Safety and Efficacy

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Safety and Efficacy of the S-ICD System : S-ICD shock efficacy

Almost 2 decades of clinical data have consistently demonstrated high overall shock efficacy and spontaneous conversion rates for the S-ICD.

First and final shock efficacy in EFFORTLESS Registry1

Safety and Efficacy of the S-ICD System
 
S-ICD has been shown to safely convert spontaneous arrhythmias. Data from the EFFORTLESS registry shows overall final shock efficacy of 98%, after 5 years of follow up.1

Spontaneous conversion efficacy in the ATLAS trial2

Spontaneous conversion efficacy in the ATLAS trial2
More recently, the ATLAS trial also demonstrated, the conversion efficacy of over 99%, at 6 months, for S-ICD2

 

 

Evidence from Four Randomized Studies

The high spontaneous conversion efficacy for S-ICD, demonstrated in over 4,000 patients across  4 randomized studies, is comparable to TV-ICD:1,3-9
Safety and Efficacy of the S-ICD System

 

 

First results of the randomized PRAETORIAN-DFT trial

Prospective validation of the PRAETORIAN score for prediction of defibrillation test success after subcutaneous ICD implant.

The findings from this first analysis demonstrate that a low (<90) PRAETORIAN score is 99% predictive for a successful DFT and a high (≥90) PRAETORIAN score is the strongest predictor for DFT-failure (odds ratio of 34 ).10
 
While the study investigators concluded their presentation by stating that the PRAETORIAN score could be used as an alternative for DFT in cases when DFT-testing is not possible or desirable, omitting DFT’s in S-ICD implants cannot be advised until the full PRAETORIAN-DFT results are available.

Circulation article:

Device-related complications in transvenous versus subcutaneous defibrillator therapy during long-term follow-up: The PRAETORIAN-XL Trial

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