ArticleHeart rhythm O22025
Pain after subcutaneous implantable cardioverter-defibrillator implantation: A secondary analysis of the PRAETORIAN-DFT trial.
Article in Heart rhythm O2, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03495297 (A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing), which is not on this map. Cited by 3 papers.
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The trial behind it
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A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing
Who cites it
3 citing papers in PubMed.
- Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT Trial.Circulation · 2026Trial
- Early complications and long-term outcomes of patients treated with a subcutaneous cardioverter-defibrillator: temporal trends and clinical implications of the anaesthetic strategies adopted at implant.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Observational
- Low defibrillation threshold in pediatric patients with subcutaneous implantable cardioverter defibrillator: Implications for a smaller generator?HeartRhythm case reports · 2026Article
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41 authors.
Funding
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Abstract
Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) overcomes transvenous lead-related complications. Its extrathoracic design results in a generator twice the size of transvenous ICDs. Objective: We investigated pain after S-ICD implantation and explore predictors for severe pain. Methods: The PRAETORIAN-DFT (PRospective randomized compArative trial of subcutanEous implanTable cardiOverter-defibrillatoR ImplANtation with and without DeFibrillation Testing) trial included 965 patients undergoing S-ICD implantation in 37 centers across Europe, the United States, and Israel. Pain was assessed using the numeric rating scale (NRS), ranging from no pain to unbearable pain. The NRS was measured before implantation, and 1 to 4 hours, 5 to 7 hours, 1 day, and 1 to 4 months after implantation. Two questions about implantation experience were asked at follow-up. Logistic regression analysis was used to identify predictors. Implanting physicians were asked their expectations on pain experience. Results: In the PRAETORIAN-DFT trial, 24% was female, mean age was 54 ± 14 years and 45% had ischemic cardiomyopathy. The median NRS within 1 day after implantation was 4. Pain was most frequently experienced at the pocket. There were 262 (29%) of 918 patients who reported severe pain (NRS ≥7) within 1 day after implantation. Predictors for severe pain were female sex (adjusted odds ratio [aOR] 2.23, Conclusion: In the period surrounding S-ICD implantation, attention should be paid to analgesia and expectation management in patients with longer procedure duration, severe pre-existing pain, and especially female sex.
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