PATCH (Preferred Attachment Strategy for Optimal Electrocardiograms)-1 Study.

Area of Science:

• Cardiology
• Medical Devices
• Clinical Diagnostics

Background:

• Standard 12-lead electrocardiography (ECG) is crucial but prone to baseline artifacts and lead placement errors.
• These common issues can impact diagnostic accuracy and treatment decisions in cardiovascular care.

Purpose of the Study:

• To compare a novel patch ECG (P-ECG) with the standard ECG (S-ECG) in patients with stable cardiovascular disease.
• To evaluate P-ECG's performance, patient preference, and artifact incidence in an ambulatory setting.

Main Methods:

• The PATCH-1 study involved 200 patients with cardiovascular conditions undergoing both S-ECG and P-ECG.
• A P-ECG device with pre-positioned electrodes was compared against the traditional S-ECG method.
• ECGs were interpreted by cardiologists blinded to the ECG method used.

Main Results:

• P-ECG acquisition was significantly faster (1.4 min vs. 2.4 min, p<0.001).
• Fewer interpretable baseline artifacts were observed with P-ECG (6.5%) compared to S-ECG (15.0%, p=0.006).
• Patient preference favored P-ECG or showed no preference; key ECG parameters were comparable between methods.

Conclusions:

• The patch ECG is a preferred, rapid, and reproducible method for electrocardiography in stable cardiovascular disease patients.
• P-ECG demonstrates reduced baseline artifacts, enhancing interpretability in ambulatory clinic settings.
• The findings support P-ECG as a viable alternative to standard ECG, improving efficiency and patient experience.