EMBLEM™ MRI S-ICD System

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 ).¹

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.

Hypothesis

The incidence of inappropriate shocks in primary prevention, LVEF ≤ 35% patients will be non-inferior to the rate in transvenous ICD patients with similar programming observed in MADIT-RIT Arms B and C.

Study Design

• Follow-up for 18 months
• Device programming with a conditional zone of 200 bpm and a shock zone of 250 bpm
• Primary endpoint of inappropriate shock-free rate at 18 months
• Secondary endpoints of all cause shock-free rate at 18 months and system and procedure complications at 30 days

Key Takeaways

1. In the UNTOUCHED study a subsequent sub-analysis demonstrated that the inappropriate shock rate with SMART Pass On was 1.8% at 1 year for EMBLEM™ S-ICDs. This is the lowest reported inappropriate shock rate for S-ICD, despite a cohort with more left ventricular dysfunction and heart failure.^2,3

The Impact of SMART Pass on IAS

S-ICD and Patients at High Risk for Infection

Bradycardia Pacing Need in ICD Patients