Source/Disclosures
Source:

Healio Interview

Disclosures: Tarakji reports he consulted and served on advisory boards for AliveCor, Boston Scientific, Johnson & Johnson and Medtronic.
September 03, 2020
7 min read
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Barriers to remote care ‘unmasked at wider scale’ due to COVID-19

Source/Disclosures
Source:

Healio Interview

Disclosures: Tarakji reports he consulted and served on advisory boards for AliveCor, Boston Scientific, Johnson & Johnson and Medtronic.
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Healio spoke with Khaldoun G. Tarakji, MD, MPH, a Cardiology Today Next Gen Innovator, about the data he presented at the virtual Heart Rhythm Society Annual Scientific Sessions.

Tarakji, who serves as associate section head of cardiac electrophysiology and director of the Center for Digital Health at the Heart and Vascular Institute at Cleveland Clinic, also highlighted other abstracts presented at the virtual Heart Rhythm Society Annual Scientific Sessions (HRS) that gave insight into the “digital health” of patients with arrhythmias.

Khaldoun Tarakj
Khaldoun G. Tarakji

Healio: Can you give us an overview of your abstract presented at HRS about the use of virtual visits?

Tarakji: Since 2016, we have been using virtual visits in our electrophysiology department at Cleveland Clinic to follow up some of our arrhythmia patients. We believe electrophysiology is best suited for virtual visit given the nature of our specialty. Many atrial fibrillation (AF) patients, for example, require long-term follow up and most of the decisions for their care are based on their history and data collected through ambulatory cardiac monitors, and both could be achieved remotely.

With the rising rate of adoption for virtual visits, it was important for us to assess patients’ satisfaction with this new modality for providing care. Therefore, we conducted a survey with a standardized questionnaire and targeted patients who conducted virtual visits between December 2018 and July 2019 and presented the results at HRS2020.

We invited 100 patients to participate in the survey. Nine of these patients could not conduct the visit due to technical difficulties mainly due to lack of high-speed internet access. Among the respondents who completed the survey, the overall satisfaction was highly favorable with over 98% reporting the experience as excellent or very good. Patients felt they were able to communicate with their physicians effectively, got all their questions answered, and 70% of them were able to share data from devices such as extended rhythm recording patches, Holter monitors, smartphone ECGs and cardiac implantable electronic devices (CIED) remotely with their physicians. This highlights the importance of supporting the virtual visit with patient generated data to provide better care. The cost of the visit was one of the items that patients did not rate favorably. The survey was performed at a time when insurance coverage was limited for virtual visits. We concluded that virtual visits can provide a viable alternative for follow up care of arrhythmia patients. Barriers to a successful experience include technical challenges and lack of insurance coverage.

While there are many advantages for using virtual visits, we never thought about a pandemic as one of them. Our study was one of its kind as it provided insight about both patient experience with using this modality prior to COVID-19. Interestingly the issues highlighted in our studies as barriers were unmasked at wider scale during the pandemic. With the unprecedented demand for telemedicine, many platforms could not keep up and the technical difficulties became a major obstacle. The government was thankfully quick to respond with swift actions that included reimbursement for these visits and also allowing caregivers to use other video conferencing secured platforms at the time of the crisis. While these rules are temporary, virtual visits are here to stay, and for the right patient coupled with the right tools, they can provide effective and high-quality care

Healio: What impact does the Apple Heart study have on practice?

Tarakji: The Apple Heart study is an example of a new wave of mega trials that are leveraging new technologies that were not available for us as clinicians and researchers. Direct-to-participant studies, siteless trials, e-consent andvirtual follow up are all new concepts and vocabulary that will probably reshape many of our research activities. These innovative research studies are enabling us to enroll large numbers of participants in a very short time. As an example, the Apple heart study enrolled around 420,000 Apple Watch users aged 22 years or older with the goal of assessing the rate of AF detection. It is important to note that the study was conducted with older generations of Apple Watches that detected irregularities in the pulse using a proprietary algorithm and notified the patient about possible AF but did not have the capability of recording ECG rhythm strip. Confirmation of the diagnosis happened through a patch monitor that was sent to patients who received the notification. At the end, 0.5% of participants received the notification alerting them about irregular heart rhythm, and among those, only a third followed up with the patch and 34% had AF document on the patch. Among the individuals who were wearing the patch simultaneously with the watch, the positive predictive value of the notification was 84% for the detection of AF. It would have been very interesting and more impactful if the Apple Heart study was conducted with the newer generation of watches that, in addition to notifying the users about irregular pulse, would have enabled them to record their ECG to document the electrical signature through the watch.

There are several issues to note with the study. First, we don’t know about the remaining 99.5% who did not receive the notification as the study was not designed to look into the negative predictive value of the watch algorithm. Among the individuals who received the notification, only 36% of them were 65 years or older and only 33% of them had CHADS VASC score of 2 or greater. This means, 64% were less than 65 years old. In fact, 16% were 22 to 39 years old. While we have many opportunities to detect AF among the high risk individuals who unfortunately continue to occasionally present with a stroke as their first manifestation of AF, it might also lead to raising anxiety or to more unnecessary interventions and testing among the young and healthy.

Healio: What should other physicians know about presentations from HRS that involve using digital health for arrhythmia patients?

Tarakji: With widespread use of smartphone and smart watches and the availability of direct-to-certain-consumer digital health products, we have great opportunities to advance the care of the arrhythmia patients. At HRS2020, two late breaking clinical trials were presented that involved the use of digital health in the care of the arrhythmia patient.

The first one addressed the common problem of suboptimal adherence to oral anticoagulation among patients with AF. Investigators in China looked at the role of using a smart watch that sends the patient daily reminders about oral anticoagulation use. This was a multicenter prospective clinical trial that enrolled 160 AF patients with relatively high CHADS VASC score and were randomly assigned to two groups; the smart watch group and standard of care. Drug adherence was measured by two methods, and at the end of the follow-up, the smartwatch group showed better adherence to the oral anticoagulation compared with the standard of care. In fact, adherence decreased in the control group over 9 months of follow up and increased in the smartwatch group.

Another late breaking clinical trial was the Blue Sync study that was designed to assess the performance of the first pacemaker in the world to use the patient’s own smart device or tablet through a dedicated app for remote monitoring. While it is widely recognized that remote monitoring of pacemakers or defibrillators improves clinic efficiency and leads to better patient outcomes, adoption and adherence to remote monitoring remain suboptimal. CIED remote monitoring has gone through multiple stages of evolution from an active patient-initiated process, to a fully automated process independent from patient action using a bedside console that transmits the data to a secured network that get accessed by the physicians.

Advancements in pacemaker capabilities and the use of Bluetooth technology, allow patients for the first time to use their own smart devices (whether smartphone or tablet) as their monitor, by leveraging an app-based platform that has the ability to transfer device data to patient management networks without the use of a traditional bedside monitor. In addition to data transfer, the dedicated app offers multiple other features to enhance the patient experience, including access to information about their implanted devices, educational material, activity tracker data and transmission schedule and history

The objective of the BlueSync evaluation was to compare long-term success rate of scheduled transmissions over 12 months of follow up between patients using MyCareLink Heart app to those using traditional manual or automatic bedside monitors. The evaluation was a prospective, multicenter, international study that incorporated patients from the United States, France, Italy and the United Kingdom. The study used three historical comparison groups, using traditional modalities for remote monitoring. Between one and 12 months, 245 BlueSync patients had 953 scheduled transmissions, of which 902 were successfully completed with a success rate of 94.6%. This is compared with a 56% transmission success rate for pacemaker patients requiring a wand to communicate with a beside console and 77% for pacemaker patients with wireless automatic communication with the bedside console, and 87% for defibrillator patients with similar automatic communication

This study shows that long-term follow-up with BlueSync-compatible pacemakers using an app-based platform produces a higher rate of success in scheduled transmissions compared with traditional remote monitoring options.

Healio: What’s on the horizon for digital health and arrhythmia care?

Tarakji: Digital technologies are transforming the practice of medicine in general but probably more so the field of electrophysiology. Our specialty is dependent on technology and remote monitoring and telemedicine have been part of our practice for decades.

There are challenges but also great opportunities. Direct to consumer devices that record ECGs can help establish the diagnosis in a patient with random episode of palpitation, they can also provide great tools for long term monitoring for arrhythmia and guide future therapies.

Large trials involving wearable devices are moving from observational studies to looking into outcomes that are highly needed for the field. The Heartline study is an example of a pragmatic, direct-to-participants’ study that is a virtual app based study. The study is an open invitation to any Medicare beneficiary. It will target 150,000 individuals who will be randomly assigned to two groups; a control group that follows standard of care and a treatment group that will use Apple Watch paired with a dedicated app for the study to enhance engagement. The primary end point is AF detection, in addition the study will look into secondary end points including stroke and other cardiovascular events. It is important to note that Heartline is an example of a virtual study that will rely on the use of an app and the end point will be measured using a health care claims database. In the midst of the pandemic when most clinical trials have come to a halt, these types of studies could continue to enroll.

The use of smartphone for implantable device remote follow up is a paradigm shift in the care of these patients. For the first time, millions of patients have some visibility to data elements from their devices. The app itself can transform the way we conduct CIED research in more effective ways.