The PRAETORIAN Trial
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.
4-YEAR TRIAL RESULTS
Primary Secondary Endpoints**
- No significant difference in overall and arrhythmic mortality rates between the two groups.
- Mortality rate was low in both groups, even though:
- 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
- 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.
- 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
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 EMBLEMTM S-ICD have demonstrated even lower rates of IAS.
S-ICD: A Smart Alternative to TV-ICD
Because it avoids some of the more major complications associated with the TV-ICD, including serious infection and lead-related complications, data shows that the S-ICD is an appropriate and potentially desirable alternative for primary and secondary ICD-indicated patients who do not require pacing.
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 PassTM, 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
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 75,000 patients worldwide—and counting.