Author + information
- Received March 30, 2017
- Revision received June 19, 2017
- Accepted June 19, 2017
- Published online September 13, 2017.
- Sanjeev P. Bhavnani, MDa,
- Srikanth Sola, MDb,
- David Adams, RCS, RDCSc,
- Ashwin Venkateshvaran, PhDb,
- P.K. Dash, MDb,
- Partho P. Sengupta, MD, DMd,∗ (, )
- ASEF-VALUES Investigators
- aScripps Clinic and Research Foundation, San Diego, California
- bSri Sathya Sai Institute of Higher Medical Sciences, Whitefield, Bangalore, India
- cDuke University School of Medicine, Durham, North Carolina
- dWest Virginia University Heart & Vascular Institute at West Virginia University School of Medicine, Morgantown, West Virginia
- ↵∗Address for correspondence:
Dr. Partho P. Sengupta, West Virginia University Heart & Vascular Institute, West Virginia University School of Medicine, 1 Medical Center Drive, Morgantown, West Virginia 26506.
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)
Supported by The American Society of Echocardiography Foundation. Dr. Bhavnani has received an educational and research grant from the Qualcomm Foundation to Scripps Health; is a consultant to Proteus Digital; and is an advisory board member to iVEDIX, WellSeek, and Misceo. Dr. Sola has received a research grant from General Electric Healthcare (outside of this investigation). Dr. Sengupta has received research grants from Heart Test Labs and Echo Sense Ltd; and is a consultant to TeleHealth Robotics, Intel, Hitachi Aloka, and Heart Test Labs. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
A complete list of investigators in the ASEF-VALUES study is provided in the Online Appendix.
Maurice Enriquez-Sarano, MD, served as Guest Editor for this paper.
- Received March 30, 2017.
- Revision received June 19, 2017.
- Accepted June 19, 2017.
- 2017 American College of Cardiology Foundation