Medtronic 7289 Reference Guide

INSYNC II MARQUIS™ 7289

Dual Chamber Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy

Reference Manual

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

InSync II Marquis 7289

Reference Manual 0

A guide to the operation and programming of the Model 7289 InSync II Marquis Dual Chamber Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy

The following are trademarks of Medtronic:

Active Can Leadless™ ECG, Marker Channel, INSYNC

, Cardiac Compass, CareLink, Checklist, Flashback®,

, MARQUIS, Patient Alert,

PR Logic, Quick Look, QuickLink, RapidRead

Introduction 11

Abbreviations and acronyms 14

Part I Quick overview

1 Quick reference 19

Physical characteristics 20

Magnet application 21

Projected longevity 22

Replacement indicators 24

Typical charge times 25

High voltage therapy energy 25

Stored data and diagnostics 26

New and enhanced features 29

2 The InSync II Marquis system 31

System overview 32

Indications and usage 35

Contraindications 36

Patient screening 36

3 Emergency therapy 37

Delivering emergency therapies 38

Part II Device implant and patient follow-up procedures

4 Implanting the device 45

Overview 46

Preparing for an implant 46

Replacing an ICD 48

Surgical approach 49

Sensing and pacing measurements 53

Connecting the leads to the device 54

Testing defibrillation operation and effectiveness 57

Positioning and securing the device 62

InSync II Marquis 7289 Reference Manual

Table of contents

Completing the implant procedure 63

5 Conducting a patient follow-up session 65

Patient follow-up guidelines 66

Verifying the status of the implanted system 66

Verifying effective cardiac resynchronization therapy 67

Verifying effective basic pacing 68

Verifying accurate detection and appropriate therapy for ventricular tachyarrhythmias 69

Part III Configuring the device for the patient

6 Detecting tachyarrhythmias 73

Detection overview 74

Setting up sensing 77

Detecting VF episodes 83

Detecting VT episodes 88

Detecting FVT episodes 94

Detecting tachyarrhythmia episodes with Combined Count 99

Monitoring episodes for termination or redetection 102

Enhancing detection with PR Logic criteria 106

Enhancing VT detection with the Stability criterion 115

Detecting double tachycardias 118

Detecting prolonged tachyarrhythmias with High Rate Timeout 119

Key terms 121

7 Treating tachyarrhythmia episodes 127

Treating VF with defibrillation 128

Treating VT and FVT with antitachycardia pacing 138

Treating VT and FVT with cardioversion 148

Optimizing therapy with Smart Mode and Progressive Episode Therapies 157

Key terms 161

8 Treating ventricular dysynchrony and bradycardia 165

Providing basic pacing therapy 166

Dual chamber pacing 174

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Table of contents

Single chamber pacing 185

Promoting continuous CRT delivery 189

Rate adjustments to optimize cardiac output 200

Managing atrial tracking to optimize A-V synchrony 211

Providing Ventricular Safety Pacing 223

Key terms 226

9 Optimizing charge time and device longevity 231

Optimizing charge time 232

Optimizing device longevity 235

Key terms 236

Part IV Evaluating and managing patient treatment

10 Using the programmer 239

Connecting the programmer hardware 240

Using an external printer 241

Using the programming head 246

Display screen features 247

Setting programmer preferences 254

Starting and ending patient sessions 258

Viewing live waveforms 261

Recording live waveforms 268

Saving and retrieving device data 270

Printing reports 274

Key terms 277

11 Using system evaluation tools 279

A summary of system evaluation tools 280

Taking a quick look at device activity 281

Using the Patient Alert feature 283

Streamlining follow-ups with Checklist 291

Key terms 294

12 Setting up and viewing collected data 295

A summary of data collection 296

Viewing battery and lead status data 298

Printing rate histograms 303

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Table of contents

Viewing the Heart Failure Management report 306

Viewing clinical trends in the Cardiac Compass report 310

Viewing the episode and therapy efficacy counters 318

Viewing episode data 322

Viewing Flashback Memory 332

Setting up data collection 334

Viewing and entering patient information 340

Automatic device status monitoring 343

Key terms 345

13 Testing the system 349

Testing overview 350

Evaluating the underlying rhythm 350

Measuring pacing thresholds 351

Measuring lead impedance 354

Measuring EGM amplitude 356

Testing the device capacitors 358

Key terms 360

14 Conducting Electrophysiologic Studies 361

EP Study overview 362

Inducing VF with T-Shock 364

Inducing VF with 50 Hz Burst 367

Inducing an arrhythmia with Manual Burst 370

Inducing an arrhythmia with PES 373

Delivering a manual therapy 376

Key terms 379

15 Solving system problems 381

Overview 382

Solving cardiac resynchronization therapy problems 383

Solving sensing problems 386

Solving tachyarrhythmia detection problems 388

Solving tachyarrhythmia therapy problems 389

Responding to device status indicators 391

Key terms 392

InSync II Marquis 7289 Reference Manual

Part V Appendices

A Warnings and precautions 397

Warnings 398

Precautions 399

B Device parameters 409

Emergency settings 410

Pacing parameters 411

Detection parameters 414

Therapy parameters 416

System maintenance parameters 418

Data collection parameters 419

System test and EP study parameters 421

Fixed parameters 424

Patient information parameters 426

Programmer symbols 427

Parameter interlocks 429

C Device Programming Recommendations 431

Device programming recommendations 432

D Medtronic CareLink Programmer Model 2090 435

Introduction 436

Software feature update 436

Table of contents

Index 439

InSync II Marquis 7289 Reference Manual

Table of contents

InSync II Marquis 7289 Reference Manual

Introduction

Using this manual

Before implanting the device, it is strongly recommended that you:

■

Refer to the product literature packaged with the device for information about prescribing the device.

■

Thoroughly read this manual and the technical manuals for the leads and the implant tools used with the device.

■

Discuss the procedure and the device system with the patient and any other interested parties, and provide them with any patient information packaged with the device.

Required Physician Training

If a physician is not familiar with implantation or follow-up of Implantable Cardioverter Defibrillators (ICDs) with cardiac resynchronization systems, the physician is required to:

1. Thoroughly read this manual, and all associated device and/or lead technical manuals.

2. Provide a copy of the patient manual to the patient and discuss it with him or her and any other interested parties.

3. Be trained on the following topics:

■

Indications for use.

■

Device operation to ensure therapy delivery.

■

Measuring and managing biventricular thresholds.

■

Assembly and use of LV lead implant tools.

■

Placement of the LV lead.

■

Patient management and system follow-up.

Introduction

Medtronic will certify that physicians are trained prior to implanting the system.

InSync II Marquis 7289 Reference Manual

Introduction

Contacting technical support

References

Medtronic employs highly trained representatives and engineers located throughout the world to serve you and, upon request, to provide training to qualified hospital personnel in the use of Medtronic products.

In addition, Medtronic maintains a professional staff of consultants to provide technical consultation to product users. For medical consultation, Medtronic can often refer product users to outside medical consultants with appropriate expertise.

For more information, contact your local Medtronic representative, or call or write Medtronic at the appropriate address or telephone number listed on the back cover.

The primary reference for background information is Zacouto FI, Guize LJ. Fundamentals of Orthorhythmic Pacing. In: Luderitz B, ed. Cardiac Pacing Diagnostic and Therapeutic Tools. New York: Springer-Verlag; 1976: 212-218.

See these additional references for more background information:

■

Singer I, Ed. Implantable Cardioverter-Defibrillator. Armonk, NY: Futura Publishing Co. 1994.

■

Singer I, Barold SS, Camm AJ, Eds. Nonpharmacological Therapy of Arrhythmias for the 21st Century: The State of the Art. Armonk, NY: Futura Publishing Co. 1998.

■

Estes M, Manolis AS, Wang P, Eds. Implantable Cardioverter-Defibrillators. New York, NY: Marcel Dekker, Inc.

1994.

■

Kroll MW, Lehmann MH, Eds. Implantable Cardioverter-Defibrillator Therapy: The Engineering-Clinical Interface. Norwell, MA: Kluwer Academic Publishers 1996.

InSync II Marquis 7289 Reference Manual

Notice

Introduction

This software is provided as an informational tool for the end user. The user is responsible for accurate input of patient information into the software. Medtronic makes no representation as to the accuracy or completeness of the data input into the software. MEDTRONIC SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTIAL OR CONSEQUENTIAL DAMAGES TO ANY THIRD PARTY WHICH RESULTS FROM THE USE OF THE INFORMATION PROVIDED IN THE SOFTWARE.

InSync II Marquis 7289 Reference Manual

Introduction

Abbreviations and acronyms

A Atrial

AF Atrial Fibrillation

AFib/AFlutter Atrial Fibrillation and/or Atrial Flutter

AFR Conducted AF Response

ARP Atrial Refractory Period

ATR Atrial Tracking Recovery

ATP Antitachycardia Pacing

AVP Atrial Vulnerable Period

BOL Beginning of Life

bpm beats per minute

CNID Combined (VT and VF) Number of Intervals to Detect

CRT Cardiac Resynchronization Therapy

CV Cardioversion

DF/Defib Defibrillation

ECG Electrocardiogram

EGM Electrogram

EOL End of Life

ERI Elective Replacement Indicator

FDI Fibrillation Detection Interval

FTI Fast Ventricular Tachycardia Detection Interval

FVT Fast Ventricular Tachycardia

ICD Implantable Cardioverter Defibrillator

J joules

LV Left Ventricle

min

ms milliseconds

mV millivolts

NCAP Non-Competitive Atrial Pacing

NID Number of Intervals to Detect

NST Non-sustained Tachycardia

PAC Premature Atrial Contraction

PAV Paced A-V Delay

PES Programmed Electrical Stimulation

PMT Pacemaker-Mediated Tachycardia

P-P an atrial interval

ppm paces or pulses per minute

-1

reciprocal minutes; for example, pacing pulses per minute

InSync II Marquis 7289 Reference Manual

Introduction

P-R an interval between a P-wave and the subsequent R-wave

PVAB Post Ventricular Atrial Blanking period

PVARP Post Ventricular Atrial Refractory Period

PVC Premature Ventricular Contraction

RAAV Rate Adaptive A-V delay

RNID Number of Intervals to Redetect

R-P an interval between an R-wave and the subsequent P-wave

R-R a ventricular interval

RV Right Ventricle

SAV Sensed A-V Delay

ST/Sinus Tach Sinus Tachycardia

SVT Supraventricular Tachycardia

TARP Total Atrial Refractory Period

TDI Tachycardia Detection Interval

V volts

V Ven tr icular

VF Ventricular Fibrillation

VF NID VF Number of Intervals to Detect

VRS Ventricular Rate Stabilization

VSP Ventricular Safety Pacing

VSR Ventricular Sense Response

VT Ventricular Tachycardia

VT NID VT Number of Intervals to Detect

InSync II Marquis 7289 Reference Manual

Introduction

InSync II Marquis 7289 Reference Manual

Quick overview

Part I

InSync II Marquis 7289 Reference Manual

Physical characteristics 20

Magnet application 21

Projected longevity 22

Replacement indicators 24

Typical charge times 25

High voltage therapy energy 25

Stored data and diagnostics 26

New and enhanced features 29

Quick reference1

InSync II Marquis 7289 Reference Manual

Chapter 1

Physical characteristics

Table 1-1. InSync II Marquis physical characteristicsa

Volume 38 cc

Mass 77 g

H x W x D

Surface area of device can 66 cm

Radiopaque IDd

Materials in contact with human tissue

73 mm x 51 mm x 13.9 mm

PLU

Titanium / polyurethane / silicone rubber / silicone adhesive

Battery Lithium silver vanadium oxide

Connectors Three IS-1 connectors for pacing and

sensing, Two DF-1 connectors for high voltage therapy, Active Can electrode (programmable)

RV RV (HVB)

Can

SVC (HVX)

Device Port

SVC (HVX) DF-1 HVX

RV (HVB) DF-1 HVB

Can n/a HVA

RV IS-1bipolar RVtip and

Connector Type

Software Names

RVr ing

LV IS-1bipolar LVtip and

LV r in g

A IS-1 bipolar Atip and Aring

Suture holes

Measurements are nominal values based on CAD (computer aided design) model measurements and are rounded to the nearest unit.

Volume with connector holes unplugged.

Grommets may protrude slightly beyond the can surface.

Engineering series number follows the radiopaque code.

These materials have been successfully tested and verified for biocompatibility. The device does not produce an injurious temperature in the surrounding tissue.

InSync II Marquis 7289 Reference Manual

Magnet application

Bringing a magnet close to the device triggers changes in device operation as shown in Table 1-2. When the magnet is removed, the device returns to its programmed operations.

For information on demonstrating Patient Alert tones to the patient, see “Instructing the patient” on page 288.

Table 1-2. Effects of magnet application on the device

Pacing mode as programmed

Pacing rate and interval as programmed

VF, VT, and FVT detection suspended

Patient Alert audible tones (20 seconds or less)

Rate response adjustments are suspended while a Patient Alert tone sounds.

Detection resumes if telemetry is established and the application software is running, or it resumes after the application software has started.

Or “VF Detection/Therapy Off” is the only alert enabled.

Quick reference

Magnet application

■

high/low dual tone (high urgency alert occurred)

■

on/off intermittent tone (lower urgency alert occurred)

■

continuous test tone (no alert occurred)

■

no tone (alerts are disabled)

InSync II Marquis 7289 Reference Manual

Chapter 1

Projected longevity

Longevity estimates are based on accelerated battery discharge data and device modeling, EGM pre-storage off, with:

■

2.5 V atrial and RV pacing amplitude, 3 V LV pacing amplitude,

0.4 ms pulse widths, and 30 J delivered therapy energy (see Table 1-3)

■

3 V atrial and RV pacing amplitude, 4 V LV pacing amplitude,

0.4 ms pulse widths, and 30 J delivered therapy energy (see Table 1-4)

Considerations for using EGM pre-storage – When the EGM pre-storage feature is programmed off, the device starts to store EGM following the third tachyarrhythmia event and also provides up to 20 seconds of information before the onset of the tachyarrhythmia, including:

■

AA and VV intervals

■

Marker Channel

■

interval plot Flashback

When the EGM pre-storage feature is programmed on, the device also collects up to 20 seconds of EGM information before the onset of the arrhythmia.

In a patient who uniformly repeats the same onset mechanisms, the greatest clinical benefit of pre-onset EGM storage is achieved after a few episodes are captured. To maximize the effectiveness of the EGM pre-storage feature and optimize device longevity, consider these programming options:

■

Turn pre-storage on to capture possible changes in the onset mechanism following significant clinical adjustments, for example, device implant, medication changes, and surgical procedures.

■

Turn pre-storage off once you have successfully captured the information of interest.

InSync II Marquis 7289 Reference Manual

Quick reference

Projected longevity

Table 1-3. InSync II Marquis projected estimated longevity in years with 2.5 V atrial and right ventricular pacing amplitude, 3 V left ventricular pacing amplitude, and 0.4 ms pulse width; DDDR mode, 100% biventricular pacing with atrial tracking at 70 bpm (min-1).

Maximum energy charging frequency (30 J)

500 ohm pacing impedance

700 ohm pacing impedance

Semi-Annual 4.9 5.2

Quarterly 4.5 4.8

Maximum energy charging frequency may include full energy therapy shocks or capacitor formations.

Table 1-4. InSync II Marquis projected estimated longevity in years with 3 V atrial and right ventricular pacing amplitude, 4 V left ventricular pacing amplitude, and 0.4 ms pulse width; DDDR mode, 100% biventricular pacing with atrial tracking at 70 bpm (min

Maximum energy charging frequency (30 J)

500 ohm pacing impedance

-1

700 ohm pacing impedance

Semi-Annual 4.2 4.6

Quarterly 3.9 4.3

Maximum energy charging frequency may include full energy therapy shocks or capacitor formations.

The longevity of the device is dependent on several factors. The following factors result in decreased longevity:

■

an increase in pacing rate, pacing amplitude or pulse width; the ratio of paced to sensed events; or the charging frequency

■

a decrease in pacing impedance

■

using the pre-onset EGM storage feature or Holter telemetry

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Chapter 1

Replacement indicators

Battery voltage and messages about replacement status appear on the programmer display and on printed reports. Table 1-5 lists the Elective Replacement Indicator (ERI) and the End of Life (EOL) conditions.

Table 1-5. Replacement indicators

Elective Replacement (ERI) ≤ 2.62 V

End of Life (EOL) 3 months after ERI

ERI date – The programmer displays the date when the battery reached ERI on the Quick Look and Battery and Lead Measurements screens.

Temporary voltage decrease – The battery voltage temporarily decreases following a high voltage charge. If a battery measurement is taken immediately after a high voltage charge, the ERI or EOL indicator may be displayed. However, this is a temporary status which will return to normal when the battery has recovered from the charge.

EOL indication – If the programmer indicates that the device is at EOL, replace the device immediately.

Post-ERI conditions – EOL device status is defined as three months following an ERI indication assuming the following post-ERI conditions: 0% DDD atrial pacing, 100% DDD RV and LV pacing at 70 ppm (min for LV; 500 Ω pacing load; and six 30 J charges. EOL may be indicated before the end of three months if the device exceeds these conditions.

InSync II Marquis 7289 Reference Manual

-1

), 3 V, 0.4 ms for atrial and RV, 4 V, 0.4 ms

Typical charge times

The most recent capacitor charge time appears on the programmer display and on printed reports and can be evaluated using the Charge/Dump test (see Table 1-6).

Ta bl e 1 -6 . Ty pi c ala full energy charge times

At Beginning of Life (BOL) 5.9 seconds

At Elective Replacement (ERI) 7.5 seconds

These charge times are typical when the capacitors are fully formed.

High voltage therapy energy

The stored energy of the device is derived from the peak capacitor voltage and is always greater than the energy delivered by the device. Table 1-7 compares the programmed energy levels delivered by the device to the energy levels stored in the capacitors before delivery.

Quick reference

Typical charge times

InSync II Marquis 7289 Reference Manual

Chapter 1

Stored data and diagnostics

Table 1-7. Comparing delivereda (programmed) and storedb energy levels

Energy (J) Charge

Delivered a/

Stored

Programmed

30 35 5.9 8 9.4 1.6

28 33 5.6 7 8.3 1.4

26 31 5.2 6 7.1 1.2

24 28 4.7 5 5.9 1.0

22 26 4.4 4 4.7 0.8

20 24 4.0 3 3.6 0.6

18 21 3.5 2 2.4 0.4

16 19 3.2 1.8 2.2 0.4

15 18 3.0 1.6 2.0 0.3

14 16 2.7 1.4 1.7 0.3

13 15 2.5 1.2 1.5 0.3

12 14 2.4 1.0 1.2 0.2

11 13 2.2 0.8 1.0 0.2

10 12 2.0 0.6 0.8 0.1

911 1.9 0.40.5 0.1

Energy delivered at connector block into a 75 ohm load.

Energy stored on capacitor at end of charge.

Typical charge time at Beginning of Life (BOL) with fully formed capacitors, rounded to the nearest tenth of a second.

Timec(sec)

Delivered a/ Programmed

Energy (J) Charge

Timec (sec)

Stored

Stored data and diagnostics

Table 1-8. Stored data and diagnostics

Episode data

Tachy episodes 150 VF/VT/FVT episodes: intervals, text, EGM

EGM capacity for tachy episodes

SVT/NST episodes 50 SVT/NST episodes: intervals, text, EGM (the

InSync II Marquis 7289 Reference Manual

14 minutes of dual-channel EGM, or

23.5 minutes of single-channel EGM

device does not usually store detailed episode records for NST episodes)

Quick reference

Stored data and diagnostics

Table 1-8. Stored data and diagnostics (Continued)

EGM capacity for SVT/NST episodes

EGM sources 14 options: atrial / RV / LV / far-field

EGM options Store before onset; Store during charging

Flashback memory 2000 intervals and markers (containing both

Mode switch episodes 53 mode switch episodes (fastest, longest, first,

Ventricular sensing episodes

Counter data

Detection counters Lifetime total, since cleared, and since last

Episode counters Episodes:

2 minutes of dual-channel EGM, or 3.6 minutes of single-channel EGM

A-A and V-V): before latest VF, before latest VT, and before interrogation

and 50 latest): episode text

9 ventricular sensing episodes (longest, first, and 7 latest): intervals, markers, and counter data text

session

■

VF, FVT, and VT

■

Atrial Fibrillation / Atrial Flutter episodes

■

Sinus Tach episodes

■

Other 1:1 SVT episodes

■

NST episodes

■

Mode switch episodes

Percentage pacing:

■

AS-VS, AS-VP, AP-VS, AP-VP percentages

Additional counters:

■

Single PVCs and PVC runs

■

Rate stabilization pulses and runs

Therapy efficacy counters

Counts for each VF, FVT, VT Therapy:

■

Delivered

■

Successful

■

Unsuccessful

■

Intervention (manually aborted)

Total number of aborted shocks

Other stored data

Patient Alert events Up to 10 log entries: text and date for the first

time an alert is triggered between interrogations

InSync II Marquis 7289 Reference Manual

Chapter 1

Stored data and diagnostics

Table 1-8. Stored data and diagnostics (Continued)

Battery and lead measurements

Lead performance trends

Rate histograms

Cardiac Compass trends

Battery voltage, last capacitor formation, last charge, lead impedance, EGM amplitude measurements, last high voltage therapy, and sensing integrity counter

14 days of daily measurements plus 80 weeks of weekly minimum and maximum measurements:

■

Lead impedance: atrial pacing, RV pacing, LV pacing, defibrillation pathway, and SVC lead (if used)

■

EGM amplitude: atrial (P-waves), RV (R-waves)

■

Atrial rate

■

Ventricular rate

■

Ventricular rate during AT/AF

14 months of daily measurements:

■

VT and VF episodes per day

■

One or more high voltage therapy delivered

■

Ventricular rate during VT or VF

■

Episodes of non-sustained tachycardia per day

■

Heart rate variability

■

Total daily time in AT/AF

■

Ventricular rate during AT/AF

■

Percent pacing per day

■

Patient activity

■

Average day and night ventricular heart rate

InSync II Marquis 7289 Reference Manual

New and enhanced features

The following features are new or changed from the 7277 InSync Marquis ICD.

Patient management

Heart Failure Management Report – The HF report provides

counter, audit, and long term trend information about clinical status and device operation. Topics include tachyarrhythmia episodes, heart rate, percent pacing, and patient activity.

Rate Histograms Report – Rate histograms for atrial rate, ventricular rate, and ventricular rate during AT/AF episodes are provided upon interrogation.

Ventricular Sensing Episodes – This diagnostic tool provides reports on extended periods of ventricular sensing to help the clinician assess continuity of CRT delivery.

Quick reference

New and enhanced features

Cardiac resynchronization therapy

CRT recovery options – Three optional CRT features help to

maintain CRT:

■

Ventricular Sense Response provides ventricular pacing in response to ventricular sensing to ensure that CRT pacing is delivered as programmed.

■

Conducted AF Response dynamically adjusts and smooths the pacing rate to maintain ventricular pacing during conducted AT/AF episodes. (Conducted AF Response does not provide therapy for atrial arrhythmias.)

■

Atrial Tracking Recovery temporarily shortens PVARP to restore atrial tracking and CRT delivery when atrial events fall in the refractory period following a sensed ventricular event.

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Chapter 1

New and enhanced features

Other features

Independently programmable pacing outputs – Pacing

outputs for RV and LV are independently programmable

True bipolar RV sensing – Both integrated and true bipolar RV sensing are available.

Programmable LV pacing vector – LV pacing can be delivered from LVtip to LVring when a bipolar LV lead is implanted.

LV lead evaluation tools – The InSync II Marquis device provides new tools for specific monitoring of the left ventricular lead:

■

LV lead impedance trend

■

Patient Alert for LV lead impedance out of range

Added EGM sources – RVring EGM sources are available in addition to LVtip to LVring (for bipolar LV leads) and LVtip to SVC.

InSync II Marquis 7289 Reference Manual

The InSync II Marquis system2

System overview 32

Indications and usage 35

Contraindications 36

Patient screening 36

InSync II Marquis 7289 Reference Manual

Chapter 2

System overview

The Model 7289 InSync II Marquis Dual Chamber Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT+ICD) is an implantable medical device system that:

■

Provides biventricular pacing for cardiac resynchronization.

■

Automatically detects and treats episodes of ventricular tachyarrhythmia (ventricular fibrillation, ventricular tachycardia, and fast ventricular tachycardia).

■

Provides single or dual chamber pacing for patients requiring rate support.

The CRT+ICD system includes three major components: the CRT+ICD device, leads, and the programmer, software, and accessories. Each is described in detail below.

Device – The device senses the electrical activity of the patient’s heart via the sensing electrodes of the implanted atrial and ventricular leads. It then analyzes the heart rhythm based on selectable sensing and detection parameters. If the device detects a tachyarrhythmia, it delivers defibrillation, cardioversion, or antitachycardia pacing therapy to the patient’s heart. The device also can provide rate support if the patient requires it.

The device provides biventricular pacing for cardiac resynchronization for patients with heart failure and ventricular dysynchrony.

Leads – The device can be used with transvenous or epicardial defibrillation leads. The lead system should consist of bipolar or paired unipolar pacing/sensing leads in the right atrium and right ventricle of the heart, a pacing lead for the left ventricle, and one or two high voltage cardioversion/defibrillation electrodes. In addition to the lead system, the Active Can acts as one of the high voltage electrodes. The device delivers pacing and cardiac resynchronization therapy via the atrial (A), right ventricular (RV), and left ventricular (LV) leads. The device senses via the atrial and RV leads. Cardioversion/defibrillation therapy is delivered via two lead-based high voltage electrodes, or via the Active Can and one or two lead-based high voltage electrodes.

InSync II Marquis 7289 Reference Manual

The InSync II Marquis system

System overview

Programmer and software – The Medtronic 9790C1 programmer or Medtronic CareLink Programmer Model 2090 and Model 9989 application software allow you to:

■

Configure the cardiac resynchronization, arrhythmia detection and therapy, and bradycardia features for your patient.

■

Perform electrophysiological studies and system tests.

■

Monitor, display, or print patient cardiac activity information.

For information about:

■

indications, contraindications, warnings and precautions, see the Implant Manual, which accompanies each device.

■

basic programmer and software desktop functions that are not included in Chapter 10, “Using the programmer” on page 239, see the manual accompanying the programmer.

■

installing the 9767 or 9767L programming head, see the manuals accompanying the programming heads.

■

implanting leads and using implant tools, refer to the manuals accompanying the leads and implant tools.

Cardiac resynchronization

To improve cardiac output in patients with ventricular dysynchrony, the device provides biventricular pacing. The device paces the right ventricle, or right and left ventricles as programmed, unless pacing is inhibited by a sensed event in the RV.

■

Programmable LV pacing vector.

■

Optional CRT features promote sustained resynchronization pacing that could be interrupted during episodes of accelerated AV conduction, atrial rate excursions, PVCs, or atrial arrhythmia.

■

Pacing amplitudes and pulse widths are selected independently for each ventricle.

With the model 9767 or 9767L programming head

With the model 2067 programming head

InSync II Marquis 7289 Reference Manual

Chapter 2

System overview

Detecting and treating tachyarrhythmias

The device monitors the cardiac rhythm for short ventricular intervals that may indicate the presence of VF, VT, or FVT.

■

Upon detection of VF, the device delivers a biphasic defibrillation shock of up to 30 joules. If the VF episode persists, up to five more individually programmed defibrillation shocks can be delivered.

■

Upon detection of VT, the device delivers either a Ramp, Ramp+, or Burst antitachycardia pacing therapy or a biphasic cardioversion shock of up to 30 joules synchronized to a ventricular depolarization. If the VT episode persists, up to five more individually programmed VT therapies can be delivered. You can also program the device to monitor the VT episode without delivering therapy.

■

Upon detection of FVT, the device delivers either a Ramp, Ramp+, or Burst antitachycardia pacing therapy or a biphasic cardioversion shock of up to 30 joules synchronized to a ventricular depolarization. If the FVT episode persists, up to five more individually programmed FVT therapies can be delivered.

You can program the device to distinguish between true ventricular arrhythmias and rapidly conducted supraventricular tachyarrhythmias (SVT) and withhold therapy for SVT.

SVT discrimination includes the capability to detect a double tachycardia (an unrelated ventricular arrhythmia occurring simultaneously with an SVT), so that therapy is not withheld for a ventricular arrhythmia in the presence of an SVT.

Treating bradycardia

The device provides rate responsive pacing to optimize hemodynamics. An internal accelerometer senses the patient’s physical activity, allowing the device to increase and decrease the pacing rate in response to changes in the level of activity.

InSync II Marquis 7289 Reference Manual

Monitoring for real-time and stored data

The device and programmer provide real-time information on

detection and therapy parameters and status during a patient session. The device also provides accumulated data on device operation, including ventricular sensing episodes, stored electrograms, detected and treated tachyarrhythmia episodes, bradycardia interventions, and the efficacy of therapy. The Cardiac Compass report provides up to 14 months of clinically significant data, including physical activity, heart rate, percent pacing, arrhythmia episodes and therapies delivered.

All of this information can be printed and retained in the patient’s file or saved in electronic format on a floppy diskette.

Conducting electrophysiologic tests

You can use the system to conduct non-invasive electrophysiologic studies including manual delivery of any of the device therapies to manage an induced or spontaneous tachyarrhythmia.

The InSync II Marquis system

Indications and usage

Alerting the patient to system events

You can use the programmable Patient Alert monitoring feature to notify the patient with audible tones if certain conditions related to the leads, battery, charge time, and therapies occur. The patient can then respond based on your prescribed instructions.

Indications and usage

The InSync II Marquis Model 7289 is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction ≤ 35% and a QRS duration ≥ 130 ms.

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Chapter 2

Contraindications

Do not use the InSync II Marquis system in:

■

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 VT or VF.

■

Patients who have a unipolar pacemaker.

Because of the potential for damage to the device and/or induction of life-threatening arrhythmias, the use of the following techniques and/or therapies is contraindicated in patients who have an implanted InSync II Marquis:

■

Magnetic Resonance Imaging (MRI).

■

Hydraulic shock-wave lithotripsy.

Patient screening

Prior to implant, patients should undergo a complete cardiac evaluation, including electrophysiologic testing. Also, electrophysiologic evaluation and testing of the safety and efficacy of the proposed tachyarrhythmia therapies are recommended during and after the implantation of the device.

Other optional screening procedures could include exercise stress testing to determine the patient’s maximum sinus rate, and cardiac catheterization to determine if there is a need for concomitant surgery and/or medical therapy.

InSync II Marquis 7289 Reference Manual

Delivering emergency therapies 38

Emergency therapy3

InSync II Marquis 7289 Reference Manual

Chapter 3

Delivering emergency therapies

The device provides the following emergency therapies:

■

defibrillation

■

cardioversion

■

fixed burst pacing

■

emergency VVI pacing

The default emergency therapy is 30 joule defibrillation. When you select [Emergency] and [DELIVER], the device charges and delivers a biphasic 30 joule shock along the AX>B pathway

The programmer resets the emergency defibrillation energy to 30 joules each time you select [Emergency]. Emergency cardioversion and fixed burst values remain as selected for the duration of the session.

To return to other programming functions from an Emergency screen, select [Exit Emergency].

Effect on system operation

The device suspends the automatic detection features when emergency defibrillation, cardioversion, or fixed burst pacing therapies are delivered. Detection is not suspended during emergency VVI pacing. Removing the programming head or pressing [Resume] turns detection on again.

Aborting an emergency therapy

As a safety precaution, the programmer also displays an [ABORT] button which immediately terminates any emergency therapy in progress.

If Active Can is turned off, the defibrillation is delivered between the HVX and HVB electrodes.

InSync II Marquis 7289 Reference Manual

On-screen and display panel buttons

The on-screen [Emergency] button and the red mechanical Emergency button by the programmer display panel function the same at all times.

Red Emergency

Button

The on-screen [DELIVER] button and the yellow-on-blue mechanical Deliver button by the programmer display panel function the same during emergency operations only. The mechanical Deliver button operates only during emergency operations.

Emergency therapy

Delivering emergency therapies

Functions the same as on-screen [Emergency] button.

Ye l l o w - o n - b l u e

Deliver Button

Temporary parameter values

Emergency tachyarrhythmia therapies use temporary values that do not change the programmed parameters of the device. values are not in effect until you select [DELIVER]. After the tachyarrhythmia therapy is complete, the device reverts to its programmed values.

Functions the same as on-screen [DELIVER], but only during Emergency functions.

These

Delivery of Emergency VVI Pacing changes the programmed bradycardia pacing values to the emergency values (see page 42).

InSync II Marquis 7289 Reference Manual

Chapter 3

Delivering emergency therapies

How to deliver emergency 30 joule defibrillation

How to deliver emergency cardioversion

1. Position the programming head over the device.

2. Select [Emergency].

3. Accept the defibrillation energy shown on the screen, or select Energy and select a new value from the window.

4. Select [DELIVER]. If delivery is not confirmed,

verify that the programming head is properly positioned and select [Retry] or [Cancel].

1. Position the programming head over the device.

2. Select [Emergency].

3. Select [Cardioversion].

4. Accept the cardioversion energy shown on the screen, or select Energy and select a new value from the window.

5. Select [DELIVER]. If delivery is not confirmed,

verify that the programming head is properly positioned and select [Retry] or [Cancel].

InSync II Marquis 7289 Reference Manual

How to deliver emergency fixed burst pacing

Emergency therapy

Delivering emergency therapies

1. Position the programming head over the device.

2. Select [Emergency].

3. Select [Fixed Burst].

4. Accept the pacing interval shown on the screen, or select Interval for a new interval value.

5. Select [BURST Press and Hold].

If delivery is not confirmed, the programmer displays an error window. Verify that the programming head is properly positioned. Select [OK] from the window and reselect [BURST Press and Hold].

InSync II Marquis 7289 Reference Manual

Chapter 3

Delivering emergency therapies

How to deliver emergency VVI pacing

1. Position the programming head over the device.

2. Select [Emergency].

3. Select [VVI Pacing].

4. Select [PROGRAM]. A successful programming

sets the device to the following maximum output bradycardia pacing values.

■

Pacing Mode: VVI

■

Lower Rate: 70 ppm

-1

(70 min

■

RV. Amplitude: 6 V

■

RV. Pulse Width: 1.6 ms

■

V. Pace Blanking: 240 ms

■

V. Pacing: RV

■

V. Sense Response: Off

■

Cond AF Response: Off

■

Ventricular Rate

)

Stabilization: Off

InSync II Marquis 7289 Reference Manual

If programming is not confirmed, verify that the programming head is properly positioned and select [Retry] or [Cancel].

Part II

Device implant and patient follow-up procedures

InSync II Marquis 7289 Reference Manual

Implanting the device4

Overview 46

Preparing for an implant 46

Replacing an ICD 48

Surgical approach 49

Sensing and pacing measurements 53

Connecting the leads to the device 54

Testing defibrillation operation and effectiveness 57

Positioning and securing the device 62

Completing the implant procedure 63

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Chapter 4

Overview

The tasks for implanting a device include:

These tasks are described in the sections that follow.

Preparing for an implant

1. Preparing for an implant

2. Replacing an ICD

3. Surgical approach

4. Sensing and pacing measurements

5. Connecting the leads to the device

6. Testing defibrillation operation and effectiveness

7. Positioning and securing the device

8. Completing the implant procedure

Warning: Keep a back-up external defibrillator available during the implant for transthoracic rescue when arrhythmias are induced.

Do not permit the patient to contact grounded equipment that could produce hazardous leakage current during implantation. Resulting arrhythmia induction could result in the patient’s death.

The device is intended for implantation with Medtronic transvenous or epicardial leads. No claims of safety and efficacy can be made with regard to other non-Medtronic acutely or chronically implanted lead systems.

Equipment for an implant

■

Model 9790C programmer and Model 9767 or 9767L programming head, or Medtronic CareLink Programmer Model 2090 and Model 2067 programming head

■

9989 software application

■

8090 Analyzer lead analysis device or equivalent pacing system analyzer

InSync II Marquis 7289 Reference Manual

■

external defibrillator

■

5358 Defibrillator Implant Support Device and software application (optional)

Sterile supplies

■

InSync II Marquis and lead system components

■

Programming head sleeve or programming head

■

Analyzer cables

■

Lead introducers and/or delivery systems appropriate for the lead system

■

Extra stylets of appropriate length and shape

How to prepare for implanting

Set up the implant support instrument

When using an implant support instrument such as the 5358 Defibrillator Implant Support Device:

1. Calibrate any monitoring or recording equipment while recording the EGM and marker outputs of the support instrument.

2. Verify the high energy output of the support instrument by delivering a high energy defibrillation shock into the test load.

Implanting the device

Preparing for an implant

Set up the programmer and start the application

1. Set up the programmer as described in the instructions provided with the programmer.

2. Install the InSync II Marquis Model 9989 software on the programmer, if it is not already installed.

3. Place the programming head over the device and start the application. Select the device model or select [Auto identify].

Note: The programmer automatically interrogates the device when the application starts.

InSync II Marquis 7289 Reference Manual

Chapter 4

Replacing an ICD

Preprogram the device

Before opening the sterile package, prepare the device for implant as follows:

1. Check the “use by” date printed on the package. Do not implant the device after the “use by” date because the battery’s longevity could be reduced.

2. Interrogate the device and print a full summary report.

3. Confirm that the battery voltage is at least 3.0 V at room temperature.a

If the device temperature is lower than room temperature or has delivered a recent high voltage charge, the battery voltage will be temporarily lower.

4. Set up data collection parameters and the device internal clock (see page 336).

5. Perform a manual capacitor formation (see page 359).

6. Program the therapy and pacing parameters to values appropriate for the patient (see page 171). Ensure that all tachyarrhythmia detection is programmed Off (see page 74).

Use the Quick Look screen to verify the voltage; see page 282.

Replacing an ICD

If you are replacing a previously implanted ICD, turn off ICD detection and therapies before explanting.

When implanting the InSync II Marquis with a chronic lead system, perform the following evaluations to ensure appropriate detection and therapy:

■

Check the integrity of the chronic high voltage leads with a test shock, chest X-ray, and inspection.

■

Perform chronic pacing and sensing measurements.

■

Measure high voltage lead impedances.

■

Test defibrillation efficacy.

■

Confirm adequate sensing during VF.

■

Ensure proper fit of the lead connectors in the device connector block.

InSync II Marquis 7289 Reference Manual

Notes:

■

To meet the implant requirements, it may be necessary to reposition or replace the chronic leads or to add a third high voltage electrode.

■

Any unused leads that remain implanted must be capped.

How to explant and replace a device

1. Program all tachyarrhythmia detection Off.

2. Dissect the leads and the device free from the surrounding tissues in the surgical pocket. Be careful not to nick or breach the lead insulation during the process of exposing the system.

3. Loosen each setscrew, and gently retract the lead from the connector block.

4. Remove the device from the surgical pocket.

5. If the connector pin of any implanted lead shows signs of pitting or corrosion, replace the implanted lead with a new lead. The damaged lead should be discarded and replaced to assure the integrity of the device system.

6. Measure sensing, pacing, and defibrillation efficacy using the replacement device or an implant support instrument.

Implanting the device

Surgical approach

The InSync II Marquis system typically requires a left ventricular lead implant via the coronary sinus and positioned in a cardiac vein. For this reason, physicians should expect that implanting an InSync II Marquis system will require more time than implanting a traditional ICD or pacemaker system.

Device Implantation

In most cases the device is implanted in the pectoral region, either submuscularly or subcutaneously, using transvenous leads for pacing, sensing, and high voltage therapies.

Follow these single-incision guidelines when implanting the device in the pectoral region. The pocket should be about 1.5 times the size of the device.

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Chapter 4

Surgical approach

Lead configurations

■

Submuscular approach: A single incision that extends over the delta-pectoral groove can provide access to the cephalic and subclavian veins, and access to form the implant pocket. Place the device sufficiently medial to the humeral head to avoid interference with shoulder motion.

■

Subcutaneous approach: The subcutaneous approach can be similar to a pacemaker implant, using a single transverse incision long enough to permit isolation of the cephalic and subclavian veins. Place the device quite far medially to keep the leads away from the axilla, and keep the upper edge of the device inferior to the incision.

The device is typically implanted with the following leads:

■

One transvenous lead for the left ventricle (LV) for pacing.

■

One bipolar transvenous lead in the right ventricle (RV) for sensing, pacing, and cardioversion/defibrillation therapies.

■

One bipolar transvenous lead in the atrium (A) for sensing and pacing.

The InSync II Marquis is an Active Can system in which the device case serves as a high voltage electrode. The device case, the RV coil, and the SVC coil form a three electrode system for simultaneous mode defibrillation and cardioversion. High voltage therapies are delivered between the RV coil and the combined device case and SVC coil.

The device may be implanted with other transvenous leads. Refer to “Using other transvenous leads” on page 52 for more information.

Notes:

■

Medtronic 3.2 mm low-profile leads are not directly compatible with the device IS-1 connector block.

■

For questions about lead and device compatibility, please contact your Medtronic representative.

InSync II Marquis 7289 Reference Manual

Lead implantation

Implanting the device

Surgical approach

Note: Do not implant the LV, atrial, and RV leads in the same venous access site. Medtronic recommends implanting the LV lead via the subclavian vein, and the atrial and RV leads via the cephalic vein.

If inserting via a subclavian approach, position the lead laterally to avoid pinching the lead body between the clavicle and the first rib. Pinching the lead may eventually cause conductor fracture, damage to the insulation, or other damage to the lead. This may result in complications such as loss of detection, loss of pacing therapies, or loss of cardioversion/defibrillation therapy.

Certain anatomical abnormalities, such as thoracic outlet syndrome, may also cause pinching and subsequent fracture of the lead. If significant resistance is encountered during a subclavian stick implant procedure, do not force passage of the lead by adjusting the patient’s posture (by raising the arm or putting a towel behind the person’s back, for example). Use an alternate venous entry site instead.

Implanting the ventricular leads

Warning: Back-up pacing should be readily available during implant. Use of the delivery system and/or leads may cause heart block.

Note: Due to the variability of cardiac venous systems, the venous anatomy should be assessed prior to implantation of the LV lead to determine an optimal LV lead position. Before placing a lead in the coronary sinus, obtain a venogram.

For LV and RV lead implantation, follow the directions for use in the respective lead technical manuals.

Final lead positioning should attempt to optimize both cardiac resynchronization and defibrillation threshold.

Test for extracardiac stimulation from the LV lead when pacing at 10 V using an external pacing device. If present, consider repositioning the lead.

Implanting the right atrial lead

Implant the atrial lead via the cephalic vein, if possible. Follow the directions for use in the lead technical manual.

InSync II Marquis 7289 Reference Manual

Chapter 4

Surgical approach

Lead positioning

For the initial lead configuration the following positions are recommended:

LV tip electrode – As far laterally into the coronary venous system as possible (deflection of the LV EGM signal as late as possible in the QRS complex).

RV tip electrode – as far apically as possible (deflection of the RV EGM signal on the RV electrode should start early in the QRS complex). Defibrillation threshold, atrial far-field sensing and RV-LV timing have to be considered when choosing the optimal location.

Atrial tip electrode – The atrial tip electrode should be positioned close to the SA node or on lateral wall to minimize the possibility of far field R wave over sensing. Lead placement in these positions potentially provides optimal atrial sensing while reducing far field R-wave sensing.

Using other transvenous leads

Follow the general guidelines below for initial positioning of other transvenous leads (the final positions will be determined by defibrillation efficacy tests):

■

For an SVC lead, place the lead tip high in the innominate vein, approximately 5 cm proximal to the atrium (A) and SVC junction.

■

For an SQ patch lead, place the patch along the left midaxillary line, centered over the fourth-to-fifth intercostal space.

InSync II Marquis 7289 Reference Manual

Sensing and pacing measurements

Epicardial lead systems

The following guidelines should be observed:

■

The distance between the RVring electrode and the RVtip electrode should not exceed 1 cm.

■

The RVtip electrode should not lie in a direct path between epicardial patches.

■

The RVtip/RVring and Atip/Aring intrinsic, post-pace, and post shock electrograms should be thoroughly evaluated for oversensing, undersensing, cross-talk, and noise.

■

The pacing thresholds and electrogram characteristics should meet the values indicated in Table 4-1.

Sensing and pacing measurements

Sensing and pacing measurements include EGM amplitudes, slew rates, capture thresholds, and pacing lead impedances. Medtronic recommends using the Model 8090 Analyzer for sensing and pacing measurements. Refer to the Analyzer technical manual for detailed procedures on performing these measurements.

Implanting the device

Do not use the intracardiac EGM telemetered from the device to assess sensing.

Table 4-1 lists the acceptable implant values for acute and chronically implanted lead systems.

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Chapter 4

Connecting the leads to the device

Table 4-1. Acceptable Implant Values

Measurement required Acute Chronic

ARVLVARVLV

EGM amplitude (during NSR) ≥ 2 mV ≥ 5 mV ≥ 3 mV ≥ 1 mV ≥ 3 mV ≥ 1 mV

Slew rate ≥ 0.5 V/s ≥ 0.75 V/s NA ≥ 0.3 V/s ≥ 0.5 V/s NA

Capture threshold (0.5 ms pulse width)

Typical pacing lead impedance

≤ 1.5 V ≤ 1.0 V ≤ 3.0 V ≤ 3.0 V ≤ 3.0 V ≤ 4.0 V

250 - 1000 ohms

Verify adequate pacing threshold margins at implant and at each follow-up visit.

The measured pacing lead impedance is a reflection of measuring equipment and lead technology.

Please refer to specific lead technical manuals for acceptable impedance values.

Connecting the leads to the device

For more detailed information about lead/connector compatibility, see the device implant manual, or contact your Medtronic representative.

(all)

Table 4-2. Lead connections

RV RV (HVB) LV

Can

Warning: Loose lead connections may result in inappropriate sensing and failure to deliver necessary arrhythmia therapy.

InSync II Marquis 7289 Reference Manual

SVC (HVX)

Device Port

Connector Type

Software Name

SVC (HVX) DF-1 HVX

RV (HVB) DF-1 HVB

Can n/a HVA

IS-1 bipolar RVtip and

RVr ing

A IS-1 bipolar

IS-1 bipolar LVtip and LVring

Atip and Aring

Implanting the device

Connecting the leads to the device

Cautions:

■

To ensure appropriate sensing and detection, insert the right ventricular lead IS-1 connector into the RVport and insert the right ventricular lead DF-1 connector into the RV (HVB) port.

■

If no SVC electrode is implanted, the pin plug provided with the device must be secured in the SVC (HVX) port.

■

Use only the torque wrench supplied with the device. It is designed to prevent damage to the device from overtightening a setscrew.

■

Do not reuse the torque wrench after this implant.

■

Lead and Active Can electrodes in electrical contact with each other during a high voltage therapy could cause current to bypass the heart, possibly damaging the device and leads. While the device is connected to the leads, make sure that no therapeutic electrodes, stylets, or guidewires are touching or connected by an accessory low impedance conductive pathway. Move any objects that contain conductive materials (e.g., an implanted guidewire) well away from all electrodes before a high voltage shock is delivered.

Notes:

■

For easier lead insertion, insert the LV IS-1 leg before the other legs.

■

If a chronic lead system uses a different size or number of leads, insert the lead connector(s) into an appropriate adaptor. See the appropriate lead technical manuals for more details.

■

LVtip, RVtip, and RVcoil all need to be connected within the connector block to provide biventricular pacing.

InSync II Marquis 7289 Reference Manual

Chapter 4

Connecting the leads to the device

How to connect the lead to the device

1. Insert the torque wrench into the appropriate setscrew.

a. If the port is obstructed by the setscrew,

retract the setscrew to clear it. Take care not to disengage the setscrew from the connector block.

b. Leave the torque wrench in the setscrew

until the lead is secure. This allows a pathway for venting trapped air when the lead is inserted.

2. Push the lead or plug into the connector port until the lead pin is clearly visible in the pin viewing area. No sealant is required, but sterile water may be used as a lubricant.

3. Tighten the setscrew by turning clockwise until the torque wrench clicks.

4. Tug gently on the lead to confirm a secure fit. Do not tug on the lead until all setscrews have been tightened.

5. Repeat these steps for each connector port.

Post pace oversensing testing

Changes in the programmed ventricular pacing configuration (RV or RV+LV) may evoke slightly different EGMs. To ensure proper sensing regardless of the pacing configuration, or in the event of lead dislodgment or failure, the sensing behavior during pacing for all configurations should be evaluated as follows:

1. Program RV Pacing.

2. Print a 10-30 second test strip.

3. Check for post pace oversensing.

Repeat steps 1-3 with ventricular pacing programmed to RV+LV.

If oversensing occurs during one of the pacing configurations, repositioning of the RV lead may help alleviate the oversensing.

InSync II Marquis 7289 Reference Manual

Implanting the device

Testing defibrillation operation and effectiveness

To demonstrate reliable defibrillation effectiveness with the implanted lead system, use the ICD to complete one of the following tests:

■

Terminate two consecutively induced VF episodes using a delivered energy of 20 joules or less.

■

Use the binary search procedure to establish a defibrillation threshold (DFT) of 18 joules or less.

Note: An external defibrillation implant support instrument can also be used to test defibrillation effectiveness. For instructions, see the applicable documentation for the specific support instrument.

High voltage implant values

Measured values must meet the following requirements at implant.

Table 4-3. High voltage therapy values at implant

Measurement Acute or Chronic Leads

V. Defib impedance

SVC (HVX) impedance (if applicable)

Defibrillation threshold

20 - 200 ohms

≤ 20 J (two consecutive) or ≤ 18 J (binary search)

Binary search protocol

By testing defibrillation efficacy at successively lower energy levels, the binary search protocol provides an accurate threshold measurement. However, it generally requires more inductions and more time. Also, cumulative charging of the device capacitor affects the device longevity.

For most reliable defibrillation efficacy testing, allow at least five minutes between VF inductions. The device software provides an on-screen timer to record elapsed time since the last induction.

The timer appears on the 50 Hz Burst and T-Shock induction screens.

Warning: Ensure that an external defibrillator is charged for a rescue shock.

InSync II Marquis 7289 Reference Manual

Chapter 4

Testing defibrillation operation and effectiveness

Figure 4-1. Binary search protocol

If a two-electrode system fails to meet the implant criterion, consider implanting a third electrode and connecting it to the SVC (HVX) port. You can also evaluate the efficacy of ventricular tachycardia and atrial arrhythmia therapies after successfully completing ventricular defibrillation testing.

Start

First induced episode

Second induced episode

Third induced episode

Defibrillation Threshold

Success Failure

Success Failure FailureSuccess

3 J

Success Failure Success Failure Success Failure

<=3 J 6 J 9 J 15 J 18 J

6 J

9 J 15 J

Implant

Criterion Met

12 J

Success

Reprogram polarity, reposition the lead, or try a different lead

Tr y t o m e et

2 at 20 J

Failure

18 J

74binary.eps

InSync II Marquis 7289 Reference Manual

Testing defibrillation operation and effectiveness

How to prepare for defibrillation threshold testing

1. Place the programming head over the device, start a patient session, and interrogate the device, if you have not already done so.

2. Observe the Marker Channel telemetry annotations and the programmer ECG display to verify that the device is sensing properly.

3. Conduct a manual Lead Impedance Test lead connections. Perform this test with the device in the surgical pocket and keep the pocket very moist. If the impedance is out of range, perform one or more of the following tasks:

■

Recheck lead connections and electrode placement.

■

Repeat the measurement.

■

Inspect the EGM for abnormalities.

■

Measure the defibrillation impedance with a manual test shock.

4. Program the ICD or support instrument to properly detect VF with an adequate safety margin (1.2 mV sensitivity).

See “Measuring lead impedance” on page 354.

Implanting the device

to verify the defibrillation

InSync II Marquis 7289 Reference Manual

Chapter 4

Testing defibrillation operation and effectiveness

How to perform defibrillation threshold testing

7 8

1. Select Tests > EP Study.

2. Select either 50 Hz BURST or T-shock induction.

3. Select [Resume at BURST] or [Resume at DELIVER].

4. Select [Adjust Permanent...].

5. Program VF Enable On.

6. Program the automatic therapy energy settings. Therapies 2-6 should be set to the maximum energy.

7. Select [Program].

8. Select [Close].

InSync II Marquis 7289 Reference Manual

Implanting the device

Testing defibrillation operation and effectiveness

9. If performing a T-Shock induction, select the [Enable] checkbox.

10. Select [DELIVER], or [50 Hz BURST Press and Hold].

If necessary, you can abort an induction or therapy in progress

by pressing [ABORT].

11. Observe the live rhythm monitor for proper post-shock sensing.

12. If using the binary search protocol, use the [Adjust Permanent...] button to program the next appropriate energy level (see Figure 4-1).

13. Wait until the on-screen timer reaches 5 minutes, then repeat steps 9 through 12 as needed.

14. Select Params > Detection and program VF, FVT, and VT detection Off before closing.

InSync II Marquis 7289 Reference Manual

Chapter 4

Positioning and securing the device

Cautions: If no SVC electrode is implanted, the pin plug

provided with the device must be secured in the SVC (HVX) port.

Program tachyarrhythmia detection Off before closing.

How to position and secure the device

Suture Hole Locations

1. Ensure that each lead pin or plug is fully inserted into the connector block and that all setscrews are tight.

2. Coil any excess lead length beneath the device. Avoid kinks in the lead conductors.

3. Implant the device within 5 cm of the skin. This position optimizes the ambulatory monitoring operations.

4. Use non absorbable sutures to secure the device within the pocket to minimize post-implant rotation and migration of the device. Use a surgical needle to penetrate the suture holes.

InSync II Marquis 7289 Reference Manual

Completing the implant procedure

After implanting the device, X-ray the patient to verify the device and leads placement. To complete programming the device, select parameters that are appropriate for the patient.

How to complete programming the device

1. After closing the pocket, program detection On. Program ventricular tachyarrhythmia therapies On as desired.

2. Do not enable the Other 1:1 SVTs PR Logic detection criterion until the atrial lead has matured (approximately one month post implant).

3. If external equipment was used to conduct the defibrillation efficacy tests, perform a final VF induction, and allow the implanted system to detect and treat the arrhythmia.

4. Monitor the patient after the implant, and take X-rays as soon as possible to document and assess the location of the leads.

5. Program patient information. See “How to view and enter new patient information” on page 342.

6. Configure the Patient Alert feature. See “Using the Patient Alert feature” on page 283.

7. Set up data collection parameters. See “Setting up data collection” on page 334.

8. Interrogate the device after any spontaneous episodes to evaluate the detection and therapy parameter settings.

9. If the patient has not experienced spontaneous episodes, you may induce the clinical tachyarrhythmias using the non-invasive EP Study features to further assess the performance of the system. See Chapter 14, “Conducting Electrophysiologic Studies” on page 361.

10. Recheck pacing and sensing values, and adjust if necessary. See “Measuring pacing thresholds” on page 351.

Implanting the device

Completing the implant procedure

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Chapter 4

Completing the implant procedure

InSync II Marquis 7289 Reference Manual

Conducting a patient

follow-up session

Patient follow-up guidelines 66

Verifying the status of the implanted system 66

Verifying effective cardiac resynchronization therapy 67

Verifying effective basic pacing 68

Verifying accurate detection and appropriate therapy for ventricular tachyarrhythmias 69

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Chapter 5

Patient follow-up guidelines

Schedule regular patient follow-up sessions to monitor the condition of the device and leads and to verify that the device is configured appropriately for your patient.

During the first few months after receiving a new device, the patient may require close monitoring. Schedule an office visit at least every three months.

The Quick Look screen, which is displayed after you interrogate the device, provides a good beginning for the follow-up review. Using this screen you can:

■

Verify that the device is functioning correctly.

■

Verify that the device is delivering biventricular pacing most or all of the time.

■

Review the clinical performance and long term trends

■

Print appropriate reports to compare the results to the patient’s history and to retain for future reference.

For details about reviewing clinical trend data, see

“Viewing the Heart Failure Management report” on page 306.

“Viewing clinical trends in the Cardiac Compass report” on page 310.

Note: The Checklist feature displays a list of standard follow-up tasks on the programmer screen, for easy reference during the follow-up session. You can also customize your own checklists if you wish. See “Streamlining follow-ups with Checklist” on page 291 for more information.

Verifying the status of the implanted system

To verify that the device and leads are functioning correctly, review the following information from the Quick Look screen and perform follow-up tests as indicated:

■

Review the displayed battery voltage for comparison to the Elective Replacement Indicator value (see page 24). Remember that battery voltage may be low if high voltage charging has occurred within 24 hours.

InSync II Marquis 7289 Reference Manual

Conducting a patient follow-up session

Verifying effective cardiac resynchronization therapy

■

Review the last full energy charge.

– For information about adjusting the capacitor formation

interval, see “Optimizing charge time” on page 232.

– If the programmer displays an Excessive Charge Time ERI,

the device should be replaced immediately.

■

Review the defibrillation and pacing lead impedance values for inappropriate values or large changes since the last follow-up. See “Measuring lead impedance” on page 354.

■

Perform an EGM Amplitude test in the RV and atrium for comparison to previous EGM amplitude measurements. See “How to perform an EGM Amplitude test” on page 358.

■

To review longer term trends in sensing and impedance measurements, select the [>>] button from the lead performance area of the Quick Look screen. The programmer displays a detailed history of automatic sensing and impedance measurements. See “Taking a quick look at device activity” on page 281.

Verifying effective cardiac resynchronization therapy

To verify that the device is providing cardiac resynchronization therapy appropriately, review the following information from the initial interrogation report or Quick Look screen and investigate as indicated:

■

Confirm that the patient is receiving adequate cardiac support for daily living activities.

■

Review Quick Look Observations related to ventricular pacing percentage or ventricular sensing episodes.

■

Check the stored Ventricular Sensing Episode records for appropriate interventions and continuity of resynchronization pacing. See “Viewing episode data” on page 322.

■

Check the rate histograms for more information on atrial and ventricular pacing in general, and ventricular rates during AT/AF episodes.

■

Review the Heart Failure Management and Cardiac Compass reports for comparison to patient history (see “Viewing the Heart Failure Management report” on page 306).

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Chapter 5

Verifying effective basic pacing

Considerations

Review the following information before assessing resynchronization therapy.

■

Undersensing, far-field oversensing, or loss of capture are basic pacing issues that can affect delivery of cardiac resynchronization therapy. These situations can often be resolved with basic programming changes and then monitored for further occurrences.

■

If CRT delivery is lost during AF or during atrial rate excursions, consider the following programming options:

– basic programming changes to increase the Upper

Tracking Rate or decrease the total atrial refractory period (for information on total atrial refractory period, see “Programming considerations for atrial rates” on page 182.)

– enable Ventricular Sense Response, Atrial Tracking

Recovery, or Conducted AF Response to promote more continuous delivery of CRT.

Verifying effective basic pacing

To verify that the device is sensing and pacing appropriately, review the following information from the initial interrogation report and Quick Look screen and investigate as indicated:

■

Confirm that the patient is receiving adequate cardiac support for daily living activities.

■

Review the pacing conduction history and rate histograms for comparison to the patient history. A sharp increase in the atrial pacing percentage may indicate a need for investigation and analysis.

■

Review the recorded Mode Switch episodes for comparison to the patient’s atrial arrhythmia history (see page 322). A dramatic increase in frequency or duration of atrial episodes may indicate a need for investigation and analysis.

■

Review the Cardiac Compass report for comparison to patient history (see page 310).

■

Conduct pacing threshold tests (see page 351) to verify that the programmed pacing outputs provide a sufficient safety margin.

InSync II Marquis 7289 Reference Manual

Conducting a patient follow-up session

Verifying accurate detection and appropriate therapy for ventricular tachyarrhythmias

Considerations

Review the following information before verifying bradycardia pacing.

Atrial Pacing – If the conduction history or rate histograms shows a predominance of atrial pacing despite a healthy sinus response, consider these options to decrease the atrial pacing burden:

■

Decrease the Lower Rate.

■

Decrease the rate response or increase the activity threshold.

Conduction History – If the reported percentages in the conduction history do not add up to 100, the percentages may be rounded.

Verifying accurate detection and appropriate therapy for ventricular tachyarrhythmias

To verify that the device is providing effective tachyarrhythmia detection and therapy, review the following information from the Quick Look screen and investigate as indicated:

■

Review Quick Look Observations that relate to patient history and device operation. To display more detailed information about any observation, select the observation and then select the [>>] button.

■

Review any Patient alerts listed in the Observations of the Quick Look screen. For the most detailed information about Patient Alerts, select Patient Alert from the Data icon and select [Events].

■

Check stored episode records for appropriate sensing and detection of arrhythmias. See “Viewing episode data” on page 322.

■

Check stored SVT episode records for appropriate identification of SVTs.

Considerations

Review the following information before verifying detection and therapy.

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Chapter 5

Verifying accurate detection and appropriate therapy for ventricular tachyarrhythmias

Flashback memory – In addition to the episode text and stored electrograms, use Flashback memory and interval plots to help investigate the accuracy and specificity of ventricular detection.

Episode misidentification – If the episode records indicate that false detections have occurred, the Sensing Integrity counter may help in determining the prevalence of oversensing. For more information, see “Sensing integrity counter” on page 302.

If the device is oversensing, consider these programming options:

■

Increase the Pace Blanking value.

■

Increase the sensitivity threshold.

Caution: Do not re-program the device to decrease oversensing without assuring that appropriate sensing is maintained. See “Setting up sensing” on page 77.

If the episode records reveal that a stable monomorphic VT has been identified and treated as VF, consider these options to improve the detection accuracy:

■

Review the Interval Plot for the episode, and adjust VF Interval, if necessary. Use caution when reprogramming the VF Interval, because changes to this value can adversely affect VF detection.

■

Consider enabling FVT via VF detection. See “Detecting FVT episodes” on page 94.

If the SVT episode records include episodes of true VT, review the SVT episode record to identify the SVT detection criterion that withheld detection. Adjust the SVT detection criteria parameters as necessary. See “Enhancing detection with PR Logic criteria” on page 106 and “Enhancing VT detection with the Stability criterion” on page 115.

InSync II Marquis 7289 Reference Manual

Part III

Configuring the device for the patient

InSync II Marquis 7289 Reference Manual

Detecting tachyarrhythmias6

Detection overview 74

Setting up sensing 77

Detecting VF episodes 83

Detecting VT episodes 88

Detecting FVT episodes 94

Detecting tachyarrhythmia episodes with Combined Count 99

Monitoring episodes for termination or redetection 102

Enhancing detection with PR Logic criteria 106

Enhancing VT detection with the Stability criterion 115

Detecting double tachycardias 118

Detecting prolonged tachyarrhythmias with High Rate Timeout 119

Key terms 121

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Chapter 6

Detection overview

The device detects ventricular tachyarrhythmias (VF, VT, and FVT) by comparing the time intervals between sensed ventricular events to a set of programmable detection intervals. If enough intervals occur that are shorter than the programmed intervals, the device detects a tachyarrhythmia, and responds automatically with a programmed therapy. After delivering the therapy, the device either redetects the arrhythmia and delivers the next programmed therapy or detects episode termination.

To avoid detecting rapidly conducted SVTs (for example, sinus tachycardia or atrial fibrillation) as ventricular tachyarrhythmias, the device provides several detection enhancements, including PR Logic and Stability detection criteria.

Figure 6-1 shows how all of these detection features interact during initial detection. During redetection, the device does not apply the PR Logic detection criterion.

Note: Detection functions can be turned off by programming the VF Enable, FVT Enable, and VT Enable parameters to Off. For an example, see ““How to program VF detection” on page 85.

InSync II Marquis 7289 Reference Manual

Detecting tachyarrhythmias

Figure 6-1. How detection features interact during initial detection

Detection overview

Ye s

No / suspended by High Rate Timeout

Ye s

Update counts and pattern information

Has High Rate Timeout suspended detection

Does Stability reset the VT event count?

Are one or more PR Logic criteria on?

Is the median ventricular interval less than the SVT

Ventricular Event

Is the interval in the

VF, FVT, or VT detection zone?

Ye s

enhancements?

(VT and FVT via VT detection only)

Has a tachyarrhythmia event count

reached an NID?

Ye s

Limit?

Ye s

Tachy

Episode

Detected

Ye s

Is there a double tachycardia in progress?

Are one or more PR Logic criteria withholding

detection?

InSync II Marquis 7289 Reference Manual

Ye s

Chapter 6

Detection overview

Suspending tachyarrhythmia detection

When detection is suspended, the device temporarily stops classifying and counting tachyarrhythmia intervals. Sensing and programmed pacing remain active, and the programmed detection settings are not modified.

Detection is suspended:

■

When the device senses the presence of a strong magnet. The programmer head contains a magnet which suspends detection, but once telemetry between the device and programmer is established, detection resumes.

■

While performing any of the manual system tests, including Underlying Rhythm, Pacing Threshold, Lead Impedance, EGM Amplitude, and Charge/Dump. Detection automatically resumes once the test is complete.

■

While performing a T-Shock, 50 Hz Burst, Manual Burst, or PES Induction. You can choose to have the device automatically resume detection after delivering the induction.

■

When you deliver a Manual or Emergency therapy. You can resume detection by selecting the [Resume] button or removing the programming head from the device.

■

When you select the on-screen [Suspend] button. You can resume detection by selecting the [Resume] button or by removing the programming head from the device.

■

During the automatic daily lead impedance measurements. Detection resumes when the measurements are complete.

■

While the device is delivering an automatic tachyarrhythmia therapy (including capacitor charging for defibrillation and cardioversion). However, the device does continue to confirm the detected episode during charging. Detection resumes when the therapy is complete.

Note: The device suspends VT detection (and Combined Count detection; see page 99) for 17 events following a defibrillation therapy delivered in response to a detected VF.

■

During charging for Automatic Capacitor Formation. Detection resumes when charging is complete.

If the defibrillation therapy is delivered as a result of a High Rate Timeout “Skip to VF Therapy” operation, VT detection is not suspended (see page 121).

InSync II Marquis 7289 Reference Manual

Setting up sensing

The device provides bipolar sensing in both the atrium and right ventricle via the sensing electrodes of the implanted atrial and RV leads. You can adjust the sensitivity to intracardiac signals using independent atrial and ventricular sensitivity settings. These settings define the minimum electrical amplitude recognized by the device as an atrial or ventricular sensed event.

Proper sensing is essential for the safe and effective use of the device. To provide appropriate sensing, the device uses:

■

auto-adjusting atrial and ventricular sensing thresholds

■

short (30 ms) cross-chamber blanking after paced events

■

no cross-chamber blanking after sensed events

See details about sensing on page 80.

Parameters

V. Sensitivity (mV) – Minimum amplitude of

electrical signal that registers as a sensed ventricular event.

Detecting tachyarrhythmias

Setting up sensing

* Medtronic nominal setting

0.15, 0.3*, 0.45, 0.6,

0.9, 1.2

Considerations

A. Sensitivity (mV) – Minimum amplitude of

electrical signal that registers as a sensed atrial event.

0.15, 0.3*, 0.45, 0.6,

0.9, 1.2, 1.5, 2.1

Review the following information before programming sensing parameters.

Dual chamber sensing and pacing modes – The device senses in both the atrium and the right ventricle at all times, except when the programmed bradycardia pacing mode is DOO. When the pacing mode is programmed to DOO or VOO mode, there is no sensing in the ventricle

. In order to program either DOO or

VOO mode, you must first disable detection.

Atrial sensing occurs in VOO mode.

InSync II Marquis 7289 Reference Manual

Chapter 6

Setting up sensing

Sensitivity thresholds – The programmed atrial and ventricular sensitivity thresholds apply to all features related to sensing, including detection and bradycardia pacing.

Bradycardia pacing and sensing – A combination of high pacing pulse width or high amplitude with a low sensitivity threshold may cause inappropriate sensing across chambers or in the same chamber. Programming a lower pulse width, lower amplitude, longer pace blanking, or a higher sensitivity threshold may eliminate this inappropriate sensing.

Recommended ventricular sensitivity threshold – A ventricular sensitivity threshold of 0.3 mV is recommended to maximize the probability of detecting VF and to limit the possibility of oversensing and cross-chamber sensing.

High ventricular sensitivity threshold – Setting V. Sensitivity to a value greater than 0.6 mV is not recommended except for testing. Doing this may cause undersensing, which can cause any of the following situations:

■

delayed or aborted cardioversion therapy

■

delayed defibrillation therapy (when VF confirmation is active)

■

asynchronous pacing

■

underdetection of tachyarrhythmias

Low ventricular sensitivity threshold – If you set V. Sensitivity to its most sensitive value of 0.15 mV, the device will be more susceptible to EMI, cross-chamber sensing, and oversensing.

Recommended atrial sensitivity threshold – An atrial sensitivity threshold of 0.3 mV is recommended to optimize the effectiveness of PR Logic detection criteria and atrial pacing operations, while limiting the possibility of oversensing and cross-chamber sensing.

High atrial sensitivity threshold – If you set the A. Sensitivity value too high, the device may not provide reliable sensing of P-waves during SVTs and sinus rhythm.

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Detecting tachyarrhythmias

Setting up sensing

Low atrial sensitivity threshold – If you set the A. Sensitivity value to its most sensitive value of 0.15 mV, the device will be more susceptible to EMI, far-field R-wave sensing, and oversensing.

Testing sensitivity after reprogramming – If you change the ventricular sensitivity threshold, evaluate for proper sensing and detection by inducing VF and allowing the device to automatically detect and treat the arrhythmia.

Atrial pacing and ventricular sensing – If you program the device to an atrial pacing mode, make sure that it does not sense atrial pacing pulses as ventricular events.

Sensing during VF – Always verify that the device senses properly during VF. If the device is not sensing or detecting properly, program detection and therapies off, and evaluate the system (making sure to monitor the patient for life-threatening arrhythmias until you enable detection and therapies again). You may need to reposition or replace the ventricular sensing lead to achieve proper sensing.

Atrial lead selection – Atrial leads with minimal tip-to-ring spacing may reduce far-field R-wave sensing.

Repositioning the atrial lead – You may need to reposition or replace the atrial sensing lead if reprogramming the atrial sensitivity threshold does not provide reliable atrial sensing during SVTs and sinus rhythm.

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Chapter 6

Setting up sensing

How to program sensitivity

1. Select Params > Detection.

2. Select the desired A. Sensitivity and V. Sensitivity parameters.

3. Select [PROGRAM].

Details about sensing

Auto-adjusting sensitivity thresholds

The device automatically adjusts the sensitivity thresholds after certain paced and sensed events to help reduce oversensing from T-waves, cross-chamber events, and pacing. Figure 6-2 shows how sensitivity thresholds are adjusted after different types of events.

InSync II Marquis 7289 Reference Manual

Detecting tachyarrhythmias

Setting up sensing

Figure 6-2. Auto-adjusting sensitivity thresholds

Sensitivity Threshold

V P

74Autoadjust.eps

1 2

Rectified and

Filtered A. EGM

Rectified and

Filtered RV EGM

Marker Channel

A S

V S

A P

V S

1 After an atrial sensed event, the atrial sensitivity threshold

increases to 75% of the EGM peak (maximum: 8x the programmed value, decay constant: 200 ms).

2 After a ventricular sensed event, the ventricular sensitivity threshold

increases to 75% of the EGM peak (maximum: 8x the programmed value, decay constant: 450 ms).

3 After an atrial paced event, the device does not adjust the atrial

sensitivity threshold. The ventricular sensitivity threshold increases by 0.45 mV (decay constant: 60 ms).

4 After a ventricular paced event, the atrial sensitivity threshold

increases to 4x the programmed value (maximum: 1.8 mV, immediate return after 60 ms).

5 After the ventricular pace blanking period is finished, the ventricular

threshold increases to 4.5x the programmed value (maximum:

1.8 mV, decay constant: 450 ms).

The exponential decay continues through a subsequent ventricular pacing pulse and its blanking period.

If the programmed sensitivity value exceeds 0.3 mV (ventricular) or 1.2 mV (atrial), the threshold is not adjusted.

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Chapter 6

Setting up sensing

Blanking periods

During a blanking period, the device does not sense electrical signals. This helps prevent sensing of device pacing, cardioversion and defibrillation pulses, post-pacing depolarization, T-waves, and multiple sensing of the same event. The blanking periods following paced events are longer than those following sensed events to avoid sensing the atrial and ventricular depolarizations.

Notes:

■

To enhance sensing and detection during tachyarrhythmias, the device does not apply cross-chamber blanking (blank sensing in the opposite chamber) after a sensed event.

■

Atrial sensing is still active during the Post-Ventricular Atrial Blanking (PVAB) period (see “Post-Ventricular Atrial Blanking Period” on page 181).

Table 6-1 shows the duration of the fixed blanking periods. For information on programmable pace blanking periods, see page 167.

Table 6-1. Fixed blanking periods

Cross-chamber blanking after atrial or ventricular pacing pulse 30 ms

Atrial blanking after sensed atrial event 100 ms

Ventricular blanking after sensed ventricular event 120 ms

Atrial and ventricular blanking after delivered cardioversion or defibrillation therapy

InSync II Marquis 7289 Reference Manual

520 ms

Refractory periods

During a refractory period, the device senses normally, but classifies sensed events as refractory and limits its response to these events. Pacing refractory periods prevent inappropriately sensed signals, such as far-field R-waves (ventricular events sensed in the atrium) or electrical noise, from triggering certain pacing timing intervals.

Synchronization refractory periods help prevent the device from delivering cardioversion and defibrillation therapies at inappropriate times. See “Synchronizing defibrillation without confirming VF” on page 132 and ““Synchronizing cardioversion after charging” on page 153.

Note: Refractory periods do not affect tachyarrhythmia detection.

Detecting VF episodes

The device detects VF episodes by examining the cardiac rhythm for short ventricular intervals. If a predetermined number of intervals occurs that are short enough to be considered VF events, the device detects VF and delivers the first programmed VF therapy. After therapy, the device continues to evaluate the ventricular rhythm to determine if the episode is ongoing.

Detecting tachyarrhythmias

Detecting VF episodes

Parameters

See details about VF detection on page 86.

VF Detection Enable – Turns VF detection on or off.

VF Interval (rate) (ms) – V-V intervals shorter than this value are counted as VF events.

VF Initial NID – Number of Intervals to Detect: number of VF events the device must count to detect a VF episode.

VF Redetect NID – Number of Intervals to Redetect: number of VF events the device must count to redetect a continuing VF after a therapy.

InSync II Marquis 7289 Reference Manual

* Medtronic nominal setting

On*, Off

240, 250, . . ., 320* , . . .,400

12/16, 18/24*, 24/32, 30/40, 45/60, 60/80, 75/100, 90/120, 105/140, 120/160

6/8, 9/12, 12/16*, 18/24, 21/28, 24/32, 27/36, 30/40

Chapter 6

Detecting VF episodes

Considerations

Review the following information before programming VF Detection parameters.

Warning: To ensure proper VF detection, you should not program the VF Interval less than 300 ms.

VF Interval minimum setting – To ensure proper VF detection, you should not program the VF Interval less than 300 ms.

VF Interval maximum setting – Programming the VF Interval to a value greater than 350 ms may cause inappropriate detection of rapidly conducted atrial fibrillation as VF or FVT via VF. Intervals shorter than the VF Interval are counted using the VF event counter, which is more sensitive than the consecutive VT event counter.

VF, FVT, and VT Intervals – To allow for normal variations in the patient’s tachycardia interval, you should program the VF, FVT, and VT intervals at least 40 ms apart.

Episode redetection – You can expedite redetection by programming the VF and VT Redetect NIDs lower than the Initial NIDs.

Enabling VF detection – When VF Detection Enable is programmed On for the first time, the device

■

enables Automatic Capacitor Formation

■

starts recording Cardiac Compass data

■

starts recording lead performance trends (starting at 3:00 AM, by the device clock)

■

clears all brady pacing counters

VF detection and PR Logic criteria – You can program the device to exclude rapidly conducted SVTs from VF Detection by enabling the PR Logic detection criteria. Note that the SVT Limit must be programmed shorter than the VF Interval in order for the PR Logic criteria to affect VF detection. See “Enhancing detection with PR Logic criteria” on page 106.

InSync II Marquis 7289 Reference Manual

Double tachycardia detection – When any PR Logic detection criteria are enabled, the device also enables double tachycardia detection (VF, VT, or FVT in the presence of an SVT). See “Detecting double tachycardias” on page 118.

Restrictions

Review the following information before programming VF Detection parameters.

Tachyarrhythmia detection and pacing – To ensure reliable ventricular tachyarrhythmia detection, the programmer regulates the values available for pacing and tachyarrhythmia detection. See “Parameter interlocks” on page 429.

VF detection backup – To ensure VF Detection backup during VT and FVT episodes, if VF Detection is off, both VT Detection and FVT Detection must also be off.

How to program VF detection

Detecting tachyarrhythmias

Detecting VF episodes

To program VF detection:

1. Select Params > Detection.

2. Select the desired values for VF Enable, VF Initial NID, VF Redetect NID, and VF Interval.

3. Select [PROGRAM].

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Chapter 6

Detecting VF episodes

Details about VF detection

The device detects VF by counting the number of VF events, which are V-V intervals shorter than the programmed VF Interval. On each event, the device counts the number of recent VF events. The number of recent events examined is called the VF detection window. The size of the VF detection window is the second number in the programmed VF NID (for example, 24 events if the VF Initial NID is 18/24).

The threshold for detecting VF is the first number in the programmed VF NID (for example, 18 events if the VF Initial NID is 18/24). This threshold is always 75% of the VF detection window. That is, if 75% of the events in the VF detection window are VF events, the device detects a VF episode (see Figure 6-3).

After the device detects VF, it delivers the first programmed VF therapy. Following the therapy, if the number of VF events reaches the programmed VF Redetect NID, the device redetects VF and delivers the next programmed VF therapy.

Note: The device can also detect VF Episodes via the Combined Count detection criterion (see page 99).

InSync II Marquis 7289 Reference Manual

Figure 6-3. Device detects VF

ECG

Detecting tachyarrhythmias

Detecting VF episodes

1 2 3

A S

A R

Marker Channel

FSFSFSFSFSFSFSFSFSF

VSVSV

VF Event Count

V S

FSFSF

V S

1 2 3 4 5 6 6 7 8 9 10 11 12 13 14 15 16 17 18

FSFSF

VF Interval

200 ms

1 VF starts, and the device begins counting VF events (intervals less than the programmed

VF Interval).

2 A ventricular interval occurs outside the VF detection zone. The VF event count is not

incremented.

3 The VF event count reaches the programmed VF NID value of 18 events out of 24, and the

device detects VF.

74VFDetection.eps

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Chapter 6

Detecting VT episodes

Parameters

The device detects VT episodes by examining the cardiac rhythm for short ventricular intervals. If enough intervals occur that are short enough to be considered VT events (but are not VF or FVT events), the device detects VT and delivers the first programmed VT therapy. After therapy, the device continues to evaluate the ventricular rhythm to determine if the episode is ongoing.

You can program the device to detect and record VT episodes without treating them with VT therapies by setting VT Detection Enable to Monitor. If a patient’s VT episodes are well-tolerated, this feature allows you to collect data about these episodes without delivering therapy or affecting VF detection.

See details about VT detection on page 90.

* Medtronic nominal setting

VT Detection Enable – Turns VT detection on or off, or enables VT monitoring.

On, Off*, or Monitor

VT Interval (Rate) (ms) – V-V intervals shorter than this value are counted as VT events.

VT Initial NID – Number of Intervals to Detect: number of VT events the device must count to detect a VT episode.

VT Redetect NID – Number of Intervals to Redetect: number of VT events the device must count to redetect a continuing VT after a therapy.

Considerations

Review the following information before programming VT Detection parameters.

VF, FVT, and VT Intervals – To allow for normal variations in the patient’s tachycardia interval, you should program the VF, FVT, and VT intervals at least 40 ms apart.

InSync II Marquis 7289 Reference Manual

280, 290, . . ., 400*, . . ., 600

12, 16*, . . ., 52, 76, 100

4, 8, 12*, . . ., 52

Detecting tachyarrhythmias

Detecting VT episodes

Episode redetection – You can expedite redetection by programming the VF and VT Redetect NIDs lower than the Initial NIDs.

VT Detection Enable, AFib/AFlutter, and Sinus Tach – When you set VT Detection Enable to On or Monitor, the AFib/AFlutter and Sinus Tach parameters are also automatically set to On.

VT detection and Combined Count detection – When VT Detection is On, the device applies the Combined Count detection criterion to help speed detection of rhythms that fluctuate between detection zones. Combined Count detection is disabled if VT Detection is set to Off or Monitor. See “Detecting tachyarrhythmia episodes with Combined Count” on page 99.

VT detection and rapidly conducted SVTs – You can program the device to exclude rapidly conducted SVTs from VT detection by enabling the PR Logic or Stability detection criteria. See “Enhancing VT detection with the Stability criterion” on page 115, and “Enhancing detection with PR Logic criteria” on page 106.

Restrictions

Double tachycardia detection – When any PR Logic detection

criteria are enabled, the device also enables double tachycardia detection (VF, VT, or FVT in the presence of an SVT; see page 118).

Review the following information before programming VT detection parameters.

VF detection backup – To ensure VF Detection backup during VT and FVT episodes, if VF Detection is off, both VT Detection and FVT detection must also be off.

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Chapter 6

Detecting VT episodes

How to program VT detection

Details about VT detection

To program VT detection:

1. Select Params > Detection.

2. Select the desired values for

VT Enable, VT Initial NID, VT Redetect NID, and VT Interval.

3. Select [PROGRAM].

The device detects VT by counting the number of consecutive VT events. A VT event is a V-V interval shorter than the programmed VT Interval but greater than or equal to the VF Interval. If the number of consecutive VT events reaches the programmed VT Initial NID, the device detects VT (see Figure 6-4).

The VT event count resets to zero whenever an interval occurs that is greater than or equal to the programmed VT Interval. The count remains at the current value if an interval is shorter than the programmed VF Interval.

After the device detects VT, it delivers the first programmed VT therapy. Following the therapy, if the VT event counter reaches the VT Redetect NID, the device redetects VT and delivers the next programmed therapy.

Note: The device can also detect VT Episodes via the Combined Count detection criterion (see page 99).

InSync II Marquis 7289 Reference Manual

Figure 6-4. Device detects VT

ECG

132

Detecting tachyarrhythmias

Detecting VT episodes

A S

ARARARARARARA

Marker Channel

VT Event Count

V S

VSV

T S

10123456

TSTSTSTSTST

VT Interval

ECG

ARARARARARARARARARARARA

Marker Channel

T D

V S

74VTDetection.eps

VT Event Count

TSTSTSTSTSTSTSTST

78910111213141516

VT Interval

200 ms

1 VT starts, and the device begins counting VT events (intervals less than the programmed

VT Interval, but greater than or equal to the VF Interval).

2 A ventricular interval occurs outside VT detection zone. The VT event count resets to zero.

3 The VT event count reaches the programmed VT NID of 16 events, and the device

detects VT.

InSync II Marquis 7289 Reference Manual

Chapter 6

Detecting VT episodes

VT monitoring

You can program the device to record VT episodes without delivering VT therapy by setting VT detection to Monitor. When VT monitoring is enabled, the device detects VT episodes but does not deliver VT therapy (see Figure 6-5). Instead, it records VT episodes, labeling them as “monitored,” and waits for episode termination to occur.

When VT detection is set to Monitor, several detection operations work differently.

VT event counting – Before the device detects an episode, it counts VT events normally. However, once the VT Initial NID is reached, the device sets the VT event count to zero and suspends VT event counting for the rest of the episode.

VF and FVT detection – VF and FVT detection operate as if VT detection is off. Specifically, Combined Count detection is disabled, and FVT via VT detection is not selectable. If a monitored VT episode accelerates into the FVT or VF detection zone, the device applies the VF Initial NID to detect the new tachyarrhythmia. Once an episode is in progress, VT event counting doesn’t resume until the episode ends.

Caution: Programming the VF Interval greater than 350 ms may result in inappropriate detection of rapidly conducted atrial fibrillation as VF or FVT via VF. Intervals shorter than the VF Interval are counted using the VF event counter, which is more sensitive than the consecutive VT event counter.

PR Logic and Stability criteria – Before the device detects a tachyarrhythmia episode, the PR Logic and Stability criteria, if turned on, are applied. If a monitored VT episode accelerates into the FVT or VF detection zone, the device continues to apply PR Logic criteria as initial VF or FVT detection begins. However, since Stability affects neither VF detection nor FVT via VF detection, it is not applied.

Episode termination – The device compares ventricular intervals to the VT Interval to identify when a VT monitored episode has ended. However, if a VF episode or FVT via VF episode occurs when VT monitoring is enabled, the device compares ventricular intervals to the VF Interval to identify episode termination.

InSync II Marquis 7289 Reference Manual

Figure 6-5. Device detects and monitors VT

ECG

Detecting tachyarrhythmias

Detecting VT episodes

2 31

A S

ARARA

ARARARARA

A R

Marker Channel

VT Event Count

V S

VSTSTSTST

1234

TSTSTSTDTSTST

13 14 15 16 0 0 0

74VTmonitor.eps

VT Interval

200 ms

1 VT starts, and the device begins counting VT events (intervals less than the programmed

VT Interval but greater than or equal to the VF Interval).

2 The VT event count reaches the programmed VT NID of 16 events, and the device

detects VT.

3 After detecting the VT episode, the device resets the VT event count to zero and monitors

the episode until termination.

InSync II Marquis 7289 Reference Manual

Chapter 6

Detecting FVT episodes

Parameters

The device detects episodes of Fast Ventricular Tachycardia (FVT) by examining the cardiac rhythm for short ventricular intervals. If enough intervals occur in the programmed FVT detection zone, the device detects FVT and delivers the first programmed FVT therapy. After therapy, the device continues to evaluate the ventricular rhythm to determine if the episode is ongoing. To make sure it delivers sufficiently aggressive therapies, the device can merge the programmed detection zones during redetection to increase sensitivity.

See details about FVT detection on page 96.

* Medtronic nominal setting

FVT Detection Enable – Enables FVT detection via the VF or the VT detection algorithm.

Off*, via VF, or via VT

Considerations

FVT Interval (Rate) (ms) – V-V

intervals between this value and the programmed VF Interval are marked as FVT events.

200, 210, . . ., 600

Review the following information before programming FVT Detection parameters.

VF, FVT, and VT Intervals – To allow for normal variations in the patient’s tachycardia interval, you should program the VF, FVT, and VT intervals at least 40 ms apart.

Episode redetection – You can expedite redetection by programming the VF and VT Redetect NIDs lower than the Initial NIDs.

InSync II Marquis 7289 Reference Manual

Detecting tachyarrhythmias

Detecting FVT episodes

FVT detection enable – Your choice for an appropriate setting for FVT Detection should depend on the patient’s VF and VT cycle lengths. After determining a reliably sensitive VF Interval, consider the following suggestions:

■

If the patient presents with a clinical VT interval in the VF zone, select via VF to ensure reliable detection of VF. (VT Detection need not be enabled at all.)

■

If the patient presents with two clinical VTs, both outside the VF zone, select via VT to allow for correct classification of the faster VT and to offer a separate therapy regimen for each VT.

■

If the patient presents with only one clinical VT which is outside the VF zone, select VF and VT Detection only, and set FVT Enable to Off.

FVT detection and PR Logic criteria – You can program the device to exclude rapidly conducted SVTs from FVT Detection by enabling the PR Logic detection criteria. Note that the SVT Limit must be programmed shorter than the VF Interval for the PR Logic criteria to affect FVT via VF detection.

Restrictions

Double tachycardia detection – When any PR Logic detection

criteria is enabled, the device also enables double tachycardia detection (VF, VT, or FVT in the presence of an SVT, see page 118).

Review the following information before programming FVT Detection parameters.

Tachyarrhythmia detection and bradycardia pacing – To ensure reliable ventricular tachyarrhythmia detection, the programmer regulates the values available for bradycardia pacing and tachyarrhythmia detection. See “Parameter interlocks” on page 429.

VF detection backup – To ensure VF Detection backup during VT and FVT episodes, VT and FVT Detection cannot be on unless VF Detection is also on.

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Chapter 6

Detecting FVT episodes

How to program FVT detection

FVT detection – To ensure reliable ventricular tachyarrhythmia

detection, the programmer regulates the values available for the FVT parameter as follows:

■

VT Detection must be set to On if FVT Detection is set to via VT.

■

If FVT Detection is set to via VF, the FVT Interval must be programmed to a value shorter than the VF Interval.

■

If FVT Detection is set to via VT, the FVT Interval must be programmed to a value greater than the VF Interval and less than or equal to the VT Interval.

To program FVT detection:

1. Select Params > Detection.

2. Select the desired values for FVT Enable and FVT Interval.

3. Select [PROGRAM].

Details about FVT detection

You can program the device to detect FVT episodes via the VF or VT detection zone and NID.

When FVT Detection is set to via VF, a V-V interval within the FVT detection zone is marked as an “FVT via VF” event. When the VF NID is reached, the device reviews the last eight intervals:

■

If any of the last eight intervals are in the VF zone, it detects the episode as VF.

■

If all of the last eight intervals are outside the VF zone, it detects the episode as FVT (see Figure 6-6).

InSync II Marquis 7289 Reference Manual

When FVT Detection is set to via VT, a V-V interval within the FVT detection zone is marked as an “FVT via VT” event. When the VT NID is reached, the device reviews the last eight intervals:

■

If any of the last eight intervals are in the VF or FVT zones, it detects the episode as FVT.

■

If all of the last eight intervals are outside the FVT and VF zones, it detects the episode as VT.

Note: The device can also detect FVT episodes via the Combined Count detection criterion (see page 99).

Figure 6-6. Device detects FVT via VF

Detecting tachyarrhythmias

Detecting FVT episodes

1 2

ECG

A S

ARARA

A R

ARARARARARARARARA

Marker Channel

VF Event Count

V S

TFTFTFT

1 12345

TFT

TFTFTFTFTFV

13 14 15 16 17 18

VF and FVT Intervals

1 A fast ventricular tachycardia starts, and the first event falls into the FVT detection zone.

2 The second event of the FVT episode has an interval that falls into the VT zone. The VF

event count is not incremented.

3 The device detects FVT after the VF event count reaches the VF Initial NID.

74FvtDetect.eps

200 ms

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Chapter 6

Detecting FVT episodes

Figure 6-7. FVT zone merging

Zone merging after detection

To ensure the device delivers sufficiently aggressive therapies during an extended or highly variable tachyarrhythmia episode, the device merges detection zones during redetection in some instances, as shown in Figure 6-7. The merged zone configuration uses the event counting and therapies for the faster arrhythmia and remains in effect until episode termination.

FVT set to “via VF” FVT set to “via VT”

Before detection:

After VF detection:

After FVT detection:

FVT

VF and FVT zones merge, leaving a larger VF zone.

FVT

VT and FVT zones merge, leaving a larger FVT zone.

FVT

All zones remain unchanged. VT and FVT zones merge, leaving a

larger FVT zone.

FVT

Detection Intervals: VF Interval: 320 ms, FVT Interval: 280 ms / 360 ms , VT Interval: 400 ms

FVT

FVT1.eps

FVT2.eps

FVT3.eps

InSync II Marquis 7289 Reference Manual

Detecting tachyarrhythmias

Detecting tachyarrhythmia episodes with Combined Count

Because the device counts VF and VT events separately, rhythms with variable cycle lengths can cause both event counts to increment during an episode. To prevent these rhythms from delaying detection, the device automatically enables the Combined Count detection criterion if both VF and VT detection are programmed On.

The Combined Count criterion compares the sum of the VF and VT event counts to the Combined Number of Intervals to Detect (CNID), which the device calculates automatically from the programmed VF NID values. If the CNID is met, the device reviews the recent intervals to determine if the episode should be treated as a VF, FVT, or VT episode. The Combined Count criterion applies during both initial detection and redetection.

Details about Combined Count detection

The Combined Count detection algorithm expedites detection or redetection of ventricular tachyarrhythmias with ventricular intervals that fluctuate between the VF and VT detection zones. When VT detection is on, the device applies Combined Count detection, which tracks the combined number of VT and VF events counted. If this sum reaches the Combined Number of Intervals to Detect (CNID), the device detects VF, FVT, or VT. Combined Count detection also applies to redetected episodes.

Note: Combined Count detection is off when VT detection is set to Monitor or Off.

If the VF event counter reaches six, the device automatically applies the Combined Number of Intervals to Detect (CNID). The CNID is calculated by multiplying the current VF NID (Initial or Redetect) by 7/6 and rounding down. Table 6-2 shows the CNID values that correspond to each VF NID value.

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100

Chapter 6

Detecting tachyarrhythmia episodes with Combined Count

Table 6-2. CNID values for each initial or redetect VF NID value

VF NID CNID VF NID CNID VF NID CNID

6/8 7 24/32 28 75/100 87

9/12 10 27/36 31 90/120 105

12/16 14 30/40 35 105/140 122

18/24 21 45/60 52 120/160 140

21/28 24 60/80 70

Combined Count detection is fulfilled when the sum of the VF and VT event counts equals or exceeds the CNID. The device then reviews the last eight intervals and classifies the episode as

■

VF, if any of the last eight were in the VF zone.

■

FVT, if FVT Detection is enabled and none of the last eight was in the VF zone, but one or more was in the FVT zone.

■

VT, if all eight were outside the VF zone (and FVT zone, if FVT detection is enabled).

InSync II Marquis 7289 Reference Manual

Medtronic 7289 Reference Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of contents

Introduction

Abbreviations and acronyms

Quick overview

Quick reference1

Physical characteristics

Magnet application

Projected longevity

Replacement indicators

Typical charge times

High voltage therapy energy

Stored data and diagnostics

New and enhanced features

The InSync II Marquis system2

System overview

Indications and usage

Contraindications

Patient screening

Emergency therapy3

Delivering emergency therapies

Device implant and patient follow-up procedures

Implanting the device4

Overview

Preparing for an implant

Replacing an ICD

Surgical approach

Sensing and pacing measurements

Connecting the leads to the device

Testing defibrillation operation and effectiveness

Positioning and securing the device

Completing the implant procedure

Patient follow-up guidelines

Verifying the status of the implanted system

Verifying effective cardiac resynchronization therapy

Verifying effective basic pacing

Verifying accurate detection and appropriate therapy for ventricular tachyarrhythmias

Configuring the device for the patient

Detecting tachyarrhythmias6

Detection overview

Setting up sensing

Detecting VF episodes

Detecting VT episodes

Detecting FVT episodes

Detecting tachyarrhythmia episodes with Combined Count