Comparing the Feasibility of S-Patch vs 24-Hour Holter in Frail Older People With Falls: Randomized Open-Label Crossover Pilot Study.

Background: Falls commonly cause injuries in older adults and can present with syncope or presyncope. Typically, frail older adults with cognitive impairment are underrepresented in research and experience difficulty tolerating conventional ECG monitoring devices. S-Patch is a novel, lightweight dual-lead device designed to provide continuous ECG monitoring for up to 72 hours with minimal interference to daily activities. Objective: This study aimed primarily to evaluate the feasibility, tolerability, and adherence of the S-Patch compared with standard 24-hour Holter monitoring in older adults (aged ≥60 years) presenting with unwitnessed falls, syncope, or near-syncope, as assessed by wear duration, completion rates, and patient-reported experience. The secondary objective of this study was to assess device usability and compare arrhythmia detection rates between the devices in a real-world setting. Methods: This prospective, single-center, randomized, open-label, crossover feasibility pilot study was conducted from March 8, 2020, to February 28, 2023. Participants were randomized 1:1 into group A (Holter followed by S-Patch) or group B (S-Patch followed by Holter), enabling up to 4 days of continuous monitoring. Results: Seventy patients were enrolled, of whom 32 (45.7%) had cognitive impairment, and the majority were frail. Group A participants were older (86.9 vs 82.9 years) with higher use of dementia medications (6/35, 17.1% vs 3/35, 8.6%). Frailty was highly prevalent across the cohort, and fear of falling was significantly greater among frail patients (P=.04). Both devices were well tolerated, with no difference in overall device preference, but S-Patch enabled substantially longer monitoring durations compared to Holter. Mean S-Patch wear time exceeded 60 hours and was significantly longer when the device was applied first (68.8 vs 62.9 h; P=.04), suggesting acceptance and adherence. Importantly, tolerability was maintained in frail patients with cognitive impairment. Arrhythmia detection rates were observed as comparable, with both devices identifying one clinically significant arrhythmia, resulting in pacemaker implantation. Conclusions: S-Patch is a feasible, well-tolerated cardiac monitoring device in frail older adults and those with cognitive impairment. Compared with Holter, S-Patch supported longer continuous monitoring without compromising patient acceptability, an important consideration in real-world clinical practice.