ALTRUA EL Reference Guide

Page 1

Reference Guide

ALTRUA™

Pacing System

ALTRUA™ Pacing System –

Full Options for a Full Life

www.bostonscientific-international.com

All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings

and instructions for use can be found in the product labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations.

Printed in Germany by medicalvision.

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© 2009 Boston Scientific Corporation

or its affiliates. All rights reserved.

DINCRM0260EB

Page 2

ALTRUA™

Pacing System

7

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.

2

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 16

14

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