EMBLEM™ MRI S-ICD System

Patient Selection Tool
The S-ICD Patient Selection Tool could help you assess your patient’s suitability for S-ICD therapy. Based on the questions, provided information and definitions, this tool will support your choice of treatment for your ICD indicated patient. 

Key Resources

EDUCARE online education Directions for use Patient Selection Tool S-ICD Patient Website Indications, Safety & Warnings
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2017 AHA HRS ACC Guidelines Recommendations

Two levels of recommendation:
  1. Class I recommendation for the S-ICD for patients who have no adequate vascular access or are at high risk for infection.
  2. Class IIa recommendation for the S-ICD for all ICD-indicated patients, without a pacing requirement.
COR LOE Recommendations
I B-NR 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 for bradycardia or VT termination or as part of CRT is neither needed nor anticipated, a subcutaneous implantable cardioverter-defibrillator is recommened (1-5).
II B-NR 2. In patients who meet indication for an ICD, implantation of a subcutaneous implantable cardioverter-defibrillator is reasonable if pacing for bradycardia or VT termination or as part of CRT is neither needed nor anticipated (1-4).
III: Harm B-NR 3. In patients with an indication for bradycardia pacing or CRT, or for whom antitachycardia pacing for VT termination is required, a subcutaneaus implantable cardioverter-defibrillator should not be implanted (1-4, 6-8).

“The risk of infection appears to be lower with subcutaneous implantable cardioverter-defibrillators than with transvenous ICDs (1-4).Therefore, a subcutaneous implantable cardioverter-defibrillator may be preferred in patients who are at high risk of infection, such as those with a prior device infection, ESRD, diabetes mellitus, or who are chronically immunosuppressed.”*

*  Al-Khatib, SM, Stevenson, WG, Ackerman, MJ, et al., 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. Heart Rhythm, 2017.

2015 ESC Guidelines Recommendations

Two levels of recommendation:
  1. Class IIa to support a clinical workflow in which S-ICD is recommended1 for all ICD-indicated patients without pacing requirement2.
  2. Class IIb to provide additional guidance to the stratification process of patients who could benefit most from the S-ICD: supported by expert opinion
Prof. Priori highlights the ESC Guidelines
Patient requiring:  At implant  Post implant
Pacing1 6 %  2 % / Year2
ATP3 1.8 % / Year 1.8 % / Year
Extraction for: (985 patients)4
Pacing 1 % (0.1 %)
ATP 5 % (0.5 %)

 

The S-ICD has been implanted in a Broad Range of Patients

S-ICD System Patient Population from the IDE Study5

The S-ICD System is an effective option for a majority of ICD candidates, both with primary and secondary indications.

 

S-ICD System Implants from the Pooled Analysis1

13.7% of S-ICD System implants were replacements for transvenous ICDs, some due to system malfunctions and /or infections.

Patient Prioritization

* <65 (10 – 15 years life expectancy) as defined by ESC guidelines for management of atrial fi brillation, 2011
** The S-ICD System is indicated for patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with antitachycardia pacing.
Dr. Poole explores the criteria for ICD vs. S-ICD

 
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