subcutaneous icd - société suisse de cardiologie · r is k p ro file in s ig h t Þ s m a r t p a...
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2009 2015 2016
Images courtesy of Boston Scientific
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Patient Name
Patient Name
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2
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Risk Profile INSIGHT™ SMART Pass
INSIGHT™ Algorithm: Architecture
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-384027-AA MAR2016
S-ECG signal similar
to a surface ECG4 double-detection algorithms
designed to reduce oversensing
3 rhythm discriminators
to confirm therapy
PHASE I:Detection
PHASE II: Certification
PHASE III: TherapyDecision
Subcutaneous signal detection
Heart rate determined
HR assessed, therapy confirmed
INSIGHT™
Slide courtesy of Boston Scientific
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Priori et al. 2015 ESC VA and SCD guidelines Elliot et al. 2014 ESC HCM guidelines
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Risk Profile INSIGHT™ SMART Pass
12.0%
6.4% 7.0%
2.8% 3.1% 3.6%
0.0%
3.0%
6.0%
9.0%
12.0%
Single zone Dual zone EFFORTLESS(blended total)
SMR8Projection*
SMR8 & SMART PassProjection**
MADIT RIT (high rate)
MADIT RIT (delayed)
PREPARE
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-384027-AA MAR2016
Reported inappropriate shock rates
and projected technology impact
* Estimated number based on bench testing showing 30-40% reduction of T-wave oversensing with the addition of the Alternating Morphology Algorithm in the heart rate certification phase of the EMBLEM S-ICD INSIGHT™ Technology# (Data on file at Boston Scientific, validation report DN-23333)
** Estimated number on bench testing showing > 40% reduction of inappropriate therapy with the addition of SMART Pass filter38
Note: SMART Pass will be automatically disabled when measured ECG amplitudes are <0.5mV# These studies involved transvenous ICDs only
1-y
ear
incid
ence (
% p
ts) of IA
S
Programming optimisation
EFFORTLESS data
Technology Improvement
Projection (bench testing)
5.1 -5.6% 3.9 -
4.2%
6 6
7
4.0%2.5%
MADIT-RIT: <65 years
MADIT-RIT: ≥65 years8
4
44
8
Risk ProfileRisk Profile INSIGHT™ SMART Pass
12.0%
6.4% 7.0%
2.8% 3.1% 3.6%
0.0%
3.0%
6.0%
9.0%
12.0%
Single zone Dual zone EFFORTLESS(blended total)
SMR8Projection*
SMR8 & SMART PassProjection**
MADIT RIT (high rate)
MADIT RIT (delayed)
PREPARE
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-384027-AA MAR2016
Reported inappropriate shock rates
and projected technology impact
* Estimated number based on bench testing showing 30-40% reduction of T-wave oversensing with the addition of the Alternating Morphology Algorithm in the heart rate certification phase of the EMBLEM S-ICD INSIGHT™ Technology# (Data on file at Boston Scientific, validation report DN-23333)
** Estimated number on bench testing showing > 40% reduction of inappropriate therapy with the addition of SMART Pass filter38
Note: SMART Pass will be automatically disabled when measured ECG amplitudes are <0.5mV# These studies involved transvenous ICDs only
1-y
ear
incid
ence (
% p
ts) of IA
S
Programming optimisation
EFFORTLESS data
Technology Improvement
Projection (bench testing)
5.1 -5.6% 3.9 -
4.2%
6 6
7
4.0%2.5%
MADIT-RIT: <65 years
MADIT-RIT: ≥65 years8
4
44
8
Risk Profile
Risk Profile INSIGHT™ SMART Pass
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-384027-AA MAR2016
1.2
0.80.2
4.8
S-ICD is excellent at appropriately
identifying (and not shocking)
Afib/SVT in the conditional zone
Inappropriate Therapy Rate(% of Patients, 360 days)
7.0%
EFFORTLESS4
Non-cardiac Over-sensing
There was only 1 discrimination error (in the conditional zone) in 456 patients
Cardiac Over-sensing
Discrimination Error
SVT above shock zone
In the START3 study,
the authors noted:
“specificity of supraventricular
arrhythmia detection varied considerably among devices and was best for the S-ICD system”
»
Risk Profile
Priori et al. 2015 ESC VA and SCD guidelines Slide courtesy of Boston Scientific
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Gen 1: SQ-RX ⎮ Gen 2: EMBLEM™ S-ICD ⎮ Gen 2.5: EMBLEM™ MRI
Risk Profile INSIGHT™ SMART Pass
12.0%
6.4% 7.0%
2.8% 3.1% 3.6%
0.0%
3.0%
6.0%
9.0%
12.0%
Single zone Dual zone EFFORTLESS(blended total)
SMR8Projection*
SMR8 & SMART PassProjection**
MADIT RIT (high rate)
MADIT RIT (delayed)
PREPARE
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-384027-AA MAR2016
Reported inappropriate shock rates
and projected technology impact
* Estimated number based on bench testing showing 30-40% reduction of T-wave oversensing with the addition of the Alternating Morphology Algorithm in the heart rate certification phase of the EMBLEM S-ICD INSIGHT™ Technology# (Data on file at Boston Scientific, validation report DN-23333)
** Estimated number on bench testing showing > 40% reduction of inappropriate therapy with the addition of SMART Pass filter38
Note: SMART Pass will be automatically disabled when measured ECG amplitudes are <0.5mV# These studies involved transvenous ICDs only
1-y
ear
incid
ence (
% p
ts) of IA
S
Programming optimisation
EFFORTLESS data
Technology Improvement
Projection (bench testing)
5.1 -5.6% 3.9 -
4.2%
6 6
7
4.0%2.5%
MADIT-RIT: <65 years
MADIT-RIT: ≥65 years8
4
44
8
Risk Profile
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Acute major implant-related: 2% (TV-ICD: VR 1.9%, DR 2.9%)2
No systemic infection
No electrode failures
IDE + EFFORTLESS N = 8821
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Patient Name
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AF PrevalenceAF Monitor™
BenefitAF Monitor™
AlgorithmAF Monitor™ Programming
AF Monitor™ AlgorithmAF Monitor™ uses Ventricular scatter and HRDI algorithms
to identify and classify rhythm1 (based on internal bench testing)
Ventricular Scatter Algorithm: AF/non-AF
(Based on RR interval)
Classify:
AF/non-AF
Heart Rate Density Index Algorithm:
AF/non-AF (Based on heart rate distribution)
RR1 RR2 RR3 RR4 RR5
Input Beat by Beat Heart Rate
Both Ventricular Scatter and HRDI algorithms need to be met
in a 192 beat window for the rhythm to be classified as AF1.
AF Monitor™ Algorithm
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-382002-AA APR2016
AF PrevalenceAF Monitor™
BenefitAF Monitor™
AlgorithmAF Monitor™ Programming
AF Monitor™ Algorithm
1. Ventricular Scatter Algorithm 2. Heart Rate Distribution Algorithm
time
AF episodenon-AF episode
250
40
Rate
Heart Rate Density Index = 81%
Heart Rate Mode = 60bpm
Heart Rate Density Index = 23%
Heart Rate Mode = 90bpm
AF Monitor™ Algorithm
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-382002-AA APR2016
AF PrevalenceAF Monitor™
BenefitAF Monitor™
AlgorithmAF Monitor™ Programming
AF Monitor™ Algorithm
1. Ventricular Scatter Algorithm 2. Heart Rate Distribution Algorithm
time
AF episodenon-AF episode
250
40
Rate
Heart Rate Density Index = 81%
Heart Rate Mode = 60bpm
Heart Rate Density Index = 23%
Heart Rate Mode = 90bpm
AF Monitor™ Algorithm
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-382002-AA APR2016
Slide courtesy of Boston Scientific
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Patient Name
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©Boston Scientific 2015
Tachy Therapies -Future Product PipelineEMBLEM™ S-ICD + Leadless Cardiac Pacemaker
Coordinate S-ICD with leadless pacemaker.
Convert arrhythmias with ATP instead of a shock.
Allow leadless pacemaker to be added any time after initial S-ICD implant with femoral access, instead of adding a transvenous system.
Give even more people access to the S-ICD by offering a combined S-ICD plus Leadless pacemaker system.
Operational
Efficiency
Patient
Experience
Quality
Outcomes
Financial
Health
Design Parameters Design Goals
Caution: Investigationaldevices. LimitedbyFederallawtoinvestigationaluseonly. Notavailableforsale.
Slide courtesy of Boston Scientific
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Advantages Disadvantages
Less lead failure No anti-bradycardia pacing or CRT
No systemic infection No ATP
Preserved vascular access Lack of long term follow-up
No/less fluoroscopy Shorter battery life
No risk of transvenous lead extraction Higher risk of IAS
Predictability of implantation Limited programming options
Less procedural risk Higher cost
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• “Sicker” patients :
• - renal failure,
• - coagulopathy,
• - weight loss.
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