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EMBLEM™ S-ICD PRAETORIAN Trial

Proven Protection. Personalised Care.

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PRAETORIAN Trial1

Head-to-head Trial: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) vs the Transvenous ICD (TV-ICD)

A prospective, randomised, controlled noninferiority trial comparing the S-ICD with the TV-ICD in patients with an ICD indication and no pacing requirement.1

Patient Population

•Total: N=849

•S-ICD group: n=426

•TV-ICD group: n=423

Key Results

Bar graph: Severe lead-related complications S-ICD 1.4% vs TV-ICD 6.6%

Severe Lead-Related Complications

S-ICD patients experienced over four times fewer severe lead-related complications than those with a TV-ICD (p=0.001).

PRAETORIAN XL Trial2

A 4-year extension of PRAETORIAN, evaluating long-term outcomes over 8 years in a subset of the original cohort.

Patient Population

•S-ICD group: n=263

•TV-ICD group: n=265

Key Results

Bar graph: Major complications comparison graph: TV-ICD 10.2 vs S-ICD 5.7%

Major Complications

The S-ICD group had a 42% lower risk of major complications compared with the TV-ICD group (HR: 0.58; 95% CI: 0.36–0.95; p=0.03).

Bar graph: Lead-related complication statistics bar image: S-ICD 2.4% VS 8.3 TV-ICD

Lead-Related Complications

S-ICD patients had a threefold lower risk of lead-related complications compared with TV-ICD patients (HR: 0.33; 95% CI: 0.17–0.63; p<0.001).

Conclusion

The PRAETORIAN-XL trial showed no significant difference in overall device-related complications between S-ICD and TV-ICD during long-term follow-up. However, S-ICD was associated with a lower risk of major and lead-related complications compared with TV-ICD therapy.

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 ).3

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

Read the publication

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References:

1.Knops RE, Olde Nordkamp LRA, Delnoy PHM, et al. Subcutaneous or Transvenous Defibrillator Therapy. N Engl J Med. 2020;383(6):526–536.

2.Nordkamp LO. Device-related complications in transvenous versus subcutaneous defibrillator therapy during long-term follow-up: The PRAETORIAN XL Trial. Circulation. 2025. doi: 10.1161/CIRCULATIONAHA.125.074576.

3.Nordkamp LO. Device-related complications in transvenous versus subcutaneous defibrillator therapy during long-term follow-up: The PRAETORIAN XL Trial. HRS 2025. 

CI, confidence interval; HR, hazard ratio; ICD, implantable cardioverter defibrillator; S-ICD, subcutaneous ICD; TV-ICD, transvenous ICD.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device. or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.