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Contemporary implantable cardiac device trials for sudden cardiac death and future guidelines: how can we shape the
Fabian Fastenrath1, Katherine Sattler1, Daniel Duerschmied1
1Section for Invasive Cardiology and Electrophysiology, I. Medical Department, Cardiology, Hemostasiology and Intensive Care, University Medical Centre Mannheim, Mannheim, Germany.
Insights
Sudden cardiac death prevention needs updated implantable cardioverter-defibrillator (ICD) guidelines. Current recommendations, based on ejection fraction, are outdated; future strategies require multimodal risk assessment and personalized device selection.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Trials
Background:
- Sudden cardiac death (SCD) remains a significant cause of mortality.
- Current implantable cardioverter-defibrillator (ICD) guidelines, primarily based on left ventricular ejection fraction (LVEF), may not reflect current patient demographics or treatments.
- Advances in heart failure management and arrhythmia prevention have occurred.
Purpose of the Study:
- To critically review the historical and current evidence supporting ICD recommendations.
- To explore evolving factors influencing ICD efficacy, including background therapies, non-arrhythmic death risks, device technology, and risk stratification.
- To propose a future framework for ICD trials and guideline development.
Main Methods:
- Review of ICD trials cited in major international guidelines.
- Supplemented by a targeted PubMed literature search (through September 2025) using relevant ICD keywords.
- Emphasis on emerging technologies like cardiac MRI, genomics, AI, remote monitoring, and modular systems.
Main Results:
- Existing ICD guidelines may be based on outdated evidence.
- Contemporary patient populations and therapies necessitate a re-evaluation of ICD indications.
- Emerging technologies offer new avenues for risk stratification and personalized treatment.
Conclusions:
- A paradigm shift is needed for SCD prevention, moving towards individualized, digitally supported, and modular approaches.
- Future ICD trials should incorporate multimodal risk assessment, competing-risk adjusted endpoints, and adaptive designs.
- Guidelines should evolve to include enriched patient phenotyping, precision risk prediction, and personalized device selection.
Introduction:
Sudden cardiac death (SCD) remains a major cause of mortality despite substantial progress in heart failure management and arrhythmia prevention. Current implantable cardioverter-defibrillator (ICD) guideline recommendations, mainly based on left ventricular ejection fraction (LVEF), are largely derived from historical trials and may no longer reflect contemporary patient populations or therapies.
Areas Covered:
This review critically appraises the historical and contemporary ICD evidence base with particular attention to evolving background therapy, competing risks of non-arrhythmic death, device technology, and modern risk stratification strategies. ICD trials cited in major international guidelines were reviewed and supplemented by a targeted PubMed literature search using ICD-related keywords, including relevant publications through September 2025. We emphasize emerging tools such as cardiac magnetic-resonance-imaging, genomics, artificial intelligence, remote monitoring data, and modular cardiac rhythm management systems.
Expert Opinion:
We propose a future ICD trial framework grounded in multimodal risk assessment, competing-risk-adjusted endpoints, pragmatic and adaptive trial designs, and device-specific evaluation pathways. We further outline how future guidelines may evolve to incorporate enriched patient phenotyping, precision risk prediction, and personalized device selection. Together, these developments signal a paradigm shift toward an individualized, digitally supported, and modular approach to SCD prevention in the next decade.
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