Subkutan ICD

Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997;337:1576–1583

Bardy G.H., Lee K.L., Mark D.B., et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352:225–237

Connolly S.J., Hallstrom A.P., Cappato R., et al. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg. Canadian Implantable Defibrillator Study. Eur Heart J. 2000;21:2071–2078

Buxton A.E., Lee K.L., Fisher J.D., Josephson M.E., Prystowsky E.N., Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999;341:1882–1890

Kadish A., Dyer A., Daubert J.P., et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004;350:2151–2158

Lee D.S., Krahn A.D., Healey J.S., et al. Evaluation of early complications related to De Novo cardioverter defibrillator implantation insights from the Ontario ICD database. J Am Coll Cardiol. 2010;55:774–782

Reynolds M.R., Cohen D.J., Kugelmass A.D., et al. The frequency and incremental cost of major complications among medicare beneficiaries receiving implantable cardioverter-defibrillators. J Am Coll Cardiol. 2006;47:2493–2497

Steckman D.A., Varosy P.D., Parzynski C.S., et al. In-hospital complications associated with reoperations of implantable cardioverter defibrillators. Am J Cardiol. 2014;114:419–426

Koneru J.N., Jones P.W., Hammill E.F., Wold N., Ellenbogen K.A. Risk factors and temporal trends of complications associated with transvenous implantable cardiac defibrillator leads. J Am Heart Assoc. 2018;7

Ranasinghe I., Parzynski C.S., Freeman J.V., et al. Long-term risk for device-related complications and reoperations after implantable cardioverter-defibrillator implantation: an observational cohort study. Ann Intern Med. 2016;165:20–29.

Kleemann T., Becker T., Doenges K., et al. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 years. Circulation. 2007;115:2474–2480

Duray G.Z., Schmitt J., Cicek-Hartvig S., Hohnloser S.H., Israel C.W. Complications leading to surgical revision in implantable cardioverter defibrillator patients: comparison of patients with single-chamber, dual-chamber, and biventricular devices. Europace. 2009;11:297–302

Brouwer T.F., Yilmaz D., Lindeboom R., et al. Long-term clinical outcomes of subcutaneous versus transvenous implantable defibrillator therapy. J Am Coll Cardiol. 2016;68:2047–2055

Ezzat V.A., Lee V., Ahsan S., et al. A systematic review of ICD complications in randomised controlled trials versus registries: is our 'real-world' data an underestimation? Open Heart. 2015;2

Knops R.E., Olde Nordkamp L.R.A., Delnoy P.H.M., et al. Subcutaneous or transvenous defibrillator therapy. N Engl J Med. 2020;383:526–536

Olde Nordkamp L.R., Postema P.G., Knops R.E., et al. Implantable cardioverter-defibrillator harm in young patients with inherited arrhythmia syndromes: a systematic review and meta-analysis of inappropriate shocks and complications. Heart Rhythm. 2016;13:443–454

Russo A.M., Daugherty S.L., Masoudi F.A., Wang Y., Curtis J., Lampert R. Gender and outcomes after primary prevention implantable cardioverter-defibrillator implantation: findings from the National Cardiovascular Data Registry (NCDR) Am Heart J. 2015;170:330–338

Prutkin J.M., Reynolds M.R., Bao H., et al. Rates of and factors associated with infection in 200 909 Medicare implantable cardioverter-defibrillator implants: results from the National Cardiovascular Data Registry. Circulation. 2014;130:1037–1043

Olde Nordkamp L.R.A., Warnaars J.L.F., Kooiman K.M., et al. Which patients are not suitable for a subcutaneous ICD: incidence and predictors of failed QRS-T-wave morphology screening. J Cardiovasc Electrophysiol. 2014;25:494–499

Groh C.A., Sharma S., Pelchovitz D.J., et al. Use of an electrocardiographic screening tool to determine candidacy for a subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2014;11:1361–1366

Randles D.A., Hawkins N.M., Shaw M., Patwala A.Y., Pettit S.J., Wright D.J. How many patients fulfil the surface electrocardiogram criteria for subcutaneous implantable cardioverter-defibrillator implantation? Europace. 2014;16:1015–1021

Bardy G.H., Smith W.M., Hood M.A., et al. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010;363:36–44

Brouwer T.F., Miller M.A., Quast A.B., et al. Implantation of the subcutaneous implantable cardioverter-defibrillator: an evaluation of 4 implantation techniques. Circ Arrhythm Electrophysiol. 2017;10

Brouwer T.F., Driessen A.H.G., Olde Nordkamp L.R.A., et al. Surgical management of implantation-related complications of the subcutaneous implantable cardioverter-defibrillator. JACC Clin Electrophysiol. 2016;2:89–96

Smietana J., Frankel D.S., Serletti J.M., et al. Subserratus implantation of the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2021;18:1799–1804

Knops R.E., Olde Nordkamp L.R., de Groot J.R., Wilde A.A. Two-incision technique for implantation of the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2013;10:1240–1243

Heist E.K., Belalcazar A., Stahl W., Brouwer T.F., Knops R.E. Determinants of subcutaneous implantable cardioverter-defibrillator efficacy: a computer modeling study. JACC Clin Electrophysiol. 2017;3:405–414

Brisben A.J., Burke M.C., Knight B.P., et al. A new algorithm to reduce inappropriate therapy in the S-ICD system. J Cardiovasc Electrophysiol. 2015;26:417–423

Theuns D., Brouwer T.F., Jones P.W., et al. Prospective blinded evaluation of a novel sensing methodology designed to reduce inappropriate shocks by the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2018;15:1515–1522

Boersma L.V., El-Chami M.F., Bongiorni M.G., et al. Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): clinical characteristics and perioperative results. Heart Rhythm. 2019;16:1636–1644

Gold M.R., Lambiase P.D., El-Chami M.F., et al. Primary results from the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) trial. Circulation. 2021;143:7–17

Weiss R., Knight B.P., Gold M.R., et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013;128:944–953

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;70:830–841

Gold M.R., Aasbo J.D., El-Chami M.F., et al. Subcutaneous implantable cardioverter-defibrillator post-approval study: clinical characteristics and perioperative results. Heart Rhythm. 2017;14:1456–1463

Dabiri Abkenari L., Theuns D.A., Valk S.D., et al. Clinical experience with a novel subcutaneous implantable defibrillator system in a single center. Clin Res Cardiol. 2011;100:737–744

Lambiase P.D., Barr C., Theuns D.A., et al. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J. 2014;35:1657–1665

Burke M.C., Gold M.R., Knight B.P., et al. Safety and efficacy of the totally subcutaneous implantable defibrillator: 2-year results from a pooled analysis of the IDE study and EFFORTLESS registry. J Am Coll Cardiol. 2015;65:1605–1615

Priori S.G., Blomstrom-Lundqvist C., Mazzanti A., et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: the Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC) Eur Heart J. 2015;36:2793–2867

Al-Khatib S.M., Stevenson W.G., Ackerman M.J., et al. 2017 AHA/ACC/HRS Guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2018;72:e91. –e220

Kremers M.S., Hammill S.C., Berul C.I., et al. The National ICD Registry Report: version 2.1 including leads and pediatrics for years 2010 and 2011. Heart Rhythm. 2013;10:e59–e65

U.S. Food & Drug Administration Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures 2020. 2021. February 10, 2021. Accessed August 30, 2022

U.S. Food & Drug Administration Boston Scientific Corporation recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit. February 19, 2021. Accessed August 30, 2022

Friedman D.J., Parzynski C.S., Varosy P.D., et al. Trends and in-hospital outcomes associated with adoption of the subcutaneous implantable cardioverter defibrillator in the United States. JAMA Cardiol. 2016;1:900–911

Moss A.J., Schuger C., Beck C.A., et al. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012;367:2275–2283.

Poole J.E., Johnson G.W., Hellkamp A.S., et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008;359:1009–1017

van Rees J.B., Borleffs C.J., de Bie M.K., et al. Inappropriate implantable cardioverter-defibrillator shocks: incidence, predictors, and impact on mortality. J Am Coll Cardiol. 2011;57:556–562

Li A., Kaura A., Sunderland N., Dhillon P.S., Scott P.A. The significance of shocks in implantable cardioverter defibrillator recipients. Arrhythm Electrophysiol Rev. 2016;5:110–116

Basu-Ray I., Liu J., Jia X., et al. Subcutaneous versus transvenous implantable defibrillator therapy: a meta-analysis of case-control studies. JACC Clin Electrophysiol. 2017;3:1475–1483

Gold M.R., Theuns D.A., Knight B.P., et al. Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study. J Cardiovasc Electrophysiol. 2012;23:359–366

Mesquita J., Cavaco D., Ferreira A., et al. Effectiveness of subcutaneous implantable cardioverter-defibrillators and determinants of inappropriate shock delivery. Int J Cardiol. 2017;232:176–180

Healey J. Heart Rhythm Society; 2022. Subcutaneous versus transvenous defibrillators: the ATLAS trial. Late-Breaking Clinical Trials Session—LB-733 Randomized Clinical Trials. Heart Rhythm Society 2022 Annual Meeting, San Francisco, California, April 29–May 1, 2022

Olgun H., Karagoz T., Celiker A., Ceviz N. Patient- and lead-related factors affecting lead fracture in children with transvenous permanent pacemaker. Europace. 2008;10:844–847

Lee J.C., Shannon K., Boyle N.G., Klitzner T.S., Bersohn M.M. Evaluation of safety and efficacy of pacemaker and defibrillator implantation by axillary incision in pediatric patients. Pacing Clin Electrophysiol. 2004;27:304–307.

Fong K.Y., Ng C.J.R., Wang Y., Yeo C., Tan V.H. Subcutaneous versus transvenous implantable defibrillator therapy: a systematic review and meta-analysis of randomized trials and propensity score-matched studies. J Am Heart Assoc. 2022;11

Tjong F.V., Brouwer T.F., Smeding L., et al. Combined leadless pacemaker and subcutaneous implantable defibrillator therapy: feasibility, safety, and performance. Europace. 2016;18:1740–1747

Roger S., Borggrefe M., Kuschyk J. Heart failure with reduced ejection fraction and a narrow QRS complex: combination of a subcutaneous defibrillator with cardiac contractility modulation. J Atr Fibrillation. 2015;8:1081

Kuschyk J., Stach K., Tulumen E., et al. Subcutaneous implantable cardioverter-defibrillator: First single-center experience with other cardiac implantable electronic devices. Heart Rhythm. 2015;12:2230–2238

Sidhu B.S., Gould J., Porter B., et al. Completely leadless cardiac resynchronization defibrillator system. JACC Clin Electrophysiol. 2020;6:588–589

Elliott M.K., Sidhu B.S., Mehta V.S., Gould J., Martic D., Rinaldi C.A. The importance of leadless pacemaker positioning in relation to subcutaneous implantable cardioverter-defibrillator sensing in completely leadless cardiac resynchronization and defibrillation systems. HeartRhythm Case Rep. 2021;7:628–632

Boston Scientific Corporation Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing (MODULAR ATP) 2023. 2021. https://ClinicalTrials.gov/show/NCT04798768 Updated January 31, 2022. Accessed August 30, 2022.

Boston Scientific Corporation User’s Manual EMBLEM S-ICD, EMBLEM MRI S-ICD. 2008. https://www.bostonscientific.com/content/dam/Manuals/us/current-rev-en/359480-004_EMBLEM_S-ICD_UM_en-US_S.pdf Accessed August 30, 2022

Boston Scientific Corporation User’s Manual. 2019. https://www.bostonscientific.com/content/dam/Manuals/au/current-rev-en/359499-004_ICD_PTM_en-AUS_S.pdf Accessed August 30, 2022.

Boriani G., Ritter P., Biffi M., et al. Battery drain in daily practice and medium-term projections on longevity of cardioverter-defibrillators: an analysis from a remote monitoring database. Europace. 2016;18:1366–1373

Biffi M., Bongiorni M.G., D'Onofrio A., et al. Is 40 Joules enough to successfully defibrillate with subcutaneous implantable cardioverter-defibrillators? JACC Clin Electrophysiol. 2021;7:767–776

Rav Acha M., Milan D. Who should receive the subcutaneous implanted defibrillator?: timing is not right to replace the transvenous implantable cardioverter defibrillator. Circ Arrhythm Electrophysiol. 2013;6:1246–1251. discussion 1251

Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997;337:1576–1583

Bardy G.H., Lee K.L., Mark D.B., et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352:225–237

Connolly S.J., Hallstrom A.P., Cappato R., et al. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg. Canadian Implantable Defibrillator Study. Eur Heart J. 2000;21:2071–2078

Buxton A.E., Lee K.L., Fisher J.D., Josephson M.E., Prystowsky E.N., Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999;341:1882–1890

Kadish A., Dyer A., Daubert J.P., et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004;350:2151–2158

Lee D.S., Krahn A.D., Healey J.S., et al. Evaluation of early complications related to De Novo cardioverter defibrillator implantation insights from the Ontario ICD database. J Am Coll Cardiol. 2010;55:774–782

Reynolds M.R., Cohen D.J., Kugelmass A.D., et al. The frequency and incremental cost of major complications among medicare beneficiaries receiving implantable cardioverter-defibrillators. J Am Coll Cardiol. 2006;47:2493–2497

Steckman D.A., Varosy P.D., Parzynski C.S., et al. In-hospital complications associated with reoperations of implantable cardioverter defibrillators. Am J Cardiol. 2014;114:419–426

Koneru J.N., Jones P.W., Hammill E.F., Wold N., Ellenbogen K.A. Risk factors and temporal trends of complications associated with transvenous implantable cardiac defibrillator leads. J Am Heart Assoc. 2018;7

Ranasinghe I., Parzynski C.S., Freeman J.V., et al. Long-term risk for device-related complications and reoperations after implantable cardioverter-defibrillator implantation: an observational cohort study. Ann Intern Med. 2016;165:20–29.

Kleemann T., Becker T., Doenges K., et al. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 years. Circulation. 2007;115:2474–2480

Duray G.Z., Schmitt J., Cicek-Hartvig S., Hohnloser S.H., Israel C.W. Complications leading to surgical revision in implantable cardioverter defibrillator patients: comparison of patients with single-chamber, dual-chamber, and biventricular devices. Europace. 2009;11:297–302

Brouwer T.F., Yilmaz D., Lindeboom R., et al. Long-term clinical outcomes of subcutaneous versus transvenous implantable defibrillator therapy. J Am Coll Cardiol. 2016;68:2047–2055

Ezzat V.A., Lee V., Ahsan S., et al. A systematic review of ICD complications in randomised controlled trials versus registries: is our 'real-world' data an underestimation? Open Heart. 2015;2

Knops R.E., Olde Nordkamp L.R.A., Delnoy P.H.M., et al. Subcutaneous or transvenous defibrillator therapy. N Engl J Med. 2020;383:526–536

Olde Nordkamp L.R., Postema P.G., Knops R.E., et al. Implantable cardioverter-defibrillator harm in young patients with inherited arrhythmia syndromes: a systematic review and meta-analysis of inappropriate shocks and complications. Heart Rhythm. 2016;13:443–454

Russo A.M., Daugherty S.L., Masoudi F.A., Wang Y., Curtis J., Lampert R. Gender and outcomes after primary prevention implantable cardioverter-defibrillator implantation: findings from the National Cardiovascular Data Registry (NCDR) Am Heart J. 2015;170:330–338

Prutkin J.M., Reynolds M.R., Bao H., et al. Rates of and factors associated with infection in 200 909 Medicare implantable cardioverter-defibrillator implants: results from the National Cardiovascular Data Registry. Circulation. 2014;130:1037–1043

Olde Nordkamp L.R.A., Warnaars J.L.F., Kooiman K.M., et al. Which patients are not suitable for a subcutaneous ICD: incidence and predictors of failed QRS-T-wave morphology screening. J Cardiovasc Electrophysiol. 2014;25:494–499

Groh C.A., Sharma S., Pelchovitz D.J., et al. Use of an electrocardiographic screening tool to determine candidacy for a subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2014;11:1361–1366

Randles D.A., Hawkins N.M., Shaw M., Patwala A.Y., Pettit S.J., Wright D.J. How many patients fulfil the surface electrocardiogram criteria for subcutaneous implantable cardioverter-defibrillator implantation? Europace. 2014;16:1015–1021

Bardy G.H., Smith W.M., Hood M.A., et al. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010;363:36–44

Brouwer T.F., Miller M.A., Quast A.B., et al. Implantation of the subcutaneous implantable cardioverter-defibrillator: an evaluation of 4 implantation techniques. Circ Arrhythm Electrophysiol. 2017;10

Brouwer T.F., Driessen A.H.G., Olde Nordkamp L.R.A., et al. Surgical management of implantation-related complications of the subcutaneous implantable cardioverter-defibrillator. JACC Clin Electrophysiol. 2016;2:89–96

Smietana J., Frankel D.S., Serletti J.M., et al. Subserratus implantation of the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2021;18:1799–1804

Knops R.E., Olde Nordkamp L.R., de Groot J.R., Wilde A.A. Two-incision technique for implantation of the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2013;10:1240–1243

Heist E.K., Belalcazar A., Stahl W., Brouwer T.F., Knops R.E. Determinants of subcutaneous implantable cardioverter-defibrillator efficacy: a computer modeling study. JACC Clin Electrophysiol. 2017;3:405–414

Brisben A.J., Burke M.C., Knight B.P., et al. A new algorithm to reduce inappropriate therapy in the S-ICD system. J Cardiovasc Electrophysiol. 2015;26:417–423

Theuns D., Brouwer T.F., Jones P.W., et al. Prospective blinded evaluation of a novel sensing methodology designed to reduce inappropriate shocks by the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2018;15:1515–1522

Boersma L.V., El-Chami M.F., Bongiorni M.G., et al. Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): clinical characteristics and perioperative results. Heart Rhythm. 2019;16:1636–1644

Gold M.R., Lambiase P.D., El-Chami M.F., et al. Primary results from the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) trial. Circulation. 2021;143:7–17

Weiss R., Knight B.P., Gold M.R., et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013;128:944–953

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;70:830–841

Gold M.R., Aasbo J.D., El-Chami M.F., et al. Subcutaneous implantable cardioverter-defibrillator post-approval study: clinical characteristics and perioperative results. Heart Rhythm. 2017;14:1456–1463

Dabiri Abkenari L., Theuns D.A., Valk S.D., et al. Clinical experience with a novel subcutaneous implantable defibrillator system in a single center. Clin Res Cardiol. 2011;100:737–744

Lambiase P.D., Barr C., Theuns D.A., et al. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J. 2014;35:1657–1665

Burke M.C., Gold M.R., Knight B.P., et al. Safety and efficacy of the totally subcutaneous implantable defibrillator: 2-year results from a pooled analysis of the IDE study and EFFORTLESS registry. J Am Coll Cardiol. 2015;65:1605–1615

Priori S.G., Blomstrom-Lundqvist C., Mazzanti A., et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: the Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC) Eur Heart J. 2015;36:2793–2867

Al-Khatib S.M., Stevenson W.G., Ackerman M.J., et al. 2017 AHA/ACC/HRS Guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2018;72:e91. –e220

Kremers M.S., Hammill S.C., Berul C.I., et al. The National ICD Registry Report: version 2.1 including leads and pediatrics for years 2010 and 2011. Heart Rhythm. 2013;10:e59–e65

U.S. Food & Drug Administration Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures 2020. 2021. February 10, 2021. Accessed August 30, 2022

U.S. Food & Drug Administration Boston Scientific Corporation recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit. February 19, 2021. Accessed August 30, 2022

Friedman D.J., Parzynski C.S., Varosy P.D., et al. Trends and in-hospital outcomes associated with adoption of the subcutaneous implantable cardioverter defibrillator in the United States. JAMA Cardiol. 2016;1:900–911

Moss A.J., Schuger C., Beck C.A., et al. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012;367:2275–2283.

Poole J.E., Johnson G.W., Hellkamp A.S., et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008;359:1009–1017

van Rees J.B., Borleffs C.J., de Bie M.K., et al. Inappropriate implantable cardioverter-defibrillator shocks: incidence, predictors, and impact on mortality. J Am Coll Cardiol. 2011;57:556–562

Li A., Kaura A., Sunderland N., Dhillon P.S., Scott P.A. The significance of shocks in implantable cardioverter defibrillator recipients. Arrhythm Electrophysiol Rev. 2016;5:110–116

Basu-Ray I., Liu J., Jia X., et al. Subcutaneous versus transvenous implantable defibrillator therapy: a meta-analysis of case-control studies. JACC Clin Electrophysiol. 2017;3:1475–1483

Gold M.R., Theuns D.A., Knight B.P., et al. Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study. J Cardiovasc Electrophysiol. 2012;23:359–366

Mesquita J., Cavaco D., Ferreira A., et al. Effectiveness of subcutaneous implantable cardioverter-defibrillators and determinants of inappropriate shock delivery. Int J Cardiol. 2017;232:176–180

Healey J. Heart Rhythm Society; 2022. Subcutaneous versus transvenous defibrillators: the ATLAS trial. Late-Breaking Clinical Trials Session—LB-733 Randomized Clinical Trials. Heart Rhythm Society 2022 Annual Meeting, San Francisco, California, April 29–May 1, 2022

Olgun H., Karagoz T., Celiker A., Ceviz N. Patient- and lead-related factors affecting lead fracture in children with transvenous permanent pacemaker. Europace. 2008;10:844–847

Lee J.C., Shannon K., Boyle N.G., Klitzner T.S., Bersohn M.M. Evaluation of safety and efficacy of pacemaker and defibrillator implantation by axillary incision in pediatric patients. Pacing Clin Electrophysiol. 2004;27:304–307.

Fong K.Y., Ng C.J.R., Wang Y., Yeo C., Tan V.H. Subcutaneous versus transvenous implantable defibrillator therapy: a systematic review and meta-analysis of randomized trials and propensity score-matched studies. J Am Heart Assoc. 2022;11

Tjong F.V., Brouwer T.F., Smeding L., et al. Combined leadless pacemaker and subcutaneous implantable defibrillator therapy: feasibility, safety, and performance. Europace. 2016;18:1740–1747

Roger S., Borggrefe M., Kuschyk J. Heart failure with reduced ejection fraction and a narrow QRS complex: combination of a subcutaneous defibrillator with cardiac contractility modulation. J Atr Fibrillation. 2015;8:1081

Kuschyk J., Stach K., Tulumen E., et al. Subcutaneous implantable cardioverter-defibrillator: First single-center experience with other cardiac implantable electronic devices. Heart Rhythm. 2015;12:2230–2238

Sidhu B.S., Gould J., Porter B., et al. Completely leadless cardiac resynchronization defibrillator system. JACC Clin Electrophysiol. 2020;6:588–589

Elliott M.K., Sidhu B.S., Mehta V.S., Gould J., Martic D., Rinaldi C.A. The importance of leadless pacemaker positioning in relation to subcutaneous implantable cardioverter-defibrillator sensing in completely leadless cardiac resynchronization and defibrillation systems. HeartRhythm Case Rep. 2021;7:628–632

Boston Scientific Corporation Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing (MODULAR ATP) 2023. 2021. https://ClinicalTrials.gov/show/NCT04798768 Updated January 31, 2022. Accessed August 30, 2022.

Boston Scientific Corporation User’s Manual EMBLEM S-ICD, EMBLEM MRI S-ICD. 2008. https://www.bostonscientific.com/content/dam/Manuals/us/current-rev-en/359480-004_EMBLEM_S-ICD_UM_en-US_S.pdf Accessed August 30, 2022

Boston Scientific Corporation User’s Manual. 2019. https://www.bostonscientific.com/content/dam/Manuals/au/current-rev-en/359499-004_ICD_PTM_en-AUS_S.pdf Accessed August 30, 2022.

Boriani G., Ritter P., Biffi M., et al. Battery drain in daily practice and medium-term projections on longevity of cardioverter-defibrillators: an analysis from a remote monitoring database. Europace. 2016;18:1366–1373

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