PACING THERAPIES VENTRICULAR TACHY SENSING INTERACTIONS 5-65 When the programming interaction described in this scenario is present, a message will describe the interaction of Tachy Rate Threshold with LRL and AV Delay. Similar messages may describe the interaction of V-Blank After A-Pace with MTR, MPR, or LRL. Along with each message, the pertinent programmable parameters are displayed to assist you in resolving the interaction.
5-66 PACING THERAPIES VENTRICULAR TACHY SENSING INTERACTIONS • If Rate Smoothing or Rate Adaptive Pacing are not required for the patient, consider programming these features Off. Programming these features Off can reduce the likelihood of atrial pacing at elevated rates. • If atrial pacing is not required for the patient, consider using VDD rather than DDD pacing mode.
6-1 SYSTEM DIAGNOSTICS CHAPTER 6 This chapter contains the following topics: • "Battery Status" on page 6-2 • "Lead Tests" on page 6-6 - DRAFT -
6-2 SYSTEM DIAGNOSTICS BATTERY STATUS BATTERY STATUS Pulse generator battery summary information is displayed on the Summary screen.
SYSTEM DIAGNOSTICS BATTERY STATUS • 6-3 Explant—the pulse generator’s battery is nearing depletion and the pulse generator has reached the point at which explant is recommended. This status indicates that pulse generator replacement must be scheduled. Once Explant status is reached there is sufficient battery capacity to monitor and pace 100% under existing conditions for three months and to deliver six maximum-energy shocks.
-4 SYSTEM DIAGNOSTICS BATTERY STATUS Battery Detail Summary Screen The Battery Detail summary screen provides the following information about pulse generator battery status (Figure 6-1 on page 6-5): • Last Delivered Shock––date, energy, charge time, and shock impedance data • Beep When Explant Is Indicated––if this feature is programmed to On, the pulse generator emits 16 beeping tones every six hours after it reaches the Explant indicator. The tone can then be programmed to Off.
SYSTEM DIAGNOSTICS BATTERY STATUS Figure 6-1. 6-5 Battery Detail summary screen Capacitor Re-formation Automatic Capacitor Re-form. Capacitor deformation may occur during periods when no shocks are delivered, resulting in longer charge times. To reduce the effect of capacitor deformation on charge time, the capacitors are automatically re-formed.
6-6 SYSTEM DIAGNOSTICS LEAD TESTS Last Delivered Ventricular Shock When a shock has been delivered to the patient, the following information from the last shock delivered is stored in the pulse generator’s memory and displayed on the Battery Detail screen: • Date • Energy level • Charge time • Shocking lead impedance This does not include auto capacitor re-forms or shocks that may have been diverted. If a fault condition is encountered (i.e.
SYSTEM DIAGNOSTICS LEAD TESTS 6-7 1. From the main screen, select the Tests tab 2.
6-8 SYSTEM DIAGNOSTICS LEAD TESTS Lead Impedance Test A lead impedance test can be performed and used as a relative measure of lead integrity over time. A shock impedance test is a useful tool in detecting shocking lead integrity changes over time.
SYSTEM DIAGNOSTICS LEAD TESTS 6-9 The test begins at a specified starting value and steps that value down (amplitude or pulse width) as the test progresses. The PRM beeps with each decrement. The values used during the threshold test are programmable. The parameters are only in effect during the test. Testing for a chamber is allowed only when pacing is active for that chamber in the mode specified in the start column.
6-10 SYSTEM DIAGNOSTICS LEAD TESTS The threshold test is complete and all parameters are returned to the normal programmed values when any of the following occur: • The test is terminated via a command from the PRM (e.g.
SYSTEM DIAGNOSTICS LEAD TESTS 6-11 setting have occurred, the test is automatically terminated. The final threshold test value will be displayed (the value is one step above the value when the test was terminated). NOTE: The threshold test result can be edited by selecting the Edit Today’s Test button on the Threshold Test screen 6. To perform another test, make changes to the test parameter values if desired, then begin again. Results of the new test will be displayed.
6-12 SYSTEM DIAGNOSTICS LEAD TESTS - DRAFT -
7-1 PATIENT DIAGNOSTICS CHAPTER 7 This 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 DIAGNOSTICS THERAPY HISTORY THERAPY HISTORY The pulse generator automatically records detection and therapy information for each detected episode. This data can be reviewed at various levels of detail using the PRM. History data storage includes the following information for each episode: • Episode detail • Electrograms with annotated markers • Intervals The data includes information from all active electrodes.
PATIENT DIAGNOSTICS TRENDS • 7-3 An episode in progress has the highest priority until its type can be determined. Table 7-1. Episode Priority Episode Type Priority Minimum number of episodes stored Maximum number of episodes stored VF 1 5 10 Patient Triggered Monitor 1 1 1 VT/VT-1 2 3 5 Cmd V 3 0 2 NonSustV 3 1 2 ATR 4 1 3 PMT 4 1 3 Once the history data is saved to a disk, it can be accessed at any time without device interrogation.
7-4 PATIENT DIAGNOSTICS TRENDS • HRV Footprint––displays the percentage of the graph area used by the HRV plot. The graph area portrays an “at-a-glance snapshot” of the distribution of variability versus heart rate over a 24-hour period. The trended percentage is a normalized score based on the footprint in the graph. If an HRV plot was not obtained for the 24-hour period, then the HRV Footprint is not calculated and a value of “N/R” is displayed.
PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 7-5 • Adjust the start and end dates by moving the slider bar at the top of the window. You can also adjust these dates by selecting the left- and right-arrow buttons. • Move the vertical axis across the graph by moving the slider bar at the bottom of the display window.
7-6 PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK • Figure 7-1. Duration of the event Arrhythmia Logbook screen To display Arrhythmia Logbook data, use the following steps: 1. From the Events tab, select Arrhythmia Logbook. If necessary, the pulse generator will be automatically interrogated and current data will be displayed. 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 Disk option. 2.
PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 7-7 the toolbar. Choose the selected Episodes Report and select the Print button. NOTE: An “in-progress” episode will not be saved; an episode must be complete before it will be saved by the application. Events Summary The Events Summary screen displays additional details about the selected episode corresponding to the Arrhythmia Logbook.
7-8 PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 1. Select the desired episode on the Arrhythmia Logbook screen. The Stored Event screen will appear. 2. From the Stored Event screen, select the EGM tab to view the detailed information for this episode. 3. Select the Previous Event or the Next Event button to display a previous or more current episode, one episode at a time. 4. Select the Print Event button to print the episode detail being viewed. 5.
PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 7-9 • Therapy data is displayed. In the case of ATP therapy, a maximum of 4 bursts and up to 20 seconds of data, for each burst, will be retained • Post-therapy or diverted therapy retains up to 10 seconds of data Episode onset refers to the period of time (measured in seconds) of EGM prior to the first attempt.
7-10 PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK The End EGM storage starts following therapy delivery and stores up to 10 seconds of EGM (Figure 7-2 on page 7-10). Shock 5s 10 s Onset after 3 fast beats 10 s 10 s Duration expires 10 s Charging begins Note: Charging may begin when duration expires. Figure 7-2. recording 10 s 10 s 10 s Start End-ofEpisode timer End-of-Episode times out. Episode is over.
PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 7-11 Intervals The pulse generator stores event markers and associated time stamps. The PRM 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 episode data is not visible in the window, use the scroll bar to view more data. 2.
7-12 PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 3. 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 counts by chamber. Heart Rate Variability (HRV) Heart Rate Variability (HRV) is a measure of the changes in a patient’s intrinsic heart rate within a 24-hour collection period. This feature can assist in evaluating the clinical status of heart failure patients.
PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK Figure 7-3. 7-13 Heart Rate Variability display Consider the following information when using HRV: • The cardiac cycle (R–R interval) in HRV is determined by RV sensed and paced events (LV paced events when the pacing chamber is programmed to LV). • Programming the pacing parameters causes the data acquired for the current 24-hour collection period to be invalid.
7-14 PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK The HRV monitor screen displays a set of measurements and a HRV plot based on the most recent 24-hour collection period in the Last Measured portion of the screen; measurements from a previously saved collection period are displayed in the Reference portion of the screen. Both collection periods can be viewed simultaneously to compare data that could show trends in the patient’s HRV changes over a period of time.
PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 7-15 An 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 because the Brady parameters were programmed after the device was taken out of Storage. HRV data is successfully calculated and reported at the end of the second 24-hour collection period. Subsequent HRV data is not reported until the end of Collection Period 5.
7-16 PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK • Nontreated––No Therapy Programmed, Nonsustained, and Other Untreated Episodes Ventricular Tachy Therapy counters consist of ventricular shock and ATP therapy attempts. They can provide useful data about the effectiveness of a patient’s therapy prescription.
PATIENT DIAGNOSTICS PATIENT TRIGGERED MONITOR • Intrinsic Promotion––includes Rate Hystereses % successful • Atrial burden––includes Episodes by Duration and Total PACs • Ventricular counters––includes total PVCs and Three or More PVCs 7-17 PATIENT TRIGGERED MONITOR Patient Triggered Monitor allows the patient to trigger the storage of EGMs, intervals, and annotated marker data during a symptomatic episode by placing a magnet over the device.
7-18 PATIENT DIAGNOSTICS PATIENT TRIGGERED MONITOR 3. From Ventricular Tachy Therapy, select the V-Tachy Therapy Setup details button. 4. Program the Magnet Response to Store EGM. CAUTION: Determine if the patient is capable of activating this feature prior to being given the magnet and prior to enabling Patient Triggered Monitor. Remind the patient to avoid strong magnet fields so the feature is not inadvertently triggered.
8-1 ELECTROPHYSIOLOGIC TESTING CHAPTER 8 This 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 TESTING EP TEST FEATURES EP TEST FEATURES Electrophysiologic (EP) Testing features enable you to induce and terminate arrhythmias noninvasively in order to monitor and test the effectiveness of selected detection criteria and therapies. The EP Test features can be used in conjunction with the ECG display so that real-time traces may be viewed. The status of the pulse generator/patient interaction is also displayed.
ELECTROPHYSIOLOGIC TESTING EP TEST FEATURES Figure 8-1. 8-3 EP Test Screen The screen provides the following information: • Status messages indicate detection and therapy status and are described below: – Ventricular episode status—if an episode is occurring, the duration of the episode is displayed. (If it is greater than 10 minutes, then it is displayed as > 10:00 m:s).
8-4 ELECTROPHYSIOLOGIC TESTING INDUCTION METHODS • Therapy prescriptions—Only those therapy prescriptions that are programmed are displayed. As each therapy is delivered, a check mark or number will appear in the box adjacent to the respective therapy. ATP therapies indicate the scheme type as well as the programmed number of bursts in the scheme. A number will appear and increment (1, 2, etc.) in the ATP therapy box each time an ATP burst is delivered.
ELECTROPHYSIOLOGIC TESTING INDUCTION METHODS 8-5 activity until the induction delivery is ceased, at which time the programmed mode 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 a magnet is positioned over the pulse generator (if magnet response is set to Inhibit Therapy).
8-6 ELECTROPHYSIOLOGIC TESTING INDUCTION METHODS declared before the VFib induction pulses are started. A new episode (with initial detection and therapy) can be declared after the VFib induction is completed. Event markers and EGMs are interrupted during VFib induction and will automatically restart following induction. 4. To stop the induction train, release the button (the button will become dimmed again). 5. To deliver another fibrillation induction, repeat these steps.
ELECTROPHYSIOLOGIC TESTING INDUCTION METHODS 8-7 4. Select the Induce button to begin delivery of the drive train. The pulses are delivered in sequence until the programmed number of pulses is reached. Once induction is initiated, the drive train delivery will not stop if you interrupt telemetry communication. You can press the DIVERT THERAPY key to stop the induction delivery command. 5.
8-8 ELECTROPHYSIOLOGIC TESTING INDUCTION METHODS Performing PES Induction 1. Select the PES option. Buttons for the S1–S5 pulses and the corresponding burst 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 a value from the box or use the plus or minus symbols to change the value visible in the value box. Figure 8-4. PES induction options 3. Select the Enable checkbox. 4.
ELECTROPHYSIOLOGIC TESTING INDUCTION METHODS 8-9 50 Hz/Manual Burst Pacing 50 Hz/Manual Burst pacing induction is used to induce or terminate arrhythmias and allows two separate pacing inductions, both of which can be delivered to either the atrium or ventricle. Manual Burst pacing pulses are delivered in XOO mode (where X is the chamber) at the programmed EP Test pacing parameters through the rate-sensing leads. For Atrial Manual Burst, backup pacing parameters are provided.
8-10 ELECTROPHYSIOLOGIC TESTING COMMANDED THERAPY METHODS The ventricular 50 Hz Burst will be delivered up to 30 seconds as long as the 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 the Hold for Burst button is held and the telemetry link is maintained. NOTE: During Hold for 50 Hz Burst pacing, the S1 interval is automatically set to 20 ms and the decrement to 0. These values will not be displayed on the screen. 4.
ELECTROPHYSIOLOGIC TESTING COMMANDED THERAPY METHODS 8-11 2. Select the desired values for the Coupling interval and Shock Energy. 3. Select the Enable checkbox. The Deliver Shock button will become available. 4. Select the Deliver Shock button to initiate shock delivery. The Commanded Shock is recorded in therapy history. 5. To deliver subsequent shocks, repeat these steps.
8-12 ELECTROPHYSIOLOGIC TESTING COMMANDED THERAPY METHODS 6. After using Commanded ATP, remember to program the EP Temp V Mode to Monitor + Therapy or leave the screen so that the EP Temp V Mode is ended and the permanent Tachy Mode is resumed. NOTE: If any button other than the Continue button is selected during delivery of a Commanded ATP scheme, the scheme will be reset and the Bursts Remaining box will be restored to its initial value.
9-1 IMPLANT INFORMATION CHAPTER 9 This chapter contains the following topics: • "Implanting the Pulse Generator" on page 9-2 - DRAFT -
9-2 IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR IMPLANTING THE PULSE GENERATOR Step A: Step A: Check Equipment Step B: Interrogate and Check the Pulse Generator Step C: Implant the Lead System Step D: Take Baseline Measurements Step E: Form the Implantation Pocket Step F: Connect the Leads to the Pulse Generator Step G: Evaluate Lead Signals Step H: Program the Pulse Generator Step I: Implant the Pulse Generator Step J: Complete and Return the Implantation Form Check Equipment
IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR Step B: 9-3 Interrogate and Check the Pulse Generator To maintain sterility, test the pulse generator as described below before opening the sterile blister tray. The pulse generator should be at room temperature to ensure accurately measured parameters. 1. Interrogate the pulse generator using the PRM. Verify that the pulse generator’s Tachy mode is programmed to Storage.
9-4 IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR NOTE: If the coronary venous lead cannot be used and the physician’s medical judgment indicates that a limited left thoracotomy is justified to place an epicardial lead, the use of sutureable, steroid-eluting pace/sense epicardial leads is recommended. CAUTION: The absence of a lead or plug in a lead port may affect device performance. If a lead is not used, be sure to properly insert a plug in the unused port.
IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR • Table 9-1. 9-5 Connect the pace/sense lead(s) to a pacing system analyzer (PSA). Pace/sense lead measurements, measured approximately 10 minutes after placement, are listed below (Table 9-1 on page 9-5). Note that the pulse generator measurements may not exactly correlate to the PSA measurements due to signal filtering.
9-6 IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR may help avoid erosion or extrusion in some patients. Verify magnet function and wanded telemetry to ensure the pulse generator is within acceptable range. Consider the following situations during the implant the procedure: Step F: • If an abdominal implant is suitable, it is recommended that implantation occur on the left abdominal side. • Tunnel the leads if necessary.
IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR 9-7 Defib (-) Suture Hole Defib (+) RV (-) RA (-) LV (-) Front of Pulse Generator Defib (-) Suture Hole Defib (+) RV (-) RA (-) LV (-) Front of Pulse Generator Figure 9-2. Setscrew and suture hole locations Lead to pulse generator connections CAUTION: Do not insert a lead into the pulse generator connector without first visually verifying that the setscrew is sufficiently retracted to allow insertion.
9-8 IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR d. Apply gentle traction to the leads to ensure a secure connection. 2. In models with IS-1 connectors, insert and secure the right ventricular pace/sense lead terminal into the RV lead port. NOTE: When connecting leads to a device header, connect the RV lead first. An RV lead is required to establish RV-based timing cycles that yield appropriate sensing and pacing in all chambers, regardless of the programmed configuration. 3.
IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR Step G: 9-9 • The LV-1 pace/sense lead port(s) has one setscrew for securing the terminal pin. • Avoid allowing blood or other body fluids to enter the lead ports in the pulse generator header. If fluid inadvertently enters the ports, they should be thoroughly cleaned using sterile water. • To connect leads to the pulse generator, use only the tools provided in the pulse generator tray or accessory kit to avoid damage to the seal plugs.
9-10 IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR ECG. A discontinuous signal may indicate a poor connection, lead fracture or otherwise damaged lead, or an insulation break that would necessitate lead replacement. Inadequate signals may result in failure of the pulse generator system to detect an arrhythmia, inability to deliver programmed therapy, or unnecessary delivery of therapy. Lead measurements should reflect those in (Table 9-1 on page 9-5).
IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR 9-11 5. Shocks intended for VF therapy should be programmed with a 10 J safety margin above the shock energy level that the physician determines is required for successful VF conversion. CAUTION: To prevent inappropriate shocks, ensure that the pulse generator’s Tachy Mode is programmed to Off when not in use and before handling the device. For tachyarrhythmia therapy, verify that the Tachy Mode is activated. Step I: Implant the Pulse Generator 1.
9-12 IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR Defib (-) Suture Hole Defib (+) RV (-) RA (-) LV (-) Front of Pulse Generator Defib (-) Suture Hole Defib (+) RV (-) RA (-) LV (-) Front of Pulse Generator Figure 9-3. Setscrew and suture hole locations 3. Close the implantation pocket. Consideration should be given to place the leads in a manner to prevent contact with suture materials. It is recommended that absorbable sutures be used for closure of tissue layers. 4.
IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR 9-13 copy of the Warranty Validation and Lead Registration form and programmer printouts, 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 a permanent identification card. NOTE: A registration form is packaged with each pulse generator lead.
9-14 IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR - DRAFT -
10-1 POST IMPLANT INFORMATION CHAPTER 10 This 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 INFORMATION FOLLOW UP TESTING FOLLOW UP TESTING It is recommended that device functions be evaluated during follow-up testing. WARNING: Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. Predischarge Follow Up During the pre-discharge follow-up test, the following procedures should be performed via telemetry using the PRM: 1.
POST IMPLANT INFORMATION POST IMPLANT FEATURES 10-3 2. Perform pacing thresholds and lead impedance tests, and intrinsic amplitude measurements. 3. Print and review the Quick Notes report, and retain it in your files for future reference. 4. For episodes of interest, review the Arrhythmia Logbook screen and print episode details and stored electrogram information. 5. It is important to clear the therapy counters so that at the next follow-up session the most recent episode data will be displayed.
10-4 POST IMPLANT INFORMATION POST IMPLANT FEATURES If proper sensing cannot be restored with an adjustment or if any undersensing is observed after making a change, consider repositioning the lead or implanting a new sensing lead and then programming the setting back to nominal. CAUTION: Following any sensing range adjustment or any modification of the sensing lead, always verify appropriate sensing.
POST IMPLANT INFORMATION POST IMPLANT FEATURES 10-5 Beep when Explant is indicated 1. 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 Beep when 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.
10-6 POST IMPLANT INFORMATION POST IMPLANT FEATURES Position the magnet over the pulse generator as shown. Top View Magnet (model 6860) 3.0 cm Pulse generator Figure 10-1. Proper position of magnet Model 6860 to activate the pulse generator magnet feature The pulse generator Magnet Response settings can be programmed to control the behavior of the pulse generator when a magnet is detected. The Magnet Response settings are located in the Magnet and Beeper section of the V-Tachy Therapy Setup screen.
POST IMPLANT INFORMATION POST IMPLANT FEATURES 10-7 When the Magnet Response is programmed to Inhibit Therapy, application of the magnet will inhibit and/or divert charging for a shock, divert a shock that is about to be delivered, or inhibit and/or divert further ATP therapy. When Magnet Response is programmed to Inhibit Therapy, initiation of tachyarrhythmia therapy and arrhythmia induction is inhibited any time the magnet is properly positioned over the pulse generator.
10-8 POST IMPLANT INFORMATION EXPLANTATION NOTE: If tachy detection occurs while the magnet is in place, detailed therapy history will indicate that therapy was not delivered because the device was in Monitor Only mode. EXPLANTATION An Observation/Complication/Out-of-Service Reporting form should be completed and sent to Boston Scientific when a product is removed from service.
POST IMPLANT INFORMATION EXPLANTATION 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 remove leads with hemostats or any other clamping tool that may damage the leads. Resort to tools only if manual manipulation cannot free the lead.
10-10 POST IMPLANT INFORMATION EXPLANTATION - DRAFT -
A-1 PROGRAMMABLE OPTIONS APPENDIX A Table A-1. ZIP Telemetry settings Parameter Programmable Values Nominal Communication Mode Enable use of ZIP telemetry (May require limited use of wand), Use wand for all telemetry Enable use of ZIP telemetry (May require limited use of wand) Parameter Programmable Values Nominal Tachy Mode Off, Monitor Only, Monitor + Therapy, Enable Electrocautery Protection Storage Table A-2. Table A-3.
A-2 PROGRAMMABLE OPTIONS Table A-4. Detection parameters for 1-zone, 2-zone, and 3-zone configurations (continued) Parameter VT-1 Zone VT Zone VF Zone Nominal Initial Durationb (sec) 2 zones –– 1.0, 1.5, ..., 5.0, 6.0, 7.0, ..., 15.0, 20.0, 25.0, 30.0 1.0, 1.5, ..., 5.0, 6.0, 7.0, ..., 15.0 2.5 (Tolerance ± 1 cardiac cycle) for VT Zone 1.0 (Tolerance ± 1 cardiac cycle) for VF Zone Initial Durationb (sec) 1 zone –– –– 1.0, 1.5, ..., 5.0, 6.0, 7.0, ..., 15.0 1.
PROGRAMMABLE OPTIONS A-3 Table A-6. Onset/Stability detection enhancement parameters for 2-zone and 3-zone configurations (continued) Parameter VT-1 Zone VT Zone VF Zone Nominal AFib Rate Threshold ( bpm) 3 zones Off, 100, 110, ..., 300 –– –– 170 (Tolerance ± 5 ms) AFib Rate Threshold ( bpm) 2 zones –– Off, 100, 110, ..., 300 –– 170 (Tolerance ± 5 ms) Stability (ms) 3 zones Off, 6, 8, ..., 32 35, 40, ..., 60 70, 80, ...
A-4 PROGRAMMABLE OPTIONS Table A-6.
PROGRAMMABLE OPTIONS Table A-7.
A-6 PROGRAMMABLE OPTIONS Table A-8. Post-shock Onset/Stability detection enhancement parameters for 2-zone and 3-zone configurations Parameter VT-1 Zone VT Zone VF Zone Nominal Post-shock V Rate > A Rate 3 zones Off, On –– –– On Post-shock V Rate > A Rate 2 zones –– Off, On –– On Post-shock AFib Rate Threshold ( bpm) 3 zones Off, 100, 110, ..., 300 –– –– 170 (Tolerance ± 5 ms) Post-shock AFib Rate Threshold ( bpm) 2 zones –– Off, 100, 110, ...
PROGRAMMABLE OPTIONS A-7 Table 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 Nominal 0:15 (Tolerance ± 1 cardiac cycle) 0:15 (Tolerance ± 1 cardiac cycle) Post-shock Sustained Rate Duration (min:sec) 3 zones Off, 00:10, 00:15, 01:00, 01:15, ..., 02:00, 02:30, ..., 10:00, 15:00, ..., 60:00 Off, 00:10, 00:15, 01:00, 01:15, ..., 02:00, 02:30, ..., 10:00, 15:00, ...
A-8 PROGRAMMABLE OPTIONS Table A-10. Ventricular ATP parameters (specified into a 750 Ω load) (continued) Parameter VT-1 Zone VT Zone VF Zone Nominal Coupling Interval (% or ms) 2 zones –– 50, 53, 56, 59; 63, 66, ..., 84, 88, 91, 94, 97% or 120, 130, ..., 750 ms –– 81% (Tolerance ± 5 ms) Coupling Interval Decrement (ms) 3 zones 0, 2, ..., 30 0, 2, ..., 30 –– 0 (Tolerance ± 5 ms) Coupling Interval Decrement (ms) 2 zones –– 0, 2, ...
PROGRAMMABLE OPTIONS Table A-10. A-9 Ventricular ATP parameters (specified into a 750 Ω load) (continued) Parameter VT-1 Zone VT Zone VF Zone Nominal Left Ventricular ATP Pulse Widtha (ms) 3 zones (one value 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; ± 0.08 ms at ≥ 1.8 ms) Left Ventricular ATP Pulse Widtha (ms) 2 zones (one value for all zones) –– 0.1, 0.2, ..., 2.0 –– 1.0 (Tolerance ± 0.03 ms at < 1.8 ms; ± 0.08 ms at ≥ 1.
A-10 PROGRAMMABLE OPTIONS Table A-11. Ventricular Shock Parameters Parameter Programmable Values Nominal 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.
PROGRAMMABLE OPTIONS A-11 Table A-12. Pacing therapy parameters (Normal, Post-Therapy, and Temporary) (specified into a 750 Ω load) (continued) Parameter Programmable Values Nominal Response Factorg j 1, 2, ..., 16 8 Recovery Timeg j 2, 3, ..., 16 2 Maximum PVARPa g (ms) 150, 160, ..., 500 280 (Tolerance ± 5 ms) Minimum PVARPa g (ms) 150, 160, ..., 500 240 (Tolerance ± 5 ms) Off, 150, 200, ...
A-12 PROGRAMMABLE OPTIONS Table A-12. Pacing therapy parameters (Normal, Post-Therapy, and Temporary) (specified into a 750 Ω load) (continued) Parameter Maximum Pacing Rateag (ppm) Post-therapy Pacing Period (min:sec) (available post-shock only) Programmable Values Nominal 30, 35, ... ,185 130 (Tolerance ± 5 ms) 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 60:00 00:30 (Tolerance ± 1 cardiac cycle) a.
PROGRAMMABLE OPTIONS Table A-13.
A-14 PROGRAMMABLE OPTIONS Table A-14. Atrial Tachy Parameters (continued) Parameter Atrial Flutter Responseb Atrial Flutter Response ( bpm) PMT Terminationb VRRb c Rateb c c c Programmable Values Nominal Off, On Off 100, 110, ..., 300 170 (Tolerance ± 5 ms) Off, On On Off, Min, Med, Max Off a. 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.
PROGRAMMABLE OPTIONS Table A-17. Sensitivity Adjustment (continued) Parameter Programmable Values Nominal Right Ventricular Sensitivity AGC 0.15, AGC 0.2, AGC 0.25, AGC 0.3, AGC 0.4, ..., AGC 1.0, AGC 1.5 AGC 0.6 Left Ventricular Sensitivity AGC 0.15, AGC 0.2, AGC 0.25, AGC 0.3, AGC 0.4, ..., AGC 1.0, AGC 1.5 AGC 1.0 Table A-18.
A-16 PROGRAMMABLE OPTIONS Table A-19. 50 Hz/Manual Burst Pacing (continued) Parametera Programmable Values Nominal Minimum Interval (ms) 20, 30, ...,750 200 (Tolerance ± 5 ms) 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 Shock Parameter Programmable Values Nominal Shock (stored energy) (J) 0.1, 0.3, 0.6, 0.9, 1.1, 1.
PROGRAMMABLE OPTIONS Table A-23. PES (Programmed Electrical Stimulation) (continued) Parametera Programmable Values Nominal S4 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.
A-18 PROGRAMMABLE OPTIONS - DRAFT -
B-1 CLINICAL STUDY - COMPANION APPENDIX B CLINICAL STUDY POPULATIONS Guidant CRT-Ds, when compared to OPT alone, have been demonstrated with reasonable assurance, to be safe and effective in significantly reducing: the risk of a composite of all-cause mortality or first hospitalization by 20%, the risk of all-cause mortality by 36%, and heart failure symptoms in patients who have moderate to severe heart failure (NYHA III/IV) including left ventricular dysfunction (EF ≤ 35%) and QRS duration ≥120 ms and re
B-2 CLINICAL STUDY - COMPANION The clinical study began January 20, 2000 and was conducted at 128 centers within the United States. The COMPANION clinical study was monitored using a sequential design and on November 18, 2002, after review of the data by the Data Safety and Monitoring Board, enrollment in the study was stopped.
CLINICAL STUDY - COMPANION B-3 patients). Of the 1520 patients randomized, 903 were randomized to OPT and CRT-D. This summary focuses on data and analyses for the CRT-D and OPT groups, only, with the exception of the Exercise Performance results, which are based on pooled CRT-D and CRT-P data. The CRT-D devices (CONTAK CD) in this trial, were approved for commercial distribution via the CONTAK CD study, which provided a reasonable assurance of safety.
B-4 CLINICAL STUDY - COMPANION Table 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.
CLINICAL STUDY - COMPANION Table B-1. B-5 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.
B-6 CLINICAL STUDY - COMPANION Table 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.
CLINICAL STUDY - COMPANION Table B-2. B-7 Patient-related adverse events (continued) Total Events (Patients) % of Patients with Events Events/Patient Year CRT-D OPT CRT-D N = 595 Patients OPT N = 308 Patients CRT-D 281 Years OPT 134 Years Vascular 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.
B-8 CLINICAL STUDY - COMPANION Table B-2. Patient-related adverse events (continued) Total Events (Patients) % of Patients with Events Events/Patient Year CRT-D OPT CRT-D N = 595 Patients OPT N = 308 Patients CRT-D 281 Years OPT 134 Years Febrile 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.
CLINICAL STUDY - COMPANION Table B-3. B-9 CRT-D and OPT cause of death (continued) Cause of Death Unknown/ Unclassified Total Deaths OPT Arm (N = 308) CRT-D Arm (N = 595) Total (N = 903) 8 (2.6%) 5 (0.8%) 13 (1.4%) 77 (25.0%) 105 (17.6%) 182 (20.2%) NOTE: After the study was stopped in November 2002, follow-up for safety continued for approximately one more year on 151 OPT and 449 CRT-D patients with the final data cut-off on November 26, 2003.
B-10 CLINICAL STUDY - COMPANION INCLUSION/EXCLUSION CRITERIA The study population consisted of patients with moderate to severe heart failure, New York Heart Association Classification III or IV, left ventricular ejection fraction ≤ 35%, and QRS width ≥ 120 ms due to ischemic or non-ischemic cardiomyopathy. All patients were required to have been treated with a stable dose of beta-blocker, ACE inhibitor or ARB, diuretic, and aldosterone antagonist.
CLINICAL STUDY - COMPANION B-11 Additional 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.
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 in excess of 4 hours in the 30 days prior to enrollment •
B-13 CLINICAL STUDY - COMPANION on 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 rate in the OPT cohort. All-cause mortality was defined as death from any cause. Hospitalization is defined below: Qualifying Duration for Hospitalization––the intent behind hospitalization was to capture hospitalizations that were of sufficient duration to enter into a composite with all-cause mortality.
B-14 CLINICAL STUDY - COMPANION contrasting patients randomized to CRT-D in addition to OPT versus patients randomized to OPT alone. Cardiac morbidity––the hospitalization component of the primary endpoint included non-cardiac events that may not be impacted by CRT-D. The cardiac morbidity endpoint was unique to the COMPANION study.
