BIOTRONIK Lumax VR ICD, Lumax DR-T ICD, Lumax VR-T ICD, Lumax DR ICD, Lumax HF-T CRT-D Technical Manual

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Lumax

Family of Implantable Cardioverter

Defibrillators and Cardiac

Resynchronization Therapy

Defibrillators

• VR ICD

• VR-T ICD

• DR ICD

• DR-T ICD

• HF CRT-D

• HF-T CRT-D

Technical Manual

X-ray Identification

Lumax Family

Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Defibrillators Inside the housing:

X-Ray identification Year of manufacture

HR nn

Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician.

CAUTION

Lumax Technical Manual i

Contents

1.1 System Description .......................................................1

1.2 Indications and Usage...................................................3

1.3 Contraindications...........................................................4

1.4 Warnings and Precautions ............................................4

1.4.1 Sterilization, Storage, and Handling ......................7

1.4.2 Device Implantation and Programming .................7

1.4.3 Lead Evaluation and Connection ..........................9

1.4.4 Follow-up Testing ................................................11

1.4.5 Pulse Generator Explant and Disposal ...............11

1.4.6 Hospital and Medical Hazards.............................11

1.4.7 Home and Occupational Hazards .......................13

1.4.8 Cellular Phones ...................................................13

1.4.9 Electronic Article Surveillance (EAS) ..................14

1.4.10 Home Appliances ................................................14

1.4.11 Home Monitoring .................................................15

1.5 Potential/Observed Effects of the Device on Health ...16

1.5.1 Potential Adverse Events ....................................16

1.5.2 Observed Adverse Events...................................17

1.6 Clinical Studies............................................................27

1.6.1 Kronos LV-T Study ..............................................27

1.6.2 Tupos LV/ATx Study............................................29

1.7 Patient Selection and Treatment.................................48

1.7.1 Individualization of Treatment .............................48

1.7.2 Specific Patient Populations................................49

1.8 Patient Counseling Information ...................................50

1.9 Evaluating Prospective CRT-D/ICD Patients ..............50

2.1 Cardiac Resynchronization Therapy (CRT) ................53

2.2 Sensing (Automatic Sensitivity Control) ......................56

2.2.1 Right Ventricular Sensitivity Settings...................57

2.2.2 Minimum Right Ventricular Threshold .................59

2.2.3 Atrial Sensitivity Settings .....................................59

2.2.4 Minimum Atrial Threshold....................................60

2.2.5 Left Ventricular Sensitivity Settings .....................60

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2.2.6 Minimum Left Ventricular Threshold....................61

2.2.7 Far Field Protection .............................................61

2.2.8 Additional Sensing Parameters ...........................62

2.3 Automatic Threshold Measurement (ATM) .................63

2.3.1 Functional Description.........................................63

2.4 Intra-Thoracic Impedance Measurement ....................65

2.4.1 Functional Description.........................................65

2.5 Ventricular Tachyarrhythmia Detection .......................66

2.5.1 VF Classifications ................................................67

2.5.2 VT Interval Counters............................................67

2.5.3 VT Classification..................................................67

2.5.4 SMART Detection™ ............................................68

2.5.5 Onset ...................................................................69

2.5.6 Stability ................................................................69

2.5.7 Sustained VT Timer.............................................70

2.5.8 VT Monitoring Zone .............................................70

2.5.9 Atrial Monitoring Zone .........................................71

2.6 Tachyarrhythmia Redetection......................................71

2.6.1 VT Redetection....................................................71

2.6.2 SMART Redetection............................................72

2.6.3 Forced Termination .............................................72

2.6.4 VF Redetection....................................................72

2.7 Tachyarrhythmia Termination ......................................72

2.8 Tachyarrhythmia Therapy............................................72

2.8.1 Therapy Options ..................................................73

2.8.2 Anti-Tachycardia Pacing (ATP) ...........................73

2.8.3 Shock Therapy ....................................................76

2.8.4 Progressive Course of Therapy...........................82

2.9 Bradycardia Therapy ...................................................83

2.9.1 Bradycardia Pacing Modes .................................83

2.9.2 Basic Rate ...........................................................84

2.9.3 Night Rate............................................................85

2.9.4 Rate Hysteresis ...................................................85

2.9.5 Dynamic AV Delay...............................................88

2.9.6 IOPT ....................................................................91

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2.9.7 Upper Tracking Rate ...........................................91

2.9.8 Mode Switching ...................................................93

2.9.9 PMT Management ...............................................94

2.9.10 VES Discrimination after Atrial Sensed Events ...97

2.9.11 Rate Adaptive Pacing ..........................................98

2.9.12 Pulse Amplitude...................................................99

2.9.13 Pulse Width .........................................................99

2.9.14 Post Ventricular Atrial Refractory Period...........100

2.9.15 PVARP after VES ..............................................100

2.9.16 Auto PVARP ......................................................100

2.9.17 Noise Response ................................................100

2.9.18 Post Shock Pacing ............................................101

2.10 EP Test Functions .....................................................101

2.10.1 P and R-wave Amplitude Measurements ..........101

2.10.2 Pacing Impedance Measurements....................102

2.10.3 Shock Impedance Measurements.....................103

2.10.4 Testing for Retrograde Conduction ...................103

2.10.5 Pacing Threshold...............................................104

2.10.6 Arrhythmia Induction Features ..........................104

2.10.7 Manual Shock ....................................................105

2.10.8 Test Shock.........................................................105

2.10.9 Manual ATP .......................................................106

2.10.10 Emergency Shock .............................................106

2.11 Special Features........................................................107

2.11.1 ICD Therapy Status ...........................................107

2.11.2 Home Monitoring ...............................................107

2.11.3 Real-time IEGM Transmission ..........................117

2.11.4 Capacitor Reforming .........................................118

2.11.5 Patient and Implant Data ...................................118

2.11.6 System Status ...................................................119

2.11.7 HF Monitor Statistics .........................................119

2.11.8 Holter Memory ...................................................121

2.11.9 Timing Statistics ....................................................2

2.11.10 Atrial Arrhythmias ..................................................3

2.11.11 Ventricular Arrhythmias .........................................3

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2.11.12 Sensor ...................................................................3

2.11.13 Sensing..................................................................3

2.11.14 Impedances ...........................................................4

2.11.15 Automatic Threshold..............................................4

4.1 Implant Preparation .......................................................7

4.2 Lead System Evaluation..............................................12

4.3 Opening the Sterile Container.....................................12

4.4 Pocket Preparation......................................................13

4.5 Lead to Device Connection .........................................13

4.6 Blind Plug Connection.................................................16

4.7 Program the ICD/CRT-D .............................................17

4.8 Implant the ICD/CRT-D ...............................................18

5.1 General Considerations ..............................................23

5.2 Longevity .....................................................................24

5.2.1 Lumax 300/340 Devices......................................25

5.2.2 Lumax 500/540 Devices......................................26

5.3 Explantation.................................................................29

*Lumax VR (-T) and DR (-T) ICDs do not have coronary sinus pace/sense ports ** Lumax VR (-T) ICDs do not have atrial pace/sense ports

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Lumax Specifications and Description

Battery Voltage: 3.2 Volts 300/500 models:

30 Joules programmed

Maximum Shock Energy: 340/540 models:

40 Joules programmed

Maximum Shock Energy: Defibrillation Lead Ports Two DF-1 (3.2 mm) Pacing Lead Ports Three IS-1 (3.2 mm)

(one for Lumax VR (-T) and two for

Lumax DR (-T)s) Dimensions: Volume:

See Technical Details in

Section 6

Mass: Housing Material: Titanium Header Material: Epoxy Resin Sealing Plug Material: Silicone

vi Lumax Technical Manual

Lumax Technical Manual 1

1. General

1.1 System Description

The Lumax family of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) detect and treat ventricular tachyarrhythmias and provide rate adaptive bradycardia pacing support. The HF and HF-T versions of Lumax provide Cardiac Resynchronization Therapy (CRT) through biventricular pacing. Both CRT-Ds and ICDs detect and treat ventricular tachyarrhythmias and provide rate adaptive bradycardia pacing support. They are designed to collect diagnostic data to aid the physician’s assessment of a patient’s condition and the performance of the implanted device.

The Lumax family of devices provides therapy for ventricular tachyarrhythmias with a sophisticated range of programmable anti-tachycardia pacing (ATP), and/or defibrillation therapy features. The shock polarity and energy may be programmed to tailor the therapy to appropriately treat each patient's tachyarrhythmias. The ICDs/CRT-Ds provide shock therapies with programmable energies from 5 to 40 joules.

The Lumax family of ICDs/CRT-Ds includes the following members:

• Lumax HF - provides three chamber rate adaptive bradycardia pacing support including biventricular pacing via a left ventricular pacing lead. The CRT-D uses right atrial and ventricular sensing/pacing leads to provide enhanced atrial and ventricular tachyarrhythmia discrimination through BIOTRONIK’s SMART DetectionTM algorithm.

• Lumax HF-T - In addition to the functionality found with HF model Lumax HF-T also has the added functionality of BIOTRONIK’s Home Monitoring system. The Home Monitoring System enables automatic exchange of information about a patient’s cardiac status from the implant to the physician remotely.

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• Lumax DR - provides dual chamber rate adaptive bradycardia pacing support. The ICD uses atrial and ventricular sensing/pacing leads to provide enhanced atrial and ventricular tachyarrhythmia discrimination through BIOTRONIK’s SMART Detection

algorithm.

• Lumax DR-T - In addition to the functionality found with the DR model it also has the added functionality of BIOTRONIK’s Home Monitoring system. The Home Monitoring System enables automatic exchange of information about a patient’s cardiac status from the implant to the physician remotely.

• Lumax VR - provides single chamber rate adaptive bradycardia pacing support as well as tachyarrhythmia detection and therapy.

• Lumax VR-T - In addition to the functionality found with standard VR model it also has the added functionality of BIOTRONIK’s Home Monitoring system. The Home Monitoring System enables automatic exchange of information about a patient’s cardiac status from the implant to the physician remotely.

The 300/500 and 340/540 designation for each of the abovedescribed models denote the maximum programmable shock energy of 30 joules and 40 joules, respectively.

The Lumax 500/540 models also feature a third programmable shock path for delivery of defibrillation/cardioversion shocks. The shock path is programmable between the different shock coils (SVC/RV) and/or the device housing. Section 2.8.3.6 provides further details on the available shock configurations.

Additionally, the Lumax 500/540 models feature Automatic Threshold Measurement (ATM) of ventricular pacing thresholds. This feature is separately programmable for the right (RV) and left (LV) ventricle. Section 2.3 provides further details.

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The Lumax HF (-T) models have three IS-1 pacing/sensing header ports and two DF-1 defibrillation/cardioversion ports. The Lumax DR (-T) models have two IS-1 pacing/sensing header ports. The Lumax VR (-T) models have one IS-1 pacing/sensing header ports. IS-1 refers to the international standard whereby leads and generators from different manufacturers are assured a basic fit [Reference ISO 5841-3:1992]. DF-1 refers to the international standard for defibrillation lead connectors [Reference ISO 11318:1993].

External devices that interact with and test the implantable devices are also part of the ICD/CRT-D System. These external devices include the ICS 3000 Programming and Tachyarrhythmia Monitoring System and the Implant Module System Analyzer or Pacing System Analyzer for acute lead testing. The ICS 3000 programmer is used to interrogate and program the ICD/CRT-Ds.

1.2 Indications and Usage

The Lumax CRT-Ds are indicated for use in patients with all of the following conditions:

• Indicated for ICD therapy

• Receiving optimized and stable Congestive Heart Failure

(CHF) drug therapy

• Symptomatic CHF (NYHA Class III/IV and LVEF ≤ 35%); and

• Intraventricular conduction delay (QRS duration ≥130 ms)

The Lumax Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation, for automated treatment of lifethreatening ventricular arrhythmias.

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1.3 Contraindications

The Lumax devices are contraindicated for use in patients with the following conditions:

• Patients whose ventricular tachyarrhythmias may have transient or reversible causes such as:

• Acute myocardial infarction

• Digitalis intoxication

• Drowning

• Electrocution

• Electrolyte imbalance

• Hypoxia

• Sepsis

• Patients with incessant ventricular fibrillation (VF) and

ventricular tachycardia (VT)

• Patients whose only disorder is brady arrhythmias or atrial arrhythmias

1.4 Warnings and Precautions

MRI (Magnetic Resonance Imaging) - Do not expose a patient

to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient.

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

• Active or passive fixation technology

• Insertion and withdrawal forces as specified by

ISO 5841-3 (IS-1)

The following LV leads were evaluated in the OPTION CRT/ATx study with BIOTRONIK’s CRT-Ds:

• Guidant-Easytrak IS-1

• Guidant-Easytrak LV-1

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• Guidant-Easytrak 2

• Guidant-Easytrak 3

• Medtronic-Attain

• St. Jude-Aescula

• St. Jude-Quicksite

• Biomec-Myopore Epicardial

• Medtronic-Epicardial 5071

• Medtronic-CapSure EPI

• Biotronik-ELC 54-UP

The following LV leads were bench tested for compatibility with BIOTRONIK’s CRT-Ds:

• Guidant EasyTrak 4512 (unipolar)

• Guidant EasyTrak 4513 (bipolar)

• Guidant EasyTrak 3 4525 (bipolar)

• Medtronic Attain OTW 4193 (unipolar)

• Medtronic Attain OTW 4194 (bipolar)

• Medtronic Attain LV 2187 (unipolar)

• St. Jude Medical QuickSite 1056K (unipolar)

• ELA Situs OTW (unipolar)

• Biotronik Corox OTW 75-UP Steroid #346542 (unipolar)

• Biotronik Corox+ LV-H 75-BP #341885 (bipolar)

ICD Lead Systems – BIOTRONIK ICDs/CRT-Ds maybe implanted with any legally marketed, compatible ICD lead. Compatibility is defined as:

• IS-1 pacing and sensing connector(s)

• DF-1 shock coil connector(s)

• Integrated or dedicated bipolar pacing and sensing

configuration

• Active or passive fixation technology

• Single or dual defibrillation shock coil (s)

• High energy shock accommodation of at least 30 joules

• Insertion and withdrawal forces as specified by

ISO 5841-3 (IS-1) and ISO 11318:1993 (E) DF-1

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The following leads were evaluated in a retrospective study with BIOTRONIK’s ICDs/CRT-Ds:

• Medtronic Sprint 6932

• Medtronic Sprint 6943

• Medtronic Sprint Quattro 6944

• Medtronic Transvene RV 6936

• St. Jude (Ventritex) TVL- ADX 1559

• St. Jude SPL SP02

• Guidant Endotak DSP

• Guidant Endotak Endurance EZ, Endotak Reliance

• Guidant (Intermedics) 497-24.

The following leads were bench tested for compatibility with BIOTRONIK’s ICDs/CRT-Ds:

• Guidant Endotak Endurance “CPI 0125”

• Guidant Endotak Reliance 0148

• Medtronic Sprint 6932

• Medtronic Sprint 6942

• Medtronic Sprint 6943

• Medtronic Sprint 6945

• Medtronic Sprint Quattro 6944

• St. Jude Riata 1571/65

• St. Jude SPL SPO1

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.

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.

Rate-Adaptive Pacing – Use rate-adaptive pacing with care in patients unable to tolerate increased pacing rates.

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1.4.1 Sterilization, Storage, and Handling

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.

Re-sterilization - Do not re-sterilize and re-implant explanted devices.

Storage (temperature) - Store the device between 5° to 45°C (41° - 113° F) because temperatures outside this range could damage the device.

Storage (magnets) - To avoid damage to the device, store the device in a clean area, away from magnets, kits containing magnets, and sources of electromagnetic interference (EMI).

Temperature Stabilization - Allow the device to reach room temperature before programming or implanting the device because temperature extremes may affect initial device function.

Use Before Date - Do not implant the device after the USE BEFORE DATE because the device may have reduced longevity.

1.4.2 Device Implantation and Programming

Blind Plug - A blind plug must be inserted and firmly connected

into any unused header port to prevent chronic fluid influx and possible shunting of high energy therapy.

Capacitor Reformation - Infrequent charging of the high voltage capacitors may extend the charge times of the ICD/CRT-D. The capacitors are reformed automatically at least every 85 days. For further information, please refer to Section 2.11.4, Capacitor Reforming.

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.

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ERI (Elective Replacement Indicator) - Upon reaching ERI, the battery has sufficient energy remaining to continue monitoring for at least three months and to deliver a minimum of six maximum energy shocks. After this period (EOS), all tachyarrhythmia detection and therapy is disabled. Bradycardia functions are still active at programmed values until the battery voltage drops below

1.75 volts.

Magnets - Positioning of a magnet or the programming wand over the ICD/CRT-D will suspend tachycardia detection and treatment. The minimum magnet strength required to suspend tachycardia treatment is 1.8 mT. When the magnet strength decreases to less than 1 mT, the reed contact is reopened.

Programmed Parameters – Program the device parameters to appropriate values based on the patient’s specific arrhythmias and condition.

Programmers - Use only BIOTRONIK ICS 3000 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.

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 nonconversion of the arrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventricular tachycardia during arrhythmia conversion testing is no assurance that conversion will occur post-operatively.

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.

Charge Time - When preparing a high energy shock the charge circuit stops charging the capacitors after 20 seconds, and delivers the stored energy as shock therapy. After the device reaches ERI the stored energy may be less than the maximum programmable energy for each shock.

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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 automatically deactivated as soon as electrophysiological tests (e.g., Impedance measurement) have been performed. To ensure delivery of programmed shock energy, make sure shipment mode is disabled prior to completion of implant procedure.

Shock Therapy Confirmation – Programming CONFIRMATION to OFF may increase the incidence of the ICD/CRT-D delivering inappropriate shocks.

Shock Impedance - If the shock impedance is less than twentyfive ohms, 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 twentyfive ohms. Damage to the device may result.

Negative AV Hysteresis – This feature insures ventricular pacing, a technique which has been used in patients with hypertrophic obstructive cardiomyopathy (HOCM) with normal AV conduction in order to replace intrinsic ventricular activation. No clinical study was conducted to evaluate this feature, and there is conflicting evidence regarding the potential benefit of ventricular pacing therapy for HOCM patients. In addition, there is evidence with other patient groups to suggest that inhibiting the intrinsic ventricular activation sequence by right ventricular pacing may impair hemodynamic function and/or survival.

1.4.3 Lead Evaluation and Connection

Capping Leads - If a lead is abandoned rather than removed, it

must be capped to ensure that it is not a pathway for currents to or from the heart.

Gripping Leads - Do not grip the lead with surgical instruments or use excessive force or surgical instruments to insert a stylet into a lead.

Kinking Leads - Do not kink leads. This may cause additional stress on the leads that can result in damage to the lead.

10 Lumax Technical Manual

Liquid Immersion - Do not immerse leads in mineral oil, silicone oil, or any other liquid.

Short Circuit - Ensure that none of the lead electrodes are in contact (a short circuit) during delivery of shock therapy as this may cause current to bypass the heart or cause damage to the ICD/CRT-D system.

Far-field sensing of signals from the atrium in the ventricular channel or ventricular signals in the atrial channel should be avoided by appropriate lead placement, programming of pacing/sensing parameters, and maximum sensitivity settings. If it is necessary to modify the Far Field Blanking parameter, the parameter should be lengthened only long enough to eliminate far-field sensing as evidenced on the IEGMs. Extending the parameter unnecessarily may cause under sensing of actual atrial or ventricular events.

Suturing Leads - Do not suture directly over the lead body as this may cause structural damage. Use the appropriate suture sleeve to immobilize the lead and protect it against damage from ligatures.

Tricuspid Valve Bioprosthesis - Use ventricular transvenous leads with caution in patients with a tricuspid valvular bioprosthesis.

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).

Cross Threading Setscrew(s) – To prevent cross threading the setscrew(s), do not back the setscrew(s) completely out of the threaded hole. Leave the torque wrench in the slot of the setscrew(s) while the lead is inserted.

Tightening Setscrew(s) – Do not overtighten the setscrew(s). Use only the BIOTRONIK supplied torque wrench.

Sealing System – Be sure to properly insert the torque wrench into the perforation at an angle perpendicular to the connector receptacle. Failure to do so may result in damage to the plug and its self-sealing properties.

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1.4.4 Follow-up Testing

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 the arrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventricular tachycardia during arrhythmia conversion testing is no assurance that conversion will occur post-operatively.

Resuscitation Availability - Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are present during post-implant device testing should the patient require external rescue.

Safe Program – Within the EP Test screen, pressing the “Safe Program” key on the programmer head immediately sends the safe program to the ICD/CRT-D.

1.4.5 Pulse Generator Explant and Disposal

Device Incineration – Never incinerate the ICD/CRT-D due to

the potential for explosion. The ICD/CRT-D must be explanted prior to cremation.

Explanted Devices – Return all explanted devices to BIOTRONIK.

1.4.6 Hospital and Medical Hazards

Electromagnetic interference (EMI) signals present in hospital and medical environments may affect the function of any ICD/CRT-D or pacemaker. The ICD/CRT-D is designed to selectively filter out EMI noise. However, due to the variety of EMI signals, absolute protection from EMI is not possible with this or any other ICD/CRT-D.

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The ICD/CRT-D system should have detection and therapy disabled (OFF) prior to performing any of the following medical procedures. In addition, the ICD/CRT-D should be checked after the procedures to assure proper programming:

Diathermy - Diathermy therapy is not recommended for ICD/CRT-D patients due to possible heating effects of the pulse generator and at the implant site. If diathermy therapy must be used, it should not be applied in the immediate vicinity of the pulse generator or lead system.

Electrocautery - Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation, or may cause device malfunction or damage. If use of electrocautery is necessary, the current path and ground plate should be kept as far away from the pulse generator and leads as possible (at least 6 inches (15 cm)).

External Defibrillation - The device is protected against energy normally encountered from external defibrillation. However, any implanted device may be damaged by external defibrillation procedures. In addition, external defibrillation may also result in permanent myocardial damage at the electrode-tissue interface as well as temporary or permanent elevated pacing thresholds. When possible, observe the following precautions:

• Position the adhesive electrodes or defibrillation paddles of the external defibrillator anterior-posterior or along a line perpendicular to the axis formed by the implanted device and the heart.

• Set the energy to a level not higher than is required to achieve defibrillation.

• Place the paddles as far as possible away from the implanted device and lead system.

• After delivery of an external defibrillation shock, interrogate the ICD/CRT-D to confirm device status and proper function.

Lithotripsy - Lithotripsy may damage the ICD/CRT-D. If lithotripsy must be used, avoid focusing near the ICD/CRT-D implant site.

MRI (Magnetic Resonance Imaging) - Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient.

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Radiation - High radiation sources such as cobalt 60 or gamma

radiation should not be directed at the pulse generator. If a patient requires radiation therapy in the vicinity of the pulse generator, place lead shielding over the device to prevent radiation damage and confirm its function after treatment.

Radio Frequency Ablation - Prior to performing an ablation procedure, deactivate the ICD/CRT-D during the procedure. Avoid applying ablation energy near the implanted lead system whenever possible.

1.4.7 Home and Occupational Hazards

Patients should be directed to avoid devices that generate strong electromagnetic interference (EMI) or magnetic fields. EMI could cause device malfunction or damage resulting in non-detection or delivery of unneeded therapy. Moving away from the source or turning it off will usually allow the ICD/CRT-D to return to its normal mode of operation.

The following equipment (and similar devices) may affect normal ICD/CRT-D operation: electric arc or resistance welders, electric melting furnaces, radio/television and radar transmitters, power-generating facilities, high-voltage transmission lines, and electrical ignition systems (of gasoline-powered devices) if protective hoods, shrouds, etc., are removed.

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.

Patients having an implanted BIOTRONIK ICD/CRT-D who operate a cellular telephone should:

• Maintain a minimum separation of 6 inches (15 centimeters) between a hand-held personal cellular telephone and the implanted device.

14 Lumax Technical Manual

• Set the telephone to the lowest available power setting, if possible.

• Patients should hold the phone to the ear opposite the side of the implanted device. Patients should not carry the telephone in a breast pocket or on a belt over or within 6 inches (15 centimeters) of the implanted device as some telephones emit signals when they are turned ON, but not in use (i.e., in the listen or stand-by mode). Store the telephone in a location opposite the side of implant.

Based on results to date, adverse effects resulting from interactions between cellular telephones and implanted ICDs/CRT-Ds have been transitory. The potential adverse effects could include inhibition or delivery of additional therapies. If electromagnetic interference (EMI) emitting from a telephone does adversely affect an implanted ICD/CRT-D, moving the telephone away from the immediate vicinity of the ICD/CRT-D should restore normal operation. A recommendation to address every specific interaction of EMI with implanted ICDs/CRT-Ds is not possible due to the disparate nature of EMI.

1.4.9 Electronic Article Surveillance (EAS)

Equipment such as retail theft prevention systems may interact with pulse generators. Patients should be advised to walk directly through and not to remain near an EAS system longer than necessary.

1.4.10 Home Appliances

Home appliances normally do not affect ICD/CRT-D operation if the appliances are in proper working condition and correctly grounded and shielded. There have been reports of the interaction of electric tools or other external devices (e.g. electric drills, older models of microwave ovens, electric razors, etc.) with ICDs/CRT-Ds when they are placed in close proximity to the device.

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1.4.11 Home Monitoring

Patient’s Ability - Use of the Home Monitoring system requires

the patient and/or caregiver to follow the system instructions and cooperate fully when transmitting data.

If the patient cannot understand or follow the instructions because of physical or mental challenges, another adult who can follow the instructions will be necessary for proper transmission.

Use in Cellular Phone Restricted Areas - The mobile patient device (transmitter/receiver) should not be utilized in areas where cellular phones are restricted or prohibited (i.e., commercial aircraft).

Event-Triggered Report – A timely receipt of the event report cannot be guaranteed. The receipt is also dependent on whether the patient was physically situated in the required coverage range of the patient device at the time the event information was sent.

Not for Diagnosis - The data transmitted by Home Monitoring are not suitable for diagnosis, because not all information available in the implant is being transmitted.

Follow-Ups - The use of Home Monitoring does not replace regular follow-up examinations. Therefore, when using Home Monitoring, the time period between follow-up visits may not be extended.

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1.5 Potential/Observed Effects of the Device on Health

1.5.1 Potential Adverse Events

The following are possible adverse events that may occur relative to the implant procedure and chronic implant of the CRT-D:

• Air embolism

• Allergic reactions to

contrast media

• Arrhythmias

• Bleeding

• Body rejection

phenomena

• Cardiac tamponade

• Chronic nerve damage

• Damage to heart valves

• Device migration

• Elevated pacing

thresholds

• Extrusion

• Fluid accumulation

• Hematoma

• Infection

• Keloid formation

• Lead dislodgment

• Lead fracture/ insulation

damage

• Lead-related thrombosis

• Local tissue reaction /

fibrotic tissue formation

• Muscle or nerve stimulation

• Myocardial damage

• Myopotential sensing

• Pacemaker mediated

tachycardia

• Pneumothorax

• Pocket erosion

• Thromboembolism

• Undersensing of intrinsic

signals

• Venous occlusion

• Venous or cardiac

perforation

Lumax Technical Manual 17

In addition, patients implanted with the ICD/CRT-D system may have the following risks. These are the same risks relate with implantation of any ICD/CRT-D system:

• Acceleration of arrhythmias (speeding up heart rhythm caused by the CRT-D)

• Dependency

• Depression

• Fear of premature

battery depletion (fear that battery will stop working before predicted time)

• Fear of shocking while awake

• Fear that shocking ability may be lost

There may be other risks associated with this device that are not currently unforeseeable.

• Anxiety about the CRT-D resulting from frequent shocks

• Imagined shock (phantom shock)

• Inappropriate detection of ventricular arrhythmias

• Inappropriate shocks

• Potential death due to

inability to defibrillate or pace

• Shunting current or insulating myocardium during defibrillation with external or internal paddles

1.5.2 Observed Adverse Events

Reported Adverse Events are classified as either observations or complications. Complications are defined as clinical events that require additional invasive intervention to resolve. Observations are defined as clinical events that do not require additional invasive intervention to resolve.

1.5.2.1 Kronos LV-T Study

NOTE:

The Kronos LV-T CRT-D is an earlier generation of BIOTRONIK devices. The Lumax CRT-Ds are based upon the Kronos LV-T and other BIOTRONIK CRT-Ds and ICDs (i.e., Tupos LV/ATx CRT-D, Lexos and Lumos families of ICDs).

18 Lumax Technical Manual

The HOME-CARE Observational study, conducted outside the US on the Kronos LV-T cardiac resynchronization defibrillator (CRT-D) in patients with congestive heart failure (CHF) involved 45 devices implanted with a cumulative implant duration of 202 months (mean implant duration of 4.5 months).

Of the 31 adverse events reported, there have been 26 observations in 23 patients and 5 complications in 3 patients with a cumulative implant duration of 202 months (16.8 patientyears). 6.7% of the enrolled patients have experienced a complication with two patients experiencing 2 separate complications. The rate of complications per patient-year was

0.30. 51% of the enrolled study patients had a reported observation with 3 patients having more than 1 observation. The rate of observations per patient-year is 1.54. Complications and observations for the patient group are summarized in Tab le 1 and

Table 2, respectively.

Table 1: Summary of Complications – Kronos LV-T

Category

Number

Patients

% of

Patient

Number

Per

patient-

year

Left Ventricular Lead Related

Dislodgement 1 2.2% 1 No Capture 1 2.2% 1

Total 2 4.4% 2

0.06

0.12

ICD Lead Related

Dislodgement 1 2.2% 1 Elevated Pacing

Threshold

12.2% 1

Total 2 4.4% 2

0.06

0.12

Unrelated to CRT-D or Leads

Hemathorax 1 2.2% 1

Total 1 2.2% 1

Overall

Complication Totals

Number of Patients = 45, Number of Patient-Years = 16.8

36.7% 5

0.06

0.30

Lumax Technical Manual 19

Table 2: Summary of Observations – Kronos LV-T

Category

Unsuccessful LV lead implant

Elevated LV pacing threshold

Phrenic nerve stimulation

Elevated DFT measurement

T-wave oversensing

Worsening CHF Elevated RV pacing

threshold Hepatitis

Arrhythmias Cardiac

Decompensation

Number

Patients

%of

Patients

Number

8 17.8% 8 0.48

5 11.1% 5 0.30

3 6.7% 3 0.18

2 4.4% 2 0.12

2 4.4% 2 0.12 2 4.4% 2 0.12

1 2.2% 1 0.06

1 2.2% 1 0.06 1 2.2% 1 0.06

1 2.2% 1 0.06

per

patient-

year

All Observations 23 51.1% 26 1.54

Number of Patients = 45, Number of Patient-Years = 16

Two patient deaths were reported during the HOME-CARE Observational Study. One death resulted from worsening heart failure and the second death resulted from cardiogenic shock due to ischemic cardiomyopathy. None of the deaths were related to the implanted CRT-D system. There were no device explants during the HOME-CARE Observational Study.

20 Lumax Technical Manual

1.5.2.2 Tupos LV/ATx Study

NOTE:

The clinical study information included in this section and in

Section 1.6.2 was performed with the Tupos LV/ATx CRT-D,

which is an earlier version of the Lumax CRT-D/ICD families. The clinical study data presented here is applicable because the Lumax family are downsized versions of the Tupos LV/ATx CRT-D and Tachos ICD families. The Lumax family is slightly different as compared to the Tupos LV/ATx (and Tachos family) in the following areas:

• Reduced size from 50/48 cc to 40/35 cc

• Addition of Home Monitoring functionality

• Addition of triggered pacing for biventricular pacing

modes

• True three chamber pacing and sensing capabilities (CRT-Ds)

The OPTION CRT/ATx study was a prospective, randomized, multi-center study to demonstrate the safety and effectiveness of the investigational Tupos LV/ATx Cardiac Resynchronization Therapy Defibrillator (CRT-D) in patients with congestive heart failure (CHF) and atrial tachyarrhythmias. All patients enrolled into the clinical study were randomly assigned to either the study group or the control group at a 2 to 1 ratio. Patients in the study group were implanted with the Tupos LV/ATx. Patients in the control group were implanted with a legally marketed ICD that provides CRT.

Of the 278 adverse events reported in the Tupos LV/ATx study group, there have been 210 observations in 104 patients and 68 complications in 50 patients with a cumulative implant duration of

1240.4 months (101.9 patient-years). 37.6% of the enrolled study patients have experienced a complication. The rate of complications per patient-year is 0.67. 78.2% of the enrolled study patients have a reported observation. The rate of observations per patient-year is 2.06.

Lumax Technical Manual 21

Complications and observations for the Tupos LV/ATx study group are summarized in Table 3 and Ta ble

4. The total number

of patients may not equal the sum of the number of patients listed in each category, as an individual patient may have experienced more than one complication or observation.

Table 3: Summary of Complications – Tupos LV/ATx

Number

Category

Hematoma 4 3.01% 4 0.04

Pneumothorax 2 1.50% 2 0.02

Total 6 4.51% 6 0.06

Dislodgement 3 2.26% 3 0.03

Total 3 2.26% 3 0.03

High threshold/ No capture Diaphragmatic/ Intercostal stimulation (RV)

Total 3 2.26% 3 0.03

High threshold/ Intermittent biventricular capture/ No capture Unable to implant lead via coronary sinus

Dislodgement 4 3.01% 4 0.04 Diaphragmatic/

Intercostal stimulation

Total 27 20.3% 29 0.28

Patients

Procedure Related

Atrial Lead Related

2 1.50% 2 0.02

1 0.75% 1 0.01

11 8.27% 12 0.12

11 8.27% 11 0.11

1 0.75% 2 0.02

% of

Patients

ICD Lead Related

LV Lead Related

Number of

omplications

Complication

per patient-

year

22 Lumax Technical Manual

Table 3: Summary of Complications – Tupos LV/ATx

Number

Category

Infection 3 2.26% 7 0.07

Device migration 4 3.01% 4 0.04 Elective replacement

indicator reached Inductions and conversions Unable to interrogate device

Total 12 9.02% 17 0.17

Total Procedure and Device Related

Non-CHF Cardiac Symptoms Ventricular arrhythmias

Other medical 2 1.50% 2 0.02

Atrial arrhythmia 1 0.75% 1 0.01

Total 9 6.77% 10 0.10

Total – All Patients and Categories

Patients

4 3.01% 4 0.04

1 0.75% 1 0.01

43 32.33% 58 0.57

Other Medical Related

4 3.01% 4 0.04

2 1.50% 3 0.03

50 37.59% 68 0.67

% of

Patients

Device Related

Number of

omplications

Complication

per patient-

year

Number of Patients = 133, Number of Patient-Years = 101.9

* 1 Unanticipated Adverse Device Effect (UADE) occurred with a Tupos LV/ATx CRT-D during the OPTION clinical study. The device was explanted after it was unable to be interrogated with the programmer software and no pacing output was evident. The analysis showed an appropriately depleted battery and no anomalies with the IC module. The battery depletion strongly suggests that the high voltage circuit was activated over a prolonged period due to a single-bit execution path failure. The current programmer software with Automatic Battery Management (ABM) would have prevented the battery from becoming completely depleted. There were no other instances of this failure mechanism in Tupos LV/ATx devices.

Lumax Technical Manual 23

For the Tupos LV/ATx study group, there were 210 observations in 104 patients with cumulative implant duration of 1240.4 months (101.9 patient years). 78.2% of the enrolled study patients have a reported observation. The rate of observations per patient-year was 2.06. Table 4 summarizes by category each type of observation for the study group.

Table 4: Summary of Observations – Tupos LV/ATx

Number

Category

Hematoma 10 7.52% 10 0.10

Cardiac arrest 2 1.50% 2 0.02 Unable to implant

system

Total 13 9.77% 13 0.13

Dislodgement 1 0.75% 1 0.01

High threshold 1 0.75% 1 0.01

Total 2 1.50% 2 0.02

High threshold/No capture

Total 1 0.75% 1 0.01

High threshold/ Intermittent biventricular capture/ No capture Diaphragmatic/ Intercostal stimulation

Total 30 22.56% 32 0.31

Patients

Procedure Related

1 0.75% 1 0.01

Atrial Lead Related

ICD Lead Related

1 0.75% 1 0.01

LV Lead Related

24 18.05% 24 0.24

8 6.02% 8 0.08

% of

Patients

Number

per patient-

year

24 Lumax Technical Manual

Table 4: Summary of Observations – Tupos LV/ATx

Number

Category

Infection 1 0.75% 1 0.01 Inductions and

conversions Inappropriate sensing 20 15.04% 20 0.20 Symptomatic with

biventricular pacing

Total 25 18.80% 29 0.28

Total Procedure, Lead and Device Related

Non-CHF Cardiac Symptoms Ventricular arrhythmias

Other medical 26 19.55% 32 0.31

Atrial arrhythmia 14 10.53% 14 0.14

Dizziness 4 3.01% 4 0.04

Medication 5 3.76% 5 0.05

Worsening CHF 46 34.59% 46 0.45

Total 82 61.65% 133 1.31

Total – All Patients and Categories

Number of Patients = 133 Number of Patient-Years = 101.9

Patients

Device Related

6 4.51% 6 0.06

2 1.50% 2 0.02

61 45.86% 77 0.76

Other Medical Related

21 15.79% 21 0.21

11 8.27% 11 0.11

104 78.20% 210 2.06

% of

Patients

Number

per patient-

year

Lumax Technical Manual 25

There have been 4 patient deaths reported for the control group (out of 67 total control patients) and 10 patient deaths have been reported for the study group (out of 133 total study patients). None of the deaths were related to the implanted CRT-D system. One patient in the control group died prior to receiving a biventricular device implant. There is no significant difference between the number of deaths in the study group versus the control group (p = 0.777, Fisher's Exact Test, 2 sided). Table 5 provides a summary of reported patient deaths and Table 6 provides survival percentages by follow-up interval during the first 12 months of study participation.

Table 5: Summary of Patient Deaths

Category of

Death

Study

(N = 133)

Control

(N = 67)

Number of Patients Number of Patients

Sudden Cardiac 1 1

Non-Sudden

Cardiac

Non-Cardiac 4 1

All Causes

10 4

Figure 1 shows the associated Kaplan-Meier survival curves for

the study and control group. The significance level for the difference between the two study groups based on a Log Rank test was p = 0.795.

26 Lumax Technical Manual

1.0

0.9

0.8

0.7

0.6

0.5

0.4

0.3

Cumulative Survival

0.2

0.1

0.0

Log Rank = 0.795

Control

Study

211815129630

Survival Time (months)

Figure 1: Kaplan-Meier Survival Curves

Table 6 Survival Table

Study Group

(n = 133)

Control Group

(n = 66)

Number % Number % Enrollment 133 100.00% 67 100.00% 3-month 131 98.50% 63 94.03% 6-month 127 95.49% 63 94.03% 12-month 123 92.48% 63 94.03%

Lumax Technical Manual 27

1.6 Clinical Studies

The Kronos LV-T Clinical study (HOME-CARE, Section 1.6.1) supports the safety of the Lumax CRT-D/ICD device family. Additionally, because the Tupos LV/ATx and the Lumax CRT-D devices have identical CRT and ventricular ICD therapy, the effectiveness results from the OPTION CRT/ATx IDE Clinical study (Tupos LV/ATx, Section 1.6.2) support the effectiveness of the Lumax family.

1.6.1 Kronos LV-T Study

The purpose of the HOME-CARE Observational Study is to demonstrate the safety of the CE-marked Kronos LV-T cardiac resynchronization defibrillator (CRT-D) in patients with congestive heart failure (CHF).

1.6.1.1 Methods

The multi-center, non-randomized observational study was designed to evaluate the safety of the Kronos LV-T through an analysis of the complication-free rate through three months.

The Home-CARE Observational Study Primary Endpoint was to evaluate complications (adverse events that require additional invasive intervention to resolve) related to the implanted CRT system which includes the Kronos LV-T, the right atrial lead, the right ventricular ICD lead, and the left ventricular lead

Inclusion Criteria

To support the objectives of this investigation, patients were required to meet the following inclusion criteria prior to enrollment:

• Indication for Cardiac Resynchronization Therapy

• Sufficient GSM-network coverage in the patient’s area

• Age greater than or equal to 18 years

28 Lumax Technical Manual

Exclusion Criteria To support the objectives of this investigation, the exclusion

criteria at the time of patient enrollment included the following:

• Permanent atrial fibrillation

• Myocardial infarction or unstable angina pectoris within

the last 3 prior to enrollment

• Planned cardio-surgical intervention within 3 months after enrollment (e.g. PTCA, CABG, HTX)

• Acute myocarditis

• Life expectancy less than 6 months

• Pregnant or breast-feeding woman

• Drug or Alcohol abuse

• The patient is mentally or physically unable to take part in

the observational study

• No signed declaration of consent for the patient

At the enrollment screening, the physician evaluated the patient to verify that all inclusion/exclusion criteria were met in accordance to the protocol and the patient signed the informed consent. After successful enrollment, all patients were implanted with the Kronos LV-T CRT-D. Evaluations at the One- and Threemonth follow-ups included resting ECG, NYHA classification, medications, and activation of Home Monitoring.

1.6.1.2 Summary of Clinical Results

The study involved 45 patients (37 males, 82.2%, and 8 females,

17.8%), with a mean age of 64 years (range: 36-79), a left ventricular ejection fraction of 26 % (range: 15-43), NYHA Class III (NHYA Class 1 (2.3%), Class II (11.4%), Class III (79.5%), Class IV (6.8%)) and QRS duration of 154 ms (range: 84-208).

The mean implant duration was 4.5 months with a cumulative implant duration of 202 months. The patient follow-up compliance rate was 95.9% out of 221 required follow-ups.

Lumax Technical Manual 29

Primary Endpoint

The safety of the Kronos LV-T was evaluated based on complications (adverse events that require additional invasive intervention to resolve) related to the implanted CRT system which includes the Kronos LV-T, the right atrial lead, the right ventricular ICD lead, and the left ventricular lead. 5 complications were seen in 3 patients with cumulative implant duration of 202 months (16.8 patient-years). 6.7% of the patients had a reported complication. The rate of complications per patient-year is 0.30.

The freedom from Kronos LV-T system-related complications is

93.3% with a two sided lower 95% confidence bound of 83.8%. The null hypothesis is rejected, and it is concluded that the complication-free rate is equivalent to 85% within 10%.

1.6.2 Tupos LV/ATx Study

NOTE:

The clinical study information included in this section was performed with the Tupos LV/ATx CRT-D, which is an earlier version of the Lumax CRT-D/ICD families. The clinical study data presented here is applicable because the Lumax family are downsized versions of the Tupos LV/ATx CRT-D and Tachos ICD families. The Lumax family is slightly different as compared to the Tupos LV/ATx (and Tachos family) in the following areas:

• Reduced size from 50/48 cc to 40/35 cc

• Addition of Home Monitoring functionality

• Addition of triggered pacing for biventricular pacing

modes

• True three chamber pacing and sensing capabilities (CRT-Ds)

30 Lumax Technical Manual

1.6.2.1 Study Overview

The purpose of the prospective, randomized, multi-center OPTION CRT/ATx study was to demonstrate the safety and effectiveness of the investigational Tupos LV/ATx Cardiac Resynchronization Therapy Defibrillator (CRT-D) in patients with congestive heart failure (CHF) and atrial tachyarrhythmias. Patients in the study group were implanted with a BIOTRONIK Tupos LV/ATx. Patients in the control group were implanted with any legally marketed CRT-D. Patients in both the study and control groups were implanted with a legally marketed left ventricular lead.

1.6.2.2 Methods

Primarily, the study evaluates and compares the functional benefits of CRT between the two randomized groups using a composite endpoint consisting of a six-minute walk test (meters walked) and quality of life measurement (assessed using the Minnesota Living with Heart Failure Questionnaire). Relevant measurements were completed twice for each patient: once at the Baseline evaluation (two-week post implant follow-up) and again at a six-month follow-up evaluation. The data collected during this clinical study was used to demonstrate equivalent treatment of CHF in both the study and control groups. This study also evaluated other outcomes including: the effectiveness of atrial therapy to automatically convert atrial tachyarrhythmias, the percentage of time CRT is delivered, and other measures of CHF status including NYHA classification, peak oxygen consumption during metabolic exercise testing, and the rate of hospitalization for CHF.

Inclusion Criteria

To support the objectives of this investigation, patients were required to meet the following inclusion criteria prior to enrollment:

• Stable, symptomatic CHF status

• NYHA Class III or IV congestive heart failure

• Left ventricular ejection fraction ≤ 35% (measured within

Six-Months prior to enrollment)

• Intraventricular conduction delay (QRS duration greater than or equal to 130 ms)

Lumax Technical Manual 31

• For patients with an existing ICD/CRT-D, optimal and stable CHF drug regimen including ACE-inhibitors and beta-blockers unless contraindicated (stable is defined as changes in dosages less than 50% during the last 30 days)

• Indicated for ICD therapy

• History or significant risk of atrial tachyarrhythmias

• Willing to receive possibly uncomfortable atrial shock

therapy for the treatment of atrial tachyarrhythmias

• Able to understand the nature of the study and give informed consent

• Ability to tolerate the surgical procedure required for implantation

• Ability to complete all required testing including the sixminute walk test and cardiopulmonary exercise testing

• Available for follow-up visits on a regular basis at the investigational site

• Age greater than or equal to 18 years

Exclusion Criteria

To support the objectives of this investigation, the exclusion criteria at the time of patient enrollment included the following:

• Previously implanted CRT device

• ACC/AHA/NASPE indication for bradycardia pacing

(sinus node dysfunction)

• Six-minute walk test distance greater than 450 meters

• Chronic atrial tachyarrhythmias refractory to

cardioversion shock therapy

• Receiving intermittent, unstable intravenous inotropic drug therapy (patients on stable doses of positive inotropic outpatient therapy for at least One-Month are permitted)

• Enrolled in another cardiovascular or pharmacological clinical investigation

• Expected to receive a heart transplant within 6 months

• Life expectancy less than 6 months

• Presence of another life-threatening, underlying illness

separate from their cardiac disorder

32 Lumax Technical Manual

• Acute myocardial infarction, unstable angina or cardiac revascularization within the last 30 days prior to enrollment

• Conditions that prohibit placement of any of the lead systems

1.6.2.3 Summary of Clinical Results

A total of 200 patients were enrolled in the OPTION CRT/ATx clinical study at 25 sites:

There were 133 study patients and 67 active control patients in this prospective, multi-center, randomized clinical study. For the study group, there were 129 successful implants (91.4%) of the Tupos LV/ATx CRT-D system. For the active control group, there were 64 successful implants (92.2%) of the legally marketed CRT-D systems.

Patient Accountability

After randomization and enrollment, 7 patients (4 in the study group and 3 in the control group) did not receive an implant. The reasons for patients not receiving an implant are outlined in

Figure 2.

Enrolled and Randomized

Patients

Study 133 Control 67

Implant Attempted

Study 130 Control 65

Successful implant

Study 129 Control 64

Patients completed 6-Month

Follow-up

Study 100 Control 49

Lumax Technical Manual 33

No implant Attempted

Withdrawal of Consent

Study 2 Control 1

Not Meeting Inclusion Criteria

Study 1 Control 1

Unsuccessful implant

Withdrawal of IC before 2nd Attempt

Study 1 Control 0

Expired before Second Attempt

Study 0 Control 1

6-Month Follow-up Data

Patient Death before 6-Month

Study 7 Control 3

Withdrawal before 6-Month

Study 1 Control 2

Not Reached 6-Month FU

or Data Pending

Study 21 Control 10

Figure 2: Patient Accountability

Overall Results

• There were 192 endocardial and 19 epicardial leads implanted in 193 patients. Investigators were allowed to choose among any legally marketed LV lead according to familiarity with the lead and patient anatomy. The Tupos LV/ATx CRT-D was implanted with 7 endocardial and 4 epicardial lead models from 6 different manufacturers. There were no adverse events reported attributable to lead-generator incompatibility.

• The cumulative implant duration was 1240.4 months with a mean duration of 9.6 months for the study group. The cumulative implant duration is 596.5 months with a mean duration of 9.3 months for the control group.

34 Lumax Technical Manual

• For the study group, there have been 278 adverse events (210 observations in 104 patients and 68 complications in 50 patients). There has been one unanticipated adverse device effect reported.

• For the control group, there have been 105 adverse events (81 observations in 44 patients and 24 complications in 19 patients). There have been no unanticipated adverse device effects reported.

• There have been 10 patient deaths reported in the study group and 4 patient deaths reported in the control group. The clinical investigators have determined that no deaths were related to the study device.

1.6.2.4 Primary Endpoint 1: Six Minute Walk Test & QOL (Effectiveness)

The purpose of Primary Endpoint 1 is to evaluate the effectiveness of the Tupos LV/ATx system in providing CRT as measured by the average composite rate of improvement in six minute walk test and QOL.

Table 7 presents the average composite rate of improvement in

six minute walk test distance and QOL score, the average 6minute walk test distance and the average QOL score at Baseline and at the Six-Month follow-up, as well as the average difference in 6-minute walk test distance and QOL score between Baseline and the Six-Month follow-up for the Study and Control Groups for those patients with six minute walk test data and complete QOL data at both Baseline and the Six-Month follow-up.

Lumax Technical Manual 35

Table 7: Composite of Six Minute Walk Test and QOL

(Effectiveness)

Category

Distance Walked at

Baseline

Distance Walked at

Six-Months

∆ Distance Walked

QOL Score at

Baseline

QOL Score at Six-

Months

∆ in QOL Score**

Study

Group

(N = 74)

Mean ± SE

310.51 ±

10.89

340.77 ±

12.32

30.26 ±

10.40

17.27% ±

5.59%

44.39 ± 2.78 45.53 ± 4.13 0.817

28.68 ± 2.66 33.95 ± 4.35 0.279

15.72± 2.83

19.08% ±

12.21%

Control

Group

(N = 38)

Mean ± SE

288.76 ±

15.37

301.84 ±

17.02

13.08 ±

13.05

8.71% ±

5.26%

11.58 ± 3.45

-13.42% ±

34.54%

P-value*

0.249

0.067

0.322

0.326

0.376

0.281

Composite Rate***

*The calculated p-values are associated with a Student's t-test (2-sided) of the equality of means in the two groups, except for the p-value of the composite rate, which is associated with a test of equivalence (noninferiority). **∆ in QOL Score is calculated as the average of the individual differences between Baseline and Six-Months for each patient. Negative values for mean ∆ QOL in percent are possible when positive mean values for absolute changes in QOL are recorded. In some cases, small, negative changes in absolute QOL scores resulted in relatively large percentage changes. ***The Composite Rate (=(∆ Distance Walked (%) + ∆ QOL Score (%)) /

2) is calculated for each patient and then averaged to obtain the

Composite Rates. For all calculations, a positive number represents improvement from Baseline to Six-Months.

18.18% ±

7.07%

-2.36% ±

17.73%

0.030

36 Lumax Technical Manual

1.6.2.5 Effectiveness Endpoint Analysis and Conclusions

A composite rate of six minute walk test and QOL improvement from Baseline to the Six-Month follow-up is evaluated as a measure of CRT effectiveness. For this analysis both six minute walk test and QOL are equally weighted at 50%.

The mean difference in the composite rate between study and control group was 20.53% with an associated one-sided, 95% confidence bound is (-6.10%). The p-value for non-inferiority within 10% is 0.030. The analysis of the composite rate in six minute walk test distance and QOL score demonstrates that the study group is non-inferior to the control group and that the primary effectiveness endpoint was met (p=0.030).

1.6.2.6 Primary Endpoint 2: Complication-Free Rate (Safety)

The purpose of Primary Endpoint 2 was to evaluate complications (adverse events that require additional invasive intervention to resolve) related to the implanted CRT system which includes the Tupos LV/ATx, the right atrial lead, the right ventricular ICD lead, the left ventricular lead, and the implant procedure. The target complication-free rate at Six-Months is 85%.

Table 8

provides the categorized complication rates at 6-months for the study and the control group as well as a comparison between the study and the control group.

Lumax Technical Manual 37

Table 8: Complications at 6-Month – Study and Control

Study versus Control

Comparison

Delta 95% CI P-value

3.02%[-3.64%,

8.45%]

0.76%[-5.74%,

5.37%]

6.53%]

6.12%[-5.50%,

16.45%]

[-11.42%,

3.78 %

6.94%[-6.46%,

9.21%[-4.96%,

4.77%]

[-3.82%,

10.13%]

19.17%]

21.99%]

Category

Procedure Related Atrial Lead Related ICD Lead Related LV Lead Related

Device Related

Other Medical Related

Total Procedure, Lead and Device Related

Total

Study

N = 133

6 (4.51%) 1

3 (2.26%) 1

3 (2.26%) 0 (0%) 2.26%[-3.03%,

(19.55%)9(13.43%)

7 (5.26%) 5

9 (6.77%) 2

(29.32%)15(22.39%)

(34.59%)17(25.37%)

Control

N = 67

(1.49%)

(7.46%)-2.20

(2.99%)

0.428

1.000

0.552

0.329

0.541

0.341

0.317

0.201

1.6.2.7 Primary Safety Enpoint Analysis and Conclusions

The observed procedure, lead and device related complicationfree rate at 6 months was 70.68%. The 95% confidence interval for the complication-free rate was [62.16%, 78.25%]. The lower, one-sided 95% confidence bound for the complication-free rate was 63.50%. Therefore the procedure, lead and device related complication-free rate at 6 months did not meet the pre-specified acceptance criterion for this endpoint.

38 Lumax Technical Manual

1.6.2.8 Post-hoc Safety Analysis

BIOTRONIK did not meet the pre-specified objective performance criteria of 85% within 10% for the safety endpoint. Therefore, a post-hoc safety analysis was conducted. It was noted that

79.80% (39 out of 49 events) of the complications were right atrial lead, right ventricular ICD lead, left ventricular lead and procedure related. The atrial, ICD and LV leads used during this study are legally marketed devices.

This post-hoc analysis evaluated the LV lead complications that were “related” or “possibly related” to the Tupos LV/ATx CRT-D, but excludes the complications that were “not related” to the Tupos LV/ATx device (see Table 9). There were 11 patients who had an attempt to implant the LV lead, but the physician was unsuccessful in either obtaining coronary sinus (CS) access or unable to find a stable position for the LV lead. Additionally, there were 4 patients with a documented LV lead dislodgement that has no direct relationship to the implanted Tupos LV/ATx.

Table 9: Complications at 6-Months (Excluding LV Lead

Related) - Study versus Control

Difference

Study vs

Control

8.36%

11.39%

Category

Procedure Related Atrial Lead Related ICD Lead Related LV Lead Related Device Related Other Medical Related

Total Procedure, Lead and Device

Total

Study

N=133

Control

N=67

6 (4.51%) 2 (2.99%) 1.53% 3 (2.26%) 1 (1.49%) 0.76% 3 (2.26%) 0 (0%) 2.26%

11 (8.27%) 1 (1.49%) 6.78%

7 (5.26%) 5 (7.46%) -2.20% 9 (6.77%) 2 (2.99%) 3.78%

(20.30%)8(11.94%)

(26.32%)10(14.93%)

Lumax Technical Manual 39

The pulse generator related complication rate is higher in the control group as compared to the study group. The complication rates for procedure related, atrial lead related, ICD lead related, LV lead related and other medical related are higher in the study group as compared to the control group.

1.6.2.9 Post hoc Safety Analysis Conclusion

There are no clinically substantial differences in the total complication rate or in the rates for the different complication rate categories between the study and the control group.

Table 10 compares this post-hoc Safety Endpoint analysis to

previous CRT-D clinical studies:

Table 10 Safety Endpoint Comparisons

CRT-D Study

BIOTRONIK OPTION (Original Analysis)

BIOTRONIK OPTION (Post-hoc Analysis)

Estimated

freedom from

Complications

Lower 95%

@ 6mos.

70.68% 63.5% 75%

78.95% 72.29% 75%

95%

lower

bound

criteria

Medtronic Insync ICD 81.1% 77.6% 67% Guidant Contak CD N/A N/A 70% St. Jude Medical Epic

93.4% 90.6% 70%

This analysis confirms that the safety profile of the Tupos LV/ATx is within a similar range determined during trials of other legally marketed CRT-D devices.

40 Lumax Technical Manual

1.6.2.10 Secondary Endpoint Results

1. The purpose of Secondary Endpoint 1 is to evaluate the overall ability of the Tupos LV/ATx to appropriately convert spontaneous AT (atrial tachycardia) and AF (atrial fibrillation). The results from the OPTION study were compared to the results from BIOTRONIK’s TACT study (P000009/S4, dated 09-09-2002) that demonstrated the effectiveness of these atrial therapy features in the Tachos DR - Atrial Tx ICD.

Table 11 summarizes success rates for each individual atrial

tachyarrhythmia therapy type and overall success rate from the OPTION study compared to the TACT study. The number of episodes and patients receiving any therapy is less than the total episodes of each therapy type, as episodes may have included more than one type of therapy.

Table 11 Overall Atrial Conversion Rate

OPTION Study

Patients

Patients Success Episodes

Conversion

rate

ATP 3 3 5 60.0%

HF Burst 17 45 111 40.5%

Shock 12 30 34 88.2%

All

Therapies

25 78 129 60.5%

TACT Study

ATP 29 62 142 43.6 %

HF Burst 49 156 408 38.2 %

Shock 42 84 108 77.8 %

All

Therapies

66 302 542 55.7 %

The overall conversion rate and the conversion rates for each therapy are comparable to the conversion rates observed in the TACT study, demonstrating that the Tupos LV/ATx device has similar atrial conversion capabilities as the legally marketed Tachos DR – Atrial Tx ICD.

Lumax Technical Manual 41

2. The purpose of Secondary Endpoint 2 is to evaluate VT (ventricular tachycardia) and VF (ventricular fibrillation) detection times of the Tupos LV/ATx. This is a measure of the ability of the ventricular detection algorithm to detect VT and VF in an appropriate timeframe. This endpoint was evaluated based on the review of electrograms following induced VT/VF episodes. A comparison of data from the TACT study that utilized the legally marketed Tachos DR – Atrial Tx ICD (P000009/S4, dated 09-09-2002) to data collected during the OPTION study for the Tupos LV/ATx was performed.

Table 12 summarizes and compares the results from these

two clinical studies.

Table 12: Summary of Detection Times

Detection

Time

Individual Readings

Tachos DR -

Atrial Tx ICD

Mean (SE) / N

2.27 (0.06) / 52

By Patient 2.27 (0.07) / 26

Tupos

LV/ATx Mean

(SE) / N

2.26 (0.06) / 71

2.24 (0.06) / 35

Difference

0.01

0.03

The analysis demonstrates that the average detection times of the Tupos LV/ATx are comparable to the detection times observed with the legally marketed Tachos DR - Atrial Tx ICD. Both devices utilize identical ventricular detection algorithms and only sense with the right ventricular lead. This clinical data demonstrates that the ventricular detection times are similar in both devices.

3. The purpose of Secondary Endpoint 3 is to evaluate the percentage of ventricular pacing (thus, CRT) as demonstrated by the device diagnostics at required followups. This data was based on diagnostic data stored by the Tupos LV/ATx.

Table 13 summarizes the percentage of ventricular pacing

between follow-ups as shown by device diagnostics for patients in the study group.

42 Lumax Technical Manual

Table 13: Percentage of Ventricular Pacing – 3-Month and

6-Month Follow-ups

Percentage of

Ventricular

Pacing

3-Months

Patients

(percentage)

6-Months Patients

(percentage)

<80% 9 (7.4%) 4 (4.0%)

81 – 85 % 4 (3.3%) 2 (2.0%)

86 – 90 % 13 (10.7%) 9 (9.1%)

91 – 95 % 19 (15.7%) 20 (20.2%)

96 – 100 % 76 (62.8%) 64 (64.7%)

Totals 121 (100%) 99 (100%)

The majority of the follow-ups (84.9%) show a percentage of ventricular pacing of 91% or more at Six-Months.

4. The purpose of secondary endpoint 4 is to evaluate improvement in functional capacity as measured by the six minute walk test. The six minute walk test is a well-accepted measure of functional capacity and exercise tolerance. Also, this test more closely mimics the patient’s day-to-day activities than maximal exercise testing.

Table 14 summarizes the six minute walk test distance at

Baseline and the Six-Month follow-up for patients in the study group and the control group.

Lumax Technical Manual 43

Table 14: Six Minute Walk Distance

Distance

(meters)

Study Control

Baseline

Mean ± SE

Range

Median

127

283.14 ± 9.27 23 to 511

302.00

269.43 ± 13.77 29 to 507

244.00

Six-Month

Mean ± SE

Range

Median

* Student's t-test, 2-sided

329.73 ± 10.82 78 to 596

335.00

310.70 ± 15.49 91 to 489

313.00

There are no clinically relevant differences in the six minute walk test results between the study and the control group.

5. The purpose of Secondary Endpoint 5 is to evaluate the improvement in the patient’s NYHA classification. Table 15 summarizes the average improvement in NYHA from Baseline to Six-Months for 140 patients that were able to complete both NYHA classification evaluations.

Table 15: Improvement in NYHA Classification at Six-Months

from Baseline

NYHA Change During OPTION Study

Change in NYHA

Class

Improved 2 classes

Improved 1 class

Total improved

No change

Worsened 1 class

Study Patients

(N=97)

(percentage)

Control Patients

(N=43)

(percentage)

10 (10.3%) 2 (4.7%)

47 (48.5%) 20 (46.5%)

57 (58.8%) 23 (51.2%)

39 (40.2%) 20 (46.5%)

1 (1.0%) 1 (2.3%)

44 Lumax Technical Manual

The study and the control group have similar NYHA classes and similar rates of improvement in NYHA class from Baseline to the Six-Month follow-up.

6. The purpose of Secondary Endpoint 6 is to evaluate the rate of hospitalization, for CHF and for all other causes. The occurrence rate and reasons for hospitalization of the study group were compared to the control group. To be consistent with other large-scale clinical trials, clinical sites were instructed to report hospitalizations for CHF using the following definitions: 1) hospitalization for heart failure management, 2) outpatient visit in which IV inotropes or vasoactive infusion are administered continuously for at least 4 hours, or 3) emergency room (ER) visit of at least 12 hours duration in which intravenous heart failure medications including diuretics are administered.

Table 16 summarizes hospitalization, ER visits and outpatient

visits for enrolled patients.

Lumax Technical Manual 45

Table 16: Hospitalization, ER Visits and Outpatient Visits

Medical Visits

Hospital

Study

(N=128)

CHF Related:

Control

(N=65)

CHF Related:

Admissions

Patients

Hospitalizations

Patients

Hospitalizations

20 (15.6%)

28 All causes: 68 (53.1%)

5 (7.7%)

9 All causes: 29 (44.6%)

Emergency

Room Visits

Patients

CHF Related:

Visits

1 (0.8%)

1 All causes: 13 (10.1%)

CHF Related:

0 (0.0%)

All causes:

2 (3.1%)

Outpatient Visits

Patients

CHF Related:

Visits

1 (0.8%)

1 All causes:

5 (3.9%)

CHF Related:

0 (0.0%)

All causes:

2 (3.1%)

A large percentage of All Cause hospitalizations can be attributed to pacing lead revisions, device infections, or other device-related interventions (e.g., pocket revision or device replacements for ERI or device recall). The CHF hospitalization rate for both the study and control groups is clinically acceptable considering the enrollment CHF status of the patients.

46 Lumax Technical Manual

7. The purpose of Secondary Endpoint 7 is to evaluate the observation rate. Observations are defined as clinical events that do not require additional invasive intervention to resolve. For the study group, there were 210 observations in 104 patients with cumulative implant duration of 1240.4 months (101.9 patient years). 78.2% of the enrolled study patients have a reported observation. The rate of observations per patient-year is 2.06. For the control group, there were 81 observations in 44 patients with cumulative implant duration of 596.5 months (49.0 patient years). 65.7% of the enrolled control patients had a reported observation. The rate of observations per patient-year was 1.65.

8. The purpose of Secondary Endpoint 8 is to evaluate peak VO2 as a measure of effectiveness of the Tupos LV/ATx system in providing CRT. The core lab was blinded to study randomization assignments during evaluation of the results of the cardiopulmonary exercise (CPX) testing in order to minimize the potential for bias. According to the protocol, to be included in the analysis, patients were required to attain a respiratory exchange ratio (RER) of ≥ 1.

Table 17 provides a summary of peak VO

results for 42

patients with CPX testing completed at Baseline and the SixMonth follow-up and with an RER of ≥ 1.

Lumax Technical Manual 47

Table 17: Peak VO2 Testing Results – Patients with RER ≥ 1

Results Study Control

Peak VO

(ml/kg/min)

N=32

Baseline:

Mean:

13.46 ± 0.57 Range:

6.9 to 21.1

Six-Month:

Mean:

13.39 ± 0.53 Range:

7.6 to 20.70

Difference:

Mean:

-0.06 ± 0.42 Range:

-7.9 to 4.9

N=10

Baseline:

Mean:

12.58 ± 0.75 Range:

8.0 to 14.8

Six-Month:

Mean:

12.89 ± 0.94 Range:

7.0 to 17.2

Difference:

Mean:

0.31 ± 0.67 Range:

-2.7 to 4.6

1.6.2.11 Multi-site Poolability and Gender Analysis

The OPTION CRT/ATx clinical report includes data from multiple centers with centralized coordination, data processing, and reporting at BIOTRONIK. All of the clinical centers followed the requirements of an identical clinical protocol, and all of the clinical centers used the same methods to collect and report the clinical data. In order to justify pooling of the data from multiple centers, several analyses were completed. All of the centers were divided into two groups based on implant volume. Comparisons were then made between the patient populations based on the results of each of the endpoints. Additionally, analyses were performed on the data collected in the OPTION CRT/ATx clinical investigation in order to compare results between males and females. The first type of analysis compared enrollment by patient gender in each of the study and control groups. The second type of analysis compared effectiveness outcomes in each gender.

The results of these analyses demonstrate poolability of the data between sites. There were no significant differences in the second primary endpoint or any of the secondary endpoints between high and low volume implant centers.

48 Lumax Technical Manual

The gender distribution in this clinical investigation is consistent within the study groups and includes a representative proportion of female participants. There were no significant differences in any of the primary or secondary endpoints between the male and female population.

1.6.2.12 Conclusions

The IDE Clinical study (OPTION LV/ATx) demonstrated that the safety and effectiveness of the Tupos LV/ATx CRT-D device is equivalent to that of similar legally marketed CRT-D devices. Although the study missed its primary safety endpoint, additional post hoc analyses were conducted to reassure that the safety profile of the device is comparable to other legally marketed CRT-D devices.

1.7 Patient Selection and Treatment

1.7.1 Individualization of Treatment

• Determine whether the expected device benefits

outweigh the possibility of early device replacement for patients whose ventricular tachyarrhythmias require frequent shocks.

• Determine if the device and programmable options are

appropriate for patients with drug-resistant supraventricular tachyarrhythmias (SVTs), because drugresistant 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. It is strongly recommended that candidates for an ICD/CRT-D have a complete cardiac evaluation including EP testing prior to device implant to gather electrophysiologic information, including the rates and classifications of all the patient’s cardiac rhythms. When gathering this information, delineate all clinically significant ventricular and atrial arrhythmias, whether they occur spontaneously or during EP testing.

Lumax Technical Manual 49

If the patient’s condition permits, use exercise stress testing to do the following:

• Determine the maximum rate of the patient’s normal

rhythm.

• Identify any supraventricular tachyarrhythmias.

• Identify exercise-induced tachyarrhythmias.

The maximum exercise rate or the presence of supraventricular tachyarrhythmias may influence selection of programmable parameters. Holter monitoring or other extended ECG monitoring also may be helpful.

If the patient is being treated with antiarrhythmic or cardiac drugs, the patient should be on a maintenance drug dose rather than a loading dose at the time of pulse generator implantation. If changes to drug therapy are made, repeated arrhythmia inductions are recommended to verify pulse generator detection and conversion. The pulse generator also may need to be reprogrammed.

Changes in a patient’s antiarrhythmic drug or any other medication that affect the patient’s normal cardiac rate or conduction can affect the rate of tachyarrhythmias and/or efficacy of therapy.

If another cardiac surgical procedure is performed prior to implanting the pulse generator, it may be preferable to implant the lead system at that time. This may prevent the need for an additional thoracic operation.

1.7.2 Specific Patient Populations

Pregnancy - If there is a need to image the device, care should

be taken to minimize radiation exposure to the fetus and the mother.

Nursing Mothers - Although appropriate biocompatibility testing has been conducted for this implant device, there has been no quantitative assessment of the presence of leachables in breast milk.

50 Lumax Technical Manual

Geriatric Patients - Most (about 71%) of the patients receiving a CRT-D or ICD in the clinical studies detailed in this manual were over the age of 60 years (see Clinical Studies).

Handicapped and Disabled Patients - Special care is needed in using this device for patients using an electrical wheel chair or other electrical (external or implanted) devices.

1.8 Patient Counseling Information

The implanted devices are subject to random component failure. Such failure could cause inappropriate shocks, induction of arrhythmias or inability to sense arrhythmias, and could lead to the patient’s death.

Persons administering CPR may experience the presence of voltage on the patient’s body surface (tingling) when the patient’s CRT-D/ICD system delivers a shock.

A patient manual is available for the patient, patient’s relatives, and other interested people. Discuss the information in the manual with concerned individuals both before and after pulse generator implantation so they are fully familiar with operation of the device. (For additional copies of the patient manual, contact the BIOTRONIK at the address listed in this manual.)

1.9 Evaluating Prospective CRT-D/ICD

Patients

The prospective ICD/CRT-D implant candidate should undergo a cardiac evaluation to classify any and all tachyarrhythmias. In addition, other patient specific cardiac information will help in selecting the optimal device settings. This evaluation may include, but is not limited to:

• an evaluation of the specific tachycardia rate(s)

• the confirmation and/or evaluation of any supraventricular

arrhythmias or bradyarrhythmias

• the evaluation of various ATP and cardioversion

therapies

• the presence of any post-shock arrhythmias, and

Lumax Technical Manual 51

• an evaluation of the maximum sinus rate during exercise

If a patient’s drug regimen is changed or adjusted while the CRT-D/ICD is implanted, additional EP testing may be required to determine if detection or therapy parameter settings are relevant and appropriate.

Empirical changes to the detection or therapy parameters should be assessed based on patient safety. Some changes may necessitate a re-assessment of sensing, pacing, or arrhythmia conversion treatment. Thorough technical knowledge of BIOTRONIK CRT-D/ICDs, additional CRT-D/ICD experience, and individual medical judgment will aid in determining the need for additional testing and follow-up.

52 Lumax Technical Manual

Lumax Technical Manual 53

2. Device Features

The Lumax family feature set is presented under the following sub-headings: Tachyarrhythmia Detection, Tachyarrhythmia Redetection / Acceleration, Tachyarrhythmia Therapy, Tachyarrhythmia Termination, Bradycardia Therapy, EP Test Functions and Special Features. The features apply to all members of the Lumax family except where specifically referenced differently.

CAUTION

Programmed Parameters – Program the device

parameters to appropriate values based on the patient’s specific arrhythmias and condition.

2.1 Cardiac Resynchronization Therapy

(CRT)

HF versions only

For Cardiac Resynchronization Therapy (CRT), a sensing/pacing lead is placed in the right atrium, while an ICD lead is placed in the right ventricle. The third lead is positioned to pace the left ventricle. When connected together, this system provides coordinated, simultaneous stimulation of the right and left ventricles. This resynchronization therapy is designed to coordinate the contraction of both ventricles, which allows the heart to contract more efficiently. As a result, patients with CHF and intraventricular conduction delay may have a greater ability to complete physical activities thus improving their quality of life.

54 Lumax Technical Manual

As a result of the device design and header configuration, ventricular pacing pulses can be delivered between the right / left ventricular lead tip electrodes simultaneously (cathode) and the ring of the right ventricular lead (anode). Ventricular sensing primarily uses the poles of the right ventricular lead tip and ring. This design avoids sensing of ventricular activity twice during a single cardiac cycle (double counting) in patients with a wide QRS complex. However, for diagnostic purposes and LV pacing protection the Lumax HF devices can be programmed to sense in the left ventricle.

Atrial Channel

The Lumax ICDs/CRT-Ds pace and sense in bipolar configuration, between the atrial lead’s tip and ring electrodes. A bipolar atrial lead must be used to ensure reliable sensing of atrial activity.

Ventricular Channel

The Lumax HF devices can be programmed to pace in both the right and left ventricle (as well as RV only). The Lumax HF primarily senses in a bipolar configuration in the right ventricle. However, for diagnostic purposes and LV pacing protection the Lumax HF devices can be programmed to sense in the left ventricle.

Potential Ventricular lead configurations are provided in Table 18.

Sensing

Lumax Technical Manual 55

Table 18. Lead Configurations

Configuration Explanation

RV Only

Sensing takes place between the tip and ring electrodes of the right ventricular lead.

Pacing

LV Only

RV & LV Together (BiV)

RV Only

Sensing takes place between the tip and ring electrodes (bipolar) or the tip electrode of the left ventricular lead and the CRT-D housing (unipolar).

Pacing configuration is programmable between the tip and ring electrodes of the right and left ventricular leads. See Figure 3

Pacing takes place between the tip and ring electrodes of the right ventricular lead.

Figure 3 Programmable BiV Pacing Configurations

56 Lumax Technical Manual

For CRT to be effective, ventricular pacing must occur. Therefore, AV delays must be programmed short enough to override intrinsic ventricular contractions. Additional information to further optimize AV delays can be obtained with echocardiography.

CRT can be programmed ON or OFF via the programmer using the [Ventricular Pacing] parameter. Ventricular Pacing Configuration allows either standard right ventricular [RV] (CRT = OFF) pacing or Cardiac Resynchronization Therapy [BiV] (CRT = ON).

The Lumax HF CRT-D can provide triggered biventricular pacing. This is a functional expansion of the basic ventricular modes (DDD(R); DDI(R); VDI(R); VDD(R); VVI(R)) used for biventricular pacing. The “RVs triggering” was designed to ensure CRTis delivered even when rapid intrinsic activation interferes with pacing, such as in the case of conducted atrial fibrillation. This function triggers LV pacing (Vp) after intrinsic sensing (RVs) in the right ventricle. Triggered pacing can be programmed to react to only normal RV sensed events or to right ventricular extrasystoles as well as normal RV sensed events. The maximum Trigger rate is normally limited by the programmed UTR, but can also be programmed to function up to a separate and higher maximum trigger rate.

2.2 Sensing (Automatic Sensitivity Control)

The Lumax ICDs/CRT-Ds use Automatic Sensitivity Control (ASC) to adjust the input stage sensitivity threshold for each channel to appropriately detect the various cardiac signals. The characteristics of the sensing circuitry have been optimized to ensure appropriate sensing during all potential cardiac rhythms.

Cardiac signals vary in amplitude; therefore detection thresholds cannot be static. With the Automatic Sensitivity Control (ASC) every sensed event is measured, and the upper and lower thresholds are re-set accordingly (also known as beat-by-beat adaptation). The ASC begins by tracking the cardiac signals (R and P-waves) during the sensed refractory periods. The peak values measured during this time are used to set the sensing thresholds during the active detection periods.

Lumax Technical Manual 57

2.2.1 Right Ventricular Sensitivity Settings

There are three programmable preset options for setting the sensitivity of the right ventricular input stage. The sensitivity selections are designed to adapt the parameters of the input stage to various signal conditions. The predefined parameter sets are described in Table 19.

Table 19: Sensitivity Settings

Setting Definition for Use

Standard This setting is recommended for most

patients, especially for those with measured R-wave amplitude of ≥3 mV.

Enhanced T Wave Suppression

Enhanced VF Sensitivity

This setting offers suppression of T-wave oversensing. This mode should not to be used on patients with the following conditions:

• Sinus rhythms with small signal amplitudes, R-waves <4 mV

• VF with highly fluctuating signal amplitudes.

This setting enhances VF detection, in cases of highly fluctuating signal amplitudes. It is not to be used for patients that have sinus rhythms containing large amplitude T-waves.

Typically, the upper threshold is reset with each sensed R-wave, but in order to ensure that pacing does not occur during an episode of VF, the ASC behaves differently with paced events. Each paced event is followed by a paced refractory period after which the ventricular threshold is set to the minimum programmed value.

58 Lumax Technical Manual

For example, the upper threshold is set at 50% of the measured R-wave for the Standard sensitivity setting following the 100 ms sensed refractory period. The upper threshold decays 0.125 mV every 250 ms through the T-wave discrimination period (hold of upper threshold: 360 ms). After the T-wave discrimination period, the threshold is decreased to the lower threshold. The lower threshold is set to 25% of the measured peak R-wave. The lower threshold then decreases 0.125 mV every 500 ms until the Minimum Threshold is reach or until the next sensed (or paced) event.

Figure 4 Automatic Sensitivity Control with Standard Setting

Figure 4 provides an illustration of Automatic Sensitivity Control

with the sensitivity programmed to Standard. The tracked R – wave is measured to be 6.0 mV, following the sensed refractory period the upper threshold is set to 3.0 mV. After the T-wave discrimination period, the threshold is further reduced to 1.5 mV. Both the Upper and Lower Thresholds decay over time, but the Minimum Threshold is never violated. Nominally, the minimum threshold is set to 0.8 mV, but it can be adjusted by the user.

The Enhanced VF Sensitivity setting is specifically designed to improve VF detection when the VF signal is very small. Two adjustments are made to ASC with this setting:

Lumax Technical Manual 59

• The T-wave discrimination period (hold of upper threshold) is decreased to 100 ms, thus eliminating the Upper Threshold.

• The decay rate of the Lower Threshold is increased to

0.125 mV every 250 ms.

These adjustments ensure that the threshold reaches the lower values more quickly in order to assure that all VF signals are sensed appropriately.

The Enhanced T-Wave Suppression setting is specifically designed to avoid double counting of each QRS-T complexes during normal sinus rhythms. With sensitivity programmed to Enhanced T-Wave Suppression:

• High pass filtering is increased to reduce low frequency signal components such as T-waves and respiratory artifacts.

• The Upper Threshold is increased to 75% of the measured R-wave.

• The Upper Threshold may not retrigger with each sensed event, it is only triggered when the new sensed R-wave crosses the 50% point of the previous measured R-wave.

2.2.2 Minimum Right Ventricular Threshold

This parameter limits the minimum sensitivity of the ICD/CRT-D to a programmable value. Nominally, the minimum threshold is set to 0.8 mV, but it can be adjusted from 0.5 to 2.5 mV.

2.2.3 Atrial Sensitivity Settings

DR and HF versions only

The primary option for setting the sensitivity of the atrial input stage is “Standard”. When atrial sensing is active, the sensitivity is set to “Standard” for most patients, which is designed to adapt the parameters of the input stage to various signal conditions. The available settings are described in Table 20.

60 Lumax Technical Manual

Table 20: Atrial Sensitivity Settings

Setting Definition for Use

Standard This setting is recommended for all

patients with a functioning atrial lead.

Inactive This setting deactivates the atrial channel

for sensing, EGM telemetry and Holter recording and is typically used when no atrial lead is implanted.

Typically, the upper threshold is reset with each sensed P-wave, but in order to ensure that pacing does not occur during an episode of AF/VF, the ASC behaves differently with paced events. Each paced event is followed by a paced refractory period after which the atrial threshold is set to the minimum programmed value.

2.2.4 Minimum Atrial Threshold

This parameter limits the minimum sensitivity of the ICD/CRT-D to a programmable value. Nominally, the minimum threshold is set to 0.4 mV, but it can be adjusted from 0.2 to 2.0 mV.

2.2.5 Left Ventricular Sensitivity Settings

HF versions only

The primary option for setting the sensitivity of the left ventricular input stage is “Standard”. When LV sensing is active, the sensitivity is set to “Standard” for most patients, which is designed to adapt the parameters of the input stage to various signal conditions. The available settings are described in Table 20.

Lumax Technical Manual 61

Table 21: Atrial Sensitivity Settings

Setting Definition for Use

Standard This setting is recommended for all

patients with a functioning left ventricular lead.

Inactive This setting deactivates the left ventricular

channel for sensing, EGM telemetry and Holter recording and is typically used when no LV lead is implanted.

2.2.6 Minimum Left Ventricular Threshold

This parameter limits the minimum sensitivity of the CRT-D to a programmable value. Nominally, the minimum threshold is set to

0.8 mV, but it can be adjusted from 0.5 to 2.5 mV.

2.2.7 Far Field Protection

DR and HF versions only

This parameter blanks the atrial channel of the ICD/CRT-D to the period before and after each ventricular event. This blanking period is programmable separately based on whether the ventricular event is a paced or sensed event and is designed to prevent sensing of ventricular signals with the atrial leads.

CAUTION

Far-field sensing of signals from the atrium in the

ventricular channel or ventricular signals in the atrial channel should be avoided by appropriate lead placement, programming of pacing/sensing parameters, and maximum sensitivity settings. If it is necessary to modify the Far Field Blanking parameter, the parameter should be lengthened only long enough to eliminate far-field sensing as evidenced on the IEGMs. Extending the parameter unnecessarily may cause undersensing of actual atrial or ventricular events.

62 Lumax Technical Manual

2.2.8 Additional Sensing Parameters

The parameters of the Additional Sensing Parameters menu are to provide additional flexibility for physicians to non-invasively correct over/undersensing situations. The ranges and nominal values are located in table titled Additional Sensing Parameters in

Section 6.

Upper Threshold (A, RV & LV) - This feature allows the user to

change the upper sensing threshold level (UT in Figure 4) from the nominal value of 50% of the sensed R-wave / P-wave amplitude to either 75% or 87.5% of the R-wave / P-wave value. This feature is used in the ventricle for example to eliminate oversensing of large T-waves.

Hold of Upper Threshold (RV & LV) - This parameter determines when the sensing decrement begins after an event (small step-down on the 50% threshold before LT in the figure above). This parameter “holds” the threshold at a constant value (UT in Figure 4) for the programmed time. Maximum Hold Time is programmable from 10 to 600 ms (T-Wave discrimination period).

Lower Threshold (A, RV & LV)- This feature allows the user to change the lower sensing threshold (labeled LT in Figure 4) from the default value of 25% of the sensed R-wave / P-wave amplitude to either 12.5 or 50% of the measured R-wave/ P-wave value. This feature is also used in the ventricles to alleviate T-wave oversensing and/or undersensing of small amplitude events (e.g., fine VF).

Blank after atrial pacing (RV) - This feature is used to eliminate sensing of artifacts after atrial paced events. Blank Post atrial Pace in the RV is programmable from 50 to 100 ms. For the left ventricle, this parameter is equal to the safety window time (100 ms).

VES Discrimination after As - This feature is used to correctly identify and classify ventricular extrasystoles (VES). With each atrial sensed event (also with Ars falling into PVARP) a special timing interval is started for the ventricle, if the subsequent ventricular event does not fall within the AV delay or the programmed VES discrimination interval, it is classified as a VES.

Lumax Technical Manual 63

LV T-wave Protection - Used to eliminate unintended pacing in

the vulnerable period of the left ventricle. This feature is only used when left ventricular sensing is active. HF versions only.

2.3 Automatic Threshold Measurement (ATM)

Lumax 500/540 Models only

The Lumax 500/540 models have automatic threshold measurement (ATM) feature for determining ventricular pacing thresholds. This feature is separately programmable for the right (RV) and left (LV) ventricles.

ATM is initiated once each day, typically during the nighttime while the patient is normally sleeping. It can measure the right and the left ventricular pacing thresholds and stores this information for use in trends of daily threshold values. This information is available on the programmer during in-office follow-ups and via BIOTRONIK’s Home Monitoring system. The permanent pacing amplitude is not adjusted by the ATM feature.

2.3.1 Functional Description

The ATM features of Lumax 500/540 are based on the evaluation of the morphology of the ventricular evoked response (VER) to determine if the pacing pulse has captured the myocardium. In order to measure the pacing threshold, a sequence of two algorithmic steps is carried out:

• Signal Quality Check (SQC)

• Threshold Measurement

64 Lumax Technical Manual

The signal quality check determines if the morphology of the evoked response of a captured beat is sufficiently different from the morphology of the evoked response of a non-captured pace. If the SQC is sufficient (i.e., if the algorithm can clearly distinguish between capture and non-capture), then the automatic threshold measurement is activated by initiating a series of pacing pulses. The amplitude of these pulses is continuously decreased until a loss of capture is detected. When loss of capture is detected a back-up pulse is delivered (right ventricle only) to avoid ventricular pauses caused by the threshold measurement.

2.3.1.1 Signal Quality Check

During the Signal Quality Check, five single effective pacing pulses are delivered. These pulses are followed by five double pulses. The second pulse of each double pulse is delivered into the refractory phase of the ventricle (as a non-capturing pulse). The VER morphology of the single pulses and the second pulse of the double pulses are assessed. The signal quality check is successful if the single pulses are recognized as capturing pulses and the second pulses of the double pulses are classified as noncapturing pulses. The AV delay of the 2 x 5 pulses is shortened to 50 ms in order to avoid ventricular fusion beats which would otherwise disturb the SQC. If the SQC is successful, then the threshold measurement is started, if not, the SQC is repeated again after 30 minutes.

2.3.1.2 Threshold Measurement

The threshold measurement begins by delivering pulses at the programmed pacing amplitude. The pulse amplitude is decreased in steps of 0.6 Volts (V) each until loss of capture is detected. During the loss of RV-capture sequence, a backup pulse is issued. The back-up is set to a value of the programmed pacing amplitude plus 0.6 V with a pulse width of 1.5 ms. There are no backup paces for left ventricular ATM (LV-ATM).

The pulse amplitude is then set to the last effective value (0.6 Volts above the initial non-capture level) and then subsequent pacing pulses are reduced in 0.1 V steps until loss of capture reoccurs. The last effective pacing amplitude is then recorded as the pacing threshold.

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2.3.1.2.1 Loss of Capture Detection

In order to ensure against ATM loss of capture detection due to an isolated non-capture event (i.e. as a result of VES), loss of capture is only declared if two out of three consecutive cycles show loss of capture.

2.3.1.2.2 ATM in Lumax HF-T Models

If the device is programmed to biventricular pacing (BiV), the RV ATM functions in the RV mode as described above. The LV ATM, if active, is initiated after the RV ATM is complete. For the LV ATM, the left ventricle is stimulated first with a VV delay of 50 ms and then completed in a similar manner.

2.4 Intra-Thoracic Impedance Measurement

Lumax 500/540 Models only

2.4.1 Functional Description

The intra-thoracic impedance measurement of Lumax 500/540 is based on the painless shock impedance feature of the Lumax ICD/CRT-D Family. It utilizes 24 measurement windows evenly distributed over the course of 24 hours to trend the data. With a total of 1,024 impedance measurements per hour, there is a significant amount of data being stored in the ICD/CRT-D.

The impedance is measured between RV tip and the distal shock coil with a programmable excitation current. The device calculates and stores the mean hourly impedance values and the corresponding time points. All hourly values obtained within one Home Monitoring interval are transmitted to the Home Monitoring service center along with the daily message.

Upon interrogation, the programmer calculates and displays an intra-thoracic impedance trend of the mean daily impedance values. This feature is only available after inserting a special code into the programmer.

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2.5 Ventricular Tachyarrhythmia Detection

The Lumax ICDs/CRT-Ds detect and measure the rate of sensed cardiac signals to discriminate ventricular tachyarrhythmias from supraventricular tachycardias, sinus rhythm or sinus bradycardia. This is accomplished through programmable rate detection parameters in the device. When a tachyarrhythmia is present, the ICD/CRT-D classifies the arrhythmia and delivers the appropriate therapy. If a tachyarrhythmia continues following the first therapy attempt, then the ICD/CRT-D will redetect the tachyarrhythmia and deliver subsequent therapies as necessary.

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.

Classification of cardiac signals is accomplished primarily by measuring the cardiac cycle length (R-R, P-R and P-P). In addition, the ICD/CRT-D can also utilize abrupt changes in rate or irregularity of the cardiac signal to further differentiate ventricular tachyarrhythmias. Each detected ventricular tachyarrhythmia is classified into one of the following zones:

• VT-1 Lower rate ventricular tachycardia

• VT-2 Higher rate ventricular tachycardia

• VF Ventricular fibrillation

Each rhythm class is programmable to a separate rate with the zone limit defining the lowest rate in each class. The upper rate limit of each class is equal to the zone limit of the next higher class, creating a continuous range of rate classes.

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2.5.1 VF Classifications

Detection of ventricular fibrillation (VF) utilizes programmable X out of Y criterion. Both X and Y are programmable. If X number of intervals within the sliding window (defined by Y) are shorter than the programmed VF rate interval (>bpm), VF is detected. After fibrillation is detected, the programmed therapy sequence for VF is initiated.

Nominal settings for classification of ventricular fibrillation (VF) are 8 of 12 intervals; meaning that within a sample window of 12 intervals, 8 intervals must meet or exceed the VF zone rate criteria.

2.5.2 VT Interval Counters

The VT Interval Counters are separately programmable for VT-1 and VT-2 rate classifications. The Counter: Detection is the number of intervals required to declare a tachyarrhythmia as VT. A tachyarrhythmia must meet both the rate/interval criteria and the programmed Counter / Detection criteria, in addition to any other detection enhancements to be declared a tachycardia.

2.5.3 VT Classification

Both VT-1 and VT-2 classification zones utilize separately programmable detection parameters. Classification of VT-1 or VT-2 is based on the last interval average preceding declaration of tachyarrhythmia detection. If this average falls within the VT-1 zone, the programmed VT-1 therapy is delivered. If the average falls within the VT-2 limits, the programmed VT-2 therapy is delivered. If additional detection parameters are activated, each of these supplemental criteria must also be satisfied before a VT rhythm can be classified and treated.

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The ICDs/CRT-Ds may be programmed to use ventricular-only information, or both atrial and ventricular information for the discrimination of ventricular tachycardias. With SMART Detection™ turned ON, the Lumax ICDs/CRT-Ds use atrial and ventricular signals for discrimination of fast heart rhythms. With SMART Detection™ turned OFF, only the ventricular rate is used to discriminate between ventricular rhythm classes. If SMART Detection is enabled, this algorithm evaluates all cardiac signals within the VT range and increments the VT Sample Count for all intervals that are deemed VT. A full description of SMART Detection™ is provided in the following text.

In addition, when the Lumax senses the programmed number of consecutive intervals (termination count) within the sinus rate zone, all tachyarrhythmia detection criteria, including the VT sample counters are reset.

2.5.4 SMART Detection™

DR and HF versions only

This discrimination algorithm enhances VT-1 and VT-2 detection by applying a series of tests to the sensed cardiac signal. SMART Detection™ is intended to discriminate VT from a variety of supraventricular arrhythmias that are conducted to the ventricle and that would otherwise satisfy VT-1 or VT-2 rate detection criteria.

First, the average ventricular rate is compared to the average atrial rate. In the event that the measured ventricular rate is faster than the atrial rate, the device immediately declares the rhythm a VT and delivers programmed ventricular therapy for the detected VT zone.

In the event that an atrial rate is faster compared to the ventricular rate one of three tests are performed:

Ventricular rhythm stability, (see Stability on page 69) if the ventricular signal is unstable, then the rhythm is declared a supraventricular tachyarrhythmia, (SVT) and ventricular therapy is typically withheld.

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If the ventricular signal is stable, and the atrial rate is a multiple of the ventricle rate, then the rhythm is declared a supraventricular tachyarrhythmia (SVT) and ventricular therapy is typically withheld.

If the ventricular rhythm is stable and the atrial rate is not a multiple of the ventricular rate, then the rhythm is declared a VT and ventricular tachycardia therapy is delivered.

In the event that both the atrial and ventricular signals are detected at the same rate, a series of additional discrimination tests are applied.

2.5.5 Onset

Another detection enhancement that may be used independently (VT-1 or VT-2, when SMART Detection is active) or as an adjunct to the SMART Detection™ algorithm is the Onset parameter. This parameter measures abrupt changes in ventricular cycle length to discriminate between sinus tachycardias and ventricular and atrial tachyarrhythmias, which characteristically begin with an abrupt change in cardiac rate.

This feature allows therapy to be withheld if a sinus tachycardia rate crosses into one of the VT zones.

2.5.6 Stability

In VT-1 and VT-2 zones, the purpose of STABILITY is to assist in discriminating between stable ventricular tachyarrhythmias and supraventricular tachyarrhythmias that conduct irregularly to the ventricles. STABILITY evaluates sudden changes in the regularity of cardiac events (R-R and P-P intervals) on a beat by beat basis. The STABILITY criterion compares the current measured interval with the three preceding cardiac intervals. If a difference between the current interval and each of the three preceding intervals is less than the stability range, then the current intervals are stable.

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The SMART Detection™ algorithm utilizes both atrial and ventricular STABILITY as integral parts of the discrimination algorithm. Therefore, when SMART Detection™ is enabled, the STABILITY parameter must also remain enabled and set to 12%.

2.5.7 Sustained VT Timer

The Sustained VT Timer can be programmed between 30 seconds and 30 minutes (or to OFF). When the timer expires, therapy is initiated regardless of the detection enhancements.

The Sustained VT parameter is intended to force tachycardia therapy in cases where a cardiac rhythm meets the VT rate criteria but does not satisfy one or more detection enhancement criterion (Onset, SMART Detection, or Stability) for an extended duration. This “safety” timer is initiated within one of the VT zones. If the programmed Sustained VT time period expires without tachycardia detection, redetection is initiated without utilizing the detection enhancements.

A simple up/down counter is used to initiate the safety timer. The counter is incremented by one when an interval falls into a VT zone and decrements by one when an interval falls into the sinus zone. When the counter reaches a number equal to the programmed VT detection counter, the safety timer is started. The timer runs until the programmed time expires and therapy is delivered or until the timer is reset. The timer is reset with initial detection or VT termination.

The safety timer is not used in redetection. If initial detection was due to the safety timeout and SMART Redetection is programmed “ON”, then SMART Detection will not be used for redetection.

2.5.8 VT Monitoring Zone

The VT1 zone can be programmed to monitor for non-sustained arrhythmias not requiring therapy. The monitoring zone can be programmed with all the standard detection enhancements including SMART DetectionTM to monitor for non-sustained ventricular tachycardia or atrial tachyarrhythmias. Any tachyarrhythmia meeting the Monitor Zone criteria will store an IEGM.

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2.5.9 Atrial Monitoring Zone

This feature allows the device to store an IEGM for atrial tachyarrhythmias such as Atrial Fibrillation or Atrial Flutter. The zone is programmed by rate with a range of 100 bpm to 250 bpm. Any atrial tachyarrhythmia meeting the Atrial Arrhythmia Monitor Zone criteria will store an IEGM.

2.6 Tachyarrhythmia Redetection

The Lumax ICDs/CRT-Ds offer independently programmable settings for determining if tachyarrhythmias remain after therapy has been delivered. The redetection routine allows the ICDs/CRT-Ds to determine whether further therapy is required when the initial therapy was unsuccessful in terminating the arrhythmia.

Tachyarrhythmia redetection criteria are based on cardiac cycle length and number of intervals. The number of intervals is distinct and independent of the initial detection criteria.

2.6.1 VT Redetection

The Counter: Redetection parameter may be programmed separately for each arrhythmia class, independent of the initial detection parameters:

Redetection of an ongoing tachyarrhythmia is declared when the Counter: Redetection is satisfied (based on individual cycles). If a sensed cardiac signal meets any VT rate criteria, following therapy, that signal is counted and compared to the programmed Counter: Redetection setting.

Redetection functions are based exclusively on the VT criterion.

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2.6.2 SMART Redetection

DR and HF versions only

With SMART Redetection programmed ON, both atrial and ventricular signals are used for redetection after initial detection and therapy for a VT. SMART Detection™ will function identically as in initial VT detection.

2.6.3 Forced Termination

DR and HF versions only

With SMART Redetection programmed ON, this programmed parameter sets a time after which the SMART Redetection will be terminated even if the SVT is still ongoing. This forces the device to terminate the episode and allow detection of a new VT or VF episode.

2.6.4 VF Redetection

VF redetection uses the same X in Y algorithm as initial detection. The X and Y values for initial detection are also used for redetection to ensure consistent classification of VF.

2.7 Tachyarrhythmia Termination

Termination of a ventricular tachyarrhythmia episode is declared when 12 out of 16 consecutive sensed intervals are longer than the VT-interval parameter of the lowest VT class (sinus or bradycardia rhythm).

2.8 Tachyarrhythmia Therapy

The Lumax ICDs/CRT-Ds offer a variety of therapy options that can be tailored to meet a patient’s specific anti-tachycardia or defibrillation therapy requirements. Anti-tachycardia pacing (ATP) therapies can be combined with defibrillation therapies to provide a broad spectrum of tachyarrhythmia treatment options.

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2.8.1 Therapy Options

The Lumax ICDs/CRT-Ds offer multiple therapy options for each tachyarrhythmia class (VT1, VT2, VF). Therapy options (up to 10 ATP sequences and 8 shocks) are available for the VT1 and VT2 zones, whereas ATP One Shot and up to 8 shock therapies are available for the VF class. The specific characteristics of an ATP and shock therapy are independently programmed for each VT/VF zone.

The ATP and shock therapy options are discussed in detail in the following sections.

2.8.2 Anti-Tachycardia Pacing (ATP)

Anti-tachycardia pacing therapy (ATP) is available in both VT detection zones. Available modes of ATP include Burst, Ramp, and Burst + PES (Programmed Extra Stimuli). In addition, the Burst and Ramp modes allow interval scanning of the R-S1 Interval, the S1 Decrement, or both. The Attempts parameter determines the number of burst schemes to be delivered before the scan parameter is incremented.

Burst – This mode will deliver a series of pacing stimuli with user defined duration of the burst (Number S1), coupling cycle length (R-S1) and burst rate (S1-S1). The coupling interval and the start interval are calculated from the intrinsic R-R average.

Ramp - This mode will deliver a series of pacing stimuli with the above options including a parameter which decrements each successive stimuli interval in the burst.

Burst + PES - This mode provides a pulse train followed by one additional timed stimuli. The coupling cycle length of the burst and each extra stimulus (S1-S2 Interval) is individually programmed either as an adaptive value (as a percentage) or as an absolute value (expressed in milliseconds).

Ventricular Pacing - This parameter defines the type of ventricular pacing performed during delivery of ATP sequences in CRT-Ds and is programmable to biventricular (VV delay = 0 ms) or right ventricular only.

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Number S1 - This parameter defines the number of stimuli for an ATP. For Burst + PES, a single extra stimulus with a separate parameter setting is coupled.

Add S1 - This feature can be programmed with any Burst, Ramp, or Burst + PES scheme. When “Add S1” is “ON,” the number of S1 intervals is incremented by one on each successive ATP therapy. The next S1-S1 interval is dependent on the initial start interval (S1 decrement) and the programmed Scan Decrement (if activated).

R-S1 Interval - The R-S1 programmable coupling interval occurs at the beginning of each ATP. It defines the interval between the last R-wave signal and the first stimulus (S1). The second stimulus always follows the first one with the same interval.

S1 Decrement - The S1 decrement continuously reduces the pulse intervals of the ATP from the second pulse onward.

S1-S2 Interval - The S1-S2 programmable coupling interval occurs between the Burst sequence and the extra stimuli (PES). It defines the interval between the first stimulus (S1) and the extra stimuli (S2).

Scan Decrement - The Scan decrement continuously reduces the starting pulse intervals of each Burst or Scan.

Minimum ATP Interval - The programmed minimum interval prevents ATPs from being given with stimulation values less than the minimum interval. When the ATP interval reaches the value of the minimum interval with the S1 decrement or scan decrement, it then assumes this value and remains constant.

2.8.2.1 ATP Help

ATP help is a useful tool to assist the physician in choosing and confirming appropriate ATP programming. The “ATP Help” button is displayed in each ATP therapy option. When the ATP help button is pressed, a histogram of the chosen therapy scheme is shown. The histogram displays the intervals for the programmed ATP scheme. When rate adaptive intervals are programmed, the displayed intervals are based on the programmed R-R average.

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2.8.2.2 ATP Optimization

In order to optimize future therapies, the ICD will store the parameter configuration of the last successful ATP attempt in each the VT1 and VT2 classes. The last successful stored ATP attempt is then used as the starting point for the next detected episode of the same arrhythmia class. If the stored parameter configuration is not successful, it is deleted from the ATP optimization memory of the respective arrhythmia class and subsequent therapy sequences will begin with ATP1 for the next detected episode.

ATP Optimization is programmable ON or OFF for all ATP therapies and VT zones with one parameter.

NOTE:

In VT zones, the ICD/CRT-D stores successful ATP therapies only. The stored information includes not only the number of the ATP therapy (e.g., ATP2), but also the successful configuration in detail (for example: Burst; R-S1 Interval: 320 ms, S1-S1 Interval: 320 ms; etc.).

2.8.2.3 ATP Timeout

ATP Timeout is a timer that decrements after the initial ventricular ATP is delivered (VT-1 zone) and limits the additional ATP therapies that may be delivered. Once the timer expires, all further ATP therapies in the sequence are blocked. If further therapy is required after the timer has expired, the system advances to the first programmed shock therapy for the applicable VT zone. Therapy continues until arrhythmia termination or all programmed therapy (in the applicable zone) has been delivered. The ATP Timeout is reset each time an arrhythmia is terminated.

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2.8.2.4 ATP One Shot

ATP One Shot offers the opportunity to treat fast VTs that are detected in the VF zone with a single ATP sequence delivered immediately before charging of the high energy capacitors. The device performs a stability check (same as VT zones, criterion 12% fixed) to determine if the arrhythmia might be a fast VT and if the rhythm is stable, the programmed ATP sequence is delivered prior to charging. Charging starts without redetection and the successful treatment of the arrhythmia will be confirmed prior to shock delivery during shock charging. If the arrhythmia is converted by the ATP, the shock is aborted. All ATP therapy parameters are available for programming ATP One Shot and it can only be used with shock therapy is programmed ON.

2.8.3 Shock Therapy

Shock Therapy is developed by internal circuitry that stores energy across high energy capacitors. The voltage level for the charging cycle is based on the programmed energy level. The energy is then delivered over the connected ICD lead and through the ICD/CRT-D housing utilizing a biphasic waveform. The first and second shock energies in each shock module have independently programmable Shock Energy.

A synchronization window is started at the end of the charging period. During this window, the device will attempt to synchronize the shock therapy to an R-wave. If no R-wave is detected and Confirmation is programmed to OFF, the shock will be delivered asynchronously at the end of the synchronization period (DF). If no R-wave is detected and Confirmation is programmed to ON, the shock will be aborted at the end of the synchronization period (DFc = Cardio Version).

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2.8.3.1 Confirmation

The Confirmation parameter is used to verify the presence of a tachyarrhythmia during charging of the shock capacitors. This function is designed to avoid delivery of shock therapy if a tachyarrhythmia has spontaneously terminated. The programmed shock will be delivered unless bradycardia or a normal sinus rhythm is detected during the Confirmation period. Confirmation may be programmed ON or OFF for each zone (VT1, VT-2 or VF). Although if a shock is aborted and redetection occurs (even in a zone with confirmation programmed ON) the subsequent shock will be delivered without confirmation (see confirmation OFF).

Confirmation OFF

When Confirmation is programmed OFF, shock therapy will be delivered to the patient during the synchronization period regardless of the detected cardiac signal.

Confirmation ON

If the tachyarrhythmia spontaneously converts to bradycardia or a normal sinus rhythm during the confirmation period, shock therapy is aborted. If the device confirms the presence of the tachyarrhythmia, the device will deliver the programmed shock therapy synchronized to the R-wave.

2.8.3.2 Number of Shocks

The number of shocks defines the total number of shock attempts per therapy zone (VT-1, VT-2 or VF). Up to 8 shocks are available in each therapy zone. The first and second shock energies are independently programmable, while the remaining shocks are fixed at maximum energy (30 joules for 300 series devices and 40 joules for 340 series devices).

2.8.3.3 Shock Waveform

Two waveforms of shock therapy are available with the Lumax ICDs/CRT-Ds, Biphasic and Biphasic 2 (ms). The following diagram describes each of the shock waveforms.

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Figure 5. Biphasic Waveforms

Both waveforms start at the calculated voltage, based on the programmed energy level. After an exponential discharge through the lead system to 40% of the initial charge voltage, both shock waveforms switch polarity. At the second phase the:

• Biphasic waveform discharges to 20% of the initial charge voltage before the waveform is truncated

• Biphasic 2ms waveform discharges the remaining energy for two milliseconds before the waveform is truncated

Figure 5 provides a pictorial representation of both biphasic

waveforms.

BIOTRONIK recommends use of the standard Biphasic shock waveform for initial defibrillation threshold testing. If testing demonstrates high defibrillation thresholds, testing with the Biphasic 2ms waveform is offered as a therapeutic alternative to the standard Biphasic shock.

2.8.3.4 Shock Energy

The Lumax ICDs/CRT-Ds are designed to charge to the energy selected on the programmer screen, but similar to all other commercially available ICDs/CRT-Ds, the actual therapy delivered is somewhat less depending on several factors including the shock lead impedance. The first two shock energies in each therapy class are programmable between 1 joules and maximum energy for the device type. The energy of the second shock is always greater than the first shock. The remaining shock energies will be delivered at maximum programmable energy.

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Actual energy delivered for each programmable shock energy is approximately equal to the “Energy Delivered” for the high energy Lumax 340/540 variants in Table 22, and for the Lumax 300/500 in Table 23.

Table 22 Delivered Shock Energy (340/540 Variants)

Programmed Energy

(joules)

Approximate Delivered

Energy (joules)

10.8

21.7

32.6

43.5

54.3

65.2

76.1

86.9

97.8 10 8.7 11 9.6 12 10.5 13 11.3 14 12.2 15 13.1 16 13.9 18 15.7 20 17.3 22 19.1 24 21.1 26 22.8 28 24.4 30 26.3 32 27.9 34 29.7 36 31.5 38 33.3 40 35.0

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Table 23 Delivered Shock Energy (300/500 Variants)

Programmed Energy

(joules)

Approximate Delivered

Energy (joules)

10.8

21.7

32.5

43.3

54.3

65.1

76.0

87.0

97.8 10 8.6 11 9.6 12 10.6 13 11.4 14 12.3 15 13.1 16 14.2 18 16.0 20 17.7 22 19.5 24 21.4 26 23.2 28 24.9 30 27.0

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CAUTION

Shock Impedance - If the shock impedance is less than

twenty-five ohms, 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 twenty-five ohms. Damage to the device may result.

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 the arrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventricular tachycardia during arrhythmia conversion testing is no assurance that conversion will occur post-operatively.

Shock Therapy Confirmation – Programming CONFIRMATION to OFF may increase the incidence of the ICD/CRT-D delivering inappropriate shocks.

2.8.3.5 Shock Polarity

The polarity of the shock therapy may be programmed and changed non-invasively. The Normal polarity configures the HV 1 connector port as the negative electrode and the HV 2 connector port and the outer housing of the ICD/CRT-D as the positive electrode for the first phase of the shock. Reversed polarity will switch the electrical polarity of the connector ports and housing. The shock polarity is separately programmable for each arrhythmia zone.

Alternating polarity is automatically employed when a maximum energy shock with normal polarity fails to cardovert. The next shock will have reversed polarity and alternates the polarity for all subsequent shocks.

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2.8.3.6 Third Programmable Shock Pathway

Lumax 500/540 Models only

The Lumax 500/540 models offer three programmable shock delivery configurations. The defibrillation shock pathways include a “non-active housing” shock path and a shock paths between the ICD/CRT-D housing and either or both shock coils when connected to a dual coil shock lead.

The Shock Configuration parameter operates independently of Shock Polarity. So each of the pathways described below can be reversed for delivered defibrillation/cardioversion shocks.

Table 24 outlines the current shock pathways that are available

with Lumax 500/540 models.

Table 24 Lumax 500/540 Programmable Shock Pathways

# Electrical Pathway

RVÎ SVC and Housing (can)*

RV Î SVC

RV Î Housing (can)

- 300/340 Models are limited to this configuration.

2.8.4 Progressive Course of Therapy

By design, the Lumax ICDs/CRT-Ds will deliver more aggressive therapy for each successive attempt within a single detected episode. Therefore, the device will not deliver ATP1 therapy following ATP2 therapy, and will not deliver ATP therapy following a high voltage defibrillation shock.

When Progressive Course of Therapy is turned ON, the ICD/CRTD will always deliver a maximum energy shock after re-detecting in an arrhythmia class with programmed shock energy less than or equal to the previously delivered therapy. In addition, the ICD/CRT-D blocks all ATP therapy during the current episode if a shock has already been delivered during the episode.

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Furthermore, the ICD/CRT-D prevents therapies of different arrhythmia classes from permanently retarding or accelerating a VT in such a way that the cardiac rhythm fluctuates between the different arrhythmia classes without achieving termination of the arrhythmia regardless of the Progressive Course of Therapy setting.

For example, a 10-joule defibrillation shock is delivered for an arrhythmia detected in the VT-2 zone and results in a deceleration of the VT so that it is subsequently redetected in the VT-1 zone. At that point, the Lumax ICDs/CRT-Ds would continue with shock therapy, but all shocks programmed at less than 10 joules would be delivered at 10 joules.

If a defibrillation shock is delivered but does not terminate the arrhythmia, the next shock will always have the same or higher energy than the last delivered shock. Beginning with the third shock, all shocks are delivered at maximum energy.

2.9 Bradycardia Therapy

The Lumax 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 a separate subsection from the normal bradycardia pacing support values.

2.9.1 Bradycardia Pacing Modes

The available bradycardia pacing modes for each member of the Lumax ICD/CRT-D family are listed in Table 25.

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Table 25 Lumax Pacing Modes

Mode Lumax HF Lumax DR Lumax VR

DDDR X X N/A

DDIR X X N/A

VDDR X X N/A

VDIR X X N/A

AAIR X X N/A

VVIR X X X

DDD X X N/A

DDI X X N/A

VDD X X N/A

VDI X X N/A

AAI X X N/A

VVI X X X

OFF X X X

The basic rate timer is started by a sensed or paced event. A sensed event outside of the refractory period inhibits pacing and resets the lower rate time; in the absence of a sensed event, a pacing pulse will be delivered at the end of the lower rate interval.

The pacing modes with an “R” indicate rate adaptive pacing controlled by a motion based capacitive sensor. These modes are functionally the same as the corresponding non-rate-adaptive modes, except that the pacing rate is increased based on physical activity.

2.9.2 Basic Rate

The basic rate is the pacing rate in the absence of a patient’s intrinsic rhythm. This rate may be independently programmed for normal and post-shock bradycardia pacing.

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2.9.3 Night Rate

The night rate is the effective basic rate during the programmed “sleep” period for the patient. This parameter provides a different pacing rate during the patient’s normal sleep time in an attempt to match for example the decreased metabolic needs during sleep. When Night Mode is active, the basic rate automatically changes to the programmed NIGHT RATE during the nighttime hours.

At the programmed start time (Begin of Night), the rate gradually adapts to the night rate. When the internal clock reaches the programmed end time (End of Night), the pacing rate gradually changes to the programmed basic rate. The rate changes at the same rate as the Sensor Gain decrease and increase parameters.

NOTE:

The Night Mode time is based on the programmer clock. Therefore, the programmer time should be checked prior to device programming. If a patient travels across different time zones, the Night Mode time may require adjustment.

2.9.4 Rate Hysteresis

The ability to decrease the effective lower rate through Hysteresis is intended to preserve a spontaneous rhythm. The pulse generator operates by waiting for a sensed event throughout the effective lower rate interval (Hysteresis interval). If no sensed event occurs, a pacing pulse is emitted following the Hysteresis interval.

Hysteresis can be programmed OFF or to values as low as

-90 bpm of the basic rate. Hysteresis is initiated by a sensed event. The resulting Hysteresis rate is always less than the lower rate. The Hysteresis rate can only be programmed to provide a basic rate that is 30 bpm or greater.

NOTES:

If rate adaptation is active, the Hysteresis rate is based on the current sensor-indicated rate and the value of the programmable parameter.

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If Hysteresis is used in the DDI mode, the AV delay must be programmed shorter than the spontaneous AV conduction time. Otherwise, stimulation in the absence of spontaneous activity occurs at the hysteresis rate instead of the lower rate.

Night Rate is the limit for the Hysteresis when Night Mode is active. Programming conflicts arise when the total decrease in rate is below 30 ppm. Care should be exercised to avoid programming a Night Mode rate and hysteresis that are below what is appropriate and may be tolerated by the individual patient.

2.9.4.1 Repetitive Hysteresis

Repetitive hysteresis is expanded programmability of the Hysteresis feature. Repetitive hysteresis searches for an intrinsic cardiac rhythm, which may exist below the programmed lower rate (or sensor-indicated rate) of the patient. Following 180 consecutive sensed events, this feature allows the intrinsic rhythm to drop to or below the hysteresis rate. During the time when the intrinsic rate is at or below the hysteresis rate, pacing occurs at the hysteresis rate for the programmed number of beats (up to 10). Should the number of programmed beats be exceeded, the stimulation rate returns to the lower rate (or sensor-indicated rate).

If an intrinsic cardiac rhythm is detected within the programmed number of beats between the hysteresis rate and the lower rate, the intrinsic rhythm is allowed and inhibits the pulse generator.

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Figure 6. Repetitive Hysteresis

Repetitive hysteresis has been incorporated to promote spontaneous cardiac rhythm and may reduce pulse generator energy consumption.

NOTE:

Repetitive and Scan Hysteresis are only available when Hysteresis is selected on.

There is one Standard Hysteresis interval which occurs before the programmable number of Repetitive Hysteresis.

2.9.4.2 Scan Hysteresis

Scan hysteresis is expanded programmability of the Hysteresis feature. Scan hysteresis searches for an intrinsic cardiac rhythm, which may exist just below the programmed lower rate (or sensorindicated rate). Following 180 consecutive paced events, the stimulation rate is temporarily decreased to the hysteresis rate for a programmed number of beats. If a cardiac rhythm is not detected within the programmed number of beats at the hysteresis rate, the stimulation rate returns back to the original lower rate (or sensor-indicated rate). Several programmable beat intervals are available to allow a greater probability of detecting a spontaneous rhythm.

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If an intrinsic cardiac rhythm is detected within the programmed number of beats between the hysteresis rate and the lower rate, the intrinsic rhythm is allowed and the pulse generator inhibits.

Figure 7. Scan Hysteresis

Scan hysteresis has been incorporated to promote intrinsic cardiac rhythm and may reduce pulse generator energy consumption.

2.9.5 Dynamic AV Delay

DR and HF versions only

The AV Delay defines the interval between an atrial paced or sensed event and the ventricular pacing pulse. If the pulse generator is programmed to a dual chamber sensing mode, an intrinsic ventricular event falling within the AV Delay will inhibit the ventricular pacing pulse. If not contraindicated, a longer AV Delay can be selected to preserve intrinsic AV conduction.

Dynamic AV Delay is where the AV Delay is varied depending on the spontaneous atrial rate. Dynamic AV Delay provides a linear change of AV Delays depending on current rate at preset lower and upper AV Delay values.

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In addition to selecting the preset values (Low, Medium, and High) with the Dynamic AV Delay window, the Dynamic

AV Delays may be programmed individually (Individual) for each rate zone or to a fixed AV Delay (Fixed).

The AV Delay feature includes an AV Delay shortening option (Sense Compensation) for dual chamber pacing modes. When enabled, the AV Delay is shortened by the programmed value (5 to 60 ms) from the programmed AV Delay after an intrinsic atrial sensed event.

The Dynamic AV Delay is intended to mimic physiologicshortening of the AV Delay with increasing heart rate. It also serves for automatic prevention and termination of “circus movement” pacemaker mediated tachycardia and for prevention of reentrant supraventricular tachycardias. Dynamic AV Delay is available with the Lumax DR-T and HF-T ICDs/CRT-Ds.

2.9.5.1 Positive AV Hysteresis

Positive AV Hysteresis allows a user-programmable change in AV delay that is designed to encourage normal conduction of intrinsic signals from the atrium into the ventricles. With Positive AV hysteresis enabled, the AV delay is extended by a defined time value after sensing a ventricular event (10 … (10) …150 ms). The long AV interval is used as long as intrinsic ventricular activity is detected. The programmed short AV delay interval resumes after a ventricular paced event.

2.9.5.2 AV Repetitive Hysteresis

With AV Repetitive Hysteresis, the AV delay is extended by a defined hysteresis value after sensing an intrinsic ventricular event. When a ventricular paced event occurs, a long AV delay is used for the programmed number of cycles. (OFF, 1 … 10). If an intrinsic rhythm occurs during one of the repetitive cycles, the long duration AV delay interval remains in effect. If an intrinsic rhythm does not occur during the repetitive cycles, the original AV delay interval resumes.

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2.9.5.3 AV Scan Hysteresis

With AV Scan Hysteresis enabled, after 180 consecutive pacing cycles, the AV delay is extended for the programmed number of pacing cycles. (OFF, 1 … 10). If an intrinsic rhythm is detected within the extended AV delay and the longer AV delay remains in effect. If an intrinsic rhythm is not detected within the number of scan cycles, the original AV delay value resumes.

2.9.5.4 Negative AV Hysteresis

With Negative AV Hysteresis, the AV delay is decreased by a programmable value (10 … (10) …150 ms) after a ventricular event is sensed, thereby promoting ventricular pacing. The shorten AV interval is used for one time.

2.9.5.5 Negative AV Repetitive Hysteresis

With AV Repetitive Hysteresis and negative AV Hysteresis, the AV delay is shortened by a defined hysteresis value after sensing an intrinsic ventricular event as described above. The short AV Delay will retain until the programmed number of cycles has elapsed. (OFF,1 … 180). The normal AV delay resumes after the programmed number of consecutive ventricular paced events (Repetitive Negative AV Hysteresis) elapses.

CAUTION

Negative AV Hysteresis – This feature insures ventricular

pacing, a technique which has been used in patients with hypertrophic obstructive cardiomyopathy (HOCM) with normal AV conduction in order to replace intrinsic ventricular activation. No clinical study was conducted to evaluate this feature, and there is conflicting evidence regarding the potential benefit of ventricular pacing therapy for HOCM patients. In addition, there is evidence with other patient groups to suggest that inhibiting the intrinsic ventricular activation sequence by right ventricular pacing may impair hemodynamic function and/or survival.

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2.9.6 IOPT

DR versions only

The IOPT function serves to support the patient’s intrinsic rhythm and avoid excessive ventricular pacing. This feature simply activates all of the AV hysteresis parameters with a single selection. Table 26 details the settings that are preset when IOPT is turned ON:

Table 26 IOPT Parameters

Parameter IOPT

AV Hysteresis (max AV Delay) 400 ms AV Scan Hysteresis 5 Repetitive AV Hysteresis 5

2.9.7 Upper Tracking Rate

DR and HF versions only

In the atrial tracking modes (DDDR, VDDR, DDD, and VDD) ventricular pacing tracks atrial pace/sense events. The maximum tracking rate (ventricular pacing rate) is limited by the Upper Rate parameter.

The UTR response will automatically toggle between 2:1 and WKB (Wenkebach) depending on the relative programmed values for upper rate and atrial refractory period (AV Delay + PVARP).

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If the UTR is less than the maximum sensed atrial rate, defined by the atrial refractory period (60,000/ARP), the WKB response is utilized. Atrial rates exceeding the selected upper rate will result in a Wenckebach-type pacing pattern. This is accomplished by progressively lengthening the AV delay to keep the ventricular pacing rate at the upper rate. Lengthening of the AV interval is interrupted as soon as: 1) a P-wave falls within the atrial blanking period and is not detected; or 2) a succeeding P-wave is detected before the end of the AV delay previously started. In the second case, the corresponding ventricular pacing pulse is suppressed. If the atrial rate is just above the upper rate, a low degree (i.e. 6:5) block results. Higher atrial rates result in higher degrees of AV block until the intrinsic atrial cycle length violates the programmed atrial refractory period causing a 2:1 or greater block.

The 2:1 response is utilized when the rate defined by the atrial refractory period is less than the upper rate. In such a case, the maximum pacing rate is regulated by the inability to respond to P-waves falling within the atrial refractory period.

If the resulting length of the spontaneous atrial cycle is shorter than the atrial refractory period in a rate-adaptive mode, the resulting pacing rate will depend on whether the 2:1 rate has been exceeded. If this is the case, the pulse generator will use the sensor rate as the pacing rate. If the 2:1 rate is not exceeded, the pulse generator will use a rate that lies between the sensor rate and the rate determined by the atrial refractory period.

Atrial Upper Rate is designed to prevent pacing in the vulnerable period after an atrial sensed event during PVARP. It ensures that the next atrial pace is emitted outside of the patient’s normal sinus atrial refractory period. Atrial Upper Rate is limited to 240 ms or OFF.

NOTE:

Lumax DR ICDs and Lumax HF CRT-Ds allow the UTR to be programmed within the VT-1 zone. This feature is for patients that are active and have exercise and VT rates that overlap. This may be desirable in young active patients. Also, with RVsense Triggering programming the UTR in the VT-1 zone is blocked.

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