EMBLEM™ MRI S-ICD System
Subcutaneous Implantable Defibrillator
S-ICD Clinical Data
ATLAS Randomized Controlled Trial: S-ICD Superior to TV-ICD1
The ATLAS Trial is an investigator-sponsored research study (ISR) initiated, designed and led by Population Health Research Institute (PHRI), Jeff S. Healey MD, MSc, FHRS, and the ATLAS Steering Committee. It is the first prospective randomized controlled trial where the primary objective was to evaluate lead-related complication rates between the S-ICD and single chamber TV-ICD devices at six months after implant.
The trial hypothesis is that S-ICD is superior to TV-ICD with respect to serious lead-related complications*, including:
- Moderate-severe or severe tricuspid regurgitation,
- Hemothorax or pneumothorax
- Cardiac perforation, tamponade, or pericardial effusion or pericarditis
- Ipsilateral upper extremity deep vein thrombosis
- Lead dislodgement or loss of sensing or pacing requiring revision
Sample Size and Timing
The trial randomized 503 patients, who passed electrocardiographic screening, from clinical centers across Canada between February 2017 and July 2021.
Patients in the S-ICD group showed significantly fewer serious lead-related complications* than patients implanted with a single-chamber TV-ICD.
PRAETORIAN: S-ICD vs. TV-ICD
Analysis of the UNTOUCHED Study
The incidence of inappropriate shocks in primary prevention, LVEF ≤ 35% patients will be non-inferior to the rate in transvenous ICD patients with similar programming observed in MADIT-RIT Arms B and C.
- Follow-up for 18 months
- Device programming with a conditional zone of 200 bpm and a shock zone of 250 bpm
- Primary endpoint of inappropriate shock-free rate at 18 months
- Secondary endpoints of all cause shock-free rate at 18 months and system and procedure complications at 30 days
1. The inappropriate shock rate of 2.4% at 1 year for EMBLEM™ MRI S-ICDs is the lowest reported for S-ICD, despite a cohort with more left ventricular dysfunction and heart failure.2
TV-ICD Lead Complications in the Real World
S-ICD is Guideline Recommended
Analysis of MADIT RIT Data22
A new analysis of data from MADIT RIT demonstrates patients are more likely to develop complications from transvenous leads than they are to benefit from ATP.
- There is a statistically significant reduction in ATP with contemporary programming, suggesting that many VTs are self-terminating and earlier interventions may lead to an overestimation of the value of ATP.
- Despite the use of significantly more ATP in the conventional programming arm of MADIT RIT, there was no reduction in the final shock rate when compared to the contemporary programming arms.
SMART Pass Significantly Reduces IAS
Clinical Data Resources
Training & Education
Explore continuing education courses, best practices modules and other training and resources for S-ICD.
See how S-ICD helps protect patients at risk for sudden cardiac death while also eliminating the risk of TV-ICD lead complications.
Learn about advancements in the S-ICD implant procedure, including the 2-incision and intermuscular implant techniques.
- Healey JS et al. Subcutaneous Versus Transvenous Defibrillators: The Atlas Trial. Heart Rhythm Society Late Breaking Clinical Trials LB-733 Randomized Clinical Trials. 2022
- Gold, MR, et al. The UNTOUCHED Study. Circulation. 2020.
- Weiss, et al. The Safety and Efficacy of a Totally Subcutaneous Implantable-Defibrillator. CIRCULATION. Vol. 128, no. 9. (August 2013.): 944-953.
- Boersma, L, Barr, C, Knops, R, et al., Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study. J Am Coll Cardiol, 2017. 70(7): p. 830-841.
- Knops R. et al., The PRAETORIAN Trial. Heart Rhythm Society Late Breaking Clinical Trials LBCT-01 2020.
- Theuns, et al. Prospective Blinded Evaluation of a Novel Sensing Methodology Designed to Reduce Inappropriate Shocks by S-ICD. Heart Rhythm. 2018.
- Gasparini, M, Lunati, MG, Proclemer, A, et al., Long Detection Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality. JACC: Clinical Electrophysiology, 2017.
- Kutyifa, et al., Novel ICD Programming and Inappropriate ICD Therapy in CRT-D Versus ICD Patients: A MADIT-RIT Sub-Study. Circ Arrhythm Electrophysiol, 2016. 9(1): p. e001965.
- Burke MC, et al. 1-Year Prospective Evaluation of Clinical Outcomes and Shocks. JACC: Clinical Electrophysiology. 2020.
- Healey, J, et al. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE). The Lancet. 2015.
- Blatt, JA, Poole, JE, Johnson, GW, et al., No benefit from defibrillation threshold testing in the SCD-HeFT. J Am Coll Cardiol, 2008. 52(7): p. 551-6.
- Swerdlow CD et al. The Dilemma of ICD Implant Testing. PACE 2007; 30:675–700
- Kutyifa V, et al. Clinical Impact, Safety, and Efficacy of Single- versus Dual-Coil ICD Leads in MADIT-CRT J Cardiovasc Electrophysiol 2013;24:1246-52
- Gold MR et al. Efficacy and Temporal Stability of Reduced Safety Margins for Ventricular Defibrillation: Primary Results From the Low Energy Safety Study (LESS)Circulation 2002.
- Koneru, JN, Jones, PW, Hammill, EF, Wold, N, and Ellenbogen, KA, Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads. J Am Heart Assoc, 2018. 7(10).
- Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, et al., 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death, Heart Rhythm (2017), doi: 10.1016/j.hrthm.2017.10.036.
- Polyzos, KA, Konstantelias, AA, and Falagas, ME, Risk factors for cardiac implantable electronic device infection: a systematic review and meta-analysis. Europace, 2015. 17(5): p. 767-777.
- Greenspon, AJ, Patel, JD, Lau, E, et al., 16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States. Journal of the American College of Cardiology, 2011. 58(10): p. 1001-1006.
- Friedman, DJ, Parzynski, CS, Varosy, PD, et al., Trends and In-Hospital Outcomes Associated With Adoption of the Subcutaneous Implantable Cardioverter Defibrillator in the United States. JAMA Cardiol, 2016. 1(8): p. 900-911.
- LATITUDE data on file. Boston Scientific 2017.
- Kusumoto, FM, Schoenfeld, MH, Wilkoff, BL, et al., 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm, 2017.
- Schuger, et al. Avoiding Unnecessary Therapy for Ventricular Arrhythmias ≥ 200 bpm: Results from MADIT-RIT. S-PO03 at HRS 2019, San Francisco, CA.
- Theuns, et al. Evaluation of a Novel Algorithm Designed to Reduce Oversensing in the S-ICD. HRS 2016; AB05-01.
*In the ATLAS trial, serious complications were defined as moderate-severe or severe tricuspid regurgitation, hemothorax/pneumothorax, cardiac perforation, tamponade, pericardial effusion or pericarditis, ipsilateral upper extremity deep vein thrombosis and lead dislodgement or loss of sensing or pacing requiring revision.