EMBLEM™ MRI S-ICD System
Subcutaneous Implantable Defibrillator
![Explore the data and science behind S-ICD technology.](https://www.bostonscientific.com/en-US/products/defibrillators/emblem-s-icd-system/clinical-data/praetorian-trial/_jcr_content/maincontent-par/image_790843757_copy.img.podcasts.png)
The PRAETORIAN Trial1, 2
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.
![SICD-background-image SICD-background-image](/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/EMBLEM_S-ICD/07_Clinical_Data/sicd-clinical-hero-d-2-940.jpg)
4-YEAR TRIAL RESULTS
Data from the PRAETORIAN trial confirmed that the S-ICD can be the preferred therapy choice over the TV-ICD for protection from sudden cardiac death. The S-ICD offers comparable performance for the majority of ICD-indicated patients who do not have a need for pacing, while avoiding the serious complications associated with TV-ICDs such as serious infections and lead-related complications.
Primary and secondary endpoints**
![4 to 5% low annual mortality rates for S-ICD and TV-ICD.](/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/EMBLEM_S-ICD/BSC_PRAE_Trial_Web_Assets-01_crop.png)
Mortality rates1,2
- 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: 6.6% for TV-ICD and 1.4% for S-ICD.](/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/EMBLEM_S-ICD/07_Clinical_Data/BSC_PRAE_Trial_Web_Assets-02.png)
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.2
- 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.3
![2 times more device extractions for infection with TV-ICD.](/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/EMBLEM_S-ICD/BSC_PRAE_Trial_Web_Assets-03_crop.png)
Infections requiring device extraction
- Numerically, TV-ICD patients experienced twice as many infections that required device extraction as S-ICD patients did.1,2
- Data in >91,000 transvenous lead extractions demonstrated that those extracted for infection had significantly higher rates of complications and mortality.4
![Trend in lower complications at 4 years; TV-ICD has higher cumulative event rate that S-ICD.](/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/EMBLEM_S-ICD/BSC_PRAE_Trial_Web_Assets-04_crop.png)
Device-related complications1,2
- 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.1,2
![Very low 1-year inappropriate shock rates: 4.8% for S-ICD and 4.1% for TV-ICD.](/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/EMBLEM_S-ICD/BSC_PRAE_Trial_Web_Assets-05_crop.png)
Inappropriate shock rates
- No significant difference in inappropriate shock rates between the two groups.1,2
- 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.5,6
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.
Additional trial results1
- Mean implant time for S-ICD was only 5 minutes more than TV-ICD (55 minutes vs. 50 minutes implant time).
- 2-incision technique was utilized in 70% of all S-ICD implants
- Appropriate shock rates for the S-ICD group were higher than the TV-ICD group; only one patient with an S-ICD was converted to a CRT-D at two years for slow VT where ATP could potentially benefit
- Higher rates in S-ICD group likely due to: (1) devices used prior to 2016 without SMART Pass, (2) conditional programming zone of 180 bpm.5-6***
- Other contemporary S-ICD studies featured appropriate shock rates of 5.2%5 [1 yr.] in patients with a SMART Pass enabled S-ICD (comparable to 6.5% and 5.9% rates for single chamber TV-ICDs in the PainFree SST and ADVANCE III trials).7, 9
![Lead extraction rates for TV-ICDs.](/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/EMBLEM_S-ICD/07_Clinical_Data/Lead-Extraction.png)
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.4
- In this same study, the median cost of lead extraction was $39,308 for infected devices and $14,916 for non-infected devices.
![68% reaction in IAS rates.](/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/EMBLEM_S-ICD/07_Clinical_Data/IAS-rate-reduction.png)
Contemporary S-ICDs further rduce rates of inappropriate shock
SMART PassTM, included in the EMBLEM MRI S-ICD, has been shown to reduce IAS rates by 68%.6
- In the more recent UNTOUCHED study, the 1-year IAS rate was 3.1%,5,6 which is comparable to or lower than the rates observed with TV-ICDs in other studies, including the PRAETORIAN trial.1,7-9
- In addition, the 1-year IAS rate was 2.4% for those who received an EMBLEM MRI with SMART Pass.6
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 130,000 patients worldwide—and counting.
![SICD-background-image SICD-background-image](/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/EMBLEM_S-ICD/07_Clinical_Data/sicd-clinical-hero-d-3-940.jpg)
WHAT'S NEXT FOR THE TRIAL
PRAETORIAN XL is expected to complete in 2024. The primary objective of PRAETORIAN XL Trial is to evaluate acute and chronic complications of the S-ICD compared to single chamber TV-ICD's.