altrua_reference_guide.pdf
Page 1
Reference Guide
ALTRUA™ Pacing System –
Full Options for a Full Life
Page 2
ALTRUA™
Pacing System
Page 3
Table of Contents
1
2
3
4
5
6
7
Sick Sinus Syndrome
1.1 Patient Indication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 4
1.2 Proposed Treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 5
1.3 How to Program?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 11
1.4 Which ALTRUA™ Device? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 13
1st & 2nd Degree AV Block
2.1 Patient Indication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2 Proposed Treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.3 How to Program?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.4 Which ALTRUA™ Device? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
page 16
page 17
page 21
page 23
3rd Degree AV Block
3.1 Patient Indication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.2 Proposed Treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3 How to Program?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.4 Which ALTRUA™ Device? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
page 26
page 27
page 29
page 30
Atrial Fibrillation
4.1 Patient Indication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2 Proposed Treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3 How to Program?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.4 Which ALTRUA™ Device? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
page 32
page 33
page 35
page 36
Ease of Use
5.1 Patient Follow-Up Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 38
5.2 Stored Onset EGM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 39
5.3 Longevity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 40
ALTRUA™ Device Family. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 41
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 44
Table of Contents
Page 4
Introduction
Welcome
As experts in the field of cardiac devices
we can look back at a rich history of
innovative algorithms and products.
From the discovery of the first solid state
lithium batteries which provided long-lasting
pacemakers to the introduction of the first ICD and
CRT devices, we always pursue high standards.
• Patient safety
• Ease of use
• Physiological treatment
• Longevity
are our 4 key objectives for any device
we bring to the market.
When focusing on these aspects we know
we are producing a state of the art product
which is treating patients and helping
physicians in the most optimal way.
Introduction
Page 5
Sick Sinus Syndrome
1. Sick Sinus Syndrome
1
3
Page 6
ALTRUA™
Pacing System
1.1 Patient Indication
Sinus Node Disease
4
1.1 Patient Indication
Page 7
1
Sick Sinus Syndrome
1.2 Proposed Treatment
Extended AVSH+
The 400 ms extended AV delay provides
increased efficiency1 to reduce the amount
of RV pacing while ensuring a physiological
treatment in case the patient's heart deteriorates
towards an AV block.
Evidence
The INTRINSIC RV study, the largest Boston Scientific CRM study to date,
demonstrates that AVSH+ significantly reduces the amount of RV pacing2.
Mean RV pacing2a
59%
10%
DAVID
study
59%
RV pacing DDDR
DAVID study2a
INTRINSIC
RV study
•1
08 centres, 1530 patients
screened/enrolled, 988 patients
randomized
• INTRINSIC RV population had
a slightly worse NYHA class
compared with DAVID study
population (21% class III /IV vs. 12%)
• INTRINSIC RV study was conducted
with a 300 ms max. AV delay.
The extension to 400 ms provides
increased flexibility for pacing
avoidance.
10%
RV pacing DDDR + AVSH arm
INTRINSIC RV study2
1.2 Proposed Treatment
5
Page 8
ALTRUA™
Pacing System
Algorithm
• If the AV conduction is preserved: our algorithm will listen to the heart and search the intrinsic
rhythm (functional AAI(R)).
• If the patient develops an AV block: AVSH+ will provide an effective treatment, always assuring
ventricular activity whether it is paced or sensed: functional AAI(R) DDD(R).
AV Search Hysteresis
allows intrinsic conduction
AV Search not active
AV Search begins
Searches for intrinsic conduction every 32–1024 ventricular cycles
Returns to programmed AV delay if intrinsic conduction is lost
Image source: Data on file at Boston Scientific; System Guide
6
1.2 Proposed Treatment (continued)
Page 9
1
Sick Sinus Syndrome
AutoLifestyle™
ALTRUA™ blended sensor restores chronotropic competence.
It provides the appropriate heart rate for any given level of activity
whether it is purely physical, emotional or related to stress.
ith AutoLifestyle™, the ALTRUA™ pacemaker listens twice as carefully
W
to the patients’ needs and adjusts automatically. The combination of
the accelerometer and the dual sensor minute ventilation ensures a
physiological alternative that mimics the natural rhythm of the heart.
?
How many times per
day does the average
person under age 65 raise his
or her heart rate above 90
beats per minute?
178 times!
3
?
How many times per
day does the average
person over age 65 raise his
or her heart rate above 90
beats per minute?
All
patients
3
151
times!
benefit from
the ability to
raise their heart
rates when
needed.
1.2 Proposed Treatment (continued)
7
Page 10
ALTRUA™
Pacing System
Evidence
Down Stairs
Up Stairs
Brisk Walk
Slow Walk
— Rate for
chronotropically
competent patient
— Accelerometer only
indicated rate
Elevator
Up Stairs
Down Stairs
Brisk Walk
Slow Walk
Elevator
— Rate for
chronotropically
competent patient
— Blended Sensor
(Minute Ventilation
& Accelerometer)
indicated rate
Images Source: Data on file at Boston Scientific. Recognizing the Symptoms of Chronotropic Incompetence and Treating them with Minute Ventilation Blended Sensor (In-service presentation).
8
1.2 Proposed Treatment (continued)
Page 11
Sick Sinus Syndrome
1
Patient cases
61 year old marathon runner*
• Indication: sick sinus syndrome with complete heart block
• Programming: initial programming was DDDR with rate response using the
accelerometer only (Response Factor = 8, LRL = 60, MSR = 130)
• At follow-up 2 weeks post implant: MV turned on and AutoLifestyle™ activated
• 6 months after activating MV: evaluation of programmed settings
showed the sensor settings were appropriate.
85-year-old house-wife*
•
•
•
•
Indication: sick sinus syndrome with complete heart block
Programming: initial device programming was DDD, with LRL = 60 and MTR = 120
At follow-up 2 weeks post implant: MV turned on and AutoLifestyle™ activated
5 months after activating MV: patient activity level increased
by 50% as recorded in the device activity
70 year old active farmer*
• Indication: sick sinus syndrome with atrial fibrillation
• Programming: Initial programming was DDDR with accelerometer rate response only:
LRL = 60 and MTR = 130
• At follow-up 2 weeks post implant: MV turned on
• After activating MV: evaluation of programmed settings
showed the sensor settings were appropriate
* For more information regarding the patient cases, please contact your local sales representative.
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
Patients should consult a physician or qualified health care provider regarding their medical condition and appropriate medical treatment.
1.2 Proposed Treatment (continued)
9
Page 12
ALTRUA™
Pacing System
Algorithm
Long-term:
At implant:
AutoLifestyle
automatically programs
initial response factors at
a very conservative level,
based on patient ages.
™
Post implant:
AutoLifestyle™
automatically adjusts
the Minute Ventilation
response factor to the
appropriate level, based on
patient exertion level
over several weeks.
AutoLifestyle™
automatically makes
minor adjustments to
Minute Ventilation and
accelerometer response
factors as needed,
based on patient
exertion.
Maximum rate at
maximum ventilation
220-Age
HEART RATE
Normal heart rate zone
MSR
Fine adjustment
Coarse adjustment
More response
Starting response
Less response
LRL
Rest
10
EXERTION
(correlates to ventilation)
Maximum
1.2 Proposed Treatment (continued)
Page 13
1
Sick Sinus Syndrome
1.3 How to Program?
Extended AVSH+
Programming Parameters
Search Interval:
Controls how often AV
Search Hysteresis promotes
intrinsic AV conduction during
episodes of AV sequential pacing.
Every 32 cycles (nominal value) the
device will lengthen the AV delay
promoting the intrinsic AV
conduction and thus
AV Increase:
reducing
the unnecessary
Determines to what
RV
pacing.
extent the AV delay
will lengthen to promote
intrinsic AV conduction.
This percentage is applied
to the current AV delay.
ALTRUA™ 40:
AV Search Hysteresis
allows a maximum of 300 ms
ALTRUA™ 50 & 60:
AV Search Hysteresis
allows a maximum
of 400 ms
Go to:
Brady Parameters AV Delay.
Determine the AVSH Parameters:
The search interval (32 – 1024 cycles)
and the AV Increase (10 – 100%)
Images source: Data on file at Boston Scientific
1.3 How to Program?
11
Page 14
ALTRUA™
Pacing System
AutoLifestyle™
If you know your patient’s age,
you have everything you need
to optimize Blended Sensor.
Go to:
1. Select a rate response mode (e.g. DDDR)
2. Go to sensor screen and program
Minute Ventilation on:
4 on -V (ventricular MV measurement) or
4 on -A (atrial MV measurement)
3. Go to Expert Ease for AutoLifestyle™
and activate AutoLifestyle™
4. Fill in patient age and AutoLifestyle™ will
optimize according to patient condition
Images source: Data on file at Boston Scientific
12
1.3 How to Program? (continued)
Page 15
1
Sick Sinus Syndrome
1.4 Which ALTRUA™ Device?
Sick Sinus Syndrome
ALTRUA™ 40
ALTRUA™ 50
ALTRUA™ 60
X
X
Treatment
• AVSH – 400 ms (pacing avoidance)
• AVSH – 300 ms (pacing avoidance)
• Accelerometer Sensor
• Minute Ventilation Sensor
X
X
X
X
X
X
Prevention
• Sudden Bradycardia Response
• Rate Smoothing
X
X
X
X
X
X
X
X
X
X
X
Device Management
• AutoLifestyle™
• Autosensing
• Diagnostics
X
X
For more detailed information please contact your local sales representative.
1.4 Which ALTRUA™ Device?
13
Page 17
1st & 2nd Degree AV Block
2. 1st & 2nd Degree AV Block
2
15
Page 18
ALTRUA™
Pacing System
2.1 Patient Indication
First Degree AV Block
Second Degree AV Block
16
2.1 Patient Indication
Page 19
1st & 2nd Degree AV Block
2
2.2 Proposed Treatment
Extended AVSH+
The 400 ms extended AV delay provides
increased efficiency1 to reduce the amount
of RV pacing while ensuring a physiological
treatment in case the patient's heart deteriorates
towards an AV block.
Evidence
The INTRINSIC RV study, the largest Boston Scientific CRM study to date,
demonstrates that AVSH+ significantly reduces the amount of RV pacing2.
Mean RV pacing2a
59%
10%
DAVID
study
59%
RV pacing DDDR
DAVID study2a
INTRINSIC
RV study
•1
08 centres, 1530 patients
screened/enrolled, 988 patients
randomized
• INTRINSIC RV population had
a slightly worse NYHA class
compared with DAVID study
population (21% class III /IV vs. 12%)
• INTRINSIC RV study was conducted
with a 300 ms max. AV delay.
The extension to 400 ms provides
increased flexibility for pacing
avoidance.
10%
RV pacing DDDR + AVSH arm
INTRINSIC RV study2
2.2 Proposed Treatment
17
Page 20
ALTRUA™
Pacing System
Algorithm
• If the AV conduction is preserved: our algorithm will listen to the heart and search the intrinsic
rhythm (functional AAI(R)).
• If the patient develops an AV block: AVSH+ will provide an effective treatment, always assuring
ventricular activity whether it is paced or sensed: functional AAI(R) DDD(R).
AV Search Hysteresis
allows intrinsic conduction
AV Search not active
AV Search begins
Searches for intrinsic conduction every 32–1024 ventricular cycles
Returns to programmed AV delay if intrinsic conduction is lost
Image source: Data on file at Boston Scientific; System Guide
18
2.2 Proposed Treatment (continued)
Page 21
2
1st & 2nd Degree AV Block
Automatic Capture
Treating your patient with AV block in an optimal and safe way… just one touch away.
Save time on ventricular threshold testing and programming, let the device
worry about that. Independent of the type of lead and device configuration,
Automatic Capture is designed to ensure a safe therapy providing beat to beat
capture verification with high energy back-up pulse.
Increased capture efficiency, resulting in a reduced % of RV pacing, leading
to increased battery lifetime while maintaining a high level of flexibility,
a combination you and your patient can benefit from.
Evidence4,5
The purpose of ventricular automatic capture pacing systems should be three-fold:
Unlike other commercially available
VAC features, Automatic Capture
1. is specifically designed to be used
with a wide variety of leads
= increased flexibility
2. incorporates a fusion avoidance
algorithm, which inhibits stimulation
in case of intrinsic rhythm (fusion beats
are estimated at 39% of paced beats) 8
= increased longevity impact
3. provides beat to beat
analysis of capture
= increased patient safety
On top of that, Automatic Capture does not
require set-up measurements at implant
= Ease of Use
Patient Safety
•b
eat to beat
analysis of capture
• back-up pulse in case
of loss of capture
• pacing avoidance with
fusion management
algorithm
• dedicated ER
channel
Longevity
•a
utomatic adjustment
of pacing output to
maintain capture
• pacing avoidance with
fusion management
algorithm
2.2 Proposed Treatment (continued)
Flexibility
• no additional
tests required
• use any lead
• use any pacing
and sensing
combination
19
Page 22
ALTRUA™
Pacing System
Algorithm
Threshold Output
Threshold Output without Automatic Capture
Even with a safety margin of two times measured threshold
every device runs the risk of losing capture.
Pacing Threshold
No Capture
Threshold Output x2
Threshold Output
Time
Threshold Output with Automatic Capture
Automatic Capture will look at the evolution of the heart and
provide a safe and accurate threshold management system.
Threshold Output
Pacing Threshold
Automatic Capture Output
Time
Threshold
adjustment
Image source: Data on file at Boston Scientific; System Guide
20
2.2 Proposed Treatment (continued)
Page 23
1st & 2nd Degree AV Block
2.3 How to Program?
Extended AVSH+
Programming Parameters
2
Search Interval:
Controls how often AV
Search Hysteresis promotes
intrinsic AV conduction during
episodes of AV sequential pacing.
Every 32 cycles (nominal value) the
device will lengthen the AV delay
promoting the intrinsic AV
conduction and thus
AV Increase:
reducing
the unnecessary
Determines to what
RV
pacing.
extent the AV delay
will lengthen to promote
intrinsic AV conduction.
This percentage is applied
to the current AV delay.
ALTRUA™ 40:
AV Search Hysteresis
allows a maximum of 300 ms
ALTRUA™ 50 & 60:
AV Search Hysteresis
allows a maximum
of 400 ms
Go to:
Brady Parameters AV Delay.
Determine the AVSH Parameters:
The search interval (32 – 1024 cycles)
and the AV Increase (10 – 100%)
Images source: Data on file at Boston Scientific
2.3 How to Program?
21
Page 24
ALTRUA™
Pacing System
Automatic Capture
One button to activate
One button to follow-up
Go to:
Brady Parameters
Ventricular Output
Amplitude:
Select "AUTO"
22
2.3 How to Program? (continued)
Page 25
2
1st & 2nd Degree AV Block
2.4 Which ALTRUA™ Device?
1st & 2nd Degree AV block
ALTRUA™ 40
Treatment
• AVSH + – 400 ms (pacing avoidance)
• AVSH – 300 ms(pacing avoidance)
• Rate Hysteresis with Search
Device Management
• Automatic Capture
• Autosensing
ALTRUA™ 50
ALTRUA™ 60
X
X
X
X
X
X
X
X
X
X
X
For more detailed information please contact your local sales representative.
2.4 Which ALTRUA™ Device?
23
Page 27
3rd Degree AV Block
3. 3rd Degree AV Block
3
25