EMBLEM™ MRI S-ICD System

Why S-ICD Therapy

Clinical Data

EMBLEM S-ICD System

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Managing the ICD Patient

Patient Selection

Patient Prioritisation

Patient Prioritisation for the S-ICD

A majority of ICD indicated patients are suitable for S-ICD, as demonstrated by clinical data and EU and US guidelines. 

The arrow indicates the patient prioritisation for the S-ICD based on guidelines and clinical literature(1 2 3), in increasing order.

Key Resources

EDUCARE online education Directions for use Patient Selection Tool S-ICD Patient Website Indications, Safety & Warnings
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Click on the titles to explore the indications

Bradycardia Pacing
“Typical” ICD Patients
Need for ATP at implant
Older ICD Patients
Future need for ATP
High Risk Patients
 

Bradycardia Pacing

Among patients with no pacing indication at the time of ICD implant, the development of RVP is uncommon within the first 2 years after implantation15.

No significant increased risk of pacing need until age 8015.

Occurrence of new pacing need was low in real-world S-ICD registries:

Extraction for new pacing requirement: No. of patients 
EFFORTLESS mid-term follow-up6 1 / 985 (0.1%)
Dutch 6 year follow-up16 1 / 118 (0.8%)
Austrian Registry17 2 / 336 (0.8%)
 

Need for ATP at implant

ATP has been shown to be effective for termination of fast monomorphic VT (>188 bpm).

Who needs ATP:

From SCDHeFT, recurrent mVT occurred in only 7% of patients18, with 0.5 – 2% reoccurence/year19
The impact of device programming:
Contemporary programming significantly reduces therapy delivered, suggesting that given sufficient time, a majority of mVT episodes will self-terminate23, 24, 25.

Rate of appropriate shock delivery

Multiple studies have shown similar rates of appropriate shocks despite reductions in ATP delivered:

1 year rate of Appropriate Therapy

Multiple studies have shown similar rates of appropriate shocks despite reductions in ATP delivered.
1 year Kaplan Meier incidence shown for S-ICD, PainFREE SST and ADVANCE III. 1 year rate for MADIT-RIT annualised at an average follow-up of 1.4 years. MADIT-RI, PainFREE SST and ADVANCE III did not include S-ICD devices.
 

Future need for ATP

Benefit of ATP:

In studies of long detection programming, 97-98.4% of patients received no benefit from ATP23, 26.

Shocks avoided by ATP in major clinical trials

Future need for ATP
Future need for ATP

Risk of VT acceleration:

ATP has been shown to accelerate arrhythmias in up to 8.5% of cases. Placing the patient at greater risk of degeneration of the
rhythm to a faster, unstable, and poorly tolerated rhythm24, 27, 28, 29.

What is the role of an ICD: SCD prevention or VT management?

Catheter ablation is recommended (ESC Class I indication)11 in patients with:

  • Scar-related heart disease presenting with incessant VTs
  • Ischemic heart disease and recurrent ICD shocks due to sustained VTs

Real world SICD data show very low rate of change out to TV-ICD due to need for ATP:

Extraction for new pacing requirements: No. of patients 
EFFORTLESS mid-term follow-up6 5 / 985 (0.5%)
Austrian Registry17 1 / 236 (0.4%)
 

“Typical” ICD Patients

ICD benefit in low EF/CHF patients

  • 34% reduction in SCD risk by ICD in MADIT II population30
  • 23% reduction in SCD risk by shockonly ICD at five years among (ischemic and non ischemic) CHF patients18

Proportion of low EF patients implanted with an SICD has increased over time:2, 6, 31

Proportion of low EF patients implanted with an SICD has increased over time

Risk factors:

High proportion of patients at high risk of infection among low EF/CHF patients:

  • 31-33% of patients with diabetes in SCDHeFT and MADIT II18, 32
  • 25% of patients with renal disfunction in CHF population18, 32

S-ICD is the preferred therapy for patients who are at high risk of infections (AHA/ACC/HRS guidelines, Class I recommendation)1.

S-ICD: Class IIa recommendation for ALL ICD indicated patients without need for pacing1, 11.

S_ICD has a class I and class Iia recommendation in AHA/ACC/HRS guidelines
 

Older ICD Patients

AHA/ACC/HRS guidelines: class IIa recommendation for patients >75 years old with at least 1 year of life expectancy1

S-ICD performs better than TV-ICD in discrimination of SVT37, 38.

Inappropriate shocks due to SVT in patients implanted with TV-ICD

Appropriate ICD therapy delivered in up to 23% of older patients (with EF>25%)39.

 

 

High Risk Patients

Inadequate venous access:
As many as 61% of patients may have venous stenosis following initial device implantation34.

Predictors of device infection33,34,40:

  • Diabetes
  • Heart Failure
  • Kidney disease
  • Previous device infection
Prevalence of risk factors for infection are high in the general ICD population
Top

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  2. Gold, M.R. The subcutaneous ICD Post-Market Approval Study: Clinical Characteristic and perioperative Results, Heart Rhythm (2017), doi: 10.1016/j.hrthm.2017.05.016.
  3. Ziacchi M, et al. Electrocardiographic Eligibility for Subcutaneous Implantable Cardioverter Defibrillator: Evaluation during Bicycle Exercise. Heart Lung Circ. 2016 May;25(5):476-83.
  4. Botto GL, et al. The Italian subcutaneous implantable cardioverter-defibrillator survey: S-ICD, why not? Europace 2016; Epub 2016/12/25.
  5. de Bie MK, et al. Suitability for subcutaneous defibrillator implantation: results based on data from routine clinical practice. Heart 2013;99:1018–1023.
  6. Boersma, L. et al. Implant and mid-term outcomes of the complete EFFORTLESS subcutaneous implantable-defibrillator cohort. JACC, 2017; 70,7.
  7. Poole, J. & Gold, M. The Subcutaneous Implantable Cardioverter Defibrillator (ICD) Should Be Considered in all ICD Patients Who Do Not Require Pacing. Circulation: Arrhythmia and Electrophysiology. 2013;6:1236-1245.
  8. Olde-Nordkamp, L.R.A. et al. Implantable Cardioverter-Defibrillator Harm in Young Patients with Inherited Arrhythmia Syndromes: A Systematic Review and Meta-Analysis of Inappropriate Shocks and Complications. Heart Rhythm 2015.
  9. Groh CA, et al. Use of an electrocardiographic screening tool to determine candidacy for a subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2014 Aug;11(8):1361-6.
  10. Boersma, L. ICD from real life to the future: ICD innovations. ESC 2014.
  11. Priori, SG. et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2015; Nov 1;36(41):2793-867.
  12. Deftereos, S. et al. Relation of ventricular tachycardia/fibrillation to beta-blocker dose maximization guided by pacing mode analysis in nonpacemaker-dependent patients with implantable cardioverter defiibrillator. Am J Cardiol, 2011.
  13. Kutyifa. et al. The Need for Pacing in patients who qualify for and ICD: Clinical Implications. ESC abstract 2014.
  14. Boriani, G. et al. Battery drain in daily practice and medium-term projections on longevity of cardioverter-defibrillators: an analysis from a remote monitoring database. Europace, https://dx.doi.org/10.1093/europace/euv436.
  15. Kalantarian S, et al. Predictors of Right Ventricular Pacing (RVP) in ICD Recipients Without Baseline Pacing Needs: A report from the NCDR Registry. Presented at American Heart Association in Los Angeles 2017. Poster: M3118.
  16. Quast ABE, et al. Six year follow-up of the initial dutch subcutaneous implantable cardioverter defibrillator cohort: Long term complications and battery longevity. EP Europace 2017; 19:iii128-iii9.
  17. Sponder M, et al. Specific indications and clinical outcome in patients with subcutaneous ICD - A nationwide multicentre registry. European journal of internal medicine 2017; Epub 2017/10/06.
  18. Bardy G, et al. and Sudden Cardiac Death in Heart Failure Trial. NEngl J Med 2005;352:225–237.
  19. Poole, J. et al. Who Should Receive the Subcutaneous Implanted Defibrillator? The Subcutaneous Implantable Cardioverter Defibrillator (ICD) Should Be Considered in all ICD Patients Who Do Not Require Pacing. Circulation: Arrhythmia and Electrophysciology 2013; 6: 1236-1245
  20. Borleffs, C.J.W. et al. Risk of Failure of Transvenous Implantable Cardioverter-Defibrillator Leads. CLINICAL PERSPECTIVE. Circ Arrhythmia Electrophysiol. 2009; 2:411-416.
  21. Kleeman, T. et al. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 Years Circulation 2007; 115:2474-2480.
  22. Atalleh, J. et al. Multi-Institutional Study of Implantable Defibrillator Lead Performance in Children and Young Adults Results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study. Circulation. 2013; 127:2393-2402.
  23. Moss, A.J. et al. Reduction in Inappropriate Therapy and Mortality through ICD Programming. NEJM, 2012; 367: 24.
  24. Schukro C, et al. Impact of accelerated ventricular tachyarrhythmias on mortality in patients with implantable cardioverter-defibrillator therapy. Int J. Cardiol 2013;167:3006-10.
  25. Clementy, N. et al. Very-high-rate programming in primary prevention patients with reduced ejection fraction implanted with a defibrillator: Results from a large multicenter controlled study. Heart Rhythm 2017; 14: 2, 211 – 217.
  26. Gasparini, M. et al., Long Detection Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality: The ADVANCE III Trial. JACC: Clinical Electrophysiology, 2017; 3: 11.
  27. Sweeney MO, et al. Appropriate and inappropriate ventricular therapies, quality of life, and mortality among primary and secondary prevention implantable cardioverter defibrillator patients: results from the Pacing Fast VT REduces Shock ThErapies (PainFREE Rx II) trial. Circulation. 2005;111:2898–2905.
  28. Wathen MS, et al. PainFREE Investigators. Shock reduction using antitachycardia pacing for spontaneous rapid ventricular tachycardia in patients with coronary artery disease. Circulation. 2001;104:796–801.
  29. Young JB, et al. Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD) Trial Investigators. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. 2003;289:2685–2694.
  30. Moss, A. et al. Long-Term Benefit of Primary Prevention With an Implantable Cardioverter-Defibrillator An Extended 8-Year Follow-Up Study of the Multicenter Automatic Defibrillator Implantation Trial, Circulation. 2010;122:1265-1271.
  31. Burke, M. et al. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-year Results from a Pooled Analysis of the IDE Study and EFFORTLESS Registry. JACC 2015; 65: 16.
  32. Betz, J., et al. Outcomes Among Older Patients Receiving Implantable Cardioverter-Defibrillators for Secondary Prevention From the NCDR ICD Registry. JACC, 2017; 69, 3.
  33. Kusumoto, FM, et al., 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm, 2017.
  34. Friedman, D.J., et al., Trends and In-Hospital Outcomes Associated With Adoption of the Subcutaneous Implantable Cardioverter Defibrillator in the United States. JAMA Cardiol, 2016. 1(8): p. 900-911.
  35. 2015 ACC/AHA/HRS Guideline for the Management of Adult Patients With Supraventricular Tachycardia. Richard L. Page et al. Circulation. 2015;10.1161/CIR.0000000000000311.
  36. Gold, M. R., et al. (2011). Head-to-Head Comparison of Arrhythmia Discrimination Performance of Subcutaneous and Transvenous ICD Arrhythmia Detection Algorithms: The START Study. J Cardiovasc Electrophysiol. In press Epub, doi: 10.1111/j.1540-8167.2011.02199
  37. Basu-Ray, I. et al. Subcutaneous Versus Transvenous Implantable Defibrillator Therapy. A Meta-Analysis of Case-Control Studies. JACC 2017.
  38. Ferretto, S. et al. Implantable cardioverter-defibrillator in the elderly: Predictors of appropriate interventions andmortality at 12-month follow-up. Pacing Clin Electrophysiol. 2017;1–6.
  39. Bardy, G. H., et al. (2010). “An entirely subcutaneous implantable cardioverter-defibrillator.” N Engl J Med 363(1): 36-44.
  40. Polyzos, KA, et al. Risk factors for cardiac implantable electronic device infection: a systematic review and meta-analysis. Europace, 2015. 17(5): p. 767-777.

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