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 s s IN S IG H T Þ A lg o r ith m : A r c h ite c tu r e ¯ 2 0 1 6 B o s to n

2009 2015 2016

Images courtesy of Boston Scientific

Patient Name

Patient Name

2

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

Priori et al. 2015 ESC VA and SCD guidelines Elliot et al. 2014 ESC HCM guidelines


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


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%


SMR8Projection*



MADIT RIT (delayed)

PREPARE







1-y

ear

incid

ence (

% p

ts) of IA

S


EFFORTLESS data



5.1 -5.6% 3.9 -

4.2%

6 6

7

4.0%2.5%



4

44

8

Risk Profile



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

Gen 1: SQ-RX ⎮ Gen 2: EMBLEM™ S-ICD ⎮ Gen 2.5: EMBLEM™ MRI


12.0%

6.4% 7.0%

2.8% 3.1% 3.6%

0.0%

3.0%

6.0%

9.0%

12.0%


SMR8Projection*



MADIT RIT (delayed)

PREPARE







1-y

ear

incid

ence (

% p

ts) of IA

S


EFFORTLESS data



5.1 -5.6% 3.9 -

4.2%

6 6

7

4.0%2.5%



4

44

8

Risk Profile

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 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





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









1. Ventricular Scatter Algorithm 2. Heart Rate Distribution Algorithm

time

AF episodenon-AF episode

250

40

Rate








Patient Name

©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.


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.

Documents

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 s s IN S IG H T Þ A lg o r ith m : A r c h ite c tu r e ¯ 2 0 1 6 B o s to n