Effectiveness of 6-lead consumer-grade ECG monitoring on the detection of newly diagnosed arrhythmias in patients taking proarrhythmic medications: an interim analysis
K H Lee, S J Eom, H J Ahn, S H Joo, M O Chang, Y Y Na, H J Seo, Y H Lee, C H KimAbstract
Introduction
Medications with proarrhythmic potential, such as certain anticancer agents and antiarrhythmics, can induce or exacerbate arrhythmias. Consequently, continuous cardiac monitoring is advisable for patients receiving these drugs. Contemporary consumer-grade handheld electrocardiogram (ECG) monitoring devices now facilitate rhythm detection within a patient's daily environment.
Purpose
This study aimed to compare the detection rates of newly diagnosed arrhythmias between a handheld 6-lead ECG monitoring group and a standard care group.
Methods
This prospective randomised clinical trial, conducted across three tertiary hospitals was planned to recruit 600 participants from March 2024. Participants receiving arrhythmogenic medications were randomly assigned to either the ECG monitoring or the standard care arm. Over a study period of 3 (±1) months, the ECG monitoring participants were instructed to record a 30-second, 6-lead ECG at least once per week or whenever symptomatic. Both groups underwent a mandatory 6-lead ECG recording at enrolment and at the final follow-up visit; otherwise, the standard care group received no study-related procedures. The primary endpoint was the detection rate of newly diagnosed arrhythmias, defined by the new occurrence of (1) atrial fibrillation or flutter (AF), premature atrial/ventricular contraction or other rhythm disorders; (2) bradycardia (<50 bpm) or tachycardia (>100 bpm); (3) prolonged absolute intervals (PR > 200ms, QRS >140ms, QTcmale > 440ms, QTcfemale > 450ms); or (4) a significant relative change from baseline (PR or QRS > 25% increase, or QTc > 20ms increase). Detection rates were compared between the two groups using a per-protocol analysis.
Results
A total of 272 participants were enrolled in the ECG monitoring group and 277 in the standard care group. Out of the analysed cohort, 45 were cancer patients, 468 were arrhythmia patients, and 13 had both conditions. During a mean follow-up of 102.4 days, a mean of 61 times of 6-lead ECG recordings was taken per participant in the ECG monitoring group. 236 ECG monitoring (236/256, 92.2%) and 91 standard care (91/270, 33.7%) participants were newly diagnosed with arrhythmias confirmed by the two electrophysiologists (p <0.001) (Table 1). Nine ECG monitoring participants and one standard care participant were diagnosed with AF (3.52% vs. 0.3%, p<0.001). Specifically, QTc prolongation was highly detected in the ECG monitoring group compared to the standard care group (112/256 [43.8%] vs. 11/270 [4.1%], p <0.001).
Conclusion
Monitoring patients on arrhythmogenic medications was significantly more effective at detecting new arrhythmias than standard care, particularly concerning AF and QTc interval prolongation. Participants in the ECG monitoring group successfully monitored their cardiac status in daily life, leading to the timely detection of potential arrhythmias and subsequent medical evaluation.