Available online 5 March 2023

Author links open overlay panel, , , , , , , , , , , AbstractBackground

A smartphone 12-Lead ECG that enables layman ECG screening is still lacking. We aimed to validate D-Heart ECG device, a smartphone 8/12 Lead electrocardiograph with an image processing algorithm to guide secure electrode placement by non-professional users.

Methods

One-hundred-fourty-five patients with HCM were enrolled. Two uncovered chest images were acquired using the smartphone camera. An image with virtual electrodes placement by imaging processing algorithm software was compared to the ‘gold standard’ electrode placement by a doctor. D-Heart 8 and 12-Lead ECG were obtained, immediately followed by 12‑lead ECGs and were assessed by 2 independent observers. Burden of ECG abnormalities was defined by a score based on the sum of 9 criteria, identifying four classes of increasing severity.

Results

A total of 87(60%) patients presented a normal/mildly abnormal ECG, whereas 58(40%) had moderate or severe ECG alteration. Eight(6%) patients had ≥1 misplaced electrode. D-Heart 8-Lead and 12‑lead ECGs concordance according to Cohen's weighted kappa test was 0,948 (p < 0,001, agreement of 97.93%). Concordance was high for the Romhilt–Estes score (kw = 0,912; p < 0.01). Concordance between D-Heart 12-Lead ECG and standard 12-Lead ECG was perfect (kw = 1). PR and QRS intervals measurements comparison with Bland-Altman method showed good accuracy (95% limit of agreement ±18 ms for PR and ± 9 ms for QRS).

Conclusions

D-Heart 8/12-Lead ECGs proved accurate, allowing an assessment of ECG abnormalities comparable to the standard 12‑lead ECG in patients with HCM. The image processing algorithm provided accurate electrode placement, standardizing exam quality, potentially opening perspectives for layman ECG screening campaigns.

Section snippetsMethods

Consecutive patients with a diagnosis of HCM referred for outpatient evaluation at a referral national institution for cardiomyopathies were enrolled. All patients were older than 18 years old. Patients with paced ventricular rhythm at the time of the ECG were excluded from the study. Informed written consent for the study participation and the publication of the images was acquired for each patient. The study was approved by the local ethics committee (Comitato Etico Area Vasta Centro Toscano,

Clinical and echocardiographic profile

The 145 consecutive HCM study patients were 51 ± 16 years old, and 90 (62%) were males. Mean BMI was 23 ± 4 (19 to 28) kg/m2, 125 patients were asymptomatic or had mild symptoms (86%, in NYHA class I-II), 41 (28%) had LV outflow obstruction >30 mmHg at rest and 32 (22%) had atrial fibrillation (AF) (Table 1). Syncope had occurred in 13 (9%) and 19 (13%) had a history of non-sustained ventricular tachycardia (NSVT). Mean Left atrial (LA) diameter was 40 ± 6 mm, with a mean Left Ventricular

Discussion

Despite the many ways in which telemedicine is transforming healthcare, mHealth faces a number of major challenges. Specifically, the validation of novel technologies represents a critical step in our understanding of whether they can substitute or implement current methodologies [11,12]. With this aim, we assessed the accuracy of the D-Heart 8/12-Lead electrocardiograph, demonstrating that tracings obtained from smartphones may compare favorably with the current gold standard 12‑lead in

Conclusions

D-Heart 8/12-Lead ECGs proved accurate, allowing a stratification of ECG abnormalities comparable to the standard 12‑lead ECG in a patient with HCM, characterized by high prevalence of abnormal ECGs. The image processing algorithm guided the users to accurate electrode placement, standardizing the exam quality. Novel smartphone-based techniques open promising perspectives for low-cost cardiovascular screening programs. Further studies are clearly needed to assess whether such technologies would

Author contribution

NM, CF, AF, MT were involved in patient enrollment, data acquisition and analysis. NM, FC, NM, IO were responsible for project design. IS, HL were involved in the statistical analysis. PM, OM, IO, FC, NM gave critical revision to the manuscript.

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© 2023 Published by Elsevier Inc.