Contemporary implantable cardiac device trials for sudden cardiac death and future guidelines: how can we shape the future?

Abstract

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.