EMBLEM™ MRI S-ICD System

The PRAETORIAN Trial is an investigator-sponsored study (ISR)* initiated, designed and led by Academic Medical Center in Amsterdam (AMC) and Reinoud E. Knops, MD, PhD. It is the first prospective randomized head-to-head trial comparing the performance of S-ICD and TV-ICD.

The trial hypothesis was that the S-ICD is non-inferior to the TV-ICD with respect to major ICD-related adverse events, including:

• Inappropriate shocks
• ICD-related complications that require intervention
• Lead-related complications

The trial enrolled 849 patients between March 2011 and January 2017 within the EU and US.

Mortality Rates

• No significant difference in overall and arrhythmic mortality rates between the two groups.
• Mortality rate was low in both groups, even though:
  • Over 90% had ischemic (>68%) or non-ischemic heart failure
  • Secondary prevention for 19% of S-ICD patients and 20% of TV-ICD patients
  • Median EF was 30%
  • Median age was 63 years

• Arrhythmic deaths were identical in both groups.
• Numerically, more deaths occurred in the S-ICD group; this difference was due to non-cardiac causes including cancer and gastrointestinal disease.

Lead-Related Complications

• Data showed a statistical difference in lead-related complications, with TV-ICD patients experiencing more than 4 times as many as S-ICD patients did.¹
• The S-ICD leaves the vasculature untouched, thereby reducing the risk of acute and future complications associated with transvenous leads.
• Eliminating device leads within the vasculature is particularly important for ICD-indicated patients with co-morbidities such as diabetes and renal disease who often are at an increased risk of infection and may have vascular access issues.²

Infections Requiring Device Extraction

• Numerically, TV-ICD patients experienced twice as many infections that required device extraction as S-ICD patients did.
• Data in >91,000 transvenous lead extractions demonstrated that those extracted for infection had significantly higher rates of complications and mortality.³

Device-Related Complications

• No statistical difference in device-related complications at the median 4-year follow-up.
• The trial authors have initiated an extended follow-up, PRAETORIAN XL, and anticipate that at 8 years the S-ICD will demonstrate superiority to TV-ICD for all device-related complications.¹

Inappropriate Shock Rates

• No significant difference in inappropriate shock rates between the two groups.
• The PRAETORIAN trial used mainly devices available prior to 2016. Studies using modern S-ICDs like the EMBLEM^TM S-ICD have demonstrated even lower rates of IAS.⁵

Reducing TV-ICD Infections Can Lower Mortality Rates

When it comes to reducing complications, lowering mortality rates and cutting costs, avoiding infected TV-ICD leads can go a long way.

• Data in >91,000 transvenous lead extractions found that those extracted for infection had a higher overall complication rate and a higher in-hospital mortality rate compared to those without infection.³
• In this same study, the median cost of lead extraction was $39,308 for infected devices and $14,916 for non-infected devices.

Contemporary S-ICDs Further Reduce Rates of Inappropriate Shock

SMART Pass^TM, included in the EMBLEM MRI S-ICD, has been shown to reduce IAS rates by 68%.⁴

• In the more recent UNTOUCHED study, the 1-year IAS rate was 3.1%,⁵ which is comparable to or lower than the rates observed with TV-ICDs in other studies, including the PRAETORIAN trial.^{1, 6-8}
• In addition, the 1-year IAS rate was 2.4% for those who received an EMBLEM MRI with SMART Pass.^{5, 9}

S-ICD Procedures Are Becoming More Common Than Ever

Optimized implant techniques (such the intermuscular technique) and implant best practices have emerged as experience with S-ICD has increased to over 87,000 patients worldwide—and counting.