Abstract
Abstract
Objective
Sudden unexpected death in epilepsy (SUDEP) is a leading cause of premature mortality in people with epilepsy, particularly in those with tonic–clonic seizures (TCSs), developmental and epileptic encephalopathies (DEEs), and drug‐resistant epilepsy. Although awareness of SUDEP has increased, major uncertainties remain regarding individualized risk stratification, mechanistic interpretation, and implementation of preventive strategies in routine care. This Italian expert consensus statement was developed to formalize a shared multidisciplinary position on SUDEP risk profiles, pathophysiological mechanisms, and preventive and therapeutic strategies.
Methods
The consensus was supported by a focused narrative appraisal of current evidence, rather than a systematic review, and developed through a structured multidisciplinary process based on a nominal group technique. The panel comprised 11 Italian experts: nine epileptologists from the Italian League Against Epilepsy (LICE) and its SUDEP Working Group, one cardiologist with expertise in epilepsy‐related cardiac complications and SUDEP, and one biomedical engineer with expertise in seizure‐detection devices and wearable technologies. Statements were generated across three macro‐areas, discussed in working groups and plenary sessions, prioritized through an initial in‐person vote, refined after discussion, and submitted to a second online round. Consensus was predefined as at least 75% agreement on a 5‐point Likert scale.
Results
A final set of 33 statements was generated, of which 26 reached consensus; two of these (serotonergic modulation as a preventive strategy and fenfluramine's mechanisms beyond seizure control) reached the threshold only narrowly and are discussed as hypothesis‐generating rather than as established clinical guidance. The resulting framework supports an extension of seizure‐centered prevention toward an integrated, individualized, and mechanism‐informed approach, in which reduction of convulsive seizure burden remains central while post‐ictal respiratory, autonomic, cardiac, arousal, genetic, and treatment‐related vulnerabilities are considered in selected high‐risk patients.
Significance
This consensus provides the first formalized Italian multidisciplinary position on SUDEP, offering an evidence‐informed and mechanism‐aware framework intended to support more consistent risk communication, individualized risk stratification, and preventive care in clinical practice.
Plain Language Summary
Sudden unexpected death in epilepsy (SUDEP) is uncommon but is more likely in people with frequent tonic–clonic seizures and some severe epilepsy syndromes. An Italian multidisciplinary expert panel developed consensus statements on SUDEP risk, possible mechanisms, monitoring, and prevention. Reducing convulsive seizures and supporting treatment adherence remain the main preventive priorities; SUDEP information should be offered broadly, while counseling and additional measures should be tailored to individual risk. These statements reflect expert agreement and available evidence and are not formal clinical practice guidelines.