Presented at 44 Congreso Argentino de Cardiología, Buenos Aires, October 2018

1. Rol actual del
cardiodesfibrilador
implantable subcutáneo en
la prevención de la muerte
súbita
Dr. Sergio L. Pinski
Cleveland Clinic Florida
Weston, Florida, USA
@SergioPinski

2. Moss AJ. Circulation 2005;111:2537

3. El CDI indicado en otros síndromes con alto
riesgo de muerte súbita
• Miocardiopatía hipertrófica
• QT largo
• Brugada
• Displasia arritmogénica del VD
• Miocardio no compactado
• Algunas distrofias musculares
• Sarcoidosis

9. Cost, complication & mortality rate were significantly
higher for infected vs non-infected devices
Trends in Complications Related to Infection Indication for TV Lead Extraction
Trends in Complications Related to Non-infection Indication for TV Lead Extraction
• The median costs of lead extraction was $39,308 for infected devices vs $14,916 for non-
infected leads.
• Lead extraction for infected device had a higher overall complication rate (9.2% vs 7.8%).
• In hospital mortality was 3.6% for those with infection versus 1.2% without infection.
*
*
*
*
* p=<0.001 for infected versus non-infected
Deschmuck et al. Circulation 2015;132:363

10. El pronóstico de pacientes con infecciones no
es muy bueno, aún luego de la extracción
Tarakji et al. Europace 2014;16:1490

11. Complicaciones a 6 meses: Registro danés
Kirkfeldt et al. Eur Heart J 2014;35:1186

12. Complicaciones y reoperaciones. Registro de
British Columbia
Hawkins et al. Heart 2018;104:237

13. The S-ICD Journey
IDE Trial2 321pts
EFFORTLESS3,4 985pts
PRAETORIAN Randomized Trial5 – enrolled 850pts
Post Approval Study8 - 1637pts
UNTOUCHED9 - enrolling 1100pts
43,000+ patients implanted WW12
4,000+ patients enrolled in completed
and on-going S-ICD clinical studies##
2008 2009 2010 2011 2012 2013 2014 2015 2016
Pooled
Analysis6
CE Mark study1 55pts
1st Generation
Inclusion in
ESC guidelines
(Class IIa)7
2nd Generation 3rd Generation
»
»
## Estimation from completed and ongoing clinical trials
2001- 2017+
Inclusion in
AHA/ACC/HRS
guidelines (Class
1 and IIa)10
S-ICD vs TV-ICD Meta-analysis 11 - >6400pts

14. Experiencia inicial con el CDI SC: Bardy,
Cameron Health
Bardy et al. N Engl J Med 2010;363:36

15. Características de la terapia del CDI subcutáneo
• Detección alrededor de 5 s
• Descarga bifásica
• 80J (entregados)
• Hasta 5 choques por episodio
• Tiempo de carga de 80J ≤ 10 s.
• Estimulación sólo post-choque (30 .)
• Almacenamiento de episodios (128 s) (44
episodios)
• Longevidad: 7.3 años*
* Uso normal, definido con reformas de condensadores cada 4 meses, cargas max. por episodios tratados/no tratados
retrasan la reforma

17. Nuestra técnica preferida: 2 incisiones submuscular
Migliore et al. PACE 2017;40:278

18. Escepticisimo
• Puede el desfibrilador SC detectar la fibrilación ventricular?
• Puede el desfibrilador SC desfibrilar consistentemente?
• Puede el desfibrilador SC discriminar entre arritmias ventriculares y
supraventriculares?

19. Valoración pre-operatoria basada en electrodos cutáneos posicionados a
lo largo de los vectores de sensado del sistema S-ICD
Screening pre-implante
• Valoración simple y rápida
• ECG registrados en dos
posturas: supina & sedestación
o bipedestación
• Electrocardiógrafo standard o
programador Boston
ALTERNATIVA
RA
LA
LL
DERIVADAI

20. ECG Screening
200 150 100 90 80 70 60 50 40 30
HEART RATE (25 mm/sec) 2 x RR FROM REFERENCE ARROW
200
400
600
800
1000
12000
8 cm GUIDE

21. INSIGHT™ Algorithm: Architecture
S-ECG signal similar
to a surface ECG
4 double-detection algorithms
designed to reduce over-
sensing
3 rhythm discriminators
to confirm therapy
PHASE I:
Detection
PHASE II:
Certification
PHASE III:
Therapy
Decision
Subcutaneous
signal detection
Heart rate
determined
HR assessed,
therapy confirmed

22. Bardy et al. N Engl J Med 2010;363:1

24. Prediction of an insufficient safety margin
for SQ defibrillation
Pacing
Higher Body Mass Index
White race
Lower LVEF
No previous CABG
Friedman et al. Circulation 2018;137:2463

25. Determinants of Subcutaneous ICD Efficacy
A Computer Modeling Study
Heist et al. JACC Clin EP 2017;3:405

26. Brouwer et al. JACC Clin EP 2016;2:89

27. The PRAETORIAN score
Quast et al. Heart Rhyhthm 2018 (in press)

28. @SergioPinski

29. @SergioPinski

30.  The SMART Pass feature activates an additional high-pass filter designed to reduce
cardiac over-sensing while still maintaining an appropriate sensing margin
 SMART Pass is only applied in the sensing path, while the morphology is unchanged
The SMART Pass filtering reduces the amplitude of lower frequency (slower moving) signals such as T-waves, by applying
an additional High Pass filter (lets higher frequencies “pass” through).
Higher Frequency (faster moving) signals such as R-waves, VT and VF amplitudes remain largely unchanged.
New sensing algorithm improves detection
Theuns et al. Heart Rhythn 2018;15:1515

31. Migliore et al. J Cardiovasc Med 2018;19;633

32. Migliore et al. J Cardiovasc Med 2018;19;633

33. Meta-análisis: Choques apropiados e inapropiados
Auricchio et al. Europace 2017;19:1973

34. Expected reduction in inappropriate shocks
from T wave oversensing
Theuns et al. Heart Rhythn 2018;15:1515

35. EFFORTLESS Registry Follow-Up, 985 pts
Boersma et al. JACC 2017;70;830

36. 1-year outcomes EFFORTLESS Registry
Boersma et al. JACC 2017;70;830

37. Meta-análisis de ICD SC vs TV
Basu-Ray et al. JACC Clin EP 2017;3:1475
Lead complications
Infection
System or device failure
Inappropriate shocks

38. SQ ICD in pts with previous TV-ICD infection
Boersma et al. Heart Rhythm 2016;13:157

39. Candidacy for SQ ICD based on surface ECG
template screening in pts with HCM
Maurizi et al. Heart Rhythm 2016;13;457

40. SQ ICD in Hypertrophic Cardiomyopathy
Lambiase et al. Heart Rhythm 2016;13;1066

42. ~76% of ICD patients in the U.S. have ≥1
comorbidity associated with high risk for
infection.2,4
76%
37% 39%
20%
23%
Heart Failure
(Class II-IV)
Diabetes Renal Disease (GFR<60) COPD Anticoagulant Use
% of ICD Patients in the U.S. with the following comorbidities4
Data on rates of comorbidities from Table 1 Friedman et al. JAMA Cardiology 2016

43. Algorithm for ICD selection
Al-Khatib et al. Circulation 2016;134:1390

44. NCDR Predictors Analysis Points to >80
Age as predictor of >5% RV Pacing
Effect Odds Ratio (95% CI) P value Overall P
value
PR interval & flutter
No AF/ PR interval <230 ms Reference
No AF/ PR interval≥230 ms 2.53 (0.83 - 7.69) 0.1028 <.0001
History of AF 3.337 (1.63 - 6.82) 0.0009 .
Ongoing AF at implant 11.717 (7.21 - 19.05) <.0001 .
Age
≤ 50 Reference
50-60 0.86 (0.38 - 1.93) 0.7101 0.0106
60-70 1.37 (0.67 - 2.82) 0.3936 .
70-80 1.96 (0.95 - 4.05) 0.0702 .
>80 3.29 (1.36 - 7.91) 0.008 .
Characteristics that were significantly associated with >5% right ventricular pacing
in the multivariate analysis in patients with a single chamber ICD.
Among patients with no pacing indication
at the time of ICD implant1:
• 1635 patients followed for 2 years
• Age >80 and history of AF related to the
development of pacing need after
implant
• Only 108 (6.6%) developed >5% RVP for
any 90 day period
• “The development of RVP is
uncommon”
ONLY Age >80 and history of AF were statistically significantly related to the
development of pacing need after implant
Kalantarian et al. Circulation. 2017;136:A19187

45. Baja incidencia de taquicardia ventricular
monomórfica en el seguimiento de SCD-HeFT
Of the 811 patients followed 45.5 months in SCD-HeFT
Total Patients
over 45.5
months
100%
Patients with
no therapy @
45.5 months
78%
Patients with
only VF or PVT
over 45.5
months
Patients with
only 1 MVT
over 45.5
months
Patients with
>1 MVT over
45.5 months
7%
7%
7%
The annualized risk that a patient had ANY MVT was 3.6% and the
annualized risk that a patient had multiple occurrences of MVT was 1.8%
Poole &. Gold. Circulation Arrh Electrophysiol. 2013;6:1236

46. Large randomized studies using contemporary programming
with long detection intervals has greatly reduced the number
of patients who receive ATP
Gasparini et al. JACC EP 2017 ;3:1275
7.0% 3.2%10.4%
4.8%
81.4%
90.8%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
ADVANCE III - Control ADVANCE III - Long detection
ADVANCE III Appropriate Therapy by Type
ATP Only ATP & Shock Shock only No Therapy
16.7% 3.8% 1.6%
4.9%
3.8% 2.5%
77.8%
91.0% 94.4%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
Conventional Therapy High-Rate Therapy Delayed Therapy
MADIT RIT Appropriate Therapy By Type (1.4 year follow-up)
ATP Only ATP & Shock Shock Only No Therapy
Moss et al. N Engl J Med 2012; 367:2275

47. Adopción lenta?
Friedman et al. JAMA Cardiol 2016;1:900

48. Italian survey demonstrates disconnect between real
vs. perceived need for pacing
Botto et al. Europace 2017;19:1826

49. PRAETORIAN: estudio holandés, n=850, 2020
Nordkamp et al. Am Heart J 2012;163:753

50. MADIT S-ICD, post MI, DBT, >65, LVEF 36-50%
Kutyifa et al. Am Heart J 2017;189:158

51. Futuros desarrollos tecnológicos
• Defibrilador subesternal
• Desfibrilador SC acoplado a marcapasos leadless

52. Conclusiones
• El CDI subcutáneo es efectivo en detectar y terminar la TV/FV
• Tiene un menor riesgo de complicaciones severas que el CDI
• Debe considerarse en todo paciente con una indicación de CDI y sin
indicación para estimulación cardíaca
• Estudios randomizados en marcha van a solidificar el rol del CDI SC