Feasibility of a Palm-sized Visualized Phonocardiogram Device for Screening Valvular Heart Disease in Community-dwelling Adults: A Study Protocol Based on the Nagasaki Islands Study

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BACKGROUND: Early diagnosis of valvular heart disease is critical. Recently, a palm-sized visualized phonocardiogram device (AMI-SSS01) equipped with artificial intelligence was developed.

METHODS: We initiated a three-year prospective cohort study in fiscal year 2024 (April 2024 to March 2025) to evaluate the feasibility of this method in a health checkup setting, including the completion rate and safety of phonocardiography. We collected phonocardiogram and bipolar single-lead electrocardiogram data, along with artificial intelligence-based assessments, using the AMI-SSS01. Outcomes were categorized as no abnormality, mild abnormality, requiring further examination, or requiring continued medical follow-up, based on AI/staff assessments and participants’ self-reported cardiac history. Participants requiring further examination were referred to a hospital for echocardiography. This report summarizes the findings obtained during fiscal year 2024.

RESULTS: A total of 342 participants (43.6% men; mean age, 68.7 years) underwent phonocardiography without difficulties in device attachment, device malfunction, or adverse events, including contact dermatitis. Two participants were categorized as “requiring continued medical follow-up,” both of whom self-reported aortic stenosis. Twenty-three participants, who were generally older, were categorized as “requiring further examination,” and 11 of them underwent echocardiography. Among these, the artificial intelligence correctly identified all four diagnosed cases (one case each of moderate aortic stenosis, moderate mitral regurgitation, severe aortic regurgitation, and mild-to-moderate aortic regurgitation) as moderate or severe valvular heart diseases.

CONCLUSIONS: Phonocardiographic screening using this device is technically feasible in a health checkup setting. Artificial intelligence-based assessments may aid in identifying individuals who are likely to have clinically significant valvular heart diseases.