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The Subcutaneous Defibrillator S-ICD: Advantages & Disadvantages
Hussam Ali, Pierpaolo Lupo, Sara Foresti, Guido De Ambroggi, Gianluca Epicoco, Angelica Fondaliotis and Riccardo Cappato
Arrhythmia & Electrophysiology Unit II
Humanitas Gavazzeni Clinics Bergamo- Italy
Arrhythmia &Electrophysiology Research Center
Humanitas Clinical & Research Center Rozzano (Milan)- Italy
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ICDs: hystorical background
• The inventor of ICDs was Mieczyslaw (Michel) Mirowski, a Polish cardiologist formed between Israel and United States.
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Randomized Clinical Trials and ICDs
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- ICDs have proven their efficacy and superiority to AADs for prevention of SCD in survivors of cardiac arrest and in selected pts at high risk.
- However, clinical benefits of conventional ICD therapy have been partially offset by the morbidity mostly related to the transvenous leads, the weakest link or Achilles Tendon of the transvenous ICD system.
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- Adequate experience/skills are required to perform venous access and to position the intracardiac leads. - Related complications: pneumothorax, hemothorax, cardiac perforation, pericarditis, venous occlusion/thrombosis, systemic infection/endocarditis, valvular dysfunction, lead dislocation/failure.
- Fluoroscopy is required.
- Children: - small venous capacity - more prone to lead failure in the long term. - growth! - Selected pts Venous anomaly/occlusion, no venous access to the heart Intracardiac shunts (thromboembolic risk) High infection risk: HIV, dialisis Pts, etc. - Transvenous leads extraction, when needed, is associated with considerable morbidity & mortality, and requires considerable skills/costs.
Problematic aspects with transvenous leads:
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S"ICD&Therapy&
&&&&"&The&en/rely&Subcutaneous&(S)&"ICD&is&designed&to&provide&the&life"saving&benefit&of&conven/onal&ICDs&whilst&avoiding&the&shortcomings&of&transvenous&leads.&&&&
&&&&&
&&&&"&By&simplifying&implant&techniques,&S"ICD&is&also&meant&to&expand&the&use&of&ICDs&in&clinical&prac/ce.&
&
Aim of technology
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Evolving ICD Technologies
Epicardial ICD
Transvenous ICD
1980 1989 2008
Subcutaneous ICD
Invasiveness
Most Least
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a&
b&CAN&
PRIMARY&(b"Can)&
ALTERNATE&(a"b)&
A B
14 c
m G
UIDE
(Not
e: F
or s
cree
ning
, EC
G e
lect
rode
s sh
ould
not
ext
end
beyo
nd 1
4 cm
arro
ws)
2.#SELECT#the#colored#profile.##The#largest###QRS#peak#must#be#within#a#Peak#Zone.#
UNACCEPTABLELEAD
ACCEPTABLELEAD
3.##VERIFY#at#least#one#lead#is#####acceptable#in#all#postures.
INCORRECTPROFILE
CORRECTPROFILEPeak Zones
144cm
RA
LA
LL
LEAD4II
LEAD4III
LEAD4I
1.#RECORD:#Supine+Standing####25#mm/s,#5E20#mm/mV
SIMULTANEOUS439LEAD4ECG
14 cm
C
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• Entirely subcutaneous technology • Fluoroscopy is not required • Canister C (left lateral thorax) connected
to a single lead tunneled subcutaneously to the left parasternal line
• 3 sensing electrodes (A, B and D), Coil C • A pre-operative screening tool to ensure
adequate subcutaneous signals of pts
The S-ICD System:
A C
B D
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1st generation S-ICD SQ-RX 1010
(Cameron Health)
2nd generation S-ICD EMBLEM
(Boston Scientific)
12.7&&&mm&59.5&&&cc&
130&&&gram&7.3&&&years&LATTITUDE&
15.7&&&mm&69.9&&&cc&
145&&&gram&5.1&&&years&
Not&avaliable&
Thickness&&↓&20%&Volume&Weight&
Longevity&↑&40%&Remote"Monitoring&
The$subcutaneous$lead A$tripolar$parasternal$electrode$$(polycarbonate5urethane$55D,$3$mm$diameter,$45$cm$length)$
*From: Ali H, Lupo P, Cappato R. The Entirely Subcutaneous Defibrillator: A New Generation and Future Expectations. Journal of Arrhythmia & Electrophysiology Review, August 2015;4(2):116-121.
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14 cm GUIDE (Note: For screening, ECG electrodes should not extend beyond 14 cm arrows)
2.#SELECT#the#colored#profile.##The#largest###QRS#peak#must#be#within#a#Peak#Zone.#
UNACCEPTABLELEAD
ACCEPTABLELEAD
3.##VERIFY#at#least#one#lead#is#####acceptable#in#all#postures.
INCORRECTPROFILE
CORRECTPROFILEPeak Zones
144cm
RA
LA
LL
LEAD4II
LEAD4III
LEAD4I
1.#RECORD:#Supine+Standing####25#mm/s,#5E20#mm/mV
SIMULTANEOUS439LEAD4ECG
14 cm
A&Pre5Opera@ve$Screening$Tool$was&developed&to&ensure&that&pts&have&suitable&subcutaneous&sensing&signals&
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Implantation Technique Cartoon by
Boston Scientific
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PA and laterla CXR after S-ICD implantation:
Optimal position: AP view Sub-optimal position: lateral view
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Sensing&the&subcutaneous&signal….&
• Three& bipolar& sensing& vectors&provide& maximum& sensing&flexibility.&
• The& ICD& automa/cally& selects&the&signals&from&the&best&vector&for&arrhythmia&detec/on&and&to&avoid& double& coun/ng& and& T"wave&oversensing&
A
B
CAN
PRIMARY (B-Can)
ALT
ER
NAT
E (A
-B)
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S-ICD Rhythm Detection
• All detection algorithms work together to identify S-ECG rhythm: heart rate, QRS width and dynamic template matching with learning from previous beats
S-ICD Technical Manual
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50#Hz#Induction#Pulse50#Hz#Induction#Pulse
Standard'Polarity'Shock Reversed'Polarity'ShockStandard'Polarity'Shock Reversed'Polarity'Shock
S-ICD Test in The EP-Lab, induced VF
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Programming$Simplicity$
Only few programmable parameters!
A programmable conditional shock zone
(170-240 bpm)
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Spontaneous Events
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Europe/New&Zealand&• Enrolment:&&55&pts&12&Dec&2008&!&13&Feb&2009.&Follow"up&10&mo&&Detec/on&of&VF&• 137/137&episodes:&&Sensi/vity&100%&• Time"to"therapy: &14&±&2&sec&Conversion&of&VF&@&65J&• 52/53&(>98%)&pts&met&the&&primary&conversion&endpoint&
CE Trial; 55 Patients
Bardy et al, NEJM 2010;363:36
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Evaluation oF FactORs AffecTing the CLinical Outcome and Cost EffectiveneSS of the S-ICD
The EFFORTLESS S-ICD Registry Design
• International, multicentre, standard of care Registry to collect short, mid and long-term operational and clinical outcome data on the S-ICD system
• Retrospective and prospective patients implanted since CE mark
• Aiming to recruit up to 1000 patients • 5 year data post implant • Centers to be included from all current commercial countries
EFFORTLESS S-ICD Therapy
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Infection rate
Inappropriate shocks
Successful term
ination of spontaneous VT/VF
Successful term
ination of induced VF
Follow-up (m
o)
Ischemic%
EF%
I ° Prevention %
�%
Mean A
ge .yrs
No.Patients
S-ICD Cohorts/ Clinical Trials
3.6 %9%100%98%10
±167%34%78%80%5655CE Trial Bardy et al/NEJM 2010
5.6 %13%95.2%100%1141%36%79%74%52314IDE Study (US FDA)
Weis et al/Circulation 2013
9.9 %15%100%100%1214% -50%-33111UK Cohort
Jarman et al/Europace 2013
5.9 %13%100%100%1838%41%60%75%50118Dutch Cohort
Nordkamp et al/JACC 2012
-5%100%97.5%7.622.5%47%42.5
%70%4240German I Cohort Aydin et al/CircArrhy 2012
1.4 %7.2%100%95.5%7.215.9
%46%59.4%72%4569
German II Cohort Case-Control Study
Kobe et al /H.Rhythm 2013
2.8%13%100%99.7%18.637%42%63%72%49472EFFORTLESS Registry
Lambiase et al/EHJ 2014
11.1 at 3
years
13.1 at 3
years98.2%98.6%21.37.840% 70%50882
Pooled data (EFFORTLESS+ IDE)
Burke et al/JACC 2015
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S-ICD Therapy
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The START Study: Subcutaneous vs Transvenous
Arrhythmia Recognition Testing
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S"ICD&System&Performance:&Therapy&Delivery&(inappropriate&therapy)…&
• Inappropriate&Therapy:&– Low$annual$inappropriate$
shock$rate$
– Reprogramming$has$been$very$successful$at$mi9ga9ng$further$events$
– Of$the$inappropriate$therapy$delivered,$the$majority$occurred$within$the$first$six$months$from$implant$and$was$subsequently$managed$with$reprogramming$
54%
19% 19%
6%1% 0% 0% 0%
01002003004005006007008009001000110012001300140015001600
0%
20%
40%
60%
80%
100%
Patient2population2(shaded2area)
%2of2all2shocks2for
inappropriate2sensing2(columns)
Months2since2implant
Timing2of2shocks2for2Inappropriate2Sensing(5.5%2of2pts2w/2shocks2 due2to2inappropriate2sensing)
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- Patient screening prior to the implant to insure adequate transcutaneous signals (pre-operating screening tool)
- Device optimizing to select the best sensing vector (supine/o r t h o s t a t i c p o s i t i o n s ) - Dual zone programming is preferred (ex: conditional shock z o n e 1 8 0 - 2 2 0 b p m , s h o c k z o n e > 2 2 0 b p m ) - Exercise test maybe helpful to evaluate the occurrence of myopotential oversensing/functional BBB during excercise
How to minimize inappropriate shocks in S-ICD Pts?!
2.#SELECT#the#colored#profile.##The#largest###QRS#peak#must#be#within#a#Peak#Zone.#
UNACCEPTABLELEAD
ACCEPTABLELEAD
3.##VERIFY#at#least#one#lead#is#####acceptable#in#all#postures.
INCORRECTPROFILE
CORRECTPROFILEPeak Zones
144cm
RA
LA
LL
LEAD4II
LEAD4III
LEAD4I
1.#RECORD:#Supine+Standing####25#mm/s,#5E20#mm/mV
SIMULTANEOUS439LEAD4ECG
14 cm
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200
800 600 400
1000 1200 1400 1600 1800 2000 2200 2400 2600 2800 3000 3200 3400 3600 3800 4000 4200 4400 4600 4800 5000 5200 5400 5600 5800 6000
Ch
ron
ic P
ha
se I
I
CE
Stu
dy
NE
JM
po
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lati
on
Co
mm
erc
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lua
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ep
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IDE
Stu
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au
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Ja
n 2
01
0
En
rolle
d M
ay
20
11
FD
A A
pp
rova
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ep
20
12
Worldwide S-ICD implants
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S-ICD TV-ICD Advantages/Disadvantages -/+ ++ Data on long-term performance
- (only 30 sec post-shock) ++ Chronic Pacing: antibrady- CRT- ATP
+/- ++ Device size/volume
> 7 years > 10 years Device longevity
Lattitude ++ Remote monitoring
(2016?) already availiable MRI Conditional
+/- (in women +?), submascular! + Cosmetic aspect
-- -/+ Device cost $
++ +/- (recalls, lead failures, crush syndrom)
Lead performance
+ - Fluroscopy during implantation
- + Need for deep sedation/general anesthesia
- recommended +/- not routinely performed DFT is mandatory
simple, flexible sensing (3 vectors) Complex, numerous parameters programmable
Programming
+ - - Serious acute complications/infections
+ - - Extraction complexity
++ ++ Detection & Defibrillation efficacy
+/- (TWOS) +/- (AF + SVT) Inappropriate therapies
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*From: Ali H, Lupo P, Cappato R. The Entirely Subcutaneous Defibrillator: A New Generation and Future Expectations. Journal of Arrhythmia & Electrophysiology Review, August 2015;4(2):116-121.
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The&PRAETORIAN&Trial&A&Prospec/ve,&RAndomizEd&comparision&of&&subcuTaneOus&&&tRansvenous&ImplANtable&cardiovertor"defibrillator&therapy&
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ESC Guidelines 2015
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• After more than a decade of continuous research/studies, the S-ICD has become a real life clinical practice for primary/secondary prevention of SCD unless pacing is required.
• S-ICD avoids procedural difficulties/complications associated with TV- leads, and does not require routine fluoroscopy use.
• The S-ICD is particulary beneficial in young patients, those with electrical syndromes, patients who had already experienced complications related to the TV-leads (serious infections, venous occlusion..)
• Further technology innovations as Leadless Pacing, if integrated with the S-ICD might offer an attractive therapeutic approach in the future
• Considering the simplicity of its implantation/removal, the S-ICD may fill the gap between the current indications for ICD therapy and the clinical practice. It might expand indications for ICD therapy in the future?!
CONCLUSIONS
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Thank you for your attention