Page 1 Cardiac Rhythm Management // Inventra Family of ICDs and CRT-Ds Inventra Family of ICDs and CRT-Ds Technical Manual...
Page 3: Table Of Contents
Table of Contents Inventra Technical Manual Contents 1. General ............................... 1 1.1 System Description ........................1 1.2 Indications for Use ........................2 1.3 Contraindications .......................... 2 1.4 Warnings and Precautions ......................3 1.4.1 Sterilization, Storage, and Handling ..................3 1.4.2 Device Implantation and Programming ..................4 1.4.3 Lead Evaluation and Connection ....................
Page 4 Table of Contents Inventra Technical Manual 3. Programming Overview ........................33 3.1 General Overview ........................33 3.2 Parameters Overview ........................34 3.2.1 Bradycardia/CRT Parameters ....................34 3.2.2 Tachycardia ..........................46 3.2.3 Home Monitoring ........................54 ® 3.2.4 Diagnostics ..........................55 3.2.5 Patient .............................
Page 5 Table of Contents Inventra Technical Manual 5.6.1 Forced Termination Timer ..................... 105 5.7 Monitoring Zones ........................106 6. Tachyarrhythmia Therapy ......................107 6.1 Atrial Anti‑tachycardia Therapies ....................107 6.1.1 ATP Schemes ........................107 6.1.2 HF Burst ..........................108 6.2 Ventricular Antitachycardia Pacing Therapy (ATP)..............108 6.2.1 ATP Schemes ........................
Page 6 Table of Contents Inventra Technical Manual 7.8.1 Overview ..........................135 7.8.2 How the Vp Suppression Algorithm Works ................137 7.9 Ventricular Pacing (HF‑T Devices Only) ................... 140 7.9.1 Ventricular Pacing ........................ 140 7.9.2 Trigger Pacing ........................140 7.9.3 LV T‑wave Protection ......................140 7.9.4 Maximum Trigger Rate ......................
Page 7 Table of Contents Inventra Technical Manual 10.1.2 Intrinsic Rhythm (test) ......................182 10.2 Pacing Lead Impedance ......................183 10.3 Retrograde Conduction Test ....................184 10.3.1 Measuring Retrograde Conduction ..................184 10.3.2 Programming to prevent PMT ..................... 185 10.4 Pacing Threshold Test ......................185 10.5 ...
Page 8 Figure 1: Inventra ICDs and CRT‑Ds Inventra Specifications Battery Voltage 3.2 Volts Maximum Shock Energy Inventra Models 45 joules stored Inventra IS‑1/DF‑1 Models VR‑T Models One IS‑1 (3.2 mm), Two DF‑1 (3.2 mm) DR‑T/VR‑T DX Models Two IS‑1 (3.2 mm), Two DF‑1 (3.2 mm) HF‑T Models Three IS‑1 (3.2 mm), Two DF‑1 (3.2 mm) Inventra DF4 Models...
Page 9: General
• Inventra VR‑T DX – provides ventricular rate adaptive bradycardia pacing support that can include atrial tracking with a single pass ICD lead. The DX system uses a BIOTRONIK DX lead with two atrial sensing electrodes to provide enhanced atrial and ventricular tachyarrhythmia discrimination through BIOTRONIK’s SMART Detection...
Page 10: Indications For Use
ICDs: The Inventra family of Implantable Cardioverter Defibrillators (ICDs) is intended to provide ventricular tachycardia pacing and ventricular defibrillation, for automatic treatment of life‑threatening ventricular arrhythmias. The VR‑T DX ICDs are part of a system that includes both a BIOTRONIK DX ICD lead and an Inventra DX ICD. CRT‑Ds: The Inventra CRT‑Ds are indicated for use in patients with all of the following conditions: •...
Page 11: Warnings And Precautions
Electrical Isolation ‑ To prevent inadvertent arrhythmia induction, electrically isolate the patient during the implant procedure from potentially hazardous leakage currents. Left Ventricular Lead Systems – BIOTRONIK CRT‑Ds may be implanted with any legally marketed, compatible LV lead. Compatibility is defined as: • IS‑1 pacing connector •...
Page 12: Device Implantation And Programming
Programmed Parameters – Program the device parameters to appropriate values based on the patient’s specific arrhythmias and condition. Programmers ‑ Use only BIOTRONIK ICS 3000 or Renamic programmers to communicate with the device. Sealing System ‑ Failure to properly insert the torque wrench into the perforation at an angle perpendicular to the connector receptacle may result in damage to the sealing system and its self‑sealing properties.
Page 13: Lead Evaluation And Connection
Chapter 1 General Inventra Technical Manual Shipment Mode – The shipment mode is a factory set mode that controls the charge current of automatic capacitor reformations. This mode controls the charge current to avoid temporary low battery readings. The shipment mode is deactivated when a valid impedance measurement is obtained by the programmer.
Page 14: Follow-Up Testing
Chapter 1 General Inventra Technical Manual Tightening Setscrew(s) – Do not over‑tighten the setscrew(s). Use only the BIOTRONIK supplied torque wrench. Sealing System – Be sure to properly insert the torque wrench into the perforation perpendicular to the connector receptacle. Failure to do so may result in damage to the plug and its self‑sealing properties.
Page 15: Home And Occupational Hazards
1.4.8 Cellular Phones Testing has indicated there may be a potential interaction between cellular phones and BIOTRONIK ICD/CRT‑D systems. Potential effects may be due to either the cellular phone signal or the magnet within the telephone and may include inhibition of therapy when the telephone is within 6 inches (15 centimeters) of the ICD/CRT‑D, when the ICD/CRT‑D is programmed to standard sensitivity.
Page 16: Electronic Article Surveillance (Eas)
ICDs/CRT‑Ds when they are placed in close proximity to the device. 1.4.11 Home Monitoring ® BIOTRONIK’s Home Monitoring system is designed to notify clinicians in less than 24 hours of ® changes to the patient’s condition or status of the implanted device. Updated data may not be available •...
Page 17 Chapter 1 General Inventra Technical Manual • Air emboli • Lead dislodgment • Allergic reactions to contrast media • Lead fracture/ insulation damage • Arrhythmias • Lead‑related thrombosis • Bleeding • Local tissue reaction / fibrotic tissue formation • Body rejection phenomena •...
Page 18: Patient Selection And Treatment
(SVTs), because drug‑resistant SVTs can initiate unwanted device therapy. • Direct any questions regarding individualization of patient therapy to your BIOTRONIK representative or BIOTRONIK technical services at 1‑800‑547‑0394. The prospective patient’s size and activity level should be evaluated to determine whether a pectoral or abdominal implant is suitable.
Page 19: Patient Counseling Information
(For additional copies of the patient manual, contact BIOTRONIK at the address listed in this manual.) 1.8 Evaluating Prospective CRT‑D/ICD Patients The prospective ICD/CRT‑D implant candidate should undergo a cardiac evaluation to classify any...
Page 20 Chapter 1 General Inventra Technical Manual PAGE 12...
Page 21: Programmer
Chapter 2 Programmer Inventra Technical Manual 2. Programmer The Renamic or ICS 3000 programmers may be used to communicate with the Inventra family of ICDs. When the programmed is turned ON, the screen shown in Figure 2 is seen. The devices able to be interrogated with the programmer software can be viewed by selecting the Device list button at the bottom of the screen.
Page 22: Master Switch Behavior
Chapter 2 Programmer Inventra Technical Manual 2.2 Master Switch Behavior Programming the Inventra devices does not automatically turn the tachycardia detection/therapy ON. The Master Switch must be turned ON and the Status Indicator must show Enabled. Figure 3: Master switch Three colors are used for the Status Indicator of the Master Switch: Green = full detection and therapy options available Yellow = limited detection and therapy options available...
Page 23: Temporarily Active
Chapter 2 Programmer Inventra Technical Manual Figure 6: Master switch disabled 2.2.3 Temporarily Active Temporarily active, as shown in Figure 7, is used for the temporary DFT test. Tachyarrhythmia detection is enabled for temporary VF zone only. All VF tachyarrhythmias will be treated with shock therapy sequences as programmed in the temporary program on the DFT screen.
Page 24: Safesync Rf Telemetry
Chapter 2 Programmer Inventra Technical Manual WARNING Unwanted Shocks – Always program ICD Therapy to OFF prior to handling the device to prevent the delivery of serious shocks to the patient or the person handling the device during the implant procedure. 2.3 SafeSync RF Telemetry The Inventra models offer ”wandless”...
Page 25: Economy Mode
Chapter 2 Programmer Inventra Technical Manual Figure 11: Session initiation message Once RF telemetry has been established, the programming head cannot be used again for the duration of the RF telemetry session. In order to indicate this to the user, the LED on the programming head will start blinking with an orange light. This notifies the user that there is an active RF telemetry session.
Page 26: Ending A Follow-Up Session
Chapter 2 Programmer Inventra Technical Manual Figure 12: Economy mode message 2.3.3 Ending a Follow‑up Session Always end a follow‑up session by pressing the “End” button on the screen as shown in Figure 13. This ends the RF telemetry link to the device and prevents the possibility of errant programming. Figure 13: End session 2.3.4 Switch between RF and Wand To switch between RF and wand (PGH) telemetry, go to the Inventra tab under the More section.
Page 27: Power Consumption Consideration
Chapter 2 Programmer Inventra Technical Manual To activate RF telemetry, place the wand on the device and press the RF button. A message stating that “RF telemetry is active. Programming head can be removed.” will appear on the screen. Figure 14: Switch between PGH and RF telemetry 2.3.5 Power Consumption Consideration SafeSync telemetry requires somewhat more power than telemetry via the programming head.
Page 28: Real-Time Iegm Transmission
Chapter 2 Programmer Inventra Technical Manual Figure 15: Far‑field IEGM option screen 2.4.2 Real‑time IEGM Transmission The Inventra ICDs provide real time transmission of the intracardiac electrogram (IEGM) to the programmer. IEGMs from the atrium and ventricles can be simultaneously recorded with a bandwidth of 18 to 80 Hz in the atrium and 24 to 100 Hz in the ventricle.
Page 29 Chapter 2 Programmer Inventra Technical Manual The freeze icon may be used to capture a snapshot of the IEGM. Electronic calipers (vertical dotted lines) will appear with the snapshot, allowing the user to measure intracardiac distances. Calipers can be adjusted by touching the vertical dotted lines on the screen (Figure 17) or by using the arrows on the right side of the screen Figure 17: The freeze ECG page Figure 18: The freeze ECG page with one‑second gridlines...
Page 30: Additional Programmer Functions
Chapter 2 Programmer Inventra Technical Manual Figure 19: Window content The programmer is capable of storing the last 60 seconds of temporary memory when the Freeze icon is selected. This information can be printed by the user. The Print/Save options are opened when pressing on “Window Content,”...
Page 31 Chapter 2 Programmer Inventra Technical Manual Figure 20: Main follow‑up screen Immediately to the left of the freeze icon is an adjust icon. This brings up a pop‑up menu, allowing the user to change screen sweep speed, display color scheme, ECG display for testing, gains for the ECG and IEGMs, as well as the display mode.
Page 32: Preferences
Chapter 2 Programmer Inventra Technical Manual 2.4.3.1 Speed Adjusts the sweep speed of the display. 2.4.3.2 ECG Selects the ECG lead to be visualized during testing. A check box underneath the ECG section allows the user to use the far‑field signal instead of the ECG for devices that use a far‑field signal. 2.4.3.3 Color scheme Changes the color scheme of the ECG/IEGM display to white‑on‑black or black‑on‑white. 2.4.3.4 AC Frequency Allows the user to choose 50 Hz or 60 Hz frequency to be filtered out. 60 Hz is recommended.
Page 33 Chapter 2 Programmer Inventra Technical Manual 2.4.4.1 Follow‑up Preferences The Follow‑up screen, as shown in Figure 22, allows the user to select which tests are performed automatically by the programmer during a follow‑up. Not all devices will have the capabilities shown on this screen.
Page 34 Chapter 2 Programmer Inventra Technical Manual Figure 23: Test preferences screen 2.4.4.3 Print Preferences The print preference screen, shown in Figure 24, permits the user to set up four custom printing scenarios for follow‑up data. Each of these can be individually labeled. Simply select the follow‑up data to be printed by touching the box to place an “X”...
Page 35 Chapter 2 Programmer Inventra Technical Manual The four default name choices of A‑D can be changed by the user to tailor to a specific physician or clinic preference. For example, by pressing on letters A‑D under Standard, an alphanumeric keyboard appears to let the user change the title name to the print package, as shown in Figure 25. Figure 25: Alphanumeric keyboard Below the print package names, the user can select the Standard or default print package for a follow‑up (Figure 26).
Page 36: System Preferences
Chapter 2 Programmer Inventra Technical Manual 2.4.4.4 System Preferences The system preference screen, shown in Figure 28, allows the date and time of the programmer to be set. Additionally, several other basic programmer functions can be set on this screen. Figure 28: System preference screen The programmer can adjust its time to daylight saving time (DST) by programming DST ON.
Page 37: Print Manager
Chapter 2 Programmer Inventra Technical Manual Signal beep provides an audible tone when selecting parameters or making programming changes when the signal beep feature is ON. Print 1st interrogation provides an automatic option that prints the permanent parameters when the device is first interrogated. A setting of manual requires the user to press the print button if a printout is ...
Page 38 Chapter 2 Programmer Inventra Technical Manual The user can select which data is to be printed by selecting the Preference choice. By default, these are named Standard, min, B + Statistics, and All. These can be renamed under the preferences print screen.
Page 39 Chapter 2 Programmer Inventra Technical Manual Figure 32: Preview screen PAGE 31...
Page 40 Chapter 2 Programming Overview Inventra Technical Manual PAGE 32...
Page 41: Programming Overview
Chapter 3 Programming Overview Inventra Technical Manual 3. Programming Overview 3.1 General Overview The Follow‑up screen is the first screen displayed following interrogation of the Inventra ICD/CRT‑D. It is confirmed the device has been successfully interrogated by the appearance of the patient name, device name, and serial number on the right side of the Follow‑up header bar located at the top of the screen. Furthermore, below the ECG/IEGM portion of the screen is an information status bar that provides information related to interrogation (i.e., “Interrogation was successful”) and testing status.
Page 42: Parameters Overview
Chapter 3 Programming Overview Inventra Technical Manual 3.2 Parameters Overview 3.2.1 Bradycardia/CRT Parameters The Bradycardia/CRT Screen allows the user to program parameters related to the bradycardia function of the device. Each of these parameters are described in this section. Figure 34: The Bradycardia/CRT screen and Sensing Parameters 3.2.1.1 Mode Figure 35 shows the available modes for Inventra DR‑T or Inventra HF‑T ICD.
Page 43: Rate Hysteresis
Chapter 3 Programming Overview Inventra Technical Manual 3.2.1.2 Basic Rate and Night Rate Basic Rate: 30 … (5) … 60 … (5) … 100 … (10) …160 bpm Night Rate: OFF; 30 … (5) … 100 bpm Night Begins: 22:00 Night Ends: 06:00 NOTE: The clock only appears once a Night Rate is selected. The basic rate and the night rates cannot be programmed less than 30 bpm.
Page 44 Chapter 3 Programming Overview Inventra Technical Manual Motion based rate adaptive pacing will take over if the CLS pacing algorithm switches into a passive mode. Figure 36: CLS parameter screen 3.2.1.4.1 Max Sensor Rate 80 … (10) … 120 … (10) … 160 bpm This is the maximum atrial paced rate the device will allow when using CLS.
Page 45: Sensor Gain
Chapter 3 Programming Overview Inventra Technical Manual 3.2.1.5.1 Max Sensor Rate 80 … (10) … 120 … (10) … 160 bpm This is the maximum atrial paced rate the device will allow when using the accelerometer of the device. This rate must be at least ten beats lower than the Upper Tracking Rate. 3.2.1.5.2 Sensor Gain AUTO, Very low, Low, Medium, High, Very high This refers to the rate of increase and decrease.
Page 46: Upper Tracking Rate
Chapter 3 Programming Overview Inventra Technical Manual 3.2.1.6 Upper Tracking Rate 90 … (10) … 130 … (10) … 160 bpm Wenckebach Response The Wenckebach response zone is the distribution of rates between the Upper Tracking Rate and the calculated 2:1 response rate. The resulting behavior is a prolongation of the AV interval until a P‑wave is not tracked.
Page 47 Chapter 3 Programming Overview Inventra Technical Manual 3.2.1.7.1 Intervention Rate OFF, 120 … (10) … 160 … (10) … 200 bpm The Intervention Rate is the atrial rate above which intervals will count toward Mode Switch. The nominal value is 160 bpm. 3.2.1.7.2 Mode DDIR, DDI The Mode that the device Mode Switches to when programmed DDD(R).
Page 48 Chapter 3 Programming Overview Inventra Technical Manual 3.2.1.7.7 Triggering (HF‑T devices only) OFF, RVs, RVs + PVC When triggering is turned ON, the device will trigger an LV paced event when an RV sensed event occurs. RVs is a sensed RV event following an AV Delay (i.e., Sinus tachycardia). RVES is an extrasystolic event (PVC) that can trigger a BiV pace as long as it does not violate the Maximum Trigger Rate or Tachycardia zone.
Page 49 Chapter 3 Programming Overview Inventra Technical Manual 3.2.1.9 Ventricular Pacing (HF‑T devices only) There are six sub‑parameters found under this menu. 1. Ventricular Pacing – BiV or RV 2. Triggering – OFF, RVs, RVs + PVC When triggering is turned ON, the device will trigger a BiV paced event when an RV sensed event occurs.
Page 50 Chapter 3 Programming Overview Inventra Technical Manual Figure 39: AV Delay screen 3.2.1.10.2 Sense Compensation OFF, ‑5 … (‑5) … ‑40 … (‑5)… ‑120 ms This feature is designed to help ensure that the physiologic AV delay intervals (atrial filling times) are the same from Ap to Vp as it is from As to Vp. NOTE: Conflicts occur if the AV Delay minus Sense Compensation is less than 40 ms.
Page 51 Chapter 3 Programming Overview Inventra Technical Manual 3.2.1.10.4 AV Hysteresis Mode OFF, Positive, Negative, I‑Opt (Inventra DR‑T and VR‑T DX ICDs) Positive: AV Hysteresis – 70, 110, 150, 200 ms AV Scan/Repetitive ‑ OFF, ON (5) Negative: AV Hysteresis – 10 … (10) … 50…(10)…150 ms ...
Page 52 Chapter 3 Programming Overview Inventra Technical Manual 3.2.1.13 Right/Left Ventricular Capture Control (VCC) Capture control; OFF, ATM, ON Threshold test start: 2.5 … (0.5) … 3.5 … (0.5) … 5.0 V Minimum Amplitude: 1.0 … (0.25) … 4.0 V Safety margin; 1.0 or 1.2 V 3.2.1.14 Sensing * †...
Page 53: Pvarp Extension
Chapter 3 Programming Overview Inventra Technical Manual 3.2.1.15 Refractory period / Blanking 3.2.1.15.1 PVARP Auto, 175 … (25) … 225 … (25) … 600 ms PVARP is used to prevent pacemaker mediated tachycardia by not allowing retrograde atrial events to be tracked by the device. Retrograde conduction should be confirmed before making any programming ...
Page 54: Pmt Protection
Chapter 3 Programming Overview Inventra Technical Manual 3.2.1.18 PMT Protection ON, OFF This algorithm is designed to break a PMT by changing the AV Delay after the device has sensed eight consecutive events in which the Ventricular pace to Atrial sense interval is less than the VA Criterion value.
Page 55: Detection Rate
Chapter 3 Programming Overview Inventra Technical Manual Figure 40: The Detection screen 3.2.2.2.1 Detection Rate VT1: OFF, 100 – 222 bpm or 270 – 600 ms VT2: OFF, 120 – 222 bpm or 270 – 500 ms VF: 150 – 250 bpm or 240 – 400 ms; Default 200 bpm (300 ms) VT1 is the lowest zone for programming; therefore, when programming multiple zones, the rate must be ...
Page 56 Chapter 3 Programming Overview Inventra Technical Manual 3.2.2.2.3 Redetection Counter VT1: 10 … (2) … 20 … (2) … 50 VT2: 10 … (2) … 14 … (2) … 40 VF: 6 out of 8, 8 out of 12, 10 out of 14, 12 out of 16, 16 out of 20, 18 out of 24, 20 out of 26, 22 out of 30, 24 out of 30 This parameter determines the minimal number of VT events for each zone that must be counted to redetect VT/VF and prompt therapy delivery.
Page 57 Chapter 3 Programming Overview Inventra Technical Manual 3.2.2.2.9 Forced Termination Timer 1 minute This parameter terminates an SVT episode following VT therapy after one minute. It will reset all therapy and start a new episode. If the patient is in an SVT when the Forced Termination timer expires, a new SVT episode will begin.
Page 58 Chapter 3 Programming Overview Inventra Technical Manual 3.2.2.3.1 Atrial ATP Burst, Ramp The device allows for a single ATP delivery or burst or ramp ATP. Back‑up pacing is available. 3.2.2.3.2 Atrial HF Burst OFF, HF Burst Burst frequency and duration are programmable. Back‑up pacing is available. 3.2.2.3.3 Back‑up stimulation (pacing support) OFF, 70 or 90 bpm Provides VVI back‑up pacing for Atrial ATP and VOO back‑up for HF Burst.
Page 59: Minimum Interval
Chapter 3 Programming Overview Inventra Technical Manual 3.2.2.4.2 Ventricular Pacing (HF‑T devices only) RV, BiV BiV pacing for ATP may be a better option for therapy if the VT origin is left‑sided. 3.2.2.4.3 Number S1 1 … (1) … 5 … (1) … 10 This sets the number of stimuli delivered for each ATP attempt.
Page 60: Shock Therapy
Chapter 3 Programming Overview Inventra Technical Manual 3.2.2.4.10 ATP Help Displays the programmed ATP schemes as programmed. The VT interval can be changed to show what the ATP scheme will be, based on a specific interval. This screen cannot be printed. 3.2.2.4.11 Shock Therapy OFF, 1, 2, 6, 8 shocks per VT zone 6 or 8 shocks for the VF zone The first two shocks for each zone are programmable. The remaining shocks are at maximum output. ...
Page 61 Chapter 3 Programming Overview Inventra Technical Manual 3.2.2.4.14 Waveform Biphasic, Biphasic 2 Applies to all shocks within a zone and may be programmed differently for each zone. 3.2.2.4.15 Shock Path RV to proximal Coil/Can, RV to Can, RV to proximal Coil In Inventra VR‑T DX, the default is RV to Can.
Page 62: Home Monitoring
Chapter 3 Programming Overview Inventra Technical Manual ATP One‑Shot programming options Parameter Burst Ramp Attempts One Only Ventricular pacing RV, BiV (HF‑T only) Number of S1 1 … (1) … 8 … (1) … 10 R‑S1 Interval 70 … (5) … 85 … (5) … 95% S1 Decrement 5…...
Page 63: Diagnostics
Chapter 3 Programming Overview Inventra Technical Manual NOTE: Always verify the programmer time prior to programming the transmission time as the device time is based on the current programmer time. 3.2.3.3 IEGM for Therapy Episodes ON, OFF When programmed ON, the device will transmit the IEGM stored during a therapy episode to the service center.
Page 64 Chapter 3 Programming Overview Inventra Technical Manual 3.2.4.1 Recording Episodes For AT/AF: OFF, ON, Advanced ON This allows the user to record atrial tachyarrhythmias into the Holter based on the programmed rate selected in the Tachycardia tab of the device. Selecting Advanced ON doubles the prehistory time of the recording (circa 1 min), allowing the user to view more information related to the onset of the arrhythmia.
Page 65: Patient
Chapter 3 Programming Overview Inventra Technical Manual 3.2.4.7 Thoracic Impedance (TI) ON, OFF The thoracic impedance is measured between the distal shock‑coil of the RV lead and the ICD housing. Up to 1,024 measurements are taken every hour, and these measurements are then averaged. The 24 measurements per day are averaged and stored in the device and transmitted daily via Home Monitoring as a single average point per day.
Page 66 Chapter 3 Programming Overview Inventra Technical Manual Figure 48: Last Name Date of Birth This section allows the user to input the patient’s birth date. The birth date is entered as MM/DD/YYYY, as shown in Figure 49. When initially accessed, the current day will be displayed. The date can be changed using the following methods: •...
Page 67 Chapter 3 Programming Overview Inventra Technical Manual Gender This section allows the user to select the patient’s gender. Figure 50: Gender Symptom This section allows the user to select the symptom related to the patient. Only one choice can be selected.
Page 68 Chapter 3 Programming Overview Inventra Technical Manual Etiology This section allows the user to select one etiology related to the patient. The selection will appear on the main patient page. Figure 53: Etiology Date of Implant The implantation date is automatically added after implantation when valid impedance values are measured by the device.
Page 69 Chapter 3 Programming Overview Inventra Technical Manual Figure 55: Physician information Remark Free text remarks can be entered into the device. Up to 42 characters (including spaces) can be entered. Figure 56: Remark LVEF This refers to the left ventricular ejection fraction. Here the user can select the LVEF, if known. Figure 57: LVEF NYHA This refers to the New York Heart Association classification. A value can be entered if it is known.
Page 70 Chapter 3 Programming Overview Inventra Technical Manual Figure 58: NYHA Lead Information Inventra series allows atrial and ventricular lead information to be added to the device memory. Lead Model The lead model number can be entered here using both letters and numbers. Figure 59: Lead Model Lead Serial Number/Manufacturer This box allows the user to input the lead serial number and select the lead manufacturer.
Page 71 Chapter 3 Programming Overview Inventra Technical Manual Figure 61: Lead type Implantation This box allows the user to enter the implantation date of the leads Figure 62: Implantation date Brady / Tachy Channels This box allows the user to choose the channel to which the lead is connected for bradycardia and tachycardia positions.
Page 72: Conflict Manager
Chapter 3 Programming Overview Inventra Technical Manual Figure 64: Tachy channel 3.3 Conflict Manager Inventra ICD software includes programming rules that result in parameter conflicts when selected values lead to unsafe or illogical parameter combinations. The programmer will not transmit parameters with conflicts present. However, the software includes a Conflict Manager, which displays a Conflict button with each conflict. When the button is selected, a pop‑up editing window reveals a short message to guide reprogramming. An example showing the Conflict Manager is shown in Figure 65. In this case, the VT1 zone and Max Sensor Rate program overlap. To resolve the conflict, the Max Sensor Rate must be programmed to a ...
Page 73: Sensing
350 ms ‡ Table 5: Programming of sensing options in the Inventra ICD Default values are in bold. * † ‡ * HF‑T devices with LV sensing set to Standard † Inventra VR‑T DX default is 75% UT in the right atrium ‡ Accessible by BIOTRONIK personnel only PAGE 65...
Page 74: Atrial Sensitivity In Dual-Chamber And Hf-T Icds
Chapter 4 Sensing Inventra Technical Manual 4.1.1 Atrial Sensitivity in Dual‑Chamber and HF‑T ICDs The Inventra VR‑T DX, DR‑T and HF‑T ICDs have two sensitivity settings in the atrium: Standard and OFF. The Standard atrial setting is recommended for all patients and works similarly to the ventricular Standard setting.
Page 75 Chapter 4 Sensing Inventra Technical Manual Summary of RV sensitivity settings Standard Upper Threshold Lower Threshold UT duration 350 ms 350 ms 110 ms (sense) UT duration (pace) 400 ms 400 ms 110 ms High pass filter 24 Hz 32 Hz 32 Hz Table 6: Summary of RV sensitivity settings 4.1.2.1 Standard Sensitivity In the Standard ventricular setting, each R‑wave is measured and used to reset the upper and...
Page 76 Chapter 4 Sensing Inventra Technical Manual The 12.5% decrement is measured from the previous setting. For example, if the lower threshold was 2.0 mV, the next decrement would be 1.75 mV. The one after that would be 1.53 mV (1.75 x 87.5%) and so on. The Upper threshold duration after sensing may be extended in patients with T‑wave oversensing due to Long QT syndrome. 4.1.2.2 Enhanced T‑wave Suppression (TWS) If oversensing of the T‑wave complex occurs during normal sinus rhythm, then Enhanced T‑wave Suppression may be programmed.
Page 77 Chapter 4 Sensing Inventra Technical Manual NOTE: While Enhanced VF Sensitivity can help with undersensing, the setting should be used with caution, as oversensing of the intrinsic complex may occur. Detection of VF should be retested when the sensitivity setting is reprogrammed. Duration of upper threshold (50%);...
Page 78: Left Ventricular Sensitivity In Inventra Hf-T Icds
Chapter 4 Sensing Inventra Technical Manual An additional option following post‑paced events is available to program the sensing threshold following the blank after RV pacing period to a specific value. When Post pace T‑wave is programmed ON, the post pace threshold defaults to 3 mV (Figure 71). This feature may be used when the patient has small amplitude R‑waves (<...
Page 79: Far-Field Protection
Chapter 4 Sensing Inventra Technical Manual Duration of upper threshold (50%); Duration of upper threshold (50%); without decrementation; 350ms Default without decrementation; 350ms Default 100 % 100 % Lower threshold (25%) Lower threshold (25%) Additional decrementation of Additional decrementation of 12.5% every 156ms 12.5% every 156ms 50 % 50 %...
Page 80: Far-Field Protection After Ventricular Paced (Vp) Events
Chapter 4 Sensing Inventra Technical Manual Far‑field protection after Vs initiates an atrial blanking period with each ventricular sensed event. As seen in Figure 75, blanking in the atrial channel occurs before and after each ventricular sensed (Vs) event. When the far‑field protection parameter is programmed at the default value of 75 ms, 16 ms of blanking is applied before the Vs event and the remaining 59 ms is applied after the Vs event. When reprogramming this parameter, measure the VA interval and remember that 16 ms is applied before the event when selecting a new value. For example; if the VA interval was measured at 110 ms. ...
Page 81 Chapter 4 Sensing Inventra Technical Manual When reprogramming this parameter, measure the VA interval and remember that 16 ms is applied before the event when selecting a new value. For example; if the VA interval was measured at 110 ms. The selection of 125 ms would provide 16 ms prior to the event and 109 ms after the event. Therefore, the choice of 150 ms would be more appropriate.
Page 82: Safety Pacing
Chapter 4 Sensing Inventra Technical Manual Figure 77: Atrial oversensing IEGM Figure 78: Atrial channel oversensing corrected IEGM NOTE: Should the 75 ms Far‑field protection default value not prevent Far‑field oversensing, thoroughly analyze the IEGM before making any programming changes. It is important to determine the exact lengthening ...
Page 83: Blanking After Pacing
Blank after atrial pace in the Right atrium. When the device delivers an atrial pace, the atrial channel is blanked for 140 ms to prevent oversensing the pace artifact. * HF‑T devices with LV sensing set to Standard † Accessible by BIOTRONIK personnel only PAGE 75...
Page 84: Blank After Atrial Pace In The Right Ventricle
Chapter 4 Sensing Inventra Technical Manual 4.4.2 Blank after Atrial Pace in the Right Ventricle This feature is designed to prevent sensing of the paced atrial artifact from being sensed in the ventricle, resulting in Safety pacing. This screen is found under Sensing details on the Bradycardia screen.
Page 85: Blanking After Lv Pace (Hf-T Device Only)
Chapter 4 Sensing Inventra Technical Manual CAUTION Blanking after RV pace – Extending this value too long may lead to delays in arrhythmia detection. Consult Technical Services prior to extending this value. 4.4.5 Blanking after LV Pace (HF‑T device only) Blanking after LV pace in the RV channel: This prevents oversensing in the RV channel that may lead to inhibition of RV pacing if the initially paced chamber is the left ventricle.
Page 86 Chapter 4 Sensing Inventra Technical Manual PAGE 78...
Page 87: Detection
Chapter 5 Detection Inventra Technical Manual 5. Detection Initial Ventricular Arrhythmia Detection: To ensure that appropriate ICD therapy is delivered, ventricular tachycardia and fibrillation must be distinguished from normal sinus rhythm and supraventricular tachycardias. This is accomplished by proper device sensing, as well as appropriate detection. Detection activation/deactivation: Detection is activated and deactivated via the ICD Therapy field in the upper right corner of the programmer screen, under the Master Switch. When the device is disabled, tachyarrhythmia detection and therapy are inhibited, and the upper right corner will display “disabled”.
Page 88 Chapter 5 Detection Inventra Technical Manual 5.1.1.1 Ventricular‑Only Detection As its name implies, Ventricular‑only detection (i.e., SMART Detection = OFF), uses only information ® obtained from the ventricular sensing lead. Specifically, ventricular rate (or interval), Stability and Sudden Onset are used for rhythm classification. Therefore, Ventricular‑only detection relies on the standard enhancement criteria used in single‑chamber ICDs. In its most basic form, Ventricular‑only detection uses an interval count and rate/interval cut‑off as criteria.
Page 89: Ventricular-Only Vt Detection
Chapter 5 Detection Inventra Technical Manual 5.1.1.4 Sliding Averages While not a specific criteria of Ventricular‑only or SMART Detection , the Inventra ICD uses 4‑beat ® sliding rate averages for several of its calculations. With SMART Detection , the devices use sliding ® averages to compare atrial and ventricular rate to: determine whether the atrial and ventricular rates are equal or not, used with Multiplicity to determine the N:1 ratio; and Stability, to determine whether the ...
Page 90 Chapter 5 Detection Inventra Technical Manual Figure 84: Rate‑only detection of VT1 An example of rate‑only VT1 detection is shown in Figure 84. In this case, there are three tachyarrhythmia zones programmed (i.e., VT1, VT2, and VF). VT detection begins with the first short interval (i.e., the first interval that falls into the VT1 zone). The VT1 Detection Counter increments with each interval shorter than the VT1 limit of 400 ms, including intervals that fall into the VT2 zone. The VT2 Detection Counter increments with each interval shorter than the VT2 limit of 350 ms and decrements with each interval longer than the VT2 limit.
Page 91 Chapter 5 Detection Inventra Technical Manual Stability = +/‑ 24 ms Stability = +/‑ 24 ms Stability = +/‑ 24 ms Stability = +/‑ 24 ms Current interval = 460 ms Current interval = 460 ms Current interval = 390 ms Current interval = 390 ms Compare to three previous intervals Compare to three previous intervals...
Page 92: Stability
Chapter 5 Detection Inventra Technical Manual 5.1.2.4 MorphMatch MorphMatch is a detection enhancement using far‑field signal morphology to differentiate SVT from VT. Therefore, it is only available when the device is programmed to ventricular‑only sensing/detection modes and is recommended for single chamber ICDs or dual chamber ICDs which may experience inconsistent atrial sensing. MorphMatch is programmable in both the VT1 and VT2 zones. MorphMatch compares the signal morphology of sinus events to events seen in the VT zone.
Page 93: Trend Av
Chapter 5 Detection Inventra Technical Manual Figure 87: Calculation of ventricular stability with SMART Detection® 5.2.2 Trend AV To determine whether a consistent pattern between the atrial and ventricular rhythms (AV association) is present, SMART Detection measures AV trend (Figure 88). ®...
Page 94: Rate (Interval)
Chapter 5 Detection Inventra Technical Manual In the Inventra ICD, Onset confirmation is activated when an event meets the Onset criteria. Once the first fast interval (in a tachycardia zone) meeting Onset criteria occurs, the device uses that interval and the next three additional intervals to determine a new four‑interval average and compares that new average against the previous four‑interval average. This function of Onset is designed to prevent single fast events (PVCs) from declaring Onset and providing inappropriate therapy to the patient. Onset is satisfied only when the difference between the current four‑interval average and the previous ...
Page 95: Multiplicity
Chapter 5 Detection Inventra Technical Manual An AV interval is determined to be regular if the interval does not differ from the three preceding AV intervals by more than the AV limit. In other words, the device compares the current AV interval against the three previous without averaging.
Page 96: Smart Detection
Chapter 5 Detection Inventra Technical Manual Figure 92: Calculation of Multiplicity 5.3 SMART Detection ® SMART Detection is one of the most sophisticated detection algorithms available for the discrimination ® of ventricular tachycardia (VT) and supraventricular tachycardia (SVT). SMART Detection (Figure 93) ®...
Page 97: Vt Counters With Smart Detection ® On
Chapter 5 Detection Inventra Technical Manual When ventricular and atrial rates are equal, discrimination of tachyarrhythmias is more difficult. Additional detection criteria are used to identify biarrhythmias, sinus tachycardia, and VT with retrograde conduction, among other rhythms. 5.3.1 VT Counters with SMART Detection ® SMART Detection uses two separate programmable VT Counters (i.e., one counter for VT1 and one ®...
Page 98 Chapter 5 Detection Inventra Technical Manual Figure 94: SMART Detection® of mVT ‑ Branch 1 Figure 95 shows an example of SMART Detection of a mVT. Detection begins after the device has ® detected one short (fast) interval. The interval falls into a VT1 zone, and the average atrial rate is less than the average ventricular rate.
Page 99 Chapter 5 Detection Inventra Technical Manual 5.3.2.2 Discrimination of Atrial Flutter (Branch 2) Typically, VT is difficult for discrimination algorithms to identify when it occurs in the presence of an ongoing atrial arrhythmia. In the worst case scenario, VT could go unrecognized and untreated. However, SMART Detection distinguishes these arrhythmias by carefully comparing atrial and ®...
Page 100 Chapter 5 Detection Inventra Technical Manual Figure 97: IEGM sample of atrial flutter ‑ Branch 2 PAGE 92...
Page 101 Chapter 5 Detection Inventra Technical Manual 5.3.2.3 Atrial Tachycardia or Fibrillation with VT (Branch 3) Using SMART Detection , a biarrhythmia (i.e., a concurrent atrial and ventricular arrhythmia) is ® identified along several branches of the SMART Detection decision tree (Figure 98). The biarrhythmia ® in this section occurs when the atrial rate is greater than the ventricular rate, the ventricular rate is stable, and multiplicity cannot be established.
Page 102 Chapter 5 Detection Inventra Technical Manual Figure 99: Example of VT when multiplicity it not met 5.3.2.4 Atrial Fibrillation (Branch 4) Atrial fibrillation has more than one focus and by nature is irregular or chaotic with atrial intervals of varying lengths. In turn, these atrial intervals are conducted irregularly to the ventricles. SMART Detection identifies irregular conduction and declares atrial fibrillation when the atrial rate is greater ® than the ventricular rate and the ventricular intervals are unstable (Figure 100).
Page 103 Chapter 5 Detection Inventra Technical Manual Figure 101: IEGM sample of atrial fibrillation ‑ Branch 4 NOTE: An event declared as Atrial Fibrillation will decrease the VT counter by four (‑4) to reduce the potential of delivering inappropriate therapy. 5.3.2.5 VT with an Unstable Atrial Arrhythmia (Branch 5) Discrimination of VT is most difficult when atrial and ventricular rates are equal. Therefore, SMART Detection branches out to identify six different classification pathways when the atrial and ventricular ...
Page 104 Chapter 5 Detection Inventra Technical Manual When SMART Detection identifies equal atrial and ventricular rates, the algorithm tests stability in both ® chambers. If the ventricle is stable and the atrium is unstable, the algorithm concludes that the rhythms are disassociated (i.e., independent). In other words, the fast ventricular rate results from a stable VT, while the atrial rate results from an unstable atrial arrhythmia (i.e., multifocal atrial tachycardia).
Page 105 Chapter 5 Detection Inventra Technical Manual Figure 104: SMART Detection® ‑ Branch 6 Figure 105: Example of AV trend 5.3.2.7 Distinguishing VT from Sinus Tachycardia (Branch 7 and Branch 8) When atrial and ventricular rates are similar and stable with no AV trend, SMART Detection branches ®...
Page 106 Chapter 5 Detection Inventra Technical Manual monomorphic VT with retrograde conduction from Sinus Tachycardia, as shown in Figure 106. Figure 107 shows an example of VT with retrograde conduction. Intervals classified as Sinus Tachycardia are labeled with a SinusT marker (Figure 108). Figure 106: SMART Detection® ‑ Branches 7 and 8 Figure 107: Example of VT with retrograde conduction PAGE 98...
Page 107 Chapter 5 Detection Inventra Technical Manual Figure 108: IEGM sample of sinus tachycardia The example in Figure 108 shows a gradual increase in rate due to sinus tachycardia. The Sudden Onset criterion is not met, and therapy is correctly withheld for this episode. 5.3.2.8 Polymorphic VT with Retrograde Conduction (Branch 9) Usually polymorphic VT occurs at higher rates than monomorphic VT.
Page 108 Chapter 5 Detection Inventra Technical Manual Figure 109: SMART Detection® ‑ Branch 9 Figure 110: Polymorphic VT with retrograde conduction 5.3.2.9 Multifocal AT with Antegrade Conduction (Branch 10) In this SMART Detection branch (Figure 111), as in the last, the ventricular and atrial rhythms are ®...
Page 109 Chapter 5 Detection Inventra Technical Manual Figure 111: SMART Detection® ‑ Branch 10 Figure 112: Example of multifocal AT PAGE 101...
Page 110: Sustained Vt Timer
Chapter 5 Detection Inventra Technical Manual 5.3.3 Sustained VT Timer A Sustained VT timer can be programmed as a “safety net” to override Onset and Stability in initial ventricular‑only VT detection. The Sustained VT timer begins with the detection of a fast interval (i.e., an interval that falls into the VT or VF zones).
Page 111: Ventricular Tachyarrhythmia Redetection
Chapter 5 Detection Inventra Technical Manual Figure 114: IEGM example of VF detection Figure 114 shows an example of VF detection. In this example, the VF zone is programmed to eight out of twelve events at an interval of 300 ms, or 200 bpm. One Vs event is seen after the first VF marker, shown in red. A sliding window of 12 intervals is continuously monitored for VF. VF is declared when eight of twelve intervals are found to be 300 ms or less.
Page 112: Smart ® Redetection
Chapter 5 Detection Inventra Technical Manual 5.5.1 SMART Redetection ® SMART Redetection is automatically ON when SMART Detection is programmed. It is used after ® ® VT therapy delivery to withhold further therapy if the delivered VT therapy resulted in an SVT. VT redetection with SMART Redetection ON is based on the programmable Redetection Count; however, ...
Page 113: Forced Termination Timer
Chapter 5 Detection Inventra Technical Manual If a VT Monitoring Zone is programmed, intervals in the VT Monitoring Zone count toward termination and do not count towards redetection. For example, a VT Monitoring Zone is programmed to 130 bpm, a VT2 zone at 150 bpm and a VF zone at 200 bpm. Termination of the arrhythmia will occur when 12 of 16 events are slower than the VT 2 zone (150 bpm).
Page 114: Monitoring Zones
Chapter 5 Detection Inventra Technical Manual In addition to the annotation of the IEGM, the episode details will also provide a Forced Termination message. An example is shown in Figure 117. Figure 117: Forced termination message in the episode details The Forced Termination timer is set to one minute and is not programmable and is not visible on the programmer screen.
Page 115: Tachyarrhythmia Therapy
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual 6. Tachyarrhythmia Therapy The Inventra ICDs/CRT‑Ds offer a variety of therapy options that can be tailored to meet a patient’s specific atrial or ventricular therapy requirements. Anti‑tachycardia pacing (ATP) therapies can be combined with defibrillation therapies to provide a broad spectrum of tachyarrhythmia treatment options for ventricular tachyarrhythmias. ATP therapies and HF burst options are available for atrial tachyarrhythmias in the Inventra DR‑T and CRT‑D devices.
Page 116: Hf Burst
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual 6.1.2 HF Burst OFF, HF Burst HF burst is an option for atrial therapy that allows the physician to program a train of very fast atrial pacing pulses in an attempt to terminate atrial fibrillation. The physician can program the rate, expressed in Hertz (Hz), as well as duration (in seconds). 6.2 Ventricular Antitachycardia Pacing Therapy (ATP) Ventricular therapy programming for Inventra Shock 3 ‑...
Page 117 Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual The ATP Type, Number of Attempts, Number of S1 pulses, and R‑S1 Interval parameters define each ATP scheme. In addition, the S1 Decrement, S1‑S2 Interval, and Add S1 parameters can be programmed as shown below in Table 11. ATP programming options ATP Type Burst Ramp Attempts OFF, 1…(1)…10 OFF, 1…(1)…10 Ventricular pacing RV, BiV...
Page 118 Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual Figure 119: Burst ATP scheme Ramp An ATP Ramp scheme is a series of pulses whose S1‑S1 intervals vary within a single train. To modify the S1‑S1 interval, the S1 Decrement is programmed. For example, when the S1 Decrement is programmed to 20 ms, the S1‑S1 interval shortens by 20 ms with each successive pulse within the train.
Page 119 Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual Figure 121: The Scan Decrement programmed with a Burst ATP scheme Figure 122: The Scan Decrement programmed with a Ramp ATP scheme ATP Enhancement ‑ Add S1 Add S1 is programmed ON by default in the Inventra ICD. When Add S1 parameter is programmed ON, the number of S1 pacing pulses increments by one with each successive ATP delivery.
Page 120: Atp One-Shot
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual 6.2.2 ATP One‑Shot Default ON with Burst ATP, S1 to 8 paced events, R‑S1 interval at 85%. ATP One‑Shot is a feature that allows the physician to program a single ATP therapy for a stable rhythm in the VF zone prior to charging. The rhythm in the VF zone must be regular (12%), such as a stable monomorphic VT. Once the ATP is delivered, charging begins. During charging, the device looks to see if the arrhythmia has terminated (Figure 123).
Page 121: Atp Optimization
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual 6.2.3 ATP Optimization ON or OFF Located on the bottom center of the tachycardia screen and only programmable when an ATP is programmed. ATP Optimization counts the number of successes for each programmed ATP scheme and assigns future ATP delivery based on the highest success counts for each attempt on the highest success count per sequence to the lowest.
Page 122: Minimum Atp
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual The thin black horizontal line on the screen indicated the programmed minimum ATP interval of the device. By default, the minimum ATP interval is 200 ms for all zones including the VF zone. Figure 125: ATP Help 6.2.5 Minimum ATP To prevent ATP intervals from becoming too short (due to programming of the adaptive parameters) and...
Page 123: Standard Biphasic Shock Waveform
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual Shock therapy programming by zone for Inventra ICD/CRT‑D Shock pathway RV→SVC/Can, RV→Can, RV→SVC † (applies to all zones) Table 12: Shock Therapy programming by zone for Inventra ICD/CRT‑D The Inventra ICD will allow programming of one to eight shocks in the VF zone for induction testing. This is done through the temporary VF therapy section of the DFT screen.
Page 124: Biphasic 2 Shock Waveform
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual 6.3.2 Biphasic 2 Shock Waveform For a biphasic 2 waveform (Figure 127), the initial charging voltage is 100%, the switching voltage is equal to 40% of the initial voltage, and the cutoff voltage for phase 2 is time‑controlled at 2 ms. The voltages are automatically calculated based on the programmed energy. The Biphasic 2 programmable shock waveform option offers an additional option for lowering defibrillation thresholds. A study by Merkely et al, showed that the Biphasic 2 waveform may help lower ...
Page 125: Maximum Capacitor Charge Time
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual 6.3.3 Maximum Capacitor Charge Time The maximum capacitor charge time (i.e., capacitor reformations and defibrillation shocks) is 20 seconds. This means that after charging for 20 seconds, the ICD will deliver the energy that is stored in the capacitors, regardless of whether it is fully charged. This could result in delivering less energy for a tachycardia episode than was programmed for the device.
Page 126: Committed Shocks (Confirmation Off)
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual Figure 129 shows five different shock scenarios for an uncommitted shock. Shock is delivered in the first three cases, since the abort conditions are not satisfied. In each instance, the shock delivery occurs on a tachyarrhythmia event. The last two examples show aborted shocks. 6.3.5 Committed Shocks (Confirmation OFF) Independently programmable by zone when Configure zones separately is selected. A committed shock is a shock delivered after detection and charge. There is no attempt to recheck or verify the rhythm prior to shock delivery. The device tries to synchronize with the first ventricular ...
Page 127: Shock Polarity
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual Inventra Shock Types Shock Type Confirmation Shock Delivery R‑wave synchronization attempted Committed Shock can NOT be aborted/dumped R‑wave synchronization attempted Shock aborted/dumped if 3 out of 4 intervals are slower than the Uncommitted slowest tachy therapy zone during the charge One fast tachy event after charging is required to deliver energy Table 14: Inventra Shock Types...
Page 128: Shock Pathway Programming For The Inventra Series Icd/Crt-D
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual Figure 131: Normal and Reversed shock polarities 6.3.7 Shock Pathway Programming for the Inventra Series ICD/CRT‑D The Inventra ICD/CRT‑Ds allow the user to program different shock vectors to provide additional options for patients with high DFTs. The device provides shock pathway configurations, as seen in Figure 132. If selecting the RV to SVC option, a release button will appear, asking the user to select “release”.
Page 129: Therapy Progression
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual 6.4 Therapy Progression Progressive Course of Therapy is automatically enabled (ON) whenever a VT Zone therapy is activated. Therapy within an episode will always be delivered more aggressively with Progressive Course of Therapy. Once shock therapy is delivered, all ATP therapy in the VT zone is suspended, allowing therapy to progress to programmed shock therapy.
Page 130: Shock Energy
Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual Post‑Shock Pacing is delivered in the DDI mode when the Normal Pacing mode is DDD(R), DDI(R), or AAI(R). The Post‑Shock mode is VDI when the Normal Pacing mode is VDD(R) or VDI(R). When the Normal Pacing mode is VVI(R), the Post‑Shock mode is VVI.
Page 131 Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual Delivered Shock Energy Programmed Energy (joules) Approximate Delivered Energy (joules) 10.0 10.9 11.6 12.7 13.4 14.4 16.3 18.0 19.9 22.3 23.1 24.0 25.9 27.8 29.6 31.4 32.7 33.7 35.2 36.9 41.5 Table 16: Delivered Shock Energy Each maximum energy (45 joule) high‑voltage charging sequence reduces the longevity of the device by approximately 22 days.
Page 132 Chapter 6 Tachyarrhythmia Therapy Inventra Technical Manual CAUTION Shock Impedance ‑ If the shock impedance is less than twenty‑five ohms (25 ), reposition the lead system to allow a greater distance between the electrodes. Never implant the device with a lead system that has measured shock impedance as less than 25 ohms (25 ). Damage to the device may result.
Page 133: Bradycardia Therapy
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7. Bradycardia Therapy The Inventra ICDs/CRT‑Ds have independently programmable single‑, dual‑ and triple‑chamber and post‑shock pacing functions. The post‑shock bradycardia parameters may be programmed to higher rates or output values for the period following a delivered shock, without significantly compromising the longevity of the ICD/CRT‑D for patients who require chronic bradycardia pacing. The post‑shock programmable values are presented in Section 7.11 and differ from the normal bradycardia pacing support values.
Page 134: Basic And Hysteresis Rates
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7.2 Basic and Hysteresis Rates Basic Rate: 30… (5)…60…(5)…100… (10)…160 bpm (DR‑T and HF‑T) Basic Rate: 30… (5)…40…(5)…100… (10)…160 bpm (VR‑T and VR‑T DX) Figure 135: Basic Rate Rate Hysteresis: OFF, ‑5… (‑5)… ‑25, ‑45, ‑65 bpm Figure 136: Rate Hysteresis Both a Basic Rate and a Hysteresis Rate may be programmed for normal bradycardia pacing.
Page 135: Scan And Repetitive Rate Hysteresis
Chapter 7 Bradycardia Therapy Inventra Technical Manual Figure 137: The Basic and Hysteresis intervals with VVI pacing 7.2.1 Scan and Repetitive Rate Hysteresis Scan/Repetitive Hysteresis: OFF; ON at 10 events (non‑programmable) Both Scan and Repetitive Rate Hysteresis are available in the Inventra ICD. These features encourage a patient’s own rhythm, periodically allowing for or looking for intrinsic activity.
Page 136: Night Rate
Chapter 7 Bradycardia Therapy Inventra Technical Manual NOTES: If rate adaptation is active, the Hysteresis rate is based on the current sensor‑indicated rate minus the Rate Hysteresis value. If Hysteresis is used in the DDI mode, the AV delay must be programmed shorter than the spontaneous AV conduction time.
Page 137: Closed Loop Stimulation (Cls)
Chapter 7 Bradycardia Therapy Inventra Technical Manual Scan/Repetitive Hysteresis – ON (fixed ‑ set at 5 events) I‑Opt (intrinsic optimization) is a feature found in the Inventra DR‑T and VR‑T DX ICDs to promote ventricular intrinsic rhythm. The feature is found under the AV hysteresis parameter. When programmed, the hysteresis AV Delay is set to a fixed value of 400 ms, regardless of programmed AV Delay. It uses the AV Hysteresis functions as described in Section 7.3, with fixed scan and repetitive AV hysteresis values of 5.
Page 138: Maximum (Cls) Sensor Rate
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7.4.1 Maximum (CLS) Sensor Rate 80…(10)…120…(10)… 160 bpm The maximum CLS sensor rate is the highest pacing rate that may be achieved with sensor activity and should be programmed based on the patient’s activity level. This value must be less than the programmed Upper tracking rate value.
Page 139: Vp Required
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7.4.4 Vp Required Yes, No This parameter allows the device to update the CLS algorithm for paced and sensed events. When programmed to No, the device modulates the AV interval to ensure the algorithm is using current data. Vp required to yes may be selected in patients complete heart block as no underlying rhythm may be present.
Page 140: Sensor Threshold
Chapter 7 Bradycardia Therapy Inventra Technical Manual Figure 145: Sensor Gain When the Sensor gain is programmed to Auto, the sensor is designed to adjust the gain setting automatically based on the patient’s activity level. The gain will increase in value (more aggressive) if the patient has not reached 90% or more of the maximum sensor rate for 60 minutes in a seven‑day ...
Page 141: Rate Increase/Decrease
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7.5.4 Rate Increase/Decrease The Rate Increase and Rate Decrease parameters work with Sensor Gain to determine how quickly the pacing rate increases or decreases with changes in the sensor output. There are four different Rate Increase settings (1, 2, 4, or 8 bpm/cycle) and four different Rate Decrease settings (0.1, 0.2, 0.5 or 1.0 bpm/cycle).
Page 142: Mode Switching
Chapter 7 Bradycardia Therapy Inventra Technical Manual NOTE: In this example, there is no separate Mode Switch Basic Rate programmed. When Mode Switch occurs, the rate equals the Normal Basic Rate. If the Change of Basic Rate is programmed, the pacing rate during Mode switch will the programmed Basic Rate plus the Change of Basic Rate value.
Page 143: Change Of Basic Rate
Chapter 7 Bradycardia Therapy Inventra Technical Manual These are shown in Table 19. Activation/Deactiviation Criterion Mode Switch X value Y value Activation Criteria 3, 4, 5, 6, 7, 8 Deactivation Criteria 3, 4, 5, 6, 7, 8 Table 19: Activation/Deactivation Criterion The Mode Switching automatically reverts to the Normal Bradycardia pacing mode when the atrial rate falls below the Intervention Rate.
Page 144 Chapter 7 Bradycardia Therapy Inventra Technical Manual Figure 149: Vp Suppression The Vp Suppression parameter determines how aggressive the algorithm will be in switching to the ADI(R) mode. The default setting is six with a programmable range of 1‑8 events. This means the device requires six consecutive Vs events before the device switches to the ADI(R) mode.
Page 145: How The Vp Suppression Algorithm Works
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7.8.2 How the Vp Suppression Algorithm Works Once the algorithm is programmed ON, a Vs Continuity test is performed with the first intrinsic ventricular event (Figure 152) or after 30 seconds (Figure 153), whichever comes first. Continuity test looks for 6 consecutive Vs responses Continuity test looks for 6 consecutive Vs responses Vp Suppression activated Vp Suppression activated After a single intrinsic Vs event, the AV Delay is extended to 450 ms for the continuity After a single intrinsic Vs event, the AV Delay is extended to 450 ms for the continuity Programmed AV Delay Programmed AV Delay...
Page 146 Chapter 7 Bradycardia Therapy Inventra Technical Manual Pacing at Pacing at Continuity test looks for 6 consecutive Vs res ponses in 8 events Continuity test looks for 6 consecutive Vs res ponses in 8 events Pacing at Pacing at programmed AV Delay programmed AV Delay programmed AV Delay programmed AV Delay...
Page 147 Chapter 7 Bradycardia Therapy Inventra Technical Manual Pacing at programmed Pacing at programmed Pacing at programmed Vp Suppression active Vp Suppression active Vp Suppression active AV Delay AV Delay AV Delay Programmed AV Delay Programmed AV Delay If no Vs events occur within 2 seconds, 2 cycles or if the If no Vs events occur within 2 seconds, 2 cycles or if the programmable number of cycles without a Vs event has been programmable number of cycles without a Vs event has been...
Page 148: Ventricular Pacing (Hf-T Devices Only)
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7.9 Ventricular Pacing (HF‑T Devices Only) Figure 156: Ventricular pacing screen for HF‑T devices 7.9.1 Ventricular Pacing The Inventra HF‑T provides the option for BiV or RV pacing. These can be independently programmable for the permanent, Mode Switch, and Post shock pacing. 7.9.2 Trigger Pacing Programmable RV sense, RV sense + PVC or OFF.
Page 149: Dynamic Av Delay
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7.10 Dynamic AV Delay Inventra Dynamic AV Delay Dynamic AV Delay Default (ms) for Inventra HF‑T Rate Medium High 60 bpm – Lower Rate 130 bpm – Upper Rate Dynamic AV Delay Default (ms) for Inventra DR‑T Rate Medium High...
Page 150: Positive Av Hysteresis With Scan/Repetitive
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7.10.1 Positive AV Hysteresis with Scan/Repetitive Positive Scan/Repetitive Hysteresis: OFF; ON at 5 events (non‑programmable) This function should not be used in Inventra HF‑T because it could encourage intrinsic ventricular activity and impact the effects of CRT pacing therapy. With AV Hysteresis ON, the AV Delay is extended to the programmed hysteresis delay after every Vs event to encourage intrinsic conduction; see Figure 158: •...
Page 151 Chapter 7 Bradycardia Therapy Inventra Technical Manual Figure 159: Repetitive Hysteresis By adding the Scan enhancement, after 180 consecutively paced cycles, the AV delay is extended for five pacing cycles • Each Vs event will reset the scan counter and initiate the extended AV delay (see green arrow in Figure 160).
Page 152 Chapter 7 Bradycardia Therapy Inventra Technical Manual To program Positive AV Hysteresis ON: 1. Press AV hysteresis mode to select Positive hysteresis. 2. Select the AV Hysteresis value desired. The choices are 70, 110, 150, 200 ms. 3. AV scan/repetitive is automatically ON when Positive hysteresis is selected. Figure 161: Dynamic AV delay screen with AV hysteresis choices Figure 162: AV hysteresis Figure 163: AV scan/repetitive...
Page 153: Negative Av Hysteresis
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7.10.2 Negative AV Hysteresis AV Hysteresis: 10 … (10) … 50…(10)… 150 ms The intent of Negative AV Hysteresis (Figure 164) is to reduce the chance of intrinsic activity occurring in patients with hypertrophic cardiomyopathy (HCM) or heart failure patients when trying to optimize the AV Delay for maximum cardiac output and high (bi‑)ventricular pacing percentages.
Page 154: Sense Compensation
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7.10.3 Sense Compensation OFF, ‑5…(‑5)…‑40…(‑5)…‑120 ms When Sense Compensation is activated, the AV Delay following an atrial sensed event differs from the AV Delay following an atrial paced event. The AV Delay after a sensed event is shortened by a programmed value (i.e., between ‑5 and ‑120 ms) to provide a similar PR interval, whether atrial depolarization is accomplished by pacing or intrinsic activity.
Page 155: Capture Control
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7.12 Capture Control 7.12.1 Atrial Capture Control Capture control; OFF, ATM, ON Threshold test start: Programmed output value Key numbers for Atrial Capture Control (ACC) 20% higher than the intrinsic rate Test Rate AV Delay/Mode The AV Delay is shortened to 50 ms in the DDI mode Each test cycle consists of five paced atrial events Test cycle Loss of capture is determined when at least two sensed events...
Page 156: Minimum Amplitude
Chapter 7 Bradycardia Therapy Inventra Technical Manual Parameters associated with Atrial Capture Control are shown in Table 22. Parameter Range Default Capture Control ON, ATM, OFF Minimum Amplitude 0.5...(0.25)...4.0 V 1.0 V Capture Test Start 2.5...(0.5)...5.0 V 3.5 V Safety Margin 0.5, 1.0, 1.2 V 1.0 V Table 22: Atrial Capture Control Parameters...
Page 157: Ventricular Capture Control
Chapter 7 Bradycardia Therapy Inventra Technical Manual 7.12.1.2.4 Safety Margin 0.5, 1.0, 1.2 V, default of 1.0 V This is the amount of pacing output added to the measured threshold value to ensure capture. This takes into account minor changes in thresholds throughout the day. For example, if the threshold was 0.7 V, the device would add the 1.0 V safety margin to the 0.7 V threshold and program the pacing output to 1.7 V.
Page 158 Chapter 7 Bradycardia Therapy Inventra Technical Manual Figure 166: Signal Evaluation 7.12.2.1.1 Signal Quality Check (SQC) and Capture Threshold Search (CTS) When the VCC or ATM algorithm is activated, an SQC and CTS sequence is initiated. The progression of this sequence is shown by a message displayed at the bottom of the programmer screen. The programmer wand must be in place during the initial SQC/CTS initialization.
Page 159 Chapter 7 Bradycardia Therapy Inventra Technical Manual If any non‑capture events occur during the capture phase or if the polarization amplitude violates the pre‑set threshold, the SQC attempt is unsuccessful. If the first SQC attempt is unsuccessful upon initialization, the VCC algorithm is set to pending and repeated. The SQC/CTS sequence generally takes less than one minute. 7.12.2.1.2 Capture Threshold Search The purpose of the Capture Threshold Search (CTS) is to determine the minimum ventricular pacing amplitude that will capture the heart to a resolution of 0.1 V. The pacing threshold is defined as the ...
Page 160: Pmt Protection
Chapter 7 Bradycardia Therapy Inventra Technical Manual • When LV ATM/VCC is performed, the V‑V interval is temporarily changed to 50 ms. This means the RV channel will pace 50 ms after the LV channel so a back‑up pulse is not required. RV pacing will occur at all times during the test, regardless of whether LV capture occurred.
Page 161: Channel Programming For Pacing Polarity
Chapter 7 Bradycardia Therapy Inventra Technical Manual Under certain conditions, retrograde conducted atrial events may be tracked by the device and lead to Pacemaker Mediated Tachycardia (PMT). These retrograde atrial events may occur following a premature ventricular beat, loss of atrial capture, or a prolonged AV Delay. PMT Protection is an optional bradycardia algorithm (programmed ON or OFF) designed to terminate a PMT.
Page 162: Rate Smoothing (Non-Programmable)
Chapter 7 Bradycardia Therapy Inventra Technical Manual The Inventra HF‑T allows the user to program bipolar or unipolar sensing. Unipolar sensing is from the LV tip to the ICD housing. Figure 171: LV sensing polarity choices 7.15 Rate Smoothing (non‑programmable) Rate Smoothing is a hidden feature to prevent sudden rate changes and is utilized for Mode Switching, Night rate, following Post Shock duration, and Post Mode Switch Duration.
Page 163: Diagnostics
Chapter 8 Diagnostics Inventra Technical Manual 8. Diagnostics 8.1 Tachycardia Diagnostics 8.1.1 Recording Memory Various device information is available within the Recording memory. The Recording memory can be configured a number of different ways depending on the physician’s preference. 8.1.1.1 Episode List Detailed information about each individual episode is presented as a table of events ordered from most recently delivered to the first delivered. Each IEGM segment can be viewed from the episode ...
Page 164 Chapter 8 Diagnostics Inventra Technical Manual 8.1.1.2 Episode Details Figure 173: Episode details The Details Icon provides detection and therapy specifics for each episode. The time and date of the episode are noted in the bottom left, along with the duration of the episode and the time of termination. Similarly, the measured stability (in milliseconds) is shown for the last 4 R‑R intervals prior to detection in the upper left portion of the panel.
Page 165 Chapter 8 Diagnostics Inventra Technical Manual The Inventra VR‑T ICD provides ventricular and far‑field IEGMs and the Inventra DR‑T ICD and VR‑T DX provide atrial and ventricular IEGM recordings as well as far‑field recordings. The Inventra HF‑T CRT‑D provides three channels of electrograms in three programmable offerings: atrial, right and left ventricular IEGMs; atrial, right ventricle, far‑field; and far‑field, right and left ventricle. All ventricular tachyarrhythmia recordings (i.e., VT1, VT2, and VF episodes) are triggered when detection occurs and includes the predetection as well as the preterminiation IEGM. A maximum recording time of up to four minutes, including prehistory and termination, is stored.
Page 166 Chapter 8 Diagnostics Inventra Technical Manual Delivered shocks will provide a charge time and a shock impedance value. Aborted shocks will provide a charge time but no impedance value as the energy was not delivered. Aborted energies are not dumped by the device after the episode immediately, but rather bleed off over several minutes. If a new episode resulting in shock delivery occurs before the stored energy bleeds off the device, the user may see “^45”...
Page 167: Bradycardia Diagnostics
Diagnostics are not automatically restarted any time a parameter change is made within the bradycardia parameters. This is different from previous BIOTRONIK ICDs. Trends will be marked at the day of follow‑up with “F” at a follow‑up session without reprogramming or with “P” at a follow‑up session with reprogramming.
Page 168: Timing Statistics
Chapter 8 Diagnostics Inventra Technical Manual Figure 177: The Timing statistics screen 8.2.2 Timing Statistics The ICD/CRT‑D stores a variety of useful diagnostic data of the bradycardia history as described in the following sections. 8.2.2.1 Event Episode and Events This section presents data collected on the different pacing states of the device; As‑Vp, As‑Vs, Ap‑Vp, Ap‑Vs and Vx‑Vx.
Page 169: Atrial Arrhythmia Data
Chapter 8 Diagnostics Inventra Technical Manual Key Points: • The Rate Histogram displays the percentage of paced and sensed events in each rate bin listed along the horizontal axis. • The Rate Histogram is based on Ap, As, Ars, As(PVARP), RVp, RVs, PVC, and RVrs events. •...
Page 170: Atrial Burden
Chapter 8 Diagnostics Inventra Technical Manual 8.2.3.1 Atrial Burden The Atrial burden section provides information for the following: 8.2.3.2 Total Number of Episodes This represents the number of atrial tachycardia episodes that have occurred since the last follow‑up. Ongoing atrial episodes are not counted in this number. 8.2.3.3 Atrial Arrhythmia Burden % This represents the average daily atrial burden since the last time the diagnostics were reset.
Page 171: Hf Monitor
Chapter 8 Diagnostics Inventra Technical Manual 8.2.4 HF Monitor Figure 179: HF Monitor diagnostic 8.2.4.1 Rate The top of the graph in the HF Monitor tab displays Mean Heart Rate and Mean Heart Rate at Rest. Mean Heart Rate is designated by the “RV,” and the Mean Heart Rate at Rest is designated by “RV at Rest”.
Page 172: Hours
Chapter 8 Diagnostics Inventra Technical Manual interrogation of the ICD. The TI trend does not replace assessments that are part of standard of care for the clinical practice. The clinical value of this feature has not been established for management of patients.
Page 173: More Statistics
Chapter 8 Diagnostics Inventra Technical Manual Figure 180: 48 hours 8.2.5.1 Rate The atrial and right ventricular rates are displayed over the last 48 hours prior to interrogation. 8.2.5.2 Atrial arrhythmia burden Presents atrial burden data for the last 48 hours prior to interrogation. 8.2.5.3 Paced Presents the paced percentages for all programmed channels.
Page 174: Pulse Amplitude
Chapter 8 Diagnostics Inventra Technical Manual LVrs ‑ refers to LV refractory events. These are events that occur within 200 ms of the previous LV event and are non‑programmable Figure 181: Counters screen This page provides the percentage of each of the different states of pacing and the percentage of BiV pacing in HF‑T devices.
Page 175 Chapter 8 Diagnostics Inventra Technical Manual Figure 182: Pulse amplitudes Key Points: • Pulse amplitude displays the measured threshold for each day throughout the duration of the statistics. • Pacing threshold measurements can be programmed to ATM or VCC in the device from the parameters screen under the Bradycardia/CRT tab.
Page 176 Chapter 8 Diagnostics Inventra Technical Manual Key Points: • The Rate Trend shows the rate of each chamber plotted separately for the duration of the statistics. • The Rate Trend is based upon As, Ap, Ars, As(PVARP), Vs, Vp, PVC, and Vrs events. •...
Page 177 Chapter 8 Diagnostics Inventra Technical Manual 8.2.6.5 PVC/h The PVC/h statistic shows the average number of PVCs per hour for each 24‑hour period. The date the orange line intersects is shown at the bottom of the graph. Figure 185: PVC/h graph Key Points: •...
Page 178 Chapter 8 Diagnostics Inventra Technical Manual PAGE 170...
Page 179: Additional Features
BIOTRONIK conducted the TRUST study to evaluate the safety and effectiveness of Home Monitoring ® With the TRUST study, BIOTRONIK was able to show the following with regards to Home Monitoring ® • BIOTRONIK Home Monitoring information may be used as a replacement for device interrogation ®...
Page 180: Transmitting Data
For more information on registering for Home Monitoring , contact your BIOTRONIK sales ® representative. The password protected BIOTRONIK Home Monitoring website can be accessed at the following URL: ® www.biotronik‑homemonitoring.com An online help menu is available in order to assist with the use of the Home Monitoring website.
Page 181: Types Of Report Transmissions
Chapter 9 Additional Features Inventra Technical Manual 9.1.1.3 Types of Report Transmissions When the Home Monitoring function is activated, the transmission of information from the implant can ® be triggered as follows: • Daily report – the time period (daily) initiates the transmission (IEGM included if not yet sent) •...
Page 182: Description Of Transmitted Data
Chapter 9 Additional Features Inventra Technical Manual • ERI Programmer Triggered Report With the device status screen, it is possible to test the ICD/CRT‑D’s Home Monitoring capabilities during device implantation or follow‑up. To do this, the CardioMessenger must be within range of the Inventra ICD/CRT‑D and powered ON.
Page 183 Chapter 9 Additional Features Inventra Technical Manual • Complete Paced Rhythm (ApVp) • VV sequence (Vx‑Vx) [%] • Ap, RVp, LVp [%] Pacing Counters (CRT) • LV‑RV‑Sequences • BiVp (RVp‑LVp or LVp‑RVp • RVs‑LVp • RVp‑no LVp, RVs‑noLVp (LV T‑wave protection ON) • LVp, no LVp (LV pacing only) •...
Page 184 Chapter 9 Additional Features Inventra Technical Manual • Mean ventricular heart rate • Mean ventricular heart rate at rest • Max/mean ventricular heart rate during atrial burden • Heart Rate Variability • Atrial SDANN per day (5 min periods of As‑As) •...
Page 185: Thoracic Impedance
Chapter 9 Additional Features Inventra Technical Manual • For the periodic IEGM only one part is available. Such recordings are performed right before a periodic message, and after each interval as configured. The Inventra ICD/CRT‑D transmits the following data from the Episode List with the IEGM message: •...
Page 186: Capacitor Reformation
Chapter 9 Additional Features Inventra Technical Manual NOTE: Pocket and or lead revisions may affect the TI trend data. Therefore, the TI trend data should be interpreted cautiously within 6‑10 weeks of an implant or revision procedure. 9.3 Capacitor Reformation Shock charge times may be prolonged if the high‑voltage capacitors remain uncharged for an extended period of time.
Page 187: Asynchronous Pacing Modes
Chapter 9 Additional Features Inventra Technical Manual 9.4 Asynchronous Pacing Modes The Inventra models offer the following asynchronous pacing modes for use during medical procedures: • VOO – asynchronous pacing in the ventricle • DOO – asynchronous pacing in the atrium and ventricle with a fixed AV delay for conduction between chambers.
Page 188 Chapter 9 Additional Features Inventra Technical Manual PAGE 180...
Page 189: Implantation Testing, Ep Test Functions And Follow-Up
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual 10. Implantation Testing, EP Test Functions and Follow‑up All tests related to an ICD implant and follow‑up are located on the Tests screen. These tests include: P/R amplitude measurements, pacing impedance, retrograde conduction test, threshold (pacing), DFT test, and ATP test.
Page 190: Intrinsic Rhythm (Test)
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual 10.1.2 Intrinsic Rhythm (test) The sensing test can be performed by selecting and holding down the Intrinsic Rhythm button. The test ends when the button is released. NOTE: When selecting the Intrinsic Rhythm button, there is no pacing support for the duration the button is pressed.
Page 191: Pacing Lead Impedance
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual 10.1.2.4 AV Delay 100 ms This is a fixed value available only when the VDD mode is selected. 10.1.2.5 LV Sensing Polarity Programmed polarity 10.1.2.6 Report OFF, 5, 10, 25 or 50 mm/sec Report is the paper speed when performing the sensing test. NOTE: During the sensing test, PVARP is set to 200 ms if PVARP is set to AUTO.
Page 192: Retrograde Conduction Test
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual The pacing impedances are measured from the Impedance tab found under the Tests button. To measure the impedance, simply press the Start button at the bottom of the screen. The word TEMP (temporary) appears on the marker channel when the test has started and across the bottom of the screen the phrase “Lead detection in progress.
Page 193: Programming To Prevent Pmt
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual The programmer displays the results as the maximum, minimum, and average retrograde conduction time (RCT), and the measured V‑A times are displayed on the marker channel. Generally, if the min, mean and max times are within 25 ms, retrograde conduction is suspected.
Page 194 Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual selected. In addition, the atrial IEGM screen can be displayed during the atrial threshold test by toggling the ECG/IEGM button. As with all screens, the patient’s intrinsic rate is displayed on the screen. The intrinsic rate helps the user select the best pacing rate for the test.
Page 195: Defibrillation Threshold Testing (Dft)
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual Figure 194: The Pacing Threshold Test using the far‑field option As the threshold test begins, the selected pacing parameters are transmitted temporarily to the device. These parameters are default parameters (i.e., the parameters programmed between test parameters) and should be adjusted to guarantee capture.
Page 196 Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual Figure 195: The Inventra DFT Test screen WARNING Resuscitation Availability ‑ Do not perform induction testing unless an alternate source of patient defibrillation such as an external defibrillator is readily available. In order to implant the ICD/CRT‑D system, induce and convert the patient’s ventricular tachyarrhythmias. CAUTION Defibrillation Threshold ...
Page 197: Induction
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual 10.5.1 Induction The Start induction button is located on the bottom left portion of the screen. Two different induction schemes are available: Shock‑on‑T and HF Burst. If the rhythm is not converted by the device after induction, an emergency shock can be delivered via the Deliver Emergency Shock button found on the bottom center of the screen or Manual shock button located at the right lower portion of the screen.
Page 198 Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual Figure 196: R‑S1 interval options for 1 joule test shock Figure 197: DFT screen with 1 J Test Shock being delivered As seen in Figure 197, the ICD will deliver three ventricular pacing pulses (500 ms; 7.5 V @ 1.5 ms) as well as a 1‑J shock following a 30 ms delay after the third ventricular paced pulse. Should the user try to deliver the test shock while the device ICD therapy is OFF, a caution message is displayed to require the user to activate ICD therapy before the test shock can be delivered.
Page 199 Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual WARNING Resuscitation Availability ‑ Do not perform induction testing unless an alternate source of patient defibrillation such as an external defibrillator is readily available. In order to implant the ICD/CRT‑D system, it is necessary to induce and convert the patient’s ventricular tachyarrhythmias. CAUTION Defibrillation Threshold ‑ Be aware that the changes in the patient’s condition, drug regimen, and other factors may change the defibrillation threshold (DFT), which may result in non‑conversion of ...
Page 200: Defibrillation Threshold Testing
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual 10.5.2.1 Wand Application / RF Telemetry Placing the wand over the ICD closes the reed switch and allows communication — including real‑time IEGM transmission — between the device and the programmer. Wand application does NOT inhibit tachyarrhythmia detection and therapy.
Page 201: Arrhythmia Induction Types
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual The second testing method is to determine only if an adequate safety margin exists. Standard practice for all ICD implants dictates that an induced fibrillation should be successfully converted twice by a shock that is 10 joules less than the maximum energy output of the device. (See Figure 200.) Figure 200: Safety Margin Test 10.5.4 Arrhythmia Induction Types The Inventra devices can be programmed to induce arrhythmias for DFT testing using two different...
Page 202 Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual The Shock‑on‑T‑wave induction scheme begins with a train of pacing pulses. The number of paced pulses (i.e., Number S1) and the coupling interval (i.e., R‑S1 Interval.) are programmable. Generally, the coupling interval R‑S1 is programmed between 300 and 450 ms with the number of S1 pulses between 4 and 8 pulses.
Page 203: Manual Therapy
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual Figure 202: HF Burst induction 10.5.5 Manual Therapy 10.5.5.1 Non‑Invasive Programmed Stimulation Testing (NIPS) Available in the EPE/ATP section of the DFT screen. Type: Ramp, Burst or Burst + PES, Rapid pacing Ventricular pacing: RV or BiV (HF‑T only) Number S1: 1… (1)…25; Default 5 R‑S1 Interval: 70% … (5%) …95%, 200 … (10) …600 ms; Default 80%...
Page 204: Manual Shock
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual Figure 203: Example of NIPS using Burst + PES induction 10.5.5.2 Manual Shock Energy: 1‑45 joules Polarity: Normal or Reversed Waveform: Biphasic or Biphasic 2 Manual ATP therapy and manual shock therapy can be delivered from the DFT Test screen regardless of the magnet mode.
Page 205: Non-Invasive Programmed Stimulation Testing (Nips)
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual CAUTION Manual Shocks – User‑commanded shocks may be withheld if the ICD/CRT‑D is already busy processing a manual command or the Battery Status is low. 10.5.6 Non‑Invasive Programmed Stimulation Testing (NIPS) To perform the NIPS testing, the programmer wand must be placed directly over the pulse generator to enable continuous telemetry or wandless telemetry session initiated.
Page 206: Programmed Stimulation
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual Burst Stimulation, shown in Figure 205, offers a burst of pacing pulses in the atrium up to a rate of 800 bpm. The duration of the burst is as long as the burst key on the programmer is pressed. When the burst key is no longer pressed, the program reverts to the back‑up program.
Page 207 Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual Parameter Range Default Setting S1‑S1 (ms) 80…(10)…2000 ms 600 ms S1 Cycles 0…(1)…10 S1‑S2 None, 80…(10)…1000 ms None S2‑S3 None, 80…(10)…1000 ms None S3‑S4 None, 80…(10)…1000 ms None Table 26: Programmed Stimulation S1‑S1: This is the pacing drive train for Programmed Stimulation therapy.
Page 208: Emergency Shocks
Chapter 10 Implantation Testing, EP Test Functions and Follow‑up Inventra Technical Manual CAUTION Short Pacing Intervals – Use of short pacing intervals (high pacing rates) with long atrial and/or ventricular refractory periods may result in intermittent asynchronous pacing and, therefore, may be contraindicated in some patients.
Page 209: Sterilization And Storage
Return the device to BIOTRONIK. Re‑sterilization ‑ Do not re‑sterilize and re‑implant explanted devices. Storage (temperature) ‑ Store the device between 5° to 45°C (41°...
Page 210 Chapter 11 Sterilization and Storage Inventra Technical Manual PAGE 202...
Page 211: Implant, Follow-Up And Explantation Procedures
PK‑144 cable. The PA‑3 adapter is used to connect DF‑1 compatible leads to the PK‑144 cable. • The BIOTRONIK patient adapter PA 10 is used to connect a lead with DF4 connector to the alligator clips on one of the following legally marketed BIOTRONIK patient cables or patient adaptors: •...
Page 212 Chapter 12 Implant, Follow‑up and Explantation Procedures Inventra Technical Manual WARNING Left Ventricular Lead Systems – BIOTRONIK CRT‑Ds may be implanted with any legally marketed, compatible LV lead. Compatibility is defined as: • IS‑1 pacing connector • Active or passive fixation technology •...
Page 213: Lead System Evaluation
CAUTION Device Packaging ‑ Do not use the device if the device’s packaging is wet, punctured, opened or damaged because the integrity of the sterile packaging may be compromised. Return the device to BIOTRONIK. PAGE 205...
Page 214: Pocket Preparation
Chapter 12 Implant, Follow‑up and Explantation Procedures Inventra Technical Manual 12.1.4 Pocket Preparation Using standard surgical technique, create a pocket for the device either in the patient’s pectoral or abdominal region, dependent on patient anatomy. The device may be implanted either below the subcutaneous tissue or in the muscle tissue.
Page 215 CAUTION Connector Compatibility ‑ ICD/CRT‑D and lead system compatibility should be confirmed prior to the implant procedure. Consult your BIOTRONIK representative regarding lead/pulse generator compatibility prior to the implantation of an ICD/CRT‑D system. For further information, please refer to Appendix A. Setscrew Adjustment – Back‑off the setscrew(s) prior to insertion of lead connector(s) as failure to do so may result in damage to the lead(s), and/or difficulty connecting lead(s).
Page 216: Blind Plug Connection
Programmed Parameters – Program the device parameters to appropriate values based on the patient’s specific arrhythmias and condition. Programmers ‑ Use only BIOTRONIK’s ICS 3000 or Renamic programmers to communicate with the device. Defibrillation Threshold ‑ Be aware that changes in the patient’s condition, drug regimen, and other factors may change the defibrillation threshold (DFT) which may result in non‑conversion of ...
Page 217: Implant The Icd/Crt-D
CAUTION Connector Compatibility ‑ ICD/CRT‑D and lead system compatibility should be confirmed prior to the implant procedure. Consult your BIOTRONIK representative regarding lead/pulse generator compatibility prior to the implantation of an ICD/CRT‑D system. For further information, please refer to Appendix A. Shock Impedance – If the shock impedance is less than twenty‑five ...
Page 218 Chapter 12 Implant, Follow‑up and Explantation Procedures Inventra Technical Manual CAUTION Pacing Threshold ‑ Testing of the pacing threshold by the ICD/ CRT‑D system should be performed with the pacing rate programmed to a value higher than the patient’s intrinsic rate. Defibrillation Threshold ...
Page 219: Follow-Up Procedures
Chapter 12 Implant, Follow‑up and Explantation Procedures Inventra Technical Manual 12.2 Follow‑up Procedures 12.2.1 General Considerations An ICD/CRT‑D follow‑up serves to verify appropriate function of the ICD/CRT‑D system and to optimize the programmable parameter settings. In addition to evaluating the patient’s stored therapy history and electrograms, acute testing of sensing and pacing is recommended.
Page 220: Follow-Up Assistant
Chapter 12 Implant, Follow‑up and Explantation Procedures Inventra Technical Manual Figure 208: Programmer time and date setup 12.2.3 Follow‑up Assistant When the Inventra ICD is first interrogated, the Follow‑up Assistant screen is shown. It can be accessed at any time by selecting the “Follow‑up” button at the right side of the programmer screen. Figure 209: The Follow‑Up screen after interrogation The Follow‑up page is divided into five sections; Patient, Device status, New episodes/event ...
Page 221: Device Status
Chapter 12 Implant, Follow‑up and Explantation Procedures Inventra Technical Manual Figure 210: Follow‑up History page The History page automatically tracks the entire test data measured at implant and follow‑up. The data may reveal gradual or abrupt changes that suggest further lead assessment. Follow‑up data is entered into the Measurement Trend table at device interrogation and is only entered once per 24‑hour period (day).
Page 222: Test Results
Chapter 12 Implant, Follow‑up and Explantation Procedures Inventra Technical Manual Event messages, such as the one shown in red in Figure 209, are also provided in the section. Other messages include out of range values such as shock or pacing impedances. Touching the message takes the user to the appropriate diagnostic or recordings page for more detailed information.
Page 223: Data Retrieval
Chapter 12 Implant, Follow‑up and Explantation Procedures Inventra Technical Manual Figure 212: Diagnostics Information provided includes Rate histogram data, Event episodes, Longest atrial episode duration, and Long‑term trend information since the last follow‑up. The buttons along the bottom of the page function in the same manner as discussed in the Trends section.
Page 224: Iegm Storage
Chapter 12 Implant, Follow‑up and Explantation Procedures Inventra Technical Manual The IEGM records and details for each episode and can be viewed by selecting the buttons beside each episode number in the Episode List. Each IEGM record should be printed during follow‑up. The selection of an IEGM for viewing will also store the IEGM in the Print manager.
Page 225: Reprogramming
New parameters should be printed and a printout kept with the patient’s records for future reference. NOTE: Unlike previous generations of BIOTRONIK ICDs, reprogramming the Inventra device will NOT automatically enable detection and therapy. 12.2.7 Manual Follow‑Up If desired, all tests in the Follow‑up Assistant can be performed separately.
Page 226 Chapter 12 Implant, Follow‑up and Explantation Procedures Inventra Technical Manual Figure 215: Impedance Test One can expect a slightly higher reading with a single‑coil lead, as opposed to a dual‑coil lead. It is also important to note that at implant testing with a single‑coil lead, the can must be in the device pocket in order to get a reading.
Page 227: Threshold Test
Chapter 12 Implant, Follow‑up and Explantation Procedures Inventra Technical Manual Figure 216: Sensing Test 12.2.7.3 Threshold Test The Threshold test can be done with a surface ECG, far‑field signal or by viewing the IEGM. The user can select the pacing mode and chamber to be tested. Changes can be made “on the fly” at any time while an active test is ongoing. Any value that is in bold on the screen can be changed. See Figure 217 for an example of the threshold test screen.
Page 228 Chapter 12 Implant, Follow‑up and Explantation Procedures Inventra Technical Manual The Pulse amplitude and Pulse width values that are displayed will match the Mode of the Test program. For example, in Figure 217, the threshold test is being performed in the RV chamber in a VVI mode.
Page 229: Temporary Programming
Explanted ICDs/CRT‑Ds, lead systems, and accessories may not be reused. Please complete the appropriate out of service (OOS) form and return it to BIOTRONIK with the explanted devices. All explanted devices should be sent either to the local BIOTRONIK representative or the BIOTRONIK home office for expert disposal. Contact BIOTRONIK if you need assistance with returning explanted ...
Page 230 Chapter 12 Implantation, Follow‑up and Explantation Procedures Inventra Technical Manual PAGE 222...
Page 231: Longevity
Chapter 13 Longevity Inventra Technical Manual 13. Longevity The service time of an ICD/CRT‑D can vary based on several factors, including the number of charge sequences, programmed parameters, number of tachyarrhythmias detected, relative amount of bradycardia pacing required, pacing lead impedance, storage time, battery properties, and circuit operating characteristics.
Page 232 Chapter 13 Longevity Inventra Technical Manual Inventra VR‑T Longevity Estimates with a UBD of 6 months 500 ohms 700 Ohms Maximum energy pacing impedance pacing impedance % Pacing charging frequency RV: 2.5V RV: 2.5V 0% VVI Quarterly 10.6 10.6 15% VVI Quarterly 10.3 10.4 50% VVI Quarterly...
Page 233 Chapter 13 Longevity Inventra Technical Manual Inventra DR‑T Longevity Estimates with a UBD of 6 months 500 ohms 700 Ohms Maximum energy pacing impedance pacing impedance % Pacing charging frequency RV: 2.5V RV: 2.5V 15% Atrial, 15% Quarterly Ventricular, DDD 15% Atrial, 50% Quarterly Ventricular, DDD 50% Atrial, 50% ...
Page 234 Chapter 13 Longevity Inventra Technical Manual ERI and EOS Voltages for Inventra ICDs Operating Mode Voltage Elective Replacement Indicator (ERI) 2.50 Volts End of Service (EOS) 1.75 Volts Table 35: ERI and EOS Voltages for ICDs with the LiSVO battery PAGE 226...
Page 235: Technical Specifications
Chapter 14 Technical Specifications Inventra Technical Manual 14. Technical Specifications The following are the technical specifications for the Inventra ICDs/CRT‑Ds. The ranges are presented in the format: x…(y)…z where x = the lowest value, y = the increment, and z = the largest value. Mechanical Properties Inventra IS‑1/DF‑1 models Inventra VR‑T Inventra DR‑T/ VR‑T DX Inventra HF‑T 65 mm x 65 mm x...
Page 236 Chapter 14 Technical Specifications Inventra Technical Manual Parameter Range Standard Bradycardia Atrial Sensing Parameters STD ‑ standard, Sensing OFF ‑ inactive Minimum threshold 0.2…(0.1)…2.0 mV 0.4 mV Far‑field protection after Vp 50…(25)…225 ms 75 ms Far‑field protection after Vs Off, 25…(25)…225 ms 75 ms Upper threshold 25, 50, 75% (75% for VR‑T DX) Right‑ventricular Sensing Parameters STD ‑...
Page 237 Chapter 14 Technical Specifications Inventra Technical Manual Parameter Range Standard Polarity Pace / Sense LV‑tip ‑> LV‑ring LV‑tip ‑> RV‑coil LV polarity pace LV‑ring ‑> LV‑tip LV‑tip ‑> RV‑coil LV‑ring ‑> RV‑coil LV‑tip > Case (housing) UNIP (LV‑tip/housing), UNIP LV polarity sense BIPL (LV‑tip/LV‑ring) RV ‑>...
Page 238 Chapter 14 Technical Specifications Inventra Technical Manual Parameter Range Standard AV rate 1 50..(10)..130 bpm 60 bpm AV delay 2 15, 40..(5)..350 ms 120 ms AV rate 2 60..(10)..140 bpm 130 bpm ‑40 ms Sense compensation OFF; ‑5..(‑5)..‑120 ms (N/A VR‑T DX) AV‑hysteresis mode OFF, Positive, Negative, I‑Opt AV hysteresis 70, 110, 150, 200 ms...
Page 239 Chapter 14 Technical Specifications Inventra Technical Manual Parameter Range Standard Mode Switching Intervention rate OFF, 120..(10)..200 bpm 160 bpm Activation criterion 3..(1)..8 Deactivation criterion 3..(1)..8 DDI, DDIR at permanent DDD(R) DDIR Mode VDIR VDI, VDIR at permanent VDD(R) Modes (VR‑T DX Only) VDI, VDIR at permanent VDD(R) VDIR Change in basic rate...
Page 240 Chapter 14 Technical Specifications Inventra Technical Manual Parameter Range Standard Sustained VT (without SMART Detection and without SMART Redetection) Sustained VT OFF, 1,2,3,5,10, 20 or 30 min [OFF] Forced Termination (with SMART Detection Including SMART Redetection) Forced termination 1 minute [1 min] Redetection Counter Redetection counter VT1 10…(2)…50...
Page 241 Chapter 14 Technical Specifications Inventra Technical Manual Parameter Range Standard Ventricular NIPS Burst, Ramp, Burst + PES, Rapid ATP type Ramp pacing Attempts Ventricular Pacing BiV, LV, RV S1 number 1…(1)…25 200…(10)…600 ms (absolute); R‑S1 interval [80%] 70…(5)…95 % (adaptive) S1 decrement 5…(5)…40 ms [10 ms] 200…(10)…600 ms S1‑S2 interval simply alterable via [+ / ‑] buttons...
Page 242 Chapter 14 Technical Specifications Inventra Technical Manual Parameter Range Standard Post‑Shock Pacing DDI at permanent DDD(R), DDI (R), AAI(R) Mode VDI at permanent VDD(R), VDI(R), VVI at permanent VVI(R), OFF Basic rate 30 .. (5)..100..(10) .. 160 bpm 60 bpm Rate hysteresis AV delay 50..(10)..350 ms (fixed AV delay) 140 ms...
Page 243: Appendix A - Connector Compatibility
Appendix A Inventra Technical Manual Appendix A – Connector Compatibility The Inventra family of ICDs/CRT‑Ds are mechanically compatible with: • IS‑1 sensing/pacing lead connectors • DF‑1 defibrillation lead connectors. The Inventra DR‑T and Inventra VR‑T DX ICDs have two IS‑1 header ports and two DF‑1 header ports while the Inventra VR‑T ICD has a single IS‑1 header port and two DF‑1 header ports.
Page 244 Appendix A Inventra Technical Manual PAGE 236...
Page 245: Appendix B - Known Anomalies
Appendix B Inventra Technical Manual Appendix B – Known Anomalies Inventra Application (Programmer Software) Possible Effect on Patient or Anomaly Implant Procedure Runtime error occurs and programmer needs to be restarted if after initial interrogation the shock path is changed to “RV ‑> Can” May cause follow‑up and the “OK”...
Page 246 Appendix B Inventra Technical Manual PAGE 238...
Page 247: Appendix C - Glossary
Appendix C Inventra Technical Manual Appendix C – Glossary active housing When the housing of the ICD is used as an electrode for shock delivery. anode The positive pole of a circuit. ATP (Anti‑Tachycardia Pacing) Rapid pacing therapy used to terminate tachyarrhythmias. ASC (Auto Sensitivity Control) The sensing algorithm used in ICDs to sense the cardiac signal over a wide range of intrinsic amplitudes.
Page 248 Appendix C Inventra Technical Manual device‑based testing A process using the ICD and a programming system to perform DFT (induction) testing. DFT (defibrillation threshold) The minimum energy or voltage required to successfully terminate a tachyarrhythmia. EOS A term used to describe battery status. EOS indicates End Of Service. ERI A term used to describe battery status.
Page 249 Inventra Technical Manual PES (Programmed Electrical Stimulus or Premature Extra Stimulus) A series of pacing pulses delivered at fixed or decreasing cycle lengths used to induce arrhythmias. polarity The condition of being positive or negative relative to a given reference. In BIOTRONIK ICDs, normal polarity refers to the configuration with the distal shock coil as the cathode and the can as the anode. polymorphic VT A ventricular tachycardia that may have more than one focus post‑shock pacing Pacing, typically high in amplitude, that occurs after shock therapy.
Page 250 Appendix C Inventra Technical Manual PAGE 242...
Page 251 Appendix C Inventra Technical Manual PAGE 243...
Page 252: Technical Manual
Inventra Family of ICDs and CRT-Ds Technical Manual BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 M4167-B 02/15 (800) 547-0394 (24-hour) © 2015 BIOTRONIK, Inc. All rights reserved. (800) 291-0470 (fax) MN035r1 2/26/15 www.biotronik.com...

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