate.The stored data are shared by all events. The total amount of stored EGMdata associated with an episode may be limited; EGMs from the middle of theepisode may be removed for episodes greater than 4 minutes in duration.When the memory allocated to EGM storage is full, the device overwrites olderEGM data segments in order to store the new EGM data. The EGM is recordedin segments consisting of episode Onset, Attempt, and End EGM storage.Each segment of data is visible when the left caliper is in the specific section.The following information is retained:• Onset retains up to 25 seconds of data prior to Duration expiring• Reconfirmation retains up to 20 seconds of data prior to therapy delivery- DRAFT -
PATIENT DIAGNOSTICSARRHYTHMIA LOGBOOK 7-9• Therapy data is displayed. In the case of ATP therapy, a maximum of 4bursts and up to 20 seconds of data, for each burst, will be retained• Post-therapy or diverted therapy retains up to 10 seconds of dataEpisode onset refers to the period of time (measured in seconds) of EGM priorto the first attempt. Onset includes the following information:• Type of event• Average RA Rate at the start of Event• Average RV Rate at start of Event• Programming of Detection Enhancements (Rate only, Rhythm ID, orOnset/stability)Attempt information may be displayed as Attempt or In Progress, if an attemptis in progress. Attempt includes the following information:• Detection information:– Average RA Rate at start of Attempt– Average RV Rate at start of Attempt–RateZone• Measured Values of Detection Enhancements• Therapy Attempt Information:– Attempt Number– Type (diverted, commanded, or inhibited)– Number of bursts (ATP attempt)–Chargetime– Lead impedance– Lead polarity– Shock faults– Reason for No Therapy- DRAFT -
7-10 PATIENT DIAGNOSTICSARRHYTHMIA LOGBOOKThe End EGM storage starts following therapy delivery and stores up to 10seconds of EGM (Figure 7-2 on page 7-10).Onset after 3 fast beats Duration expires Charging begins Start End-of-Episode timerEnd-of-Episode times out. Episode is over. 5 s 10 s 10 s 10 s 10 s 10 s 10 s 10 s Note: Charging may begin when duration expires. Shock Figure 7-2. Relationship between ventricular tachy episode EGM storage and surface ECG strip chartrecordingTo view the EGM data, select the desired episode on the Arrhythmia Logbookscreen. Use the following steps to view specific details about each episode:1. Select the EGM tab to view the stored EGMs on the screen.• EGM strips for the appropriate sources are displayed. Each stripincludes the EGMs sensed during the episode with the correspondingannotated markers. Blue vertical bars indicate the segment (Onset,Attempt, End) boundaries.• You can move the calipers along the trace and will display the timeinterval between the calipers.• A speed button changes the trace speed in millimeters/seconds.2. Select the Previous Event or Next Event button to display a different eventstrip. If EGMs are not available for an episode, the Episode Detail screenwill be displayed.3. To print the entire episode report, select the Print Event button. To save theentire episode report, select the Save to Disk button.NOTE: Refer to "Use of Atrial Information" on page 3-5 for additionalinformation about device performance when the atrial lead is programmed toOff.- DRAFT -
PATIENT DIAGNOSTICSARRHYTHMIA LOGBOOK 7-11IntervalsThe pulse generator stores event markers and associated time stamps. ThePRM derives event intervals from the event markers and time stamps.To view the episode intervals, use the following steps:1. From the Stored Event screen, select the Intervals tab. If all of the episodedata is not visible in the window, use the scroll bar to view more data.2. Select the Previous Event or the Next Event button to display a previousor more current episode, one episode at a time.3. Select the Print Event button to print the entire episode report.4. Select the Save to Disk button to save the entire episode report to a patientdata disk.HistogramsThe Histograms feature retrieves information from the pulse generator anddisplays the total number and percentage of paced and sensed events forthe chamber.Histograms data can provide the following clinical information:• The distribution of the patient’s heart rates• How the ratio of paced to sensed beats varies by rate• How the ventricle responds to paced and sensed atrial beats across ratesWhen combined with verified biventricular capture, Histograms can be used todetermine the amount of CRT delivery. The percentage of paced and sensedventricular events indicates delivery of biventricular pacing.Use the following steps to access the Histograms screen:1. From the Events screen, select the Patient Diagnostics tab.2. The initial display shows the paced and sensed data since the last time thecounters were reset.- DRAFT -
7-12 PATIENT DIAGNOSTICSARRHYTHMIA LOGBOOK3. Select the Details button to display the data type and time period.4. Select the Rate Counts button on the Details screen to view rate countsby chamber.Heart Rate Variability (HRV)Heart Rate Variability (HRV) is a measure of the changes in a patient’s intrinsicheart rate within a 24-hour collection period.This feature can assist in evaluating the clinical status of heart failure patients.The HRV monitor feature provides the following information using the intrinsicinterval data from the 24-hour collection period that meets the HRV collectioncriteria (Figure 7-3 on page 7-13):• Date and time the 24-hour collection period was completed.• % of Time Used—displays the percentage of time during the 24-hourcollection period in which there are valid intrinsic beats. If the % of TimeUsed falls below 67%, data will not be displayed for that collection period.• HRV footprint plot—shows the percentage of the graph area used bythe HRV plot. The graph area portrays an “at-a-glance snapshot” of thedistribution of variability versus heart rate over a 24-hour period. Thetrended percentage is a normalized score based on the footprint in thegraph.• Standard Deviation of Averaged Normal R to R intervals (SDANN)—theHRV collection period comprises 288 5-minute segments (24-hours) ofintrinsic intervals. The SDANN is the standard deviation of the averagesof intrinsic intervals in the 288 5-minute segments. This measurement isalso available in the Trends.• Current Normal Brady/CRT parameters––Mode, LRL, MTR, Sensed AVDelay, and Pacing Chamber with LV Offset.• An HRV plot for current and previous collection periods including a linethat shows the mean heart rate. The HRV plot summarizes the cardiacvariation on a cycle-to-cycle basis. The x-axis shows the heart rate range;the y-axis shows the beat-to-beat variability displayed in milliseconds. Thecolor indicates the frequency of beats at any particular heart rate and heartrate variability combination.- DRAFT -
PATIENT DIAGNOSTICSARRHYTHMIA LOGBOOK 7-13Figure 7-3. Heart Rate Variability displayConsider the following information when using HRV:• The cardiac cycle (R–R interval) in HRV is determined by RV sensed andpaced events (LV paced events when the pacing chamber is programmedto LV).• Programming the pacing parameters causes the data acquired for thecurrent 24-hour collection period to be invalid.• The device saves only one set of values and corresponding HRV plot forthe Reference portion of the screen. Once the values are copied from LastMeasured to Reference, older data cannot be retrieved.•Thefirst time the HRV feature is used, the Reference screen will show thedata from the first valid 24-hour collection period.Follow the steps below to view HRV:1. To access the HRV monitor screen, select the Events tab.2. From the Events screen, select the Patient Diagnostics tab.3. Once the device is interrogated, Last Measured and Reference data isdisplayed.4. Select the Heart Rate Variability Details button to view the Last Measuredand Reference data.5. To copy the Last Measured HRV measurements into the Reference section,select the Copy From Last to Reference button.- DRAFT -
7-14 PATIENT DIAGNOSTICSARRHYTHMIA LOGBOOKThe HRV monitor screen displays a set of measurements and a HRV plotbased on the most recent 24-hour collection period in the Last Measuredportion of the screen; measurements from a previously saved collection periodare displayed in the Reference portion of the screen. Both collection periodscan be viewed simultaneously to compare data that could show trends in thepatient’s HRV changes over a period of time. By saving the Last Measuredvalues to the Reference portion of the screen, you can view the last measureddata during a later session.HRV Collection CriteriaThe pulse generator only collects interval data for HRV when the NormalBrady/CRT mode is programmed to non-rate-responsive tracking modes (VDDor DDD). In addition, only valid sinus rhythm intervals are used in the HRV datacalculations. For HRV, valid intervals are those which include only valid HRVevents. HRV event validation criteria are listed below:Valid HRV Events Invalid HRV EventsAS with an interval not fasterthan MTR, followed by a VSAPAS followed by VP at the programmedAV DelayAS with an interval faster than MTRNon-tracked VP eventsConsecutive AS events (nointervening V event)VP-NsRate Smoothing events (e.g., RVP↑)PVCHRV data may not be reported for a variety of reasons; the most commonare as follows:• Brady mode is not DDD or VDD• Less than 67% of the 24-hour collection period (approximately 16 hours)contains valid HRV events• Brady Parameters were programmed within the last 24 hours- DRAFT -
PATIENT DIAGNOSTICSARRHYTHMIA LOGBOOK 7-15An example of how HRV data is recorded is shown (Figure 7-4 on page 7-15).In this example, the HRV data in the first collection period is invalid becausethe Brady parameters were programmed after the device was taken out ofStorage. HRV data is successfully calculated and reported at the end of thesecond 24-hour collection period. Subsequent HRV data is not reported untilthe end of Collection Period 5.Invalid ValidValid Invalid Invalid24-hour Collection Period 1Collection Period 1:Invalid HRV due to Brady parameters modification (programming)Collection Period 2:Valid HRV; greater than 67% of collection criteria met; HRV footprint createdCollection Period 3:Invalid HRV due to Brady parameter modifications (programming)Collection Period 4:Invalid HRV; less than 67% of daily intervals were validCollection Period 5:Valid HRV; greater than 67% of collection criteria met24-hour Collection Period 224-hour Collection Period 324-hour Collection Period 424-hour Collection Period 524 hour collection period beginsFigure 7-4. Example of HRV data collectionCountersThe following counters are recorded by the pulse generator and displayed onthe Patient Diagnostics screen:• Ventricular Tachy• Brady/CRTVentricular Tachy CountersInformation about Ventricular Tachy Counters is available by selecting theVentricular Tachy Counters button. This screen displays both Ventricular TachyEpisode and Therapy counters. For each counter, the number of events sincelast reset and device totals are displayed. Ventricular Tachy Episode counterscontains the following data:• Total episodes• Treated––VF, VT, VT-1, and Commanded- DRAFT -
7-16 PATIENT DIAGNOSTICSARRHYTHMIA LOGBOOK• Nontreated––No Therapy Programmed, Nonsustained, and OtherUntreated EpisodesVentricular Tachy Therapy counters consist of ventricular shock and ATPtherapy attempts. They can provide useful data about the effectiveness of apatient’s therapy prescription. These counters include the following information:• ATP Delivered• ATP % Successful––the percent of time that the arrhythmia is convertedand the episode ends without delivery of a programmed shock• Shocks Delivered• First Shock % Successful––the percent of time that the arrhythmia isconverted and the episode ends without requiring a second programmedshock•ShocksDivertedThe ventricular ATP counter is incremented at the start of the delivery of thefirst burst of an ATP scheme. Subsequent ATP bursts in the same scheme arenot counted individually during the same episode.An ATP scheme is counted as diverted only if it is diverted prior to deliveryof the first burst.Brady/CRT CountersInformation about Brady/CRT Counters are displayed by selecting theBrady/CRT Counters button. This screen displays the Brady/CRT episodecounters. For each counter, the number of events since last reset and resetbefore last are displayed. Brady/CRT counters contains the following details:• Percent of atrial paced• Percent of RV pacedNOTE: The RV pace event for a BiVentricular Trigger pace will be countedas an RV sense.• Percent of LV paced- DRAFT -
PATIENT DIAGNOSTICSPATIENT TRIGGERED MONITOR 7-17• Intrinsic Promotion––includes Rate Hystereses % successful• Atrial burden––includes Episodes by Duration and Total PACs• Ventricular counters––includes total PVCs and Three or More PVCsPATIENT TRIGGERED MONITORPatient Triggered Monitor allows the patient to trigger the storage of EGMs,intervals, and annotated marker data during a symptomatic episode by placinga magnet over the device.Patient Triggered Monitor is enabled by selecting Store EGM as the desiredmagnet response. This can be found in the Magnet and Beeper section on theV-Tachy Therapy Setup screen. When enabled, the device will store up to 2minutes of patient monitor data prior to and up to 1 minute after triggeringthe monitoring. The stored data include the episode number, the atrial andventricular rates at magnet application, and the start time and date of magnetapplication.When data are stored, the corresponding episode type is recorded as PTMin the Arrhythmia Logbook.Use care when enabling Patient Triggered Monitor, because the followingconditions will exist:• All other magnet features are disabled, including inhibiting therapy (untilthe EGM is stored). The Magnet/Beeper feature will not indicate magnetposition.• Device longevity is impacted. Once the patient has triggered this feature tostore episode data or the feature is disabled, the impact on device longevityis no longer present. To help reduce the longevity effect, this feature isautomatically disabled after 60 days from the day it was enabled.• Once the EGM is stored, the device magnet response automatically will beset to Inhibit Therapy.To program the Patient Triggered Monitor feature, follow these steps:1. From the Settings tab on the main screen, select Settings Summary.2. From the Settings Summary tab, select Ventricular Tachy Therapy.- DRAFT -
7-18 PATIENT DIAGNOSTICSPATIENT TRIGGERED MONITOR3. From Ventricular Tachy Therapy, select the V-Tachy Therapy Setup detailsbutton.4. Program the Magnet Response to Store EGM.CAUTION: Determine if the patient is capable of activating this featureprior to being given the magnet and prior to enabling Patient TriggeredMonitor. Remind the patient to avoid strong magnet fields so the feature isnot inadvertently triggered.CAUTION: Consider having the patient initiate a stored EGM at the timePatient Triggered Monitor is enabled to assist with patient education andfeature validation. Verify the activation of the feature on the ArrhythmiaLogbook screen.WARNING: Ensure that Patient Triggered Monitor is enabled priorto sending the patient home by confirming the magnet response isprogrammed to Store EGM. If the feature is inadvertently left in the InhibitTherapy setting, the patient could potentially disable tachyarrhythmiadetection and therapy.WARNING: Once the Patient Triggered Monitor feature has beentriggered by the magnet and an EGM has been stored, or after 60 dayshave elapsed from the day that Store EGM was enabled, the MagnetResponse programming automatically will be set to Inhibit Therapy.When this happens, the patient should not apply the magnet becausetachyarrhythmia therapy could be inhibited.NOTE: When the Magnet Response programming has automaticallybeen set to Inhibit Therapy, magnet application will cause the device toemit beeping tones. Inform the patient that if they hear tones coming fromtheir device after applying the magnet, they should remove the magnet.5. Patient Triggered Monitor can only be enabled for a 60-day period of time.To disable the feature within the 60-day time period, reprogram the magnetresponse to a setting other than Store EGM. When 60 days have passedsince enabling Patient Triggered Monitor, the feature will automaticallydisable itself and the magnet response will revert to Inhibit Therapy. Tore-enable the feature, repeat these steps.For additional information, contact Technical Services at the number shown onthe back cover of this manual.- DRAFT -
8-1ELECTROPHYSIOLOGIC TESTINGCHAPTER 8This chapter contains the following topics:• "EP Test Features" on page 8-2• "Induction Methods" on page 8-4• "Commanded Therapy Methods" on page 8-10- DRAFT -
8-2 ELECTROPHYSIOLOGIC TESTINGEP TEST FEATURESEP TEST FEATURESElectrophysiologic (EP) Testing features enable you to induce and terminatearrhythmias noninvasively in order to monitor and test the effectiveness ofselected detection criteria and therapies. The EP Test features can be used inconjunction with the ECG display so that real-time traces may be viewed. Thestatus of the pulse generator/patient interaction is also displayed.The features allowing noninvasive EP testing of arrhythmias include thefollowing:• VFib induction• Shock on T induction• PES induction• 50 Hz/Manual Burst pacing induction• Commanded Shock therapy• Commanded ATP therapyTemporary EP ModeTemporary EP Mode allows you to program the device mode to a temporaryvalue for EP test delivery, and ensures that the normal device mode remainsunchanged.Backup Ventricular Pacing During Atrial EP TestingBackup ventricular pacing is available during atrial EP testing (PES, 50Hz/Manual Burst) regardless of the programmed Normal or Post-therapypacing modes. (The mode can also be programmed to Off.) Program thebackup pacing parameters by selecting the EP Test Pacing button displayed onthe relevant atrial EP tests.EP Test ScreenThe EP Test screen displays the real-time status of the detection and therapyprocess of the pulse generator when telemetry communication is occurring.Viewing this display allows you to induce and test either a programmeddetection/therapy prescription or optional therapies while monitoring the pulsegenerator’s progress.Refer to the EP Test screen (Figure 8-1 on page 8-3):- DRAFT -
ELECTROPHYSIOLOGIC TESTINGEP TEST FEATURES 8-3Figure 8-1. EP Test ScreenThe screen provides the following information:• Status messages indicate detection and therapy status and are describedbelow:– Ventricular episode status—if an episode is occurring, the duration ofthe episode is displayed. (If it is greater than 10 minutes, then it isdisplayed as > 10:00 m:s).– Ventricular detection status—if an episode is occurring, it indicateswhether ventricular detection is in Initial Detection, Redetection, or thezone in which that detection is met. If no episode is occurring, theprogrammer will also display the text Time since last V therapy alongwith the continually updated time in minutes (up to 10).– Brady pacing and SRD status.– The type of therapy initiated and the zone.– The status of the therapy such as In progress, Diverted, or Delivered.• Duration timer—Progression of the duration timer is graphically displayedusing a scale. The bar in the scale moves from left to right to show thepercent complete of programmed duration. When duration is expired andtherapy delivery begins, the bar is removed.• Detection status—The status for each programmed detection enhancementis displayed. When enhancement criteria are met, a mark appears in theadjacent box.- DRAFT -
8-4 ELECTROPHYSIOLOGIC TESTINGINDUCTION METHODS• Therapy prescriptions—Only those therapy prescriptions that areprogrammed are displayed. As each therapy is delivered, a check markor number will appear in the box adjacent to the respective therapy. ATPtherapies indicate the scheme type as well as the programmed number ofbursts in the scheme. A number will appear and increment (1, 2, etc.) inthe ATP therapy box each time an ATP burst is delivered. Shock therapiesindicate the programmed energy level for the programmable shocks. Anumber will appear and increment (1, 2, etc.) in the Max box each time amaximum-energy shock is delivered.Follow the steps below to perform EP Test functions:1. Select the Tests tab, then select the EP Tests tab.2. Establish telemetry communication. Telemetry communication between theprogrammer and the pulse generator should be maintained throughout allEP test procedures.3. Program the EP Temp V mode appropriate to the EP Test method(Table 8-1 on page 8-4).Table 8-1. EP Temp V Mode for EP Test FunctionsEP Temp V ModeEP Test MethodaMonitor + TherapydMonitor OnlyeOff50 Hz/Manual BurstbXPESbXVFibcXShock on TcXCommanded ATPcXCommanded ShockcXXa. EP functions cannot be performed if the pulse generator is in Storage Mode.b. Available method for both atrial and ventricular induction.c. Available method only for ventricular induction.d. The Ventricular Tachy Mode must be programmed to Monitor + Therapy.e. The Ventricular Tachy Mode must be programmed to Monitor Only or Monitor + Therapy.INDUCTION METHODSEach induction method available from the EP Test screen is described belowwith instructions for performing the induction. During any type of inductiondelivery, the pulse generator recognizes the induction and performs no other- DRAFT -
ELECTROPHYSIOLOGIC TESTINGINDUCTION METHODS 8-5activity until the induction delivery is ceased, at which time the programmedmode will take effect and the pulse generator will respond accordingly.Consider the following information when using these methods:• Ventricular PES, Shock on T wave, and Ventricular ATP are BiV.• All inductions and tachycardia therapy delivery are inhibited when amagnet is positioned over the pulse generator (if magnet response is set toInhibit Therapy).• Pacing pulses during induction are delivered at the programmed EP Testpacing parameters.VFib InductionVFib induction uses the shocking electrodes to stimulate the right ventricleat very fast rates.The following settings are available to allow use of the minimum energynecessary for induction:• VFib Low delivers a stimulation waveform of 9 volts• VFib High delivers a stimulation waveform of 15 voltsPerforming VFib InductionNOTE: The patient should be sedated prior to delivery of fibrillation inductionpulses. The large surface area of the shocking electrodes tends to stimulatethe surrounding muscle and can be uncomfortable.1. Select the VFib option. Buttons for each test and an Enable checkboxare displayed.2. Select the Enable checkbox.3. Select the desired Hold for Fib button to initiate delivery of the fibrillationinduction train. The induction train is delivered up to 15 seconds as long asthe button is held and the telemetry link is maintained.During induction the pulse generator is automatically disabled fromdetecting, and automatically re-enabled following induction delivery.If VFib induction is initiated during an episode, the end-of-episode is- DRAFT -
8-6 ELECTROPHYSIOLOGIC TESTINGINDUCTION METHODSdeclared before the VFib induction pulses are started. A new episode (withinitial detection and therapy) can be declared after the VFib induction iscompleted. Event markers and EGMs are interrupted during VFib inductionand will automatically restart following induction.4. To stop the induction train, release the button (the button will becomedimmed again).5. To deliver another fibrillation induction, repeat these steps.Shock on T InductionA Shock on T wave induction method allows the device to deliver a drive train(up to 30 equally timed pacing pulses, or S1 pulses) through the ventricularpace/sense electrodes followed by shock delivery through the shockingelectrodes (Figure 8-2 on page 8-6).400 400 400 400 400 400 S1 S1 S1 S1 S1 S1 Last sensed or paced beat Coupling Interval Drive Pulses Shock S1 Interval Figure 8-2. Shock on T induction drive trainThe initial S1 pulse follows the last sensed or paced event at the S1 interval.The shock is coupled to the last S1 pulse of the drive train.Performing Shock on T Induction1. Select the Shock on T option. The programmable induction parameterswill be displayed.2. Select the desired value for each parameter.3. Select the Enable checkbox. The Induce button will no longer be dimmed.- DRAFT -
ELECTROPHYSIOLOGIC TESTINGINDUCTION METHODS 8-74. Select the Induce button to begin delivery of the drive train. The pulses aredelivered in sequence until the programmed number of pulses is reached.Once induction is initiated, the drive train delivery will not stop if youinterrupt telemetry communication. You can press the DIVERT THERAPYkey to stop the induction delivery command.5. Shock on T induction is complete when the drive train and shock aredelivered, at which time the pulse generator automatically restartsdetection.NOTE: Prior to drive train delivery, tones will be heard indicating capacitorcharging in preparation for shock delivery.NOTE: The shock delivered during Shock on T induction does not incrementepisode or therapy counters.Programmed Electrical Stimulation (PES)PES induction allows the pulse generator to deliver up to 30 equally timedpacing pulses (S1) followed by up to 4 premature stimuli (S2–S5) to induce orterminate arrhythmias. Drive pulses, or S1 pulses, are intended to capture anddrive the heart at a rate slightly faster than the intrinsic rate. This ensures thatthe timing of the premature extra stimuli will be accurately coupled with thecardiaccycle(Figure8-3onpage8-7).The initial S1 pulse is coupled to the last sensed or paced beat at the S1interval. All pulses are delivered in XOO modes (where X is the chamber) atthe programmed EP Test pacing parameters.S1 S1 S1 S1 S1 S2 S3600 400600 600 600 600 450Coupling IntervalCoupling IntervalExtra StimuliDrive PulsesFigure 8-3. PES induction drive train- DRAFT -
8-8 ELECTROPHYSIOLOGIC TESTINGINDUCTION METHODSPerforming PES Induction1. Select the PES option. Buttons for the S1–S5 pulses and the correspondingburst cycle lengths are displayed.2. Select the desired value for the S1–S5 intervals (Figure 8-4 on page 8-8).You can either select a value box for the desired S interval and choose avalue from the box or use the plus or minus symbols to change the valuevisible in the value box.Figure 8-4. PES induction options3. Select the Enable checkbox.4. Select (do not hold) the Induce button to begin delivery of the drive train.When the programmed number of S1 pulses is delivered, the pulsegenerator will then deliver the programmed S2–S5 pulses. The pulses aredelivered in sequence until a pulse is encountered that is set to Off (e.g.,if S1 and S2 are set to 600 ms, and S3 is Off, then S3, S4, and S5 willnot be delivered). Once induction is initiated, the PES delivery will notstop if you interrupt telemetry communication. (You can press the DIVERTTHERAPY key to stop induction delivery.) If PES induction is initiatedduring an episode, the end-of-episode is declared before the PES inductionpulses are started. A new episode (with initial detection and therapy) canbe declared after the PES induction is completed.5. PES induction is complete when the drive train and extra stimuli aredelivered, at which time the pulse generator automatically restartsdetection.NOTE: Ensure the PES induction is complete before beginning anotherinduction.NOTE: When PES is used to terminate an arrhythmia that has been detected(and an episode declared), the episode is terminated when the PES iscommanded regardless of whether it is successful or not. The PES itself is notrecorded in therapy history; this may result in several episodes being countedin therapy history.- DRAFT -
ELECTROPHYSIOLOGIC TESTINGINDUCTION METHODS 8-950 Hz/Manual Burst Pacing50 Hz/Manual Burst pacing induction is used to induce or terminate arrhythmiasand allows two separate pacing inductions, both of which can be delivered toeither the atrium or ventricle.Manual Burst pacing pulses are delivered in XOO mode (where X is thechamber) at the programmed EP Test pacing parameters through therate-sensing leads. For Atrial Manual Burst, backup pacing parameters areprovided.Performing Manual Burst Pacing1. Select the 50 Hz/Manual Burst option.2. Select the desired value for the Burst Interval, Minimum, and Decrement.This indicates the cycle length of the intervals in the drive train.3. Select the Enable checkbox.4. To deliver the burst, select and hold the Hold for Burst button.The ventricular Manual Burst will be delivered up to 30 seconds as long asthe Hold for Burst button is held and the telemetry link is maintained.The atrial Manual Burst will be delivered up to 45 seconds as long as theHold for Burst button is held and the telemetry link is maintained. Theintervals will continue to be decremented until the minimum interval isreached, then all further pulses will be at the Minimum interval.5. To stop the burst delivery, release the Hold for Burst button. The Hold forBurst button will become dimmed again.6. To deliver additional Manual Burst pacing, repeat these steps.Performing 50 Hz Burst Pacing1. Select the 50 Hz/Manual Burst option.2. Select the Enable checkbox.3. To deliver the burst, select and hold the Hold for 50 Hz Burst button.- DRAFT -
8-10 ELECTROPHYSIOLOGIC TESTINGCOMMANDED THERAPY METHODSThe ventricular 50 Hz Burst will be delivered up to 30 seconds as long asthe Hold for Burst button is held and the telemetry link is maintained.The atrial 50 Hz Burst will be delivered up to 45 seconds as long as theHold for Burst button is held and the telemetry link is maintained.NOTE: During Hold for 50 Hz Burst pacing, the S1 interval is automaticallyset to 20 ms and the decrement to 0. These values will not be displayed on thescreen.4. To stop the burst delivery, release the Hold for 50 Hz Burst button. TheHold for 50 Hz Burst button will become dimmed again.5. To deliver additional 50 Hz Burst pacing, repeat these steps.COMMANDED THERAPY METHODSThe commanded EP test methods, Commanded Shock and Commanded ATP,may be delivered independently of the programmed detection and therapyparameters. If the pulse generator is in the process of delivering therapy whena commanded method is initiated, the EP Test function overrides and abortsthe therapy in process. If an episode is not in progress, then a CommandedVentricular Episode will be recorded in the Arrhythmia Logbook. CommandedShock and Commanded ATP delivery is inhibited when a magnet is positionedover the pulse generator, if it is programmed to Inhibit Therapy.Commanded ShockThe Commanded Shock feature allows delivery of a shock with programmableenergy and coupling interval.All Commanded Shocks are Committed and delivered R-wave synchronouslywhen the coupling interval is programmed to Sync. Shock waveform andpolarity are identical to detection-initiated shocks but a programmed couplinginterval may be specified. The coupling interval is initiated at the point wherethe shock would have been delivered in Sync mode, but is instead delivered atthe programmed coupling interval. Following any Commanded Shock delivery,Post-shock Redetection is used and post-shock pacing is activated.Performing Commanded Shock Delivery1. Select the Commanded Shock option.- DRAFT -
ELECTROPHYSIOLOGIC TESTINGCOMMANDED THERAPY METHODS 8-112. Select the desired values for the Coupling interval and Shock Energy.3. Select the Enable checkbox. The Deliver Shock button will becomeavailable.4. Select the Deliver Shock button to initiate shock delivery. The CommandedShock is recorded in therapy history.5. To deliver subsequent shocks, repeat these steps.Commanded ATPCommanded ATP allows you to manually deliver ATP schemes, independentof the programmed detection and therapy parameters. You can configurethe Commanded ATP by either selecting the type of ATP scheme or byprogramming ATP parameters on the Details screen in order to deliverCommanded ATP.The EP Temp V Mode must be programmed to Monitor Only to ensure theCommanded ATP does not interfere with detection-initiated ATP.Performing Commanded ATP1. If the pulse generator Ventricular Tachy Mode is not currently programmedto Monitor Only, select the Monitor Only EP Temp V Mode option.2. Select the type of ATP scheme and select the value for Number of Bursts.3. Select the Start ATP button to initiate the first burst in the selected ATPscheme. The Bursts Remaining counter will decrement as each burst iscompleted.4. Select the Continue button for each additional burst delivery desired. If allbursts in a scheme have been delivered, the Bursts Remaining counter willreturn to the initial count, and the Continue button will be dimmed.5. Other ATP schemes may be selected at any time; select the desiredscheme and repeat the above sequence. The Commanded ATP isrecorded as a physician-commanded therapy counter and displayed onthe counters screen.- DRAFT -
8-12 ELECTROPHYSIOLOGIC TESTINGCOMMANDED THERAPY METHODS6. After using Commanded ATP, remember to program the EP Temp V Modeto Monitor + Therapy or leave the screen so that the EP Temp V Mode isended and the permanent Tachy Mode is resumed.NOTE: If any button other than the Continue button is selected during deliveryof a Commanded ATP scheme, the scheme will be reset and the BurstsRemaining box will be restored to its initial value. The Start ATP button must bereselected to initiate the scheme again.- DRAFT -
9-1IMPLANT INFORMATIONCHAPTER 9This chapter contains the following topics:• "Implanting the Pulse Generator" on page 9-2- DRAFT -
9-2 IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATORIMPLANTING THE PULSE GENERATORStep A: Check EquipmentStep B: Interrogate and Check the Pulse GeneratorStep C: Implant the Lead SystemStep D: Take Baseline MeasurementsStep E: Form the Implantation PocketStep F: Connect the Leads to the Pulse GeneratorStep G: Evaluate Lead SignalsStep H: Program the Pulse GeneratorStep I: Implant the Pulse GeneratorStep J: Complete and Return the Implantation FormStep A: Check EquipmentIt is recommended that instrumentation for cardiac monitoring, defibrillation,and lead signal measurement should be available during the implant procedure.This includes the PRM system with its related accessories and the softwareapplication. Before beginning the implantation procedure, become completelyfamiliar with the operation of all the equipment and the information in therespective operator’s and user’s manuals. Verify the operational status of allequipment that may be used during the procedure. Sterile duplicates of allimplantable items and the following accessories should be available in case ofaccidental damage or contamination:• Internal defibrillator paddles•Externaldefibrillator paddles• Torque and non-torque wrenchesDuring the implantation procedure, a standard transthoracic defibrillatorwith external pads or internal paddles should be available for use duringdefibrillation threshold testing.- DRAFT -
IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATOR 9-3Step B: Interrogate and Check the Pulse GeneratorTo maintain sterility, test the pulse generator as described below before openingthe sterile blister tray. The pulse generator should be at room temperature toensure accurately measured parameters.1. Interrogate the pulse generator using the PRM. Verify that the pulsegenerator’s Tachy mode is programmed to Storage. If otherwise, callTechnical Services at the phone number provided on the back of thismanual.2. Perform a manual capacitor re-formation.3. Review the pulse generator’s current battery status. Counters should beat zero. If the pulse generator battery status is not at BOL, do not implantthe pulse generator. Call Technical Services at the phone number providedon the back of this manual.Step C: Implant the Lead SystemThe pulse generator requires a lead system for sensing, pacing, and deliveringshocks. The pulse generator uses its case as a defibrillating electrode.Selection of lead configuration and specific surgical procedures is a matter ofprofessional judgement. The following lead system configurations are availablefor use with the pulse generator:• ENDOTAK endocardial cardioversion/defibrillation and pacing lead system• Ventricular endocardial bipolar lead• Atrial bipolar lead• Guidant transvenous coronary venous (pace/sense) lead• Unipolar sutureless myocardial leads and, if necessary, an appropriateGuidant lead adapter• Superior vena cava lead coupled with a ventricular patch lead• Two-patch epicardial leads configuration- DRAFT -
9-4 IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATORNOTE: If the coronary venous lead cannot be used and the physician’smedical judgment indicates that a limited left thoracotomy is justified to placean epicardial lead, the use of sutureable, steroid-eluting pace/sense epicardialleads is recommended.CAUTION: The absence of a lead or plug in a lead port may affect deviceperformance. If a lead is not used, be sure to properly insert a plug in theunused port.Whichever lead configuration is used for both pacing/sensing and defibrillating,several considerations and cautions should be heeded. Such factors ascardiomegaly or drug therapy may necessitate repositioning of the defibrillatingleads or substituting one lead for another to facilitate arrhythmia conversion.In some instances, no lead configuration may be found that provides reliablearrhythmia termination at energy levels available from the pulse generator;implantation of the pulse generator is not recommended in these cases.Implant the leads via the surgical approach chosen.CAUTION: Do not suture directly over the lead body as this may causestructural damage. Use the lead stabilizer to secure the lead lateral to thevenous entry side.Step D: Take Baseline MeasurementsOnce the leads are implanted, take baseline measurements. Evaluate thelead signals. If performing a pulse generator replacement procedure, existingleads should be reevaluated, (e.g., signal amplitudes, pacing thresholds, andimpedance). The use of radiography may help ensure lead position andintegrity. If testing results are unsatisfactory, lead system repositioning orreplacement may be required.- DRAFT -
IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATOR 9-5• Connect the pace/sense lead(s) to a pacing system analyzer (PSA).Pace/sense lead measurements, measured approximately 10 minutesafter placement, are listed below (Table 9-1 on page 9-5). Note that thepulse generator measurements may not exactly correlate to the PSAmeasurements due to signal filtering.Table 9-1. Lead measurementsPace/sense lead(acute)Pace/sense lead(chronic)Shocking lead(acute)Shocking lead(chronic)R-wave amplitudeab > 5 mV > 5 mV > 1.0 mV > 1.0 mVP-wave amplitudeab >1.5mV >1.5mVR-wave durationbcd < 100 ms < 100 msPacing threshold (rightventricle)<1.5Vendocardial< 2.0 V epicardial< 3.0 V endocardial<3.5VepicardialPacing threshold (leftventricle)< 2.5 V coronaryvenous< 2.0 V epicardial< 3.5 V coronaryvenous<3.5VepicardialPacing threshold (atrium) <1.5Vendocardial< 3.0 V endocardialLead impedance (at 5 V and0.5 ms atrium and ventricle)200–2000 Ω200–2000 Ω20–80 Ω20–80 ΩLead impedance (at 5 Vand 0.5 ms left ventricle)200–2000 Ω200–2000 Ω20–80 Ω20–80 Ωa. Amplitudes less than 2 mV cause inaccurate rate counting in the chronic state, and result in inability to sense a tachyarrhythmia orthe misinterpretation of a normal rhythm as abnormal.b. Lower R-wave amplitudes and longer duration may be associated with placement in ischemic or scarred tissues. Since signalquality may deteriorate chronically, efforts should be made to meet the above criteria by repositioning the leads to obtain signalswith the largest possible amplitude and shortest duration.c. Durations longer than 135 ms (the pulse generator’s refractory period) may result in inaccurate cardiac rate determination, inabilityto sense a tachyarrhythmia, or in the misinterpretation of a normal rhythm as abnormal.d. This measurement is not inclusive of current of injury.Step E: Form the Implantation PocketUsing standard operating procedures to prepare an implantation pocket,choose the position of the pocket based on the implanted lead configuration andthe patient’s body habitus. Giving consideration to patient anatomy and pulsegenerator size and motion, gently coil any excess lead and place adjacent tothe pulse generator. It is important to place the lead into the pocket in a mannerthat minimizes lead tension, twisting, sharp angles, and/or pressure. Pulsegenerators are typically implanted subcutaneously in order to minimize tissuetrauma and facilitate explant. However, deeper implantation (e.g., subpectoral)- DRAFT -
9-6 IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATORmay help avoid erosion or extrusion in some patients. Verify magnet functionand wanded telemetry to ensure the pulse generator is within acceptable range.Consider the following situations during the implant the procedure:• If an abdominal implant is suitable, it is recommended that implantationoccur on the left abdominal side.• Tunnel the leads if necessary. If a Guidant tunneler is not used, capthe lead terminal pins, gently tunnel the leads subcutaneously to theimplantation pocket, and reevaluate the lead signals to determine if any ofthe leads have been damaged during the tunneling procedure. A Penrosedrain, large chest tube, or tunneling tool may be used to tunnel the leads.• If the lead terminal pins are not connected to a pulse generator at the timeof lead implantation, they must be capped before closing the incision.Step F: Connect the Leads to the Pulse GeneratorLead connections are illustrated below.– + RV RA DF-1 IS-1 BI DF-1 LV LV-1 UNI/BI IS-1 BI – + RV RA DF-1 IS-1 BI DF-1 IS-1 BI LV IS-1 UNI/BIFigure 9-1. Lead connectionsSetscrew locations are illustrated below.- DRAFT -
IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATOR 9-7Front of Pulse Generator Suture Hole RA (-) LV (-) Defib (-) RV (-) Defib (+) Front of Pulse Generator Suture Hole RA (-) LV (-) Defib (-) RV (-) Defib (+) Figure 9-2. Setscrew and suture hole locationsLead to pulse generator connectionsCAUTION: Do not insert a lead into the pulse generator connector withoutfirst visually verifying that the setscrew is sufficiently retracted to allow insertion.Fully insert each lead into its lead port and then tighten the setscrew ontothe electrodes.1. As each lead is inserted into the pulse generator, secure the lead in placeby tightening the setscrew with the torque wrench.a. Insert the wrench into the center, preslit depression of the seal plug.b. Place pressure on the lead to maintain its position in the pulsegenerator lead port. Be certain that the lead remains fully insertedintheleadport.c. The large-handled torque wrench is preset to apply the proper amountof force to the captive setscrew. Tighten the setscrew, making sure it isnot crooked, until the wrench ratchets; additional force is unnecessary.- DRAFT -
9-8 IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATORd. Apply gentle traction to the leads to ensure a secure connection.2. In models with IS-1 connectors, insert and secure the right ventricularpace/sense lead terminal into the RV lead port.NOTE: When connecting leads to a device header, connect the RV leadfirst. An RV lead is required to establish RV-based timing cycles that yieldappropriate sensing and pacing in all chambers, regardless of the programmedconfiguration.3. In models with atrial connectors, insert and secure the atrial pace/senselead terminal into the A lead port.4. Insert and secure the left ventricular coronary venous pace/sense leadterminal into the LV lead port.5. In models with DF-1 connectors, insert the defibrillating lead anode(+, proximal) into the pulse generator’s (+) Defib lead port. For properconnection, be certain that the lead terminal pin is fully inserted in the pulsegenerator lead port. When viewed through the side of the header, the pintip should extend through the terminal block.6. Insert and secure the defibrillating cathode (–, distal) in the (–) Defibleadport in a similar manner as above.CAUTION: For IS-1/DF-1 leads, never change the shock waveformpolarity by physically switching the lead anodes and cathodes in the pulsegenerator header—use the programmable Polarity feature. Device damageor nonconversion of the arrhythmia post-operatively may result if the polarityis switched physically.CAUTION: The absence of a lead or plug in a lead port may affect deviceperformance. If a lead is not used, be sure to properly insert a plug in theunused port.Consider the following lead connection information during the implantprocedure:• The IS-1 pace/sense lead port(s) has one setscrew for securing theterminal pin.• The DF-1 port has one setscrew for securing the terminal pin.- DRAFT -
IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATOR 9-9• The LV-1 pace/sense lead port(s) has one setscrew for securing theterminal pin.• Avoid allowing blood or other body fluids to enter the lead ports in the pulsegenerator header. If fluid inadvertently enters the ports, they should bethoroughly cleaned using sterile water.• To connect leads to the pulse generator, use only the tools provided in thepulse generator tray or accessory kit to avoid damage to the seal plugs.Failure to properly insert the wrench in the preslit depression of the sealplug may result in damage to the plug and its sealing properties. Failureto use the supplied torque wrench may result in damage to the screw orconnector threads. Do not implant the pulse generator if the seal plugsappear to be damaged. Retain the tools until all testing procedures arecomplete and the pulse generator is implanted.• If necessary, lubricate the lead connectors sparingly with sterile water tomake insertion easier.• If a lead terminal encounters resistance on insertion into the lead port,insert the wrench into the preslit depression of the seal plug and angle itgently to open the valve and allow excess air to bleed out of the seal plug.•Significant amounts of fluid or sterile water in a lead bore may make itdifficult to fully insert leads. If significant amounts of fluid or sterile waterare present, insert the torque wrench into the setscrew before inserting theleads. This will allow fluid to drain from the lead bore.• For proper connection of an IS-1 lead to the pulse generator, be certain thatthe connector pin visibly extends through the connector block at least 1 mm.Step G: Evaluate Lead Signals1. Take the pulse generator out of power-saving Storage mode byprogramming the Tachy Mode to Off.CAUTION: To prevent inappropriate shocks, ensure that the pulse generator’sTachy Mode is programmed to Off when not in use and before handling thedevice. For tachyarrhythmia therapy, verify that the Tachy Mode is activated.2. Evaluate the pace/sense and defibrillation lead signals by viewing thereal-time EGMs and markers. The signal from the implanted defibrillationleads should be continuous and without artifact, similar to a body-surface- DRAFT -
9-10 IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATORECG. A discontinuous signal may indicate a poor connection, lead fractureor otherwise damaged lead, or an insulation break that would necessitatelead replacement. Inadequate signals may result in failure of the pulsegenerator system to detect an arrhythmia, inability to deliver programmedtherapy, or unnecessary delivery of therapy. Lead measurements shouldreflect those in (Table 9-1 on page 9-5).CAUTION: Take care to ensure that artifacts from the ventricles are notpresent on the atrial channel, or atrial oversensing may result. If ventricularartifacts are present in the atrial channel, the atrial lead may need to berepositioned to minimize its interaction.3. Evaluate all lead impedances using the Lead Impedance test accessedfrom the Diagnostic Evaluation tool.CAUTION: Never implant the device with a lead system that has less than15 Ωtotal shock lead impedance. Device damage may result. If a shockinglead impedance is less than 20 Ω, reposition the shocking electrodes to allow agreater distance between the shocking electrodes.CAUTION: Patients should be tested for diaphragmatic stimulation by pacingthe LV lead through the pulse generator at 7.5 V and adjusting the leadposition as necessary. PSA testing at higher outputs (e.g., 10.0 V) may alsobe considered to better characterize stimulation margins. The probability ofdiaphragmatic stimulation increases when a pacing system includes an LV leadbecause of this lead’s proximity to the phrenic nerve.Step H: Program the Pulse Generator1. Check the programmer clock and set and synchronize the pulse generatoras necessary so that the proper time appears on printed reports and PRMstrip chart recordings.2. It may be useful to program the Beep During Capacitor Charge feature toOn during conversion testing and implantation to help recognize when thepulse generator is charging to deliver shock.3. Perform a manual capacitor re-formation if not already performed.4. Program the pulse generator to desired parameters appropriate for thepatient for necessary testing.- DRAFT -
IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATOR 9-115. Shocks intended for VF therapy should be programmed with a 10 J safetymargin above the shock energy level that the physician determines isrequired for successful VF conversion.CAUTION: To prevent inappropriate shocks, ensure that the pulse generator’sTachy Mode is programmed to Off when not in use and before handling thedevice. For tachyarrhythmia therapy, verify that the Tachy Mode is activated.Step I: Implant the Pulse Generator1. Program the Tachy Mode to Off.2. Ensure that the pulse generator has good contact with surrounding tissueof the implantation pocket. Suture hole locations are illustrated below.Gently coil excess lead and place adjacent to the pulse generator. Flushthe pocket with saline solution, if necessary, to avoid a dry pocket.WARNING: Kinking leads may cause additional stress on the leads,possibly resulting in lead fracture.CAUTION: Improper insertion can cause insulation damage near theterminal end that could result in lead failure.- DRAFT -
9-12 IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATORFront of Pulse Generator Suture Hole RA (-) LV (-) Defib (-) RV (-) Defib (+) Front of Pulse Generator Suture Hole RA (-) LV (-) Defib (-) RV (-) Defib (+) Figure 9-3. Setscrew and suture hole locations3. Close the implantation pocket. Consideration should be given to placethe leads in a manner to prevent contact with suture materials. It isrecommended that absorbable sutures be used for closure of tissue layers.4. Complete any electrocautery procedures before reactivating the pulsegenerator.5. Program the Tachy Mode to the desired setting and confirm finalprogrammed parameters.6. Print out parameter reports and save all data to disk using the programmer’sSave to Disk option.Step J: Complete and Return the Implantation FormWithin ten days of implantation, complete the Warranty Validation and LeadRegistration form and return the original to Boston Scientificalongwithacopyof the patient data disk. This information enables Boston Scientifictoregistereach implanted pulse generator and set of leads, initiate the warranty period,and provide clinical data on the performance of the implanted system. Keep a- DRAFT -
IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATOR 9-13copy of the Warranty Validation and Lead Registration form and programmerprintouts, and the original patient data disk for the patient’s file.Complete the temporary patient identification card and give it to the patient.After receiving the validation form, Boston Scientific sends the patient apermanent identification card.NOTE: A registration form is packaged with each pulse generator lead. Ifcompleting the pulse generator Warranty Validation and Lead Registrationform for the pulse generator, completing separate validation forms for eachlead is not necessary.- DRAFT -
9-14 IMPLANT INFORMATIONIMPLANTING THE PULSE GENERATOR- DRAFT -
10-1POST IMPLANT INFORMATIONCHAPTER 10This chapter contains the following topics:• "Follow Up Testing" on page 10-2• "Post Implant features" on page 10-3• "Explantation" on page 10-8- DRAFT -
10-2 POST IMPLANT INFORMATIONFOLLOW UP TESTINGFOLLOW UP TESTINGIt is recommended that device functions be evaluated during follow-up testing.WARNING: Ensure that an external defibrillator and medical personnel skilledin CPR are present during post-implant device testing should the patientrequire external rescue.Predischarge Follow UpDuring the pre-discharge follow-up test, the following procedures should beperformed via telemetry using the PRM:1. Interrogate the pulse generator and review the Summary screen.2. Perform pacing thresholds and lead impedance tests, and intrinsicamplitude measurements.3. Review Histograms.4. When all testing is complete, perform a final interrogation and save all thedata to a patient data disk.5. Print the Quick Notes and Patient Data reports to retain in your files forfuture reference.6. It is important to clear the therapy counters so that at the next follow-upsession the most recent episode data will be displayed. Note that thehistogram counters can be cleared from either the Brady or Tachy Countersscreen as well.NOTE: Echo-Doppler studies may be used to evaluate AV Delay and otherprogramming options non-invasively post-implant.Routine Follow UpYou should conduct routine follow-up examinations one month after thepre-discharge study and every three months thereafter. During the routinefollow-up test, the following procedures should be performed via telemetryusing the programming system:1. Interrogate the device and review the Summary screen.- DRAFT -
POST IMPLANT INFORMATIONPOST IMPLANT FEATURES 10-32. Perform pacing thresholds and lead impedance tests, and intrinsicamplitude measurements.3. Print and review the Quick Notes report, and retain it in your files for futurereference.4. For episodes of interest, review the Arrhythmia Logbook screen and printepisode details and stored electrogram information.5. It is important to clear the therapy counters so that at the next follow-upsession the most recent episode data will be displayed.CAUTION: Verify with a conversion test that the patient’s tachyarrhythmiascan be detected and terminated by the pulse generator system if the patient’sstatus has changed or parameters have been reprogrammed.POST IMPLANT FEATURESSensitivity AdjustmentThe Sensitivity Adjustment feature allows you to shift the atrial sensing range tomake it less sensitive (i.e., a larger signal would be required for the device todetect). It allows shifting the ventricular sensing range to make it less or moresensitive. While the Nominal setting is primarily indicated for both atrial andventricular sensing, an adjustment can be made if, in a rare situation, atrial orventricular oversensing/undersensing has been observed post-implant (i.e.,inhibition of bradycardia pacing or inappropriate tachy therapy).WARNING: Left ventricular lead dislodgment to a position near the atria canresult in atrial oversensing or left ventricular pacing inhibition.Should it become necessary to adjust the sensing range in a chamber,always choose the setting that allows the greatest sensitivity, but resolvesoversensing/undersensing:• To reduce oversensing, program the sensitivity to a higher value.• To reduce undersensing, program the sensitivity to a lower value.After any change to sensitivity, evaluate for appropriate sensing for bothbradycardia pacing and tachycardia detection.- DRAFT -
10-4 POST IMPLANT INFORMATIONPOST IMPLANT FEATURESIf proper sensing cannot be restored with an adjustment or if any undersensingis observed after making a change, consider repositioning the lead or implantinga new sensing lead and then programming the setting back to nominal.CAUTION: Following any sensing range adjustment or any modification ofthe sensing lead, always verify appropriate sensing.Beeper FeatureThe pulse generator contains a beeper that emits audible tones tocommunicate status information. The beeper includes both programmable andnonprogrammable features.Programmable FeaturesThe following beeper features are programmable:• Beep During Capacitor Charge—When programmed to On, regardless ofthe Tachy mode, a warbling tone will sound continuously while the pulsegenerator is charging (except when charging during an auto capacitorre-form). The tone will continue until charging is complete. When thisfeature is programmed to Off, there is no audible indication that the pulsegenerator is charging. This feature is useful during EP testing.• Beep When Explant Is Indicated—When this feature is programmed toOn, the pulse generator emits tones upon reaching Explant. The Explantindicator consists of 16 tones repeated every six hours after the pulsegenerator reaches Explant until the feature is turned off via the programmer.When this feature is programmed to Off, there is no audible indicationof Explant.Perform the following steps to program the magnet and beeper features:Magnet and Beeper Response1. Select the Settings tab.2. From Ventricular Tachy, select the Therapy button.3. Select the V-Tachy Therapy Setup button.4. Enter the desired values.- DRAFT -
POST IMPLANT INFORMATIONPOST IMPLANT FEATURES 10-5Beep when Explant is indicated1. Select the Summary tab.2. Select the Battery button.3. From the Battery Status summary screen, select the Battery Detail button.4. From the Battery Detail summary screen, select the desired value for Beepwhen Explant is indicated.NOTE: When the Magnet Response is programmed to Inhibit Therapy,magnet application will cause other types of beeping tones to be emitted,depending on the device mode. Refer to "Magnet Feature" on page 10-5 formore information.Nonprogrammable FeaturesThe following beeper features are nonprogrammable:• Battery capacity depleted—Regardless of whether Beep When ExplantIs Indicated is programmed to On or Off, once the battery capacity isdepleted, the pulse generator will emit the explant indicator tones• Fault code tones—For certain fault codes or when safety mode is entered,the pulse generator will beep 16 times every 6 hours.NOTE: Beeping tones may emit under nonprogrammable scenarios inresponse to device self-diagnostic testing. Advise patients to have theirpulse generator checked whenever they hear tones coming from the device.Contact Technical Services at the phone number on the back of this manualfor assistance.Magnet FeatureThe magnet feature allows certain device functions to be triggered when amagnet is placed in close proximity to the pulse generator (Figure 10-1 onpage 10-6).- DRAFT -
10-6 POST IMPLANT INFORMATIONPOST IMPLANT FEATURESPosition the magnet over the pulse generator as shown.Magnet (model 6860)3.0 cmPulse generatorTop ViewFigure 10-1. Proper position of magnet Model 6860 to activate the pulse generator magnet featureThe pulse generator Magnet Response settings can be programmed to controlthe behavior of the pulse generator when a magnet is detected. The MagnetResponse settings are located in the Magnet and Beeper section of the V-TachyTherapy Setup screen. The following Magnet Response settings are available:• Off—no response• Store EGM—patient monitoring data will be stored• Inhibit Therapy—therapy will be stoppedOffWhen the Magnet Response is programmed to Off, application of the magnetwill have no effect on the pulse generator.Store EGMWhen the Magnet Response is programmed to Store EGM, application of themagnet will activate the patient triggered monitor functionality. Refer to "PatientTriggered Monitor" on page 7-17 for additional information.Inhibit Therapy- DRAFT -
POST IMPLANT INFORMATIONPOST IMPLANT FEATURES 10-7When the Magnet Response is programmed to Inhibit Therapy, application ofthe magnet will inhibit and/or divert charging for a shock, divert a shock that isabout to be delivered, or inhibit and/or divert further ATP therapy.When Magnet Response is programmed to Inhibit Therapy, initiation oftachyarrhythmia therapy and arrhythmia induction is inhibited any time themagnet is properly positioned over the pulse generator. The tachyarrhythmiadetection process continues, but therapy or induction cannot be triggered.When a magnet is placed over the pulse generator, the following will occur:• If the Tachy mode is Monitor + Therapy or Off when the magnet is applied,the Tachy mode changes temporarily to Monitor Only mode and willremain in Monitor Only mode as long as the magnet is applied. Threeseconds after the magnet is removed, the mode will return to the previouslyprogrammed mode.• If the pulse generator is charging to deliver shock therapy when the magnetis applied, the charging continues but is then terminated within one to twoseconds of magnet application, and the charge is diverted. (This delayoccurs in case the magnet is inadvertently passed over the device whentherapy inhibition is not desired.) The pulse generator remains in temporaryMonitor Only mode while the magnet is applied. No further therapy isinitiated until the magnet is removed; however, detection will continue.• If charging is complete or completes within the 1–2 second delay period,holding the magnet over the pulse generator for more than two secondswill divert the shock. (If the magnet is removed during the delay period,the shock could still be delivered.) Shocks will not be delivered with themagnet in place.• If the pulse generator is initiating fibrillation induction or ATP pulses, itterminates the delivery after one to two seconds of magnet application. Nofurther induction or ATP pulse sequences are initiated until the magnetis removed.• If the Tachy Mode is Monitor Only or Off, magnet application will produce aconstant tone to indicate that the device is in a non-therapy mode.• If the Tachy Mode is Monitor + Therapy or the pulse generator is inElectrocautery Protection Mode, magnet application will cause the pulsegenerator to beep once per second to indicate that the device is in atherapy mode.- DRAFT -
10-8 POST IMPLANT INFORMATIONEXPLANTATIONNOTE: If tachy detection occurs while the magnet is in place, detailed therapyhistory will indicate that therapy was not delivered because the device wasin Monitor Only mode.EXPLANTATIONAn Observation/Complication/Out-of-Service Reporting form should becompleted and sent to Boston Scientific when a product is removed fromservice. Return all explanted pulse generators and leads with productperformance allegations or warranty considerations to Boston Scientific.Examination of explanted devices provides information for continuedimprovement in device reliability and will permit calculation of any warrantyreplacement credit use.In the event of patient death (regardless of cause), the explanted pulsegenerator and/or lead should be returned to Boston Scientificalongwith the Observation/Complication/Out-of-Service Reporting form andcopies of the autopsy report, if performed. For other observation orcomplications reasons, also complete and return to Boston ScientifictheObservation/Complication/Out-of-Service Reporting form.NOTE: Disposal of explanted devices is subject to local, state, and federalregulations. Contact your sales representative or call the phone number on theback cover of this manual for a Returned Product Kit.NOTE: Discoloration of the pulse generator may have occurred due to anormal process of anodization, and has no effect on the pulse generatorfunction.CAUTION: Be sure that the pulse generator is removed before cremation.Cremation and incineration temperatures might cause the pulse generator toexplode.CAUTION: Before explanting, cleaning, or shipping the device, complete thefollowing actions to prevent unwanted shocks, overwriting of important therapyhistory data, and audible tones:• Program the pulse generator Tachy and Brady Modes to Off.• Program the Magnet Response feature to Off.• Program the Beep When Explant is Indicated feature to Off.Consider the following items when explanting and returning the pulse generator:- DRAFT -
POST IMPLANT INFORMATIONEXPLANTATION 10-9• Interrogate the pulse generator and print a Combined Follow-up report.• Deactivate the pulse generator before explantation.• Disconnect the leads from the pulse generator.• If leads are also explanted, attempt to remove them intact. Do not removeleads with hemostats or any other clamping tool that may damage theleads. Resort to tools only if manual manipulation cannot free the lead.• Wash, but do not submerge, the pulse generator and leads to removebody fluids and debris using a disinfectant solution. Do not allow fluids toenter the pulse generator’s lead ports.• UseaBostonScientific Returned Product Kit to properly package thepulse generator.• Complete the Observation/Complication/Out-of-Service Reporting form.• Send the form and the Returned Product Kit to Boston Scientific.- DRAFT -
10-10 POST IMPLANT INFORMATIONEXPLANTATION- DRAFT -
A-1PROGRAMMABLE OPTIONSAPPENDIX ATable A-1. ZIP Telemetry settingsParameter Programmable Values NominalCommunication Mode Enable use of ZIP telemetry (Mayrequire limited use of wand), Usewand for all telemetryEnable use of ZIP telemetry (Mayrequire limited use of wand)Table A-2. Tachy Mode parameterParameter Programmable Values NominalTachy Mode Off, Monitor Only, Monitor + Therapy,Enable Electrocautery ProtectionStorageTable A-3. Ventricular Zones parameterParameter Programmable Values NominalVentricular Zones 1, 2, 3 2Table A-4. Detection parameters for 1-zone, 2-zone, and 3-zone configurationsParameter VT-1 Zone VT Zone VF Zone NominalRatea( bpm) 3 zones(intervals in ms)90, 95, ..., 200(667–300)110, 115, ..., 210(545–286) 220 (273)130, 135, ..., 210(462–286), 220, 230,240, 250 (273–240)140 (Tolerance ± 5ms) for VT-1 Zone160 (Tolerance ± 5ms) for VT Zone200 (Tolerance ± 5ms) for VF ZoneRatea( bpm) 2 zones(intervals in ms)–– 90, 95, ..., 210(667–286) 220 (273)110, 115, ..., 210(545–286) 220, 230,240, 250 (273–240)160 (Tolerance ± 5ms) for VT Zone200 (Tolerance ± 5ms) for VF ZoneRatea( bpm) 1 zone(intervals in ms)–– –– 90, 95, ..., 210 (667–286) 220 (273)200 (Tolerance ± 5ms)Initial Durationb(sec) 3 zones1.0, 1.5, ..., 5.0, 6.0,7.0, ..., 15.0, 20.0,25.0, ..., 60.01.0, 1.5, ..., 5.0, 6.0,7.0, ..., 15.0, 20.0,25.0, 30.01.0, 1.5, ..., 5.0, 6.0,7.0, ..., 15.02.5 (Tolerance ± 1cardiac cycle) forVT-1 Zone2.5 (Tolerance ± 1cardiac cycle) for VTZone1.0 (Tolerance ± 1cardiac cycle) for VFZone- DRAFT -
A-2 PROGRAMMABLE OPTIONSTable A-4. Detection parameters for 1-zone, 2-zone, and 3-zone configurations (continued)Parameter VT-1 Zone VT Zone VF Zone NominalInitial Durationb(sec) 2 zones–– 1.0, 1.5, ..., 5.0, 6.0,7.0, ..., 15.0, 20.0,25.0, 30.01.0, 1.5, ..., 5.0, 6.0,7.0, ..., 15.02.5 (Tolerance ± 1cardiac cycle) for VTZone1.0 (Tolerance ± 1cardiac cycle) for VFZoneInitial Durationb(sec) 1 zone–– –– 1.0, 1.5, ..., 5.0, 6.0,7.0, ..., 15.01.0 (Tolerance ± 1cardiac cycle)RedetectionDurationb(sec) 3zones1.0, 1.5, ..., 5.0, 6.0,7.0, ..., 15.01.0, 1.5, ..., 5.0, 6.0,7.0, ..., 15.01.0(nonprogrammable)1.0 (Tolerance ± 1cardiac cycle) for allzonesRedetectionDurationb(sec) 2zones–– 1.0, 1.5, ..., 5.0, 6.0,7.0, ..., 15.01.0(nonprogrammable)1.0 (Tolerance ± 1cardiac cycle) for allzonesRedetectionDurationb(sec) 1zone–– –– 1.0(nonprogrammable)1.0 (Tolerance ± 1cardiac cycle)Post-shockDurationb(sec) 3zones1.0, 1.5, ..., 5.0, 6.0,7.0, ..., 15.0, 20.0,25.0, ..., 60.01.0, 1.5, ..., 5.0, 6.0,7.0, ..., 15.0, 20.0,25.0, 30.01.0(nonprogrammable)1.0 (Tolerance ± 1cardiac cycle) for allzonesPost-shockDurationb(sec) 2zones–– 1.0, 1.5, ..., 5.0, 6.0,7.0, ..., 15.0, 20.0,25.0, 30.01.0(nonprogrammable)1.0 (Tolerance ± 1cardiac cycle) for allzonesPost-shockDurationb(sec) 1zone–– –– 1.0(nonprogrammable)1.0 (Tolerance ± 1cardiac cycle)a. The Rate difference between each tachy zone must be at least 20 bpm. The lowest Tachy Rate Threshold must be ≥5 bpmhigher than the Maximum Tracking Rate, Maximum Sensor Rate, and the Maximum Pacing Rate; and the lowest Tachy RateThreshold must be ≥15 bpm higher than the Lower Rate Limit.b. The Duration in a zone must be equal to or greater than the Duration in the next highest zone.Table A-5. Ventricular Detection Enhancement Type for 2-zone and 3-zone configurationsParameter Programmable Values NominalDetection Enhancement Type Off, Rhythm ID, Onset/Stability Onset/StabilityTable A-6. Onset/Stability detection enhancement parameters for 2-zone and 3-zone configurationsParameter VT-1 Zone VT Zone VF Zone NominalV Rate > A Rate 3zonesOff, On –– –– OnV Rate > A Rate 2zones–– Off, On –– On- DRAFT -
PROGRAMMABLE OPTIONS A-3Table A-6. Onset/Stability detection enhancement parameters for 2-zone and 3-zone configurations(continued)Parameter VT-1 Zone VT Zone VF Zone NominalAFib Rate Threshold( bpm) 3 zonesOff, 100, 110, ..., 300 –– –– 170 (Tolerance ± 5ms)AFib Rate Threshold( bpm) 2 zones–– Off, 100, 110, ..., 300 –– 170 (Tolerance ± 5ms)Stability (ms) 3zonesOff, 6, 8, ..., 32 35,40, ..., 60 70, 80, ...,120–– –– 20 (Tolerance ± 5ms)Stability (ms) 2zones–– Off, 6, 8, ..., 32 35,40, ..., 60 70, 80, ...,120–– 20 (Tolerance ± 5ms)Shock If Unstable(ms) 3 zones–– Off, 6, 8, ..., 32 35,40, ..., 60 70, 80, ...,120–– 30 (Tolerance ± 5ms)Shock If Unstable(ms) 2 zones–– Off, 6, 8, ..., 32 35,40, ..., 60 70, 80, ...,120–– Off (Tolerance ± 5ms)Onset (% or ms) 3zonesOff, 9, 12, 16, 19, ...,37 41, 44, 47, 50%or 50, 60, ..., 250 ms–– –– 9% (Tolerance ± 5ms)Onset (% or ms) 2zones–– Off, 9, 12, 16, 19, ...,37, 41, 44, 47, 50%or 50, 60, ..., 250 ms–– 9% (Tolerance ± 5ms)Stability And/OrOnset 3 zonesAnd, Or –– –– AndStability And/OrOnset 2 zones–– And, Or –– AndSustained RateDuration (min:sec) 3zonesOff, 00:10, 00:15, ...,00:55 01:00, 01:15,..., 02:00 02:30,03:00, ..., 10:0015:00, 20:00, ...,60:00–– –– 03:00 (Tolerance ± 1cardiac cycle)Sustained RateDuration (min:sec) 2zones–– Off, 00:10, 00:15, ...,00:55 01:00, 01:15,..., 02:00 02:30,03:00, ..., 10:0015:00, 20:00, ...,60:00–– 03:00 (Tolerance ± 1cardiac cycle)DetectionEnhancement 3zonesOff, On Off, On –– On (VT-1) Off (VT)- DRAFT -
A-4 PROGRAMMABLE OPTIONSTable A-6. Onset/Stability detection enhancement parameters for 2-zone and 3-zone configurations(continued)Parameter VT-1 Zone VT Zone VF Zone NominalDetectionEnhancement 2zones–– Off, On –– OnAtrialTachyarrhythmiaDiscrimination 3zonesOff, On –– –– OnAtrialTachyarrhythmiaDiscrimination 2zones–– Off, On –– OnSinus TachycardiaDiscrimination 3zonesOff, On –– –– OnSinus TachycardiaDiscrimination 2zones–– Off, On –– OnPolymorphic VTDiscrimination 3zones–– Off, On –– OnPolymorphic VTDiscrimination 2zones–– Off, On –– OffTable A-7. Rhythm ID detection enhancement parameters for 2-zone and 3-zone configurationsParameter VT-1 Zone VT Zone VF Zone NominalDetectionEnhancement 3zonesOff, On Off, On –– On (VT-1) Off (VT)DetectionEnhancement 2zones–– Off, On –– OffSustained RateDuration (min:sec) 3zonesOff, 00:10, 00:15,..., 01:00, 01:15,..., 02:00, 02:30,..., 10:00, 15:00, ...,60:00Off, 00:10, 00:15,..., 01:00, 01:15,..., 02:00, 02:30,..., 10:00, 15:00, ...,60:00–– 03:00 (VT-1 andVT) (Tolerance ± 1cardiac cycle)Sustained RateDuration (min:sec) 2zones–– Off, 00:10, 00:15,..., 01:00, 01:15,..., 02:00, 02:30,..., 10:00, 15:00, ...,60:00–– 03:00 (Tolerance ± 1cardiac cycle)- DRAFT -
PROGRAMMABLE OPTIONS A-5Table A-7. Rhythm ID detection enhancement parameters for 2-zone and 3-zone configurations (continued)Parameter VT-1 Zone VT Zone VF Zone NominalPassive Method 3zones (one value forall zones)Off, On Off, On –– OnPassive Method 2zones (one value forall zones)–– Off, On –– OnActive Method 3zones (one value forall zones)Off, On Off, On –– OnActive Method 2zones (one value forall zones)–– Off, On –– OnTemp LRL ( ppm)(one value for allzones)Use Norm LRL, 30,35, ..., 105Use Norm LRL, 30,35, ..., 105–– Use Norm LRL(Tolerance ± 5 ms)Temp LRL 2 zones( ppm) (one value forall zones)–– Use Norm LRL, 30,35, ..., 105–– Use Norm LRL(Tolerance ± 5 ms)Atrial TachyDiscrimination 3zones (one value forall zones)Off, On Off, On –– OnAtrial TachyDiscrimination 2zones (one value forall zones)–– Off, On –– OnAFib Rate Threshold( bpm) 3 zones (onevalue for all zones)100, 110, ..., 300 100, 110, ..., 300 –– 170 (Tolerance ± 5ms)AFib Rate Threshold( bpm) 2 zones (onevalue for all zones)–– 100, 110, ..., 300 –– 170 (Tolerance ± 5ms)Stability (ms) 3zones (one value forall zones)6, 8, ..., 32, 35, 40,..., 60, 70, ..., 1206, 8, ..., 32, 35, 40,..., 60, 70, ..., 120–– 20 (Tolerance ± 5ms)Stability (ms) 2zones (one value forall zones)–– 6, 8, ..., 32, 35, 40,..., 60, 70, ..., 120–– 20 (Tolerance ± 5ms)- DRAFT -
A-6 PROGRAMMABLE OPTIONSTable A-8. Post-shock Onset/Stability detection enhancement parameters for 2-zone and 3-zoneconfigurationsParameter VT-1 Zone VT Zone VF Zone NominalPost-shock V Rate >A Rate 3 zonesOff, On –– –– OnPost-shock V Rate >A Rate 2 zones–– Off, On –– OnPost-shock AFibRate Threshold( bpm) 3 zonesOff, 100, 110, ..., 300 –– –– 170 (Tolerance ± 5ms)Post-shock AFibRate Threshold( bpm) 2 zones–– Off, 100, 110, ..., 300 –– 170 (Tolerance ± 5ms)Post-shock Stability(ms) 3 zonesOff, 6, 8, ..., 32, 35,40, ..., 60, 70, 80, ...,120–– –– 20 (Tolerance ± 5ms)Post-shock Stability(ms) 2 zones–– Off, 6, 8, ..., 32, 35,40, ..., 60, 70, 80, ...,120–– 20 (Tolerance ± 5ms)Post-shockSustained RateDuration (min:sec) 3zonesOff, 00:10, 00:15, ...,00:55, 01:00, 01:15,..., 02:00, 02:30,03:00, ..., 10:00,15:00, 20:00, ...,60:00–– –– 00:15 (Tolerance ± 1cardiac cycle)Post-shockSustained RateDuration (min:sec) 2zones–– Off, 00:10, 00:15, ...,00:55, 01:00, 01:15,..., 02:00, 02:30,03:00, ..., 10:00,15:00, 20:00, ...,60:00–– 00:15 (Tolerance ± 1cardiac cycle)Table A-9. Post-shock Rhythm ID detection enhancement parameters for 2-zone and 3-zone configurationsParameter VT-1 Zone VT Zone VF Zone NominalPost-shockDetectionEnhancement 3zonesOff, On Off, On –– OffPost-shockDetectionEnhancement 2zones–– Off, On –– Off- DRAFT -
PROGRAMMABLE OPTIONS A-7Table A-9. Post-shock Rhythm ID detection enhancement parameters for 2-zone and 3-zone configurations(continued)Parameter VT-1 Zone VT Zone VF Zone NominalPost-shockSustained RateDuration (min:sec) 3zonesOff, 00:10, 00:15,01:00, 01:15, ...,02:00, 02:30, ...,10:00, 15:00, ...,60:00Off, 00:10, 00:15,01:00, 01:15, ...,02:00, 02:30, ...,10:00, 15:00, ...,60:00–– 0:15 (Tolerance ± 1cardiac cycle)Post-shockSustained RateDuration (min:sec) 2zones–– Off, 00:10, 00:15,01:00, 01:15, ...,02:00, 02:30, ...,10:00, 15:00, ...,60:00–– 0:15 (Tolerance ± 1cardiac cycle)Table A-10. Ventricular ATP parameters (specified into a 750 Ωload)Parameter VT-1 Zone VT Zone VF Zone NominalATP Type 3 zones Off, Burst, Ramp,Scan, Ramp/ScanOff, Burst, Ramp,Scan, Ramp/Scan–– Off (VT-1); Burst (VTATP1); Ramp (VTATP2)ATP Type 2 zones –– Off, Burst, Ramp,Scan, Ramp/Scan–– Burst (VT ATP1);Ramp (VT ATP2)Number of Bursts(per scheme) 3zonesOff, 1, 2, ..., 30 Off, 1, 2, ..., 30 –– Off (VT-1); 2 (VTATP1); 1 (VT ATP2)Number of Bursts(per scheme) 2zones–– Off, 1, 2, ..., 30 –– 2 (VT ATP1); 1 (VTATP2)Initial Pulse (pulses)3 zones1, 2, ..., 30 1, 2, ..., 30 –– 4 (VT-1); 10 (VT)Initial Pulse (pulses)2 zones–– 1, 2, ..., 30 –– 10Pulse Increment(pulses) 3 zones0, 1, ..., 5 0, 1, ..., 5 –– 0Pulse Increment(pulses) 2 zones–– 0, 1, ..., 5 –– 0Maximum Numberof Pulses 3 zones1, 2, ..., 30 1, 2, ..., 30 –– 4 (VT-1); 10 (VT)Maximum Numberof Pulses 2 zones–– 1, 2, ..., 30 –– 10Coupling Interval (%or ms) 3 zones50, 53, 56, 59; 63,66, ..., 84, 88, 91,94, 97% or 120, 130,..., 750 ms50, 53, 56, 59; 63,66,...,84,88,91,94, 97% or 120, 130,..., 750 ms–– 81% (Tolerance ± 5ms)- DRAFT -
A-8 PROGRAMMABLE OPTIONSTable A-10. Ventricular ATP parameters (specified into a 750 Ωload) (continued)Parameter VT-1 Zone VT Zone VF Zone NominalCoupling Interval (%or ms) 2 zones–– 50, 53, 56, 59; 63,66,...,84,88,91,94, 97% or 120, 130,..., 750 ms–– 81% (Tolerance ± 5ms)Coupling IntervalDecrement (ms) 3zones0, 2, ..., 30 0, 2, ..., 30 –– 0(Tolerance±5ms)Coupling IntervalDecrement (ms) 2zones–– 0, 2, ..., 30 –– 0(Tolerance±5ms)Burst Cycle Length(BCL) (% or ms) 3zones50, 53, 56, 59; 63,66, ..., 84, 88, 91,94, 97% or 120, 130,..., 750 ms50, 53, 56, 59; 63,66,...,84,88,91,94, 97% or 120, 130,..., 750 ms–– 81% (Tolerance ± 5ms)Burst Cycle Length(BCL) (% or ms) 2zones–– 50, 53, 56, 59; 63,66,...,84,88,91,94, 97% or 120, 130,..., 750 ms–– 81% (Tolerance ± 5ms)Ramp Decrement(ms) 3 zones0, 2, ..., 30 0, 2, ..., 30 –– 0(VT-1);0(VTATP1); 10 (VT ATP2)(Tolerance ± 5 ms)Ramp Decrement(ms) 2 zones–– 0, 2, ..., 30 –– 0 (VT ATP1); 10 (VTATP2) (Tolerance ±5ms)Scan Decrement(ms) 3 zones0, 2, ..., 30 0, 2, ..., 30 –– 0(Tolerance±5ms)Scan Decrement(ms) 2 zones–– 0, 2, ..., 30 –– 0(Tolerance±5ms)Minimum Interval(ms) 3 zones120, 130, ..., 400 120, 130, ..., 400 –– 220 (Tolerance ± 5ms)Minimum Interval(ms) 2 zones–– 120, 130, ..., 400 –– 220 (Tolerance ± 5ms)Right VentricularATP Pulse Widtha(ms) 3 zones (onevalue for all zones)0.1, 0.2, ..., 2.0 0.1, 0.2, ..., 2.0 –– 1.0(Tolerance±0.03 ms at < 1.8 ms;±0.08msat≥1.8ms)Right VentricularATP Pulse Widtha(ms) 2 zones (onevalue for all zones)–– 0.1, 0.2, ..., 2.0 –– 1.0(Tolerance±0.03 ms at < 1.8 ms;±0.08msat≥1.8ms)- DRAFT -
PROGRAMMABLE OPTIONS A-9Table A-10. Ventricular ATP parameters (specified into a 750 Ωload) (continued)Parameter VT-1 Zone VT Zone VF Zone NominalLeft Ventricular ATPPulse Widtha(ms) 3zones (one value forall zones)0.1, 0.2, ..., 2.0 0.1, 0.2, ..., 2.0 –– 1.0(Tolerance±0.03 ms at < 1.8 ms;±0.08msat≥1.8ms)Left Ventricular ATPPulse Widtha(ms) 2zones (one value forall zones)–– 0.1, 0.2, ..., 2.0 –– 1.0(Tolerance±0.03 ms at < 1.8 ms;±0.08msat≥1.8ms)Right VentricularATP Amplitudea(V)3 zones (one valuefor all zones)0.1, 0.2, ..., 3.5, 4.0,..., 7.50.1, 0.2, ..., 3.5, 4.0,..., 7.5–– 5.0(Tolerance±15% or ± 100 mV,whichever is greater)Right VentricularATP Amplitudea(V)2 zones (one valuefor all zones)–– 0.1, 0.2, ..., 3.5, 4.0,..., 7.5–– 5.0(Tolerance±15% or ± 100 mV,whichever is greater)Left Ventricular ATPAmplitudea(V) 3zones (one value forall zones)0.1, 0.2, ..., 3.5, 4.0,..., 7.50.1, 0.2, ..., 3.5, 4.0,..., 7.5–– 5.0(Tolerance±15% or ± 100 mV,whichever is greater)Left Ventricular ATPAmplitudea(V) 2zones (one value forall zones)–– 0.1, 0.2, ..., 3.5, 4.0,..., 7.5–– 5.0(Tolerance±15% or ± 100 mV,whichever is greater)ATP Time-outb(seconds) 3 zonesOff, 10, 15, ..., 60,75, 90, ..., 120, 150,..., 600, 900, ...,3600Off, 10, 15, ..., 60,75, 90, ..., 120, 150,..., 600, 900, ...,3600–– 60 (Tolerance ± 1cardiac cycle)ATP Time-outb(seconds) 2 zones–– Off, 10, 15, ..., 60,75, 90, ..., 120, 150,..., 600, 900, ...,3600–– 60 (Tolerance ± 1cardiac cycle)QUICK CONVERTATP (VF Only) 3zones–– –– Off, On OnQUICK CONVERTATP (VF Only) 2zones–– –– Off, On Ona. The programmed Amplitude and Pulse Width values affect Post Therapy Brady Pacing, but are separately programmable fromNormal Brady Pacing, Temporary Brady Pacing, and EP Test.b. The VT-1 ATP Time-out must be greater than or equal to the VT ATP Time-out.- DRAFT -
A-10 PROGRAMMABLE OPTIONSTable A-11. Ventricular Shock ParametersParameter Programmable Values NominalShocks 1 and 2 energy (J)abc(stored energy)Off, 0.1, 0.3, 0.6, 0.9, 1.1, 1.7, 2, 3,5, 6, 7, 9, 11, 14, 17, 21, 23, 26, 29,31, 36 (HE), 41 (HE)41 J (Tolerance ± 60% for ≤0.3 J, ±40% for ≤0.6–3 J, ± 20% for 5–36J, ± 10% for 41 J)Energy of Remaining Shocks (J)ac(stored energy)Off, 41 (HE) 41 J (Tolerance ± 10% for 41 J)Lead PolaritydInitial, Reversed InitialCommitted Shock Off, On OffShock Lead Vector RV Coil to RA Coil and Can, RV Coilto Can, RV Coil to RA CoilRV Coil to RA Coil and Cana. Biphasic energy is specified.b. The Shock 2 energy level must be greater than or equal to the Shock 1 energy level.c. In a VT-1 zone of a 3-zone configuration or a VT zone of a 2-zone configuration, all or some of the shocks may be programmed toOff while other shocks in that zone are programmed in joules.d. A commanded STAT SHOCK is delivered at the programmed Polarity.Table A-12. Pacing therapy parameters (Normal, Post-Therapy, and Temporary) (specified into a 750 Ωload)Parameter Programmable Values NominalModeabg DDD(R), DDI(R), VDD(R), VVI(R),AAI(R), Off; Temporary: DDD, DDI,DOO, VDD, VVI, VOO, AAI, AOO,OffDDDLower Rate Limit (LRL)ac( ppm) 30, 35, ..., 185 45 (Tolerance ± 5 ms)Maximum Tracking Rate (MTR) gj( ppm)30, 35, ..., 185 130(Tolerance±5ms)Maximum Sensor Rate (MSR)gj( ppm)30, 35, ..., 185 130(Tolerance±5ms)Pulse Amplitudeadef(atrium) (V) 0.1, 0.2, ... 3.5, 4.0, ..., 5.0 3.5 (5.0 post-therapy) (Tolerance± 15% or ± 100mV, whichever isgreater)Pulse Amplitudeadef(right ventricle)(V)0.1, 0.2, ..., 3.5, 4.0, ..., 7.5 3.5 (5.0 post-therapy) (Tolerance± 15% or ± 100mV, whichever isgreater)Pulse Widthadef(atrium, rightventricle) (ms)0.1, 0.2, ..., 2.0 0.4 (1.0 post-therapy) (Tolerance ±0.03 ms at < 1.8 ms; ± 0.08 ms at≥1.8 ms)Atrial Pace/Sense Configurationag Bipolar, Off BipolarActivity Thresholdgj Very High, High, Medium High,Medium, Medium Low, Low, VeryLowMediumReaction Timegj(sec) 10, 20, ..., 50 30- DRAFT -
PROGRAMMABLE OPTIONS A-11Table A-12. Pacing therapy parameters (Normal, Post-Therapy, and Temporary) (specified into a 750 Ωload) (continued)Parameter Programmable Values NominalResponse Factorgj 1, 2, ..., 16 8Recovery Timegj(min) 2, 3, ..., 16 2Maximum PVARPag(ms) 150, 160, ..., 500 280(Tolerance±5ms)Minimum PVARPag(ms) 150, 160, ..., 500 240(Tolerance±5ms)PVARP After PVCag(ms) Off, 150, 200, ..., 500 400 (Tolerance ± 5 ms)RV-Blank After A-Paceah(ms) 45, 65, 85, Smart Smart (Tolerance ± 5 ms)A-Blank After V-Paceah(ms) 85, 105, 125, Smart Smart (Tolerance ± 5 ms)A-Blank After RV-Senseah(ms) 45, 65, 85, Smart Smart (Tolerance ± 5 ms)Maximum VRP (right ventricle)ai(ms)150, 160, 170, ..., 500 250(Tolerance±5ms)Minimum VRP (right ventricle)ai(ms)150, 160, ..., 500 230(Tolerance±5ms)Maximum Paced AV Delayag(ms) 30, 40, ..., 300 180(Tolerance±5ms)Minimum Paced AV Delayag(ms) 30, 40, ..., 300 180(Tolerance±5ms)Maximum Sensed AV Delayag(ms) 30, 40, ..., 300 120(Tolerance±5ms)Minimum Sensed AV Delayag(ms) 30, 40, ..., 300 120(Tolerance±5ms)Respiratory Sensorag Off, On OnTracking Preferencegj Off, On OnRate Hysteresis Hysteresis Offsetgj( ppm)-80, -75, ... ,-5, Off Off (Tolerance ± 5 ms)Rate Hysteresis Search Hysteresisgj(cycles)Off, 256, 512, 1024, 2048, 4096 Off (Tolerance ± 1 cycle)Rate Smoothing (up, down)gj(%) Off, 3, 6, 9, 12, 15, 18, 21, 25 Off (Tolerance 1%)Noise Responseag AOO, VOO, DOO, Inhibit Pacing DOO for DDD(R) and DDI(R)modes; VOO for VDD(R) and VVI(R)modes; AOO for AAI(R) mode- DRAFT -
A-12 PROGRAMMABLE OPTIONSTable A-12. Pacing therapy parameters (Normal, Post-Therapy, and Temporary) (specified into a 750 Ωload) (continued)Parameter Programmable Values NominalMaximum Pacing Rateag (ppm) 30, 35, ... ,185 130(Tolerance±5ms)Post-therapy Pacing Period(min:sec) (available post-shockonly)00:15, 00:30, 00:45, 01:00, 01:30,02:00, 03:00, 04:00, 05:00, 10:00,15:00, 30:00, 45:00, and 60:0000:30 (Tolerance ± 1 cardiac cycle)a. The programmed Normal Brady values will be used as the nominal values for Temporary Brady pacing.b. Refer to the NASPE/BPEG codes below for an explanation of the programmable values. The identification code of the NorthAmerican Society of Pacing and Electrophysiology (NASPE) and the British Pacing and Electrophysiology Group (BPEG) is basedon the categories listed in the table.c. The basic pulse period is equal to the pacing rate and the pulse interval (no hysteresis). Runaway protection circuitry inhibitsbradycardia pacing above 205 ppm. Magnet application does not affect pacing rate (test pulse interval).d. Separately programmable for ATP/Post-Shock, Temporary Brady, and EP Test.e. The minimum value of energy delivered at 5 V and 0.5 ms is 20 µJ with 200–500 Ω, and 12 µJ with 1000 Ωresistive loadat 37°C ± 1°C for BOL and Explant.f. Values are not affected by temperature variation within the range 20°–43°C.g. This parameter is used globally in Normal Brady pacing and Post-shock Brady pacing. Changing the value for Normal Brady willchange the value for Post-shock Brady.h. This parameter is automatically set to at least 85 ms for Post-Shock Brady.i. This parameter is automatically adjusted in Post-Shock Brady to allow appropriate sensing.j. This parameter is disabled during Temporary Brady.Table A-13. Brady/CRT left ventricular pacing parameters (specified into a 750 Ωload)Parameter Programmable Values NominalaVentricular Pacing ChamberbRV Only, BiV BiVLV Offsetbg(ms) -100, -90, ..., 0 0(Tolerance±5ms)Pulse Amplitudecde(left ventricle)(V)0.1, 0.2, ..., 3.5, 4.0, ..., 7.5 3.5 (5.0 post therapy) (Tolerance± 15% or ± 100mV) (whichever isgreater)Pulse Widthcde(left ventricle) (ms) 0.1, 0.2, ..., 2.0 0.4 (1.0 post therapy) (Tolerance ±0.03 ms at < 1.8 ms; ± 0.08 ms at≥1.8 ms)LV-Blank After A-Pacef(ms) 45, 65, 85, Smart Smart (Tolerance ± 5 ms)LVRPb(ms) 250, 260, ..., 500 250 (Tolerance ± 7.5 ms)LVPPb(ms) 300, 350, ..., 500 400(Tolerance±5ms)BiV TriggerbOff, On OnLeft Ventricular ElectrodeConfigurationbDual, Single, None None- DRAFT -
PROGRAMMABLE OPTIONS A-13Table A-13. Brady/CRT left ventricular pacing parameters (specified into a 750 Ωload) (continued)Parameter Programmable Values NominalaLeft Ventricular Pace ConfigurationbSingle or Dual:LVtip>>CanLVtip>>RVDual Only:LVring>>CanLVring>>RVLVtip>>LVringLVring>>LVtipSingle: LVtip>>RVDual: LVtip>>LVringLeft Ventricular SenseConfigurationbSingle or Dual:LVtip>>CanLVtip>>RVOffDual Only:LVring>>CanLVring>>RVLVtip>>LVringSingle: LVtip>>RVDual: LVtip>>LVringa. The programmed Normal Brady values will be used as the nominal values for Temporary Brady pacing.b. This parameter is used globally in Normal Brady pacing and Post-shock Brady pacing. Changing the value for Normal Brady willchange the value for Post-shock Brady.c. Separately programmable for ATP/Post-Shock, Temporary Brady, and EP Test.d. The minimum value of energy delivered at 5 V and 0.5 ms is 20 µJ with 200–500 Ω, and 12 µJ with 1000 Ωresistive loadat 37°C ± 1°C for BOL and Explant.e. Values are not affected by temperature variation within the range 20°–43°C.f. This parameter is automatically set to at least 85 ms for Post-Shock Brady.g. WhentheLVOffsetis0theLVPacefollowstheRVPaceby2.5msTable A-14. Atrial Tachy ParametersParameter Programmable Values NominalATR Mode Switchab Off, On OnATR Trigger Rateab( bpm) 100, 110, ..., 300 170(Tolerance±5ms)ATR Durationab(cycles) 0, 8, 16, 32, 64, 128, 256, 512,1024, 20488(Tolerance±1cardiaccycle)Entry Countab(cycles) 1, 2, ..., 8 8Exit Countab(cycles) 1, 2, ..., 8 8ATR Fallback Modeab VDI, DDI, VDIR, DDIR DDIATR Fallback Timeab(min:sec) 0, 0:15, 0:30, 0:45, 1:00, 1:15, 1:30,1:45, 2:000:30ATR/VTR Fallback LRLab( ppm) 30, 35, ..., 185 70 (Tolerance ± 5 ms)ATR VRRab Off, Min, Med, Max MinATR Maximum Pacing Rateab( ppm)30, 35, ..., 185 130ATR BiV Triggerab Off, On On- DRAFT -
A-14 PROGRAMMABLE OPTIONSTable A-14. Atrial Tachy Parameters (continued)Parameter Programmable Values NominalAtrial Flutter Responsebc Off, On OffAtrial Flutter Response Ratebc( bpm)100, 110, ..., 300 170(Tolerance±5ms)PMT Terminationbc Off, On OnVRRbc Off, Min, Med, Max Offa. The programmed Normal Brady values will be used as the nominal values for Temporary Brady pacing.b. This parameter is used globally in Normal Brady pacing and Post-shock Brady pacing. Changing the value for Normal Brady willchange the value for Post-shock Brady.c. This parameter gets disabled during Temporary Brady.Table A-15. Brady Mode values based on NASPE/BPEG codesPosition I II III IV VCategory ChambersPacedChambersSensedResponseto SensingProgrammability,rate modulationAntitachyarrhythmiaFunctionsLetters 0–None 0–None 0–None 0–None 0–NoneA–Atrium A–Atrium T–Triggered P–SimpleProgrammableP–Pacing(Antitachyarrhythmia)V–Ventricle V–Ventricle I–Inhibited M–Multiprogrammable S–ShockD–Dual (A&V) D–Dual (A&V) D–Dual (T&I) C–Communicating D–Dual (P&S)R–Rate ModulationMfrs.DesignationOnlyS–Single (A orV)S–Single (A orV)Table A-16. Magnet and Beeper functionsParameter Programmable Values NominalMagnet Response Off, Store EGM, Inhibit Therapy Inhibit TherapyBeep During Capacitor Charge Off, On OffBeep When Explant is Indicated Off, On OnTable A-17. Sensitivity AdjustmentParameter Programmable Values NominalAtrial Sensitivity AGC 0.15, AGC 0.2, AGC 0.25,AGC 0.3, AGC 0.4, ..., AGC 1.0,AGC 1.5AGC 0.25- DRAFT -
PROGRAMMABLE OPTIONS A-15Table A-17. Sensitivity Adjustment (continued)Parameter Programmable Values NominalRight Ventricular Sensitivity AGC 0.15, AGC 0.2, AGC 0.25,AGC 0.3, AGC 0.4, ..., AGC 1.0,AGC 1.5AGC 0.6Left Ventricular Sensitivity AGC 0.15, AGC 0.2, AGC 0.25,AGC 0.3, AGC 0.4, ..., AGC 1.0,AGC 1.5AGC 1.0Table A-18. Ventricular Commanded ATPParameteraProgrammable Values NominalCommanded Ventricular ATP (Type) Burst, Ramp, Scan, Ramp/Scan BurstNumber Of Bursts 1, 2, ..., 30 30Initial Pulses per Burst (pulses) 1, 2, ..., 30 4Pulse Increment (pulses) 0, 1, .., 5 0Maximum Number of Pulses 1, 2, ..., 30 4Coupling Interval (% or ms) 50, 53, 56, 59; 63, 66, ..., 84; 88, 91,94, 97% or 120, 130, ..., 750 ms81%(Tolerance±5ms)Coupling Interval Decrement (ms) 0, 2, ..., 30 0(Tolerance±5ms)Burst Cycle Length (BCL) (% or ms) 50, 53, 56, 59; 63, 66, ..., 84; 88, 91,94, 97% or 120, 130, ..., 750 ms81%(Tolerance±5ms)Ramp Decrement (ms) 0, 2, ..., 30 0(Tolerance±5ms)Scan Decrement (ms) 0, 2, ..., 30 0(Tolerance±5ms)Minimum Interval (ms) 120, 130, ..., 400 200(Tolerance±5ms)a. The ventricular Commanded ATP Pulse Width and Amplitude values are the same as programmed for ventricular ATP therapy.Table A-19. 50 Hz/Manual Burst PacingParameteraProgrammable Values NominalBurst Interval (ms) 20, 30, ..., 750 600(Tolerance±5ms)- DRAFT -
A-16 PROGRAMMABLE OPTIONSTable A-19. 50 Hz/Manual Burst Pacing (continued)ParameteraProgrammable Values NominalMinimum Interval (ms) 20, 30, ...,750 200(Tolerance±5ms)Decrement (ms) 0, 10, ..., 50 50 (Tolerance ± 5 ms)a. Applied to the atrium or ventricle depending on the chamber selected.Table A-20. Ventricular Commanded ShockParameter Programmable Values NominalShock (stored energy) (J) 0.1, 0.3, 0.6, 0.9, 1.1, 1.7, 2, 3, 5, 6,7, 9, 11, 14, 17, 21, 23, 26, 29, 31,36 (HE), 41 (HE)41 (Tolerance ± 60% for ≤0.3 J; ±40% for ≤0.6–3 J; ± 20% for 5–36J, ± 10% for 41 J)Coupling Interval (ms) Sync, 50, 60, ..., 500 SyncTable A-21. VFib (Ventricular Fibrillation) InductionParameter ValuesVFib High 15V (nonprogrammable) (Tolerance ± 10V)VFib Low 9V (nonprogrammable) (Tolerance ± 7V)Table A-22. Shock on T InductionParameter Programmable Values NominalShock (stored energy) (J) 0.1, 0.3, 0.6, 0.9, 1.1, 1.7, 2, 3, 5, 6,7, 9, 11, 14, 17, 21, 23, 26, 29, 31,36 (HE), 41 (HE)1.1 J (Tolerance ± 60% for ≤0.3 J;± 40% for ≤0.6–3 J; ± 20% for 5–36J, ± 10% for 41 J)Number of S1 Pulses 1, 2, ..., 30 8S1 Interval (ms) 120, 130, ..., 750 400Coupling Interval (ms) Sync, 10, 20, , ..., 500 310Table A-23. PES (Programmed Electrical Stimulation)ParameteraProgrammable Values NominalNumber of S1 Intervals (pulses) 1, 2, ..., 30 8S2 Decrement 0, 10, ..., 50 0S1 Interval (ms) 120, 130, ..., 750 600(Tolerance±5ms)S2 Interval (ms) Off, 120, 130, ..., 750 600 (Tolerance ± 5 ms)S3 Interval (ms) Off, 120, 130, ..., 750 Off (Tolerance ± 5 ms)- DRAFT -
PROGRAMMABLE OPTIONS A-17Table A-23. PES (Programmed Electrical Stimulation) (continued)ParameteraProgrammable Values NominalS4 Interval (ms) Off, 120, 130, ..., 750 Off (Tolerance ± 5 ms)S5 Interval (ms) Off, 120, 130, ..., 750 Off (Tolerance ± 5 ms)a. Applied to the atrium or right ventricle as commanded by the programmer.- DRAFT -
A-18 PROGRAMMABLE OPTIONS- DRAFT -
B-1CLINICAL STUDY - COMPANIONAPPENDIX BCLINICAL STUDY POPULATIONSGuidant CRT-Ds, when compared to OPT alone, have been demonstrated withreasonable assurance, to be safe and effective in significantly reducing: therisk of a composite of all-cause mortality or first hospitalization by 20%, therisk of all-cause mortality by 36%, and heart failure symptoms in patients whohave moderate to severe heart failure (NYHA III/IV) including left ventriculardysfunction (EF ≤35%) and QRS duration ≥120 ms and remain symptomaticdespite stable, optimal heart failure drug therapy, based on the Guidantsponsored COMPANION clinical study. (Guidant devices were the only devicesstudied in the COMPANION clinical trial.)SUMMARYThe COMPANION clinical study was designed to determine whether combinedall-cause mortality or first hospitalization in heart failure patients receivingoptimal pharmacologic therapy (OPT) can be reduced by combining OPT andeither of the following:• Biventricular pacing therapy alone (CRT-P)• Biventricular pacing with defibrillation (CRT-D)All-cause mortality or first hospitalization (time to first event) analyzed from thetime of randomization, was the primary endpoint of the study.Guidant conducted the COMPANION study in part to demonstrate the safetyand effectiveness of Guidant CRT-D and CRT-P devices in the COMPANIONpatient population. Trial objectives included establishing that OPT combinedwith biventricular pacing with defibrillation (CONTAK CD) is superior to OPTalone in improving exercise performance (Sub-study), reducing combinedall-cause mortality or first hospitalization (Primary endpoint), reducing cardiacmorbidity (Secondary endpoint) and reducing all-cause mortality (Secondaryendpoint).The COMPANION trial utilized a Steering Committee, Data Safety MonitoringBoard (DSMB), and Morbidity and Mortality Committee for study conduct,safety, and event adjudication respectively.- DRAFT -
B-2 CLINICAL STUDY - COMPANIONThe clinical study began January 20, 2000 and was conducted at 128 centerswithin the United States.The COMPANION clinical study was monitored using a sequential designand on November 18, 2002, after review of the data by the Data Safety andMonitoring Board, enrollment in the study was stopped. The CRT-D arm ofthe trial had reached the target number of events for the combined primaryall-cause mortality or first hospitalization endpoint, as well as the secondaryall-cause mortality endpoint. All effectiveness follow-ups ended by December1, 2002.OBSERVED ADVERSE EVENTSPrior HistoryThe CONTAK RENEWAL 3, CONTAK RENEWAL, and CONTAK CD devicesprovide the same defibrillation and cardiac resynchronization therapy(biventricular pacing) and have the same Indications for Use. Therefore,the Comparison of Medical, Pacing, and Defibrillation Therapies in HeartFailure (COMPANION) clinical trial data (based on CONTAK CD devices)used to support expanding Guidant CRT-D indications to the COMPANIONpatient population, are also applicable to CONTAK RENEWAL and CONTAKRENEWAL 3.The primary difference between CONTAK CD devices and CONTAKRENEWAL/CONTAK RENEWAL 3 devices is that CONTAK CD utilizes anelectrically common RV and LV sensing/pacing circuit whereas CONTAKRENEWAL and CONTAK RENEWAL 3 incorporate an independent RV andLV sensing/pacing circuit. Additional clinical analysis was conducted withCONTAK RENEWAL, in a European study, to provide confirmation that theindependent sensing and pacing capability did not adversely affect the abilityof the device to detect ventricular tachyarrhythmias or provide continuousbiventricular pacing therapy.Study BackgroundThe Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure(COMPANION) Study was a prospective, open-label, randomized, controlled,multi-center, unblinded study conducted at 128 sites and enrolled a total of1638 patients, of which 1520 were randomized. Patients were randomlyassigned 1:2:2 to receive optimal pharmacological therapy (OPT, 308 patients)or a cardiac resynchronization therapy pacemaker (CRT-P, 617 patients) or acardiac resynchronization therapy pacemaker with defibrillator (CRT-D, 595- DRAFT -
CLINICAL STUDY - COMPANION B-3patients). Of the 1520 patients randomized, 903 were randomized to OPT andCRT-D. This summary focuses on data and analyses for the CRT-D and OPTgroups, only, with the exception of the Exercise Performance results, which arebased on pooled CRT-D and CRT-P data.The CRT-D devices (CONTAK CD) in this trial, were approved for commercialdistribution via the CONTAK CD study, which provided a reasonable assuranceof safety. A similar safety analysis was applied to the COMPANION patientpopulation. The results were consistent with safety measurements obtained inthe CONTAK CD trial.Adverse Event DefinitionsAdverse events were defined as any undesirable clinical occurrence, whetherit was related to the device or not. Table B-1 on page B-3 includes adverseevents occurring in the first six months related to the device (pulse generatorand leads) and implant procedures (including attempts). Table B-2 on page B-6includes adverse events occurring in the first six months related to patientcondition (i.e., worsening heart failure). Adverse events are listed in descendingorder by total number of patients experiencing the event.Adverse events related to the device were further reported using twosub-categories based on the nature of the intervention. These events weredefined as a complication if the event resulted in invasive intervention,loss of significant device function, and death or permanent disability.An observation was a device-related adverse event that was resolvednon-invasively. Forty-nine percent of CRT-D patients reported a device and/orprocedure-related adverse event.Table B-1. Device- and procedure-related adverse eventsTotal Events(Patients)% Comps(Patients)%Obs(Patients)Total Adverse Eventsa498 (290) 13.1 (77) 43.4 (255)Post surgical wound discomfort 68 (62) 0.0 (0) 10.5 (62)Phrenic nerve/diaphragm stimulation 77 (59) 1.4 (8) 9.0 (53)Brady capture - LV 38 (36) 4.3 (25) 2.2 (13)Hematoma 37 (34) 0.3 (2) 5.4 (32)Inappropriate shock above rate cutoff 26 (24) 0.0 (0) 4.1 (24)Multiple counting - tachy 22 (17) 0.3 (2) 2.9 (17)Pocket infection 19 (17) 0.5 (3) 2.6 (15)- DRAFT -
B-4 CLINICAL STUDY - COMPANIONTable B-1. Device- and procedure-related adverse events (continued)Total Events(Patients)% Comps(Patients)%Obs(Patients)Dissection, coronary sinus 15 (15) 0.0 (0) 2.6 (15)Brady capture - atrium 14 (12) 1.5 (9) 0.5 (3)Inappropriate shock due to oversensing 11 (11) 0.0 (0) 1.9 (11)Pneumothorax 10 (10) 1.0 (6) 0.7 (4)Hypotension 10 (9) 0.2 (1) 1.4 (8)Brady capture - RV 8 (8) 0.9 (5) 0.5 (3)Physical trauma 8 (8) 0.2 (1) 1.2 (7)AV Block - heart block, complete 7 (7) 0.2 (1) 1.0 (6)Pacemaker-mediated tachycardia (PMT) 7 (6) 0.0 (0) 1.0 (6)Physiological reactionb6 (6) 0.0 (0) 1.0 (6)Arrhythmia - atrial fibrillation 5 (5) 0.0 (0) 0.9 (5)Bleeding/fluid accumulation 5 (5) 0.0 (0) 0.9 (5)Perforation, coronary venous 5 (5) 0.5 (3) 0.3 (2)Renal failure 5 (5) 0.0 (0) 0.9 (5)Thrombosis 5 (5) 0.0 (0) 0.9 (5)Vascular related 5 (5) 0.0 (0) 0.9 (5)Oversensing - atrium pace sense 4 (4) 0.3 (2) 0.3 (2)Allergic reaction 3 (3) 0.0 (0) 0.5 (3)Congestive heart failure 3 (3) 0.0 (0) 0.5 (3)Nausea (2), Constipation (1) 3 (3) 0.0 (0) 0.5 (3)High DFTs - tachy 3 (3) 0.2 (1) 0.3 (2)Oversensing - ventricle rate - tachy 3 (3) 0.2 (1) 0.3 (2)Respiratory related 3 (3) 0.2 (1) 0.3 (2)Ventricular tachycardia 3 (3) 0.2 (1) 0.3 (2)Cardiac tamponade 2 (2) 0.3 (2) 0.0 (0)Dyspnea (shortness of breath) 2 (2) 0.0 (0) 0.3 (2)Electrolyte/lab 2 (2) 0.0 (0) 0.3 (2)Hemorrhage 2 (2) 0.2 (1) 0.2 (1)Insulation breach suspected 2 (2) 0.3 (2) 0.0 (0)Migration of device 2 (2) 0.0 (0) 0.3 (2)- DRAFT -
CLINICAL STUDY - COMPANION B-5Table B-1. Device- and procedure-related adverse events (continued)Total Events(Patients)% Comps(Patients)%Obs(Patients)Muscle stimulation 2 (2) 0.0 (0) 0.3 (2)Myocardial infarction 2 (2) 0.0 (0) 0.3 (2)Numbness 2 (2) 0.0 (0) 0.3 (2)Perforation, venous 2 (2) 0.0 (0) 0.3 (2)Phantom shock 2 (2) 0.0 (0) 0.3 (2)Undersensing - atrium pace sense - brady 2 (2) 0.2 (1) 0.2 (1)Altered hemodynamic status 1 (1) 0.0 (0) 0.2 (1)Arrhythmia 1 (1) 0.0 (0) 0.2 (1)Arrhythmia - sinus tachycardia 1 (1) 0.0 (0) 0.2 (1)Bruise 1 (1) 0.0 (0) 0.2 (1)Cardiac arrest 1 (1) 0.2 (1) 0.0 (0)Change in arrhythmia - SVT 1 (1) 0.0 (0) 0.2 (1)Change in arrhythmia - brady 1 (1) 0.0 (0) 0.2 (1)Change in arrhythmia - junctional 1 (1) 0.0 (0) 0.2 (1)Change in physical status 1 (1) 0.0 (0) 0.2 (1)Chest pain 1 (1) 0.0 (0) 0.2 (1)Dizziness, cause undetermined 1 (1) 0.0 (0) 0.2 (1)Edema 1 (1) 0.0 (0) 0.2 (1)Fatigue 1 (1) 0.0 (0) 0.2 (1)Febrile 1 (1) 0.0 (0) 0.2 (1)Unable to urinate 1 (1) 0.0 (0) 0.2 (1)Helix related (screw tip), broken or stretched 1 (1) 0.2 (1) 0.0 (0)Hemoglobin drop 1 (1) 0.2 (1) 0.0 (0)Hypertension 1 (1) 0.0 (0) 0.2 (1)Infection 1 (1) 0.2 (1) 0.0 (0)Insulation breech observed 2 (1) 0.2 (1) 0.0 (0)Malfunction, memory problem 1 (1) 0.2 (1) 0.0 (0)Materials unretrieved in body 1 (1) 0.2 (1) 0.0 (0)Pacemaker mediated tachycardia (PMT) 1 (1) 0.0 (0) 0.2 (1)Pacemaker syndrome 1 (1) 0.0 (0) 0.2 (1)- DRAFT -
B-6 CLINICAL STUDY - COMPANIONTable B-1. Device- and procedure-related adverse events (continued)Total Events(Patients)% Comps(Patients)%Obs(Patients)Pericardial effusion 1 (1) 0.2 (1) 0.0 (0)Pericarditis 2 (1) 0.0 (0) 0.2 (1)Placement difficulty, stylet related 1 (1) 0.2 (1) 0.0 (0)Pleural effusion 1 (1) 0.2 (1) 0.0 (0)Pleurisy 2 (1) 0.0 (0) 0.2 (1)Pocket erosion/extrusion 1 (1) 0.2 (1) 0.0 (0)Anxiety 1 (1) 0.0 (0) 0.2 (1)Respiratory arrest 1 (1) 0.2 (1) 0.0 (0)Ventricular fibrillation 1 (1) 0.0 (0) 0.2 (1)a. Observations and complications may not sum to total because some patient may have events in both categories.b. Physiological reaction includes: swelling, rash, and/or drainage.Table B-2. Patient-related adverse eventsTotal Events (Patients) % of Patients withEventsEvents/Patient YearCRT-D OPT CRT-DN=595PatientsOPTN=308PatientsCRT-D281 YearsOPT134 YearsTotal Patient RelatedAdverse Events1437 (443) 625 (207) 74.5 67.2 5.11 (1437) 4.66 (625)Cardiovascular RelatedEvents814 (351) 399 (176) 59.0 57.1 2.90 (814) 2.98 (399)Congestive heart failurea269 (166) 185 (111) 27.9 36.0 0.96 (269) 1.38 (185)Chest pain 83 (65) 50 (37) 10.9 12.0 0.30 (83) 0.37 (50)Supraventriculartachyarrhythmia69 (56) 11 (11) 9.4 3.6 0.25 (69) 0.08 (11)Ventricular tachyarrhythmia 66 (51) 16 (15) 8.6 4.9 0.23 (66) 0.12 (16)Electrolyte/lab 51 (42) 17 (16) 7.1 5.2 0.18 (51) 0.13 (17)Hypotension 42 (40) 16 (15) 6.7 4.9 0.15 (42) 0.12 (16)Dizziness, causeundetermined33 (30) 26 (23) 5.0 7.5 0.12 (33) 0.19 (26)Renal failure 40 (29) 16 (14) 4.9 4.5 0.14 (40) 0.12 (16)Fatigue 27 (25) 12 (12) 4.2 3.9 0.10 (27) 0.09 (12)Bradyarrhythmia 32 (30) 5 (5) 5.0 1.6 0.11 (32) 0.04 (5)- DRAFT -
CLINICAL STUDY - COMPANION B-7Table B-2. Patient-related adverse events (continued)Total Events (Patients) % of Patients withEventsEvents/Patient YearCRT-D OPT CRT-DN=595PatientsOPTN=308PatientsCRT-D281 YearsOPT134 YearsVascular 14 (11) 11 (10) 1.8 3.2 0.05 (14) 0.08 (11)Syncope 12 (12) 7 (7) 2.0 2.3 0.04 (12) 0.05 (7)GI bleed 14 (13) 4 (4) 2.2 1.3 0.05 (14) 0.03 (4)Arrhythmia 12 (10) 6 (6) 1.7 1.9 0.04 (12) 0.04 (6)Hypertension 12 (9) 6 (5) 1.5 1.6 0.04 (12) 0.04 (6)Palpitations 9(9) 3(3) 1.5 1.0 0.03 (9) 0.02 (3)Myocardial infarction 7 (7) 4 (4) 1.2 1.3 0.02 (7) 0.03 (4)Stroke syndrome or CVA 7 (7) 2 (2) 1.2 0.6 0.02 (7) 0.01 (2)Deep vein thrombosis 4(4) 0(0) 0.7 0.0 0.01 (4) 0.00 (0)Transient ischemic attack(TIA)3(3) 1(1) 0.5 0.3 0.01 (3) 0.01 (1)Hematuria 3(3) 0(0) 0.5 0.0 0.01 (3) 0.00 (0)Ischemia 2(2) 1(1) 0.3 0.3 0.01 (2) 0.01 (1)Coagulopathy 2 (2) 0 (0) 0.3 0.0 0.01 (2) 0.00 0(0)Bleeding/fluid accumulation 1 (1) 0 (0) 0.2 0.0 0.00 (1) 0.00 (0)Non-cardiovascular RelatedEvents623 (293) 226 (119) 49.2 38.6 2.22 (623) 1.69 (226)Respiratory relatedb130 (108) 53 (41) 18.2 13.3 0.46 (130) 0.40 (53)GIc124 (95) 30 (24) 16.0 7.8 0.44 (124) 0.22 (30)Pain 82 (66) 40 (32) 11.1 10.4 0.29 (82) 0.30 (40)Physiological reactiond76 (61) 20 (18) 10.3 5.8 0.27 (76) 0.15 (20)Infection 54 (37) 18 (15) 6.2 4.9 0.19 (54) 0.13 (18)Endocrine 41 (35) 16 (14) 5.9 4.5 0.15 (41) 0.12 (16)Psychological effects 24 (19) 13 (12) 3.2 3.9 0.09 (24) 0.10 (13)Change in physical status 20 (18) 9 (9) 3.0 2.9 0.07 (20) 0.07 (9)Physical trauma 26 (22) 4 (4) 3.7 1.3 0.09 (26) 0.03 (4)Neurologic 14 (14) 6 (6) 2.4 1.9 0.05 (14) 0.04 (6)Genitourinary 9 (7) 5 (4) 1.2 1.3 0.03 (9) 0.04 (5)Cancer, other 5 (5) 6 (5) 0.8 1.6 0.02 (5) 0.04 (6)- DRAFT -
B-8 CLINICAL STUDY - COMPANIONTable B-2. Patient-related adverse events (continued)Total Events (Patients) % of Patients withEventsEvents/Patient YearCRT-D OPT CRT-DN=595PatientsOPTN=308PatientsCRT-D281 YearsOPT134 YearsFebrile 7(7) 0(0) 1.2 0.0 0.02 (7) 0.00 (0)Respiratory failure 4 (4) 1 (1) 0.7 0.3 0.01 (4) 0.01 (1)Tumors, growths 1(1) 2(2) 0.2 0.6 0.00 (1) 0.01 (2)Ulceration 2(1) 2(2) 0.2 0.6 0.01 (2) 0.01 (2)Diabetes complications 2(2) 0(0) 0.3 0.0 0.01 (2) 0.00 (0)Pulmonary embolism 1(1) 1(1) 0.2 0.3 0.00 (1) 0.01 (1)Pneumonia (respiratoryinfection)1(1) 0(0) 0.2 0.0 0.00 (1) 0.00 (0)a. Congestive heart failure includes: congestive heart failure, dyspnea, volume overload, edema, pulmonary edema, change indrug therapy.b. The most frequent three events in this category were: upper respiratory infection, bronchitis, and influenza.c. The most frequent three events in this category were: nausea, diarrhea, and abdominal pain.d. The most frequent three events in this category were: swelling, rash, and weight gain.DeathsThere were a total of 182 deaths (77 OPT, 105 CRT-D) that occurred duringthe trial and recorded through November 30, 2002. Table B-3 on page B-8presents cause of death stratified by treatment group.Table B-3. CRT-D and OPT cause of deathCause of Death OPT Arm(N = 308)CRT-D Arm(N = 595)Total(N = 903)Cardiac 58 (18.8%) 76 (12.8%) 134 (14.8%)Vascular 0 (0.0%) 3 (0.5%) 3 (0.3%)Non-Cardiac 11 (3.6%) 21 (3.5%) 32 (3.5%)- DRAFT -
CLINICAL STUDY - COMPANION B-9Table B-3. CRT-D and OPT cause of death (continued)Cause of Death OPT Arm(N = 308)CRT-D Arm(N = 595)Total(N = 903)Unknown/ Unclassified 8 (2.6%) 5 (0.8%) 13 (1.4%)Total Deaths 77 (25.0%) 105 (17.6%) 182 (20.2%)NOTE: After the study was stopped in November 2002, follow-up for safetycontinued for approximately one more year on 151 OPT and 449 CRT-Dpatients with the final data cut-off on November 26, 2003. During this post-trialfollow-up period, an additional 54 deaths were reported, consisting of 14/151(9.3%) OPT patients and 40/449 (8.9%) CRT-D patients.The mortality rates are approximately equal during this post-trial follow-upperiod. This may be because CRT devices were made available to OPTpatients. Thus, most patients were receiving the same therapy during thisinterval.STUDY DESIGNThe COMPANION study design and study results have been previouslydescribed in the medical literature.12The COMPANION study was a prospective, randomized (1:2:2 to OPT, CRT-P[delivered by the CONTAK TR device], or CRT-D [delivered by the CONTAKCD device]), controlled, multi-center study. Both of these devices becamecommercially available during the course of the study.Randomization was stratified by centers and by beta-blocker use toassure proper balance between the treatment groups within each center.Each randomized patient remained counted as a member of the originalrandomization assignment (intention-to-treat) regardless of subsequentcrossover or protocol adherence.Eligible patients were also enrolled in a sub-study designed to measureimprovement in exercise performance in patients randomized to CRT (CRT-Pand CRT-D pooled data) therapy compared to OPT.1. Bristow MR, Feldman AM, Saxon LA. Heart failure management using implantable devices forventricular resynchronization: Comparison of Medical Therapy, Pacing, and Defibrillation inChronic Heart Failure (COMPANION) trial. J Card Fail. 2000;6(3):276-285.2. Bristow MR, Saxon LA, Boehmer J, et al. Cardiac resynchronization therapy with or without animplantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350:2140-2150.- DRAFT -
B-10 CLINICAL STUDY - COMPANIONINCLUSION/EXCLUSION CRITERIAThe study population consisted of patients with moderate to severe heartfailure, New York Heart Association Classification III or IV, left ventricularejection fraction ≤35%, and QRS width ≥120 ms due to ischemic ornon-ischemic cardiomyopathy.All patients were required to have been treated with a stable dose ofbeta-blocker, ACE inhibitor or ARB, diuretic, and aldosterone antagonist. Astable dose was defined as 30 days for all drugs except beta-blocker, whichrequired 90 days stabilization from last up titration prior to randomization.Diuretic dosage could be adjusted any time by the investigator using medicaldiscretion.Patients enrolled in the study were required to meet the following inclusioncriteria:• Moderate or severe heart failure, defined as symptomatic heart failurefor at least six months with NYHA class III or IV symptoms at the time ofenrollment, and at least one of the following events in the previous 12months:– Hospitalization for heart failure management– Outpatient visit in which intravenous (IV) inotropes or vasoactiveinfusion were administered continuously for at least 4 hours– Emergency room visit of at least twelve hours duration in which IVheart failure medications were administered (including diuretics)•QRS≥120 ms and PR interval > 150 ms from any two leads of a 12–leadECG• Left ventricular ejection fraction ≤35%• Left ventricular end diastolic dimension ≥60 mm (required only if LVEFmeasured by echo) or > 3.0 cm/m2(The cm/m2is calculated by LVEDD [incm] divided by BSA [body surface area])•Age≥18 years• Optimal pharmacologic therapy for heart failure (beta blocker, ACE inhibitor,diuretics, and spironolactone)- DRAFT -
CLINICAL STUDY - COMPANION B-11Additional eligibility criteria for the Exercise Performance sub-study:• Understand the nature of the sub-study and provide informed consent• Have been enrolled at a participating sub-study investigational center• Have no neuromuscular or vascular disability that prevents normal walking(e.g., intermittent claudication, arthritis, residual stroke weakness)• Have no history of angina during previous exercise testing•FEV1/FVC ≥50%•150m≤Six-minute walk distance ≤425 m• Baseline Peak VO2< 22 ml/kg/min• Have no cardiac disabilities that would ordinarily contraindicate exercisetesting:– Changing pattern on the ECG– Changing pattern of chest discomfort– Decompensated heart failure– Uncontrolled arrhythmiasPatients were excluded from the investigation if they met any of the followingcriteria:• Unable or unwilling to undergo device implant and follow-up testing• Patients with a hypersensitivity to 0.7 mg nominal dose of dexamethasoneacetate• Meet the general indications for an implantable cardioverter defibrillator• Surgically uncorrected primary valvular disease• Meet the general indications for antibradycardia pacing• Coronary artery disease (CAD) in which surgical or percutaneous correctionis recent (within 60 days of randomization)- DRAFT -
B-12 CLINICAL STUDY - COMPANION• Expected to receive a heart transplant in the next six months• Women who are pregnant or not using medically acceptable birth control• Chronic, medically refractory atrial tachyarrhythmias• Hypertrophic obstructive cardiomyopathy• Unexplained syncope• Amyloid disease• Myocardial infarction within 60 days of randomization• Hospitalization for heart failure or IV inotropic or vasoactive therapy inexcess of 4 hours in the 30 days prior to enrollment• History of non-compliance with oral heart failure therapy• Involved in any other investigational studies• Progressive or unstable angina• Life expectancy < 6 months due to any other medical conditions• Uncontrolled blood pressure: Systolic BP > 160 mm Hg or < 85 mm Hgor diastolic BP > 90 mm HgENDPOINTSThis summary focuses on the CRT-D vs. OPT contrast, providing evidenceof safety and effectiveness for Guidant CRT-Ds in the COMPANION patientpopulation.3The clinical data and analyses herein address the following studyendpoints for all patients randomized to CRT-D and OPT only, unless otherwisestated as a sub-study measurement (where CRT-D and CRT-P data werepooled for exercise performance).Primary EndpointThe primary endpoint was a composite consisting of all-cause mortality or firsthospitalization (time to first event) as analyzed from the date of randomization3. Guidant CRT-Ps are already approved for use in the COMPANION patient population,P030005, approved 01/26/04.- DRAFT -
CLINICAL STUDY - COMPANION B-13on an intention-to-treat basis. The study was designed to demonstrate a 25%relative reduction with CRT-D when compared to an estimated 40% annual ratein the OPT cohort. All-cause mortality was defined as death from any cause.Hospitalization is defined below:Qualifying Duration for Hospitalization––the intent behind hospitalizationwas to capture hospitalizations that were of sufficient duration to enter into acomposite with all-cause mortality. Thus, hospitalization was defined as careprovided at a hospital in which hospital admission and discharge occurred onseparate dates. Patients excluded from this definition were those who receivedcare at a hospital, but were discharged on the same day as admission. Inaddition to hospitalizations, the use of intravenous inotropes or vasoactiveagents for a duration of greater than four hours was also considered to be ofsignificant importance to be treated as an instance of hospitalization.Hospitalizations Related to the Implant Procedure––hospitalizationsassociated with device implant (initial and reattempted for unsuccessfulinitial implant) were not considered to be an event for evaluating the primaryendpoint. Similarly, hospitalizations associated with elective implant of devices(i.e., absence of an electrophysiological indication or an ongoing hospitalizationrequiring intravenous therapy) in the OPT cohort also were not considered tobe a primary endpoint event. Surgical revisions of a previous implanted systemdid count as a primary endpoint event if the revision was of a sufficient durationto result in different admission and discharge dates. Table B-4 on page B-13summarizes the criteria for determining which hospitalization events wereconsidered as a primary endpoint event.Table B-4. Hospitalizations contributing to primary endpointEvent Description CRT-D OPTInitial implant/reattempts No NoSurgical revisions of system YesaYe saHospitalization with no calendar date change No NoHospitalization with a calendar date change Yes YesIV inotrope and/or vasoactive drug use > 4 hours Yes Yesa. If calendar date change.Secondary EndpointsAll-cause mortality––the all-cause mortality (death from any cause) endpointwas designed to show a 25% reduction in mortality in the CRT-D arm from anOPT annual mortality rate of 24%. Difference in mortality was determined by- DRAFT -
B-14 CLINICAL STUDY - COMPANIONcontrasting patients randomized to CRT-D in addition to OPT versus patientsrandomized to OPT alone.Cardiac morbidity––the hospitalization component of the primary endpointincluded non-cardiac events that may not be impacted by CRT-D. The cardiacmorbidity endpoint was unique to the COMPANION study. It is a more specificoutcome measure intended to determine whether CRT-D when compared toOPT would reduce the type of events that are pertinent to a hospitalizationfor heart failure.Cardiac morbidity was defined as the occurrence of one or more of thefollowing events:• Worsening heart failure resulting in use of intravenous vasoactive orinotropic therapy exceeding four hours• Mechanical respiratory or cardiac support• Any cardiac surgery, including heart transplant• Resuscitated cardiac arrest or sustained ventricular tachycardia requiringintervention (e.g., chest thump, external cardioversion, or externaldefibrillation)• Hospitalization for acute decompensation of heart failure• Hospitalization that results in death from cardiac causes•Significant device-related events resulting in:– Permanent disability– Hospitalization for pending death or permanent disabilitySafety––CRT-D system-related complication-free rate is determined bymeasuring complications related to any of the implanted components ortheir associated implant procedure in those patients who were successfullyimplanted with the CRT-D system.NOTE: During the course of the COMPANION clinical study, the EASYTRAKCoronary Venous pace/sense lead was established as safe and effective in aseparate clinical study and was approved for commercial distribution (P010012,05/02/02). Refer to the commercially available EASYTRAK Coronary Venouspace/sense lead labeling for clinical safety and performance characteristics.- DRAFT -

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