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Subcutaneous ICD (S-ICD):

Where are we at?

Bandar Al-Ghamdi, MD
Items
 Introduction

 S-ICD:
Technology
Safety and efficacy
Advantages and disadvantages

 Guidelines
Introduction
 SCD is a leading cause of mortality worldwide

 The ICD is an effective and proven therapy for:


Primary prevention of SCD (MUSTT, MADIT, MADIT II, SCD-HeFT)
Secondary prevention of SCD (AVID, meta-analysis of AVID/CASH/CIDS Trials)

 ICDs reduce mortality and are cost-effective in specific high risk


patients Buxton AE. N Engl J Med. 1999;341:1882-90
Moss AJ. N Engl J Med. 1996;335 1930-40
Moss AJ. N Engl J Med. 2002;346:877-83
Bardy G NEJM (2005) 352;225-37
Connolly et al. Eur Heart J 2000;21:2071-8.
Evolving ICD Technologies
TV-ICD
 Adequate experience/skills
 Procedure related complications:
Vascular accesses: pneumothorax, venous thrombosis
Lead: dislodgement, malfunction, and perforation

 Fluoroscopy is required
 Children: - small venous capacity
- more prone to lead failure
- growth Russo et al. Am J of Cardiol 2015

 Selected patients:
Venous anomaly/occlusion, no venous access to the heart
Intracardiac shunts (thromboembolic risk)
High infection risk: HIV, dialysis Pts, etc.
TV-ICD
 Transvenous leads extraction, when needed, is associated with
considerable morbidity & mortality, and requires considerable
skills/costs
S-ICD Therapy: Aim of technology

 The entirely S-ICD is designed to provide


the life-saving benefit of conventional ICDs
whilst avoiding the shortcomings of TV-
leads

 Simplifying implant techniques (S-ICD is


meant to expand the use of ICDs in clinical
practice)
The S-ICD System
 The S-ICD System is comprised of the following four
devices:
 Pulse Generator
 80-J biphasic shock
 Charge time to 80-J ≤ 10 seconds
 5.1 to 7.3 year longevity
 30 seconds post-shock pacing
 Subcutaneous Electrode
 Electrode Insertion Tool (EIT)
 Programmer
Implantation of S-ICD
 All components implanted below the skin
 Only requires 2 or 3 incisions
 Can be an outpatient procedure
Sensing the subcutaneous signal

 Three bipolar sensing vectors provide


maximum sensing flexibility

 The ICD automatically selects the signals


from the best vector for arrhythmia
detection and to avoid double counting
and T-wave oversensing
S-ICD: Screening
 A Pre-operative Screening Tool was developed to ensure
that pts have suitable subcutaneous sensing signals
Advantages

• Effective defibrillation for VT/VF


S-ICD: Safety and efficacy
Pooled Study Implanted Patients (N=882)
Primary Prevention low EF
Primary Prevention

Demographic N (%)
Secondary
Age (years) 50.3 ± 16.9
Prevention Primary Male (n, %) 636 (72.5)
30% Prevention Ischemic 330 (37.8%)
low EF Weight (kg) 86.1 ±22.8
Other 43% Genetic 58 (6.7%)
Primary Idiopathic VF 40 (4.6%)
Prevention Channelopathies 90 (10.3%)
27% NYHA Classification II-IV 327 (37.5%)
Atrial Fibrillation 143 (16.4%)
Previous Defibrillator 120 (13.7%)
43% of the study population were primary prevention patients with
an EF 35%
Effortless registry, Lambiase P, Eur Heart J. 2014 Jul 1;35(25):1657-65
IDE study, Weiss R, Circulation. 2013;128:944-953
1 Boersma et al. EFFORTLESS 3 year results May 6th 2016 HRS LBCT AMEA_PSST_16027 AA NOV 2016 @ 2016 Boston Scientific Corporation or its affiliates. All rights reserved
S-ICD was as effective as TV-ICD in treating
spontaneous arrhythmias

Spontaneous Shock Efficacy


First Shock Final Shock in episode

S-ICD* EFFORTLESS 3 year


88.5% 97.4%
Analysis1
S-ICD Pooled 2 year Analysis2
90.1% 98.2%

SIMPLE Testing Group 3 88.5% 95.7%


SIMPLE No Testing Group 3 92.0% 94.8%
SCD-HeFT4 83%
PainFree Rx II5 87%
MADIT-CRT6 89.8%
LESS Study7 97.3%
1. Boersma et al. EFFORTLESS 3 year results May 6th 2016 HRS LBCT 4. Cha YM et al. Heart Rhythm 2013;10:702–708
2. .J Am Coll Cardiol. 2015; 65(16):1605–15. 5. Swerdlow CD et al. PACE 2007; 30:675–700
3. Healey, J, et al. The Lancet. Online before print doi: 10.1016/S0140-6736(14)61903-6. 6. Kutyifa V, et al. J Cardiovasc Electrophysiol 2013;24:1246-52
7. Gold MR et al. Circulation 2002;105:2043-2048.
AMEA_PSST_16027 AA NOV 2016 @ 2016 Boston Scientific Corporation or its affiliates. All rights reserved
Advantages

• Effective defibrillation for VT/VF


• Extravascular (preserves venous access) • Anti-bradycardia pacing/ ATP
• Low risk of systemic infection • Atrial and ventricular diagnostics
•Avoids risks associated with TV- lead • Familiar implant technique
extraction • Smaller device
• Less or no fluoroscopy • Better battery longevity
• Esthetic considerations • Long-term follow up
Disadvantages

• Pocket infection/ erosion/ hematoma


• Pulse generator complications
• Inappropriate shocks
• Lead related complications
Complications: Infection
S-ICD TV-ICD
 Ranging from 0% to 3.2%
 Infection rate reported as 0.13% to
 The U.S. IDE trial: 18 /330 implants
1.9%
(5.5%); 4 of these patients required device
 Risk of bacteremia and IE (reported in
explant
22% to 54%)

 Early results of the EFFORTLESS S-ICD


registry: 18 of 472 (3.8%) patients had
documented or suspicion of infection
related to the S-ICD procedure
10 patients (2.1%) required device explant

Effortless registry, Lambiase P, Eur Heart J. 2014 Jul 1;35(25):1657-65 Wilkoff BL. Heart Rhythm 2007;4:1467–70.
IDE study, Weiss R, Circulation. 2013;128:944-953 Le KY, PACE 2011;34:450–9.
Infection
Complications: Pocket related (erosion)
S-ICD TV-ICD
 Jarman et al. reported an alarming  Mostly related to chronic
18.8% (3 of 16) rate of device pocket infection
erosion
 Among the minority of trials
reporting any cases of pulse
generator erosion, rates ranged
from 1.7% to 1.8%
Jarman JW. Europace 2013;15:1158–65.
Olde Nordkamp LR. J Am Coll Cardiol 2012;60:1933–9.
Jarman JW. Eur Heart J 2012;33:1351–9.
Complications: Pocket related (Hematoma)
S-ICD TV-ICD

 Köbe et al. report a single hematoma  The rates 0.86%, as reported in the
among 69 S-ICD implants National Cardiovascular Data Registry
 Early results of the EFFORTLESS S-
ICD registry report only a single  1.2% to 2.4% in randomized clinical
hematoma in 472 patients (0.2%) trials
evaluated over a mean of 558 days of
follow-up EzzatVA. Open Heart 2015;2:e000198.
 Multiple other cohorts, including the Freeman JV. Circulation. 2012;125:57–64.
van Rees JB. J Am Coll Cardiol 2011; 58:995–1000.
IDE trial, report no implant-related
hematomas Hematoma formation rates
with the S-ICD Köbe J. Heart Rhythm 2013;10:29–36.
Effortless registry, Lambiase P, Eur Heart J. 2014 Jul 1;35(25):1657-65.
IDE study, Weiss R, Circulation. 2013;128:944-953
Complications: Inappropriate shocks
S-ICD TV-ICD
 The first trials and patient cohorts
 It is <5% (4% to 18%)
reported 5% to 25%
 T-wave oversensing, lead migration, or
 The prolonged interval strategy resulted
SVTs
in less therapy (ATP or shock), equivalent
 Software update with improved SVT
mortality, and reduced the inappropriate
discrimination and device
shock rate from 11.6 to 5.1 per 100
reprogramming has reduced it
patient-years
 The EFFORTLESS registry, primarily
using dual-zone programming and
higher shock cutoff rates, reports
inappropriate shock rates of 7% Moss AJ. N Engl J Med 2012;367:2275–83.
Gold MR. Heart Rhythm 2012;9:370–7.
Gilliam FR. J Cardiovasc Electrophysiol 2011;22:1023–9.
Bardy GH. N Engl J Med 2010;363:36–44. Wilkoff BL. J Am Coll Cardiol 2008;52: 541–50.
Weiss R. Circulation 2013;128: 944–53. Gasparini M. ADVANCE III randomized clinical trial.
Effortless registry, Lambiase P, Eur Heart J. 2014 Jul 1;35(25):1657-65. JAMA 2013;309:1903–11.
Inappropriate therapies
Inappropriate therapies

* Burke MC et al. JACC 2015; 16:1605-15


Complications: lead related
S-ICD TV-ICD
 Lead migration was identified as  Multiple access and lead related
an early S-ICD, often requiring complications
lead revision  The 10-year TV-ICD lead
 May lead to inappropriate ICD failure rate is approximately
shocks due to myopotentials and 20%
T-wave oversensing
 The EFFORTLESS registry
found only 4 / 472 patients
(0.85%)
Effortless registry, Lambiase P, Eur Heart J. 2014 Jul 1;35(25):1657-65. Kleemann T. Circulation 2007;115:2474–80.
Disadvantages

• Does not provide bradycardia pacing • Risk of systemic infection


or anti-tachycardia pacing (ATP)
• Lack of advanced diagnostics • Vein thrombosis / stenosis
• Size: Twice that of current TV-ICD
• Battery life: 5 -7 years • Lead fracture
• Pre-implantation ECG screening
• DFT • Risks of endovascular extraction
• Higher cost
S-ICD: Lack of pacing (brady/ATP)
 In the European Regulatory Trial cohort; 1 of 55 patients (1.8%)
developed an indication for bradycardia pacing and had the S-ICD
explanted (FU of 5.8 years)
Theuns DA. Circ Arrhythm Electrophysiol 2015;8:1159–63.

 In the same cohort, 2 of 55 patients (3.6%) developed symptomatic


heart failure and underwent S-ICD explant in favor of a TV CRT
device
Theuns DA. Circ Arrhythm Electrophysiol 2015;8:1159–63.

 An analysis of SCD-HeFT patients suggests that approximately 15% of


patients with NYH FC- II to III heart failure will experience
monomorphic VT necessitating ATP therapy over almost 45.5 months of
follow-up
Poole JE. Circ Arrhythmia Electrophysiol 2013;6:1236–44. discussion 1244–5.
S-ICD: Lack of pacing (brady/ATP)
 In this analysis only 7% of the total patient population received more
than 1 shock for high-rate monomorphic VT (1.8% per year risk)

 MADIT-RIT (Multicenter Automatic Defibrillator Implantation Trial–


Reduce Inappropriate Therapy) and ADVANCE III have shown
reduction in need for therapies with prolonged detection intervals, due
to spontaneous termination of arrhythmia
Moss AJ. N Engl J Med 2012;367:2275–83.,48).
Gasparini M. JAMA 2013;309:1903–11.
Disadvantages: Device longevity
S-ICD TV-ICD
 In 1st generation of S-ICD:  The latest single-chamber TV ICDs
5 of 55 patients (9%) required are predicted to have a >10-year
replacement within 1.5 years due to battery life
premature battery depletion during Lupo PP. Progress Cardiovasc Dis 2012;54:493–7.

the 5.8 years of follow-up

 The 2nd generation S-ICD is


predicted to have a 7.3-year
battery life
www.bostonscientific.com/en-US/products/defibrillators/emblem-s-icdsystem.html
Defibrillation threshold testing (DFT)
S-ICD TV-ICD
 It is still recommended for S-  The Shockless IMPLant
ICD systems Evaluation (SIMPLE) trial has
 Compared to TV-ICD, early shown that is not necessary for
S-ICD use was associated with TV-ICD) systems
a high rate of successful
defibrillation for VF during
DFT (Among 2,791 patients with S-ICD who underwent
DFT testing, 2,588 (92.7%), 2,629 (94.2%), 2,635 (94.4%),
and 2,784 (99.7%) were successfully defibrillated with ≤ 65,
≤ 70, ≤ 75, and ≤ 80 Joule (J), respectively)

Friedman DJ. JAMA Cardiol. 2016;1(8):900-911. Healey JS. Lancet. 2015;385(9970):785-791.


Cardiol Res. 2017;8(6):319-326
Subcutaneous Implantable Cardioverter Defibrillators
Implantation Without Defibrillation Threshold Testing: A
Single Center Experience

Al-Ghamdi et al. Cardiol Res. 2017;8(6):319-326


The impact of S-ICD coil and generator
position on DFT

Gradients (10 V/line) produced by a shock of 1,277 volts (80 joules).


(A) Standard; (B) anterior generator placement; (C) 10-mm subcoil fat; (D) 10-mm subcoil fat combined
with 20-mm subgenerator fat. Gradient strengths at the basal septum (white D) are 7.21, 5.27, 3.76, and
3.22 V/cm. The loss of field strength is particularly evident at the posterior heart. The generator is shown as
a white rectangle, the coil is at the concentrated blue location.

J. E. Kevin Heist Am Coll Cardiol EP 2017;3:405–14


Real world 2017: US Post Market Approval Study

AMEA_PSST_16027 AA NOV 2016 @ 2016 Boston Scientific Corporation or its affiliates. All rights reserved
Outcomes Comparison of S-ICD and TV-
ICD Therapy: Device-Related
Complications

Brouwer, T.F. et al. J Am Coll Cardiol. 2016;68(19):2047–55.


Device-Related Complications per Type

Brouwer, T.F. et al. J Am Coll Cardiol. 2016;68(19):2047–55.


Appropriate and Inappropriate ICD Therapy

Brouwer, T.F. et al. J Am Coll Cardiol. 2016;68(19):2047–55.


What is new?

Defibrillation with
CRT, ATP and Brady Pacing

• 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
AMEA_PSST_16027 AA NOVCaution:
adding a transvenous system.
2016 @ 2016 Boston Scientificdevices.
Investigational Limited by Federal law to investigational use only. Not available for sale.
Corporation or its affiliates. All rights reserved

JFleur V.Y. Tjong. ACC: CLINICAL ELECTROPHYSIOLOGY, 26 December 2017


Patients who need an ICD should
receive a S-ICD if:

• Need for bradycardia pacing

• Need for a CRT device

• Need for ATP


2015 ESC Guidelines
2016 CCS/CHRS Guidelines

• Congenital Heart Disease patients with no access to the ventricles

• Congenital Heart Disease patients with shunt resulting in increased


risk of thromboembolic events with TV-ICD

• Absence of a pocket site due to either prior device-related infection


and/or chronic indwelling catheters
2016 CCS/CHRS Guidelines
2017 AHA/ACC/HRS Guideline
Recommendations for Subcutaneous Implantable Cardioverter-
COR LOE
Defibrillator
1. In patients who meet criteria for an ICD who have inadequate
vascular access or are at high risk for infection, and in whom pacing
I B-NR for bradycardia or VT termination or as part of CRT is neither
needed nor anticipated, a subcutaneous implantable cardioverter-
defibrillator is recommended.
2. In patients who meet indication for an ICD, implantation of a
subcutaneous implantable cardioverter-defibrillator is reasonable if
IIa B-NR
pacing for bradycardia or VT termination or as part of CRT is
neither needed nor anticipated.
3. In patients with an indication for bradycardia pacing or CRT, or for
III: whom antitachycardia pacing for VT termination is required, a
B-NR
Harm subcutaneous implantable cardioverter-defibrillator should not be
implanted .
Ongoing studies
ATLAS:
PREATORIAN
 Pan Canadian
 Netherlands
 500 patients
 700 patients
 VVI TV-ICD vs S-ICD (1:1)
 VVI TV-ICD vs S-ICD (1:1)
 Sub studies on specific
 Combined endpoint population
(inappropriate shocks and ICD
complications) (non-inferiority)  Peri-operative complications and
long-term complications
 Shock efficacy (superiority)
 Patient mortality  Appropriate therapies failed and
arrhythmic death (non-inferiority)

NordKamp O, Am Heart J 2012;163:753-760.e2


Ongoing studies

Gulf- S-ICD
Conclusions
 After more than a decade of S-ICD implants, there is a growing
evidence suggesting its noninferiority to traditional ICD systems
with regard to safety and efficacy

 In real-world clinical situations, the S-ICD has >98% overall


shock efficacy for acute conversion of VT/VF, equivalent to TV-
ICDs

 There are certain advantages of each device type (TV-ICD/S-


ICD) and these should be taken in account when deciding about
which device to chose
Conclusions

 The S-ICD is particularly beneficial in young patients, those with


electrical syndromes, patients who had already experienced
complications related to the TV-leads (serious infections, venous
occlusion)

 It may be considered for any patient undergoing ICD implantation


with no contra-indication
Conclusions
 The rates of infection, lead dislodgement, and inappropriate
shocks has been markedly reduced by increased operator
experience and advances in implant technique and device
programming
 Further technology innovations as Leadless Pacing, if
integrated with the SICD might offer an attractive therapeutic
approach in the future
 In the coming years, data from the complete ICD registry, and
head-to-head performance versus TV-ICDs trial will provide us
with additional information
Thank you