Wearable Devices for Heart Disease, Diabetes and Health

Transcription

1 Wearable Devices for Heart Disease, Diabetes and Health Pam R. Taub MD, FACC Director of Step Family Cardiac Wellness and Rehabilitation Center Associate Professor of Medicine UC San Diego Health System

2 Disclosures I have no conflict of interest related to products presented in this talk.

3 Overview of Talk Review of Mobile Technology /Apps Arrhythmia Monitoring(Alivecor, Ziopatch, Cardionet, Preventice, Medtronic etc.) Continuous Glucose Monitoring (Dexcom, Medtronic, Abbott) Heart Failure Patient Monitoring (CoVA System, HealthPatchMD) Activity Monitors Implantable Loop Recorders Life vest Studies on digital and wearable technologies

4 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

5 Apps also can integrate with omron blood pressure cuff AliveCor

6 Ziopatch

7 Preventice Body Guardian. BodyGuardian Heart monitors (2) Note: The monitors may be white or black. Both versions operate identically. BodyGuardian Connect smartphone monitor charging cradle monitor charging cradle power cord (with adapter) Equipment may vary from the components pictured. smartphone charger BodyGuardian Strip(s)

8 Cardionet

9 Medtronic Seeq System

10 Continuous Glucose Monitoring Lower A1c Devices Reduce hypoglycemia Improve quality of life Can be used in Type I and Type II diabetes Potential applications to inpatient glucose monitoring and for clinical research

11 Dexcom: Continuous Glucose Monitoring Recently approved by CMS for type II diabetics on insulin

12 Dexcom System

13 Medtronic: Integration of Insulin Pump with Sensor It has technology that can pause insulin delivery if glucose level goes below a preset limit.

14 Abbott CGM

15 Glucose Food Logs Actigraphy Glucose

16 Other Endpoints: A1C < 7% CGM Control p Median time BG< 60 mg/dl 18 min/d 35 min/d 0.05 Time out of range < 70 or > 180 mg/dl 377 min/d 491 min/d week A1C 6.4% 6.8% <0.001 The weight of evidence suggests that CGM is beneficial for individuals with type 1 diabetes who have already achieved excellent control with A1C < 7% JDRF, Diabetes Care, 2009

17 To Sense: CoVA Monitoring System Measures heart rate, heart rate variability, thoracic fluid levels (impedance), respiration rate

18 HealthPatch MD Measures: Single-Lead ECG Heart Rate RR Interval Heart Rate Variability Respiratory Rate Skin Temperature Body Posture Fall Detection Activity including Steps -

19 Fitness Trackers/Activity Monitors Leading Manufacturers FitBit Nike+ FuelBand Garmin and Apple

20 Data on Fitness Trackers A randomized trial of 471 patients published in JAMA showed these fitness trackers had no impact on weight loss compared to control group Studies has shown that there is inaccuracy in measurement of heart rate.

21 Implantable Loop Recorders (ILR)

22 Clinical Use of ILR Very useful when symptoms (e.g. syncope) are infrequent (eg, 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.

23 Lifevest Wearable Cardiovertor Defibrillator (WCD)

24 WCD Guidelines Per ACC expert consensus There are no completed randomized trials of WCD therapy. No definitive data are available on comparative efficacy versus alternative (or no) treatment. A randomized controlled trial (VEST), which is actively enrolling subjects hospitalized with an MI who have an LVEF of 35 percent, will test the hypothesis that the WCD reduces sudden death mortality in the first 90 days after an MI in patients with reduced LV function

25 Piccini et al., Circulatoin 2016

26 WCD Indications Can be used to bridge a decision for appropriate ICD therapy in: After recent MI (Coverage during the 40-day ICD waiting period) Before and immediately after CABG or PCI (Coverage during the 90-day ICD waiting period) Listed for cardiac transplant Recently diagnosed NICM (Coverage during the three-to-nine month ICD waiting period) New York Heart Association (NYHA) Class IV heart failure Terminal disease with life expectancy of less than one year WCD may be employed in patients with transient contraindications to ICD implantation such as ongoing infection. WEARIT-II registry noted that 40% of patients who wore the LifeVest went on to improve LV function and no longer met criteria for ICD implantation.

27 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 Usual Care Arm: n=722 patients No difference in outcomes JAMA Intern Med. 2016;176(3):

28 Scripps Wired for Health Study 160 patients with hypertension, diabetes, or arrhythmia randomized Intervention Arm: n=75 patients (monitored) Control Arm: n=85 patients Devices used in study: Withings blood pressure monitor, a Sanofi IBGStar blood glucose meter for those with diabetes, or an AliveCor dvice for those with arrhythmia Patients followed for 6 months No difference in outcomes or costs

29 Conclusions Many consumer based digital health devices/apps exist. Use of these tools need to be driven by good clinical trials and outcome data. Medical grade devices including ILR/Lifevest/CGM monitoring devices have good data supporting their use