In this feature interview, EP Lab Digest speaks with Sidharth Shah, MD, MS, FACC of UNC Health in Raleigh, North Carolina, about his use of the LUX-Dx™ Insertable Cardiac Monitor (ICM) System (Boston Scientific) to provide more proactive care in heart health.
How does the LUX-Dx ICM device work?
There are three main components of the LUX-Dx ICM System (Figure 1): the device itself, the myLUX™ patient app that comes with it (Figure 2), and the data behind it, managed through the LATITUDE Clarity™ System. The device has a dual-stage algorithm that helps identify arrhythmias with high fidelity, and more importantly, reduces the error from excessive false positives.
That is a huge step in terms of where we are at with device monitoring in general. Right now, the biggest obstacle to correctly diagnosing patients and then coming up with a treatment plan is that a lot of the monitoring, whether it takes place through a wearable or implantable device, does not have the fidelity of signals that allows physicians to make a true determination of what the patient is experiencing. This can have a great impact on a patient’s life when deciding between having to take a blood thinner or undergoing an invasive procedure such as an ablation or device implantation. The fidelity of the signals is very important in eliminating false positives. Truly assessing the diagnosis of arrhythmia and its correlation to symptoms is at the forefront of this patient care model.
The myLUX patient app allows patients to take a more active role in their healthcare. Both previous and currently available ICMs have not allowed this, so there has been a disconnect between what symptoms the patients are feeling and what the data is showing. Therefore, the myLUX patient app allows patients to do a deeper dive than with traditional models. For electrophysiologists, the organization of the data is paramount in how we diagnose and come up with a treatment plan for our patients. Organizing that data in a way that allows us to assess it, review it with the nurse practitioners on our treatment team, and design a specific care plan is very important.
In addition to the innovative way the data is presented, I like how the data is accessible, not only at in-person office visits, but remote visits as well. Allowing the physician to have a glimpse of the patient’s arrhythmia without the patient ever having to come into the office is a very important feature of this device, especially with the impacts of COVID-19 and having access to care. I practice in Raleigh, North Carolina, and we have 17 offices that span the eastern part of the state. While Raleigh is a very big metropolitan city, there are several of our offices that work with underserved communities or regions without easy access to care. I was lucky to be part of a group that was one of the first to set up a robust remote monitoring system, which allowed our patients with tenuous access to our facilities to check in with their data from a remote location. Now with COVID-19, it’s even more important to avoid unnecessary time in our waiting rooms to reduce the risk of transmission. It allows our patients to take some solace in the fact that we can view their arrhythmias from home and make any adjustments that need to be done outside the office.
What are the key features of this device?
Importantly, the myLUX patient app helps patients stay connected. The interface is very intuitive and easy for patients to navigate. In the past, every time a patient would have a symptom, they would have to phone in or hit a button on the device, and then write down the symptom into a separate journal. The myLUX patient app interface allows patients to directly correlate their symptoms through the app to the provider. This offers the ability to show real-time correlation between symptoms and what may be going on from an arrhythmia standpoint.
On the website, the data is organized in a simplistic but powerful way. The color codes and bar graphs allow ease of streaming through hundreds of patients and tons of data to pull out the most important aspects. Rhythms, specifically atrial fibrillation (AFib), are analyzed with a two-step process. These beat-to-beat variabilities are verified, which offers a true assessment and a robust way of approaching and verifying arrhythmias.
What types of patients do you typically recommend the LUX-Dx ICM for, and why?
Candidates for the LUX-Dx ICM are patients who have had symptoms of palpitations, dizziness, fainting, passing out, and cryptogenic stroke. Aside from stroke, a lot of these patients do not have symptoms every day but occur often enough that the symptoms are bothersome. Most of my patients who have been implanted with the LUX-Dx ICM have already had a wearable monitor for some period of time and have either had nothing show up on that monitor, or are still having symptoms despite the wearable not showing anything. A lot of my patients have also had compliance issues with wearables where their body habitus, excessive hair, sweatiness, or vocation does not allow them to have a wearable device. Having an ICM such as the LUX-Dx ICM allows us to closely follow their arrhythmias without any issues.
A lot of what I do is also within the realm of ablation, and we typically will use the LUX-Dx ICM to follow patients longitudinally. Since the battery life of the LUX-Dx ICM is up to three years, it allows us to work with a patient who may have symptomatic AFib and find ways to best approach it. Not everyone wants an ablation or medication, and implanting the LUX-Dx ICM has helped me manage these patients at the start of their care and guide therapy for up to three years. Alerts that show up on the device allow us to better focus and tailor the therapy in real time.
What need does the LUX-Dx ICM meet for patients and physicians that was previously unavailable? How has this specifically helped patients?
As an electrophysiologist, and especially given where we’re at with the pandemic, I think moving away from manual in-person adjustments and evaluations has been the biggest thing. We now have a way to help our patients in a manner that can be done remotely. LUX-Dx ICM is the first ICM device in the United States to offer remote programming. We don’t require adjustments in the office — we can do that now with a very high fidelity of signals that allows us to make decisions based on true data.
In the past, data could often be filled with false positives, undersensing and oversensing, which led to frustration from all parties. But with the LUX-Dx ICM System, we now have a way to offer high-fidelity signals and use this program to verify arrhythmias. Most importantly, it can be done away from the office.
Can you give a specific case example of how you’ve seen the LUX-Dx ICM device work for one of your patients? How did the device improve the patient’s outcomes?
Yes, I have a male patient who was referred to me for management of his AFib. He has a commercial driver’s license, so for him, any sort of pacemaker or defibrillator would mean an end to his employment. However, he has AFib that is difficult to control. He was sent to me for defibrillator placement, and during our visit he almost had tears in his eyes. “Listen,” he said, “if I have to have this defibrillator, I’ll lose my livelihood and wouldn’t be able to support my family.” We knew that he had a brief history of AFib dating back from some previous EKGs done in the hospital. The suspicion was that he had a tachycardia-mediated cardiomyopathy.
We agreed that if we implanted the LUX-Dx ICM device, we could better assess his AFib and tachycardia burden, and come up with a specific treatment plan so that we could better control his heart rate. With his busy lifestyle and having to drive all over the country, we told him that he would always be able to check in with the app. He said, “Doc, I don’t always have the best access to clinics, so I’ll often go into an urgent care or the ER.” However, with the LUX-Dx ICM System and myLUX patient app, I’ll be able to remotely check in with him and we can continue our plan of care that accommodates his lifestyle. That is helpful, because it’s not a treatment plan that is based off of visits that are every six months or every year, but in real time. While he may be anywhere in the country, I’ll be able to check in with him and, if need be, make some medication adjustments because his heart rate is too fast. In short, I think the LUX-Dx ICM System also allows our patients to really be part of their healthcare treatment plan. Not just be a recipient of care, but an active participant in how the treatment is carried out and how it is delivered. That is very powerful.
What kind of impact has this device made on your practice?
I feel as though the LUX-Dx ICM System allows us to provide proactive care for our patients, especially right now where proactive care is necessary not only in terms of preventing further disease burden, but also during these times where delivery of healthcare is changing. Physicians and providers are all increasingly offering care through virtual visits and clinics, and that is becoming more of a mainstay. Therefore, the face of healthcare is changing, and the LUX-Dx ICM System has taken it to the next step and allowed for the streamlining of virtual care. The idea of providing care that is based on real-time adjustments and not what you see directly in the office is going to be very important as we go further into this pandemic and beyond. Allowing patients who may not have access to care, regardless if it’s during a pandemic or based on where they live, and allowing us to participate in their care and make real-time adjustments is going to be the future of all medicine going toward.
Could this have an impact on the EP field at large as well?
Yes, I think this platform will be looked at as an ideal model for how data gathering, management, and action will be used for future devices and platforms, whether that is defibrillators or pacemakers. I even had a colleague reach out to me recently about the LUX-Dx ICM System because he was so impressed with the capability to make real-time adjustments and look into the data, that he wanted to potentially use the platform to apply it to his heart failure clinic. He was interested in the same principles of keeping patients connected, reducing the burden of data being sent to clinics, having a platform that provided an easy and systematic review, and being able to enact on treatment plans through his heart failure clinic. I think these concepts will go beyond EP, and that is exciting.
Finally, how are remote programming capabilities and the LUX-Dx ICM System especially beneficial during the COVID-19 pandemic?
That is a very good question. Number one, I think the fact that patients can record their symptoms, and clinics can let patients know that they have reviewed their data through the myLUX patient app is huge. They can do that from the comfort of their own home, work, or anywhere outside of the hospital or office setting. From our end, our exposure is also important. We seamlessly go back and forth from the hospital to our clinics, and many of us are taking care of patients with COVID-19 or their families who have been exposed; therefore, any method that reduces our contact and maintains social distancing without sacrificing care is key. During a pandemic, physically reducing the capacity of our waiting rooms and allowing some patients, such as those with the LUX-Dx ICM System, to be checked in from home is essential. It allows us to provide state-of-the-art healthcare through innovative ways without exposing or compromising our care to patients.
Boston Scientific sponsored this article. Images of Boston Scientific products provided courtesy of Boston Scientific.
Dr. Shah is a consultant for Boston Scientific, but was not compensated for this interview.