Trial reportEuropean heart journal2022
Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial.
Trial report in European heart journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01296022 (Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator), which is not on this map. Cited by 48 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator (ICD) in Patients With a Class I or IIa Indication for ICD Without an Indication for Pacing
Who cites it
48 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Sudden cardiac death after myocardial infarction: individual participant data from pooled cohorts.European heart journal · 2024Pooled it
- Device-Related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-Term Follow-Up: The PRAETORIAN-XL Trial.Circulation · 2025Trial
- Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial.Circulation. Cardiovascular quality and outcomes · 2024Trial
- Diagnostic and Management Challenges in a Non-Infectious Pacemaker Pocket Swelling: A Case Report and Literature Review.Diagnostics (Basel, Switzerland) · 2026Article
- Similarities and Differences Between the Extravascular and the Subcutaneous Implantable Cardioverter-Defibrillator: Sensing, Discrimination, and Complications (Part 2).Current cardiology reports · 2026Review
- Refining risk stratification for primary prevention ICD therapy: Insights from cardiac MRI in the DO-IT registry.Heart rhythm O2 · 2026Article
- A Contemporary Review of Subcutaneous and Extravascular Implantable Cardiac Defibrillators.The Journal of innovations in cardiac rhythm management · 2026Review
- Efficacy and safety of the subcutaneous implantable cardioverter defibrillator in patients with and without obesity: An international, bicentric retrospective registry.Clinical research in cardiology : official journal of the German Cardiac Society · 2026Article
- Estimated longevity of contemporary subcutaneous implantable cardioverter-defibrillators: Multicenter real-world data.Heart rhythm O2 · 2026Article
- Infective Endocarditis After Arrythmia Device Implantation in Cardiac Surgery Patients.Journal of the American Heart Association · 2026Article
- The HONEST Cohort Study: Rationale and Design of a Nationwide Subcutaneous Implantable Cardioverter-Defibrillator Cohort.JACC. Advances · 2026Article
- Article
- 2023 European Society of Cardiology guidelines for the management of infective endocarditis : Statement of endorsement by the NVVC Full version.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2026Review
- Article
- 2023 European Society of Cardiology guidelines for the management of infective endocarditis : Statement of endorsement by the NVVC Short version.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2026Review
- A review of the extravascular implantable cardioverter-defibrillator system: technology, development, clinical outcomes, and global experience.Herzschrittmachertherapie & Elektrophysiologie · 2025Review
- [Subcutaneous defibrillator (S-ICD)].Herz · 2025Article
- Cardiac Implantable Electronic Device Placement in the Era of Transcatheter Tricuspid Replacement: Approaches and Challenges.The Journal of innovations in cardiac rhythm management · 2025Review
- Antithrombotic therapy and the risk of pocket hematoma after subcutaneous implantable cardioverter-defibrillator implantation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2025Article
- Long-term low-voltage impedance measurements in subcutaneous implantable cardioverter-defibrillators.Heart rhythm O2 · 2025Article
Corrections and comments
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Authors and funding
48 authors.
Funding
Abstract
backgroundThe 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
resultsThe 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).
conclusionThis 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.