Download Subcutaneous ICD

2009  2015  2016
Images courtesy of Boston Scientific
Patient Name
Patient Name
2
INSIGHT™ Algorithm: Architecture
PHA SE I:
Detection
Subcutaneous
signal detection
S-ECG signal similar
to a surface ECG
Risk Profile
INSIGHT™
PHA SE II:
Certification
Heart rate
determined
PHA SE III:
Therapy
Decision
4 double-detection algorithms
designed to reduce oversensing
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
Slide courtesy of Boston Scientific
HR assessed,
therapy confirmed
3 rhythm discriminators
to confirm therapy
Priori et al. 2015 ESC VA and SCD guidelines
Elliot et al. 2014 ESC HCM guidelines
S-ICD is excellent at appropriately
identifying (and not shocking)
Afib/SVT in the
conditional
Reported
shock
rates
Reportedinappropriate
inappropriate
shock
rates zone
and
technology
impact
andprojected
projected
technology
impact
Inappropriate
Therapy Rate
1-year incidence (% pts) of IAS
1-year incidence (% pts) of IAS
(% of Patients, 360 days)
Programming
optimisation
Programming
optimisation Technology
TechnologyImprovement
Improvement
EFFORTLESS
Projection
EFFORTLESSdata
data
Projection(bench
(benchtesting)
testing)
7.0%
4.0%
4.0%
12.0%
12.0%
9.0%
9.0%
6.0%
6.0%
4.8
Cardiac Over-sensing
0.2
7.0%
7.0%
0.8
Discrimination Error
5.1
-Noncardiac
Over-sensing
5.1
3.9
-3.9
5.6%
5.6%
4.2%
SVT above shock
zone
4.2%
MADIT-RIT: <65 MADIT-RIT: ≥65
MADIT-RIT:
<65 MADIT-RIT:
≥65
years 8 8
years 8 8
years
years
12.0%
12.0%
6.4%
6.4%
3.0%
3.0%
1.2
0.0%
0.0%
»
In the START3 study,
the authors noted:
“specificity of supraventric
arrhythmia detection varied
considerably
among devices
2.5%
2.5%
was best for the S-ICD sys
4
4
Single
zone
zone
SMR8
SMR8
&&
Single
zone 4 Dual
Dual
zone 4 EFFORTLESS
EFFORTLESS
SMR8
SMR8
44
EFFORTLESS
4
(blended
total)
Pass
(blended
total) Projection*
Projection* SMART
SMART
Pass
Projection**
Projection**
Priori et al. 2015 ESC VA and SCD guidelines
There was only 1 discrimination error
(in the conditional zone) in 456 patients
2.8%
2.8%
3.1%
3.1%
MADIT
RIT
MADIT
RIT
MADIT
RIT
MADIT
RIT
6
6
6
6
(high
rate)
(delayed)
(high
rate)
(delayed)
3.6%
3.6%
7
PREPARE
PREPARE
7
Slide courtesy of Boston Scientific
* Estimated
number
based
on on
bench
testing
showing
30-3040%
reduction
ofINSIGHT™
Toversensing
with
thethe
addition
of the
Alternating
Morphology
Algorithm
in the
heart
rate
certification
Risk
Profile
SMART
Pass
* Estimated
number
based
bench
testing
showing
40%
reduction
of wave
T-wave
oversensing
with
addition
of the
Alternating
Morphology
Algorithm
in the
heart
rate
certification
#
phase
of the
EMBLEM
S-ICD
INSIGHT™
Technology
on on
filefile
at Boston
Scientific,
validation
report
DN23333)
# (Data
phase
of the
EMBLEM
S-ICD
INSIGHT™
Technology(Data
at Boston
Scientific,
validation
report
DN23333)
38
** Estimated
number
on on
bench
testing
showing
> 40%
reduction
of inappropriate
therapy
with
thethe
addition
of SMART
Pass
filter
** Estimated
number
bench
testing
showing
> 40%
reduction
of inappropriate
therapy
with
addition
of SMART
Pass
filter 38
© 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
nce (% pts) of IAS
Programming optimisation
EFFORTLESS data
4.0%
12.0%
2.5
9.0%
Gen 1: SQ-RX ⎮ Gen 2: EMBLEM™ S-ICD ⎮ Gen 2.5: EMBLEM™ MRI
6.0%
Technology Improvement
Projection (bench testing)
12.0%
MADIT-RIT: <65 MADITyears 8
ye
Acute major implant-related: 2% (TV-ICD: VR 1.9%, DR 2.9%)2
No systemic infection
No electrode failures
IDE + EFFORTLESS N = 8821
Patient Name
AF Monitor ™ Algorithm
AF Monitor ™ Algorithm
1. Ventricular Scatter Algorithm
AF Monitor™ uses Ventricular scatter and HRDI algorithms™
AF Monitor
to identify and classify rhythm1 (based on internal bench testing)
1. Ventricular Scatter Algorithm
2. Heart Rate Distribution Algorithm
2. Heart Rate Distribution Algorithm
RR1
RR2
RR3
RR4
RR5
non-AF episode
Heart Rate Density Index = 81%
Heart Rate Mode = 60bpm
AF episode
Input
Heart Rate Density Index
= 81%Beat by Beat
Heart Rate Mode = 60bpmHeart250
Rate
AF episode
Ventricular Scatter
Algorithm:
AF/non-AF
Rate
250
Rate
non-AF episode
Algorithm
40
(Based on RR interval)
Classify:
AF/non-AF
40
time
Heart Rate Density
Index Algorithm:
AF/non-AF
(Based on heart rate distribution)
time
Heart Rate Density Index = 23%
Heart Rate Mode = 90bpm
Heart Rate Density Index = 23%
Heart Rate Mode = 90bpm
Both Ventricular Scatter and HRDI algorithms need to be met
in a 192 beat window for the rhythm to be classified as AF1.
AF Prevalence
AF Prevalence
AF Monitor™
Benefit
AF Monitor™
Algorithm
AF Monitor™
Benefit
AF Monitor™
Algorithm
AF Monitor™
AF Prevalence
Programming
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-382002-AA APR2016
AF Monitor™
Algorithm
AF Monitor™
Programming
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-382002-AA APR2016
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-382002-AA APR2016
AF Monitor™
Programming
AF Monitor™
Benefit
Slide courtesy of Boston Scientific
Patient Name
Tachy Therapies -Future Product Pipeline
EMBLEM™ S-ICD + Leadless Cardiac Pacemaker
Design
Parameters
Patient
Experience
Quality
Outcomes
Operational
Efficiency
Financial
Health
Design Goals
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.
Caution: Investigational devices. Limited by Federal law to investigational use only. Not available for sale.
©Boston Scientific 2015
Slide courtesy of Boston Scientific
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
2
•
•
•
•
•
“Sicker” patients :
- renal failure,
- coagulopathy,
- weight loss.