Main image of with a Heart surrounded by an EMBLEM and a EMPOWER devices

EMBLEM™ S-ICD ATLAS

Proven Protection. Personalised Care.

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ATLAS Trial1

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

A prospective, randomised, controlled trial comparing lead-related complication rates between the S-ICD and single-chamber TV-ICDs at six months post-implant.

Patient Population

•Total: N=503

•S-ICD group: n=251

•TV-ICD group: n=252

Key Results

Bar chart: Primary endpoint outcomes on serious lead-related complications at six months compared with single-chamber: S-ICD 0.4% vs TV-ICD 4.8%

Primary Superiority Endpoint

The EMBLEM™ S-ICD demonstrated a 92% reduction in serious lead-related complications at six months compared with single-chamber TV-ICDs from any manufacturer (p=0.003).

Secondary Analysis2

Based on data from nearly 450 patients, this analysis assessed the severity of tricuspid regurgitation (TR) six months post-implant.

Key Results

Patients with an S-ICD were seven times less likely to experience worsening TR compared to those with a TV-ICD (p<0.001). 

Bar chart: comparing tricuspid regurgitation in S-ICD 2.3% vs TV-ICD 6.9%

Tricuspid Regurgitation

Among patients with worsening TR, moderate or severe TR occurred in three times fewer S-ICD patients than TV-ICD patients. (p=0.02)

Conclusion

The S-ICD was associated with significantly fewer serious lead-related complications and a lower risk of worsening TR compared with single-chamber TV-ICD devices from any manufacturer.

Explore more evidence:

MODULAR ATP
PRAETORIAN


References:

1.Healey JS, Krahn AD, Bashir J, et al. Perioperative safety and early patient and device outcomes among subcutaneous versus transvenous implantable cardioverter defibrillator implantations: a randomized, multicenter trial. Ann Intern Med. 2022;175(12):165–1665.

2.Leong DP, Dokainish H, Mondésert B, et al. Effects of Implantable Cardioverter-Defibrillator Leads on the Tricuspid Valve and Right Ventricle: A Randomized Comparison of Transvenous versus Subcutaneous Leads. JACC Clin Electrophysiol. 2024;10(9):2088-2096.

ICD, implantable cardioverter defibrillator; S-ICD, subcutaneous ICD; TR, tricuspid regurgitation; 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.