Continuous cardiac monitoring in epilepsy: an implantable loop manual activation algorithm for improving ECG signal acquisition accuracy.

BACKGROUND: The muscle artifacts, caused by prominent muscle contractions, mimicking cardiac arrhythmias, might compromise the ECG signal quality and the implantable loop recorder memory capacity in patients with epilepsy. We developed an epileptic seizures clinical pattern-based implantable loop recorder manual activation algorithm, presenting its real-world efficacy here. METHODS: One hundred ninety-three patients (18-60 years) with drug-resistant focal epilepsy were consecutively enrolled and underwent a subcutaneous loop recorder implantation. Patients with focal onset-aware seizures and patients with focal impaired awareness seizures /bilateral tonic-clonic seizures without aura were recommended to use the activator once - just after the episode. Patients with focal impaired awareness seizures/bilateral tonic-clonic seizures with aura, the caregivers of patients experiencing status epilepticus, were advised to use the activator twice - during the aura and after the episode/ regaining consciousness. RESULTS: Six thousand four hundred ninety-four ECG traces (4826 - auto-triggered events, 1668 - person-activated events) were recorded and analyzed. The rate of true positive events in the person-activated group was statistically higher than in the autoactivation group (72.5% vs.19.4%, p < 0.0001). Person-activated false-positive events were observed in 30.5% of patients with focal impaired awareness seizures and 27.7% in patients with bilateral tonic-clonic seizures. The highest rate of false-positive events (61.5%) was detected in patients undergoing epileptic status, and the lowest rate (3.8%) - was in patients with focal onset aware seizures. The rate of false-positive events was significantly higher in patients with impaired awareness seizures without aura both in focal impaired awareness (45.5% vs. 19.3%, p < 0.0001) and bilateral tonic-clonic seizure groups (38.8% vs. 5.9%, p < 0.0001). CONCLUSIONS: Arrhythmias with varying clinical outcomes are expected in epilepsy patients and have been monitored continuously. The specified loop recorder external activation algorithm can improve the clinically relevant cardiac arrhythmia detection accuracy in epilepsy patients and the value of future studies.

Cardiac arrhythmias and sudden unexpected death in epilepsy: Results of long-term monitoring.

BACKGROUND: Cardiac rhythm and conduction disorders are common in patients with epilepsy and are presumably one of the leading causes of sudden unexpected death. There are only a few published reports on ictal cardiac arrhythmias detected by continuous monitoring, and the majority had a small sample size. OBJECTIVE: The aim of this study was to evaluate the frequency and type of cardiac arrhythmias recorded by an implantable loop recorder in patients with drug-resistant epilepsy. METHODS: We implanted a subcutaneous loop recorder to 193 patients with drug-resistant epilepsy. Automatic triggers to initiate cardiac rhythm recording were cardiac pauses of >3 seconds and any episodes of bradycardia (≤45 beats/min) or tachycardia (≥150 beats/min). Patients/relatives were instructed to begin peri-ictal rhythm recording by using an external activator device. The follow-up duration was 36 months, with scheduled follow-up visits every 3 months. RESULTS: A total of 6494 electrocardiogram traces were recorded during the median follow-up of 36 months (interquartile range 3-36 months). Ictal heart rhythm and rate changes were detected in 143 patients (74%). The most common finding was ictal sinus tachycardia (66.8%). Sinus bradycardia was observed in 13 patients (6.7%). Three patients had clinically relevant cardiac pauses of >6 seconds, requiring permanent pacemaker implantation. Five patients (2.6%) died suddenly. CONCLUSION: Ictal heart rhythm and rate changes occur in most of the patients with drug-resistant epilepsy. Clinically relevant cardiac events, related to ictal and postictal periods, are rare. No potentially malignant arrhythmias were detected in patients who died suddenly during the preceding follow-up period.

A retrospective, multicentre study of perampanel given as monotherapy in routine clinical care in people with epilepsy.

PURPOSE: Perampanel is approved for adjunctive treatment of focal seizures, with or without secondarily generalised seizures, and for primary generalised tonic-clonic seizures in people with epilepsy aged ≥12 years. Perampanel was recently approved for monotherapy use for partial seizures in the United States. This study provides insight into the feasibility of perampanel monotherapy in real-world settings. METHODS: This retrospective, non-interventional, multicentre study (NCT02736162) was conducted between January 2013 and March 2016 in specialist epilepsy centres in Europe and Russia. Eligible individuals had a diagnosis of epilepsy and received perampanel primary or secondary monotherapy as routine clinical care. The primary endpoint was proportion of individuals remaining on perampanel monotherapy, after conversion from perampanel adjunctive treatment, at 3, 6, 12, 18 and 24 months (retention rate). RESULTS: Sixty individuals were in the safety set (female, 63%; white, 97%; aged 18 to <65 years, 73%). Most (85%) received secondary monotherapy with perampanel. At study cut-off, 68% of individuals were continuing on perampanel monotherapy (secondary monotherapy: 55%). The median duration of retention was not calculable due to the high number of individuals ongoing on monotherapy. Twelve individuals had treatment-emergent adverse events that started during perampanel monotherapy, the most frequent was dizziness (5%). One serious treatment-emergent adverse event was reported (pneumonia during adjunctive perampanel treatment). CONCLUSIONS: In this small retrospective study of individuals who received perampanel monotherapy, the majority maintained monotherapy. Perampanel monotherapy may be an achievable option in some people with epilepsy.