New Initiatives and Research in Atrial Fibrillation Care

In this interview, we speak with Dr. David McManus, Director of the Anticoagulation Service and Co-director of the Atrial Fibrillation (AF or AFib) Program about upcoming and ongoing initiatives in care at UMass Memorial Health Care in Worcester, Massachusetts.

We last spoke in October 2017, in an article about your hospital’s involvement in the Get With The Guidelines-AFib program. Can you provide an update about what new initiatives have been taking place since then?

Quite a bit has happened since 2017. When we spoke, we at UMass Memorial Health Care were focused on our decision as a hospital system to participate in the American Heart Association’s (AHA) Get With The Guidelines^®-AFib program and why we decided to take the leap. Since then, we have continued to participate in this program and have received the Get With The Guidelines-Atrial Fibrillation Gold award every year since. Our investment has yielded large dividends. It has become a real centerpiece for our whole cardiovascular service line. 

Why do we continue to invest time, money, and effort into not just implementing the program, but continuing to support the quality initiatives, educational initiatives, and communication with our healthcare providers in the inpatient setting? The reasons are: (1)because it’s the right thing to do for our patients; (2) it’s also part of our culture here at UMass to focus on quality within the context of our whole health system; and (3) it has been helpful at distinguishing our value to patients and providers. Everyone at UMass Memorial is committed to creating a safe environment and delivering a positive patient experience; we believe that is especially true in cardiovascular care. 

We are laser focused here on our patient experience and overall quality. A lot of patients are presenting with AFib and other cardiovascular conditions, and the AHA has provided us with a guide book for how to build an interdisciplinary approach that has led to better communication, clearer standards, and more impact in terms of patient outcomes for patients with these conditions. The cardiovascular and EP teams have really adopted this interdisciplinary strategy to AFib care. For example, we meet regularly with the nursing staff to build and incorporate new educational modules. Other efforts prompted by the AHA GWTG Program have included building calculators within the EHR to facilitate stroke risk calculation and ease the process associated with documentation of that, which is another quality measure. Another of the key metrics of the AHA is handoff and making sure patients on oral anticoagulation have scheduled visits for appropriate lab tests and clinical follow-up, because although anticoagulants are highly effective, they are also one of the top causes of adverse drug events when they are not appropriately monitored. Therefore, we’ve focused on building an anticoagulation medical home that accepts all patients (including those who don’t necessarily have a primary care doctor in our system but are seen for example in the emergency room), and have created an environment where these patients can be handed off to a team that includes a pharmacy technician, an advanced practice practitioner, and a physician. In this handoff system, patients in the hospital are started on anticoagulation, but if they encounter problems with copays, side effects, or new drugs such as an antibiotic are added after discharge, we can check back with them and continue follow-up support for them. This effort has led to a hospital-wide quality award that offers national recognition for hospital systems that are doing innovative work to protect patients from harm. This new initiative that was founded by our interdisciplinary AFib team has now evolved and is providing ambulatory support in a way that it didn’t before. It started with education, but has grown and merged with the great work that is going on in our anticoagulation clinic. It’s really exciting to have these metrics that we were able to use to change our practice and cross what were traditional silos. The anticoagulation clinic was originally only an ambulatory program, but we were able to break down the ambulatory and patient barriers, and communicate more effectively and work together around these important AFib quality metrics. 

This past fall, you also participated in a Facebook Live event on the topic of atrial fibrillation. What were some of the main concerns you heard from patients?

The Facebook Live event that we did was organized by Pamela Burgwinkle. She is our key leader in the anticoagulation clinic and works with me on that team, so she joined me for the Facebook Live event in which we talked directly to UMass patients through social media to make them more aware of some of the services that we provide, as well as to listen to their questions and concerns. We want to make sure we are designing systems that help them. So that is what motivated us to go on Facebook and work with our patients to hear what they had to say and include them in the process. 

Some of the questions from patients included whether they needed to be treated with an anticoagulant, if they needed to be referred to a cardiologist, and questions about new treatment strategies such as LAA devices versus anticoagulants. There were also some basic questions such as: “If I don’t feel my AFib, does that still mean I’m at stroke risk?” and “If my Mom or Dad has atrial fibrillation, should I be concerned about AFib screening?” We addressed a variety of questions both online and afterward. Honestly, I was worried that we wouldn’t get any questions, but we had thousands of views from patients across the country, and the patients were all very thoughtful and respectful. I believe as institutions develop telemedicine and other services that can get beyond a local area, they should consider use of social media to talk to both their patients as well as new patients that are interested in learning more. Knowledge is power, and patients with AFib are more and more wanting to become involved in their treatment. There is an emphasis on shared decision making around ablation and device implantation as well as oral anticoagulation, which is why it is more important to directly communicate with our patients to elicit their concerns and fears. Folks like the people at StopAFib.org have taught me a lot about the importance of a community for AFib patients in helping one another. I hope to do a similar event again. 

You were also recently part of a study that helped develop a novel method to detect AFib from a wrist watch photoplethysmogram (PPG) signal using a smartwatch. What are your thoughts on wearable health monitoring for more accurate detection of AFib? 

One of the most interesting areas in AFib right now is mobile and digital health, and how these intersect with AFib screening and management. This intersection of how technology is going to reshape how patients engage and how they’re diagnosed and treated is exciting. This is an area that I am very interested in from a research perspective, and we have a couple of research projects that focus on different aspects of this topic. The first is working on enhancing the algorithms and processes via which wrist-based and other sensors detect AFib to make them more accurate, which is in many ways the tip of the iceberg. We need to have accurate tools for detecting AFib to avoid false positive results and unnecessary worry on the part of the patient. There are several challenges in using these devices, including that many of them are commercial devices that are being adapted or cleared for medical use. The Apple Watch is the most commonly known device with FDA clearance both for pulse assessment for AFib and an EKG feature using the bevel of the watch to obtain a single-lead ECG. AliveCor’s KardiaMobile is also available. Samsung’s new Galaxy Watch has an ECG feature that has yet to be cleared. Google also has a device called the Study Watch that is also FDA cleared for its ECG feature for detecting AFib. 

Therefore, across the whole industry, there is a lot of development in this space. I think this is because individuals want to have their health care accessible to them, and they want to be able to detect any rhythm or heart problem using devices they already own. The technical side of things has come a long way, and I believe the FDA would agree that we have sufficiently accurate technologies (ECG and PPG) to start using these devices for AFib detection in certain settings. However, in my opinion, one of the limits in the Apple Heart Study is that most study participants were younger people who had purchased an Apple Watch — very few of them were at risk for AFib, very few had AFib, and the very few with AFib did not have sufficiently high stroke risk to justify treatment. We may want to reengineer our approach to developing technologies and start from the user who would best benefit from a technology. In this case, the population who is at risk for AFib is a person over the age of 65 with risk factors for stroke. That is the population who I would want to target for screening. There is also a lot of exciting work happening in risk-based screening using genetic tests or other features in the electronic health record to refine who should consider getting an Apple Watch. That is some of the research in this space that we’re doing, including a collaboration with Massachusetts General Hospital. However, the reality right now is that if you look at who has an Apple Watch, it’s a young person who is healthy and fit — it’s not my father, whose arrhythmia was diagnosed during his cataract surgery. He wouldn’t even know what to do with an Apple Watch, nevermind read its watch face! There are key aspects of the technology in that it’s a beautiful device and there is great progress that has happened, but we have not started from the voice of potential users who are older. 

We have a research project grant (R01) called Pulse Watch from the National Institutes of Health and The National Heart, Lung, and Blood Institute that we are designing by conducting focus groups with both stroke survivors and clinicians to help the development of a smartphone app and smartwatch dyad to deploy in patients who are either leaving the hospital or receiving ambulatory care for stroke in whom they have not identified a cause for their stroke. We know that these patients are at high risk for AFib and would have their care altered by a diagnosis, so we have an ongoing randomized trial where we are giving wrist-based wearable devices powered by algorithms to detect AFib and gold-standard cache monitors to compare the accuracy of the watch to an EKG. We are also evaluating adherence to this system over time and identifying any factors that relate to non-adherence in order to better design a system that is usable and can be adhered to by older adults at risk for AFib. 

We’re excited about the Pulse Watch study. We are enrolling from neurology clinics where stroke patients often go for care, as well as from cardiovascular clinics. We’re delighted that stroke survivors took such an active role in the design of this app and smartwatch diad. In fact, in addition to the focus group, we held a “Hackathon” in which engineers, stroke survivors, and clinicians all came together for a day of programming. It was a fun day in which we hunkered down, worked late into the night, ate a lot of stale sandwiches, and iterated to refine this system so that the patients’ voices could be heard. For example, big fonts were preferred (not surprisingly), and patients preferred an option for the text on the screen to be read aloud. An audio function was suggested that allows people with visual deficits to hear alerts using a buzzing sound, and visual aids were created to help notify people who would benefit from multiple sensory inputs. The stroke survivors had very different ideas of what they wanted versus what I thought they would want, and it made me aware of my own biases as a clinician. So that was a really helpful research project. 

Another development as a result of designing the initial app was that we created a survey focused on ascertaining clinician views about whether they trusted these devices and their findings in terms of AFib detection. We asked questions such as: What do they do once they receive an alert? What is the follow-up of that alert? Do they see the patient in the office? Do they order a monitor? Do they order anticoagulation? We used some patient case scenarios to probe neurologists, geriatricians, family practitioners, and anyone else who might prescribe a watch or see a patient at risk in the ambulatory setting. We are exploring a collaboration with the Heart Rhythm Society (HRS) to further that internal survey and potentially administer it more broadly. I also want to call out the HRS Digital Medicine Workgroup, under the direction of Nassir Marrouche, who has been very helpful in designing this survey and helping us potentially reach a broader audience. This is something we may seek to present at the next HRS.

What main challenges still exist in the treatment and management of atrial fibrillation?  

As I see it, there are a few existing areas where progress needs to be made. As much as there have been technical innovations that make the detection of AFib easier, we still don’t know the risks associated with getting a diagnosis of AFib from a smartwatch or a mobile ECG. We don’t know if the risks are the same as conventionally diagnosed AFib. That might sound banal, but we may be diagnosing AFib earlier in its natural history and maybe with a lower burden of disease. We don’t necessarily know if that is as bad as when AFib presents at a more persistent or higher burden stage. So one of the key questions now pertains to the burden of AFib — is even a low amount of AFib sufficient to cause a risk for stroke? Or is there a threshold at which atrial fibrillation burden truly confers greater risk? That question is important, because it also informs whether we should be screening for AFib — such as opportunistic screening, meaning catch-as-catch-can in an office or pharmacy (such as at the time of a flu shot or in the ER). Also, should we screen all people over a certain age? There is consensus that we should try to check the pulse in older individuals, but there is not consensus about whether we should be using mobile devices or EKGs to do this. Even more controversial is whether we should be systematically screening, meaning if everyone over a certain age or with certain characteristics should receive screening for AFib. There are some exciting studies such as the VITAL-AF Study, which is assessing the effectiveness of digital health devices into primary care practices, and the unit of randomization of that study is the practice. Therefore, certain clinics are receiving kiosks and devices to screen every individual seeking care at the primary practice who is over the age of 65 and does not carry a diagnosis of AFib. They are screening these individuals and comparing the detected AFib cases to those in practices who are getting conventional care to see if there is an incremental benefit to a screening strategy. Other studies are coming that will also be powered to evaluate whether screening leads to treatment, which in turn confers a reduction in stroke risk. There is potential that screening with these devices leads to treatment and benefit, but that has yet to be definitively shown, in my opinion. So these are some interesting areas of how to use these devices to improve health instead of complicating health care. 

The other question, as I see it, is how do we better manage AFib patients once they are diagnosed? Specifically, many patients with known AFib who have a high stroke risk never get prescribed oral anticoagulation therapy. This has been a focus of the Get With The Guidelines-AFib — it is known that patients are coming through the healthcare system who have a high CHA₂DS₂-VASc score and known AFib, but for a variety of reasons, they are not being prescribed anticoagulation. We have an ongoing collaboration between our team, the HRS, and a really great team at the University of Florida Jacksonville; this collaboration is focusing on a system that we designed with our Get With The Guidelines team to automatically calculate the CHA₂DS₂-VASc score to determine if a patient receiving care has a diagnosis of AFib, query their medicines to see if they’re on an anticoagulant, and provide an alert to the clinician who is about to provide an ambulatory care visit or encounter. In some cases, they are not aware that the patient with AFib was eligible but not receiving anticoagulation — it’s a historical event that they may have missed. In other cases, there is patient refusal, bleeding, or other issues, but we don’t yet know all the factors that are driving this gap between known AFib at risk and treated known AFib at risk. This study is called the SUPPORT-AF Study, and some preliminary data are already published. It’s a very exciting project that will bring the electronic medical record that we have implemented here at UMass and have a very positive effect on the overall treatment rate. We talked earlier about quality being a point of emphasis — we have seen remarkable progress across our health system since implementing these programs. We have gone from 40-50% of our patients being treated with anticoagulants, to now up to 70-75% of our patients with AFib being treated. These are huge differences with a real impact on stroke risk. We are excited to hopefully teach other institutions how to implement this.

What is your main take-home message for patients with AFib?

My main take-home message is to learn about your disease. There are so many great resources out there including clinician perspectives, healthcare provider perspectives, and most importantly, patient perspectives. There are a variety of great, well vetted, and accessible mechanisms to learn about your disease. It’s important to also understand the risks of AFib. Prash Sanders and others have some important work showing the benefits of changing habits and health behaviors, including weight loss, blood pressure control, mindfulness, exercise, and reduction in alcohol. In addition, use the available resources out there to engage your healthcare provider in a conversation about your AFib. How does it affect you? What are your triggers? Everybody is different. 

We also need to consider the influence of genetic factors and family history. We are learning a lot more about this area in general — this is an exciting space where I think we are on the precipice of personalized medicine for AFib as far as genetics and treatment strategies. There is some exciting work being done by Steven Lubitz, Patrick Ellinor, and others, in which they are creating genetic risk scores that pair with clinical risk to help figure out whether or not to treat or what the risks are. 

It’s also important to learn about the risks and benefits of the treatments we currently have. We have more tools now than ever before to monitor and treat AFib, whether that is left atrial appendage occlusion devices, mapping and ablation techniques, and new anticoagulants that are safer and better tolerated than ever. However, all these strategies come with risks. Patients have to be involved in talking about what their fears are in order to make a better choice and help their healthcare provider advise them. 

Finally, the HRS has an app that allows patients to do some pre-work before their visit; they can calculate their stroke risk score, view frequently asked questions, and highlight the ones they want to ask their doctor. The app was co-designed by a variety of different stakeholders, and I believe UMass is looking into implementing this in the clinic as well. By filling out a few questions, patients can make better decisions about their care around anticoagulation. There have never been more tools available for healthcare providers and patients, but ultimately it comes down to knowledge, trust, communication, and competency. Patients must trust their healthcare provider and communicate effectively, and own their disease, their care, and their outcome. Over my tenure as a doctor, I’ve seen so much improvement in what can be done for AFib patients, but we also have a long way to go. I think we’re helping patients with AFib live longer and better lives. 

Is there anything else you’d like to add?

This work is part of an interdisciplinary team, and I’m very grateful for the support that my patients, partners, staff, and the leadership of the University of Massachusetts Medical School and Medical Center have shown me and my team. It’s great to see these quality initiatives be embraced as part of our identity as an institution, and I think our patients have benefited a lot from it. I’m proud to be on a team that is trying to do the right thing. 

Click here to see our earlier interview with Dr. McManus from October 2017.

Disclosures: Dr. McManus has no conflicts of interest to report regarding the content herein. Outside the submitted work, he reports research grants and consulting fees from Bristol-Myers Squibb, Pfizer, Apple, Fitbit, Samsung, BIOTRONIK, Flexcon, Boston Biomedical Associates, Rose Consulting, and Philips.