Boston Scientific CRMN11906 Implantable Defibrillator User Manual Cognis Part 3 Manual

Boston Scientific Corporation Implantable Defibrillator Cognis Part 3 Manual

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PACING THERAPIES

VENTRICULAR TACHY SENSING INTERACTIONS 5-65

When the programming interaction described in this scenario is present, a

message will describe the interaction of Tachy Rate Threshold with LRL and

AV Delay. Similar messages may describe the interaction of V-Blank After

A-Pace with MTR, MPR, or LRL. Along with each message, the pertinent

programmable parameters are displayed to assist you in resolving the

interaction. Programming Dynamic VRP can be useful in resolving these

types of interactions.

Programming Considerations

Certain programmed combinations of pacing parameters are known to interfere

with ventricular tachy detection. The risk of ventricular tachy undersensing

due to device refractory periods is indicated by the interactive warnings on

the parameter screen.

As with all device programming, you should evaluate the beneﬁts and the

risks of the programmed features for each patient (for example, the beneﬁt

of Rate Smoothing with a long AV Delay versus the risk of ventricular tachy

undersensing).

The following programming recommendations are provided to reduce the risk

of ventricular undersensing due to the refractory period caused by an atrial

pace (V-Blank after A-Pace):

• If a dual-chamber pacing mode with Rate Smoothing or Rate Adaptive

Pacing is necessary:

– Reduce the LRL

– Shorten the AV Delay or use Dynamic AV Delay and reduce the

minimum Dynamic AV Delay setting

– Increase the Down Rate Smoothing percentage to the largest possible

value

– Decrease the recovery time for Rate Adaptive Pacing modes

– Reduce the MTR or MPR if Down Rate Smoothing is on

– Reduce the MSR if the pacing mode is rate adaptive

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5-66 PACING THERAPIES

VENTRICULAR TACHY SENSING INTERACTIONS

• If Rate Smoothing or Rate Adaptive Pacing are not required for the patient,

consider programming these features Off. Programming these features Off

can reduce the likelihood of atrial pacing at elevated rates.

• If atrial pacing is not required for the patient, consider using VDD rather

than DDD pacing mode.

• In certain usage scenarios, you may elect to program long AV Delays to

reduce ventricular pacing for patients with long PR intervals, while providing

sensor pacing or rate smoothing to address other patient needs.

• In certain usage scenarios, if a pattern of atrial pacing and VT beats is

detected, the AV delay is automatically adjusted to facilitate conﬁrmation

of a suspected VT. If no VT is present, the AV delay is returned to the

programmed value. For programming scenarios where the automatic AV

delay adjustment may occur, a speciﬁc Parameter Interaction Attention

will not be displayed.

For discussion of details and additional information regarding these or other

programmed settings, please contact Technical Services at the 24-Hour

Consultation phone number on the back of this manual.

In summary, when programming the pulse generator pacing and tachy

detection parameters, it is useful to consider the possible interactions of these

features in light of the expected arrhythmias of a particular patient. In general,

the interactions will be brought to your attention through Parameter Interaction

Attention messages on the PRM screen and can be resolved by reprogramming

the pacing rate, AV delay, and/or refractory/blanking periods.

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6-1

SYSTEM DIAGNOSTICS

CHAPTER 6

This chapter contains the following topics:

• "Battery Status" on page 6-2

• "Lead Tests" on page 6-6

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6-2 SYSTEM DIAGNOSTICS

BATTERY STATUS

Pulse generator battery summary information is displayed on the Summary

screen. The Summary screen contains the following components:

• Time Remaining—screen area with the following items:

– Battery status gauge—displays a visual indication of the battery

capacity status, from BOL to explant recommendation

– Approximate Time To Explant––displays the approximate time at which

explant is recommended based on the pulse generator’s programmed

parameters and recent usage history

• Charge Time––displays the amount of time it took the pulse generator

to charge for the most recent maximum-energy shock or capacitor

re-formation

• Battery Detail icon—when selected, this icon displays the Battery Detail

screen

Battery Status Indicators

The following battery status indicators appear in the battery status gauge. All

indicated longevity projections are calculated based on the pulse generator’s

programmed parameters.

• BOL—the pulse generator’s battery is at full capacity.

• One Year Remaining—the pulse generator’s battery has approximately

one year of full function remaining.

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SYSTEM DIAGNOSTICS

BATTERY STATUS 6-3

• Explant—the pulse generator’s battery is nearing depletion and the pulse

generator has reached the point at which explant is recommended. This

status indicates that pulse generator replacement must be scheduled.

Once Explant status is reached there is sufﬁcient battery capacity to

monitor and pace 100% under existing conditions for three months and to

deliver six maximum-energy shocks. Once the battery capacity is depleted,

pulse generator functionality is degraded.

Once the battery capacity is depleted, the following occurs:

– Number of zones reverts to one ventricular zone (VF) with a rate

threshold of 165 bpm

– ATP therapy and low-energy shocks are unavailable

– The programmed mode reverts to VVI/BiV

– LRL defaults to 50 ppm

– The following features are disabled:

– RF telemetry

– Daily measurement trends

– Brady enhancement features

– Episode storage

– Diagnostic and EP tests

– Device programming (Brady Mode and Ventricular Tachy Mode can

be programmed to Off)

– Telemetry interrogation (using a wand) is still available and manual

capacitor re-formation can be selected.

If the device reaches a point where insufﬁcient battery capacity is available

for continued operation, the device will revert to Storage Mode.

NOTE: The device uses the programmed parameters and recent usage

history to predict time to Explant. Greater than normal battery usage may

result in the subsequent day’s approximate time to Explant to appear less

than expected.

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6-4 SYSTEM DIAGNOSTICS

BATTERY STATUS

Battery Detail Summary Screen

The Battery Detail summary screen provides the following information about

pulse generator battery status (Figure 6-1 on page 6-5):

• Last Delivered Shock––date, energy, charge time, and shock impedance

data

• Beep When Explant Is Indicated––if this feature is programmed to On, the

pulse generator emits 16 beeping tones every six hours after it reaches the

Explant indicator. The tone can then be programmed to Off. Once the

battery capacity is depleted, Beep When Explant Is Indicated is enabled by

the device.

CAUTION: Patients should be advised to contact their physician

immediately if they hear tones coming from their device.

• Last Capacitor Re-form––date and charge time

• Manual Re-form Capacitor––this feature is used to command a capacitor

re-formation when needed.

• Charge Remaining (measured in ampere-hours)––the amount of charge

remaining based on the pulse generator’s programmed parameters until

the battery is depleted.

• Power Consumption (measured in microwatts)––the amount of power being

consumed by the battery based on the pulse generator’s programmed

parameters.

• Power Consumption longevity impact––compares the power consumption

at the pulse generator’s currently programmed parameters with the power

consumption of the parameters used to quote device longevity.

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SYSTEM DIAGNOSTICS

BATTERY STATUS 6-5

Figure 6-1. Battery Detail summary screen

Capacitor Re-formation

Automatic Capacitor Re-form. Capacitor deformation may occur during

periods when no shocks are delivered, resulting in longer charge times. To

reduce the effect of capacitor deformation on charge time, the capacitors are

automatically re-formed. Tones will not be emitted from the pulse generator

during automatic capacitor re-formations (even if the Beep During Capacitor

Charge feature is programmed to On). During a capacitor re-formation, the

Charge Time is measured and stored for later retrieval.

Manual Capacitor Re-form. Manual capacitor re-forms are not necessary, but

may be commanded via the PRM as follows:

1. Select the Manual Re-form Capacitor button on the Battery Detail screen

and ensure that telemetry communication is established. A message

will appear indicating that the capacitors are charging. Warbling tones

from the pulse generator (if the Beep During Capacitor Charge feature is

programmed to On) will sound while the capacitors are charging.

2. The entire re-form cycle typically takes less than 15 seconds. After

completion of the cycle, the capacitor energy is delivered to the pulse

generator’s internal test load. The initial Charge Time is displayed on the

Battery Detail screen.

Charge Time Measurement

The pulse generator measures the Charge Time whenever its capacitors

charge. The last measured value is stored in pulse generator memory and

displayed by the PRM system on the Battery Detail screen.

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6-6 SYSTEM DIAGNOSTICS

LEAD TESTS

Last Delivered Ventricular Shock

When a shock has been delivered to the patient, the following information

from the last shock delivered is stored in the pulse generator’s memory and

displayed on the Battery Detail screen:

•Date

• Energy level

•Chargetime

• Shocking lead impedance

This does not include auto capacitor re-forms or shocks that may have been

diverted. If a fault condition is encountered (i.e., high or low impedance), the

fault will be indicated so that corrective action may be taken.

NOTE: For shocks of 1.0 J or less, the accuracy of the impedance

measurement decreases.

LEAD TESTS

The following lead tests are available (Figure 6-2 on page 6-6):

• Pace Impedance

• Shock Impedance

• Intrinsic Amplitude

• Pace Threshold

Figure 6-2. Lead Tests screen

Lead tests can be accessed by using the following steps:

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SYSTEM DIAGNOSTICS

LEAD TESTS 6-7

1. From the main screen, select the Tests tab

2. From the Tests screen, select the Lead Tests tab

All lead tests may be performed following two different processes:

• ViatheLeadTestsscreen––allowsyoutoperformthesameleadtests

across all chambers

• By selecting the desired chamber button––allows you to perform all tests

onthesamelead

Intrinsic Amplitude Test

The intrinsic amplitude test measures the intrinsic P- and R-wave amplitudes

for the respective chambers.

An intrinsic amplitude test can be performed from the Lead Tests screen by

completing the following steps:

1. You may change the following preselected values as necessary to elicit

intrinsic activity in the chamber(s) being tested:

• Programmed Normal Brady Mode

• LRL at 30 ppm

• AV Delay at 300 ms

2. Select the Intrinsic Amplitude button. During the test, a window will display

the test’s progress. Selecting and holding the Intrinsic Amplitude Button will

cause measurements to be repeated for up to 10 seconds until the button is

released. When the window closes, the same test can be performed again

by selecting the Intrinsic Amplitude button. To cancel the test, select the

Cancel button or press the DIVERT THERAPY key on the PRM.

3. When the test is complete, the intrinsic amplitude measurement will be

displayed. If the test is repeated, the measurements from the previous

session’s test and the current test will be displayed.

NOTE: The test results from the last measurement are stored in pulse

generator memory, retrieved during the initial interrogation, and displayed on

the Lead Tests screen. The measurements are also provided on the Quick

Notes report.

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6-8 SYSTEM DIAGNOSTICS

LEAD TESTS

Lead Impedance Test

A lead impedance test can be performed and used as a relative measure of

lead integrity over time.

A shock impedance test is a useful tool in detecting shocking lead integrity

changes over time. Evaluating this information together with the Last Delivered

Shock impedance (displayed on the Battery Detail screen) or a subsequent

high-energy shock impedance and other non-invasive diagnostic techniques

may help troubleshoot potential lead system conditions.

Pace and Shock lead impedance tests can be performed from the Lead Tests

screen by completing the following steps:

1. Select the desired lead impedance test button. Selecting and holding a

button will cause measurements to be repeated for up to 10 seconds until

the button is released.

2. During the test, a window will display the test progress. When the window

closes, the same test can be performed by once again selecting the desired

lead impedance test button. To cancel the test, select the Cancel button or

press the DIVERT THERAPY key on the PRM.

3. When the test is complete, the impedance measurement will be displayed.

If the test is repeated, the impedance measurements from the previous

session’s test and the current test will be displayed.

NOTE: The test results from the last measurement are stored in pulse

generator memory, retrieved during the initial interrogation, and displayed on

the Lead Tests screen. The measurements are also provided on the Quick

Notes report.

Pace Threshold Test

The Pace Threshold Test determines the minimum pace amplitude and/or

pulse width needed for capture in a speciﬁc chamber. The minimum 2x voltage

or 3x pulse width safety margin is recommended for each chamber based

on the capture thresholds, which should provide an adequate safety margin

and help preserve battery longevity.

Manual Pace Threshold Test

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SYSTEM DIAGNOSTICS

LEAD TESTS 6-9

Thetestbeginsataspeciﬁed starting value and steps that value down

(amplitude or pulse width) as the test progresses. The PRM beeps with each

decrement. The values used during the threshold test are programmable.

The parameters are only in effect during the test. Testing for a chamber is

allowed only when pacing is active for that chamber in the mode speciﬁed in

the start column.

NOTE: The starting values for Amplitude and Pulse Width values are

automatically calculated. The device retrieves the stored results for the

previous pace threshold measurement (for the parameter being tested) and

sets the parameter at three steps above the previous threshold measurement.

The LRL is preselected at 90 ppm. For DDD mode, the LRL is further limited

to 10 ppm below the MTR.

NOTE: If DDD mode is chosen, selecting either the atrial or ventricular test

will cause the pacing output to decrease only in the chamber selected.

CAUTION: During the LV threshold test, RV backup pacing is unavailable.

NOTE: When VVI mode and a ventricular test are selected, only the pacing

output of the selected ventricular chamber decreases; the other ventricular

chamber is not affected.

NOTE: When DDD mode and a ventricular test are selected, only the pacing

output of the selected ventricular chamber decreases; the atrium is paced at a

continuous amplitude, and the other ventricular chamber is not paced.

Once the test is started, the device operates with the speciﬁed brady

parameters. Using the programmed number of cycles per step, the device

then decrements (steps down) the selected test type parameter (Amplitude or

Pulse Width) until the test is complete. Real-time electrograms and annotated

event markers, which include the values being tested, continue to be available

during threshold testing. The display will automatically adjust to reﬂect the

chamber being tested.

During the threshold test, the programmer displays the test parameters in a

window while the test is in progress. To pause the test or perform a manual

adjustment, select the Hold button on the window. Select the + or −button to

manually increase or decrease the value being tested. To continue the test,

select the Continue button.

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6-10 SYSTEM DIAGNOSTICS

LEAD TESTS

The threshold test is complete and all parameters are returned to the normal

programmed values when any of the following occur:

• The test is terminated via a command from the PRM (e.g., pressing the End

Test button or DIVERT THERAPY key)

• The lowest available setting for Amplitude or Pulse Width is reached and

the programmed number of cycles has completed

• Telemetry communication is interrupted

A pace threshold test can be performed from the Lead Tests screen using

the following steps:

1. Select the desired chamber to be tested

2. Select the Pace Threshold details button

3. Select the test type

4. Change the following parameter values as desired to elicit pacing in the

chamber(s) being tested:

• Mode

•LRL

• Paced AV Delay

• Pacing Lead Conﬁg (programmable only for LV threshold test)

• Amplitude

• Pulse Width

• Cycles per Step

• LVPP (programmable only for LV threshold test)

For DDD mode, the normal Brady MTR is used.

NOTE: A long LVPP may inhibit left ventricular pacing at higher pacing rates.

LVPP can be temporarily programmed (for example, to a shorter LVPP or Off)

through the Pace Threshold Test screen.

5. Watch the ECG display and stop the test by selecting the End Test button

or pressing the DIVERT THERAPY key when loss of capture is observed.

If the test continues until the programmed number of cycles at the lowest

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SYSTEM DIAGNOSTICS

LEAD TESTS 6-11

setting have occurred, the test is automatically terminated. The ﬁnal

thresholdtestvaluewillbedisplayed(thevalueisonestepabovethevalue

when the test was terminated).

NOTE: The threshold test result can be edited by selecting the Edit Today’s

Test button on the Threshold Test screen

6. To perform another test, make changes to the test parameter values if

desired, then begin again. Results of the new test will be displayed.

NOTE: The test results from the most recent measurement are stored in

pulse generator memory, retrieved during initial interrogation, and displayed on

the Lead Tests screen and on the Lead Status screen. The measurements are

also provided on the Quick Notes report.

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6-12 SYSTEM DIAGNOSTICS

LEAD TESTS

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7-1

PATIENT DIAGNOSTICS

CHAPTER 7

This chapter contains the following topics:

• "Therapy History" on page 7-2

• "Trends" on page 7-3

• "Arrhythmia Logbook" on page 7-5

• "Patient Triggered Monitor" on page 7-17

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7-2 PATIENT DIAGNOSTICS

THERAPY HISTORY

The pulse generator automatically records detection and therapy information

for each detected episode. This data can be reviewed at various levels of

detail using the PRM.

History data storage includes the following information for each episode:

• Episode detail

• Electrograms with annotated markers

• Intervals

The data includes information from all active electrodes. The device

compresses the history data to store a maximum of 17 minutes of electrogram

data (13 minutes with Patient Triggered Monitor enabled). However, the

amount of time actually stored may vary based on the data being compressed

(e.g., noise on the EGM or an episode of VF).

The priority, maximum number, and minimum number of episodes to be stored

by the device for each episode type under normal conditions are speciﬁed

(Table 7-1 on page 7-3). The device stores up to the maximum number of

episodes for a speciﬁc episode type, unless the device memory is ﬁlled up ﬁrst.

The minimum number of episodes for each episode type protects a few low

priority episodes from high priority episodes when device memory is full.

Once the device memory available for episode data is ﬁlled, the device attempts

to prioritize the types of stored episodes and overwrite the stored episodes

according to the following rules:

• If the device memory is full, and there are episode types that have more

than the minimum number of episodes listed in the table, then the oldest

of the lowest priority episodes from these episode types will be deleted.

In this case, the low priority episodes are not deleted if their number of

episodes is less than the minimum number listed in the table.

• If the device memory is full, and there are no episode types that have more

than the minimum number of episodes listed in the table, then the oldest of

the lowest priority episodes of all episode types will be deleted.

• For non-commanded episodes, the episode type for VT-1, VT, and VF

episodes is determined according to the zone Duration that expires

ﬁrst. If no zone Duration expires during an episode, the episode type

is nonsustained.

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PATIENT DIAGNOSTICS

TRENDS 7-3

• An episode in progress has the highest priority until its type can be

determined.

Table 7-1. Episode Priority

Episode Type Priority Minimum number of

episodes stored

Maximum number

of episodes stored

VF 1 510

Patient Triggered

Monitor

111

VT/VT-1 235

Cmd V 302

NonSustV 312

ATR 4 1 3

PMT 4 1 3

Once the history data is saved to a disk, it can be accessed at any time without

device interrogation.

TRENDS

Trends provide a graphical view of speciﬁc patient and device data. This data

can be useful when evaluating your patient’s condition and the effectiveness of

programmed parameters. The following trends are available:

• Events––displays both atrial and ventricular events.

• Heart Rate––displays a trend of the patient’s heart rate. Intervals used in

this calculation must be valid sinus rhythm intervals. The validity of an

interval and the Heart Rate Trend data for the 24-hour collection period is

determined by the HRV collection criteria.

• Activity Level––displays a measure of the patient’s daily activity.

• Atrial Burden––the amount of time spent in an ATR mode switch.

• Respiratory Rate ––provides a trend of the patient’s daily respiratory rate.

• SDANN––Standard Deviation of Averaged Normal R to R intervals. The

HRV collection period comprises 288 5-minute segments (24 hours). The

SDANN is the standard deviation of the averages of intrinsic intervals in the

288 5-minute segments. Only intervals that meet the HRV collection criteria

are considered valid. If the HRV data for the collection period is invalid,

then a value of “N/R” is displayed.

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7-4 PATIENT DIAGNOSTICS

TRENDS

• HRV Footprint––displays the percentage of the graph area used by the

HRV plot. The graph area portrays an “at-a-glance snapshot” of the

distribution of variability versus heart rate over a 24-hour period. The

trended percentage is a normalized score based on the footprint in the

graph. If an HRV plot was not obtained for the 24-hour period, then the

HRV Footprint is not calculated and a value of “N/R” is displayed.

• ABM (Autonomic Balance Monitor)––a device calculation based on

R–R interval measurements; it mathematically functions as a surrogate

measurement for LF/HF ratio.1Intervalsusedinthecalculationmustbe

valid sinus rhythm intervals as determined by the HRV collection criteria. If

the HRV data is invalid for the 24-hour collection period, then the ABM is

not calculated for that collection period and a value of "N/R" is displayed.

• Amplitude––provides amplitude measurements

• Impedance––provides impedance measurements

Follow the steps below to access Trends:

1. From the Events screen, select the Trends Tab

2. Choose the Select Trends button to specify the trends you want to view.

You can choose from the following categories:

• Heart Failure––includes Heart Rate, SDANN, and HRV Footprint trends

• Atrial Arrhythmia––includes Events, Heart Rate, and Atrial Burden

trends

• Activity––includes Heart Rate, Activity Level, and Respiratory Rate

trends

• Custom––allows you to select three trends to customize the information

displayed on the Trends screen

Thedisplayonthescreencanbeviewedinthefollowingmanners:

• Select the desired time on the View button to choose the length of visible

trend data.

1. Parasympathetic tone is primarily reﬂected in the high-frequency (HF) component of

spectral analysis. The low-frequency (LF) component is inﬂuenced by both the sympathetic

and parasympathetic nervous systems. The LF/HF ratio is considered a measure of

sympathovagal balance and reﬂects sympathetic modulations. (Source: ACC/AHA Guidelines

for Ambulatory Electrocardiography—Part III, JACC VOL. 34, No. 3, September 1999:912–48)

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PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK 7-5

• Adjust the start and end dates by moving the slider bar at the top of

the window. You can also adjust these dates by selecting the left- and

right-arrow buttons.

• Move the vertical axis across the graph by moving the slider bar at the

bottom of the display window.

Valid Heart Rate Trend Events Invalid Heart Rate Trend Events

AS with an interval not faster than

MTR, followed by a VS

AS followed by VP at the programmed

AV Delay

AS with an interval faster than MTR

Non-tracked VP events

Consecutive AS events (no

intervening V event)

VP-Ns

Rate Smoothing events (e.g., RVP↑)

PVC

Heart Rate Trend data may not be reported for a variety of reasons; the most

common are as follows:

• Less than 67% of the 24-hour collection period (approximately 16 hours)

contains valid Heart Rate Trend events

• Brady parameters were programmed within the last 24 hours

ARRHYTHMIA LOGBOOK

The Arrhythmia Logbook screen provides the following information about each

event (Figure 7-1 on page 7-6):

• The number, date, and time of the event

• The type of event with zone

• A summary of therapy delivered or attempted (if applicable)

• Whether or not intervals and EGMs are stored as indicated by the presence

of details button

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7-6 PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK

• Duration of the event

Figure 7-1. Arrhythmia Logbook screen

To display Arrhythmia Logbook data, use the following steps:

1. From the Events tab, select Arrhythmia Logbook. If necessary, the pulse

generator will be automatically interrogated and current data will be

displayed. Data from a patient disk also can be displayed:

a. Select the Utilities button on the toolbar.

b. From the Utilities screen, select the Disk tab. Choose the Read Disk

option.

2. While retrieving the data, the programmer will display a window indicating

the progress of the interrogation. No information will be displayed if you

select the Cancel button before all of the stored data are retrieved.

3. Use the slider and View button to control the range of dates for the events

youwanttodisplayinthetable.

4. Select the Details button of an event in the table to display the event

details. Event details, available if the details button is present, are useful in

evaluating each detection or therapy sequence.

5. To sort events by date, type, therapy, or duration, select the corresponding

column header button. To reverse the order, select the column header

again.

6. To save speciﬁc events, select the event and choose the Save to Disk

button. To print speciﬁc events, select the event and choose Reports from

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PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK 7-7

the toolbar. Choose the selected Episodes Report and select the Print

button.

NOTE: An “in-progress” episode will not be saved; an episode must be

complete before it will be saved by the application.

Events Summary

The Events Summary screen displays additional details about the selected

episode corresponding to the Arrhythmia Logbook.

The summary data include the following:

Episode Details

• Episode number, date, time, type (VF, VT, VT-1, spontaneous/induced, or

PTM indicating a Patient Triggered Monitor episode)

• Average atrial and ventricular rates

• Type of therapy delivered

• For ATP therapy, the time of therapy delivery and the number of bursts

• For shock therapy, the start time of charging, charge time, impedance,

energy level

• Time the episode ended

ATR Episodes

• Episode number, date, time, and type (ATR)

• Average atrial and ventricular rate during ATR mode switch

• Duration

PMT Episodes

• Episode number, date, time, and type (PMT)

• Atrial rate at PMT start

• Average atrial and ventricular rates

Follow the steps below to view episode detail:

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7-8 PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK

1. Select the desired episode on the Arrhythmia Logbook screen. The Stored

Event screen will appear.

2. From the Stored Event screen, select the EGM tab to view the detailed

information for this episode.

3. Select the Previous Event or the Next Event button to display a previous

or more current episode, one episode at a time.

4. Select the Print Event button to print the episode detail being viewed.

5. Select the Save to Disk button to save the episode detail to a patient data

disk.

Stored Electrograms

The pulse generator can store annotated electrograms sensed from the

following leads prior to the onset of an episode around duration met, and

around therapy start and end:

• Shock lead

• RV pace/sense lead

• LV pace/sense lead

• Atrial pace/sense lead

The particular electrograms stored depend upon the episode type. The EGM

storage capacity varies depending on EGM signal condition and heart rate.

The stored data are shared by all events. The total amount of stored EGM

data associated with an episode may be limited; EGMs from the middle of the

episode may be removed for episodes greater than 4 minutes in duration.

When the memory allocated to EGM storage is full, the device overwrites older

EGM data segments in order to store the new EGM data. The EGM is recorded

in segments consisting of episode Onset, Attempt, and End EGM storage.

Each segment of data is visible when the left caliper is in the speciﬁc section.

The following information is retained:

• Onset retains up to 25 seconds of data prior to Duration expiring

• Reconﬁrmation retains up to 20 seconds of data prior to therapy delivery

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PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK 7-9

• Therapy data is displayed. In the case of ATP therapy, a maximum of 4

bursts and up to 20 seconds of data, for each burst, will be retained

• Post-therapy or diverted therapy retains up to 10 seconds of data

Episode onset refers to the period of time (measured in seconds) of EGM prior

to the ﬁrst attempt. Onset includes the following information:

• Type of event

• Average RA Rate at the start of Event

• Average RV Rate at start of Event

• Programming of Detection Enhancements (Rate only, Rhythm ID, or

Onset/stability)

Attempt information may be displayed as Attempt or In Progress, if an attempt

is in progress. Attempt includes the following information:

• Detection information:

– Average RA Rate at start of Attempt

– Average RV Rate at start of Attempt

–RateZone

• Measured Values of Detection Enhancements

• Therapy Attempt Information:

– Attempt Number

– Type (diverted, commanded, or inhibited)

– Number of bursts (ATP attempt)

–Chargetime

– Lead impedance

– Lead polarity

– Shock faults

– Reason for No Therapy

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7-10 PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK

The End EGM storage starts following therapy delivery and stores up to 10

seconds of EGM (Figure 7-2 on page 7-10).

Onset after

3 fast beats

Duration expires Charging begins Start End-of-

Episode timer

End-of-Episode

times out.

Episode is over.

5 s 10 s 10 s 10 s 10 s 10 s 10 s 10 s

Note: Charging may begin

when duration expires.

Shock

Figure 7-2. Relationship between ventricular tachy episode EGM storage and surface ECG strip chart

recording

To view the EGM data, select the desired episode on the Arrhythmia Logbook

screen. Use the following steps to view speciﬁc details about each episode:

1. Select the EGM tab to view the stored EGMs on the screen.

• EGM strips for the appropriate sources are displayed. Each strip

includes the EGMs sensed during the episode with the corresponding

annotated markers. Blue vertical bars indicate the segment (Onset,

Attempt, End) boundaries.

• You can move the calipers along the trace and will display the time

interval between the calipers.

• A speed button changes the trace speed in millimeters/seconds.

2. Select the Previous Event or Next Event button to display a different event

strip. If EGMs are not available for an episode, the Episode Detail screen

will be displayed.

3. To print the entire episode report, select the Print Event button. To save the

entire episode report, select the Save to Disk button.

NOTE: Refer to "Use of Atrial Information" on page 3-5 for additional

information about device performance when the atrial lead is programmed to

Off.

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PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK 7-11

Intervals

The pulse generator stores event markers and associated time stamps. The

PRM derives event intervals from the event markers and time stamps.

To view the episode intervals, use the following steps:

1. From the Stored Event screen, select the Intervals tab. If all of the episode

data is not visible in the window, use the scroll bar to view more data.

2. Select the Previous Event or the Next Event button to display a previous

or more current episode, one episode at a time.

3. Select the Print Event button to print the entire episode report.

4. Select the Save to Disk button to save the entire episode report to a patient

data disk.

Histograms

The Histograms feature retrieves information from the pulse generator and

displays the total number and percentage of paced and sensed events for

the chamber.

Histograms data can provide the following clinical information:

• The distribution of the patient’s heart rates

• How the ratio of paced to sensed beats varies by rate

• How the ventricle responds to paced and sensed atrial beats across rates

When combined with veriﬁed biventricular capture, Histograms can be used to

determine the amount of CRT delivery. The percentage of paced and sensed

ventricular events indicates delivery of biventricular pacing.

Use the following steps to access the Histograms screen:

1. From the Events screen, select the Patient Diagnostics tab.

2. The initial display shows the paced and sensed data since the last time the

counters were reset.

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7-12 PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK

3. Select the Details button to display the data type and time period.

4. Select the Rate Counts button on the Details screen to view rate counts

by chamber.

Heart Rate Variability (HRV)

Heart Rate Variability (HRV) is a measure of the changes in a patient’s intrinsic

heart rate within a 24-hour collection period.

This feature can assist in evaluating the clinical status of heart failure patients.

The HRV monitor feature provides the following information using the intrinsic

interval data from the 24-hour collection period that meets the HRV collection

criteria (Figure 7-3 on page 7-13):

• Date and time the 24-hour collection period was completed.

• % of Time Used—displays the percentage of time during the 24-hour

collection period in which there are valid intrinsic beats. If the % of Time

Used falls below 67%, data will not be displayed for that collection period.

• HRV footprint plot—shows the percentage of the graph area used by

the HRV plot. The graph area portrays an “at-a-glance snapshot” of the

distribution of variability versus heart rate over a 24-hour period. The

trended percentage is a normalized score based on the footprint in the

graph.

• Standard Deviation of Averaged Normal R to R intervals (SDANN)—the

HRV collection period comprises 288 5-minute segments (24-hours) of

intrinsic intervals. The SDANN is the standard deviation of the averages

of intrinsic intervals in the 288 5-minute segments. This measurement is

also available in the Trends.

• Current Normal Brady/CRT parameters––Mode, LRL, MTR, Sensed AV

Delay, and Pacing Chamber with LV Offset.

• An HRV plot for current and previous collection periods including a line

that shows the mean heart rate. The HRV plot summarizes the cardiac

variation on a cycle-to-cycle basis. The x-axis shows the heart rate range;

the y-axis shows the beat-to-beat variability displayed in milliseconds. The

color indicates the frequency of beats at any particular heart rate and heart

rate variability combination.

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PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK 7-13

Figure 7-3. Heart Rate Variability display

Consider the following information when using HRV:

• The cardiac cycle (R–R interval) in HRV is determined by RV sensed and

paced events (LV paced events when the pacing chamber is programmed

to LV).

• Programming the pacing parameters causes the data acquired for the

current 24-hour collection period to be invalid.

• The device saves only one set of values and corresponding HRV plot for

the Reference portion of the screen. Once the values are copied from Last

Measured to Reference, older data cannot be retrieved.

•Theﬁrst time the HRV feature is used, the Reference screen will show the

data from the ﬁrst valid 24-hour collection period.

Follow the steps below to view HRV:

1. To access the HRV monitor screen, select the Events tab.

2. From the Events screen, select the Patient Diagnostics tab.

3. Once the device is interrogated, Last Measured and Reference data is

displayed.

4. Select the Heart Rate Variability Details button to view the Last Measured

and Reference data.

5. To copy the Last Measured HRV measurements into the Reference section,

select the Copy From Last to Reference button.

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7-14 PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK

The HRV monitor screen displays a set of measurements and a HRV plot

based on the most recent 24-hour collection period in the Last Measured

portion of the screen; measurements from a previously saved collection period

are displayed in the Reference portion of the screen. Both collection periods

can be viewed simultaneously to compare data that could show trends in the

patient’s HRV changes over a period of time. By saving the Last Measured

values to the Reference portion of the screen, you can view the last measured

data during a later session.

HRV Collection Criteria

The pulse generator only collects interval data for HRV when the Normal

Brady/CRT mode is programmed to non-rate-responsive tracking modes (VDD

or DDD). In addition, only valid sinus rhythm intervals are used in the HRV data

calculations. For HRV, valid intervals are those which include only valid HRV

events. HRV event validation criteria are listed below:

Valid HRV Events Invalid HRV Events

AS with an interval not faster

than MTR, followed by a VS

AS followed by VP at the programmed

AV Delay

AS with an interval faster than MTR

Non-tracked VP events

Consecutive AS events (no

intervening V event)

VP-Ns

Rate Smoothing events (e.g., RVP↑)

PVC

HRV data may not be reported for a variety of reasons; the most common

are as follows:

• Brady mode is not DDD or VDD

• Less than 67% of the 24-hour collection period (approximately 16 hours)

contains valid HRV events

• Brady Parameters were programmed within the last 24 hours

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PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK 7-15

An example of how HRV data is recorded is shown (Figure 7-4 on page 7-15).

In this example, the HRV data in the ﬁrst collection period is invalid because

the Brady parameters were programmed after the device was taken out of

Storage. HRV data is successfully calculated and reported at the end of the

second 24-hour collection period. Subsequent HRV data is not reported until

the end of Collection Period 5.

Invalid ValidValid Invalid Invalid

24-hour

Collection

Period 1

Collection Period 1:

Invalid HRV due to Brady

parameters modification

(programming)

Collection Period 2:

Valid HRV; greater than 67%

of collection criteria met; HRV

footprint created

Collection Period 3:

Invalid HRV due to Brady

parameter modifications

(programming)

Collection Period 4:

Invalid HRV; less than 67%

of daily intervals were valid

Collection Period 5:

Valid HRV; greater than 67%

of collection criteria met

24-hour

Collection

Period 2

24-hour

Collection

Period 3

24-hour

Collection

Period 4

24-hour

Collection

Period 5

24 hour

collection

period begins

Figure 7-4. Example of HRV data collection

Counters

The following counters are recorded by the pulse generator and displayed on

the Patient Diagnostics screen:

• Ventricular Tachy

• Brady/CRT

Ventricular Tachy Counters

Information about Ventricular Tachy Counters is available by selecting the

Ventricular Tachy Counters button. This screen displays both Ventricular Tachy

Episode and Therapy counters. For each counter, the number of events since

last reset and device totals are displayed. Ventricular Tachy Episode counters

contains the following data:

• Total episodes

• Treated––VF, VT, VT-1, and Commanded

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7-16 PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK

• Nontreated––No Therapy Programmed, Nonsustained, and Other

Untreated Episodes

Ventricular Tachy Therapy counters consist of ventricular shock and ATP

therapy attempts. They can provide useful data about the effectiveness of a

patient’s therapy prescription. These counters include the following information:

• ATP Delivered

• ATP % Successful––the percent of time that the arrhythmia is converted

and the episode ends without delivery of a programmed shock

• Shocks Delivered

• First Shock % Successful––the percent of time that the arrhythmia is

converted and the episode ends without requiring a second programmed

shock

•ShocksDiverted

The ventricular ATP counter is incremented at the start of the delivery of the

ﬁrst burst of an ATP scheme. Subsequent ATP bursts in the same scheme are

not counted individually during the same episode.

An ATP scheme is counted as diverted only if it is diverted prior to delivery

of the ﬁrst burst.

Brady/CRT Counters

Information about Brady/CRT Counters are displayed by selecting the

Brady/CRT Counters button. This screen displays the Brady/CRT episode

counters. For each counter, the number of events since last reset and reset

before last are displayed. Brady/CRT counters contains the following details:

• Percent of atrial paced

• Percent of RV paced

NOTE: The RV pace event for a BiVentricular Trigger pace will be counted

as an RV sense.

• Percent of LV paced

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PATIENT DIAGNOSTICS

PATIENT TRIGGERED MONITOR 7-17

• Intrinsic Promotion––includes Rate Hystereses % successful

• Atrial burden––includes Episodes by Duration and Total PACs

• Ventricular counters––includes total PVCs and Three or More PVCs

PATIENT TRIGGERED MONITOR

Patient Triggered Monitor allows the patient to trigger the storage of EGMs,

intervals, and annotated marker data during a symptomatic episode by placing

a magnet over the device.

Patient Triggered Monitor is enabled by selecting Store EGM as the desired

magnet response. This can be found in the Magnet and Beeper section on the

V-Tachy Therapy Setup screen. When enabled, the device will store up to 2

minutes of patient monitor data prior to and up to 1 minute after triggering

the monitoring. The stored data include the episode number, the atrial and

ventricular rates at magnet application, and the start time and date of magnet

application.

When data are stored, the corresponding episode type is recorded as PTM

in the Arrhythmia Logbook.

Use care when enabling Patient Triggered Monitor, because the following

conditions will exist:

• All other magnet features are disabled, including inhibiting therapy (until

the EGM is stored). The Magnet/Beeper feature will not indicate magnet

position.

• Device longevity is impacted. Once the patient has triggered this feature to

store episode data or the feature is disabled, the impact on device longevity

is no longer present. To help reduce the longevity effect, this feature is

automatically disabled after 60 days from the day it was enabled.

• Once the EGM is stored, the device magnet response automatically will be

set to Inhibit Therapy.

To program the Patient Triggered Monitor feature, follow these steps:

1. From the Settings tab on the main screen, select Settings Summary.

2. From the Settings Summary tab, select Ventricular Tachy Therapy.

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7-18 PATIENT DIAGNOSTICS

PATIENT TRIGGERED MONITOR

3. From Ventricular Tachy Therapy, select the V-Tachy Therapy Setup details

button.

4. Program the Magnet Response to Store EGM.

CAUTION: Determine if the patient is capable of activating this feature

prior to being given the magnet and prior to enabling Patient Triggered

Monitor. Remind the patient to avoid strong magnet ﬁelds so the feature is

not inadvertently triggered.

CAUTION: Consider having the patient initiate a stored EGM at the time

Patient Triggered Monitor is enabled to assist with patient education and

feature validation. Verify the activation of the feature on the Arrhythmia

Logbook screen.

WARNING: Ensure that Patient Triggered Monitor is enabled prior

to sending the patient home by conﬁrming the magnet response is

programmed to Store EGM. If the feature is inadvertently left in the Inhibit

Therapy setting, the patient could potentially disable tachyarrhythmia

detection and therapy.

WARNING: Once the Patient Triggered Monitor feature has been

triggered by the magnet and an EGM has been stored, or after 60 days

have elapsed from the day that Store EGM was enabled, the Magnet

Response programming automatically will be set to Inhibit Therapy.

When this happens, the patient should not apply the magnet because

tachyarrhythmia therapy could be inhibited.

NOTE: When the Magnet Response programming has automatically

been set to Inhibit Therapy, magnet application will cause the device to

emit beeping tones. Inform the patient that if they hear tones coming from

their device after applying the magnet, they should remove the magnet.

5. Patient Triggered Monitor can only be enabled for a 60-day period of time.

To disable the feature within the 60-day time period, reprogram the magnet

response to a setting other than Store EGM. When 60 days have passed

since enabling Patient Triggered Monitor, the feature will automatically

disable itself and the magnet response will revert to Inhibit Therapy. To

re-enable the feature, repeat these steps.

For additional information, contact Technical Services at the number shown on

the back cover of this manual.

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8-1

ELECTROPHYSIOLOGIC TESTING

CHAPTER 8

This chapter contains the following topics:

• "EP Test Features" on page 8-2

• "Induction Methods" on page 8-4

• "Commanded Therapy Methods" on page 8-10

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8-2 ELECTROPHYSIOLOGIC TESTING

EP TEST FEATURES

Electrophysiologic (EP) Testing features enable you to induce and terminate

arrhythmias noninvasively in order to monitor and test the effectiveness of

selected detection criteria and therapies. The EP Test features can be used in

conjunction with the ECG display so that real-time traces may be viewed. The

status of the pulse generator/patient interaction is also displayed.

The features allowing noninvasive EP testing of arrhythmias include the

following:

• VFib induction

• Shock on T induction

• PES induction

• 50 Hz/Manual Burst pacing induction

• Commanded Shock therapy

• Commanded ATP therapy

Temporary EP Mode

Temporary EP Mode allows you to program the device mode to a temporary

value for EP test delivery, and ensures that the normal device mode remains

unchanged.

Backup Ventricular Pacing During Atrial EP Testing

Backup ventricular pacing is available during atrial EP testing (PES, 50

Hz/Manual Burst) regardless of the programmed Normal or Post-therapy

pacing modes. (The mode can also be programmed to Off.) Program the

backup pacing parameters by selecting the EP Test Pacing button displayed on

the relevant atrial EP tests.

EP Test Screen

The EP Test screen displays the real-time status of the detection and therapy

process of the pulse generator when telemetry communication is occurring.

Viewing this display allows you to induce and test either a programmed

detection/therapy prescription or optional therapies while monitoring the pulse

generator’s progress.

Refer to the EP Test screen (Figure 8-1 on page 8-3):

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ELECTROPHYSIOLOGIC TESTING

EP TEST FEATURES 8-3

Figure 8-1. EP Test Screen

The screen provides the following information:

• Status messages indicate detection and therapy status and are described

below:

– Ventricular episode status—if an episode is occurring, the duration of

the episode is displayed. (If it is greater than 10 minutes, then it is

displayed as > 10:00 m:s).

– Ventricular detection status—if an episode is occurring, it indicates

whether ventricular detection is in Initial Detection, Redetection, or the

zone in which that detection is met. If no episode is occurring, the

programmer will also display the text Time since last V therapy along

with the continually updated time in minutes (up to 10).

– Brady pacing and SRD status.

– The type of therapy initiated and the zone.

– The status of the therapy such as In progress, Diverted, or Delivered.

• Duration timer—Progression of the duration timer is graphically displayed

using a scale. The bar in the scale moves from left to right to show the

percent complete of programmed duration. When duration is expired and

therapy delivery begins, the bar is removed.

• Detection status—The status for each programmed detection enhancement

is displayed. When enhancement criteria are met, a mark appears in the

adjacent box.

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8-4 ELECTROPHYSIOLOGIC TESTING

INDUCTION METHODS

• Therapy prescriptions—Only those therapy prescriptions that are

programmed are displayed. As each therapy is delivered, a check mark

or number will appear in the box adjacent to the respective therapy. ATP

therapies indicate the scheme type as well as the programmed number of

bursts in the scheme. A number will appear and increment (1, 2, etc.) in

the ATP therapy box each time an ATP burst is delivered. Shock therapies

indicate the programmed energy level for the programmable shocks. A

number will appear and increment (1, 2, etc.) in the Max box each time a

maximum-energy shock is delivered.

Follow the steps below to perform EP Test functions:

1. Select the Tests tab, then select the EP Tests tab.

2. Establish telemetry communication. Telemetry communication between the

programmer and the pulse generator should be maintained throughout all

EP test procedures.

3. Program the EP Temp V mode appropriate to the EP Test method

(Table 8-1 on page 8-4).

Table 8-1. EP Temp V Mode for EP Test Functions

EP Temp V Mode

EP Test MethodaMonitor + TherapydMonitor OnlyeOff

50 Hz/Manual BurstbX

PESbX

VFibcX

Shock on TcX

Commanded ATPcX

Commanded ShockcXX

a. EP functions cannot be performed if the pulse generator is in Storage Mode.

b. Available method for both atrial and ventricular induction.

c. Available method only for ventricular induction.

d. The Ventricular Tachy Mode must be programmed to Monitor + Therapy.

e. The Ventricular Tachy Mode must be programmed to Monitor Only or Monitor + Therapy.

INDUCTION METHODS

Each induction method available from the EP Test screen is described below

with instructions for performing the induction. During any type of induction

delivery, the pulse generator recognizes the induction and performs no other

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ELECTROPHYSIOLOGIC TESTING

INDUCTION METHODS 8-5

activity until the induction delivery is ceased, at which time the programmed

mode will take effect and the pulse generator will respond accordingly.

Consider the following information when using these methods:

• Ventricular PES, Shock on T wave, and Ventricular ATP are BiV.

• All inductions and tachycardia therapy delivery are inhibited when a

magnet is positioned over the pulse generator (if magnet response is set to

Inhibit Therapy).

• Pacing pulses during induction are delivered at the programmed EP Test

pacing parameters.

VFib Induction

VFib induction uses the shocking electrodes to stimulate the right ventricle

at very fast rates.

The following settings are available to allow use of the minimum energy

necessary for induction:

• VFib Low delivers a stimulation waveform of 9 volts

• VFib High delivers a stimulation waveform of 15 volts

Performing VFib Induction

NOTE: The patient should be sedated prior to delivery of ﬁbrillation induction

pulses. The large surface area of the shocking electrodes tends to stimulate

the surrounding muscle and can be uncomfortable.

1. Select the VFib option. Buttons for each test and an Enable checkbox

are displayed.

2. Select the Enable checkbox.

3. Select the desired Hold for Fib button to initiate delivery of the ﬁbrillation

induction train. The induction train is delivered up to 15 seconds as long as

the button is held and the telemetry link is maintained.

During induction the pulse generator is automatically disabled from

detecting, and automatically re-enabled following induction delivery.

If VFib induction is initiated during an episode, the end-of-episode is

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8-6 ELECTROPHYSIOLOGIC TESTING

INDUCTION METHODS

declared before the VFib induction pulses are started. A new episode (with

initial detection and therapy) can be declared after the VFib induction is

completed. Event markers and EGMs are interrupted during VFib induction

and will automatically restart following induction.

4. To stop the induction train, release the button (the button will become

dimmed again).

5. To deliver another ﬁbrillation induction, repeat these steps.

Shock on T Induction

A Shock on T wave induction method allows the device to deliver a drive train

(up to 30 equally timed pacing pulses, or S1 pulses) through the ventricular

pace/sense electrodes followed by shock delivery through the shocking

electrodes (Figure 8-2 on page 8-6).

400 400 400 400 400 400

S1 S1 S1 S1 S1 S1

Last sensed or

paced beat

Coupling

Interval

Drive Pulses

Shock

S1 Interval

Figure 8-2. Shock on T induction drive train

The initial S1 pulse follows the last sensed or paced event at the S1 interval.

The shock is coupled to the last S1 pulse of the drive train.

Performing Shock on T Induction

1. Select the Shock on T option. The programmable induction parameters

will be displayed.

2. Select the desired value for each parameter.

3. Select the Enable checkbox. The Induce button will no longer be dimmed.

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ELECTROPHYSIOLOGIC TESTING

INDUCTION METHODS 8-7

4. Select the Induce button to begin delivery of the drive train. The pulses are

delivered in sequence until the programmed number of pulses is reached.

Once induction is initiated, the drive train delivery will not stop if you

interrupt telemetry communication. You can press the DIVERT THERAPY

key to stop the induction delivery command.

5. Shock on T induction is complete when the drive train and shock are

delivered, at which time the pulse generator automatically restarts

detection.

NOTE: Prior to drive train delivery, tones will be heard indicating capacitor

charging in preparation for shock delivery.

NOTE: The shock delivered during Shock on T induction does not increment

episode or therapy counters.

Programmed Electrical Stimulation (PES)

PES induction allows the pulse generator to deliver up to 30 equally timed

pacing pulses (S1) followed by up to 4 premature stimuli (S2–S5) to induce or

terminate arrhythmias. Drive pulses, or S1 pulses, are intended to capture and

drive the heart at a rate slightly faster than the intrinsic rate. This ensures that

the timing of the premature extra stimuli will be accurately coupled with the

cardiaccycle(Figure8-3onpage8-7).

The initial S1 pulse is coupled to the last sensed or paced beat at the S1

interval. All pulses are delivered in XOO modes (where X is the chamber) at

the programmed EP Test pacing parameters.

S1 S1 S1 S1 S1 S2 S3

600 400600 600 600 600 450

Coupling

Interval

Coupling

Interval

Extra

Stimuli

Drive Pulses

Figure 8-3. PES induction drive train

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8-8 ELECTROPHYSIOLOGIC TESTING

INDUCTION METHODS

Performing PES Induction

1. Select the PES option. Buttons for the S1–S5 pulses and the corresponding

burst cycle lengths are displayed.

2. Select the desired value for the S1–S5 intervals (Figure 8-4 on page 8-8).

You can either select a value box for the desired S interval and choose a

value from the box or use the plus or minus symbols to change the value

visible in the value box.

Figure 8-4. PES induction options

3. Select the Enable checkbox.

4. Select (do not hold) the Induce button to begin delivery of the drive train.

When the programmed number of S1 pulses is delivered, the pulse

generator will then deliver the programmed S2–S5 pulses. The pulses are

delivered in sequence until a pulse is encountered that is set to Off (e.g.,

if S1 and S2 are set to 600 ms, and S3 is Off, then S3, S4, and S5 will

not be delivered). Once induction is initiated, the PES delivery will not

stop if you interrupt telemetry communication. (You can press the DIVERT

THERAPY key to stop induction delivery.) If PES induction is initiated

during an episode, the end-of-episode is declared before the PES induction

pulses are started. A new episode (with initial detection and therapy) can

be declared after the PES induction is completed.

5. PES induction is complete when the drive train and extra stimuli are

delivered, at which time the pulse generator automatically restarts

detection.

NOTE: Ensure the PES induction is complete before beginning another

induction.

NOTE: When PES is used to terminate an arrhythmia that has been detected

(and an episode declared), the episode is terminated when the PES is

commanded regardless of whether it is successful or not. The PES itself is not

recorded in therapy history; this may result in several episodes being counted

in therapy history.

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ELECTROPHYSIOLOGIC TESTING

INDUCTION METHODS 8-9

50 Hz/Manual Burst Pacing

50 Hz/Manual Burst pacing induction is used to induce or terminate arrhythmias

and allows two separate pacing inductions, both of which can be delivered to

either the atrium or ventricle.

Manual Burst pacing pulses are delivered in XOO mode (where X is the

chamber) at the programmed EP Test pacing parameters through the

rate-sensing leads. For Atrial Manual Burst, backup pacing parameters are

provided.

Performing Manual Burst Pacing

1. Select the 50 Hz/Manual Burst option.

2. Select the desired value for the Burst Interval, Minimum, and Decrement.

This indicates the cycle length of the intervals in the drive train.

3. Select the Enable checkbox.

4. To deliver the burst, select and hold the Hold for Burst button.

The ventricular Manual Burst will be delivered up to 30 seconds as long as

the Hold for Burst button is held and the telemetry link is maintained.

The atrial Manual Burst will be delivered up to 45 seconds as long as the

Hold for Burst button is held and the telemetry link is maintained. The

intervals will continue to be decremented until the minimum interval is

reached, then all further pulses will be at the Minimum interval.

5. To stop the burst delivery, release the Hold for Burst button. The Hold for

Burst button will become dimmed again.

6. To deliver additional Manual Burst pacing, repeat these steps.

Performing 50 Hz Burst Pacing

1. Select the 50 Hz/Manual Burst option.

2. Select the Enable checkbox.

3. To deliver the burst, select and hold the Hold for 50 Hz Burst button.

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8-10 ELECTROPHYSIOLOGIC TESTING

COMMANDED THERAPY METHODS

The ventricular 50 Hz Burst will be delivered up to 30 seconds as long as

the Hold for Burst button is held and the telemetry link is maintained.

The atrial 50 Hz Burst will be delivered up to 45 seconds as long as the

Hold for Burst button is held and the telemetry link is maintained.

NOTE: During Hold for 50 Hz Burst pacing, the S1 interval is automatically

set to 20 ms and the decrement to 0. These values will not be displayed on the

screen.

4. To stop the burst delivery, release the Hold for 50 Hz Burst button. The

Hold for 50 Hz Burst button will become dimmed again.

5. To deliver additional 50 Hz Burst pacing, repeat these steps.

COMMANDED THERAPY METHODS

The commanded EP test methods, Commanded Shock and Commanded ATP,

may be delivered independently of the programmed detection and therapy

parameters. If the pulse generator is in the process of delivering therapy when

a commanded method is initiated, the EP Test function overrides and aborts

the therapy in process. If an episode is not in progress, then a Commanded

Ventricular Episode will be recorded in the Arrhythmia Logbook. Commanded

Shock and Commanded ATP delivery is inhibited when a magnet is positioned

over the pulse generator, if it is programmed to Inhibit Therapy.

Commanded Shock

The Commanded Shock feature allows delivery of a shock with programmable

energy and coupling interval.

All Commanded Shocks are Committed and delivered R-wave synchronously

when the coupling interval is programmed to Sync. Shock waveform and

polarity are identical to detection-initiated shocks but a programmed coupling

interval may be speciﬁed. The coupling interval is initiated at the point where

the shock would have been delivered in Sync mode, but is instead delivered at

the programmed coupling interval. Following any Commanded Shock delivery,

Post-shock Redetection is used and post-shock pacing is activated.

Performing Commanded Shock Delivery

1. Select the Commanded Shock option.

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ELECTROPHYSIOLOGIC TESTING

COMMANDED THERAPY METHODS 8-11

2. Select the desired values for the Coupling interval and Shock Energy.

3. Select the Enable checkbox. The Deliver Shock button will become

available.

4. Select the Deliver Shock button to initiate shock delivery. The Commanded

Shock is recorded in therapy history.

5. To deliver subsequent shocks, repeat these steps.

Commanded ATP

Commanded ATP allows you to manually deliver ATP schemes, independent

of the programmed detection and therapy parameters. You can conﬁgure

the Commanded ATP by either selecting the type of ATP scheme or by

programming ATP parameters on the Details screen in order to deliver

Commanded ATP.

The EP Temp V Mode must be programmed to Monitor Only to ensure the

Commanded ATP does not interfere with detection-initiated ATP.

Performing Commanded ATP

1. If the pulse generator Ventricular Tachy Mode is not currently programmed

to Monitor Only, select the Monitor Only EP Temp V Mode option.

2. Select the type of ATP scheme and select the value for Number of Bursts.

3. Select the Start ATP button to initiate the ﬁrst burst in the selected ATP

scheme. The Bursts Remaining counter will decrement as each burst is

completed.

4. Select the Continue button for each additional burst delivery desired. If all

bursts in a scheme have been delivered, the Bursts Remaining counter will

return to the initial count, and the Continue button will be dimmed.

5. Other ATP schemes may be selected at any time; select the desired

scheme and repeat the above sequence. The Commanded ATP is

recorded as a physician-commanded therapy counter and displayed on

the counters screen.

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8-12 ELECTROPHYSIOLOGIC TESTING

COMMANDED THERAPY METHODS

6. After using Commanded ATP, remember to program the EP Temp V Mode

to Monitor + Therapy or leave the screen so that the EP Temp V Mode is

ended and the permanent Tachy Mode is resumed.

NOTE: If any button other than the Continue button is selected during delivery

of a Commanded ATP scheme, the scheme will be reset and the Bursts

Remaining box will be restored to its initial value. The Start ATP button must be

reselected to initiate the scheme again.

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9-1

IMPLANT INFORMATION

CHAPTER 9

This chapter contains the following topics:

• "Implanting the Pulse Generator" on page 9-2

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9-2 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

Step A: Check Equipment

Step B: Interrogate and Check the Pulse Generator

Step C: Implant the Lead System

Step D: Take Baseline Measurements

Step E: Form the Implantation Pocket

Step F: Connect the Leads to the Pulse Generator

Step G: Evaluate Lead Signals

Step H: Program the Pulse Generator

Step I: Implant the Pulse Generator

Step J: Complete and Return the Implantation Form

Step A: Check Equipment

It is recommended that instrumentation for cardiac monitoring, deﬁbrillation,

and lead signal measurement should be available during the implant procedure.

This includes the PRM system with its related accessories and the software

application. Before beginning the implantation procedure, become completely

familiar with the operation of all the equipment and the information in the

respective operator’s and user’s manuals. Verify the operational status of all

equipment that may be used during the procedure. Sterile duplicates of all

implantable items and the following accessories should be available in case of

accidental damage or contamination:

• Internal deﬁbrillator paddles

•Externaldeﬁbrillator paddles

• Torque and non-torque wrenches

During the implantation procedure, a standard transthoracic deﬁbrillator

with external pads or internal paddles should be available for use during

deﬁbrillation threshold testing.

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IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR 9-3

Step B: Interrogate and Check the Pulse Generator

To maintain sterility, test the pulse generator as described below before opening

the sterile blister tray. The pulse generator should be at room temperature to

ensure accurately measured parameters.

1. Interrogate the pulse generator using the PRM. Verify that the pulse

generator’s Tachy mode is programmed to Storage. If otherwise, call

Technical Services at the phone number provided on the back of this

manual.

2. Perform a manual capacitor re-formation.

3. Review the pulse generator’s current battery status. Counters should be

at zero. If the pulse generator battery status is not at BOL, do not implant

the pulse generator. Call Technical Services at the phone number provided

on the back of this manual.

Step C: Implant the Lead System

The pulse generator requires a lead system for sensing, pacing, and delivering

shocks. The pulse generator uses its case as a deﬁbrillating electrode.

Selection of lead conﬁguration and speciﬁc surgical procedures is a matter of

professional judgement. The following lead system conﬁgurations are available

for use with the pulse generator:

• ENDOTAK endocardial cardioversion/deﬁbrillation and pacing lead system

• Ventricular endocardial bipolar lead

• Atrial bipolar lead

• Guidant transvenous coronary venous (pace/sense) lead

• Unipolar sutureless myocardial leads and, if necessary, an appropriate

Guidant lead adapter

• Superior vena cava lead coupled with a ventricular patch lead

• Two-patch epicardial leads conﬁguration

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9-4 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

NOTE: If the coronary venous lead cannot be used and the physician’s

medical judgment indicates that a limited left thoracotomy is justiﬁed to place

an epicardial lead, the use of sutureable, steroid-eluting pace/sense epicardial

leads is recommended.

CAUTION: The absence of a lead or plug in a lead port may affect device

performance. If a lead is not used, be sure to properly insert a plug in the

unused port.

Whichever lead conﬁguration is used for both pacing/sensing and deﬁbrillating,

several considerations and cautions should be heeded. Such factors as

cardiomegaly or drug therapy may necessitate repositioning of the deﬁbrillating

leads or substituting one lead for another to facilitate arrhythmia conversion.

In some instances, no lead conﬁguration may be found that provides reliable

arrhythmia termination at energy levels available from the pulse generator;

implantation of the pulse generator is not recommended in these cases.

Implant the leads via the surgical approach chosen.

CAUTION: Do not suture directly over the lead body as this may cause

structural damage. Use the lead stabilizer to secure the lead lateral to the

venous entry side.

Step D: Take Baseline Measurements

Once the leads are implanted, take baseline measurements. Evaluate the

lead signals. If performing a pulse generator replacement procedure, existing

leads should be reevaluated, (e.g., signal amplitudes, pacing thresholds, and

impedance). The use of radiography may help ensure lead position and

integrity. If testing results are unsatisfactory, lead system repositioning or

replacement may be required.

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IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR 9-5

• Connect the pace/sense lead(s) to a pacing system analyzer (PSA).

Pace/sense lead measurements, measured approximately 10 minutes

after placement, are listed below (Table 9-1 on page 9-5). Note that the

pulse generator measurements may not exactly correlate to the PSA

measurements due to signal ﬁltering.

Table 9-1. Lead measurements

Pace/sense lead

(acute)

Pace/sense lead

(chronic)

Shocking lead

(acute)

Shocking lead

(chronic)

R-wave amplitudeab > 5 mV > 5 mV > 1.0 mV > 1.0 mV

P-wave amplitudeab >1.5mV >1.5mV

R-wave durationbcd < 100 ms < 100 ms

Pacing threshold (right

ventricle)

<1.5V

endocardial

< 2.0 V epicardial

< 3.0 V endocardial

<3.5Vepicardial

Pacing threshold (left

ventricle)

< 2.5 V coronary

venous

< 2.0 V epicardial

< 3.5 V coronary

venous

<3.5Vepicardial

Pacing threshold (atrium) <1.5V

endocardial

< 3.0 V endocardial

Lead impedance (at 5 V and

0.5 ms atrium and ventricle)

200–2000 Ω200–2000 Ω20–80 Ω20–80 Ω

Lead impedance (at 5 V

and 0.5 ms left ventricle)

200–2000 Ω200–2000 Ω20–80 Ω20–80 Ω

a. Amplitudes less than 2 mV cause inaccurate rate counting in the chronic state, and result in inability to sense a tachyarrhythmia or

the misinterpretation of a normal rhythm as abnormal.

b. Lower R-wave amplitudes and longer duration may be associated with placement in ischemic or scarred tissues. Since signal

quality may deteriorate chronically, efforts should be made to meet the above criteria by repositioning the leads to obtain signals

with the largest possible amplitude and shortest duration.

c. Durations longer than 135 ms (the pulse generator’s refractory period) may result in inaccurate cardiac rate determination, inability

to sense a tachyarrhythmia, or in the misinterpretation of a normal rhythm as abnormal.

d. This measurement is not inclusive of current of injury.

Step E: Form the Implantation Pocket

Using standard operating procedures to prepare an implantation pocket,

choose the position of the pocket based on the implanted lead conﬁguration and

the patient’s body habitus. Giving consideration to patient anatomy and pulse

generator size and motion, gently coil any excess lead and place adjacent to

the pulse generator. It is important to place the lead into the pocket in a manner

that minimizes lead tension, twisting, sharp angles, and/or pressure. Pulse

generators are typically implanted subcutaneously in order to minimize tissue

trauma and facilitate explant. However, deeper implantation (e.g., subpectoral)

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9-6 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

may help avoid erosion or extrusion in some patients. Verify magnet function

and wanded telemetry to ensure the pulse generator is within acceptable range.

Consider the following situations during the implant the procedure:

• If an abdominal implant is suitable, it is recommended that implantation

occur on the left abdominal side.

• Tunnel the leads if necessary. If a Guidant tunneler is not used, cap

the lead terminal pins, gently tunnel the leads subcutaneously to the

implantation pocket, and reevaluate the lead signals to determine if any of

the leads have been damaged during the tunneling procedure. A Penrose

drain, large chest tube, or tunneling tool may be used to tunnel the leads.

• If the lead terminal pins are not connected to a pulse generator at the time

of lead implantation, they must be capped before closing the incision.

Step F: Connect the Leads to the Pulse Generator

Lead connections are illustrated below.

– +

RV RA

DF-1

IS-1

DF-1

LV LV-1

UNI/BI

IS-1

– +

RV RA

DF-1

IS-1

DF-1

IS-1

LV IS-1

UNI/BI

Figure 9-1. Lead connections

Setscrew locations are illustrated below.

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IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR 9-7

Front of Pulse Generator

Suture Hole

RA (-)

LV (-)

Defib (-)

RV (-)

Defib (+)

Front of Pulse Generator

Suture Hole

RA (-)

LV (-)

Defib (-)

RV (-)

Defib (+)

Figure 9-2. Setscrew and suture hole locations

Lead to pulse generator connections

CAUTION: Do not insert a lead into the pulse generator connector without

ﬁrst visually verifying that the setscrew is sufﬁciently retracted to allow insertion.

Fully insert each lead into its lead port and then tighten the setscrew onto

the electrodes.

1. As each lead is inserted into the pulse generator, secure the lead in place

by tightening the setscrew with the torque wrench.

a. Insert the wrench into the center, preslit depression of the seal plug.

b. Place pressure on the lead to maintain its position in the pulse

generator lead port. Be certain that the lead remains fully inserted

intheleadport.

c. The large-handled torque wrench is preset to apply the proper amount

of force to the captive setscrew. Tighten the setscrew, making sure it is

not crooked, until the wrench ratchets; additional force is unnecessary.

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9-8 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

d. Apply gentle traction to the leads to ensure a secure connection.

2. In models with IS-1 connectors, insert and secure the right ventricular

pace/sense lead terminal into the RV lead port.

NOTE: When connecting leads to a device header, connect the RV lead

ﬁrst. An RV lead is required to establish RV-based timing cycles that yield

appropriate sensing and pacing in all chambers, regardless of the programmed

conﬁguration.

3. In models with atrial connectors, insert and secure the atrial pace/sense

lead terminal into the A lead port.

4. Insert and secure the left ventricular coronary venous pace/sense lead

terminal into the LV lead port.

5. In models with DF-1 connectors, insert the deﬁbrillating lead anode

(+, proximal) into the pulse generator’s (+) Deﬁb lead port. For proper

connection, be certain that the lead terminal pin is fully inserted in the pulse

generator lead port. When viewed through the side of the header, the pin

tip should extend through the terminal block.

6. Insert and secure the deﬁbrillating cathode (–, distal) in the (–) Deﬁblead

port in a similar manner as above.

CAUTION: For IS-1/DF-1 leads, never change the shock waveform

polarity by physically switching the lead anodes and cathodes in the pulse

generator header—use the programmable Polarity feature. Device damage

or nonconversion of the arrhythmia post-operatively may result if the polarity

is switched physically.

CAUTION: The absence of a lead or plug in a lead port may affect device

performance. If a lead is not used, be sure to properly insert a plug in the

unused port.

Consider the following lead connection information during the implant

procedure:

• The IS-1 pace/sense lead port(s) has one setscrew for securing the

terminal pin.

• The DF-1 port has one setscrew for securing the terminal pin.

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IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR 9-9

• The LV-1 pace/sense lead port(s) has one setscrew for securing the

terminal pin.

• Avoid allowing blood or other body ﬂuids to enter the lead ports in the pulse

generator header. If ﬂuid inadvertently enters the ports, they should be

thoroughly cleaned using sterile water.

• To connect leads to the pulse generator, use only the tools provided in the

pulse generator tray or accessory kit to avoid damage to the seal plugs.

Failure to properly insert the wrench in the preslit depression of the seal

plug may result in damage to the plug and its sealing properties. Failure

to use the supplied torque wrench may result in damage to the screw or

connector threads. Do not implant the pulse generator if the seal plugs

appear to be damaged. Retain the tools until all testing procedures are

complete and the pulse generator is implanted.

• If necessary, lubricate the lead connectors sparingly with sterile water to

make insertion easier.

• If a lead terminal encounters resistance on insertion into the lead port,

insert the wrench into the preslit depression of the seal plug and angle it

gently to open the valve and allow excess air to bleed out of the seal plug.

•Signiﬁcant amounts of ﬂuid or sterile water in a lead bore may make it

difﬁcult to fully insert leads. If signiﬁcant amounts of ﬂuid or sterile water

are present, insert the torque wrench into the setscrew before inserting the

leads. This will allow ﬂuid to drain from the lead bore.

• For proper connection of an IS-1 lead to the pulse generator, be certain that

the connector pin visibly extends through the connector block at least 1 mm.

Step G: Evaluate Lead Signals

1. Take the pulse generator out of power-saving Storage mode by

programming the Tachy Mode to Off.

CAUTION: To prevent inappropriate shocks, ensure that the pulse generator’s

Tachy Mode is programmed to Off when not in use and before handling the

device. For tachyarrhythmia therapy, verify that the Tachy Mode is activated.

2. Evaluate the pace/sense and deﬁbrillation lead signals by viewing the

real-time EGMs and markers. The signal from the implanted deﬁbrillation

leads should be continuous and without artifact, similar to a body-surface

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9-10 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

ECG. A discontinuous signal may indicate a poor connection, lead fracture

or otherwise damaged lead, or an insulation break that would necessitate

lead replacement. Inadequate signals may result in failure of the pulse

generator system to detect an arrhythmia, inability to deliver programmed

therapy, or unnecessary delivery of therapy. Lead measurements should

reﬂect those in (Table 9-1 on page 9-5).

CAUTION: Take care to ensure that artifacts from the ventricles are not

present on the atrial channel, or atrial oversensing may result. If ventricular

artifacts are present in the atrial channel, the atrial lead may need to be

repositioned to minimize its interaction.

3. Evaluate all lead impedances using the Lead Impedance test accessed

from the Diagnostic Evaluation tool.

CAUTION: Never implant the device with a lead system that has less than

15 Ωtotal shock lead impedance. Device damage may result. If a shocking

lead impedance is less than 20 Ω, reposition the shocking electrodes to allow a

greater distance between the shocking electrodes.

CAUTION: Patients should be tested for diaphragmatic stimulation by pacing

the LV lead through the pulse generator at 7.5 V and adjusting the lead

position as necessary. PSA testing at higher outputs (e.g., 10.0 V) may also

be considered to better characterize stimulation margins. The probability of

diaphragmatic stimulation increases when a pacing system includes an LV lead

because of this lead’s proximity to the phrenic nerve.

Step H: Program the Pulse Generator

1. Check the programmer clock and set and synchronize the pulse generator

as necessary so that the proper time appears on printed reports and PRM

strip chart recordings.

2. It may be useful to program the Beep During Capacitor Charge feature to

On during conversion testing and implantation to help recognize when the

pulse generator is charging to deliver shock.

3. Perform a manual capacitor re-formation if not already performed.

4. Program the pulse generator to desired parameters appropriate for the

patient for necessary testing.

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IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR 9-11

5. Shocks intended for VF therapy should be programmed with a 10 J safety

margin above the shock energy level that the physician determines is

required for successful VF conversion.

CAUTION: To prevent inappropriate shocks, ensure that the pulse generator’s

Tachy Mode is programmed to Off when not in use and before handling the

device. For tachyarrhythmia therapy, verify that the Tachy Mode is activated.

Step I: Implant the Pulse Generator

1. Program the Tachy Mode to Off.

2. Ensure that the pulse generator has good contact with surrounding tissue

of the implantation pocket. Suture hole locations are illustrated below.

Gently coil excess lead and place adjacent to the pulse generator. Flush

the pocket with saline solution, if necessary, to avoid a dry pocket.

WARNING: Kinking leads may cause additional stress on the leads,

possibly resulting in lead fracture.

CAUTION: Improper insertion can cause insulation damage near the

terminal end that could result in lead failure.

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9-12 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

Front of Pulse Generator

Suture Hole

RA (-)

LV (-)

Defib (-)

RV (-)

Defib (+)

Front of Pulse Generator

Suture Hole

RA (-)

LV (-)

Defib (-)

RV (-)

Defib (+)

Figure 9-3. Setscrew and suture hole locations

3. Close the implantation pocket. Consideration should be given to place

the leads in a manner to prevent contact with suture materials. It is

recommended that absorbable sutures be used for closure of tissue layers.

4. Complete any electrocautery procedures before reactivating the pulse

generator.

5. Program the Tachy Mode to the desired setting and conﬁrm ﬁnal

programmed parameters.

6. Print out parameter reports and save all data to disk using the programmer’s

Save to Disk option.

Step J: Complete and Return the Implantation Form

Within ten days of implantation, complete the Warranty Validation and Lead

Registration form and return the original to Boston Scientiﬁcalongwithacopy

of the patient data disk. This information enables Boston Scientiﬁctoregister

each implanted pulse generator and set of leads, initiate the warranty period,

and provide clinical data on the performance of the implanted system. Keep a

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IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR 9-13

copy of the Warranty Validation and Lead Registration form and programmer

printouts, and the original patient data disk for the patient’s ﬁle.

Complete the temporary patient identiﬁcation card and give it to the patient.

After receiving the validation form, Boston Scientiﬁc sends the patient a

permanent identiﬁcation card.

NOTE: A registration form is packaged with each pulse generator lead. If

completing the pulse generator Warranty Validation and Lead Registration

form for the pulse generator, completing separate validation forms for each

lead is not necessary.

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9-14 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

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10-1

POST IMPLANT INFORMATION

CHAPTER 10

This chapter contains the following topics:

• "Follow Up Testing" on page 10-2

• "Post Implant features" on page 10-3

• "Explantation" on page 10-8

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10-2 POST IMPLANT INFORMATION

FOLLOW UP TESTING

It is recommended that device functions be evaluated during follow-up testing.

WARNING: Ensure that an external deﬁbrillator and medical personnel skilled

in CPR are present during post-implant device testing should the patient

require external rescue.

Predischarge Follow Up

During the pre-discharge follow-up test, the following procedures should be

performed via telemetry using the PRM:

1. Interrogate the pulse generator and review the Summary screen.

2. Perform pacing thresholds and lead impedance tests, and intrinsic

amplitude measurements.

3. Review Histograms.

4. When all testing is complete, perform a ﬁnal interrogation and save all the

data to a patient data disk.

5. Print the Quick Notes and Patient Data reports to retain in your ﬁles for

future reference.

6. It is important to clear the therapy counters so that at the next follow-up

session the most recent episode data will be displayed. Note that the

histogram counters can be cleared from either the Brady or Tachy Counters

screen as well.

NOTE: Echo-Doppler studies may be used to evaluate AV Delay and other

programming options non-invasively post-implant.

Routine Follow Up

You should conduct routine follow-up examinations one month after the

pre-discharge study and every three months thereafter. During the routine

follow-up test, the following procedures should be performed via telemetry

using the programming system:

1. Interrogate the device and review the Summary screen.

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POST IMPLANT INFORMATION

POST IMPLANT FEATURES 10-3

2. Perform pacing thresholds and lead impedance tests, and intrinsic

amplitude measurements.

3. Print and review the Quick Notes report, and retain it in your ﬁles for future

reference.

4. For episodes of interest, review the Arrhythmia Logbook screen and print

episode details and stored electrogram information.

5. It is important to clear the therapy counters so that at the next follow-up

session the most recent episode data will be displayed.

CAUTION: Verify with a conversion test that the patient’s tachyarrhythmias

can be detected and terminated by the pulse generator system if the patient’s

status has changed or parameters have been reprogrammed.

POST IMPLANT FEATURES

Sensitivity Adjustment

The Sensitivity Adjustment feature allows you to shift the atrial sensing range to

make it less sensitive (i.e., a larger signal would be required for the device to

detect). It allows shifting the ventricular sensing range to make it less or more

sensitive. While the Nominal setting is primarily indicated for both atrial and

ventricular sensing, an adjustment can be made if, in a rare situation, atrial or

ventricular oversensing/undersensing has been observed post-implant (i.e.,

inhibition of bradycardia pacing or inappropriate tachy therapy).

WARNING: Left ventricular lead dislodgment to a position near the atria can

result in atrial oversensing or left ventricular pacing inhibition.

Should it become necessary to adjust the sensing range in a chamber,

always choose the setting that allows the greatest sensitivity, but resolves

oversensing/undersensing:

• To reduce oversensing, program the sensitivity to a higher value.

• To reduce undersensing, program the sensitivity to a lower value.

After any change to sensitivity, evaluate for appropriate sensing for both

bradycardia pacing and tachycardia detection.

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10-4 POST IMPLANT INFORMATION

POST IMPLANT FEATURES

If proper sensing cannot be restored with an adjustment or if any undersensing

is observed after making a change, consider repositioning the lead or implanting

a new sensing lead and then programming the setting back to nominal.

CAUTION: Following any sensing range adjustment or any modiﬁcation of

the sensing lead, always verify appropriate sensing.

Beeper Feature

The pulse generator contains a beeper that emits audible tones to

communicate status information. The beeper includes both programmable and

nonprogrammable features.

Programmable Features

The following beeper features are programmable:

• Beep During Capacitor Charge—When programmed to On, regardless of

the Tachy mode, a warbling tone will sound continuously while the pulse

generator is charging (except when charging during an auto capacitor

re-form). The tone will continue until charging is complete. When this

feature is programmed to Off, there is no audible indication that the pulse

generator is charging. This feature is useful during EP testing.

• Beep When Explant Is Indicated—When this feature is programmed to

On, the pulse generator emits tones upon reaching Explant. The Explant

indicator consists of 16 tones repeated every six hours after the pulse

generator reaches Explant until the feature is turned off via the programmer.

When this feature is programmed to Off, there is no audible indication

of Explant.

Perform the following steps to program the magnet and beeper features:

Magnet and Beeper Response

1. Select the Settings tab.

2. From Ventricular Tachy, select the Therapy button.

3. Select the V-Tachy Therapy Setup button.

4. Enter the desired values.

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POST IMPLANT INFORMATION

POST IMPLANT FEATURES 10-5

Beep when Explant is indicated

1. Select the Summary tab.

2. Select the Battery button.

3. From the Battery Status summary screen, select the Battery Detail button.

4. From the Battery Detail summary screen, select the desired value for Beep

when Explant is indicated.

NOTE: When the Magnet Response is programmed to Inhibit Therapy,

magnet application will cause other types of beeping tones to be emitted,

depending on the device mode. Refer to "Magnet Feature" on page 10-5 for

more information.

Nonprogrammable Features

The following beeper features are nonprogrammable:

• Battery capacity depleted—Regardless of whether Beep When Explant

Is Indicated is programmed to On or Off, once the battery capacity is

depleted, the pulse generator will emit the explant indicator tones

• Fault code tones—For certain fault codes or when safety mode is entered,

the pulse generator will beep 16 times every 6 hours.

NOTE: Beeping tones may emit under nonprogrammable scenarios in

response to device self-diagnostic testing. Advise patients to have their

pulse generator checked whenever they hear tones coming from the device.

Contact Technical Services at the phone number on the back of this manual

for assistance.

Magnet Feature

The magnet feature allows certain device functions to be triggered when a

magnet is placed in close proximity to the pulse generator (Figure 10-1 on

page 10-6).

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10-6 POST IMPLANT INFORMATION

POST IMPLANT FEATURES

Position the magnet over the

pulse generator as shown.

Magnet (model 6860)

3.0 cm

Pulse generator

Top View

Figure 10-1. Proper position of magnet Model 6860 to activate the pulse generator magnet feature

The pulse generator Magnet Response settings can be programmed to control

the behavior of the pulse generator when a magnet is detected. The Magnet

Response settings are located in the Magnet and Beeper section of the V-Tachy

Therapy Setup screen. The following Magnet Response settings are available:

• Off—no response

• Store EGM—patient monitoring data will be stored

• Inhibit Therapy—therapy will be stopped

Off

When the Magnet Response is programmed to Off, application of the magnet

will have no effect on the pulse generator.

Store EGM

When the Magnet Response is programmed to Store EGM, application of the

magnet will activate the patient triggered monitor functionality. Refer to "Patient

Triggered Monitor" on page 7-17 for additional information.

Inhibit Therapy

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POST IMPLANT INFORMATION

POST IMPLANT FEATURES 10-7

When the Magnet Response is programmed to Inhibit Therapy, application of

the magnet will inhibit and/or divert charging for a shock, divert a shock that is

about to be delivered, or inhibit and/or divert further ATP therapy.

When Magnet Response is programmed to Inhibit Therapy, initiation of

tachyarrhythmia therapy and arrhythmia induction is inhibited any time the

magnet is properly positioned over the pulse generator. The tachyarrhythmia

detection process continues, but therapy or induction cannot be triggered.

When a magnet is placed over the pulse generator, the following will occur:

• If the Tachy mode is Monitor + Therapy or Off when the magnet is applied,

the Tachy mode changes temporarily to Monitor Only mode and will

remain in Monitor Only mode as long as the magnet is applied. Three

seconds after the magnet is removed, the mode will return to the previously

programmed mode.

• If the pulse generator is charging to deliver shock therapy when the magnet

is applied, the charging continues but is then terminated within one to two

seconds of magnet application, and the charge is diverted. (This delay

occurs in case the magnet is inadvertently passed over the device when

therapy inhibition is not desired.) The pulse generator remains in temporary

Monitor Only mode while the magnet is applied. No further therapy is

initiated until the magnet is removed; however, detection will continue.

• If charging is complete or completes within the 1–2 second delay period,

holding the magnet over the pulse generator for more than two seconds

will divert the shock. (If the magnet is removed during the delay period,

the shock could still be delivered.) Shocks will not be delivered with the

magnet in place.

• If the pulse generator is initiating ﬁbrillation induction or ATP pulses, it

terminates the delivery after one to two seconds of magnet application. No

further induction or ATP pulse sequences are initiated until the magnet

is removed.

• If the Tachy Mode is Monitor Only or Off, magnet application will produce a

constant tone to indicate that the device is in a non-therapy mode.

• If the Tachy Mode is Monitor + Therapy or the pulse generator is in

Electrocautery Protection Mode, magnet application will cause the pulse

generator to beep once per second to indicate that the device is in a

therapy mode.

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10-8 POST IMPLANT INFORMATION

EXPLANTATION

NOTE: If tachy detection occurs while the magnet is in place, detailed therapy

history will indicate that therapy was not delivered because the device was

in Monitor Only mode.

EXPLANTATION

An Observation/Complication/Out-of-Service Reporting form should be

completed and sent to Boston Scientiﬁc when a product is removed from

service. Return all explanted pulse generators and leads with product

performance allegations or warranty considerations to Boston Scientiﬁc.

Examination of explanted devices provides information for continued

improvement in device reliability and will permit calculation of any warranty

replacement credit use.

In the event of patient death (regardless of cause), the explanted pulse

generator and/or lead should be returned to Boston Scientiﬁcalong

with the Observation/Complication/Out-of-Service Reporting form and

copies of the autopsy report, if performed. For other observation or

complications reasons, also complete and return to Boston Scientiﬁcthe

Observation/Complication/Out-of-Service Reporting form.

NOTE: Disposal of explanted devices is subject to local, state, and federal

regulations. Contact your sales representative or call the phone number on the

back cover of this manual for a Returned Product Kit.

NOTE: Discoloration of the pulse generator may have occurred due to a

normal process of anodization, and has no effect on the pulse generator

function.

CAUTION: Be sure that the pulse generator is removed before cremation.

Cremation and incineration temperatures might cause the pulse generator to

explode.

CAUTION: Before explanting, cleaning, or shipping the device, complete the

following actions to prevent unwanted shocks, overwriting of important therapy

history data, and audible tones:

• Program the pulse generator Tachy and Brady Modes to Off.

• Program the Magnet Response feature to Off.

• Program the Beep When Explant is Indicated feature to Off.

Consider the following items when explanting and returning the pulse generator:

- DRAFT -

POST IMPLANT INFORMATION

EXPLANTATION 10-9

• Interrogate the pulse generator and print a Combined Follow-up report.

• Deactivate the pulse generator before explantation.

• Disconnect the leads from the pulse generator.

• If leads are also explanted, attempt to remove them intact. Do not remove

leads with hemostats or any other clamping tool that may damage the

leads. Resort to tools only if manual manipulation cannot free the lead.

• Wash, but do not submerge, the pulse generator and leads to remove

body ﬂuids and debris using a disinfectant solution. Do not allow ﬂuids to

enter the pulse generator’s lead ports.

• UseaBostonScientiﬁc Returned Product Kit to properly package the

pulse generator.

• Complete the Observation/Complication/Out-of-Service Reporting form.

• Send the form and the Returned Product Kit to Boston Scientiﬁc.

- DRAFT -

10-10 POST IMPLANT INFORMATION

EXPLANTATION

- DRAFT -

A-1

PROGRAMMABLE OPTIONS

APPENDIX A

Table A-1. ZIP Telemetry settings

Parameter Programmable Values Nominal

Communication Mode Enable use of ZIP telemetry (May

require limited use of wand), Use

wand for all telemetry

Enable use of ZIP telemetry (May

require limited use of wand)

Table A-2. Tachy Mode parameter

Parameter Programmable Values Nominal

Tachy Mode Off, Monitor Only, Monitor + Therapy,

Enable Electrocautery Protection

Storage

Table A-3. Ventricular Zones parameter

Parameter Programmable Values Nominal

Ventricular Zones 1, 2, 3 2

Table A-4. Detection parameters for 1-zone, 2-zone, and 3-zone conﬁgurations

Parameter VT-1 Zone VT Zone VF Zone Nominal

Ratea( bpm) 3 zones

(intervals in ms)

90, 95, ..., 200

(667–300)

110, 115, ..., 210

(545–286) 220 (273)

130, 135, ..., 210

(462–286), 220, 230,

240, 250 (273–240)

140 (Tolerance ± 5

ms) for VT-1 Zone

160 (Tolerance ± 5

ms) for VT Zone

200 (Tolerance ± 5

ms) for VF Zone

Ratea( bpm) 2 zones

(intervals in ms)

–– 90, 95, ..., 210

(667–286) 220 (273)

110, 115, ..., 210

(545–286) 220, 230,

240, 250 (273–240)

160 (Tolerance ± 5

ms) for VT Zone

200 (Tolerance ± 5

ms) for VF Zone

Ratea( bpm) 1 zone

(intervals in ms)

–– –– 90, 95, ..., 210 (667–

286) 220 (273)

200 (Tolerance ± 5

ms)

Initial Durationb

(sec) 3 zones

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0, 20.0,

25.0, ..., 60.0

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0, 20.0,

25.0, 30.0

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0

2.5 (Tolerance ± 1

cardiac cycle) for

VT-1 Zone

2.5 (Tolerance ± 1

cardiac cycle) for VT

Zone

1.0 (Tolerance ± 1

cardiac cycle) for VF

Zone

- DRAFT -

A-2 PROGRAMMABLE OPTIONS

Table A-4. Detection parameters for 1-zone, 2-zone, and 3-zone conﬁgurations (continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

Initial Durationb

(sec) 2 zones

–– 1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0, 20.0,

25.0, 30.0

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0

2.5 (Tolerance ± 1

cardiac cycle) for VT

Zone

1.0 (Tolerance ± 1

cardiac cycle) for VF

Zone

Initial Durationb

(sec) 1 zone

–– –– 1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0

1.0 (Tolerance ± 1

cardiac cycle)

Redetection

Durationb(sec) 3

zones

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0

1.0

(nonprogrammable)

1.0 (Tolerance ± 1

cardiac cycle) for all

zones

Redetection

Durationb(sec) 2

zones

–– 1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0

1.0

(nonprogrammable)

1.0 (Tolerance ± 1

cardiac cycle) for all

zones

Redetection

Durationb(sec) 1

zone

–– –– 1.0

(nonprogrammable)

1.0 (Tolerance ± 1

cardiac cycle)

Post-shock

Durationb(sec) 3

zones

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0, 20.0,

25.0, ..., 60.0

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0, 20.0,

25.0, 30.0

1.0

(nonprogrammable)

1.0 (Tolerance ± 1

cardiac cycle) for all

zones

Post-shock

Durationb(sec) 2

zones

–– 1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0, 20.0,

25.0, 30.0

1.0

(nonprogrammable)

1.0 (Tolerance ± 1

cardiac cycle) for all

zones

Post-shock

Durationb(sec) 1

zone

–– –– 1.0

(nonprogrammable)

1.0 (Tolerance ± 1

cardiac cycle)

a. The Rate difference between each tachy zone must be at least 20 bpm. The lowest Tachy Rate Threshold must be ≥5 bpm

higher than the Maximum Tracking Rate, Maximum Sensor Rate, and the Maximum Pacing Rate; and the lowest Tachy Rate

Threshold must be ≥15 bpm higher than the Lower Rate Limit.

b. The Duration in a zone must be equal to or greater than the Duration in the next highest zone.

Table A-5. Ventricular Detection Enhancement Type for 2-zone and 3-zone conﬁgurations

Parameter Programmable Values Nominal

Detection Enhancement Type Off, Rhythm ID, Onset/Stability Onset/Stability

Table A-6. Onset/Stability detection enhancement parameters for 2-zone and 3-zone conﬁgurations

Parameter VT-1 Zone VT Zone VF Zone Nominal

V Rate > A Rate 3

zones

Off, On –– –– On

V Rate > A Rate 2

zones

–– Off, On –– On

- DRAFT -

PROGRAMMABLE OPTIONS A-3

Table A-6. Onset/Stability detection enhancement parameters for 2-zone and 3-zone conﬁgurations

(continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

AFib Rate Threshold

( bpm) 3 zones

Off, 100, 110, ..., 300 –– –– 170 (Tolerance ± 5

ms)

AFib Rate Threshold

( bpm) 2 zones

–– Off, 100, 110, ..., 300 –– 170 (Tolerance ± 5

ms)

Stability (ms) 3

zones

Off, 6, 8, ..., 32 35,

40, ..., 60 70, 80, ...,

120

–– –– 20 (Tolerance ± 5

ms)

Stability (ms) 2

zones

–– Off, 6, 8, ..., 32 35,

40, ..., 60 70, 80, ...,

120

–– 20 (Tolerance ± 5

ms)

Shock If Unstable

(ms) 3 zones

–– Off, 6, 8, ..., 32 35,

40, ..., 60 70, 80, ...,

120

–– 30 (Tolerance ± 5

ms)

Shock If Unstable

(ms) 2 zones

–– Off, 6, 8, ..., 32 35,

40, ..., 60 70, 80, ...,

120

–– Off (Tolerance ± 5

ms)

Onset (% or ms) 3

zones

Off, 9, 12, 16, 19, ...,

37 41, 44, 47, 50%

or 50, 60, ..., 250 ms

–– –– 9% (Tolerance ± 5

ms)

Onset (% or ms) 2

zones

–– Off, 9, 12, 16, 19, ...,

37, 41, 44, 47, 50%

or 50, 60, ..., 250 ms

–– 9% (Tolerance ± 5

ms)

Stability And/Or

Onset 3 zones

And, Or –– –– And

Stability And/Or

Onset 2 zones

–– And, Or –– And

Sustained Rate

Duration (min:sec) 3

zones

Off, 00:10, 00:15, ...,

00:55 01:00, 01:15,

..., 02:00 02:30,

03:00, ..., 10:00

15:00, 20:00, ...,

60:00

–– –– 03:00 (Tolerance ± 1

cardiac cycle)

Sustained Rate

Duration (min:sec) 2

zones

–– Off, 00:10, 00:15, ...,

00:55 01:00, 01:15,

..., 02:00 02:30,

03:00, ..., 10:00

15:00, 20:00, ...,

60:00

–– 03:00 (Tolerance ± 1

cardiac cycle)

Detection

Enhancement 3

zones

Off, On Off, On –– On (VT-1) Off (VT)

- DRAFT -

A-4 PROGRAMMABLE OPTIONS

Table A-6. Onset/Stability detection enhancement parameters for 2-zone and 3-zone conﬁgurations

(continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

Detection

Enhancement 2

zones

–– Off, On –– On

Atrial

Tachyarrhythmia

Discrimination 3

zones

Off, On –– –– On

Atrial

Tachyarrhythmia

Discrimination 2

zones

–– Off, On –– On

Sinus Tachycardia

Discrimination 3

zones

Off, On –– –– On

Sinus Tachycardia

Discrimination 2

zones

–– Off, On –– On

Polymorphic VT

Discrimination 3

zones

–– Off, On –– On

Polymorphic VT

Discrimination 2

zones

–– Off, On –– Off

Table A-7. Rhythm ID detection enhancement parameters for 2-zone and 3-zone conﬁgurations

Parameter VT-1 Zone VT Zone VF Zone Nominal

Detection

Enhancement 3

zones

Off, On Off, On –– On (VT-1) Off (VT)

Detection

Enhancement 2

zones

–– Off, On –– Off

Sustained Rate

Duration (min:sec) 3

zones

Off, 00:10, 00:15,

..., 01:00, 01:15,

..., 02:00, 02:30,

..., 10:00, 15:00, ...,

60:00

Off, 00:10, 00:15,

..., 01:00, 01:15,

..., 02:00, 02:30,

..., 10:00, 15:00, ...,

60:00

–– 03:00 (VT-1 and

VT) (Tolerance ± 1

cardiac cycle)

Sustained Rate

Duration (min:sec) 2

zones

–– Off, 00:10, 00:15,

..., 01:00, 01:15,

..., 02:00, 02:30,

..., 10:00, 15:00, ...,

60:00

–– 03:00 (Tolerance ± 1

cardiac cycle)

- DRAFT -

PROGRAMMABLE OPTIONS A-5

Table A-7. Rhythm ID detection enhancement parameters for 2-zone and 3-zone conﬁgurations (continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

Passive Method 3

zones (one value for

all zones)

Off, On Off, On –– On

Passive Method 2

zones (one value for

all zones)

–– Off, On –– On

Active Method 3

zones (one value for

all zones)

Off, On Off, On –– On

Active Method 2

zones (one value for

all zones)

–– Off, On –– On

Temp LRL ( ppm)

(one value for all

zones)

Use Norm LRL, 30,

35, ..., 105

Use Norm LRL, 30,

35, ..., 105

–– Use Norm LRL

(Tolerance ± 5 ms)

Temp LRL 2 zones

( ppm) (one value for

all zones)

–– Use Norm LRL, 30,

35, ..., 105

–– Use Norm LRL

(Tolerance ± 5 ms)

Atrial Tachy

Discrimination 3

zones (one value for

all zones)

Off, On Off, On –– On

Atrial Tachy

Discrimination 2

zones (one value for

all zones)

–– Off, On –– On

AFib Rate Threshold

( bpm) 3 zones (one

value for all zones)

100, 110, ..., 300 100, 110, ..., 300 –– 170 (Tolerance ± 5

ms)

AFib Rate Threshold

( bpm) 2 zones (one

value for all zones)

–– 100, 110, ..., 300 –– 170 (Tolerance ± 5

ms)

Stability (ms) 3

zones (one value for

all zones)

6, 8, ..., 32, 35, 40,

..., 60, 70, ..., 120

6, 8, ..., 32, 35, 40,

..., 60, 70, ..., 120

–– 20 (Tolerance ± 5

ms)

Stability (ms) 2

zones (one value for

all zones)

–– 6, 8, ..., 32, 35, 40,

..., 60, 70, ..., 120

–– 20 (Tolerance ± 5

ms)

- DRAFT -

A-6 PROGRAMMABLE OPTIONS

Table A-8. Post-shock Onset/Stability detection enhancement parameters for 2-zone and 3-zone

conﬁgurations

Parameter VT-1 Zone VT Zone VF Zone Nominal

Post-shock V Rate >

A Rate 3 zones

Off, On –– –– On

Post-shock V Rate >

A Rate 2 zones

–– Off, On –– On

Post-shock AFib

Rate Threshold

( bpm) 3 zones

Off, 100, 110, ..., 300 –– –– 170 (Tolerance ± 5

ms)

Post-shock AFib

Rate Threshold

( bpm) 2 zones

–– Off, 100, 110, ..., 300 –– 170 (Tolerance ± 5

ms)

Post-shock Stability

(ms) 3 zones

Off, 6, 8, ..., 32, 35,

40, ..., 60, 70, 80, ...,

120

–– –– 20 (Tolerance ± 5

ms)

Post-shock Stability

(ms) 2 zones

–– Off, 6, 8, ..., 32, 35,

40, ..., 60, 70, 80, ...,

120

–– 20 (Tolerance ± 5

ms)

Post-shock

Sustained Rate

Duration (min:sec) 3

zones

Off, 00:10, 00:15, ...,

00:55, 01:00, 01:15,

..., 02:00, 02:30,

03:00, ..., 10:00,

15:00, 20:00, ...,

60:00

–– –– 00:15 (Tolerance ± 1

cardiac cycle)

Post-shock

Sustained Rate

Duration (min:sec) 2

zones

–– Off, 00:10, 00:15, ...,

00:55, 01:00, 01:15,

..., 02:00, 02:30,

03:00, ..., 10:00,

15:00, 20:00, ...,

60:00

–– 00:15 (Tolerance ± 1

cardiac cycle)

Table A-9. Post-shock Rhythm ID detection enhancement parameters for 2-zone and 3-zone conﬁgurations

Parameter VT-1 Zone VT Zone VF Zone Nominal

Post-shock

Detection

Enhancement 3

zones

Off, On Off, On –– Off

Post-shock

Detection

Enhancement 2

zones

–– Off, On –– Off

- DRAFT -

PROGRAMMABLE OPTIONS A-7

Table A-9. Post-shock Rhythm ID detection enhancement parameters for 2-zone and 3-zone conﬁgurations

(continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

Post-shock

Sustained Rate

Duration (min:sec) 3

zones

Off, 00:10, 00:15,

01:00, 01:15, ...,

02:00, 02:30, ...,

10:00, 15:00, ...,

60:00

Off, 00:10, 00:15,

01:00, 01:15, ...,

02:00, 02:30, ...,

10:00, 15:00, ...,

60:00

–– 0:15 (Tolerance ± 1

cardiac cycle)

Post-shock

Sustained Rate

Duration (min:sec) 2

zones

–– Off, 00:10, 00:15,

01:00, 01:15, ...,

02:00, 02:30, ...,

10:00, 15:00, ...,

60:00

–– 0:15 (Tolerance ± 1

cardiac cycle)

Table A-10. Ventricular ATP parameters (speciﬁed into a 750 Ωload)

Parameter VT-1 Zone VT Zone VF Zone Nominal

ATP Type 3 zones Off, Burst, Ramp,

Scan, Ramp/Scan

Off, Burst, Ramp,

Scan, Ramp/Scan

–– Off (VT-1); Burst (VT

ATP1); Ramp (VT

ATP2)

ATP Type 2 zones –– Off, Burst, Ramp,

Scan, Ramp/Scan

–– Burst (VT ATP1);

Ramp (VT ATP2)

Number of Bursts

(per scheme) 3

zones

Off, 1, 2, ..., 30 Off, 1, 2, ..., 30 –– Off (VT-1); 2 (VT

ATP1); 1 (VT ATP2)

Number of Bursts

(per scheme) 2

zones

–– Off, 1, 2, ..., 30 –– 2 (VT ATP1); 1 (VT

ATP2)

Initial Pulse (pulses)

3 zones

1, 2, ..., 30 1, 2, ..., 30 –– 4 (VT-1); 10 (VT)

Initial Pulse (pulses)

2 zones

–– 1, 2, ..., 30 –– 10

Pulse Increment

(pulses) 3 zones

0, 1, ..., 5 0, 1, ..., 5 –– 0

Pulse Increment

(pulses) 2 zones

–– 0, 1, ..., 5 –– 0

Maximum Number

of Pulses 3 zones

1, 2, ..., 30 1, 2, ..., 30 –– 4 (VT-1); 10 (VT)

Maximum Number

of Pulses 2 zones

–– 1, 2, ..., 30 –– 10

Coupling Interval (%

or ms) 3 zones

50, 53, 56, 59; 63,

66, ..., 84, 88, 91,

94, 97% or 120, 130,

..., 750 ms

50, 53, 56, 59; 63,

66,...,84,88,91,

94, 97% or 120, 130,

..., 750 ms

–– 81% (Tolerance ± 5

ms)

- DRAFT -

A-8 PROGRAMMABLE OPTIONS

Table A-10. Ventricular ATP parameters (speciﬁed into a 750 Ωload) (continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

Coupling Interval (%

or ms) 2 zones

–– 50, 53, 56, 59; 63,

66,...,84,88,91,

94, 97% or 120, 130,

..., 750 ms

–– 81% (Tolerance ± 5

ms)

Coupling Interval

Decrement (ms) 3

zones

0, 2, ..., 30 0, 2, ..., 30 –– 0(Tolerance±5ms)

Coupling Interval

Decrement (ms) 2

zones

–– 0, 2, ..., 30 –– 0(Tolerance±5ms)

Burst Cycle Length

(BCL) (% or ms) 3

zones

50, 53, 56, 59; 63,

66, ..., 84, 88, 91,

94, 97% or 120, 130,

..., 750 ms

50, 53, 56, 59; 63,

66,...,84,88,91,

94, 97% or 120, 130,

..., 750 ms

–– 81% (Tolerance ± 5

ms)

Burst Cycle Length

(BCL) (% or ms) 2

zones

–– 50, 53, 56, 59; 63,

66,...,84,88,91,

94, 97% or 120, 130,

..., 750 ms

–– 81% (Tolerance ± 5

ms)

Ramp Decrement

(ms) 3 zones

0, 2, ..., 30 0, 2, ..., 30 –– 0(VT-1);0(VT

ATP1); 10 (VT ATP2)

(Tolerance ± 5 ms)

Ramp Decrement

(ms) 2 zones

–– 0, 2, ..., 30 –– 0 (VT ATP1); 10 (VT

ATP2) (Tolerance ±

5ms)

Scan Decrement

(ms) 3 zones

0, 2, ..., 30 0, 2, ..., 30 –– 0(Tolerance±5ms)

Scan Decrement

(ms) 2 zones

–– 0, 2, ..., 30 –– 0(Tolerance±5ms)

Minimum Interval

(ms) 3 zones

120, 130, ..., 400 120, 130, ..., 400 –– 220 (Tolerance ± 5

ms)

Minimum Interval

(ms) 2 zones

–– 120, 130, ..., 400 –– 220 (Tolerance ± 5

ms)

Right Ventricular

ATP Pulse Widtha

(ms) 3 zones (one

value for all zones)

0.1, 0.2, ..., 2.0 0.1, 0.2, ..., 2.0 –– 1.0(Tolerance±

0.03 ms at < 1.8 ms;

±0.08msat≥1.8

ms)

Right Ventricular

ATP Pulse Widtha

(ms) 2 zones (one

value for all zones)

–– 0.1, 0.2, ..., 2.0 –– 1.0(Tolerance±

0.03 ms at < 1.8 ms;

±0.08msat≥1.8

ms)

- DRAFT -

PROGRAMMABLE OPTIONS A-9

Table A-10. Ventricular ATP parameters (speciﬁed into a 750 Ωload) (continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

Left Ventricular ATP

Pulse Widtha(ms) 3

zones (one value for

all zones)

0.1, 0.2, ..., 2.0 0.1, 0.2, ..., 2.0 –– 1.0(Tolerance±

0.03 ms at < 1.8 ms;

±0.08msat≥1.8

ms)

Left Ventricular ATP

Pulse Widtha(ms) 2

zones (one value for

all zones)

–– 0.1, 0.2, ..., 2.0 –– 1.0(Tolerance±

0.03 ms at < 1.8 ms;

±0.08msat≥1.8

ms)

Right Ventricular

ATP Amplitudea(V)

3 zones (one value

for all zones)

0.1, 0.2, ..., 3.5, 4.0,

..., 7.5

0.1, 0.2, ..., 3.5, 4.0,

..., 7.5

–– 5.0(Tolerance±

15% or ± 100 mV,

whichever is greater)

Right Ventricular

ATP Amplitudea(V)

2 zones (one value

for all zones)

–– 0.1, 0.2, ..., 3.5, 4.0,

..., 7.5

–– 5.0(Tolerance±

15% or ± 100 mV,

whichever is greater)

Left Ventricular ATP

Amplitudea(V) 3

zones (one value for

all zones)

0.1, 0.2, ..., 3.5, 4.0,

..., 7.5

0.1, 0.2, ..., 3.5, 4.0,

..., 7.5

–– 5.0(Tolerance±

15% or ± 100 mV,

whichever is greater)

Left Ventricular ATP

Amplitudea(V) 2

zones (one value for

all zones)

–– 0.1, 0.2, ..., 3.5, 4.0,

..., 7.5

–– 5.0(Tolerance±

15% or ± 100 mV,

whichever is greater)

ATP Time-outb

(seconds) 3 zones

Off, 10, 15, ..., 60,

75, 90, ..., 120, 150,

..., 600, 900, ...,

3600

Off, 10, 15, ..., 60,

75, 90, ..., 120, 150,

..., 600, 900, ...,

3600

–– 60 (Tolerance ± 1

cardiac cycle)

ATP Time-outb

(seconds) 2 zones

–– Off, 10, 15, ..., 60,

75, 90, ..., 120, 150,

..., 600, 900, ...,

3600

–– 60 (Tolerance ± 1

cardiac cycle)

QUICK CONVERT

ATP (VF Only) 3

zones

–– –– Off, On On

QUICK CONVERT

ATP (VF Only) 2

zones

–– –– Off, On On

a. The programmed Amplitude and Pulse Width values affect Post Therapy Brady Pacing, but are separately programmable from

Normal Brady Pacing, Temporary Brady Pacing, and EP Test.

b. The VT-1 ATP Time-out must be greater than or equal to the VT ATP Time-out.

- DRAFT -

A-10 PROGRAMMABLE OPTIONS

Table A-11. Ventricular Shock Parameters

Parameter Programmable Values Nominal

Shocks 1 and 2 energy (J)abc

(stored energy)

Off, 0.1, 0.3, 0.6, 0.9, 1.1, 1.7, 2, 3,

5, 6, 7, 9, 11, 14, 17, 21, 23, 26, 29,

31, 36 (HE), 41 (HE)

41 J (Tolerance ± 60% for ≤0.3 J, ±

40% for ≤0.6–3 J, ± 20% for 5–36

J, ± 10% for 41 J)

Energy of Remaining Shocks (J)ac

(stored energy)

Off, 41 (HE) 41 J (Tolerance ± 10% for 41 J)

Lead PolaritydInitial, Reversed Initial

Committed Shock Off, On Off

Shock Lead Vector RV Coil to RA Coil and Can, RV Coil

to Can, RV Coil to RA Coil

RV Coil to RA Coil and Can

a. Biphasic energy is speciﬁed.

b. The Shock 2 energy level must be greater than or equal to the Shock 1 energy level.

c. In a VT-1 zone of a 3-zone conﬁguration or a VT zone of a 2-zone conﬁguration, all or some of the shocks may be programmed to

Off while other shocks in that zone are programmed in joules.

d. A commanded STAT SHOCK is delivered at the programmed Polarity.

Table A-12. Pacing therapy parameters (Normal, Post-Therapy, and Temporary) (speciﬁed into a 750 Ωload)

Parameter Programmable Values Nominal

Modeabg DDD(R), DDI(R), VDD(R), VVI(R),

AAI(R), Off; Temporary: DDD, DDI,

DOO, VDD, VVI, VOO, AAI, AOO,

Off

DDD

Lower Rate Limit (LRL)ac( ppm) 30, 35, ..., 185 45 (Tolerance ± 5 ms)

Maximum Tracking Rate (MTR) gj

( ppm)

30, 35, ..., 185 130(Tolerance±5ms)

Maximum Sensor Rate (MSR)gj

( ppm)

30, 35, ..., 185 130(Tolerance±5ms)

Pulse Amplitudeadef(atrium) (V) 0.1, 0.2, ... 3.5, 4.0, ..., 5.0 3.5 (5.0 post-therapy) (Tolerance

± 15% or ± 100mV, whichever is

greater)

Pulse Amplitudeadef(right ventricle)

(V)

0.1, 0.2, ..., 3.5, 4.0, ..., 7.5 3.5 (5.0 post-therapy) (Tolerance

± 15% or ± 100mV, whichever is

greater)

Pulse Widthadef(atrium, right

ventricle) (ms)

0.1, 0.2, ..., 2.0 0.4 (1.0 post-therapy) (Tolerance ±

0.03 ms at < 1.8 ms; ± 0.08 ms at

≥1.8 ms)

Atrial Pace/Sense Conﬁgurationag Bipolar, Off Bipolar

Activity Thresholdgj Very High, High, Medium High,

Medium, Medium Low, Low, Very

Low

Medium

Reaction Timegj(sec) 10, 20, ..., 50 30

- DRAFT -

PROGRAMMABLE OPTIONS A-11

Table A-12. Pacing therapy parameters (Normal, Post-Therapy, and Temporary) (speciﬁed into a 750 Ω

load) (continued)

Parameter Programmable Values Nominal

Response Factorgj 1, 2, ..., 16 8

Recovery Timegj(min) 2, 3, ..., 16 2

Maximum PVARPag(ms) 150, 160, ..., 500 280(Tolerance±5ms)

Minimum PVARPag(ms) 150, 160, ..., 500 240(Tolerance±5ms)

PVARP After PVCag(ms) Off, 150, 200, ..., 500 400 (Tolerance ± 5 ms)

RV-Blank After A-Paceah(ms) 45, 65, 85, Smart Smart (Tolerance ± 5 ms)

A-Blank After V-Paceah(ms) 85, 105, 125, Smart Smart (Tolerance ± 5 ms)

A-Blank After RV-Senseah(ms) 45, 65, 85, Smart Smart (Tolerance ± 5 ms)

Maximum VRP (right ventricle)ai

(ms)

150, 160, 170, ..., 500 250(Tolerance±5ms)

Minimum VRP (right ventricle)ai

(ms)

150, 160, ..., 500 230(Tolerance±5ms)

Maximum Paced AV Delayag(ms) 30, 40, ..., 300 180(Tolerance±5ms)

Minimum Paced AV Delayag(ms) 30, 40, ..., 300 180(Tolerance±5ms)

Maximum Sensed AV Delayag(ms) 30, 40, ..., 300 120(Tolerance±5ms)

Minimum Sensed AV Delayag(ms) 30, 40, ..., 300 120(Tolerance±5ms)

Respiratory Sensorag Off, On On

Tracking Preferencegj Off, On On

Rate Hysteresis Hysteresis Offsetg

j( ppm)

-80, -75, ... ,-5, Off Off (Tolerance ± 5 ms)

Rate Hysteresis Search Hysteresisg

j(cycles)

Off, 256, 512, 1024, 2048, 4096 Off (Tolerance ± 1 cycle)

Rate Smoothing (up, down)gj(%) Off, 3, 6, 9, 12, 15, 18, 21, 25 Off (Tolerance 1%)

Noise Responseag AOO, VOO, DOO, Inhibit Pacing DOO for DDD(R) and DDI(R)

modes; VOO for VDD(R) and VVI(R)

modes; AOO for AAI(R) mode

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A-12 PROGRAMMABLE OPTIONS

Table A-12. Pacing therapy parameters (Normal, Post-Therapy, and Temporary) (speciﬁed into a 750 Ω

load) (continued)

Parameter Programmable Values Nominal

Maximum Pacing Rateag (ppm) 30, 35, ... ,185 130(Tolerance±5ms)

Post-therapy Pacing Period

(min:sec) (available post-shock

only)

00:15, 00:30, 00:45, 01:00, 01:30,

02:00, 03:00, 04:00, 05:00, 10:00,

15:00, 30:00, 45:00, and 60:00

00:30 (Tolerance ± 1 cardiac cycle)

a. The programmed Normal Brady values will be used as the nominal values for Temporary Brady pacing.

b. Refer to the NASPE/BPEG codes below for an explanation of the programmable values. The identiﬁcation code of the North

American Society of Pacing and Electrophysiology (NASPE) and the British Pacing and Electrophysiology Group (BPEG) is based

on the categories listed in the table.

c. The basic pulse period is equal to the pacing rate and the pulse interval (no hysteresis). Runaway protection circuitry inhibits

bradycardia pacing above 205 ppm. Magnet application does not affect pacing rate (test pulse interval).

d. Separately programmable for ATP/Post-Shock, Temporary Brady, and EP Test.

e. The minimum value of energy delivered at 5 V and 0.5 ms is 20 µJ with 200–500 Ω, and 12 µJ with 1000 Ωresistive load

at 37°C ± 1°C for BOL and Explant.

f. Values are not affected by temperature variation within the range 20°–43°C.

g. This parameter is used globally in Normal Brady pacing and Post-shock Brady pacing. Changing the value for Normal Brady will

change the value for Post-shock Brady.

h. This parameter is automatically set to at least 85 ms for Post-Shock Brady.

i. This parameter is automatically adjusted in Post-Shock Brady to allow appropriate sensing.

j. This parameter is disabled during Temporary Brady.

Table A-13. Brady/CRT left ventricular pacing parameters (speciﬁed into a 750 Ωload)

Parameter Programmable Values Nominala

Ventricular Pacing ChamberbRV Only, BiV BiV

LV Offsetbg(ms) -100, -90, ..., 0 0(Tolerance±5ms)

Pulse Amplitudecde(left ventricle)

(V)

0.1, 0.2, ..., 3.5, 4.0, ..., 7.5 3.5 (5.0 post therapy) (Tolerance

± 15% or ± 100mV) (whichever is

greater)

Pulse Widthcde(left ventricle) (ms) 0.1, 0.2, ..., 2.0 0.4 (1.0 post therapy) (Tolerance ±

0.03 ms at < 1.8 ms; ± 0.08 ms at

≥1.8 ms)

LV-Blank After A-Pacef(ms) 45, 65, 85, Smart Smart (Tolerance ± 5 ms)

LVRPb(ms) 250, 260, ..., 500 250 (Tolerance ± 7.5 ms)

LVPPb(ms) 300, 350, ..., 500 400(Tolerance±5ms)

BiV TriggerbOff, On On

Left Ventricular Electrode

Conﬁgurationb

Dual, Single, None None

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PROGRAMMABLE OPTIONS A-13

Table A-13. Brady/CRT left ventricular pacing parameters (speciﬁed into a 750 Ωload) (continued)

Parameter Programmable Values Nominala

Left Ventricular Pace ConﬁgurationbSingle or Dual:

LVtip>>Can

LVtip>>RV

Dual Only:

LVring>>Can

LVring>>RV

LVtip>>LVring

LVring>>LVtip

Single: LVtip>>RV

Dual: LVtip>>LVring

Left Ventricular Sense

Conﬁgurationb

Single or Dual:

LVtip>>Can

LVtip>>RV

Off

Dual Only:

LVring>>Can

LVring>>RV

LVtip>>LVring

Single: LVtip>>RV

Dual: LVtip>>LVring

a. The programmed Normal Brady values will be used as the nominal values for Temporary Brady pacing.

b. This parameter is used globally in Normal Brady pacing and Post-shock Brady pacing. Changing the value for Normal Brady will

change the value for Post-shock Brady.

c. Separately programmable for ATP/Post-Shock, Temporary Brady, and EP Test.

d. The minimum value of energy delivered at 5 V and 0.5 ms is 20 µJ with 200–500 Ω, and 12 µJ with 1000 Ωresistive load

at 37°C ± 1°C for BOL and Explant.

e. Values are not affected by temperature variation within the range 20°–43°C.

f. This parameter is automatically set to at least 85 ms for Post-Shock Brady.

g. WhentheLVOffsetis0theLVPacefollowstheRVPaceby2.5ms

Table A-14. Atrial Tachy Parameters

Parameter Programmable Values Nominal

ATR Mode Switchab Off, On On

ATR Trigger Rateab( bpm) 100, 110, ..., 300 170(Tolerance±5ms)

ATR Durationab(cycles) 0, 8, 16, 32, 64, 128, 256, 512,

1024, 2048

8(Tolerance±1cardiaccycle)

Entry Countab(cycles) 1, 2, ..., 8 8

Exit Countab(cycles) 1, 2, ..., 8 8

ATR Fallback Modeab VDI, DDI, VDIR, DDIR DDI

ATR Fallback Timeab(min:sec) 0, 0:15, 0:30, 0:45, 1:00, 1:15, 1:30,

1:45, 2:00

0:30

ATR/VTR Fallback LRLab( ppm) 30, 35, ..., 185 70 (Tolerance ± 5 ms)

ATR VRRab Off, Min, Med, Max Min

ATR Maximum Pacing Rateab

( ppm)

30, 35, ..., 185 130

ATR BiV Triggerab Off, On On

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A-14 PROGRAMMABLE OPTIONS

Table A-14. Atrial Tachy Parameters (continued)

Parameter Programmable Values Nominal

Atrial Flutter Responsebc Off, On Off

Atrial Flutter Response Ratebc

( bpm)

100, 110, ..., 300 170(Tolerance±5ms)

PMT Terminationbc Off, On On

VRRbc Off, Min, Med, Max Off

a. The programmed Normal Brady values will be used as the nominal values for Temporary Brady pacing.

b. This parameter is used globally in Normal Brady pacing and Post-shock Brady pacing. Changing the value for Normal Brady will

change the value for Post-shock Brady.

c. This parameter gets disabled during Temporary Brady.

Table A-15. Brady Mode values based on NASPE/BPEG codes

Position I II III IV V

Category Chambers

Paced

Chambers

Sensed

Response

to Sensing

Programmability,

rate modulation

Antitachyarrhythmia

Functions

Letters 0–None 0–None 0–None 0–None 0–None

A–Atrium A–Atrium T–Triggered P–Simple

Programmable

P–Pacing

(Antitachyarrhythmia)

V–Ventricle V–Ventricle I–Inhibited M–Multiprogrammable S–Shock

D–Dual (A&V) D–Dual (A&V) D–Dual (T&I) C–Communicating D–Dual (P&S)

R–Rate Modulation

Mfrs.

Designation

Only

S–Single (A or

Table A-16. Magnet and Beeper functions

Parameter Programmable Values Nominal

Magnet Response Off, Store EGM, Inhibit Therapy Inhibit Therapy

Beep During Capacitor Charge Off, On Off

Beep When Explant is Indicated Off, On On

Table A-17. Sensitivity Adjustment

Parameter Programmable Values Nominal

Atrial Sensitivity AGC 0.15, AGC 0.2, AGC 0.25,

AGC 0.3, AGC 0.4, ..., AGC 1.0,

AGC 1.5

AGC 0.25

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PROGRAMMABLE OPTIONS A-15

Table A-17. Sensitivity Adjustment (continued)

Parameter Programmable Values Nominal

Right Ventricular Sensitivity AGC 0.15, AGC 0.2, AGC 0.25,

AGC 0.3, AGC 0.4, ..., AGC 1.0,

AGC 1.5

AGC 0.6

Left Ventricular Sensitivity AGC 0.15, AGC 0.2, AGC 0.25,

AGC 0.3, AGC 0.4, ..., AGC 1.0,

AGC 1.5

AGC 1.0

Table A-18. Ventricular Commanded ATP

ParameteraProgrammable Values Nominal

Commanded Ventricular ATP (Type) Burst, Ramp, Scan, Ramp/Scan Burst

Number Of Bursts 1, 2, ..., 30 30

Initial Pulses per Burst (pulses) 1, 2, ..., 30 4

Pulse Increment (pulses) 0, 1, .., 5 0

Maximum Number of Pulses 1, 2, ..., 30 4

Coupling Interval (% or ms) 50, 53, 56, 59; 63, 66, ..., 84; 88, 91,

94, 97% or 120, 130, ..., 750 ms

81%(Tolerance±5ms)

Coupling Interval Decrement (ms) 0, 2, ..., 30 0(Tolerance±5ms)

Burst Cycle Length (BCL) (% or ms) 50, 53, 56, 59; 63, 66, ..., 84; 88, 91,

94, 97% or 120, 130, ..., 750 ms

81%(Tolerance±5ms)

Ramp Decrement (ms) 0, 2, ..., 30 0(Tolerance±5ms)

Scan Decrement (ms) 0, 2, ..., 30 0(Tolerance±5ms)

Minimum Interval (ms) 120, 130, ..., 400 200(Tolerance±5ms)

a. The ventricular Commanded ATP Pulse Width and Amplitude values are the same as programmed for ventricular ATP therapy.

Table A-19. 50 Hz/Manual Burst Pacing

ParameteraProgrammable Values Nominal

Burst Interval (ms) 20, 30, ..., 750 600(Tolerance±5ms)

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A-16 PROGRAMMABLE OPTIONS

Table A-19. 50 Hz/Manual Burst Pacing (continued)

ParameteraProgrammable Values Nominal

Minimum Interval (ms) 20, 30, ...,750 200(Tolerance±5ms)

Decrement (ms) 0, 10, ..., 50 50 (Tolerance ± 5 ms)

a. Applied to the atrium or ventricle depending on the chamber selected.

Table A-20. Ventricular Commanded Shock

Parameter Programmable Values Nominal

Shock (stored energy) (J) 0.1, 0.3, 0.6, 0.9, 1.1, 1.7, 2, 3, 5, 6,

7, 9, 11, 14, 17, 21, 23, 26, 29, 31,

36 (HE), 41 (HE)

41 (Tolerance ± 60% for ≤0.3 J; ±

40% for ≤0.6–3 J; ± 20% for 5–36

J, ± 10% for 41 J)

Coupling Interval (ms) Sync, 50, 60, ..., 500 Sync

Table A-21. VFib (Ventricular Fibrillation) Induction

Parameter Values

VFib High 15V (nonprogrammable) (Tolerance ± 10V)

VFib Low 9V (nonprogrammable) (Tolerance ± 7V)

Table A-22. Shock on T Induction

Parameter Programmable Values Nominal

Shock (stored energy) (J) 0.1, 0.3, 0.6, 0.9, 1.1, 1.7, 2, 3, 5, 6,

7, 9, 11, 14, 17, 21, 23, 26, 29, 31,

36 (HE), 41 (HE)

1.1 J (Tolerance ± 60% for ≤0.3 J;

± 40% for ≤0.6–3 J; ± 20% for 5–36

J, ± 10% for 41 J)

Number of S1 Pulses 1, 2, ..., 30 8

S1 Interval (ms) 120, 130, ..., 750 400

Coupling Interval (ms) Sync, 10, 20, , ..., 500 310

Table A-23. PES (Programmed Electrical Stimulation)

ParameteraProgrammable Values Nominal

Number of S1 Intervals (pulses) 1, 2, ..., 30 8

S2 Decrement 0, 10, ..., 50 0

S1 Interval (ms) 120, 130, ..., 750 600(Tolerance±5ms)

S2 Interval (ms) Off, 120, 130, ..., 750 600 (Tolerance ± 5 ms)

S3 Interval (ms) Off, 120, 130, ..., 750 Off (Tolerance ± 5 ms)

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PROGRAMMABLE OPTIONS A-17

Table A-23. PES (Programmed Electrical Stimulation) (continued)

ParameteraProgrammable Values Nominal

S4 Interval (ms) Off, 120, 130, ..., 750 Off (Tolerance ± 5 ms)

S5 Interval (ms) Off, 120, 130, ..., 750 Off (Tolerance ± 5 ms)

a. Applied to the atrium or right ventricle as commanded by the programmer.

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A-18 PROGRAMMABLE OPTIONS

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B-1

CLINICAL STUDY - COMPANION

APPENDIX B

CLINICAL STUDY POPULATIONS

Guidant CRT-Ds, when compared to OPT alone, have been demonstrated with

reasonable assurance, to be safe and effective in signiﬁcantly reducing: the

risk of a composite of all-cause mortality or ﬁrst hospitalization by 20%, the

risk of all-cause mortality by 36%, and heart failure symptoms in patients who

have moderate to severe heart failure (NYHA III/IV) including left ventricular

dysfunction (EF ≤35%) and QRS duration ≥120 ms and remain symptomatic

despite stable, optimal heart failure drug therapy, based on the Guidant

sponsored COMPANION clinical study. (Guidant devices were the only devices

studied in the COMPANION clinical trial.)

SUMMARY

The COMPANION clinical study was designed to determine whether combined

all-cause mortality or ﬁrst hospitalization in heart failure patients receiving

optimal pharmacologic therapy (OPT) can be reduced by combining OPT and

either of the following:

• Biventricular pacing therapy alone (CRT-P)

• Biventricular pacing with deﬁbrillation (CRT-D)

All-cause mortality or ﬁrst hospitalization (time to ﬁrst event) analyzed from the

time of randomization, was the primary endpoint of the study.

Guidant conducted the COMPANION study in part to demonstrate the safety

and effectiveness of Guidant CRT-D and CRT-P devices in the COMPANION

patient population. Trial objectives included establishing that OPT combined

with biventricular pacing with deﬁbrillation (CONTAK CD) is superior to OPT

alone in improving exercise performance (Sub-study), reducing combined

all-cause mortality or ﬁrst hospitalization (Primary endpoint), reducing cardiac

morbidity (Secondary endpoint) and reducing all-cause mortality (Secondary

endpoint).

The COMPANION trial utilized a Steering Committee, Data Safety Monitoring

Board (DSMB), and Morbidity and Mortality Committee for study conduct,

safety, and event adjudication respectively.

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B-2 CLINICAL STUDY - COMPANION

The clinical study began January 20, 2000 and was conducted at 128 centers

within the United States.

The COMPANION clinical study was monitored using a sequential design

and on November 18, 2002, after review of the data by the Data Safety and

Monitoring Board, enrollment in the study was stopped. The CRT-D arm of

the trial had reached the target number of events for the combined primary

all-cause mortality or ﬁrst hospitalization endpoint, as well as the secondary

all-cause mortality endpoint. All effectiveness follow-ups ended by December

1, 2002.

OBSERVED ADVERSE EVENTS

Prior History

The CONTAK RENEWAL 3, CONTAK RENEWAL, and CONTAK CD devices

provide the same deﬁbrillation and cardiac resynchronization therapy

(biventricular pacing) and have the same Indications for Use. Therefore,

the Comparison of Medical, Pacing, and Deﬁbrillation Therapies in Heart

Failure (COMPANION) clinical trial data (based on CONTAK CD devices)

used to support expanding Guidant CRT-D indications to the COMPANION

patient population, are also applicable to CONTAK RENEWAL and CONTAK

RENEWAL 3.

The primary difference between CONTAK CD devices and CONTAK

RENEWAL/CONTAK RENEWAL 3 devices is that CONTAK CD utilizes an

electrically common RV and LV sensing/pacing circuit whereas CONTAK

RENEWAL and CONTAK RENEWAL 3 incorporate an independent RV and

LV sensing/pacing circuit. Additional clinical analysis was conducted with

CONTAK RENEWAL, in a European study, to provide conﬁrmation that the

independent sensing and pacing capability did not adversely affect the ability

of the device to detect ventricular tachyarrhythmias or provide continuous

biventricular pacing therapy.

Study Background

The Comparison of Medical Therapy, Pacing, and Deﬁbrillation in Heart Failure

(COMPANION) Study was a prospective, open-label, randomized, controlled,

multi-center, unblinded study conducted at 128 sites and enrolled a total of

1638 patients, of which 1520 were randomized. Patients were randomly

assigned 1:2:2 to receive optimal pharmacological therapy (OPT, 308 patients)

or a cardiac resynchronization therapy pacemaker (CRT-P, 617 patients) or a

cardiac resynchronization therapy pacemaker with deﬁbrillator (CRT-D, 595

- DRAFT -

CLINICAL STUDY - COMPANION B-3

patients). Of the 1520 patients randomized, 903 were randomized to OPT and

CRT-D. This summary focuses on data and analyses for the CRT-D and OPT

groups, only, with the exception of the Exercise Performance results, which are

based on pooled CRT-D and CRT-P data.

The CRT-D devices (CONTAK CD) in this trial, were approved for commercial

distribution via the CONTAK CD study, which provided a reasonable assurance

of safety. A similar safety analysis was applied to the COMPANION patient

population. The results were consistent with safety measurements obtained in

the CONTAK CD trial.

Adverse Event Deﬁnitions

Adverse events were deﬁned as any undesirable clinical occurrence, whether

it was related to the device or not. Table B-1 on page B-3 includes adverse

events occurring in the ﬁrst six months related to the device (pulse generator

and leads) and implant procedures (including attempts). Table B-2 on page B-6

includes adverse events occurring in the ﬁrst six months related to patient

condition (i.e., worsening heart failure). Adverse events are listed in descending

order by total number of patients experiencing the event.

Adverse events related to the device were further reported using two

sub-categories based on the nature of the intervention. These events were

deﬁned as a complication if the event resulted in invasive intervention,

loss of signiﬁcant device function, and death or permanent disability.

An observation was a device-related adverse event that was resolved

non-invasively. Forty-nine percent of CRT-D patients reported a device and/or

procedure-related adverse event.

Table B-1. Device- and procedure-related adverse events

Total Events

(Patients)

% Comps

(Patients)

%Obs

(Patients)

Total Adverse Eventsa498 (290) 13.1 (77) 43.4 (255)

Post surgical wound discomfort 68 (62) 0.0 (0) 10.5 (62)

Phrenic nerve/diaphragm stimulation 77 (59) 1.4 (8) 9.0 (53)

Brady capture - LV 38 (36) 4.3 (25) 2.2 (13)

Hematoma 37 (34) 0.3 (2) 5.4 (32)

Inappropriate shock above rate cutoff 26 (24) 0.0 (0) 4.1 (24)

Multiple counting - tachy 22 (17) 0.3 (2) 2.9 (17)

Pocket infection 19 (17) 0.5 (3) 2.6 (15)

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B-4 CLINICAL STUDY - COMPANION

Table B-1. Device- and procedure-related adverse events (continued)

Total Events

(Patients)

% Comps

(Patients)

%Obs

(Patients)

Dissection, coronary sinus 15 (15) 0.0 (0) 2.6 (15)

Brady capture - atrium 14 (12) 1.5 (9) 0.5 (3)

Inappropriate shock due to oversensing 11 (11) 0.0 (0) 1.9 (11)

Pneumothorax 10 (10) 1.0 (6) 0.7 (4)

Hypotension 10 (9) 0.2 (1) 1.4 (8)

Brady capture - RV 8 (8) 0.9 (5) 0.5 (3)

Physical trauma 8 (8) 0.2 (1) 1.2 (7)

AV Block - heart block, complete 7 (7) 0.2 (1) 1.0 (6)

Pacemaker-mediated tachycardia (PMT) 7 (6) 0.0 (0) 1.0 (6)

Physiological reactionb6 (6) 0.0 (0) 1.0 (6)

Arrhythmia - atrial ﬁbrillation 5 (5) 0.0 (0) 0.9 (5)

Bleeding/ﬂuid accumulation 5 (5) 0.0 (0) 0.9 (5)

Perforation, coronary venous 5 (5) 0.5 (3) 0.3 (2)

Renal failure 5 (5) 0.0 (0) 0.9 (5)

Thrombosis 5 (5) 0.0 (0) 0.9 (5)

Vascular related 5 (5) 0.0 (0) 0.9 (5)

Oversensing - atrium pace sense 4 (4) 0.3 (2) 0.3 (2)

Allergic reaction 3 (3) 0.0 (0) 0.5 (3)

Congestive heart failure 3 (3) 0.0 (0) 0.5 (3)

Nausea (2), Constipation (1) 3 (3) 0.0 (0) 0.5 (3)

High DFTs - tachy 3 (3) 0.2 (1) 0.3 (2)

Oversensing - ventricle rate - tachy 3 (3) 0.2 (1) 0.3 (2)

Respiratory related 3 (3) 0.2 (1) 0.3 (2)

Ventricular tachycardia 3 (3) 0.2 (1) 0.3 (2)

Cardiac tamponade 2 (2) 0.3 (2) 0.0 (0)

Dyspnea (shortness of breath) 2 (2) 0.0 (0) 0.3 (2)

Electrolyte/lab 2 (2) 0.0 (0) 0.3 (2)

Hemorrhage 2 (2) 0.2 (1) 0.2 (1)

Insulation breach suspected 2 (2) 0.3 (2) 0.0 (0)

Migration of device 2 (2) 0.0 (0) 0.3 (2)

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CLINICAL STUDY - COMPANION B-5

Table B-1. Device- and procedure-related adverse events (continued)

Total Events

(Patients)

% Comps

(Patients)

%Obs

(Patients)

Muscle stimulation 2 (2) 0.0 (0) 0.3 (2)

Myocardial infarction 2 (2) 0.0 (0) 0.3 (2)

Numbness 2 (2) 0.0 (0) 0.3 (2)

Perforation, venous 2 (2) 0.0 (0) 0.3 (2)

Phantom shock 2 (2) 0.0 (0) 0.3 (2)

Undersensing - atrium pace sense - brady 2 (2) 0.2 (1) 0.2 (1)

Altered hemodynamic status 1 (1) 0.0 (0) 0.2 (1)

Arrhythmia 1 (1) 0.0 (0) 0.2 (1)

Arrhythmia - sinus tachycardia 1 (1) 0.0 (0) 0.2 (1)

Bruise 1 (1) 0.0 (0) 0.2 (1)

Cardiac arrest 1 (1) 0.2 (1) 0.0 (0)

Change in arrhythmia - SVT 1 (1) 0.0 (0) 0.2 (1)

Change in arrhythmia - brady 1 (1) 0.0 (0) 0.2 (1)

Change in arrhythmia - junctional 1 (1) 0.0 (0) 0.2 (1)

Change in physical status 1 (1) 0.0 (0) 0.2 (1)

Chest pain 1 (1) 0.0 (0) 0.2 (1)

Dizziness, cause undetermined 1 (1) 0.0 (0) 0.2 (1)

Edema 1 (1) 0.0 (0) 0.2 (1)

Fatigue 1 (1) 0.0 (0) 0.2 (1)

Febrile 1 (1) 0.0 (0) 0.2 (1)

Unable to urinate 1 (1) 0.0 (0) 0.2 (1)

Helix related (screw tip), broken or stretched 1 (1) 0.2 (1) 0.0 (0)

Hemoglobin drop 1 (1) 0.2 (1) 0.0 (0)

Hypertension 1 (1) 0.0 (0) 0.2 (1)

Infection 1 (1) 0.2 (1) 0.0 (0)

Insulation breech observed 2 (1) 0.2 (1) 0.0 (0)

Malfunction, memory problem 1 (1) 0.2 (1) 0.0 (0)

Materials unretrieved in body 1 (1) 0.2 (1) 0.0 (0)

Pacemaker mediated tachycardia (PMT) 1 (1) 0.0 (0) 0.2 (1)

Pacemaker syndrome 1 (1) 0.0 (0) 0.2 (1)

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B-6 CLINICAL STUDY - COMPANION

Table B-1. Device- and procedure-related adverse events (continued)

Total Events

(Patients)

% Comps

(Patients)

%Obs

(Patients)

Pericardial effusion 1 (1) 0.2 (1) 0.0 (0)

Pericarditis 2 (1) 0.0 (0) 0.2 (1)

Placement difﬁculty, stylet related 1 (1) 0.2 (1) 0.0 (0)

Pleural effusion 1 (1) 0.2 (1) 0.0 (0)

Pleurisy 2 (1) 0.0 (0) 0.2 (1)

Pocket erosion/extrusion 1 (1) 0.2 (1) 0.0 (0)

Anxiety 1 (1) 0.0 (0) 0.2 (1)

Respiratory arrest 1 (1) 0.2 (1) 0.0 (0)

Ventricular ﬁbrillation 1 (1) 0.0 (0) 0.2 (1)

a. Observations and complications may not sum to total because some patient may have events in both categories.

b. Physiological reaction includes: swelling, rash, and/or drainage.

Table B-2. Patient-related adverse events

Total Events (Patients) % of Patients with

Events

Events/Patient Year

CRT-D OPT CRT-D

N=595

Patients

OPT

N=308

Patients

CRT-D

281 Years

OPT

134 Years

Total Patient Related

Adverse Events

1437 (443) 625 (207) 74.5 67.2 5.11 (1437) 4.66 (625)

Cardiovascular Related

Events

814 (351) 399 (176) 59.0 57.1 2.90 (814) 2.98 (399)

Congestive heart failurea269 (166) 185 (111) 27.9 36.0 0.96 (269) 1.38 (185)

Chest pain 83 (65) 50 (37) 10.9 12.0 0.30 (83) 0.37 (50)

Supraventricular

tachyarrhythmia

69 (56) 11 (11) 9.4 3.6 0.25 (69) 0.08 (11)

Ventricular tachyarrhythmia 66 (51) 16 (15) 8.6 4.9 0.23 (66) 0.12 (16)

Electrolyte/lab 51 (42) 17 (16) 7.1 5.2 0.18 (51) 0.13 (17)

Hypotension 42 (40) 16 (15) 6.7 4.9 0.15 (42) 0.12 (16)

Dizziness, cause

undetermined

33 (30) 26 (23) 5.0 7.5 0.12 (33) 0.19 (26)

Renal failure 40 (29) 16 (14) 4.9 4.5 0.14 (40) 0.12 (16)

Fatigue 27 (25) 12 (12) 4.2 3.9 0.10 (27) 0.09 (12)

Bradyarrhythmia 32 (30) 5 (5) 5.0 1.6 0.11 (32) 0.04 (5)

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CLINICAL STUDY - COMPANION B-7

Table B-2. Patient-related adverse events (continued)

Total Events (Patients) % of Patients with

Events

Events/Patient Year

CRT-D OPT CRT-D

N=595

Patients

OPT

N=308

Patients

CRT-D

281 Years

OPT

134 Years

Vascular 14 (11) 11 (10) 1.8 3.2 0.05 (14) 0.08 (11)

Syncope 12 (12) 7 (7) 2.0 2.3 0.04 (12) 0.05 (7)

GI bleed 14 (13) 4 (4) 2.2 1.3 0.05 (14) 0.03 (4)

Arrhythmia 12 (10) 6 (6) 1.7 1.9 0.04 (12) 0.04 (6)

Hypertension 12 (9) 6 (5) 1.5 1.6 0.04 (12) 0.04 (6)

Palpitations 9(9) 3(3) 1.5 1.0 0.03 (9) 0.02 (3)

Myocardial infarction 7 (7) 4 (4) 1.2 1.3 0.02 (7) 0.03 (4)

Stroke syndrome or CVA 7 (7) 2 (2) 1.2 0.6 0.02 (7) 0.01 (2)

Deep vein thrombosis 4(4) 0(0) 0.7 0.0 0.01 (4) 0.00 (0)

Transient ischemic attack

(TIA)

3(3) 1(1) 0.5 0.3 0.01 (3) 0.01 (1)

Hematuria 3(3) 0(0) 0.5 0.0 0.01 (3) 0.00 (0)

Ischemia 2(2) 1(1) 0.3 0.3 0.01 (2) 0.01 (1)

Coagulopathy 2 (2) 0 (0) 0.3 0.0 0.01 (2) 0.00 0(0)

Bleeding/ﬂuid accumulation 1 (1) 0 (0) 0.2 0.0 0.00 (1) 0.00 (0)

Non-cardiovascular Related

Events

623 (293) 226 (119) 49.2 38.6 2.22 (623) 1.69 (226)

Respiratory relatedb130 (108) 53 (41) 18.2 13.3 0.46 (130) 0.40 (53)

GIc124 (95) 30 (24) 16.0 7.8 0.44 (124) 0.22 (30)

Pain 82 (66) 40 (32) 11.1 10.4 0.29 (82) 0.30 (40)

Physiological reactiond76 (61) 20 (18) 10.3 5.8 0.27 (76) 0.15 (20)

Infection 54 (37) 18 (15) 6.2 4.9 0.19 (54) 0.13 (18)

Endocrine 41 (35) 16 (14) 5.9 4.5 0.15 (41) 0.12 (16)

Psychological effects 24 (19) 13 (12) 3.2 3.9 0.09 (24) 0.10 (13)

Change in physical status 20 (18) 9 (9) 3.0 2.9 0.07 (20) 0.07 (9)

Physical trauma 26 (22) 4 (4) 3.7 1.3 0.09 (26) 0.03 (4)

Neurologic 14 (14) 6 (6) 2.4 1.9 0.05 (14) 0.04 (6)

Genitourinary 9 (7) 5 (4) 1.2 1.3 0.03 (9) 0.04 (5)

Cancer, other 5 (5) 6 (5) 0.8 1.6 0.02 (5) 0.04 (6)

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B-8 CLINICAL STUDY - COMPANION

Table B-2. Patient-related adverse events (continued)

Total Events (Patients) % of Patients with

Events

Events/Patient Year

CRT-D OPT CRT-D

N=595

Patients

OPT

N=308

Patients

CRT-D

281 Years

OPT

134 Years

Febrile 7(7) 0(0) 1.2 0.0 0.02 (7) 0.00 (0)

Respiratory failure 4 (4) 1 (1) 0.7 0.3 0.01 (4) 0.01 (1)

Tumors, growths 1(1) 2(2) 0.2 0.6 0.00 (1) 0.01 (2)

Ulceration 2(1) 2(2) 0.2 0.6 0.01 (2) 0.01 (2)

Diabetes complications 2(2) 0(0) 0.3 0.0 0.01 (2) 0.00 (0)

Pulmonary embolism 1(1) 1(1) 0.2 0.3 0.00 (1) 0.01 (1)

Pneumonia (respiratory

infection)

1(1) 0(0) 0.2 0.0 0.00 (1) 0.00 (0)

a. Congestive heart failure includes: congestive heart failure, dyspnea, volume overload, edema, pulmonary edema, change in

drug therapy.

b. The most frequent three events in this category were: upper respiratory infection, bronchitis, and inﬂuenza.

c. The most frequent three events in this category were: nausea, diarrhea, and abdominal pain.

d. The most frequent three events in this category were: swelling, rash, and weight gain.

Deaths

There were a total of 182 deaths (77 OPT, 105 CRT-D) that occurred during

the trial and recorded through November 30, 2002. Table B-3 on page B-8

presents cause of death stratiﬁed by treatment group.

Table B-3. CRT-D and OPT cause of death

Cause of Death OPT Arm

(N = 308)

CRT-D Arm

(N = 595)

Total

(N = 903)

Cardiac 58 (18.8%) 76 (12.8%) 134 (14.8%)

Vascular 0 (0.0%) 3 (0.5%) 3 (0.3%)

Non-Cardiac 11 (3.6%) 21 (3.5%) 32 (3.5%)

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CLINICAL STUDY - COMPANION B-9

Table B-3. CRT-D and OPT cause of death (continued)

Cause of Death OPT Arm

(N = 308)

CRT-D Arm

(N = 595)

Total

(N = 903)

Unknown/ Unclassiﬁed 8 (2.6%) 5 (0.8%) 13 (1.4%)

Total Deaths 77 (25.0%) 105 (17.6%) 182 (20.2%)

NOTE: After the study was stopped in November 2002, follow-up for safety

continued for approximately one more year on 151 OPT and 449 CRT-D

patients with the ﬁnal data cut-off on November 26, 2003. During this post-trial

follow-up period, an additional 54 deaths were reported, consisting of 14/151

(9.3%) OPT patients and 40/449 (8.9%) CRT-D patients.

The mortality rates are approximately equal during this post-trial follow-up

period. This may be because CRT devices were made available to OPT

patients. Thus, most patients were receiving the same therapy during this

interval.

STUDY DESIGN

The COMPANION study design and study results have been previously

described in the medical literature.12

The COMPANION study was a prospective, randomized (1:2:2 to OPT, CRT-P

[delivered by the CONTAK TR device], or CRT-D [delivered by the CONTAK

CD device]), controlled, multi-center study. Both of these devices became

commercially available during the course of the study.

Randomization was stratiﬁed by centers and by beta-blocker use to

assure proper balance between the treatment groups within each center.

Each randomized patient remained counted as a member of the original

randomization assignment (intention-to-treat) regardless of subsequent

crossover or protocol adherence.

Eligible patients were also enrolled in a sub-study designed to measure

improvement in exercise performance in patients randomized to CRT (CRT-P

and CRT-D pooled data) therapy compared to OPT.

1. Bristow MR, Feldman AM, Saxon LA. Heart failure management using implantable devices for

ventricular resynchronization: Comparison of Medical Therapy, Pacing, and Deﬁbrillation in

Chronic Heart Failure (COMPANION) trial. J Card Fail. 2000;6(3):276-285.

2. Bristow MR, Saxon LA, Boehmer J, et al. Cardiac resynchronization therapy with or without an

implantable deﬁbrillator in advanced chronic heart failure. N Engl J Med. 2004;350:2140-2150.

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B-10 CLINICAL STUDY - COMPANION

INCLUSION/EXCLUSION CRITERIA

The study population consisted of patients with moderate to severe heart

failure, New York Heart Association Classiﬁcation III or IV, left ventricular

ejection fraction ≤35%, and QRS width ≥120 ms due to ischemic or

non-ischemic cardiomyopathy.

All patients were required to have been treated with a stable dose of

beta-blocker, ACE inhibitor or ARB, diuretic, and aldosterone antagonist. A

stable dose was deﬁned as 30 days for all drugs except beta-blocker, which

required 90 days stabilization from last up titration prior to randomization.

Diuretic dosage could be adjusted any time by the investigator using medical

discretion.

Patients enrolled in the study were required to meet the following inclusion

criteria:

• Moderate or severe heart failure, deﬁned as symptomatic heart failure

for at least six months with NYHA class III or IV symptoms at the time of

enrollment, and at least one of the following events in the previous 12

months:

– Hospitalization for heart failure management

– Outpatient visit in which intravenous (IV) inotropes or vasoactive

infusion were administered continuously for at least 4 hours

– Emergency room visit of at least twelve hours duration in which IV

heart failure medications were administered (including diuretics)

•QRS≥120 ms and PR interval > 150 ms from any two leads of a 12–lead

ECG

• Left ventricular ejection fraction ≤35%

• Left ventricular end diastolic dimension ≥60 mm (required only if LVEF

measured by echo) or > 3.0 cm/m2(The cm/m2is calculated by LVEDD [in

cm] divided by BSA [body surface area])

•Age≥18 years

• Optimal pharmacologic therapy for heart failure (beta blocker, ACE inhibitor,

diuretics, and spironolactone)

- DRAFT -

CLINICAL STUDY - COMPANION B-11

Additional eligibility criteria for the Exercise Performance sub-study:

• Understand the nature of the sub-study and provide informed consent

• Have been enrolled at a participating sub-study investigational center

• Have no neuromuscular or vascular disability that prevents normal walking

(e.g., intermittent claudication, arthritis, residual stroke weakness)

• Have no history of angina during previous exercise testing

•FEV

1/FVC ≥50%

•150m≤Six-minute walk distance ≤425 m

• Baseline Peak VO2< 22 ml/kg/min

• Have no cardiac disabilities that would ordinarily contraindicate exercise

testing:

– Changing pattern on the ECG

– Changing pattern of chest discomfort

– Decompensated heart failure

– Uncontrolled arrhythmias

Patients were excluded from the investigation if they met any of the following

criteria:

• Unable or unwilling to undergo device implant and follow-up testing

• Patients with a hypersensitivity to 0.7 mg nominal dose of dexamethasone

acetate

• Meet the general indications for an implantable cardioverter deﬁbrillator

• Surgically uncorrected primary valvular disease

• Meet the general indications for antibradycardia pacing

• Coronary artery disease (CAD) in which surgical or percutaneous correction

is recent (within 60 days of randomization)

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B-12 CLINICAL STUDY - COMPANION

• Expected to receive a heart transplant in the next six months

• Women who are pregnant or not using medically acceptable birth control

• Chronic, medically refractory atrial tachyarrhythmias

• Hypertrophic obstructive cardiomyopathy

• Unexplained syncope

• Amyloid disease

• Myocardial infarction within 60 days of randomization

• Hospitalization for heart failure or IV inotropic or vasoactive therapy in

excess of 4 hours in the 30 days prior to enrollment

• History of non-compliance with oral heart failure therapy

• Involved in any other investigational studies

• Progressive or unstable angina

• Life expectancy < 6 months due to any other medical conditions

• Uncontrolled blood pressure: Systolic BP > 160 mm Hg or < 85 mm Hg

or diastolic BP > 90 mm Hg

ENDPOINTS

This summary focuses on the CRT-D vs. OPT contrast, providing evidence

of safety and effectiveness for Guidant CRT-Ds in the COMPANION patient

population.3The clinical data and analyses herein address the following study

endpoints for all patients randomized to CRT-D and OPT only, unless otherwise

stated as a sub-study measurement (where CRT-D and CRT-P data were

pooled for exercise performance).

Primary Endpoint

The primary endpoint was a composite consisting of all-cause mortality or ﬁrst

hospitalization (time to ﬁrst event) as analyzed from the date of randomization

3. Guidant CRT-Ps are already approved for use in the COMPANION patient population,

P030005, approved 01/26/04.

- DRAFT -

CLINICAL STUDY - COMPANION B-13

on an intention-to-treat basis. The study was designed to demonstrate a 25%

relative reduction with CRT-D when compared to an estimated 40% annual rate

in the OPT cohort. All-cause mortality was deﬁned as death from any cause.

Hospitalization is deﬁned below:

Qualifying Duration for Hospitalization––the intent behind hospitalization

was to capture hospitalizations that were of sufﬁcient duration to enter into a

composite with all-cause mortality. Thus, hospitalization was deﬁned as care

provided at a hospital in which hospital admission and discharge occurred on

separate dates. Patients excluded from this deﬁnition were those who received

care at a hospital, but were discharged on the same day as admission. In

addition to hospitalizations, the use of intravenous inotropes or vasoactive

agents for a duration of greater than four hours was also considered to be of

signiﬁcant importance to be treated as an instance of hospitalization.

Hospitalizations Related to the Implant Procedure––hospitalizations

associated with device implant (initial and reattempted for unsuccessful

initial implant) were not considered to be an event for evaluating the primary

endpoint. Similarly, hospitalizations associated with elective implant of devices

(i.e., absence of an electrophysiological indication or an ongoing hospitalization

requiring intravenous therapy) in the OPT cohort also were not considered to

be a primary endpoint event. Surgical revisions of a previous implanted system

did count as a primary endpoint event if the revision was of a sufﬁcient duration

to result in different admission and discharge dates. Table B-4 on page B-13

summarizes the criteria for determining which hospitalization events were

considered as a primary endpoint event.

Table B-4. Hospitalizations contributing to primary endpoint

Event Description CRT-D OPT

Initial implant/reattempts No No

Surgical revisions of system YesaYe sa

Hospitalization with no calendar date change No No

Hospitalization with a calendar date change Yes Yes

IV inotrope and/or vasoactive drug use > 4 hours Yes Yes

a. If calendar date change.

Secondary Endpoints

All-cause mortality––the all-cause mortality (death from any cause) endpoint

was designed to show a 25% reduction in mortality in the CRT-D arm from an

OPT annual mortality rate of 24%. Difference in mortality was determined by

- DRAFT -

B-14 CLINICAL STUDY - COMPANION

contrasting patients randomized to CRT-D in addition to OPT versus patients

randomized to OPT alone.

Cardiac morbidity––the hospitalization component of the primary endpoint

included non-cardiac events that may not be impacted by CRT-D. The cardiac

morbidity endpoint was unique to the COMPANION study. It is a more speciﬁc

outcome measure intended to determine whether CRT-D when compared to

OPT would reduce the type of events that are pertinent to a hospitalization

for heart failure.

Cardiac morbidity was deﬁned as the occurrence of one or more of the

following events:

• Worsening heart failure resulting in use of intravenous vasoactive or

inotropic therapy exceeding four hours

• Mechanical respiratory or cardiac support

• Any cardiac surgery, including heart transplant

• Resuscitated cardiac arrest or sustained ventricular tachycardia requiring

intervention (e.g., chest thump, external cardioversion, or external

deﬁbrillation)

• Hospitalization for acute decompensation of heart failure

• Hospitalization that results in death from cardiac causes

•Signiﬁcant device-related events resulting in:

– Permanent disability

– Hospitalization for pending death or permanent disability

Safety––CRT-D system-related complication-free rate is determined by

measuring complications related to any of the implanted components or

their associated implant procedure in those patients who were successfully

implanted with the CRT-D system.

NOTE: During the course of the COMPANION clinical study, the EASYTRAK

Coronary Venous pace/sense lead was established as safe and effective in a

separate clinical study and was approved for commercial distribution (P010012,

05/02/02). Refer to the commercially available EASYTRAK Coronary Venous

pace/sense lead labeling for clinical safety and performance characteristics.

- DRAFT -

Boston Scientific CRMN11906 Implantable Defibrillator User Manual Cognis Part 3 Manual

Boston Scientific Corporation Implantable Defibrillator Cognis Part 3 Manual

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