Comparing the Feasibility of S-Patch vs 24-Hour Holter in Frail Older People With Falls: Randomized Open-Label Crossover Pilot Study.
Barbara Rosario, Vern Hsen Tan, Vivian Cantiller Barrera and 3 others
A pilot study in 70 frail older adults with falls found a wearable heart-rhythm patch was as well tolerated as a standard Holter monitor and allowed longer recording, but neither device detected more arrhythmias than the other.
It does not yet prove diagnostic equivalence.
Key findings
1Both devices were well tolerated. The S-Patch was worn for a mean of 68.8 hours when it was the first device versus 62.9 hours when it was the second (P = .04). Holter wear time was similar in both groups (about 22.5 hours). Patient preference did not differ significantly between the two groups (P = .36).
2Arrhythmia detection did not differ significantly between the two devices (McNemar P = .21). Using Holter as the reference, S-Patch sensitivity was 40% and specificity was 82.2%. One clinically significant arrhythmia (sinus arrest with a long pause) was detected by both devices and led to a pacemaker recommendation.
345.7% of participants (32 of 70) had dementia or cognitive impairment, and 81.4% (57 of 70) were classified as frail on the Clinical Frailty Scale.
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What it does not show
The study recruited 73 of the 116 patients it was powered for, so it is underpowered and more likely to miss a real difference between the devices. The crossover design means the two devices were worn on different days, so arrhythmias that are intermittent may have been present during one window and absent during the other, making it hard to tell whether a difference is due to the device or to timing. Most monitoring was done during hospitalisation rather than at home, because most patients declined home monitoring, so the results may not reflect real-world use in the community. The study was open-label and single-centre; blinding was not possible because the two devices look and feel different. The sequential design makes a direct head-to-head comparison of diagnostic accuracy inherently problematic, as the authors themselves note. Recruitment was hampered by the pandemic, patient reluctance (especially those with dementia), and a period when the S-Patch was being upgraded.
Declared interests
Funded by the Changi General Hospital Research Grant (CHF2019.05-P). No conflicts of interest were declared by the authors.
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