SYSTEM GUIDE COGNIS™ 100-D CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR REF N118, N119 CAUTION: Federal law restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow-up procedures.
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ABOUT THIS MANUAL Boston Scientific Corporation acquired Guidant Corporation in April 2006. During our transition period, you may see both the Boston Scientific and Guidant names on product and patient material. As we work through the transition, we will continue to offer doctors and their patients technologically advanced and high quality medical devices and therapies. The text conventions discussed below are used throughout this manual.
AT: ATP: ATR: AV: BiV: BCL: BOL: CPR: CRT: CRT-D: ECG: DFT: EAS: EF: EGM: EMI: EP: FCC: HE: HRV: IBP: IC: ICD: LRL: LV: LVPP: LVRP: MI: MPR: MRI: MSR: MTR: NSR: PAC: PAT: PES: PMT: PRM: PSA: PVARP: PVC: RADAR: RF: Atrial Tachycardia Antitachycardia Pacing Atrial Tachy Response Atrioventricular Biventricular Burst Cycle Length Beginning of Life Cardiopulmonary Resuscitation Cardiac Resynchronization Therapy Cardiac Resynchronization Therapy Defibrillator Electrocardiogram Defibrillation Threshold Electronic
RV: RVRP: SCD: SRD: SVT: TARP: TENS: V: VFib: VF: VRP: VRR: VT: VTR: Right Ventricular Right Ventricular Refractory Period Sudden Cardiac Death Sustained Rate Duration Supraventricular Tachycardia Total Atrial Refractory Period Transcutaneous Electrical Nerve Stimulation Ventricular Ventricular Fibrillation Ventricular Fibrillation Ventricular Refractory Period Ventricular Rate Regulation Ventricular Tachycardia Ventricular Tachycardia Response - DRAFT -
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CONTENTS INFORMATION FOR USE ................................................................................................. CHAPTER 1 1-1 New or Enhanced Features................................................................................................ 1-3 Device Description.............................................................................................................. 1-4 Related Information .......................................................................................
Patient Counseling Information ........................................................................................ Patient Handbook ...................................................................................................... 1-28 1-29 USING THE PROGRAMMER/RECORDER/MONITOR..................................................... CHAPTER 2 2-1 ZOOM LATITUDE Programming System ........................................................................... 2-2 Indications-Based Programming (IBP) ..
Backup Defibrillator.................................................................................................... Programming the Device Safety Tachy Mode............................................................ 2-19 2-20 TACHYARRHYTHMIA DETECTION.................................................................................. CHAPTER 3 3-1 Device Mode....................................................................................................................... Ventricular Tachy Mode.
QUICK CONVERT ATP ............................................................................................. 4-20 Ventricular Shock Therapy and Parameters..................................................................... Ventricular Shock Vector............................................................................................ Ventricular Shock Energy........................................................................................... Charge Time ......................................
Atrial Flutter Response (AFR).................................................................................... PMT Termination........................................................................................................ 5-34 5-35 Rate Enhancements ......................................................................................................... Tracking Preference................................................................................................... Rate Hysteresis........
PATIENT DIAGNOSTICS................................................................................................... CHAPTER 7 7-1 Therapy History .................................................................................................................. 7-2 Trends ................................................................................................................................ 7-3 Arrhythmia Logbook ...............................................................................
Step H: Program the Pulse Generator .................................................................... Step I: Implant the Pulse Generator ........................................................................ Step J: Complete and Return the Implantation Form .............................................. 9-10 9-11 9-12 POST IMPLANT INFORMATION..................................................................................... CHAPTER 10 10-1 Follow Up Testing ......................................
Patient Accountability and Follow-up Duration ................................................................. B-16 Data Analysis and Results for Primary Endpoint and Secondary All-Cause Mortality Endpoint ........................................................................................................................... B-20 Additional Study Data ....................................................................................................... B-25 Additional Outcome Measures ...........
Demographic Data.............................................................................................................. D-8 Endpoints............................................................................................................................ D-8 Study Results ..................................................................................................................... D-9 Focused Confirmatory Study ..........................................................................
Study Results ..................................................................................................................... F-2 Conclusions ...................................................................................................................... F-10 CLINICAL STUDY - VITALITY.......................................................................................... APPENDIX G G-1 Clinical Study Populations ............................................................................
1-1 INFORMATION FOR USE CHAPTER 1 This chapter contains the following topics: • "New or Enhanced Features" on page 1-3 • "Device Description" on page 1-4 • "Related Information" on page 1-5 • "Indications and Usage" on page 1-6 • "Contraindications" on page 1-6 • "Warnings" on page 1-6 • "Precautions" on page 1-8 • "Potential Adverse Events" on page 1-19 • "Mechanical Specifications" on page 1-21 • "Lead Connections" on page 1-21 • "Items Included in Package" on page 1-22 • "Symbols
1-2 INFORMATION FOR USE • "Patient Counseling Information" on page 1-28 - DRAFT -
1-3 NEW OR ENHANCED FEATURES These pulse generator systems include additional features as compared to previous products. Ease of Use • • ZOOMVIEW Programmer Software: the new user interface offers the following benefits: – Clinical focus—features such as patient diagnostic trends and indications-based programming emphasize the patient’s clinical condition over device status and parameters.
1-4 INFORMATION FOR USE DEVICE DESCRIPTION Sensing • Sensing is designed to combine the strengths of both implantable cardioverter defibrillator (ICD) and pacemaker sensing capabilities to improve detection and therapy by reducing inappropriate mode switching, pacing inhibition, and shocks. DEVICE DESCRIPTION This manual contains information about the COGNIS 100 family of cardiac resynchronization therapy defibrillators (CRT-Ds) (specific models are listed in "Mechanical Specifications" on page 1-21).
INFORMATION FOR USE RELATED INFORMATION 1-5 Leads The pulse generator has independently programmable outputs and accepts the following leads: • One IS-11 atrial lead • One IS-1 coronary venous pace/sense lead • One LV-1 coronary venous pace/sense lead • One DF-1/IS-12 cardioversion/defibrillation lead The pulse generator and the leads constitute the implantable portion of the pulse generator system.
1-6 INFORMATION FOR USE INDICATIONS AND USAGE The Physician’s Technical Manual is packaged with the pulse generator. It provides the technical information needed at implant. Refer to the PRM system Operator’s Manual for specific information about the PRM such as setup, maintenance, and handling.
INFORMATION FOR USE WARNINGS 1-7 • Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to MR device scanning. Strong magnetic fields may damage the device and cause injury to the patient. • Diathermy. Do not subject a patient with an implanted pulse generator to diathermy since diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulse generator because of induced currents. Programming and Device Operations • Atrial tracking modes.
1-8 INFORMATION FOR USE PRECAUTIONS PRECAUTIONS Clinical Considerations • Pacemaker-mediated tachycardia (PMT). Retrograde conduction combined with a short PVARP might induce PMT. Sterilization, Storage, and Handling • For single use only; do not resterilize devices. Do not resterilize the device or the accessories packaged with it because the effectiveness of resterilization cannot be ensured. • If package is damaged.
INFORMATION FOR USE PRECAUTIONS 1-9 • STAT PACE settings. When a pulse generator is programmed to STAT PACE settings, it will continue to pace at the high-energy STAT PACE values if it is not reprogrammed. The use of STAT PACE parameters will decrease device longevity. • Biventricular pacing therapy. This device is intended to provide biventricular pacing therapy.
1-10 INFORMATION FOR USE PRECAUTIONS • Defibrillation power surge. Defibrillation that causes a power surge exceeding 360 watt-seconds can damage the pulse generator system. • Programming for supraventricular tachyarrhythmias (SVTs). Determine if the device and programmable options are appropriate for patients with SVTs because SVTs can initiate unwanted device therapy. • AV Delay.
INFORMATION FOR USE PRECAUTIONS 1-11 • Absence of a lead. 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. • Electrode connections. 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. • Tachy Mode to Off.
1-12 INFORMATION FOR USE PRECAUTIONS • Left Ventricular Protection Period (LVPP). Use of a long LVPP reduces the maximum LV pacing rate and may inhibit CRT at higher pacing rates. • Shunting energy. Do not allow any object that is electrically conductive to come into contact with the lead or device during induction because it may shunt energy, resulting in less energy getting to the patient, and may damage the implanted system. • Expected benefits.
INFORMATION FOR USE PRECAUTIONS 1-13 Hospital and Medical Environments • Mechanical ventilators. During mechanical ventilation, respiration rate trending may be misleading; therefore, the Respiratory Sensor should be programmed to Off. • Internal defibrillation. Do not use internal defibrillation paddles or catheters unless the pulse generator is disconnected from the leads because the leads may shunt energy. This could result in injury to the patient and damage to the implanted system.
1-14 INFORMATION FOR USE PRECAUTIONS • Electrocautery. The use of electrocautery could induce ventricular arrhythmias and/or fibrillation, cause asynchronous or inhibited pulse generator operation, or cause the pulse generator to deliver an inappropriate shock. If electrocautery cannot be avoided, observe the following precautions to minimize complications: • Select Electrocautery Protection Mode. Avoid direct contact with the pulse generator or leads.
INFORMATION FOR USE PRECAUTIONS • 1-15 Lithotripsy. Lithotripsy may permanently damage the pulse generator if the device is at the focal point of the lithotripsy beam. If lithotripsy must be used, avoid focusing near the pulse generator site. The lithotriptor is designed to trigger off the R-wave on the ECG, resulting in shock waves being delivered during the VRP. • • If the patient does not require pacing, program the pulse generator Brady Mode to Off.
1-16 INFORMATION FOR USE PRECAUTIONS • Radio frequency ablation. Exercise caution when performing radio frequency ablation procedures in device patients. If the pulse generator Tachy Mode is programmed to Monitor + Therapy during the procedure, the device may inappropriately declare a tachycardia episode and deliver therapy. Pacing therapy may also be inhibited unless the device is programmed to Electrocautery mode.
INFORMATION FOR USE PRECAUTIONS • 1-17 Radio frequency (RF) interference. RF signals from devices that operate at frequencies near that of the pulse generator may interrupt ZIP telemetry while interrogating or programming the pulse generator. This RF interference can be reduced by increasing the distance between the interfering device and the PRM and pulse generator.
1-18 INFORMATION FOR USE PRECAUTIONS • Cellular phones. Advise patients to hold cellular phones to the ear opposite the side of the implanted device. Patients should not carry a cellular phone that is turned on in a breast pocket or on a belt within 15 cm (6 inches) of the implanted device since some cellular phones may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy. Follow-up Testing • Conversion testing.
INFORMATION FOR USE POTENTIAL ADVERSE EVENTS 1-19 POTENTIAL ADVERSE EVENTS Based on the literature and on pulse generator implant experience, the following alphabetical list includes the possible adverse events associated with implantation of a pulse generator system: • Air embolism • Allergic reaction • Bleeding • Cardiac tamponade • Chronic nerve damage • Component failure • Conductor coil fracture • Death • Electrolyte imbalance/dehydration • Elevated thresholds • Erosion • Exces
1-20 INFORMATION FOR USE POTENTIAL ADVERSE EVENTS • Myocardial trauma (e.g.
INFORMATION FOR USE MECHANICAL SPECIFICATIONS 1-21 MECHANICAL SPECIFICATIONS Device mechanical specifications for specific models are listed in the table below. Table 1-1. Mechanical Specifications Model Dimensions W x H x D Volume (cm3) Mass (g) Connector Type (RV : LV) Case Electrode Surface Area (mm²) N118 6.17 x 7.95 x 0.99 32.5 72.0 IS-1/DF-1 : LV-1 6670 N119 6.17 x 7.95 x 0.99 32.5 72.0 IS-1/DF-1 : IS-1 6670 Models include ZIP telemetry with a nominal RF frequency of 916.5 MHz.
1-22 INFORMATION FOR USE ITEMS INCLUDED IN PACKAGE NOTE: The pulse generator case is used as a defibrillating electrode unless the pulse generator has been programmed to the Distal Coil to Proximal Coil (or “Cold Can”) Shock Vector. ITEMS INCLUDED IN PACKAGE The following items are included with the pulse generator: • One torque wrench • Product literature • One patient data disk NOTE: Accessories (e.g., wrenches) are intended for one-time use only. They should not be resterilized or reused.
INFORMATION FOR USE CHARACTERISTICS AS SHIPPED Table 1-2. 1-23 Symbols on packaging (continued) Description Symbol Lot number Date of manufacture Non-ionizing electromagnetic radiation Sterilized using ethylene oxide Do not reuse Dangerous voltage Consult instructions for use Temperature limitation Wand placement indicator for interrogation Opening instruction CHARACTERISTICS AS SHIPPED Refer to the table for pulse generator settings at shipment (Table 1-3 on page 1-23). Table 1-3.
1-24 INFORMATION FOR USE X-RAY IDENTIFIER Table 1-3. Characteristics as shipped (continued) Parameter Setting Pacing Therapy available DDDR Sensor Accelerometer (MV for respiratory rate trend) Pace/Sense Configuration RA: BI/BI Pace/Sense Configuration RV: BI/BI Pace/Sense Configuration LV: Off The pulse generator is shipped in a power-saving Storage mode to extend its shelf life.
INFORMATION FOR USE FEDERAL COMMUNICATIONS COMMISSION (FCC) 1-25 The x-ray identifier is embedded in the header of the device at the approximate location (Figure 1-2 on page 1-25). Header X-Ray Identifier Pulse Generator Case Figure 1-2. X-ray identifier For information on identifying the device via the PRM, refer to the PRM operator’s manual. The pulse generator model number is stored in device memory and is shown on the PRM summary screen once the pulse generator is interrogated.
1-26 INFORMATION FOR USE PULSE GENERATOR LONGEVITY PULSE GENERATOR LONGEVITY Based on simulated studies, it is anticipated that these pulse generators have average longevity to explant as shown below. The longevity expectations, which account for the energy used during manufacture and storage, apply at the conditions shown in the table along with the following: • Assumes 70 ppmLRL; DDDR mode; 100% biventricular pacing; 15% atrium pacing and 0.4 ms pacing pulse width (RA, RV, LV); RA impedance 500 Ω.
INFORMATION FOR USE WARRANTY INFORMATION • 1-27 Charging frequency Longevity is also reduced in the following circumstances: • With a decrease in pacing impedance • When Patient Triggered Monitor is programmed to On • For models with ZIP wandless telemetry, one hour of additional telemetry reduces longevity by approximately 4 days.
1-28 INFORMATION FOR USE PATIENT COUNSELING INFORMATION Refer to Boston Scientific’s CRM Product Performance Report on www.bostonscientific.com for more information about device performance, including the types and rates of malfunctions that these devices have experienced historically. While historical data may not be predictive of future device performance, such data can provide important context for understanding the overall reliability of these types of products.
INFORMATION FOR USE PATIENT COUNSELING INFORMATION • 1-29 It is Boston Scientific’s intent to provide implantable devices of high quality and reliability. However, these devices may exhibit malfunctions that may result in lost or compromised ability to deliver therapy.
1-30 INFORMATION FOR USE PATIENT COUNSELING INFORMATION - DRAFT -
2-1 USING THE PROGRAMMER/RECORDER/MONITOR CHAPTER 2 This chapter contains the following topics: • "ZOOM LATITUDE Programming System" on page 2-2 • "Indications-Based Programming (IBP)" on page 2-2 • "Manual Programming" on page 2-5 • "Software Terminology and Navigation" on page 2-5 • "Data Management" on page 2-11 • "Communicating with the Pulse Generator" on page 2-12 • "DIVERT THERAPY" on page 2-16 • "STAT SHOCK" on page 2-17 • "STAT PACE" on page 2-18 • "Safety Mode" on page 2-18 -
2-2 USING THE PROGRAMMER/RECORDER/MONITOR ZOOM LATITUDE PROGRAMMING SYSTEM ZOOM LATITUDE PROGRAMMING SYSTEM The ZOOM LATITUDE Programming System is the external portion of the pulse generator system and includes: • Model 3120 Programmer/Recorder/Monitor (PRM) • Model 2868 ZOOMVIEW Software Application • Model 6577 Accessory Telemetry Wand The ZOOMVIEW software provides advanced device programming and patient monitoring technology.
USING THE PROGRAMMER/RECORDER/MONITOR INDICATIONS-BASED PROGRAMMING (IBP) Figure 2-1. 2-3 Indications-based Programming screen Indications are clustered in general categories as illustrated above. The intent for each category of indications is described below: • • Sinus Node: – If Normal is selected, the intent is to promote intrinsic atrial events and provide CRT pacing. – If Chronotropically Incompetent is selected, the intent is to provide rate-adaptive CRT pacing.
2-4 USING THE PROGRAMMER/RECORDER/MONITOR INDICATIONS-BASED PROGRAMMING (IBP) • Ventricular Arrhythmias – – – When History of VF/SCD or Prophylaxis for VT/VF is selected, a 2-zone configuration with the following rate thresholds and therapies is provided: – 180 bpm for the VF zone with QUICK CONVERT ATP and Maximum Energy Shocks enabled – 160 bpm for the VT zone with therapy disabled (Monitor Only) When History of VT/VF is selected, a 2-zone configuration with the following rate thresholds and the
USING THE PROGRAMMER/RECORDER/MONITOR MANUAL PROGRAMMING 2-5 Primary Settings Summary Figure 2-2. Proposed Settings Summary screen The Proposed Settings Summary screen displays the primary programming recommendations. Additional details about all changed parameters are available by selecting the View Changes button from the toolbar.
2-6 USING THE PROGRAMMER/RECORDER/MONITOR SOFTWARE TERMINOLOGY AND NAVIGATION Patient name PRM Mode Indicator Device name Details button ECG/EGM display Tabs Device model Toolbar Figure 2-3. Main Screen PRM Mode Indicator The PRM Mode Indicator displays at the top of the screen to identify the current PRM operational mode. Patient—indicates that the PRM is displaying data obtained by communicating with a device.
USING THE PROGRAMMER/RECORDER/MONITOR SOFTWARE TERMINOLOGY AND NAVIGATION 2-7 ECG/EGM Display The ECG area of the screen shows real-time status information about the patient and the pulse generator. This information is useful in evaluating system performance: • Real-time EGMs can be transmitted from the pace/sense or shocking electrodes to evaluate lead system integrity and help identify faults such as lead fractures, insulation breaks, or dislodgments.
2-8 USING THE PROGRAMMER/RECORDER/MONITOR SOFTWARE TERMINOLOGY AND NAVIGATION • View attentions and warnings • End your PRM session Tabs Tabs allow you to select PRM tasks, such as viewing summary data or programming device settings. Selecting a tab displays the associated screen. Many screens contain additional tabs, which allow you to access more detailed settings and information. Buttons Buttons are located on screens and dialogs throughout the application.
USING THE PROGRAMMER/RECORDER/MONITOR SOFTWARE TERMINOLOGY AND NAVIGATION 2-9 Battery—opens a window with details on the pulse generator battery. Run—causes the programmer to perform an action. Check—indicates that an option is selected. Event—indicates that an event has occurred. When you view the Trends timeline on the Events tab, event icons display wherever events have occurred. Selecting an events icon displays details about the event.
2-10 USING THE PROGRAMMER/RECORDER/MONITOR SOFTWARE TERMINOLOGY AND NAVIGATION Scroll Icons Scroll Left—indicates that an associated item can be scrolled left. Scroll Right—indicates that an associated item can be scrolled right. Scroll Up—indicates that an associated item can be scrolled up. Scroll Down—indicates that an associated item can be scrolled down. Common Objects Common objects such as status bars, scroll bars, menus, and dialogs are used throughout the application.
USING THE PROGRAMMER/RECORDER/MONITOR DATA MANAGEMENT 2-11 When a red Warning or yellow Attention button displays in the toolbar, click the button. The Parameter Interactions screen will display, with information about corrective action. DATA MANAGEMENT The PRM system allows you to manage patient and pulse generator data by viewing, printing, storing, or retrieving it. This section describes the PRM data management capabilities.
2-12 USING THE PROGRAMMER/RECORDER/MONITOR COMMUNICATING WITH THE PULSE GENERATOR Print You can print PRM reports by using the internal printer, or by connecting to an external printer. To print a report, select the Reports button.
USING THE PROGRAMMER/RECORDER/MONITOR COMMUNICATING WITH THE PULSE GENERATOR 2-13 wanded telemetry session is initiated, the PRM checks the pulse generator’s telemetry capability. If the PRM detects a pulse generator with ZIP telemetry capability, a message will display indicating that ZIP telemetry is available and the wand can be removed. Otherwise, the session will continue with wanded telemetry.
2-14 USING THE PROGRAMMER/RECORDER/MONITOR COMMUNICATING WITH THE PULSE GENERATOR 2. Keep the telemetry wand in position until either a message appears, indicating that the telemetry wand may be removed from proximity of the pulse generator, or the ZIP telemetry light illuminates on the PRM system. Ending a Telemetry Session Select the End Session button to quit a telemetry session and return to the startup screen. You can choose to end the session or return to the current session.
USING THE PROGRAMMER/RECORDER/MONITOR COMMUNICATING WITH THE PULSE GENERATOR 2-15 RF signals in the same frequency band used by the system may interfere with ZIP telemetry communication. These interfering signals include: • Signals from other pulse generator/PRM system RF communication sessions after the maximum number of independent sessions has been reached. Other nearby pulse generators and PRMs using ZIP telemetry may prevent ZIP telemetry communication. • Interference from other RF sources.
2-16 USING THE PROGRAMMER/RECORDER/MONITOR DIVERT THERAPY The pulse generator cannot be misprogrammed as a result of interrupted ZIP telemetry. Interruptions of ZIP telemetry may be caused by RF signals that operate at frequencies near that of the pulse generator and are strong enough to compete with the ZIP telemetry link between the pulse generator and the PRM. Significant interference may result in a break or drop-outs of real-time EGMs.
USING THE PROGRAMMER/RECORDER/MONITOR STAT SHOCK 2-17 Also, the DIVERT THERAPY key can be pressed to divert ATP therapy in midburst. If redetection occurs, the ATP scheme will not be used again and the next programmed therapy in the sequence will be initiated. 1. If you are not already in a session, position the telemetry wand within range of the pulse generator. 2. Press the DIVERT THERAPY key. A message window will appear indicating that a divert attempt is being made. 3.
2-18 USING THE PROGRAMMER/RECORDER/MONITOR STAT PACE 4. Subsequent high-energy STAT SHOCKS may be delivered by repeating the previous steps. NOTE: The STAT SHOCK may be diverted using the DIVERT THERAPY key. NOTE: Following STAT SHOCK delivery, if the Tachy Mode is programmed to Monitor Only or Monitor + Therapy, post-shock redetection is initiated (initial detection criteria and enhancements are not used).
USING THE PROGRAMMER/RECORDER/MONITOR SAFETY MODE 2-19 Limited inductive telemetry and some device programming are available during Safety Mode. If you interrogate a pulse generator that is in Safety Mode, the PRM will display a warning screen directing you to call Technical Services. Backup Pacemaker The Safety Mode feature provides a simple VVI pacemaker programmed to 72.5 ppm, with the following BiV output characteristics: • 0 ms offset • 5 V amplitude • 1.
2-20 USING THE PROGRAMMER/RECORDER/MONITOR SAFETY MODE Programming the Device Safety Tachy Mode In Safety Mode, you can perform the following steps to program the Safety Tachy Mode: 1. Select the Tachy Mode button. The Change Device Mode dialog displays. 2. Click to select the required Safety Tachy Mode setting, either Off or Monitor + Therapy. Click Apply Changes to apply the new setting, or Cancel Changes to cancel the new setting. 3. Click Close to dismiss the Change Device Mode dialog.
3-1 TACHYARRHYTHMIA DETECTION CHAPTER 3 This chapter contains the following topics: • "Device Mode" on page 3-2 • "Rate Sensing" on page 3-3 • "Ventricular Detection" on page 3-6 - DRAFT -
3-2 TACHYARRHYTHMIA DETECTION DEVICE MODE DEVICE MODE The Device Mode allows you to program the device to provide the type of therapy and detection desired. Ventricular Tachy Mode The Ventricular Tachy Mode controls the availability of the detection and therapy functions in the ventricle (Table 3-1 on page 3-2). You can program the Ventricular Tachy Mode to the following modes: Table 3-1. • Off––disables ventricular tachyarrhythmia detection and automatic ventricular therapy delivery.
TACHYARRHYTHMIA DETECTION RATE SENSING Table 3-1. 3-3 Device feature availability in the Ventricular Tachy Mode settings (continued) Ventricular Tachy Mode Device features Off Monitor Only Monitor + Therapy Xd Xd Ventricular EP test Automatic ventricular tachyarrhythmia therapy X a. In order to enable ventricular sensing when the Ventricular Tachy Mode is programmed to Off, you must program the Brady Mode to a mode with ventricular sensing. b.
3-4 TACHYARRHYTHMIA DETECTION RATE SENSING • Automatic gain-controlled sensing circuit for rate sensing. This circuit ensures proper rate sensing by compensating for changing or diminished signal amplitudes. For CRT and bradycardia therapy decisions, rate sensing is based on RV sensed and ventricular paced events. Calculating Rates and Refractory Periods The pulse generator evaluates rate on an interval-by-interval basis.
TACHYARRHYTHMIA DETECTION RATE SENSING Table 3-2. 3-5 Nominal values for Ventricular Rate Threshold configurations Ventricular Zone Configuration VT-1 Zone VT Zone VF Zone 1 Zone – – – – 200 bpm 2 Zones – – 160 bpm 200 bpm 3 Zones 140 bpm 160 bpm 200 bpm Figure 3-1.
3-6 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION • Bypass ventricular therapy inhibitors if the ventricular rate is faster than the atrial rate The pulse generator will respond to atrial sensing regardless of whether an atrial lead is implanted. If an atrial lead is not implanted or it has a fault, program the atrial lead from Bipolar to Off (when programmed to Off, atrial sensing is not performed; atrial pacing will occur).
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION 3-7 The pulse generator initiates ventricular therapy when it determines that detection is met.
3-8 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION NOTE: There is no clinical data to suggest that one detection enhancement suite is superior to the other for any given patient indication. Therefore, individual programming and evaluation of detection enhancement specificity is recommended.
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION 3-9 If the passive method is enabled, the pulse generator will attempt to collect the Rhythm ID reference template every two hours using the programmed brady settings. If the active method is enabled and seven days have passed since the last successful collection of a reference template, then every 28 hours the device automatically analyzes the patient’s intrinsic rhythm by adjusting the brady parameters.
3-10 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION • Biventricular Trigger, Rate Smoothing, ATR, hysteresis, and dynamic programming (excluding Dynamic VRP) are suspended. The pacing chamber is set to Biventricular; LV Offset is set to 0. 2. After the Fallback interval, pacing parameters are restored to normal programmed parameters. This process will typically last one minute. NOTE: Rhythm ID Fallback LRL settings should be selected such that normal sinus rhythms are promoted (e.g.
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION Table 3-4. 3-11 Onset/Stability rhythm discrimination available per zone (continued) VT-1 Zone VT Zone VF Zone None None 2-zone Configuration (with Monitor Only zone)b None 1-zone Configuration a. Polymorphic VT Discrimination is only available in the VT zone. b. Rhythm discrimination is not available in the lowest zone of a multi-zone configuration if the zone is used as a Monitor Only zone (no therapy programmed for that zone).
3-12 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION • If ventricular ATP is delivered or if therapy is diverted or unavailable, the following will occur: – The redetection duration time is determined by the Redetection Duration parameter – Detection enhancements (except for Shock if Unstable) are not available during redetection Whichever duration is determined to be appropriate, that type of duration (Redetection or Post-shock) will be in effect in all zones at each zone’s programmed duration value
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION Evaluate Stability. If stable, charge and shock. If unstable, inhibit therapy. Post-shock SRD timer starts. Shock Lowest zone detection window satisfied. 0s Post-shock Duration starts in lowest zone. 0s Continue Post-shock Stability analysis throughout SRD time as long as the detection window remains satisfied. If Stability indicates therapy, charge and shock. 5s Post-shock Duration expires. 3-13 Post-shock SRD times out.
3-14 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION satisfied. The zone’s detection window will only become resatisfied when 8 of 10 intervals are again classified as fast (Figure 3-3 on page 3-14). VF window S S S S F F Intervals in ms 630 600 600 600 380 390 F 370 F F 380 370 F F F 370 350 370 S S S S 490 500 500 500 S F F 500 370 Right Ventricle 6 of 10 intervals are fast, VF window not satisfied. 7 of 10 intervals are fast, VF window not satisfied.
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION VF Zone Rate = 200 min-1 (bpm) = 300 ms 8 of 10 intervals are fast, VF window is satisfied. VT Zone Rate = 150 min-1 (bpm) = 400 ms S = Slow 3-15 F = Fast 7 of 10 intervals are fast, VF window not satisfied. 6 of 10 intervals are fast, VF window not satisfied.
3-16 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION • If at any point during Duration a zone’s detection window detects fewer than 6 of 10 fast intervals, that zone’s Duration is reset to 0 (Figure 3-7 on page 3-17). Duration will start again only if the detection window becomes resatisfied. VT detection window remains satisfied during VT Duration. Right Ventricle VT detected VT Duration 1-30 s VT window satisfied. VT Duration starts.
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION 3-17 VT detection window is no longer satisfied; fewer than 6 of 10 intervals are classified as fast. Right ventricle VT detected VT Duration 1-30 seconds VT window satisfied. VT Duration starts. Need 8 of 10 intervals classified as fast to restart VT Duration. VT Duration resets to zero. VT Duration will start again when the window becomes resatisfied. Duration resets when during the Duration period the window is no longer satisfied. Figure 3-7.
3-18 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION • If the higher zone’s detection window does not remain satisfied, then the Duration timers for the lower ventricular zones are no longer ignored. Programmed therapy for lower ventricular zones will be initiated when a lower ventricular zone’s duration is met and no higher ventricular zone’s window is satisfied (Figure 3-8 on page 3-18, Figure 3-9 on page 3-18). VF window satisfied. VF Duration starts. VF window remains satisfied.
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION 3-19 Redetection Duration is programmable in the lower ventricular zones of a multi-zone configuration. It is nonprogrammable in the VF Zone. Post-shock Duration can be programmed in the same manner; the values programmed in the lower ventricular rate zones must be greater than or equal to the values programmed in the higher zones.
3-20 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION Ventricular Episodes If three consecutive fast ventricular beats are detected, then the pulse generator performs the following: • Increments the episode number • Allocates memory for history data and electrogram storage • Starts monitoring for a detection window to be satisfied When any zone’s detection window becomes satisfied, the start of a ventricular episode is declared and duration timers begin in those zones where detection windows are sati
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION Table 3-6.
3-22 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION Detection window is no longer satisfied; fewer than 6 of 10 intervals are classified as fast. Detection window does not become satisfied. Detection window satisfied. 10 s Start Duration. Start episode. Figure 3-14. expired Duration did not expire. Duration resets to zero. Start End-of-Episode timer. End-of-Episode times out. Episode is over.
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION 3-23 Right Ventricle Ventricular rate remains fast. Shock Detection window does not become satisfied. Detection window satisfied. Shock 30 s Charging Start End-ofEpisode timer. Start Post-shock Detection met. Duration Start Charging. End-of-Episode timer resets to zero. Restart End-of-Episode timer. End-of-Episode times out. Episode is over. This example illustrates a Treated Episode when Ventricular mode is Monitor + Therapy.
3-24 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION If either Rhythm ID or Onset/Stability is selected, enhancement parameters are used in addition to ventricular rate and duration for therapy decisions (Table 3-7 on page 3-24) as follows: Table 3-7. • Vector Timing and Correlation inhibits therapy when the conduction vector (EGM morphology and timing) during tachyarrhythmia matches a reference conduction vector of the patient’s normal sinus rhythm.
3-25 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION Table 3-7. Enhancement parameters available with detection enhancements (continued) Rhythm ID Enhancement Parameter Onset/Stability Initial Post-Shock Initial Post-Shock Onset – – – – X – – SRDg X X X X a. This enhancement is not individually programmable. b. When Rhythm ID is selected, this enhancement is automatically enabled when Atrial Tachyarrhythmia Discrimination is programmed to On.
3-26 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION Table 3-8.
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION Table 3-9.
3-28 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION generator calculates a Feature Correlation Coefficient and makes the following therapy decisions based on the calculation: • If at least 3 out of 10 beats are correlated, the rhythm is classified as SVT • If fewer than 3 out of 10 beats are correlated, the rhythm is classified as VT Rhythm ID makes its decision to treat or inhibit therapy at the end of Duration.
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION Number of Intervals 1 Intervals in ms 620 2 600 3 580 4 580 5 620 6 600 7 640 8 560 3-29 9 600 Atrium Compute the sum of the atrial intervals. Average = 600 ms = 100 min-1 (bpm). Number of Intervals Average ventricular rate (150 min-1 [bpm]) is greater than average atrial rate (100 min-1 [bpm]) by at least 10 bpm, so delivery therapy. Compute the sum of 10 most recent ventricular intervals. Average = 400 ms = 150 min-1 (bpm).
3-30 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION The intrinsic atrial rate is declared to be above the AFib Rate Threshold in the following manner (Figure 3-18 on page 3-30): • Atrial analysis begins at initiation of ventricular tachyarrhythmia detection. Each atrial interval is classified as faster or slower than the AFib Rate Threshold Interval. • When 6 of the last 10 intervals are classified as faster than the AFib Rate Threshold, the device declares AF to be present.
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION 3-31 When AFib Rate Threshold and Stability are used alone, ventricular therapy is initiated when a stable rhythm is declared. Ventricular therapy is initiated for an unstable rhythm when it is determined that the atrial rate is less than the AFib Rate Threshold (Table 3-10 on page 3-31).
3-32 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION Table 3-10. AFib Rate Threshold and Stability combinations and resulting therapy (continued) Detected Ventricular Rhythma Therapy Decisionb Unstable, A < AFib Rate Threshold Treat Stable, A < AFib Rate Threshold Treat a. If the detected ventricular rhythm changes, then the appropriate, corresponding row in the table is evaluated. b. Decisions to inhibit can be overridden by V > A or expiration of SRD.
TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION 3-33 Stability to Inhibit The Stability parameter may help you identify rapid rhythms originating in the atrium, such as AF. These rhythms may result in unstable ventricular rhythms whose rate exceeds the lowest rate threshold and should not be treated. If a rhythm is declared stable when Duration expires, programmed therapy will be delivered. If the rhythm is declared unstable, ventricular therapy will be inhibited.
3-34 TACHYARRHYTHMIA DETECTION VENTRICULAR DETECTION Shock if Unstable When programmed to Shock if Unstable, the stability analysis helps determine if ventricular ATP therapy should be bypassed in preference for the first programmed ventricular shock therapy (which may be low- or high-energy) for the ventricular zone (Figure 3-20 on page 3-34).
