Wearable Devices for Heart Disease, Sleep Apnea, and Health. Jia Shen MD, MPH Assistant Professor of Medicine UC San Diego Health System

Transcription

1 Wearable Devices for Heart Disease, Sleep Apnea, and Health Jia Shen MD, MPH Assistant Professor of Medicine UC San Diego Health System

2 Disclosures I have no conflict of interest related to products presented in this talk. Slides modified with permission from Dr. Pam Taub.

3 Overview of Talk Introduction Review of Mobile Technology /Apps Activity Monitors Sleep Apnea Monitoring Arrhythmia Monitoring Implantable Loop Recorders Studies on digital and wearable technologies Continuous Glucose Monitoring Devices in Development Controversies

4 Introduction Digital Health Market is expected to double by 2022 to +27 billion USD (Forbes). Digital Health Action Plan (2017): FDA s vision for fostering digital health innovation while continuing to protect and promote public health by providing clarity on digital medical software. September, 2017: FDA s announces pre-certification pilot program highlighting software companies working in the digital health field Apple, Fitbit, John&Johnson, etc.

5 Fitness Trackers/Activity Monitors Additional sensors monitor heart rate, blood pressure, blood oxygen levels, perspiration. Measures: footsteps taken, distance travelled, type of movement, quality and duration of sleep. Information can be integrated with apps and shared with physician, friends, and family. JAMA Cardiol. 2016;1(2):239. doi: /jamacardio

6 Fitness Trackers/Activity Monitors Obesity and physical inactivity are important risk factors for heart disease. Leading Manufacturers: FitBit Charge 3 Garmin Vivofit 3 Apple Watch Bellabeat - Leaf

7 Data on Fitness Trackers 471 patients randomized to standard (telephone calls, text prompts, access to website resources) or enhanced (wearable device + web interface to monitor diet and activity) groups. No increased weight loss with wearable device. JAMA. 2016;316(11): doi: /jama

8 Accuracy of Activity Monitors Wrist worn heart rate monitors were inferior to chest electrode monitors. Variability increased with moderate and vigorous exercise. JAMA Cardiol. 2017;2(1): doi: /jamacardio

9 Conclusions Wearable activity monitors can help facilitate goal setting, monitoring, and data sharing. In select motivated patients this can encourage physical activity, dietary changes, and weight loss. Physicians and healthcare systems are figuring out the role of these devices can/should play in patient care. Some insurance companies (BCBS) have adopted the use of fitness trackers into their insurance plans.

10 Sleep Apnea Monitoring Prevalence of Sleep Apnea in the USA ranges between 9% to 38% and is higher in men. Risk increase with age and weight. 4 in 5 people with sleep apnea remain undiagnosed. Polysomnography is the gold standard: Brain waves Eye movements Heart rate Breathing pattern Blood oxygen level Body position Chest and abdominal movement Snoring and other noises made during sleeping Limb movement

11 UCSF Study with 6,115 users of the Cardiogram app for Apple Watch. All wearables (Apple Watch, Fitbit, Garmin, Android can detect Sleep Apnea when paired with an AI neural network- called DeepHeart. 90% accurate in identifying sleep apnea in participants.

12 Go2Sleep

13 SmartSleep

14 Evolution of Sleep Apnea Monitoring

15 Arrhythmia Monitoring Spectrum of options ranging from EKG for the consumer (Alivecor) to medical grade monitors (cardionet, Preventice, Ziopatch) Differences between manufacturers on live monitoring versus passive Difference in reporting formats

16 Apps also can integrate with omron blood pressure cuff AliveCor

17 Study of 1001 patients with mean CHADS2vasc score of 3

18 Apple Watch Series 4

19 Apple Watch Series 4

20 ZiopatchTM

21 Biotel MCOT Patch

22 Preventice Body Guardian

23 Implantable Loop Recorders (ILR)

24 Clinical Use of ILR Very useful when symptoms (e.g. syncope) are infrequent (e.g., less than once per month), and/or other ambulatory monitoring has been unrevealing or inconclusive ILR allows for remote monitoring Helpful in diagnosing occult arrhythmias (such as Afib in patient with cryptogenic stroke). Crystal AF study of 441 patients showed ILR was superior to conventional follow-up for detecting atrial fibrillation after cryptogenic stroke By 12 months, atrial fibrillation had been detected in 12.4% of patients in the ILR group versus 2.0% of patients in the control group

25 Beat-HF Trial 1437 hospitalized patients for HF were randomized Intervention Arm: n=715 patients Intervention: Combined health coaching telephone calls and telemonitoring (BP, HR and weight) Centralized registered nurses conducted telemonitoring reviews, protocoled actions, and telephone calls Patients followed for 180 days No difference in outcomes Usual Care Arm: n=722 patients JAMA Intern Med. 2016;176(3):

26 Continuous Glucose Monitoring Dexcom: FDA approved and covered by Medicare. ~$1000 Medtronic Minimed 630 G insulin pump with sensor. $9900 Pauses insulin delivery if BG is low.

27 WristOx2 On the Horizon itbra Quell Proteus VitalPatch

28 Controversies Hundreds of healthcare related wearable devices are now commercially available and marketed directly to patients/consumers. Accuracy high quality data? Healthcare Cost who pays? Responsibility who is responsible for healthcare data? Integration how do we integrate data in medical records? Can these devices improve individualized patient centered care and lead to reduced cardiovascular outcomes? Lack of short and long-term outcome trials.

29 Conclusions Virtual explosion of consumer based wearable medical devices and applications. Benefits include: better design, increased availability, data collection, and patient participation. Use of these tools need to be driven by good clinical trials and outcome data, which are currently lacking. Physicians, insurers, and health systems need to determine the role of wearable technology in guiding patient care. Medical grade devices including ILR/Ziopatch monitoring devices have good data supporting their use