How ICD Therapy Has Evolved From Large Devices Requiring Surgery to Small, Minimally Invasive Options

ICD Therapy: How far
we have come
Dr. Kush Kumar Bhagat

Large devices – Abdominal site
• First human implants
• Thoracotomy, multiple incisions
• General anesthesia
• Long hospital stays
• Complications from major surgery
• Perioperative mortality up to 9%
• Nonprogrammable therapy
• High-energy shock only
• Device longevity  1.5 years
• Fewer than 1,000 implants/year
1980’s Small devices – Pectoral site
• First-line therapy for VT/VF patients
• Transvenous, single incision
• Local anesthesia; conscious sedation
• Short hospital stays
• Few complications
• Perioperative mortality < 1%
• Programmable therapy options
• Single- or dual-chamber therapy
• Battery longevity up to 9 years
• More than 300,000 implants/year
• 1980-1985 clinical trial of first ICDs
• 1985 FDA approved first ICD for
human use
• Those first devices were 10 times the
size of modern ICDs!
• Their large size mandated an
abdominal implant
• Thoracotomy required to implant
leads
Today
Technological Challenges
• Capacitor technology
• Transvenous defibrillation leads
• Effective Shock reduction
• Size and Longevity
• Programming and Remote Monitoring

Evolution of ICD Implantation
Implanting Physician Cardiac surgeon EP or surgeon
Device size 120 - 140 cc < 35 cc
Procedure Median sternotomy Skin incision
Lateral thoracotomy
Procedure time 2 - 4 hours ~1 hour
Perioperative 2.5% < 0.5%
mortality
Post-implant 3 - 5 days 1 day
hospitalization
Battery longevity 18 months Up to 10 years
Thoracotomy
Transvenous/
Pectoral

The ICD: Then and 2008
144cc / 250g (1985) 31.5cc / 72g (2008)

BIOshape. Ultraslim 10mm ICDs and CRT-Ds.
• Ultraslim Devices Combined With a Smooth, Elliptical, and Body-friendly BIOshape.
Small and
slim.
Increases patient
comfort.
Reduces skin
pressure.
Eases
implantation.
BIOshape. Ultraslim 10mm ICDs
and CRT-Ds
6

BIOshape. Ultraslim 10mm ICDs.
7
• 1 Contoured housing; Rivacor VR: 60x61.5x10 mm; 30 cm3.
Rivacor CRT-D QP: 60x75x10 mm; 35 cm3; CRT-D: 60x71.5x10mm; 33 cm3.
• 2 Device shape analysis, February 2019. Data on file.
• 3 Post-Market observation; interim-analysis, December 2018. Data on file.
• Their smooth, elliptical, and body-
friendly BIOshape1
• Eases implantation
• Reduces skin pressure2
• Increases patient comfort.3
small and slim – only 10mm
from front to back.
Height (mm) 61.5 75.0
Width (mm) 60.0 60.0
Thickness (mm) 10.0 10.0
Weight (g) 75.0 82.0
Volume (cm³) 30.0 35.0
HF-T QP
VR-T

Optimized ICD Therapy
VF
VT
VT / SVT
Sinus Rhythm
Prevent Unnecessary
Right Ventricular
Pacing
Inhibit
Unnecessary
Shocks
of SVTs
Management
of Patients
With
High DFTs
Avoid
Painful
Shocks of
Fast VTs
50 bpm 100 150 200 250 300
Sensing
Heart Rate
Unfortunately, Up to 21% of ICD
Patients Receive Inappropriate
Shocks1-4
Kadish A, Dyer A, Daubert JP, et al, for the Defibrillators in Non-Ischemic Cardiomyopathy Treatment
Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic
dilated cardiomyopathy. N Engl J Med. May 20, 2004;350(21):2151-2158.
2 Daubert JP, Zareba W, Cannom DS, et al, for the MADIT II Investigators. Inappropriate implantable
cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. J Am
Coll Cardiol. April 8, 2008;51(14):1357-1365.
3 Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with
heart failure. N Engl J Med. September 4, 2008;359(10):1009-1017.
4 Mitka M. New study supports lifesaving benefits of implantable defibrillation devices. JAMA. July 8,
2009;302(2):134-135.

All ICD shocks are associated with Increased Mortality

10
ICD programming Focus in last Decade: Shock Box to No Shocks
Accurate
Sensing
•Enhanced Sensing Filtering
•True Bipolar Leads
•Remote Monitoring Alerts
Lead Integrity Alerts
•T Wave sensing Algorithms
•Small and Better Lead
Reliable
Discrimination
Zone Programming
Enhanced SVT Discriminator
Effective
Therapy
High Energy Devices
ATP in VF Zones
2019 HRS/EHRA/APHRS/LAHRS focused
update to 2015 expert consensus statement on
optimal implantable cardioverter-defibrillator
programming and testing Europace (2019) 21, 1442–

11
ABBOTT CONFIDENTIAL. DO NOT DISTRIBUTE. FOR INTERNAL USE ONLY. MAT-2005796 | Item approved for Hong Kong, India, Korea, Singapore and Thailand use.
Physician desire to
avoid inappropriate
shocks has led to
programming of
HIGHER DETECTION
RATES and LONGER
DETECTION TIMES.
This can lead to
DELAYED OR
WITHHELD THERAPY
for true arrhythmias.
Circ Arrhythm Electrophysiol. 2017;10:e005305. DOI: 10.1161/CIRCEP.117.005305. Anna Margrethe
Thøgersen, MD, DMSc; Jacob Moesgaard Larsen, MD, PhD; Jens Brock Johansen, MD, PhD; Moeen
Abedin, MD; Charles D. Swerdlow, MD.
HIGHER THERAPY ZONES AND LONGER DETECTION TIMES
CONCLUSIONS: Complex and
unanticipated interactions between
manufacturer-specific features and generic
programming can prevent therapy for VF.

12 Abbott Confidential.Internal use only. Not to be reproduced, distributed or excerpted.
MAT-1900920 v2.0 | Item approved for ID use only.
8 were programmed and followed at 1 of the 4 participating institutes out of 10 Patient in the Study (April 2015 to January 2017)
Failure to Treat Life-Threatening Ventricular Tachyarrhythmias in Contemporary
Implantable Cardioverter–Defibrillators Implications for Strategic Programming
(1) Shock for life-threatening VT/VF was either not
delivered or delayed significantly, resulting in death or
a major adverse event. For simplicity, we refer to
failure to deliver timely therapy.
(2) The ICD system functioned normally.
(3) VT/VF detection and therapies were programmed ON.
(4) Sinus R waves Amplitudes exceeded 5 mV at implant
and follow-up. Index events occurred from April 2015
to January 2017.
DELAYED OR WITHHELD THERAPY for true arrhythmias are common among Consensus Group Due to
multiple reasons
Circ Arrhythm Electrophysiol. 2017;10:e005305. DOI: 10.1161/CIRCEP.117.005305

13
VF Therapy Assurance uses the DISCRIMINATION CHANNEL to check for far-field
undersensing during a potential ventricular episode (PVE)
If it is determined that far-field UNDERSENSING is present, VFTA IS TRIGGERED
Programmed parameters are AUTOMATICALLY CHANGED for the remainder of the
episode
VF THERAPY ASSURANCE (VFTA)
1
2
3
GOOD FF SENSING: POOR FF SENSING:
VFTA looks for POOR FAR-FIELD SENSING on the Discrimination Channel at strategic times and applies NEW DETECTION
PARAMETERS when criteria is met
V
S
2
V
S
2
V
S
2
V
S
2

VF Therapy Assurance (VFTA) Is Based On large Data and
Physician Analysis from Real life Remote Monitoring
episodes
Poor Far Field Sensing
Good Far Field Sensing
Will
trigger
VFTA
Will NOT
trigger
VFTA

15
Detection is changed to a SINGLE
THERAPY ZONE – VF only
New “VF” detection rate is DECERASED
to the 150BPM (400 ms max)
NID (number of intervals to detection) is
DECREASED TO 6
VFTA IS TRIGGERED – NOW WHAT?
VFTA PARAMETER CHANGES
2
4 Therapy Delivery: First Programmed VF
ZONE THERAPIES (ATP would be skipped for
this episode )
1
3
DIAGNOSTICS AND LABELING

16 Abbott Confidential. Internal use only. Not to be reproduced, distributed or excerpted.
End of
Episode
Far field
Sensing
Shows Signal
Dropout or
Consistently
Small Signals
Apply VFTA
Detection
Parameters
VF Diagnosis/
Therapy*
*If detected
Far field
Sensing is
Good
VFTA Episode
Transmission
Potential
Ventricular
Episode
45 Cycle
Timer Expires
VT/VF
Detection
or
Normal
Detection
Protocol
VF Therapy Assurance Logic • Verify DISCRIMINATION CHANNEL to check for far-field
undersensing during a potential Episode
• If FF is UNDERSENSING is present, VFTA IS TRIGGERED
• Programmed parameters are AUTOMATICALLY CHANGED for
the episode

VFTA resulted in HV therapy for 86% of patients who would
have been otherwise untreated for potentially life-threatening arrhythmias.
VFTA therapy for life-threatening arrhythmias, the HV therapy was delivered
>2 minutes earlier compared to without VFTA.

ICD Patients Are Facing Risks
Associated with Increased Atrial
Burden
18
• 1 Supraventricular tachyarrhythmia were also main cause for inappropriate shocks in the ECOST trial:
L. Guedon-Moreau, C et al. Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial.
J Cardiovasc Electrophysiol, 25 (2014), 763-770.
• Atrial arrhythmia are known to be
the most frequent cause of
inappropriate shocks in transvenous
ICDs.1
• Atrial arrhythmia increase the
risk for hospitalization.
• Atrial arrhythmia can lead to
worsening heart failure.
• Risk of Inappropriate Shock • Risk of Hospitalization • Risk of Worsening Heart Failure

Early Detection Allows Physicians to Adjust
Therapy to Better Manage Atrial Burden1
19
• 1 Schwab JO et al. Clinical Course of Dual-Chamber Implantable Cardioverter-Defibrillator Recipients followed by Cardiac Remote Monitoring:
Insights from the LION Registry. BioMed Research International, 2018, Article ID 3120480. https://doi.org/10.1155/2018/3120480.
• 2 Varma N et al. Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up: The Lumos-T
Safely Reduces Routine Office Device Follow-Up (TRUST) Trial. Circulation, 2010;122: 325 – 332.
• Atrial sensing in the device.
• Automatic data transfer to the physician by
BIOTRONIK Home Monitoring.
• Early detection has been clearly
shown in the TRUST trial:2
• >30 days earlier physician
evaluation.
• Early detection of atrial arrhythmia is enabled
by:
1
2

Clinical Benefits of
Remote Monitoring
20
50%
Lower risk of all-cause mortality in ICD Patients4,5,6
36%
Reduction in cardiac or device-related emergency
department or urgent in-office visits7
27%
Reduction in all- cause mortality over 3 years6
66%
Reduction in hospitalization for AF or Stroke8

The Heart Rhythm Society strongly recommends remote monitoring,
with a Class 1A Recommendation
WHAT IS CLASS 1A?
• Class 1 is a strong recommendation, denoting a benefit greatly exceeding risk.
• Level of Evidence A denotes the highest level of evidence, usually from multiple randomized controlled trials or from a single
randomized clinical trial and a high-quality registry.
HRS RECOMMENDATIONS3
• Device Follow-up: All patients with Cardiac Implantable Electronic Device (CIEDs) should be offered Remote Monitoring as part
of the standard follow-up management strategy. Remote Monitoring represents the new standard of care for patients with CIEDs.
• Disease Management: Remote Monitoring is useful for the early detection and quantification of atrial fibrillation.
HRS Class 1A Recommendation
3. Slotwiner, D., Varma, N., Akar,J. G., Annas, G., Beardsall, M., Fogel, R. I., & ... Yu, C. (2015).HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable
electronic devices. Heart Rhythm, 12e69-e100. doi:10.1016/j.hrthm.2015.05.008
MAT-2007894 | Item approved for Hong Kong, India, Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam
use only.

DETECT
ARRHYTHMIC
EVENTS EARLIER
IMPROVED
PATIENT
OUTCOMES
IMPROVED SURVIVAL REDUCED
HOSPITAL
ADMISSIONS
PREFER study Crossley,
et al.
Randomized controlled
trial
Trans-telephonic
monitoring found
Clinically Actionable
Events more quickly and
frequently. (Average 2
months earlier)
COMPAS Trial
Mabo, et al.
Randomized,
controlled, non-
inferiority trial
Significantly fewer
hospitalizations for AF
and strokes with RM
group compared with
standard of care. (P <
0.05 at a mean follow-up
of 18.3 months.)
Varma, et al.
Retrospective analysis
i) RM was associated
with improved survival
across all device types.
ii) Survival was
significantly better in
patients with a higher
percentage of time in
RM vs. no time in RM
Mittal, et al.
RM activation within 3
months of implant was
associated with an 18%
increase in survival
during a mean follow-up
of 2.6 years across all
device types.
Piccini, et al.
i) RM is associated with
a reduced risk of all-
cause hospitalization
ii) RM associated with a
30% reduction in
hospitalization costs
Clinical Benefits of Remote Monitoring in Cardiac Devices

23
CEIDS Remote Monitoring Patients who are more adherent
HAVE BETTER OUTCOMES
Patients with high adherence
to remote monitoring have been shown to have
53% greater survival than patients with low
adherence to remote monitoring1
1 Mittal S, et al. Presented at HRS 2014 (LB01-05).

24 • 1 Ricci R P et al. HoMASQ Study, Europace. 2010, 12(5).
• ‘Plug in and go’ solution.
• 99% of patients agree that
BIOTRONIK Home Monitoring is easy
to use.1
• Daily, system-based transmission
check allows for high transmission
success rates.
• Smartphone-size mobile unit
• 98% of patients express their
complete satisfaction with
BIOTRONIK Home Monitoring.1
•
• User-Friendly Initialization • Data Transmission Without Any
Patient Involvement
• Mobile System
Home Monitoring with CardioMessenger Smart
Mobile Unit – Quick and Easy to Use

Remote Monitoring Industry Scope

Barrier for Remote Monitoring
47%
Of eligible SJM
device patients
used remote
monitors
 Varma, et al. J Am Coll Cardiol.
2015
 269,471 device patients
 All core device types
47%
Of eligible BSX
device patients
used remote
monitors
 Akar, et al. Circulation. 2013
 ICDs/CRT-Ds only
84%
Of eligible MDT
device patients
used remote
monitors
 Rosenfeld, et al. ESC 2016
 All core device types
 Cellular monitored patients

27

Remote Monitoring
myMerlinPulse™ mobile app and Smartphone Bluetooth Connectivity

Bluetooth Remote Monitoring: myMerlinPulse™ Mobile
App
• USER FRIENDLY
Patient can view device info, including
battery status and device model number
Device Information
Patient can view historical transmissions
and alerts
• Provides reassurance about being
monitored
View History
Patient can obtain clinic address and phone
number, Technical Support phone number,
FAQ & app version information
Help & Support
Send Transmission
Patient can send device data when
instructed by HCP. Can be de-activated via
Merlin.net™ PCN

Immediate Episode transmission and Remotely managed by Optimizing the pharmacology

Markers of Decompensation
Desai and Stevenson, 2010
• Reliable measurement of physical variables that reflect early decompensation while a
significant HF exacerbation can still be averted
• Current markers are late and indirect measures of decompensation
Desai AS, et al. N Engl J Med, 2010.
* Graph adapted from Adamson PB, et al. Curr Heart Fail Reports, 2009.
Decompensation
Pressure Changes
Impedance
Changes
Weight Changes,
BP, HF Symptoms
Hospitalization
Time
Stable
Decompensation

33
CorVue® Thoracic Impedance Monitoring
• The feature allows insight into a patient’s
impedance status by monitoring
transthoracic impedance over time across
two vectors
• An increase in fluid can cause changes in
impedance
• Lower impedance measurements over a
period of time may indicate a higher
probability of sustained impedance that
can be clinically relevant
Normal: Dry: Impedance
Congested: Wet: Impedance

What if we see the problem sooner?
Adamson PB. Curr Heart Fail Rep. 2009 Dec;6(4):287-292

HeartLogic Algorithm
35
• HeartLogic is a diagnostic tool that includes a
composite index monitored over time and is
designed to deliver proactive alerts of worsening
heart failure to clinicians.
• Multiple sensors track key physiological trends
related to heart failure from within a high voltage
Resonate™ family device.
• HeartLogic combines these trends into one
composite index. Once the composite index crosses
a programmable, clinician-set threshold, heart
failure following clinicians are sent a proactive alert
and given access to a detailed report.
• MultiSENSE Studyis completed and
demonstrated technical feasibility of the
algorithm and MANAGE-HF is ongoing trial
MANAGE-HF study is a multi-center,
global, prospective, open label, multi-
phase trial intended to evaluate the
clinical efficacy of the Heart Logic
Algorithm

The MultiSENSE Study data demonstrated that HeartLogic™ met the
• Results from the MultiSENSE Study
validated HeartLogic™ to have:
• •70% sensitivity
• •Weeks of advance notice to a
potential heart failure event
• •Alert rate of less than 2.0 per patient
year
• •10X heart failure event rate when
HeartLogic™ alerting
• •50X heart failure event rate when
HeartLogic™ augmenting baseline
NT-proBnPassessment

Battery Technology in
Defibrillators

Improvement in ICD technology after 2009
• Efficiency
• Size
• Battery Capacity

Is there really a need for longer-lasting devices?
Patients today are living longer than their device.1,2
Patients getting devices earlier, living longer and need longer lasting devices.7
ZERO
A longer lasting device
means no replacements for
higher number of
patients7,8
75%
CRT-D change-outs
avoidable for patients >70
years by using a CRT-D with
9 year longevity6
50%
ICD change-outs avoidable
for patients <50 years by
using an ICD with 12 year
longevity6
90%
Patients desire a longer
lasting device9
35-45%
Patients with an ICD or CRT-
D that are <65 years of age3
>80%
Mildly symptomatic HF CRT-
D patient survival at 7
years4
>40%
ICD patients living
after 10 years1
3%
Annual mortality rate for
CRT-D patients with
moderate heart failure5
1Hauser. The growing mismatch between patient longevity and the service life of implantable cardioverter-defibrillators. JACC 2005; 45; 2022-5.2Swedish ICD and Pacemaker Register: Annual Statistical Report
2011. https://www.pacemakerregistret.se/icdpmr/. 3Novation - Cardiovascular Watch: CRM Device Battery Life, May 2012 - https://www.novationco.com/other/apps/devicebattery/ 4Goldenberg I, Kutyifa V,
Klein H, et. al. Survival with Cardiac-Resynchronization Therapy in Mild Heart Failure. NEJM 370;18: 1694-1701. Seven year survival relates to patients with left bundle branch block with QRS ≥ 130 ms, EF ≤
30% NYHA Class I or II ischemic or NYHA Class II non-ischemic heart failure. 5Moss AJ, Cannom DS, Brown MW, et al. Cardiac-Resynchronization Therapy for the Prevention of Heart Failure Events. NEJM. Sept
2009 ePublication. 6Lau E, Hammill E, Wold N. Projected Numbers of Replacements Required During Natural Lifespan of CRTD/ICD Recipients by Age at First Implantation for Different Device Longevities.
Presented at HRS 2015. n= 115,000 CRTDs, 300,000 ICDs. 7Ramachandra. Impact of ICD Battery Longevity on Need for Device Replacements. PACE 2010; 33:314–319. 8Borleffs CJ, Thijssen J, Mihaly K, van Rees
JB, van Erven L, et al. Recurrent Implantable Cardioverter-Defibrillator Replacement is Associated with an Increasing Risk of Pocket-Related Complications. PACE 2010;33:1013–1019. 9Wild DM, Fisher JD, Kim
SG, Ferrick KJ, Gross JN, Palma EC. Pacemakers and Implantable Cardioverter Defibrillators: Device Longevity Is More Important Than Smaller Size: The Patient’s Viewpoint. Pace Nov 2004; Vol. 27:1526-1529.

Extended Longevity. Extended Warranty.
• Up to 15 Years Longevity and a Full Warranty of up to 10 years.
40
Fewer box replacements and fewer
procedures.
Reduced
costs.
Reduced
complications.
Reduced
risks.
Extended Longevity.
Extended Warranty.

2014 Ellis Study confirmed that battery capacity (a.k.a., Ampere Hours) is a predictor
of longevity.
Ampere Hour (Ah) as a Predictor of CRT-ICD
Pulse Generator Battery Longevity was a multi-
center, retrospective, observational study
comparing battery longevity of contemporary
cardiac resynchronization therapy defibrillators
(CRT-Ds) of all patients implanted with
CRT-ICDs from Aug. 1, 2008, to Dec. 31, 2010, at
5 major institutions.4
Boston Scientific = 322 patients
Medtronic = 794 patients
St. Jude Medical = 186 patients
*Survival rate calculated using device replacements for battery depletion as indicated by ERI.
Battery Capacity Study
References in notes

Advanced manufacturing capabilities enable a device that is smaller and higher battery usable capacity
Efficiency
References in notes

DR Smart. Enhanced Diagnostic Accuracy
with the Addition of the Atrial Channel
The additional information gives clear evidence on
the origin of the tachycardia
Ventricle
Far-field
Atrium
Clinical Example of an AF Episode
44

DR Smart. Enhanced Diagnostic Accuracy
with the Addition of the Atrial Channel
• Diagnostic Accuracy with Single- Versus Dual-
Chamber electrograms1
• With availability of
both atrial and
ventricular IEGMs,
diagnostic accuracy
increases for:
• the chamber of origin
from 76% to 90%.
• the specific diagnosis
from 61% to 79%.
• 1 Kim MH et al. J. Interventional Card Electrophysiol. 2003, 9(1).
Atrial and ventricular IEGM Ventricular IEGM only
79%
65%
60%
91%
47%
84%
93%
61%
45%
5%
85%
0%
68%
Overall Sinus tachycardia Paroxysmal SVT Atrial fibrillation Double
tachycardia
Ventricular
tachycardia
Ventricular
fibrillation
45

7.3
mV
8.0
mV
DX Technology
A Decade of Proven Performance
1 Niehaus M et al., Pacing Clin Electrophysiol. 2003, 26(10).
2 Lumax DX/Linox DX Evaluation.
3 Thomas G et al., Journal of Cardiovascular Electrophysiology 2019 DOI: 10.1111/JCE.14081
46
Improved Accuracy in Identifying SVT1
96.5% Rate of Appropriate Atrial Sensing2
Atrial Sensing: Stable and Reliable
Mean sensed atrial amplitude at
implant.3
• 505 analyzed episodes
• Reliability of detection for SVTs:
• ST = 96.8%
• AF & Atrial flutter = 100%
1 Dorsal lying position,
2 Sitting,
3 Sitting palms together,
4 Sitting Jendrassik’s
maneuver
Mean sensed atrial amplitude at
12-month follow-up.3
1 2 3 4 1 2 3 4 1 2 3 4

It was not significantly different to the dual-chamber cohort (p=1.00).
AHRE detection was significantly higher in the DX cohort compared to the single-chamber cohort
(p=0.026).
47
• Thomas, George; ChoI, Daniel Y.; Doppalapudi, Harish; Richards, Mark; Iwai, Sei; Daoud, Emile G. et al. (2019): Subclinical Atrial Fibrillation Detection with a Floating Atrial Sensing Dipole in
Single Lead Implantable Cardioverter-Defibrillator Systems. Results of the SENSE Trial. In Journal of Cardiovascular Electrophysiology. DOI: 10.1111/jce.14081.
• 1
• 2
Multivariate regression showed use of DX was associated with AHRE detection (adjusted Hazard
Ratio 2.40; 1.05-5.48; p = 0.038).
• 3
BIOTRONIK DX
13%
Dual-Chamber
13%
Single-Chamber
5.3%
• SENSE trial: Patients with AHRE Detections at 12 Months1
• Equivalent to Dual-Chamber ICDs and Superior to
Single-Chamber ICDs in Atrial High-Rate Episode Detection
DX Technology
Latest
data

Full 3T MRI. Autodetected.
• Self-adjusting MRI AutoDetect and Uncompromised Access to High-Resolution MRI
49
3T high-resolution MRI.
Minimized therapy suspension.
Flexibility of time and location
with MRI AutoDetect.
Full-body scanning.
Full 3T MRI.
Autodetected.

MRI AutoDetect Senses MRI
Environments and Self-Adjusts
• Integrated Sensor Provides Flexibility of Time and Location, Suspending Tachycardia Therapy for the Duration of the Scan Only
50
• MRI AutoDetect Workflow:
Optimal Therapy Mode
MRI AutoDetect can be activated with a single visit to the physician and has a
14-day window for planning.
Sensor window for up to 14 days Optimal Therapy Mode
Home Monitoring
sends full status report.
No reprogramming needed
System check MRI mode setting Sensor
activation
MRI Mode

Problems with Conventional T-ICD:
• Infections in the venous system
• 2,201 patients required lead removals between
2000-2011
• Complex and highly invasive operation
• T-ICD’s often unsuccessful in children
• Requires x-ray imaging to ensure the lead is
placed correctly
2068 ICD Patients with 2161 defibrillation
leads
• Mean follow up 36 months
• Lead failure at 1 yr 0.6%
Borleffs et al Circ Arrhythmia Electrophysiol. 2009; 2:411-416

• TV-ICD complications are more prevalent than generally assumed
TV-ICD related infections
1 year survival curves among TV-ICD patients with pocket infection and endovascular
infection following TV-ICD system removal8
Endovascular infections were
associated with
higher risk of death when compared
to a pocket infection8
3x
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. CRM-384124-AB MAY2016
TV-ICD
»
The ELECTRA Registry
reported 15.1% mortality at
1 year following systemic
infection resulting in TV lead
extraction41
»

The Subcutaneous -ICD System?
A less invasive solution for patients at risk of sudden cardiac arrest

• This system consists of a single defibrillation coil implanted
parallel to the sternum and tunnelled to the ICD generator
pocket located near the left anterior axillary line.
• It avoids the implant and intravascular infection risks associated
with a transvenous lead, but the energy requirement for
defibrillation is considerably higher than that needed for
transvenous ICD systems, and it cannot deliver painless
endocardial pacing.

Which patients should receive an S-ICD?
• Class IIa
• S-ICD SHOULD be considered for patients
who do not require brady pacing, CRT or
ATP for easily terminable VT/VF15
ICD = implantable cardioverter defibrillator.
a Class of recommendatioin.
b Level of evidence.
ESC Guidelines Recommendation Classa Levelb
Subcutaneous defibrillators should be considered
as an alternative to transvenous defibrillators in
patients with an indication for an ICD when pacing
therapy for bradycardia support, cardiac
resynchronization or antitachycardia pacing is not
needed.
IIa C
»
» EFFORTLESS Registry 3 year follow-up
reinforces the low need for pacing33

Which patient should be prioritised?
• Patient prioritization (as per McLeod et al, 2015)
STRONG INDICATION
Young age*
Primary prevention
Poor vascular access
Previous infection
Infection risk (mechanical valves,
diabetes, renal dysfunction)
RELATIVE CONTRAINDICATION
Need for ATP (difficult to define clinically)
CONTRAINDICATED
Pacing indication (bradycardia or CRT)
Failed screening (high inappropriate shock risk)
Difficult
venous access
Young patients
facing a lifetime
device therapy
Patients with
particular risk
of infection
* <65 (10 – 15 years life expectancy) as defined by ESC guidelines for management of atrial fibrillation, 2011
Optimal
S-ICD
candidate
23

S-ICD System
The S-ICD System is comprised of the following four
devices:
1.SQ-RX Pulse Generator
• 80-J biphasic shock
• Charge time to 80-J ≤ 10 seconds
• 5.1 year longevity
• 30 seconds post-shock pacing
2.Q-TRAK Subcutaneous Electrode
3.Q-GUIDE Electrode Insertion Tool (EIT)
4.Q-TECH Programmer
• Less invasive surgery
• Eliminates potential for infection
and damage to venous system
• May be implanted using
anatomical landmarks
• Potential for less inappropriate
shocks in children
• Possible Fluoro-less implant
• Fewer Lead issues with better
discriminator
Size:
Twice that of current T-ICD
Battery life
5 years as opposed to
upwards of 10 with T-ICD
• Lacks (ATP) or bradycardia
pacing and CRT
• COST
• Pre-implant Screening
• High DFT

Extravascular ICD System
• ATP and Brady Pacing Delivery
• Normal DFT leading to TV ICD
like Can
• Long Lasting
EV ICD implant overview. Left panel: Lateral view. Tunneling rod tip at the top of the cardiac silhouette (1, Tunneling Rod,
2, Xiphisternal Junction, 3, Sternum, 4, Head). Right panel: Exterior view: tunneling rod tip at the top of the cardiac
silhouette. EV, extravascular; ICD, implantable cardioverter defibrillator

IDEAL ICD
• Slim, Biological shape
• MAX warranty and good Battery life
• DX technology
• Best Algorithm (VT/SVT) App vs In app Shock
• Heart Failure Algorithm
• Blue tooth Technology
• MRI Auto detect feature

How ICD Therapy Has Evolved From Large Devices Requiring Surgery to Small, Minimally Invasive Options

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