AI-Guided Screening with Digital Stethoscope Doubles Detection of Peripartum Cardiomyopathy
A pragmatic randomized trial across six Nigerian hospitals found that AI-guided screening using a digital stethoscope significantly improved detection of left ventricular systolic dysfunction in pregnant and postpartum women, identifying 4.1% versus 2.0% of cases compared to standard care. The AI-enabled digital stethoscope met the primary endpoint with an odds ratio of 2.12, while the 12-lead AI-ECG approach showed a similar trend without reaching significance. These findings demonstrate the potential of AI-powered point-of-care diagnostics to address a major cause of maternal mortality in resource-limited settings.
The original study
Artificial intelligence guided screening for cardiomyopathies in an obstetric population: a pragmatic randomized clinical trial.
- Authors
- Adedinsewo DA, Morales-Lara AC, Afolabi BB, Kushimo OA, Mbakwem AC, Ibiyemi KF, et al.
- Journal
- Nature medicine
- Type
- Journal Article, Randomized Controlled Trial, Pragmatic Clinical Trial
- PMID
- 39223284
Original abstract
Nigeria has the highest reported incidence of peripartum cardiomyopathy worldwide. This open-label, pragmatic clinical trial randomized pregnant and postpartum women to usual care or artificial intelligence (AI)-guided screening to assess its impact on the diagnosis left ventricular systolic dysfunction (LVSD) in the perinatal period. The study intervention included digital stethoscope recordings with point of-care AI predictions and a 12-lead electrocardiogram with asynchronous AI predictions for LVSD. The primary end point was identification of LVSD during the study period. In the intervention arm, the primary end point was defined as the number of identified participants with LVSD as determined by a positive AI screen, confirmed by echocardiography. In the control arm, this was the number of participants with clinical recognition and documentation of LVSD on echocardiography in keeping with current standard of care. Participants in the intervention arm had a confirmatory echocardiogram at baseline for AI model validation. A total of 1,232 (616 in each arm) participants were randomized and 1,195 participants (587 intervention arm and 608 control arm) completed the baseline visit at 6 hospitals in Nigeria between August 2022 and September 2023 with follow-up through May 2024. Using the AI-enabled digital stethoscope, the primary study end point was met with detection of 24 out of 587 (4.1%) versus 12 out of 608 (2.0%) patients with LVSD (intervention versus control odds ratio 2.12, 95% CI 1.05-4.27; P = 0.032). With the 12-lead AI-electrocardiogram model, the primary end point was detected in 20 out of 587 (3.4%) versus 12 out of 608 (2.0%) patients (odds ratio 1.75, 95% CI 0.85-3.62; P = 0.125). A similar direction of effect was observed in prespecified subgroup analysis. There were no serious adverse events related to study participation. In pregnant and postpartum women, AI-guided screening using a digital stethoscope improved the diagnosis of pregnancy-related cardiomyopathy. ClinicalTrials.gov registration: NCT05438576.