The Identity Pacemaker Family

The Identity™ Pacemaker Family
The New Standard in

Bradycardia Therapy
Expect More from your Pacemaker

The New Standard in Bradycardia Therapy
• Description and Overview

• AF Suppression™
• AF Suppression™ Parameters
• Proven Clinical Performance of AF Suppression™
– The ADOPT-A Study Results

• Advanced Hysteresis Response
• Stored EGMs
• AutoCapture™ Pacing Systems
• AMS Log

• AMS Base Rate
• AFx™ Histogram
• Previous Test Results

Introduction and Overview
The Identity™ pacemaker family is the premier

bradycardia-device offering from St. Jude Medical.
The Identity ™ pacemaker is available in DDD/R and
SSIR models.

AFx™ Management is a suite of therapeutic and

diagnostic capabilities designed to manage
pacemaker patients suffering from AF. The Identity™
pacemaker is the only pacemaker on the market
today to feature AFx ™ Management with the AF
Suppression™ algorithm and Stored Electrograms.

AFx™ Management Includes:
• AF Suppression™
• Stored Electrograms
• AFx™ Histograms
• AMS Log
• AMS Base Rate

Description and Overview
System Dimensions and Longevity
Identity™ DR Identity™ XL Identity™ SR

Models 5370 5376 5172
Dimensions 43x44x6 44x52x6 41x44x6
Weight 18g 23.5g 17g
Volume 8cc 11cc 7.9cc
Longevity 7.3yrs* 12.6yrs* 9.1yrs*
* Calculated at 1.0V ventricle, 2.5V atrium (DR only), 500ohms, 100% pacing, 60ppm,
AutoCapture ON

AF Suppression™

AF Suppression™
The AF Suppression™ algorithm from St. Jude

Medical is designed to suppress atrial fibrillation (AF)
by pacing the atrium at rates slightly faster than the
intrinsic atrial rate.

AF Suppression™
The AF Suppression™ algorithm is designed to ensure a

high percentage of atrial stimulation (> 90%) at a rate that
follows the patient’s intrinsic rhythm. This effectively
maintains control of the atrium, reduces ectopy, and
suppresses atrial fibrillation (AF).

AF Suppression™

AF Suppression™
The AF Suppression algorithm:

• monitors the atrial channel for intrinsic atrial events,
and
• increases the atrial pacing rate if two P-waves are
sensed within a 16-cycle window.
•The rate increase is determined by the
Upper Rate Overdrive and
Lower Rate Overdrive settings.

AF Suppression™
Figure 1. The ECG above demonstrates the AF Suppression algorithm in operation. While overdrive pacing
the atrium at a rate of 84 ppm, the device detects two intrinsic atrial events and immediately responds with a
rate increase (overdrive pacing at a rate of 93 ppm). After stimulating the atrium for the selected number of
overdrive pacing cycles (15 cycles at a rate of 93 ppm), the device begins to extend the pacing cycle lengths
to search for intrinsic atrial activity (Rate Recovery). Detection of two intrinsic atrial events would again
initiate a prompt rate increase and reset the cycle length counter.

AF Suppression™ Parameters

Parameters
• Lower Rate Overdrive (LRO)
• Upper Rate Overdrive (URO)
• Number of Overdrive Pacing Cycles
• Rate Recovery

Lower Rate Overdrive (LRO):

The number of beats per minute above the previous
pacing rate that the pacemaker will atrial overdrive pace
when the pacing rate range is between 45 and 59 ppm.
Value: 10 ppm.

Upper Rate Overdrive (URO)

The number of beats per minute above the previous pacing
rate that the pacemaker will atrial overdrive pace when the
pacing rate range is between 151 and 185 ppm.
Value: 5 ppm

URO/LRO Characteristics
Rates between 60 ppm and 150 ppm

For atrial rates between 60 and 150 ppm, the atrial pacing
rate increase will be based on an algorithm which sets the
increase between the LRO and the URO.

Overdrive Pacing Cycles

The number of cycles the pacemaker will overdrive the atrial
pacing rate before starting to decrease the atrial pacing rate
to the Base Rate, Rest Rate or Sensor Indicated Rate. The
rate decrease is governed by the Rate Recovery parameter.
Programmable Values: 15 to 40 Cycles (Steps of 5)

Rate Recovery:
determines the timing of the rate decrease from the overdrive rate to
the Base Rate, Sensor Indicated Rate, or Rest Rate.
Value: 8:12
The first number ( 8:12) indicates the increase in the pacing

interval (in ms) of each successive interval for overdrive atrial pacing
rates greater than 100 ppm. The second number (8:12) indicates the
increase in the pacing interval (in ms) of each successive interval,
for overdrive atrial pacing rates less than or equal to 100 ppm.

Pre- and Post-Initiation of AF Suppression™
Event Record Documentation

Pre-AF Suppression
Enable AF
Suppression
Post-AF Suppression

Proven Clinical Performance of the AF
Suppression™ Algorithm

Proven Clinical Performance
Atrial Dynamic Overdrive Pacing Trial -A (ADOPT-A):
Randomized, controlled, single-blinded study conducted at 41

leading medical centers in the U.S., Canada and the UK.
Compared the effects of DDDR pacing with AF Suppression™

vs. just DDDR pacing alone.
Used the Integrity AFx™ DR Model 5346 and the Trilogy® DAO.
Non-specific atrial lead placement (i.e. normal implant).
Source: Atrial Dynamic Overdrive Pacing Trial-A (ADOPT-A), submitted March 7, 2001. St. Jude Medical.

ADOPT-A Results
AF burden was 25.03% less in the AF

Suppression algorithm ON group than the AF
Suppression algorithm OFF group, and there was
a consistent and decreasing AF burden observed
over time (p<0.05)

ADOPT-A Results

ADOPT-A Results
When patients with no AF> 30 days after implant

are excluded, AF burden was 36.33% less in the
AF Suppression algorithm ON group than the AF
Suppression algorithm OFF group (p<0.02)

ADOPT-A Results
60% AF episode reduction in the AF Suppression

algorithm ON group, 45% in the AF Suppression
algorithm OFF group (p < 0.0001)

ADOPT-A Results
The percentage of beats that were atrial paced was

significantly greater in the AF Suppression™
algorithm ON group (92.9%) than the AF
Suppression algorithm OFF group (67.9%),
demonstrating that the AF Suppression algorithm
performed as specified.

ADOPT-A Results
6.3% reduction in hospitalizations in the AF Suppression

algorithm ON group (p=NS).
62.7% reduction in cardioversions in the AF Suppression

algorithm ON group (p= 0.0925).

ADOPT-A Results
No demographic difference between groups.
Over 90% of the atrial arrhythmias observed during the

6-month follow-up period were atrial fibrillation
No device-related patient deaths.
No unanticipated adverse events were reported.

Atrial Dynamic Overdrive Pacing Trial -A (ADOPT-A)
In this patient, the AF Suppression algorithm was programmed

OFF for the first 6 months post-implant (per ADOPT-A protocol).
Note 6240 mode switches.
Atrial Dynamic Overdrive Pacing Trial -A (ADOPT-A)
In the same patient, the AF Suppression algorithm was

programmed ON for a comparable period of time. Note, in this
unique case, there were only 5 mode switches.
Overdrive Stimulation in Summary
Overdrive stimulation:
• is designed to minimize pauses following ectopic beats,

• suppress ectopy, and
• reduce dispersion of refractoriness by maintaining
control of rate and rhythm.

Overdrive Stimulation in Summary
But a fixed high rate may. . .

• be uncomfortable for the patient,
• induce cardiomyopathy and decrease ventricular
function over time,
• lose protection if the atrial rate exceeds the programmed
rate, and/or
• limit device functionality.
AF Suppression allows all the benefits of overdrive

stimulation without the drawbacks of high fixed rate pacing
Advanced Hysteresis Response

• Hysteresis Rate (OFF, 30 - 130 in 5 ppm, 140, 150)

• Programmable Search Interval (OFF, 5, 10, 15, or 30
min)
• Programmable Cycle Count (1-16 cycles)
• Intervention Rate (OFF, 60, 80-120 Intrinsic+0, +10,
+20, +30 ppm)
• Intervention Duration (1-10 min)
• Recovery Time (Fast, Medium, Slow, Very Slow)

Intervention Rate:
The rate at which the pacemaker will operate if the

patients intrinsic rate falls below the Hysteresis Rate
for the programmed Cycle Count. It is programmable
as a fixed value or as a function of the Intrinsic rate.**
• Programmable Values: OFF, 60, 80 - 120
(steps of 10 ppm),
• Intrinsic + 0, + 10, +20, +30 ppm
** The Intrinsic rate is calculated as the average Ventricular Rate over the
previous 64 cycles

Intervention Duration:
The time in minutes that the pacemaker will operate
at the Intervention Rate.
Following the Intervention Duration the rate will be

decreased, according to the programmed Recovery
Time, until either the Base Rate or Sensor Indicated
Rate is reached.
• Programmable Parameters: 1-10 min (steps of
1 min)

Cycle Count - 3

Stored Electrograms

Stored EGMs
Triggers:
Patient Activated (with Magnet)
High Atrial Rate
Programmable Rate (125-300) and Count (2-20)
High Ventricular Rate
Programmable Rate (125-300) and Count (2-20)
AMS Entry
AMS Exit
PVCs
Programmable # of consecutive PVCs (2-5)
PMT Termination

Stored EGMs
Programmable # of Snapshots
1, 2, 4, 8, 12
Programmable Sampling Option

Freeze or Continuous

Stored EGMs
Total Recording Time:

Dual Channel (A & V and Markers): 48
seconds
Single Channel (A, V, or X-channel and
Markers): >120 seconds
All Snapshots include:
Extended Markers (includes events under
refractory periods)
Pre-Trigger Data Collection (approximately
50% of snapshot)

Stored EGMs

Stored EGMs

Stored EGMs

AMS Log

AMS Log
AMS Log includes:
Record of the last 16 AMS Events

Time, Date, Max Rate, and Duration
Direct Navigation to Corresponding Stored EGM
Works in Conjunction with AMS Histogram

AMS Log

AMS Base Rate

Auto Mode Switch Base Rate
Auto Mode Switch Base Rate (AMS Base Rate) is a

programmable Rate to which the device will mode switch (in
the absence of activity) during periods of atrial
tachyarrhythmia

Clinical Benefits:
Compensates for the loss of atrial contribution with an

elevated ventricular pacing rate
Promotes patient comfort with reduced V-V variability
Programmable Values: Base Rate + 0 to BR + 35 (5 ppm steps)

AMS Base Rate Values

Auto Mode Switch- Initiated, AMS Base Rate 80 ppm (750 ms)


AFx™ Histogram

AFx™ Histogram
AFx™ Histogram includes:

Detailed Histogram that shows rates driven by AF
Suppression algorithm
Percent of Counts paced in Atrium
Percent of Counts driven by AF Suppression
algorithm
Percent Mode Switched

AFx™ Histogram

Previous Test Results


Results of the last Capture and Sense Tests
stored in device
Previous test results are available to view on the

appropriate test screen
Includes time and date stamp of last test with the

measured safety margin


AutoCapture™ Pacing Systems

The exclusive AutoCapture™ Pacing System algorithm

is designed to ensure capture at the lowest possible
energy output.

• The Four Cornerstones of AutoCapture™ Pacing

Systems are:
– Automatic Beat-By-Beat™ Capture Verification

– Automatic Loss of Capture Recovery (Back-up
Pulse)
– Automatic Threshold Search
– Automatic Output Regulation

What is an
evoked
response?
The signal
resulting from
the electrical
activation of the
myocardium
produced by a
pacemaker
stimulus.

What occurs in the

absence of an evoked
response?
As demonstrated, the
absence of an evoked
response during the
detection window (47
ms) results in the
delivery of a 4.5 v back-
up safety pulse within
80-100 ms of the
primary pacing pulse.


The Identity™ Pacemaker family represents our premier

bradycardia product line equipped with the most
advanced feature set available in the market today.
With its proven AF Suppression™ algorithm and new
AFx ™ Management including Stored Electrograms
and AMS Log, it provides clinicians with the tools
necessary to address their specific arrhythmia
management needs.

The Identity Pacemaker Family

Uploaded by

Copyright:

Available Formats

You might also like

The Identity Pacemaker Family

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

The Identity Pacemaker Family

Uploaded by

Copyright:

Available Formats

The Identity™ Pacemaker Family

The New Standard in

Expect More from your Pacemaker

• Description and Overview

Expect More from your Pacemaker

• Advanced Hysteresis Response

• AutoCapture™ Pacing Systems

Expect More from your Pacemaker

• AMS Base Rate

• Previous Test Results

Expect More from your Pacemaker