Reference Guide
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Page 1
Reference Guide
ALTRUA™ Pacing System – Full Options for a Full Life
ALTRUA™ Pacing System
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... page 16 2.2 Proposed Treatment... page 17 2.3 How to Program?... page 21 2.4 Which ALTRUA™ Device?... page 23 3rd Degree AV Block 3.1 Patient Indication... page 26 3.2 Proposed Treatment... page 27 3.3 How to Program?... page 29 3.4 Which ALTRUA™ Device?... page 30 Atrial Fibrillation 4.1 Patient Indication... page 32 4.2 Proposed Treatment... page 33 4.3 How to Program?... page 35 4.4 Which ALTRUA™ Device?... 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
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
ALTRUA™ Pacing System
1.1 Patient Indication Sinus Node Disease
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1.1 Patient Indication
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
• 108 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
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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
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1.2 Proposed Treatment (continued)
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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)
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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).
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1.2 Proposed Treatment (continued)
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)
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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
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EXERTION (correlates to ventilation)
Maximum
1.2 Proposed Treatment (continued)
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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?
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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
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1.3 How to Program? (continued)
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?
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1st & 2nd Degree AV Block
2. 1st & 2nd Degree AV Block
2
15
ALTRUA™ Pacing System
2.1 Patient Indication First Degree AV Block Second Degree AV Block
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2.1 Patient Indication
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
• 108 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
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
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2.2 Proposed Treatment (continued)
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 • beat to beat analysis of capture • back-up pulse in case of loss of capture • pacing avoidance with fusion management algorithm • dedicated ER channel
Longevity • automatic 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
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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
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2.2 Proposed Treatment (continued)