PACING THERAPIES ATRIAL TACHY RESPONSE 5-19 Recovery Time Paced rate MSR Nominal Recovery Time Longer Recovery Time LRL Rest Stage 1 Stage 2 Rest Time The figure shows the effect of higher and lower settings during a theoretical two-stage exercise test. Figure 5-11. Recovery Time in exercise test Programming Recovery Time for Normal Settings also changes the corresponding selection for Post-Therapy Settings.
5-20 PACING THERAPIES ATRIAL TACHY RESPONSE Detect 0 Duration Fallback Reset 8 8 0 ATR Counter Entry Count = 8 Duration Counter Exit Count = 8 8 atrial cycles > Atrial Arrhythmia Rate Threshold Rate 8 atrial cycles < Atrial Arrhythmia Rate Threshold N Atrial Arrhythmia Rate Threshold = 170 min-1 (ppm) MTR = 120 min-1 (ppm) Atrial Rate DDDR VDIR DDDR Right Ventricular Rate Sensor Rate ATR/VTR Fallback LRL = 70 min-1 (ppm) LRL = 60 min-1 (ppm) MODE SWITCHING Atrial tachycardia starts Atr
PACING THERAPIES ATRIAL TACHY RESPONSE 5-21 ATR Duration ATR Duration determines the number of cardiac cycles during which the atrial events continue to be evaluated after initial detection. This feature is intended to avoid mode switching due to short, nonsustained episodes of atrial tachycardia. If the ATR counter reaches zero during ATR Duration, the ATR algorithm will be reset, and no mode switch will occur.
5-22 PACING THERAPIES ATRIAL TACHY RESPONSE Fallback Mode Fallback Mode is the nontracking pacing mode that the pulse generator automatically switches to when ATR Duration is fulfilled. After switching modes, the pulse generator gradually decreases the ventricular paced rate to the ATR/VTR Fallback LRL, VRR rate, if enabled, or the sensor-indicated rate if programmed to an adaptive-rate mode, whichever is higher. The decrease in the ventricular paced rate is controlled by the Fallback Time parameter.
PACING THERAPIES ATRIAL TACHY RESPONSE 5-23 Fallback LRL The ATR/VTR Fallback LRL is the programmed lower rate to which the rate decreases during mode switching.
5-24 PACING THERAPIES ATRIAL TACHY RESPONSE When detection is satisfied in a ventricular tachycardia zone, the pacing mode switches to VVI (RV) or to Off if the current mode is AAI(R) or Off. When the mode switches, backup pacing occurs at the programmed ATR/VTR Fallback LRL and uses the programmed ATP ventricular Pulse Width and Amplitude values.
PACING THERAPIES ATRIAL TACHY RESPONSE 5-25 Atrial Flutter Response (AFR) Atrial Flutter Response is designed to: • Prevent pacing into the atrial vulnerable period • Provide immediate fallback for atrial rates higher than the AFR programmable rate The fallback is maintained for as long as atrial events continually exceed the AFR programmable rate.
5-26 PACING THERAPIES RATE ENHANCEMENTS During the 16 intervals, the V–A interval is monitored to determine if: • A PMT is occurring • The intrinsic atrial rate is simply meeting the MTR or exceeding it The V–A intervals are compared to the second V–A interval measured during the 16 ventricular paced events.
PACING THERAPIES RATE ENHANCEMENTS • 5-27 In DDD mode: – A single atrial pace during a cardiac cycle when an RV pace is scheduled at the hysteresis LRL – An atrial rate that rises above the MTR NOTE: In VVI mode, hysteresis is deactivated by a single ventricular pace at the hysteresis rate. When Rate Smoothing Down is enabled, Rate Hysteresis remains in effect until pacing occurs at the hysteresis rate. This allows Rate Smoothing to control the transition to the hysteresis rate.
5-28 PACING THERAPIES RATE ENHANCEMENTS NOTE: In VVI mode, the intrinsic activity would be a sensed ventricular event instead of a sensed atrial event. Rate Smoothing Rate Smoothing controls the pulse generator’s response to atrial and/or ventricular rate fluctuations that cause sudden changes in pacing intervals. Rate Smoothing is an important enhancement to ATR because it can significantly reduce the rate fluctuations associated with the onset and cessation of atrial arrhythmias.
PACING THERAPIES RATE ENHANCEMENTS 5-29 applicable between the hysteresis rate and LRL when hysteresis is active, except during Search Hysteresis. When Rate Smoothing is programmed to On, the following information applies. • Programmable Rate Smoothing values are a percentage of the RV R–R interval (3% to 25% in 3% increments) and can be independently programmed for: – • – Decrease—Rate Smoothing Down – Off The pulse generator stores the most recent R–R interval in memory.
5-30 PACING THERAPIES RATE ENHANCEMENTS Ventricular synchronization window: previous R–R interval ± Rate Smoothing value Atrial synchronization window: (previous R–R interval ± Rate Smoothing value) - AV Delay The following example explains how these windows are calculated (Figure 5-13 on page 5-30): • Previous R–R interval = 800 ms • AV Delay = 150 ms • Rate Smoothing Up = 9% • Rate Smoothing Down = 6% The windows would be calculated as follows: Ventricular Synchronization Window = 800 - 9% to 80
PACING THERAPIES LEAD CONFIGURATION 5-31 NOTE: Without Rate Smoothing, a sudden, large atrial rate increase (e.g., PAT) will cause a simultaneous sudden increase in the paced ventricular rate as high as the programmed MTR. With Rate Smoothing, the ventricular paced rate in response to such a change might not reach the programmed MTR. Rate Smoothing Up Rate Smoothing Up controls the largest pacing rate increase allowed when the intrinsic or sensor rate is increasing.
5-32 PACING THERAPIES AV DELAY AV DELAY AV Delay is the programmable time period from the occurrence of either a paced or sensed right atrial event to a paced RV event. AV Delay helps preserve the heart’s AV synchrony. If a sensed ventricular event does not occur during the AV delay following an atrial event, the pulse generator delivers a ventricular pacing pulse when AV Delay expires.
PACING THERAPIES AV DELAY 5-33 The dynamic AV Delay is not adjusted following a PVC or when the previous cardiac cycle was limited by the MTR. When the atrial rate is between the LRL and the higher of the MTR and the MSR, the pulse generator calculates the linear relationship to determine the Dynamic AV Delay (Figure 5-14 on page 5-33). Maximum AV Delay Dynamic AV Delay Minimum AV Delay Higher of MTR and MSR interval Figure 5-14.
5-34 PACING THERAPIES AV DELAY Ap = Paced atrial event As = Sensed atrial event Vp = Paced ventricular event SAV = Sensed AV Delay (As-Vp interval) PAV = Paced AV Delay (Ap-Vp interval) SAV PAV Ap As Figure 5-15. Vp Sensed AV Delay The hemodynamic impact of the Sensed AV Delay depends on the appropriateness of the timing between the atrial and ventricular contractions. An atrial pace starts the atrial contraction, whereas the atrial sense occurs during the contraction.
PACING THERAPIES AV DELAY 5-35 Maximum Paced AV Delay Minimum Paced AV Delay Shorter of MTR or MSR Interval LRL Interval Hysteresis Rate Interval Paced AV Delay Sensed AV Delay Figure 5-16. NOTE: Dynamic and Sensed AV Delay as a function of the escape interval The minimum value is programmable only in VDD(R) mode. AV Search+ AV Search+ is designed to promote intrinsic A–V conduction if present; AV Search + will watch for intrinsic AV conduction to occur beyond the programmed AV Delay.
5-36 PACING THERAPIES REFRACTORY Search AV Delay The Search AV Delay parameter determines the length of the sensed and paced AV delays during the search cycles and during the AV hysteresis period. NOTE: The Search AV Delay value must be programmed to longer than the maximum Paced AV Delay. Search Interval The Search Interval controls the frequency at which AV Search+ will attempt a search. REFRACTORY Refractory includes the features as described.
PACING THERAPIES REFRACTORY • PVARP after PVC • PMT Termination • Rate Smoothing 5-37 PVARP after PVC PVARP after PVC is designed to help prevent PMT due to retrograde conduction, which is typically associated with PVCs. When the pulse generator detects a sensed RV event without a preceding sensed or paced atrial event, including sensed events in refractory (i.e., a PVC), the atrial refractory period automatically extends to the programmed PVARP after PVC value for one cardiac cycle.
5-38 PACING THERAPIES REFRACTORY Dynamic VRP shortens Sensing window is constant Figure 5-17.
PACING THERAPIES REFRACTORY 5-39 If the value is programmed to Smart, the pulse generator automatically adjusts the sensitivity value in order to reject far-field atrial events. This allows for sensing of true ventricular events that had previously fallen in the cross-chamber blanking period. A-Blank after V-Pace A-Blank after V-Pace, a cross-chamber blanking period, inhibits atrial sensing following a ventricular pace.
5-40 PACING THERAPIES REFRACTORY A sensed V sensed A sensed V paced A paced V sensed A paced V paced ECG Atrial Channel Ventricular Channel AV Delay after paced atrial event (150 ms) Ventricular Cross Chamber Blank (programmable) AV Delay after sensed atrial event (programmable, includes 85 ms absolute refractory) V-A interval (may be lengthened by modified ventricular timing) V Sensed Refractory (135 ms) Atrial Refractory-PVARP (programmable; includes programmable atrial cross chamber blank)
PACING THERAPIES NOISE RESPONSE A sensed RV sensed* 5-41 A paced RV sensed* ECG Atrial Sensing * An RV sense occurs during AAI pacing due to the tachycardia function of the pulse generator. Ventricular Sensing Figure 5-20.
5-42 PACING THERAPIES NOISE RESPONSE RV Paced event RV Sensed event Noise window (40 ms) ECG RV Refractory: sensed = nonprogrammable paced = programmable RV Sensing Figure 5-21. Refractory periods and noise windows, RV If Noise Response is programmed to Inhibit, and the sensed noise extends the noise window beyond the programmed paced or sensed interval, the pace escape interval timing will reset and the pulse generator will not pace until one escape interval after the noise ceases.
PACING THERAPIES VENTRICULAR TACHY SENSING INTERACTIONS 5-43 VENTRICULAR TACHY SENSING INTERACTIONS Refractory periods and blanking intervals are an integral part of the pulse generator sensing system. They are used to efficiently suppress detection of pulse generator artifacts (e.g., a pace or shock) and certain intrinsic signal artifacts (e.g., a T-wave or far-field R-wave). The pulse generator does not discriminate between events that occur during refractory periods and blanking intervals.
5-44 PACING THERAPIES VENTRICULAR TACHY SENSING INTERACTIONS will not be detected because every beat will occur during the 500 ms VRP, either concurrent with a ventricular pace or 400 ms after a pace (Figure 5-22 on page 5-44). NOTE: It is not required for the VT to start concurrently with a pace for undersensing to occur. In this example, all pacing will be inhibited and tachy detection will subsequently occur, as soon as a single VT beat is detected.
PACING THERAPIES VENTRICULAR TACHY SENSING INTERACTIONS • 5-45 VT zone = 150 bpm (400 ms) In this scenario, the pulse generator is DDDR pacing at 600 ms. A VRP of 230 ms follows each ventricular pace; a ventricular refractory period of 65 ms (V-Blank After A-Pace) follows each atrial pace; an atrial pace occurs 300 ms after each ventricular pace. VT beats that occur during either refractory period are ignored for purposes of pacemaker timing and ventricular tachy detection/therapy.
5-46 PACING THERAPIES VENTRICULAR TACHY SENSING INTERACTIONS Programming Considerations Certain programmed combinations of pacing parameters are known to interfere with ventricular tachy detection. The risk of ventricular tachy undersensing due to device refractory periods is indicated by the interactive warnings on the parameter screen.
PACING THERAPIES VENTRICULAR TACHY SENSING INTERACTIONS 5-47 • In certain usage scenarios, you may elect to program long AV Delays to reduce ventricular pacing for patients with long PR intervals, while providing sensor pacing or rate smoothing to address other patient needs. • In certain usage scenarios, if a pattern of atrial pacing and VT beats is detected, the AV delay is automatically adjusted to facilitate confirmation of a suspected VT.
5-48 PACING THERAPIES VENTRICULAR TACHY SENSING INTERACTIONS - DRAFT -
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.
6-4 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 • Telemetry communication is interrupted A pace threshold test can be performed from the Lead Tests screen using the following steps: 1. Select the desired chamber to be tested 2. Select the Pace Threshold details button 3. Select the test type 4.
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 7-13 - 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 ATRa 4 1 3 PMTa 4 1 3 a. Not available in VR models. Once the history data is saved to a disk, it can be accessed at any time without device interrogation.
7-4 PATIENT DIAGNOSTICS TRENDS 2. Choose the Select Trends button to specify the trends you want to view.
PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 7-5 Rate Smoothing events (e.g., RVP↑) PVC Heart Rate Trend data may not be reported for a variety of reasons; the most common 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 hours ARRHYTHMIA LOGBOOK The Arrhythmia Logbook screen provides the following information about each event (Figure 7-1 on page 7-5): Figure 7-1.
7-6 PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 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. While retrieving the data, the programmer will display a window indicating the progress of the interrogation.
PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 7-7 • 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 ended ATR Episodes • Episode number, date, time, and type (ATR) • Average atrial and ventricular rate during ATR mode switch • Duration PMT Episodes • Episode number, date, time, and type (PMT) • Atrial
7-8 PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK Stored Electrograms The pulse generator can store annotated electrograms sensed from the following leads prior to the onset of an episode around duration met, and around therapy start and end: • Shock lead • RV pace/sense lead • Atrial pace/sense lead The particular electrograms stored depend upon the episode type. The EGM storage capacity varies depending on EGM signal condition and heart rate. The stored data are shared by all events.
PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 7-9 Attempt information may be displayed as Attempt or In Progress, if an attempt is in progress.
7-10 PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 1. Select the EGM tab to view the stored EGMs on the screen. • EGM strips for the appropriate sources are displayed. Each strip includes the EGMs sensed during the episode with the corresponding annotated markers. Blue vertical bars indicate the segment (Onset, Attempt, End) boundaries. • You can move the calipers along the trace and will display the time interval between the calipers. • A speed button changes the trace speed in millimeters/seconds. 2.
PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK 7-11 Histograms The Histograms feature retrieves information from the pulse generator and displays the total number and percentage of paced and sensed events for the chamber.
7-12 PATIENT DIAGNOSTICS ARRHYTHMIA LOGBOOK • Total episodes • Treated––VF, VT, VT-1, and Commanded • 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 and AV Search+ % successful • Atrial burden––includes Episodes by Duration and Total PACs • Ventricular counters––includes total PVCs and Three or More PVCs 7-13 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.
7-14 PATIENT DIAGNOSTICS PATIENT TRIGGERED MONITOR 1. From the Settings tab on the main screen, select Settings Summary. 2. From the Settings Summary tab, select Ventricular Tachy Therapy. 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.
PATIENT DIAGNOSTICS PATIENT TRIGGERED MONITOR 7-15 For additional information, contact Technical Services at the number shown on the back cover of this manual.
7-16 PATIENT DIAGNOSTICS PATIENT TRIGGERED MONITOR - DRAFT -
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: • 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 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 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. Shock on T induction is complete when the drive train and shock are delivered, at which time the pulse generator automatically restarts detection. NOTE: Prior to drive train delivery, tones will be heard indicating capacitor charging in preparation for shock delivery.
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 Whichever lead configuration is used for both pacing/sensing and defibrillating, several considerations and cautions should be heeded. Such factors as cardiomegaly or drug therapy may necessitate repositioning of the defibrillating leads or substituting one lead for another to facilitate arrhythmia conversion.
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 Step F: • If an abdominal implant is suitable, it is recommended that implantation occur on the left abdominal side. • Tunnel the leads if necessary. If a Guidant tunneler is not used, cap the lead terminal pins, gently tunnel the leads subcutaneously to the implantation pocket, and reevaluate the lead signals to determine if any of the leads have been damaged during the tunneling procedure.
IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR 9-7 Defib (-) Defib (+) Suture Hole RV (-) RA (-) Front of Pulse Generator Figure 9-4. Setscrew and suture hole locations, dual chamber 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. Fully insert each lead into its lead port and then tighten the setscrew onto the electrodes. 1.
9-8 IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR 3. In models with atrial connectors, insert and secure the atrial pace/sense lead terminal into the A lead port. 4. In models with DF-1 connectors, insert the defibrillating lead anode (+, proximal) into the pulse generator’s (+) Defib lead port. For proper connection, be certain that the lead terminal pin is fully inserted in the pulse generator lead port.
IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR Step G: 9-9 • If necessary, lubricate the lead connectors sparingly with sterile water to make 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 it gently 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 it difficult to fully insert leads.
9-10 IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR CAUTION: Never implant the device with a lead system that has less than 15 Ω total shock lead impedance. Device damage may result. If a shocking lead impedance is less than 20 Ω, reposition the shocking electrodes to allow a greater distance between the shocking electrodes. Step H: Program the Pulse Generator 1.
IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR 9-11 Defib (-) Suture Hole Defib (+) RV (-) Front of Pulse Generator Figure 9-5. Setscrew and suture hole locations, single chamber Defib (-) Defib (+) Suture Hole RV (-) RA (-) Front of Pulse Generator Figure 9-6. Setscrew and suture hole locations, dual chamber 3. Close the implantation pocket. Consideration should be given to place the leads in a manner to prevent contact with suture materials.
9-12 IMPLANT INFORMATION IMPLANTING THE PULSE GENERATOR and provide clinical data on the performance of the implanted system. Keep a 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.
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 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 Beeper Feature The pulse generator contains a beeper that emits audible tones to communicate status information. The beeper includes both programmable and nonprogrammable features.
POST IMPLANT INFORMATION POST IMPLANT FEATURES 10-5 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. Refer to "Magnet Feature" on page 10-5 for more information.
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 Right Ventricular ATP Amplitudea (V) 3 zones (one value for all zones) 0.1, 0.2, ..., 3.5, 4.0, ..., 7.5 0.1, 0.2, ..., 3.5, 4.0, ..., 7.5 –– 5.0 (Tolerance ± 15% or ± 100 mV, whichever is greater) Right Ventricular ATP Amplitudea (V) 2 zones (one value for all zones) –– 0.1, 0.2, ..., 3.5, 4.0, ..., 7.5 –– 5.
A-10 PROGRAMMABLE OPTIONS Table A-12. Pacing therapy parameters (Normal, Post-Therapy, and Temporary) (specified into a 750 Ω load) Parameter Programmable Values Nominal Modea DDD(R), DDI(R), VDD(R), VVI(R), AAI(R), Off; Temporary: DDD, DDI, DOO, VDD, VVI, VOO, AAI, AOO, Off DDD (DR); VVI (VR) b g k Lower Rate Limit (LRL)a c ( ppm) 30, 35, ..., 185 60 (Tolerance ± 5 ms) Maximum Tracking Rate (MTR) ( ppm) gj 30, 35, ...
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 (ms) 30, 40, ..., 400 150 (Tolerance ± 5 ms) (ms) 30, 40, ..., 400 65 (Tolerance ± 5 ms) Off, On Off 32, 64, 128, 256, 512, 1024 32 (Tolerance ± 1 cycle) 30,40 ..., 400 300 (Tolerance ± 5 ms) Off, On On -80, -75, ...
A-12 PROGRAMMABLE OPTIONS Table A-13. Atrial Tachy Parameters (continued) Parameter Programmable Values Nominal 0, 8, 16, 32, 64, 128, 256, 512, 1024, 2048 8 (Tolerance ± 1 cardiac cycle) 1, 2, ..., 8 8 1, 2, ..., 8 8 VDI, DDI, VDIR, DDIR DDI ATR Fallback Timea b (min:sec) 0, 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00 0:30 ATR/VTR Fallback LRLa b ( ppm) 30, 35, ..., 185 70 (Tolerance ± 5 ms) ATR VRRa Off, On On 30, 35, ...
PROGRAMMABLE OPTIONS Table A-15. Magnet and Beeper functions Parameter Programmable Values Nominal Magnet Response Off, Store EGM, Inhibit Therapy Inhibit Therapy Beep During Capacitor Charge Off, On Off Beep When Explant is Indicated Off, On On Parameter Programmable Values Nominal Atrial Sensitivity AGC 0.15, AGC 0.2, AGC 0.25, AGC 0.3, AGC 0.4, ..., AGC 1.0, AGC 1.5 AGC 0.25 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.
A-14 PROGRAMMABLE OPTIONS Table A-18. 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-19. 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-22. 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-16 PROGRAMMABLE OPTIONS - DRAFT -
B-1 PACEMAKER INTERACTION APPENDIX B There may be instances where patients may have a separate temporary or permanent pacemaker.
B-2 PACEMAKER INTERACTION • The ICD rate-sensing electrodes should be as far from the pacing electrodes as possible. • After implanting the pacing leads, examine the signals from the ICD rate-sensing electrodes to ensure that minimal pacemaker artifacts are present. • Since it is difficult to predict the relative magnitudes of pacemaker artifacts and various tachyarrhythmia electrograms that may occur chronically or during EP testing, it is important to reduce artifacts to a minimum.
PACEMAKER INTERACTION STEP ONE Test for inappropriate tachy therapy due to multiple counting of pacing artifacts/depolarization. STEP TWO Test for inappropriate inhibition of tachy therapy due to detection of pacing artifacts instead of the arrhythmia. STEP THREE Final device programming. Test all tachyarrhythmias. Observe the electrogram on the rate-sensing electrodes by reviewing the rate-sensing recording on the PRM programming system.
B-4 PACEMAKER INTERACTION - DRAFT -
C-1 CLINICAL STUDY - MADIT II APPENDIX C SUMMARY Guidant Cardiac Rhythm Management has received FDA approval for the following expanded indications for patients identified by the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) to be at high risk for sudden cardiac death.
C-2 CLINICAL STUDY - MADIT II reported for a total of 1,206 patients as of the data cutoff date of January 16, 2002. The number of patients is less than the total enrolled 1,232 patients because not all patients had reached the point of the one-month follow-up. The observed adverse events do not reflect an intention-to-treat analysis. Table C-1.
CLINICAL STUDY - MADIT II Table C-1. C-3 Adverse events through the randomization period (continued) Adverse Event # Of Events (# of pts)a % Complications (Patients) Complications per 100 Device Months (Events) % Observations (Patients) Observations per 100 Device Months (Events) 132 (91a) 2.9 (35) 0.2 (37) 4.9 (59) 0.4 (95) 13 (13) 0.8 (9) 0.0 (9) 0.3 (4) 0.0 (4) Lead problem 2 (2) 0.1 (1) 0.0 (1) 0.1 (1) 0.0 (1) Patient bleeding 2 (2) 0.1 (1) 0.0 (1) 0.1 (1) 0.
C-4 CLINICAL STUDY - MADIT II Table C-1. Adverse events through the randomization period (continued) Adverse Event # Of Events (# of pts)a % Complications (Patients) Complications per 100 Device Months (Events) % Observations (Patients) Observations per 100 Device Months (Events) 166 (110) 10.0 (73) 0.8 (112) 6.0 (44) 0.4 (54) Bradycardia, sinus 8 (8) 1.0 (7) 0.1 (7) 0.1 (1) 0.0 (1) Tachycardia 7 (7) 0.3 (2) 0.0 (2) 0.7 (5) 0.0 (5) AV Block, Complete 1 (1) 0.1 (1) 0.1 (1) 0.
CLINICAL STUDY - MADIT II Table C-1. C-5 Adverse events through the randomization period (continued) Adverse Event # Of Events (# of pts)a % Complications (Patients) Complications per 100 Device Months (Events) % Observations (Patients) Observations per 100 Device Months (Events) 6 (5) 0.4 (2) 0.0 (3) 0.6 (3) 0.0 (3) Syncope 35 (31) 4.8 (23) 0.3 (24) 2.1 (10) 0.1 (11) Infarction, myocardial 19 (17) 3.6 (17) 0.2 (19) 0.0 (0) 0.0 (0) Angina pectoris 93 (71) 10.7 (51) 0.8 (64) 5.
C-6 CLINICAL STUDY - MADIT II MORTALITY There were a total of 202 deaths that occurred during the trial and recorded as of the stop date, November 20, 2001. These deaths occurred during the study periods as shown in Table C-2 on page C-6 along with the cause of death as adjudicated by an independent events committee. Table C-2. Cause of death during the treatment period ICD Therapy (N=742) Patients (%) Conventional Therapy (N=490) Patients (%) Total (N=202) Noncardiac 25 (3.4%) 21 (4.3%) 46 (3.
CLINICAL STUDY - MADIT II C-7 STUDY DESIGN MADIT II was a prospective, randomized (3:2 ICD to conventional non-ICD therapy), controlled, unblinded, multicenter trial. Randomization to the ICD group consisted of implantation of a legally marketed Guidant ICD device. Randomization to the conventional therapy group consisted of beta-adrenergic blocking drugs and angiotensin-converting enzyme (ACE) inhibitors when indicated.
C-8 CLINICAL STUDY - MADIT II • Determine if Holter-recorded noninvasive electrocardiologic parameters (SAECG, heart rate variability, temporal dispersion of refractoriness, T-wave alternans, and T-wave lability) can identify patients with an increased mortality rate in the non-ICD group. • Evaluate the cost-effectiveness of ICDs in saving lives. • Determine if ICD therapy is associated with an improved quality of life.
CLINICAL STUDY - MADIT II C-9 • NYHA functional Class IV • Current use of antiarrhythmic agents except when indicated for atrial arrhythmias • Coronary artery bypass graft surgery or PTCA within the past 3 months • Enzyme-positive myocardial infarction ≤ 30 days prior to enrollment • Patients with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or PTCA in the foreseeable future • Patients
C-10 CLINICAL STUDY - MADIT II PATIENT STATUS There were a total of 1,232 patients with a prior myocardial infarction and a left ventricular ejection fraction of ≤ 0.30 enrolled in the MADIT II trial. A total of 742 patients were randomized to receive an ICD and 490 patients were randomized to conventional therapy. Figure C-1 on page C-10 provides an overview of the patient enrollment.
CLINICAL STUDY - MADIT II C-11 logarithmic transformation. The p-values were termed nominal when they were not adjusted for sequential monitoring. All p-values were two-tailed. At the recommendation of the Data and Safety Monitoring Board (DSMB), the trial was stopped on November 20, 2001, when it was revealed that the difference in mortality between the two groups had reached the prespecified efficacy boundary (p=0.027) (Figure C-2 on page C-11). 20 Upper Boundary: 11.77 + 0.1273*V 1 v.
C-12 CLINICAL STUDY - MADIT II STUDY RESULTS Study Duration Study duration, measured in months, is displayed in Table C-3 on page C-12. The mean duration was similar between the ICD group and the conventional therapy group. As expected, the ICD group accumulated >15,000 months of follow-up. Table C-3. Study duration in months Therapy No. Mean ±SD Minimum Maximum Cumulative ICD Therapy 742 20.5 12.9 0.2 51.7 15,190 Conventional Therapy 490 19.6 12.6 0.2 52.
CLINICAL STUDY - MADIT II Table C-4. C-13 Patient population characteristics (continued) Characteristic p-value ICD Patients (n=742) Conventional Therapy Patients (n=490) No CHF 179 (24.1%) 129 (26.3%) Class I 75 (10.1%) 58 (11.8%) Class II 258 (34.8%) 162 (33.1%) Class III 187 (25.2%) 111 (22.7%) Class IV 33 (4.5%) 20 (4.1%) Unknown 10 (1.4%) 10 (2.0%) Class I 126 (16.9%) 81 (16.5%) Class II, III, IV 168 (23.1%) 120 (24.4%) 35 (4.7%) 15 (3.1%) 402 (54.1%) 268 (54.
C-14 CLINICAL STUDY - MADIT II inhibitors, beta blockers, or digitalis therapy between the ICD therapy group and the conventional therapy patients. Table C-5. Patient population medication therapy ICD Patients (n = 742) Conventional Therapy Patients (n = 490) p-value Baseline/Enrollment 574 (77.4%) 377 (76.9%) 0.47 Last Follow-up 533 (71.8%) 363 (74.1%) 0.31 Baseline/Enrollment 49 (6.6%) 36 (7.3%) 0.41 Last Follow-up 94 (12.7) 51 (10.4%) 0.23 Baseline/Enrollment 18 (2.4%) 15 (3.
C-15 CLINICAL STUDY - MADIT II Table C-5. Patient population medication therapy (continued) Medication ICD Patients (n = 742) Conventional Therapy Patients (n = 490) p-value Baseline/Enrollment 7 (0.9%) 3 (0.6%) 0.38 Last Follow-up 18 (2.4%) 4 (0.8%) 0.05 All Cause Mortality The Kaplan Meier mortality curves depicting mortality for the two groups are shown in Figure C-3 on page C-15.
C-16 CLINICAL STUDY - MADIT II Table C-6. Cumulative mortality and percentage reduction (continued) Conventional Arm ICD Arm Difference Reduction CIa% p-valueb 2 Years 21.5 15.5 6.0 28% 5, 46 0.02 3 Years 30.4 21.6 8.8 29% 6, 46 0.02 Year a. Indicates Confidence Interval for the percentage reduction in cumulative mortality.
CLINICAL STUDY - MADIT II C-17 therapy group and 0.0069 each month in the ICD group, with the ratio, 0.69, in agreement with that reported above. Verification of ICD Shock Therapy Treatment Of the 710 patients that were implanted with an ICD, 134 received appropriate therapy for ventricular tachycardia/ventricular fibrillation (VT/VF) and the probability of therapy increased over time.
C-18 CLINICAL STUDY - MADIT II Table C-8. Adverse events requiring hospitalizations (Rate/Year) Treatment Group Cumulative Years of Observation Total Number of Individuals with Adverse Events Rate per Year of Individuals with Adverse Events p-value 703.6 201 (41%) 0.29 0.85 1155.97 337 (45%) 0.29 Conventional (n=490) ICD Therapy Group (n=742) Table C-9 on page C-18 provides a summary of hospitalizations that were required as a result of congestive heart failure (CHF) related adverse events.
CLINICAL STUDY - MADIT II Table C-10. C-19 Reasons for crossovers by treatment group (continued) Description ICD Therapy (n=742) Conventional Therapy (n=490) Nonconversion of arrhythmia 1 0 Physician Discretion 0 1 Total Crossovers (54) 32 22 A crossover patient was defined as a patient who, at the time of a specified data cutoff date, was receiving treatment that was different than their originally randomized assignment.
C-20 CLINICAL STUDY - MADIT II Table C-11. Follow-up compliance (continued) Follow-up Sequence Month % Compliant ICD Group % Compliant Conventional Therapy Group 43–51 months 96 100 Total Average 96 94 Subgroup Analysis of MADIT II Patient Population Figure C-5 on page C-20 provides the hazard ratios and 95 percent confidence intervals for death from any cause in the ICD group as compared to the conventional therapy group according to selected clinical characteristics.
CLINICAL STUDY - MADIT II C-21 at implant using a catheter method and 24 (12 percent) using the ICD for induction; there was no data on the method of induction for 6 patients. The Occurrence of ICD Therapy for VT, VF, or VT/VF Combined Therapy for VT was defined as antitachycardia pacing (ATP) or ICD shock delivered by the device in an attempt to stop an arrhythmia as reported by the enrolling center. Therapy for VF was defined as the delivery of ICD shock therapy.
C-22 CLINICAL STUDY - MADIT II percent (p=0.08). As a consequence of these opposite directional effects of similar magnitudes, there was no reliable evidence that inducibility affects the frequency of VT/VF events (p=0.26); it may be associated with a slight increase since VT events occur more frequently than VF. Table C-13.
D-1 CLINICAL STUDY - VENTAK AV II DR APPENDIX D CLINICAL STUDY POPULATIONS Guidant ICDs have been demonstrated to be safe and effective in patient populations including, but not limited to, those with: • Prior myocardial infarction and an ejection fraction (EF) ≤ 30%, based on the Guidant sponsored MADIT II clinical study. (Guidant devices were the only devices studied in the MADIT II clinical trial. The trial demonstrated these devices to be safe and effective in the MADIT II population.
D-2 CLINICAL STUDY - VENTAK AV II DR Patients Studied The patients (46 M/ 6 F) had a mean age of 60 years (range 30 to 78) and a left ventricular ejection fraction of 36% (14% to 76%). Most (86%) presented with coronary artery disease or ischemic cardiomyopathy and 53% presented with monomorphic ventricular tachycardia (MVT) as their primary arrhythmia. Methods This was an observational study. No control group was used.
CLINICAL STUDY - VENTAK AV II DR D-3 for 80% of patients tested; in all cases, the physician was able to program appropriate adaptive-rate settings to accommodate patient need (Table D-1 on page D-3). Table D-1. Implant study results Effectiveness Measure VENTAK AV II DR Mean + SD [95% CI] N 10.3 + 3.7 [8.8, 11.8] N = 26 Defibrillation threshold (J) stored energy Safety Measure Rate (%) Operative mortality 1/52 (1.9%) Conversion efficacy for all ventricular arrhythmias - DRAFT - 425/432 (98.
D-4 CLINICAL STUDY - VENTAK AV II DR - DRAFT -
E-1 CLINICAL STUDY - VITALITY APPENDIX E CLINICAL STUDY POPULATIONS Guidant ICDs have been demonstrated to be safe and effective in patient populations including, but not limited to, those with: • Prior myocardial infarction and an ejection fraction (EF) ≤ 30%, based on the Guidant sponsored MADIT II clinical study. (Guidant devices were the only devices studied in the MADIT II clinical trial. The trial demonstrated these devices to be safe and effective in the MADIT II population.
E-2 CLINICAL STUDY - VITALITY selected from the investigator’s general patient population who met the indications for use of the VITALITY device were followed through pre-discharge, 2-week and 1-month follow-ups and continued every 3 months thereafter until study closure. Results A total of 100 patients were enrolled in this study. Of these, 96 patients were successfully implanted, with 4 intents. Ninety-three (93) patients finished their 1-month follow-up per the study protocol.
CLINICAL STUDY - VITALITY Table E-1. E-3 VITALITY Chronic Study Results (continued) Secondary Endpoints Acute Automatic Rhythm ID Accuracy (2 weeks) 100% Automatic Rhythm ID Accuracy (1 month) 97.7% Manual Rhythm ID Accuracy (1 month) 100% a. GEE adjusted specificity = 93.7% b. Combined specificity includes both Induced and Spontaneous data.
E-4 CLINICAL STUDY - VITALITY complication and two observations reported in the acute study, all of which were non-investigational device related. No patient deaths were reported. The VT/VF detection time of the VITALITY ICD was found to be within two seconds of the VENTAK PRIZM 2 detection time, leading to the conclusion that activating the additional VITALITY features does not have a negative effect on the existing ICD sensing and detection functionality (Table E-2 on page E-4). Table E-2.
F-1 CLINICAL STUDY - SUMMARY OF GDT1000 SENSING ACUTE STUDY APPENDIX F CLINICAL STUDY POPULATIONS GDT1000 study included patients indicated for a CRT-D device.
F-2 CLINICAL STUDY - SUMMARY OF GDT1000 SENSING ACUTE STUDY Protocol Testing Four scenarios were tested, including different combinations of sensed atrial signals (AS), paced atrial signals (AP), sensed ventricular signals (VS), and paced ventricular signals (VP), i.e., AS/VS, AS/VP, AP/VS, and AP/VP. Sensing algorithm performance was analyzed from patients’ real-time electrograms (EGM) and electronic signals.
CLINICAL STUDY - SUMMARY OF GDT1000 SENSING ACUTE STUDY F-3 STUDY RESULTS Patient Characteristics The table below shows the characteristics of the patients implanted or attempted (Table F-1 on page F-3). Table F-1. All patients implanted or attempted, Phase 1 and Phase 2 Characteristic Measurement Phase 1 Result (N=29) Phase 2 Result (N=19) Age at implant Mean ± SD 65.8 ± 12.2 68.1 ± 9.6 Range [44.6, 85.5] [51.3, 81.8] Gender [N (%)] Female 14 (48.0) 14 (74.0) Male 15 (52.0) 5 (26.
F-4 CLINICAL STUDY - SUMMARY OF GDT1000 SENSING ACUTE STUDY placed in the septal wall (0/1) and unspecified location (1/0). A majority of the left ventricular leads were implanted in the lateral, postero-lateral, or posterior wall (21/15), with the remaining placed in an antero-lateral, anterior, or postero-septal location (4/3). Lead Configurations In this study, both RA and RV leads used a bipolar configuration, which was not programmable.
CLINICAL STUDY - SUMMARY OF GDT1000 SENSING ACUTE STUDY F-5 sensed events (223 undersense and 833 oversense events). The sensing algorithm used in the first phase achieved the sensitivities, specificities, positive predictive values (PPV), rates of undersensing (1-sensitivity), and rates of oversensing (1-PPV) are summarized in the table below (Table F-3 on page F-5). Table F-3.
F-6 CLINICAL STUDY - SUMMARY OF GDT1000 SENSING ACUTE STUDY Table F-4. Left Ventricular Channel Summary of Sensing Performance - Second Phase (continued) Specificity Sensitivity (Rate of Undersensing) Positive Predictive Value (Rate of Oversensing) Appropriate Sensed Beats Inappropriate Sensed Beats: Undersense Inappropriate Sensed Beats: Oversense 99.98% (0.016%) 99.99% (0.008%) 12,227 2 1 35,831 2 169 99.
CLINICAL STUDY - SUMMARY OF GDT1000 SENSING ACUTE STUDY F-7 Undersense Events LV undersense events (223) in the first phase of the study primarily occurred in one patient whose LV intrinsic amplitude was less than 1.0 mV, which is much smaller than the clinically acceptable threshold. This small LV intrinsic amplitude resulted in undersensing some LV events. Two LV undersense events occurred in the second phase of the study.
F-8 CLINICAL STUDY - SUMMARY OF GDT1000 SENSING ACUTE STUDY - DRAFT -
INDEX Symbols 50 Hz/manual burst pacing 8-9 A A-blank after RV-sense 5-39 after V-pace 5-39 A-tachy response (ATR) mode switch 5-19 Accelerate, in zone 4-3 Accelerometer 5-13 activity threshold 5-14 reaction time 5-15 recovery time 5-18 response factor 5-16 Activity threshold 5-14 Adaptive-rate pacing 5-12 Adverse event 1-18 AFib rate threshold 3-28, 3-35, 3-37 Amplitude 5-8 ATP (antitachycardia pacing) 4-18 intrinsic test 6-7 Application screen 2-6 Arrhythmia logbook 7-5 episode detail 7-6 events summary
Search Interval 5-36 B Backup VVI pacing during atrial stimulation, EP test 8-2 Battery Beginning of life (BOL) 6-2 Explant status 6-2 icon 2-9 indicator 6-2 status 6-2 Beep during capacitor charge 6-5 feature setup 10-4 Blanking A-blank after RV-sense 5-39 A-blank after V-pace 5-39 Blanking; Noise rejection, blanking 5-38 Burst ATP (antitachycardia pacing) 4-11 cycle length (BCL) 4-14 minimum interval 4-14 number of bursts 4-11 pacing, 50 Hz/manual burst 8-9 parameter 4-11 pulse count 4-11 scheme 4-15 But
onset 3-33 rate sensing 3-3 rate threshold 3-4 reconfirmation/committed shock 4-23 redetection 3-11 stability 3-31 sustained rate duration (SRD) 3-34 tachyarrhythmia 3-1 tachyarrhythmia, safety mode 2-19 V rate > A rate 3-27 vector timing and correlation 3-26 ventricular, initial 3-6 window 3-13 Device characteristics as shipped 1-22 description 1-4 mode 3-2 specification 1-19 storage 1-8 Diagnostic battery status 6-2 histogram 7-11 lead test 6-6 patient triggered monitor 7-13 Disk data 2-11 read 2-11 save
F Fallback, atrial mode switch LRL 5-23 mode 5-22 time 5-22 Federal Communications Commission (FCC) 1-24 Fibrillation VFib induction 8-5 Follow-up examination, routine 10-2 predischarge 10-2 test 10-2 H Histogram 7-11 Horizontal slider icon 2-9 I Icon battery 2-9 check 2-9 details 2-8 event 2-9 horizontal slider 2-9 increment and decrement 2-10 lead 2-9 patient 2-9 patient information 2-11 Programmer/recorder/monitor (PRM) mode indicator 2-6 run 2-9 scrolling 2-10 sorting 2-9 vertical slider 2-9 Identifi
N test 6-6 Logbook 7-5 Longevity pulse generator 1-25 Lower rate limit (LRL) 5-4 Noise response 5-41 Nominal parameter setting A-1 Number of bursts 4-11 pulse count 4-11 M Magnet 1-8 electromagnetic interference (EMI) 1-12 feature setup 10-5 inhibit tachy therapy 10-5 static magnetic fields 1-16 Magnetic fields 1-16 Magnetic Resonance Imaging (MRI) 1-7 Manual programming 2-5 Manual/50 Hz burst pacing 8-9 Maximum pacing rate 5-24 sensor rate (MSR) 5-6 tracking rate (MTR) 5-5 Maximum pacing rate rate smoot
sensitivity 5-8 sensor 5-11 temporary 5-10 therapy 5-2 Package content 1-21 symbol on 1-21 Parameter, characteristics 1-22 Patient counseling information 1-27 handbook 1-28 information icon 2-9 Patient triggered monitor 7-13 PES (programmed electrical stimulation) 8-7 PMT (pacemaker-mediated tachycardia) termination 5-25 Polarity shock 4-22 Post implant information 10-2, 10-3 beeper feature 10-4 magnet feature 10-5 sensitivity adjustment 10-3 Post-shock detection parameter 3-11 duration 3-17 pacing 5-9, 5-1
AFib threshold 3-28 calculation 3-4 lower limit (LRL) 5-4 maximum sensor 5-6 maximum tracking 5-5 sensing 3-3 sustained rate duration (SRD) 3-34 threshold, ventricular 3-4 V rate > A rate 3-27 ventricular 3-4 zone 3-4 Rate enhancement, pacing 5-26 rate hysteresis 5-26 rate smoothing 5-28 Rate smoothing 5-28 down 5-31 Maximum pacing rate 5-31 up 5-31 Rate threshold, ATR 5-20 Reaction time 5-15 Read disk 2-11 Reconfirmation 3-10, 4-23 Recovery time 5-18 Red warning conditions 2-10 Redetection 3-11 after ATP d
on T induction 8-6 polarity 4-22 post-shock pacing 5-9, 5-10 redetection 3-17 selection 4-3 sequence 4-2 STAT SHOCK 2-17 therapy 4-21 ventricular therapy 4-21 waveform 4-22 Shock if unstable 3-33 Shock on T induction 8-6 Software terminology 2-6 Sorting icon 2-9 Specification, mechanical 1-19 Stability 3-10, 3-31, 3-35, 3-37, 3-38 STAT PACE 2-18 STAT SHOCK 2-17 Sterilization 1-8 Stimulation, PES induction 8-7 Storage of device 1-8 Stored EGM arrhythmia logbook 7-8 Sustained rate duration (SRD) 3-34 Suture h
Trends 7-3 X X-ray identifier 1-23 V V rate > A rate 3-27 Vector timing and correlation 3-26, 3-35 Ventricular ATP (antitachycardia pacing) 4-10 detection, tachyarrhythmia 3-6 redetection after ventricular ATP therapy 4-8 redetection after ventricular shock therapy 4-9 redetection after ventricular therapy delivery 4-8 shock therapy 4-21 tachy mode 3-2 tachyarrhythmia therapy 4-2 Ventricular rate regulation 5-24 maximum pacing rate 5-24 Ventricular shock vector 4-21 Vertical slider icon 2-9 VFib induction
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