acap™ confirm acap™ confirm benefits automatic algorithm to adjust the atrial pacing amplitude...

ACap™ Confirm

ACap™ ConfirmBenefits

• Automatic algorithm to adjust the atrial pacing amplitude to address changing atrial thresholds

• Clinic time saved by daily automatic atrial amplitude testing and adjustment (8 – 23 hrs)

• Threshold trend with follow-up EGMs to quickly evaluate patients status

• Evaluate early lead integrity issues

ACap™ ConfirmWhat to do

At activation

•Run Setup Test

•Run Capture Test

At follow-up

•Read ACap™ Confirm results and trend

ACap™ ConfirmPolarity

•Bipolar pacing

•Uni- or bipolar sensing

- ER detection always unipolar

•Uni- or bipolar back-up pulse

configuration

ACap™ Confirm

Setup

ACap™ ConfirmSetup

The ER will be determined during the

ACap™ Confirm Setup using

Paced Depolarization Integral (PDI)

ACap™ ConfirmDetermine ER sensitivity

Ensures ER is large enough to separate from polarization

ER sensitivity is automatically set to a safe level between ER & polarization measurements

Captured pulses= ER + Polarization

Non-captured pulses= Polarization Only

ACap™ ConfirmHow the Setup Test is Run

test rate 90 bpm default (max 120 bpm)

4 paced beats at each amplitude1-2 beats between for program

changes4.5

4.254.0

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0.50.25 0.0

Back up pulse, 5.0 V, is delivered after primary pulse on non

captured events.(LOC @ 0.75V)

ACap™ Confirm Setup Test, Back-up pulse

back-up pulse:40 ms after primary pulse5.0 V, >0.5 msunipolar or bipolar

ACap™ ConfirmSetup Test, AV Delay

Test dictates AV delay 120 ms when backup pulse is delivered(timed from primary atrial pulse)

AV delay as programmed as long as capture in Setup Test

180 180 120 120 120

ACap™ ConfirmEvoked Response detection

Blanking Sensing

4.5 ms 31ms

(Alert)

PDI-area of ER in A. unipolar tip EGM channel

PDI Paced Depolarization IntegralER Evoked Response

ACap™ ConfirmProgrammable Options

On A voltage is added to the threshold to define a new automatic pulse amplitude to be used until the next search (requires a 1.7:1 safety margin)

Monitor Capture threshold is automatically measured and plotted on the trend but no automatic amplitude adjustment is made

Off No measurements performed no weekly threshold trend data available

Loss of CaptureCapture Confirmed

ER Sensitivity = 500PDI = 750

ER Sensitivity = 500PDI = 150

ACap™ ConfirmCapture - Loss of Capture

ACap™ Confirm

Capture Test

ACap™ Confirm How the Capture Test is Run (Capture @ 0.825V)

• Ensure atrial pacing: in-clinic test rate 90 bpm default (max 120 bpm)

• 4 paced beats at each amplitude

• Decrease amplitude in 0.25 V steps. 3 Consecutive pulses at the same amplitude confirm LOC (backup pulse delivered)

• Increase amplitude in 0.125 V steps until 2 consecutive pulses capture at the same amplitude (capture threshold)

• Back up pulse, 5.0 V, is delivered after every primary pulse on non captured events

ACap™ Confirm How the Capture Test is Run (Capture @ 0.825V)

0.75 0.825

2.01.75

1.251.5

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1.825

ACap™ ConfirmCapture Test

• Starts at programmed atrial pulse amplitude

• If programmed atrial pulse amplitude > 3.875 V

start the threshold search at 3.875 V

• Decrease amplitude in 0.25 V steps until 3

consecutive pulses at the same amplitude confirm

LOC (backup pulse delivered). Below 0.25 V, the

step size is 0.125 V

• Increase amplitude in 0.125 V steps until 2 consecutive pulses capture at the same amplitude

(capture threshold)

4.5 4.25 4.0 3.75 3.5 3.0 2.5 2.0 1.5 1.0 0.75 0.5 0.25 0.0

+1.0V+1.0V

+1.0V+1.0V

+1.0V

+1.5V

+2.0V

+2.0V

To5.0V

To5.0V

To5.0V

To5.0V

To5.0V

ACap™ ConfirmSafety Margin

Adding safety margin related to capture threshold

N/A

ACap™ ConfirmSafety Margin

ACap™ Confirm

Out of Clinic Test

ACap™ ConfirmPeriodic Out of Clinic Threshold Search

•Programmable: 8 or 24 (23) hrs

•Device overdrives the atrial rate

- Minimize fusion

- Maximize patient comfort by

interspersing atrial test pulses

throughout normal pacing

Threshold Search Algorithm

Monitoring Period• Search initiation: open window of 16

atrial intervals

• Determine the rate overdrive interval for atrial test pulses

• 16 pulses should cover two respiratory cycles- Continuously update rate overdrive interval

- Fusion avoidance

Test Mode Conditions under which test occurs

Fast 100% Atrial paced during monitoring period and

one of

1) AF Suppression Off

2) AF Suppression On, but not actively overdriving

Slow At least one p-wave during monitoring period and

one of

1) AF Suppression Off

2) AF Suppression On, but not actively overdriving

AF

Suppression

1) AF Suppression On and

2) AF Suppression actively overdriving rate

Threshold Search Algorithm Out of Clinic Periodic Threshold Search

Fast Mode

100% atrial pacing during monitoring period(AF Suppression is OFF or not actively overdriving)


Threshold Search (Fast)AF Suppression OFF or Not Actively Overdriving

• Search initiation: 16 beat monitoring period

• 100% atrial pacing in monitoring period: AF supression off / no AF related atrial pacing

• Test pulse overdrive interval: Current pacing interval – 40 ms If another algorithm calculates a shorter interval

than the test pulse overdrive interval, i.e.- Rate Response, the shorter interval is used

Overdrive rate limit is 120 bpm

FAST MODE

ACap™ Confirm How the Fast Mode is Run (Capture @ 0.825V)

0.75

2.01.75

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0.875

1.875Monitoring, 16 beats

0.75 0.75

Monitoring, 16 beats Monitoring, 16 beats Monitoring, 16 beats

0.8755.0 5.0 5.0

Only Paced Events

Threshold Search (Fast) cont’d

QuestionWhat if a p-wave were sensed during the threshold test?

AnswerA new 16 beat monitoring period would begin

FAST MODE

ACap™ Confirm Sensing interrupts the test

0.75

2.01.75

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Monitoring, 16 beats

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Intrinsic eventRestart of monitoring

Slow Mode

at least one atrial event is sensed during monitoring period(AF Suppression is OFF or not actively overdriving)


Threshold Search (Slow)AF suppression OFF - Not Actively Overdriving

• Search initiation: 16 beat monitoring period

• At least one sensed P- wave occurs during monitoring period

• Test pulse interval = MATRI - the max of either- 3 x ARIAD

- 40 ms


Test pulse interval = MATRI - the max of eithera) 3 x ARIADb) 40 ms

MATRIMean ATrial Rate Interval (from monitoring period, 16 atrial intervals)

ARIADAtrial Rate Interval Average Deviation (during monitoring period) Disregard the two shortest as well as the 6 longest intervals, then calculate the average deviation on the remaining 8 intervals

Threshold Search (Slow)AF Suppression OFF - Not Actively Overdriving

Rate Observation Period (Slow Mode)

- Started after 16 beat monitoring period

- 10 cycles in duration Look for a long atrial interval, ≥ MATRI (mean atrial rate

interval)

Following long interval, deliver test pulse at test pulse

interval

- If a long atrial interval is not seen within 10

cycles: Test pulse is not delivered

New 16 beat monitoring period is started

ACap™ Confirm (Slow)Monitoring and Rate Observation Period

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Test Pulse Rate intervalMATRI – (3xARIAD (or 40ms))977 – (3x25)ms = 902 (67 min-1)

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Rate Observation <10 beatsTest Pulse following

a long interval > MATRI

Interval

Variation from mean value

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Mean ATrial Rate Interval (MATRI) = 977 msAtrial Rate Interval Average Deviation (ARIAD) = 25 ms


New monitoring period is started after test pulse delivery

If no atrial events are sensed in alert during monitoring period, search switches to Fast Mode

Test proceeds as described before

Attempt test pulse delivery in the first cycle after long atrial interval

Test pulse delivery is inhibited by a sensed atrial event

New monitoring period would be started

ACap™ Confirm How the Slow Mode is Run


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SLOW MODECalculate mean atrial rate

interval (MATRI) and atrial rate

interval deviation(ARIAD)

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No long atrial interval is

seen within 10 cycles

Rate Observation PeriodI

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2.0

New Monitoring Period

No p-wavesFast-mode

p-wave duringthreshold testInitiates new

monitoring period


p-wavesCalculate MATRI

and ARIAD

Rate Observation Period

test pulse afterlong interval


No p-wavesFast-mode





Test pulse interval MATRI minus

the max of either:3 x ARIADor 40 ms

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Test pulse delivery is inhibited by a sensed atrial event.

New monitoring period would

be started

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Monitoring, 16 beats Monitoring, 16 beats

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ACap™ Confirm How the Slow Mode is Run. (Capture @ 0.825V)

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2.0 2.0

AF suppression Mode

AF Suppression ON and Actively Overdriving


Threshold Search AF Suppression Mode Search (ON and Actively Overdriving)

During AF Suppression overdrive, No monitoring periods are started after:

Test pulses Test pulse inhibition Back-up pulses

If AF Suppression stops overdriving, a new monitoring period is started.

If no atrial events are sensed → Fast Mode. If at least one atrial event is sensed → Slow

Mode

Max. AF Suppression Rate

Basic Rate

AFx

Intrinsic Rate

Threshold SearchAF Suppression Mode Search (ON and Actively Overdriving)

Second overdrive stimulus is a

test pulse @ AF Suppression

rate interval

Second overdrive stimulus is a

test pulse @ AF Suppression

rate interval Second overdrive

stimulus is atest pulse

@ AF Suppression rate interval

ACap™ Confirm

Threshold Search Interactions

ACap™ ConfirmThreshold Search Interactions

Ongoing ACap Confirm threshold search is terminated upon wand placement

Search is reinitiated upon wand removal

If an automatic ACap Confirm threshold search is scheduled to start while wand is in place:

Search delayed until wand is removed If weekly trend log is scheduled to be logged, it will be logged upon wand removal

ACap™ Confirm Threshold Search Interactions

If AMS entry occurs during a threshold search the algorithm is suspended until one hour after AMS exit

Atrial threshold search is suspended/delayed until the following processes are complete

- Automatic P and R-wave measurements

- Lead surveillance

- Actively storing a SEGMs

- Ventricular AutoCapture threshold

ACap™ Confirm Threshold Search Exceptions

•Amplitude is set to 5.0 V (high output) if:

- Capture verification occurred at 0.0 V

- Amplitude increases to 3.875 V and capture fails

•If ACap Confirm goes to High Output Mode, a new threshold search will be performed after one hour

•If capture threshold fails or is inhibited a new threshold search may be re-initiated in one hour, 8 or 24 hour clock is not reset

•If the atrial rate >120 bpm the threshold search will be canceled and attempted in 1 hour

ACap™ ConfirmHigh Output Mode

High Output Mode popup message when:

ACap Confirm is at maximum output ACap Confirm has been auto-programmed to OFF and the atrial pulse amplitude has been set to 5.0 V

High Output Mode popup message when ACC is Monitor:

ACap Confirm could not determine the threshold

ACap™ ConfirmInteractions

If an Atrial lead configuration switch occurs:-ACap Confirm in Monitor Mode:

ACap Confirm is turned OFF (Atrial pulse amplitude

remains at programmed value)

-If ACap ConfirmON:

ACap Confirm is turned OFF (Atrial pulse amplitude is set

to 5.0 V. Pulse width unchanged

ACap™ ConfirmInteractions

•At ERI, if ACC mode is ON- ACC is programmed OFF

- Pulse amplitude is set to 2 x (average of 4 most recent atrial capture thresholds), minimum 2.0 – maximum 5.0 V

•At ERI, if ACC mode is Monitor- ACC is programmed OFF

- Pulse amplitude remains at programmed value

ACap™ ConfirmSummary

•ACap™ Confirm Setup Test prior to enabling the algorithm

•Periodic threshold searches and amplitude adjustments

•Programmable Modes: Off, On and Monitor

•Follow-up EGMs and trend data available

ACC and VAC Differences

ACap Confirm V. AutoCaptureThreshold search, no beat to beat

capture verification or capture recovery

Threshold search, beat to beat capture verification

Capture detection: PDI methodCapture detection: PDI and DMAX

method

3 consecutive LOCs to confirm LOC

2 consecutive LOCs to confirm LOC

Programmable “ON” option allows amplitude adjustment after search

captureAmplitude adjusted after search

40 ms backup (5.0V) 100 ms backup (5.0V)

Fusion Avoidance -Rate overdrive

Fusion Avoidance - Short AV delay

Output set to defined safety margin (1.7:1)

Output set to threshold +0.25 V margin

acap™ confirm acap™ confirm benefits automatic algorithm to adjust the atrial pacing amplitude...

Documents

capture slide

capture test slide

setup slide

atrial pulse amplitude

bipolar slide

trend slide

amplitude capture threshold

setup test run capture