A randomized trial of pocket-echocardiography integrated mobile health device assessments in modern structural heart disease clinics
Open accessAbstract
Objectives This study sought to determine whether mobile health (mHealth) device assessments used as clinical decision support tools at the point-of-care can reduce the time to treatment and improve long-term outcomes among patients with rheumatic and structural heart diseases (SHD).Background Newly developed smartphone-connected mHealth devices represent promising methods to diagnose common diseases in resource-limited areas; however, the impact of technology-based care on long-term outcomes has not been rigorously evaluated.Methods A total of 253 patients with SHD were randomized to an initial diagnostic assessment with wireless devices in mHealth clinics (n = 139) or to standard-care (n = 114) in India. mHealth clinics were equipped with point-of-care devices including pocket-echocardiography, smartphone-connected-electrocardiogram blood pressure and oxygen measurements, activity monitoring, and portable brain natriuretic peptide laboratory testing. All individuals underwent comprehensive transthoracic echocardiography to assess the severity of SHD. The primary endpoint was the time to referral for therapy with percutaneous valvuloplasty or surgical valve replacement. Secondary endpoints included the probability of a cardiovascular hospitalization and/or death over 1 year.Results An initial mHealth assessment was associated with a shorter time to referral for valvuloplasty and/or valve replacement (83 ± 79 days vs. 180 ± 101 days; p <0.001) and was associated with an increased probability for valvuloplasty/valve replacement compared to standard-care (34% vs. 32%; adjusted hazard ratio: 1.54; 95% CI: 0.96 to 2.47; p = 0.07). Patients randomized to mHealth were associated with a lower risk of a hospitalization and/or death on follow-up (15% vs. 28%, adjusted hazard ratio: 0.41; 95% CI: 0.21 to 0.83; p = 0.013).Conclusions An initial mHealth diagnostic strategy was associated with a shorter time to definitive therapy among patients with SHD in a resource-limited area and was associated with improved outcomes. (A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics; NCT02881398).
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Tele-ultrasound has demonstrated success in producing high quality, diagnostically significant images.
“Tele-ultrasound has demonstrated success in producing high quality, diagnostically significant images which alter management, decrease time to treatment, and provide more cost-effective care, especially when coupled with supporting data such as electrocardiogram, chest radiography, laboratory results, and clinical history (29, 30, 33, 35, 37, 48).”
From Tele-Ultrasound in Resource-Limited Settings: A Systematic Review (2019) · cites this paper as [30]
The Initial Testing passage reports that 96% of pocket-echocardiographic studies had good or excellent image quality and adequate diagnostic correlation with transthoracic echocardiography for moderate or severe valve disease. The Pocket Echocardiography methods passage describes scans performed and interpreted by local physicians, not remotely transmitted or interpreted tele-ultrasound; that aspect of the claim is not established. (LLM, conf=0.85)
Experimental — accuracy not yet measuredTele-ultrasound alters management.
“Tele-ultrasound has demonstrated success in producing high quality, diagnostically significant images which alter management, decrease time to treatment, and provide more cost-effective care, especially when coupled with supporting data such as electrocardiogram, chest radiography, laboratory results, and clinical history (29, 30, 33, 35, 37, 48).”
From Tele-Ultrasound in Resource-Limited Settings: A Systematic Review (2019) · cites this paper as [30]
The Study Limitations passage says clinicians used pocket-ultrasound findings, alongside other mHealth data, to make treatment and referral decisions. The conclusion reports shorter referral times with the combined mHealth strategy. But the paper describes scans performed and interpreted by local physicians, not tele-ultrasound, and does not isolate ultrasound’s effect on management. (LLM, conf=0.84)
Experimental — accuracy not yet measuredTele-ultrasound provides more cost-effective care.
“Tele-ultrasound has demonstrated success in producing high quality, diagnostically significant images which alter management, decrease time to treatment, and provide more cost-effective care, especially when coupled with supporting data such as electrocardiogram, chest radiography, laboratory results, and clinical history (29, 30, 33, 35, 37, 48).”
From Tele-Ultrasound in Resource-Limited Settings: A Systematic Review (2019) · cites this paper as [30]
The Abstract describes lower cost as a design feature of mobile-health devices, and the Primary Endpoints section reports faster treatment referral and fewer hospitalizations or deaths. It does not report a cost-effectiveness analysis or demonstrate that care was more cost-effective; the trial also assessed a package of point-of-care devices, not tele-ultrasound alone. Page numbers are unavailable in our copy. (LLM, conf=0.79)
Experimental — accuracy not yet measuredIn Bangalore, India, tele-ultrasound reduced the time to referral for valvular interventions and reduced the likelihood of both hospitalization and death among children with structural heart disease.
“Tele-ultrasound reduced the time to referral for valvular interventions and reduced the likelihood of both hospitalization and death (30).”
From Tele-Ultrasound in Resource-Limited Settings: A Systematic Review (2019) · cites this paper as [30]
The Abstract and Primary Endpoints report a shorter time to referral for valvuloplasty or valve replacement and a lower combined risk of cardiovascular hospitalization and/or death with the mHealth assessment. The study was conducted in Bangalore, but the cited results concern patients with structural heart disease generally, not specifically children. It also reports hospitalization and death as a combined outcome, rather than demonstrating reductions in each separately. (LLM, conf=0.88)
Experimental — accuracy not yet measuredTele-ultrasound decreases time to treatment.
“Tele-ultrasound has demonstrated success in producing high quality, diagnostically significant images which alter management, decrease time to treatment, and provide more cost-effective care, especially when coupled with supporting data such as electrocardiogram, chest radiography, laboratory results, and clinical history (29, 30, 33, 35, 37, 48).”
From Tele-Ultrasound in Resource-Limited Settings: A Systematic Review (2019) · cites this paper as [30]
The Primary Endpoints section reports a shorter time to treatment with the mHealth assessment than with standard care. But the Study Procedures describe local, point-of-care pocket echocardiography as one part of a multi-device assessment, not tele-ultrasound; the result cannot be attributed specifically to tele-ultrasound. (LLM, conf=0.86)
Experimental — accuracy not yet measured
A total of 12 studies were included in the final analysis.
“A total of 12 studies were included in the final analysis (27–38).”
From Tele-Ultrasound in Resource-Limited Settings: A Systematic Review (2019) · cites this paper as [30]
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“Teleultrasound has demonstrated success in producing high quality, diagnostically significant images which alter management, decrease time to treatment, and provide more cost-effective care, especially when coupled with supporting data such as electrocardiogram, chest radiography, laboratory results, and clinical hist…”
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The Year in Cardiology 2018: imaging
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Personal mobile device-based pocket echocardiograph—The diagnostic value and clinical utility
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Journal Editors and Altmetrics
Chandrashekhar, Y., & Shaw, L. J. (2019) · JACC. Cardiovascular imaging · doi:10.1016/j.jcmg.2019.08.001 · Cited by 9 · see citing works
Progress in Cardiovascular Imaging
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Focused Cardiac Ultrasound for the Evaluation of Heart Valve Disease in Resource-Limited Settings
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Handheld ultrasonography in cardiovascular medicine, updates and controversies
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Artificial intelligence and machine learning in cardiovascular computed tomography
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Leveraging Mobile Technology to Reduce Resource-Related Health Care Disparities
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Current and future use of artificial intelligence in valvular heart disease imaging
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Primary Healthcare Innovations in India: Synthesis from a systematic reviewPreprint
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Self-citationPoint-of-care ultrasound training and education in low- and middle-income countries
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Cardiac Ultrasound Imaging: The Role of Artificial Intelligence
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Self-citationMaking a SPLASH for Rheumatic Heart Disease
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A Pocket Full of Sunshine for Early Diagnosis of Valvular Heart Disease
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How to Reduce the Environmental Impact of Clinical Practice in Cardiology
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- Authors
- Bhavnani, S. P., Sola, S., Adams, D., Venkateshvaran, A., Dash, P. K., Sengupta, P. P., Bhavnani, S., Sola, S., Venkateshvaran, A., Adams, D., Sengupta, P. P., Ryan, T., Narula, J., Thomas, J., Lang, R., Pellikka, P., Choudhary, V., Iyer, V. R., Barooah, B., Sola, S., Varyani, R., Lingan, A., Murugan, V., Kini, P., Venkateshvaran, A., Srinivas, N., Barooah, A. C., Subbarao, G. V. R., Shivakumar, C., Subramaniyan, M., Sengupta, S. P., Bansal, M., Rahaman, A., Patil, V. N., Kumar, N. R., Gahlot, M. Y., Damani, I. M., Gulati, R., Joshi, S. S., Dubey, S., Krupa, J., Irfan, S., Vidhyakar, R. B., Bidarkar, N., Shantesh, B. K., Chavan, S. S., Chandramohan, R., Kumar, V., Tirkey, S., Prasad, G., Lakshmana, S. S., Malkar, R. M., Manjunath, V., Kumar Reddy, K., Ramesha, L. G., Kumbhalkar, S., Thadlani, J. A., Basha, T. M. N., Hafeez, S. A., Leelavathi, V., Mathews, R., Daubert, M., Cleve, J., Burdulis, E., Fauss, N., Lammertin, G., Patel, B., Petrovets, E., Shah, D., Thurmond, K., Tomberlin, D., Umamaheswar, H., & Kadakia, A.
- Affiliations
- Sri Sathya Sai Institute of Higher Medical Sciences (IN)
- ORCID
- Venue
- JACC: Cardiovascular Imaging
- Publisher
- Elsevier BV
- Published
- 2018-04
- Volume
- 11
- Issue
- 4
- Pages
- 546-557
- ISSN
- 1876-7591 (ISSN-L)
- 1936-878X
- OpenAlex
- W2764038962
- Cited by
- 81
- References
- 36
- Citations by year
- 2026: 5 · 2025: 11 · 2024: 8 · 2023: 7 · 2022: 6 · 2021: 21 · 2020: 8 · 2019: 8 · 2018: 4 · 2017: 3
- FWCI
- 4.86
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- JACC. Cardiovascular imaging (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Valve Diseases and Treatments
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Ultrasound in Clinical Applications
- Keywords
- structural heart disease, mobile health, point-of-care testing, clinical decision support, valvuloplasty, valve replacement, time to treatment, cardiovascular hospitalization, mortality, resource-limited settings, brain natriuretic peptide, rheumatic heart disease
- MeSH terms
- Smartphone, Adult, Blood Pressure Determination, Electrocardiography, Equipment Design, Female, Heart Valve Diseases, Humans, India, Male, Middle Aged, Oximetry, Predictive Value of Tests, Prognosis, Referral and Consultation, Rheumatic Heart Disease, Severity of Illness Index, Signal Processing, Computer-Assisted, Time Factors, United States, Treatment Outcome, Telemedicine, Echocardiography, Doppler, Color, Point-of-Care Systems, Heart Valve Prosthesis Implantation, Young Adult, Actigraphy, Wireless Technology, Time-to-Treatment, Balloon Valvuloplasty, Mobile Applications
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