BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. METHODS AND RESULTS: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). CONCLUSION: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.

1st Department of Medicine University Medical Center Mannheim Mannheim Germany

Amsterdam UMC location University of Amsterdam Heart Center Department of Cardiology Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias Meibergdreef 9 1105 AZ Amsterdam the Netherlands

Cardiac Electrophysiology Division Department of Medicine Englewood Hospital and Medical Center Englewood NJ United States

Center for Arrhythmia Care Heart and Vascular Institute University of Chicago Pritzker School of Medicine Chicago IL United States

CorVita Science Foundation Chicago IL United States

Department of Cardiology Amphia Hospital Breda the Netherlands

Department of Cardiology and Amsterdam Cardiovascular Sciences Amsterdam UMC Location VUMC Amsterdam The Netherlands

Department of Cardiology Cardiovascular Research Institute Maastricht Maastricht University Medical Center Maastricht the Netherlands

Department of Cardiology Flevoziekenhuis Almere the Netherlands

Department of Cardiology Homolka Hospital Prague Czech Republic

Department of Cardiology Isala Heart Centre Zwolle The Netherlands

Department of Cardiology OLVG Amsterdam Netherlands

Department of Cardiology Radboud University Medical Center Nijmegen the Netherlands

Department of Cardiology St Antonius Hospital Nieuwegein The Netherlands

Department of Cardiology Tergooi MC Blaricum The Netherlands

Department of Cardiology The Heart Centre Rigshospitalet University of Copenhagen Copenhagen Denmark

Department of Electrophysiology Catharina Hospital Eindhoven Eindhoven the Netherlands

Department of Electrophysiology Heart Center at University of Leipzig Leipzig Germany

Department of Internal Medicine 1 Jena University Hospital Jena Germany

Department of Medicine 1 Ludwig Maximillians University Hospital München Germany

Department of Medicine Cardiology Columbia University Irving Medical Center New York NY United States

Division of Cardiology Northwestern Memorial Hospital Northwestern University Chicago IL United States

Division of Cardiology Section of Electrophysiology Emory University Atlanta GA United States

Division of Cardiovascular Medicine College of Medicine The Ohio State University Columbus OH United States

European Reference Network for rare low prevalence and complex diseases of the heart ERN GUARD Heart

German Center for Cardiovascular Research Munich Heart Alliance Munich Germany

German Center for Cardiovascular Research Partner Site Heidelberg Mannheim Germany

Heart Surgery Heart Center Dresden Carl Gustav Carus Medical Faculty Dresden University of Technology Dresden Germany

Icahn School of Medicine at Mount Sinai Mount Sinaï Hospital New York NY United States

Klinik für Innere Medizin 3 Schwerpunkt Kardiologie und Angiologie Universitätsklinikum Schleswig Holstein Campus Kiel Kiel Germany

Liverpool Heart and Chest Hospital Liverpool United Kingdom

Medical Spectrum Twente Enschede the Netherlands

Medisch Centrum Leeuwarden Leeuwarden The Netherlands

National Heart and Lung Institute Imperial College London London United Kingdom

Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services University College London and Barts Heart Centre London United Kingdom

Oxford Biomedical Research Centre Oxford University Hospitals NHS Trust Oxford United Kingdom

St George's University hospitals NHS Foundation Trust London United Kingdom

St George's University of London London United Kingdom

The Valley Health System Ridgewood NJ United States

University and University Hospital Würzburg Würzburg Germany

Werkgroep Cardiologische Centra Nederland Utrecht the Netherlands

Eur Heart J. 2022 Dec 14;43(47):4884-4886. doi: 10.1093/eurheartj/ehac652. PubMed

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Tarakji KG, Wazni OM, Harb S, et al. . Risk factors for 1-year mortality among patients with cardiac implantable electronic device infection undergoing transvenous lead extraction: the impact of the infection type and the presence of vegetation on survival. Europace 2014;16:1490–1495. PubMed

Sohail MR, Uslan DZ, Khan AH, et al. . Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol 2007;49:1851–1859. PubMed

Moss AJ, Zareba W, Hall WJ, et al. . Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346:877–883. PubMed

Bardy GH, Lee KL, Mark DB, et al. . Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:225–237. PubMed

Koneru JN, Jones PW, Hammill EF, et al. . Risk factors and temporal trends of complications associated with transvenous implantable cardiac defibrillator leads. J Am Heart Assoc 2018;7:e007691. PubMed PMC

Bardy GH, Smith WM, Hood MA, et al. . An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med 2010;363:36–44. PubMed

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

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. PubMed

Gold MR, Lambiase PD, El-Chami MF, 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. PubMed PMC

Burke MC, Aasbo JD, El-Chami MF, et al. . 1-Year Prospective evaluation of clinical outcomes and shocks: the subcutaneous ICD post approval study. JACC Clin Electrophysiol 2020;6:1537–1550. PubMed

Lambiase PD, Theuns DA, Murgatroyd F, et al. . Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study. Eur Heart J 2022;43:2037–2050. PubMed PMC

Ranasinghe I, Parzynski CS, Freeman JV, 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. PubMed

Palmisano P, Ziacchi M, Ammendola E, et al. . Rate and impact on patient outcome and healthcare utilization of complications requiring surgical revision: subcutaneous versus transvenous implantable defibrillator therapy. J Cardiovasc Electrophysiol 2021;32:1712–1723. PubMed

Knops RE, Nordkamp L, Delnoy P, et al. . Subcutaneous or transvenous defibrillator therapy. N Engl J Med 2020;383:526–536. PubMed

Olde Nordkamp LR, Knops RE, Bardy GH, et al. . Rationale and design of the PRAETORIAN trial: a prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy. Am Heart J 2012;163:753–760.e2. PubMed

Singer M, Deutschman CS, Seymour CW, et al. . The third international consensus definitions for sepsis and septic shock (sepsis-3). JAMA 2016;315:801–810. PubMed PMC

Birnie DH, Healey JS, Wells GA, et al. . Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med 2013;368:2084–2093. PubMed

Sheldon SH, Cunnane R, Lavu M, et al. . Perioperative hematoma with subcutaneous ICD implantation: impact of anticoagulation and antiplatelet therapies. Pacing Clin Electrophysiol 2018;41:799–806. PubMed

Knops RE, Brouwer TF, Barr CS, et al. . The learning curve associated with the introduction of the subcutaneous implantable defibrillator. Europace 2016;18:1010–1015. PubMed PMC

van der Stuijt W, Quast ABE, Baalman SWE, et al. . Complications related to elective generator replacement of the subcutaneous implantable defibrillator. Europace 2021;23:395–399. PubMed PMC

Brouwer TF, Driessen AHG, Olde Nordkamp LRA, et al. . Surgical management of implantation-related complications of the subcutaneous implantable cardioverter-defibrillator. JACC Clin Electrophysiol 2016;2:89–96. PubMed

Rordorf R, Casula M, Pezza L, et al. . Subcutaneous versus transvenous implantable defibrillator: an updated meta-analysis. Heart Rhythm 2021;18:382–391. PubMed

Fong KY, Ng CJR, Wang Y, et al. . 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:e024756. PubMed PMC

Healey J. The ATLAS trial: avoid transvenous leads in appropriate subjects. HRS 2022; April 30, 2022; San Francisco, CA2022.

Kirkfeldt RE, Johansen JB, Nohr EA, et al. . Risk factors for lead complications in cardiac pacing: a population-based cohort study of 28,860 danish patients. Heart Rhythm 2011;8:1622–1628. PubMed

Boston Scientific. Important medical device advisory: Boston Scientific; Decemebr 2020 [Available from: https://www.bostonscientific.com/content/dam/bostonscientific/quality/dlt/reg-code-228/2020Dec_BSC_EmblemElectrode3501_PhysLtr_Final.pdf.

Köbe J, Wasmer K, Andresen D, et al. . Impact of atrial fibrillation on early complications and one year-survival after cardioverter defibrillator implantation: results from the German DEVICE registry. Int J Cardiol 2013;168:4184–4190. PubMed

Brouwer TF, Knops RE, Kutyifa V, et al. . Propensity score matched comparison of subcutaneous and transvenous implantable cardioverter-defibrillator therapy in the SIMPLE and EFFORTLESS studies. Europace 2018;20:F240–F2F8. PubMed

Kirkfeldt RE, Johansen JB, Nohr EA, et al. . Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J 2014;35:1186–1194. PubMed PMC

Quast A, Baalman SWE, Brouwer TF, et al. . A novel tool to evaluate the implant position and predict defibrillation success of the subcutaneous implantable cardioverter-defibrillator: the PRAETORIAN score. Heart Rhythm 2019;16:403–410. PubMed

Tjong FVY, Koop BE. The modular cardiac rhythm management system: the EMPOWER leadless pacemaker and the EMBLEM subcutaneous ICD. Herzschrittmacherther Elektrophysiol 2018;29:355–361. PubMed PMC

Priori SG, Blomström-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. PubMed

Device-Related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-Term Follow-Up: The PRAETORIAN-XL Trial

Sudden cardiac death after myocardial infarction: individual participant data from pooled cohorts

Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial