The use of remote monitoring for patients with implantable devices has many benefits. The use of home monitoring directly involves the patient in their own care and greatly improves the speed of detection of possibly dangerous changes in their cardiac rhythm or other parameters. By timely detection and treatment of these changes, patient outcomes are improved. Furthermore, it allows the accumulation of large amounts of valuable data and, for example, allows the study of the precise electrical changes preceding, during, and after an administered shock. Join Dr. Saxon and Dr. Hayes as they discuss this new frontier in management of patients with implantable devices.

Leslie Saxon, MD: Hello. I'm Leslie Saxon, Chief of the Division of Cardiovascular Medicine at the University of Southern California (USC). I'm joined here today, at the Heart Rhythm Society (HRS) in Denver, Colorado by my good friend David Hayes, Professor of Medicine at the Mayo Clinic in Rochester, Minnesota.

Today we're going to discuss: "The Value of the Networked Patient: Improving Patient Survival."

David Hayes, MD: Leslie, from your standpoint, you've heavily been involved in remote monitoring since it started, do you think it's revolutionary from the standpoint of what we do?

Dr. Saxon: I think networked medicine will absolutely change the medical paradigm. I like to think about networked medicine and its implications in the setting of Moore's Law, which basically states that the number of transistors on a chip will double every 2 years, and while that is over 30 years old now, it's really been true and not just for medicine.

I like to use the music analogy. I don't know if you remember this device, the portable tape player, but it really revolutionized the way we work and live. That was followed by the Walkman™, which made music portable for the first time, and then the real game changer was the iPod.

For the first time we could choose our songs, we didn't have to buy an album, and it completely turned the music industry on its head. With the iPod came this increasing consumer sense; as music consumers, we wanted our devices to reflect us and our personalities, so we got into fashion technology.

Then we wanted personal entertainment on our devices and portable applications, and we wanted personalized applications, so we could live and work in a very different way.

It really freed us and changed our lives.

Unfortunately, the medical model hasn't changed much since Hippocrates. It's very paternalistic. You have a father-figure physician in a room dispensing advice to a very vulnerable, often unclothed, patient and that information is going basically nowhere outside of that room, unless you get a hold of that physician, and that hasn't changed at all. Yet we have a real game changer in medicine, which is the defibrillator.

Here is the external defibrillator, developed years ago, and as you know, survivals from cardiac arrest went from 2% to over 90%, if you have a cardiac arrest and you can be defibrillated. The defibrillator really is the iPod of medicine, because now you have an implanted device that, if you're at risk for sudden death, can change your survival from 2% to 98%. The question is, are we going to exploit that device for the patient, who I think is the new healthcare consumer, in order to improve our outcomes.

At USC, we've been very interested in using physiologic functions in the network. We developed this little heart patch at a conference we had that you've attended, the Body Computing Conference. People told us we're ahead of our time talking about networked medicine. Last year, the third year of the conference, we had real products. We put this network patch on kids, they broadcast the heart rate to their friends, and they become the patient of the future by being very familiar with their body computer, their physiologic function, and they wear a body tattoo, which is a heart rate monitor.

My vision is of a universe where you have gaming, you have patches like the one shown here, which is manufactured by a company called Corventis, Inc., that monitors heart rate, thoracic impedance, and position. There is networked defibrillator information streaming to our personal devices as part of our applications, and healthcare becomes like many other things in our lives, a part of our daily living; we open up the healthcare information stream. I know you're very involved in this work of networked medicine and information at the Mayo Clinic; you've been real leaders in this area.

Dr. Hayes: It's fantastic to see this last iteration that you've shown and how you connect the patient, especially the children. From the standpoint of the remote monitoring, it seems like that's really going to be the next step. Besides them transmitting without any effort, and it's showing up in our office, they will only get more and more involved in this. It's probably worth pointing out the different remote systems that we have.

Dr. Saxon: That's a great idea. Basically we're looking to change medicine with this networked information.

Dr. Hayes: You and I have a lot of experience with multiple remote monitoring systems and are involved with the LATITUDE^® system quite a bit. However, there are multiple systems and they all vary a little bit, but people need to understand the devices that they work with and understand the paired monitoring system, exactly what they get for their patient and what they can offer the patient to improve care.

We have the Boston Scientific LATITUDE^® system, the Medtronic, Inc. CareLink^® system, the BIOTRONIK Home Monitoring^® system, and Merlin from St. Jude Medical. One of the things we were all concerned about is the amount of information that we're getting. We would be overwhelmed with the amount of information, as it comes across any of these devices, which the patient has to get used to. Also the different alerts that we're now getting have really made it easier, and it's not so hard to sort through this information the way it's being processed for us, is it?

Dr. Saxon: I think this is an exception-based idea, just like an implantable cardioverter-defibrillator (ICD), it only tells you when it's shocking for a fast heart rhythm, otherwise it's looking, but you never hear about it. Considering this is first-out-of-the-box for these systems, this exception-based reporting has been extraordinarily helpful.

We'll get into this a little more, but large amounts of data are emerging showing that this really impacts patient outcomes. The other thing worth mentioning, because I think the national data, at least with the LATITIUDE^® system, indicates that about half of all implanters, for some reason (maybe it's just awareness), aren't referring their patients to remote follow-up. There's an excellent reimbursement for remote follow-up. It's guideline driven, and our society recommends remote follow-up and Medicare pays for it. So if there are data that improve patient outcomes, there's really no reason not to use them.

Dr. Hayes: Right, because it can only make things better for the patient. Certainly from our standpoint, patients have been really accepting of the therapy, in fact they love it, or I should say the convenience of having the remote monitoring. For us, it has, even though we still have a nurse who's going through all of the data and we're signing off on it and looking at it, a lot fewer visits and as we're reimbursed, it works out great.

Dr. Saxon: Consumer patients don't just want the 4-month visit with the doctor and a little bit of information in 5 minutes. When the patient comes in, they want multiple touches. If you convince a patient to get a primary prevention ICD or cardiac resynchronization therapy (CRT), and that's the reason 80% of them are going in, they deserve frequent follow-up and if they have an episode of atrial fibrillation (AF), you don't need to learn about that at 3 months and 29 days, you need to learn about that the following day so you can intervene; I think patients really appreciate that.

Dr. Hayes: I saw a patient this past week who had had some shocks and was psychologically very disturbed, and was not on the remote monitoring system. Simply offering that to him, and having the patient knowing that that was in his house and somebody or something was monitoring him, has made a world of difference, or at least it has had an immediate effect on his confidence in the device and what we could do for him.

Of the information that's out there, the other thing is, when you look at the size of the remote monitoring population now, besides (monitoring) being a convenience for the patient and good for us, it provides us with incredible data that we can, as you know, mine from that.

Dr. Saxon: I think nationally there are probably 30,000-40,000 patients a month going on to these systems.

Dr. Hayes: There are probably over half a million patients in the United States at this point in time or easily over that amount.

Dr. Saxon: There are lots of good data. Want to share some of it?

Dr. Hayes: We had looked, as you know, at the percent of right ventricular pacing and the effect on survival. We know from the MOST (Mode Selection Trial), and DAVID (Dual Chamber and VVI Implantable Defibrillator) trial that minimizing ventricular pacing is very important; it's even in the 2008 guidelines for the first time that we should minimize pacing whenever possible. Despite the strength of those studies that are out there, to see that play out in a real-world registry, such as LATITUDE^®, it's really striking.

What we did was to go back and look at survival based on percentage of pacing in the LATITUDE^® population. What we found was that there's a huge difference in survival, depending on percentage, again, verifying what we already knew from the other studies, but now this was in a group of something like 35,000 patients.

Even though there may be some data elements that you can't collect, it's still very striking that the survival, when the patient had more than 4% ventricular pacing, started to drop off substantially. I think it's very powerful information.

Dr. Saxon: Just the numbers, which are 50-100 times more patients than any of those clinical trials you started. Given the expense of clinical research now, the more conservative posture of the US Food and Drug Administration, and the need for post-market registries, I think what you've done here is probably a model for future research.

Dr. Hayes: From a real-world standpoint, looking at the huge population that we've got is just invaluable.

Dr. Saxon: I saw another presentation today at HRS, on this same issue, with 1200 patients. This just dwarves that. I think that these types of studies complement each other.

Dr. Hayes: From the standpoint of ICDs, we can get the same information and you've presented that information.

Dr. Saxon: I have. At the late-breaking session last year, we were very interested in looking at the issue of shock therapy delivery and survival of very large numbers of patients with ICDs and CRTs followed on a network, because the largest clinical trials that were done to prove the case and gain regulatory approval and Medicare reimbursement for ICDs and CRTs were SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) trial, the MADIT (Multicenter Automatic Defibrillator Implantation Trial) studies, and COMPANION (Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure) trial. In total, they randomized less than 5000 patients with the longest follow-up at 48 months. These data are used to determine the cost proposition of the ICD and all of our guidelines, and we're very interested in seeing whether the cost/benefit analysis would look any differently in how these devices perform long term, because all of that cost data are based, essentially, on the upfront cost of the device.

The secondary issue that we were interested in is this very interesting finding that if patients do receive shocks from their primary prevention devices, they generally do worse, and they seem to do worse from a heart failure/survival perspective. So we wanted to either validate these data observed in all 3 trials with ICDs or CRT devices or not.

We looked at these incidences of shock and survival in SCD-HeFT, COMPANION, and MADIT, and our objective again was to evaluate the mortality outcomes and the impacts of shock therapy.

What we showed in a total of around 90,000 patients followed on a network was that ICD and CRT-D survival holds up and it's better, in fact, than what was found in the clinical trials, and it's substantially better at 5 years in tens of thousands of patients, so why is that? That's something that we've talked a lot about. Is it the fact that you've got this new patient consumer who actually feels involved in their healthcare, and that we're breaking down the paternalistic model? And that, at least on the LATITUDE^® system, our patients our telling us what their symptoms are every week by filling out a quality-of-life survey on the communicator? They're getting on a scale, in many cases, they're being prompted by that in-home communicator; they then get a call from our clinics, are we then in more of a partnership? Do the engagement alone and the patient feeling included in the process give them a sense of empowerment or partnership and improve outcomes?

Dr. Hayes: Just like being in any trial, even if you're in the placebo arm, due to the connection you do better. On this, Leslie, you could tell from LATITUDE^® if they had a shock or no shock, but can you say anything about inappropriate vs appropriate shocks?

Dr. Saxon: We can, and this is something that's really fascinated us, that the survival after shock is less (and that validates previously observed trials) than if you didn't have a shock. We think that's because it's a sign that the heart is failing, and that's a very important notification for the physician, to take that patient and take a look at them from the heart failure standpoint a little more, and maybe look at their ischemic burden and other potential therapies that may be available for that patient. We also found that what people traditionally classify as inappropriate shocks, may not be so clinically inappropriate. We have many, many episodes, and the most common cause of an inappropriate shock is AF.

We have many episodes where the device knows that it's shocking for AF, but it reaches the timeout where it will just shock for high rate. In patients with CRT devices whose rate has been over 230 bpm for 5-7 minutes, I think you could argue that a shock for that, clinically, might be fairly appropriate.

Dr. Hayes: With network data, how were you able to tell they were appropriate vs inappropriate?

Dr. Saxon: We hired a bunch of junior people from your institution and ours and all over, to look at all of these shocks and actually look at the electrogram (EGM) at the time of shock therapy, both preshock and shock, and adjudicate every single one of those shock episodes. We're in the process of doing that and we're learning an enormous amount.

Dr. Hayes: It also points out that the amount of data in any network system may have limitations. It also then allows you to go in and do other work around that, like looking at all of these EGMs and deciding what's appropriate. So I think it's great, in terms of how there is almost limitless opportunities to look at this.

Dr. Saxon: I think to be able to really talk to a patient about a primary prevention device and say, "Look, if you have AF, this is your risk of getting a shock." You can really inform patients better. One of the things that just fascinates me, as we follow patients, and Medtronic, Inc. has sponsored a couple of interesting studies, the PARTNER (Placement of Aortic Transcatheter Valve Trial) study and the PREFER (Pacemaker Remote Follow-up Evaluation and Review) trial, recently published in the Journal of the American College of Cardiology, showing that networked follow-up with both pacemakers and devices, particularly CRT-D devices, can help you predict heart failure decompensation and reduce in-clinic visits that improve patient quality of life and reduce hospitalizations, by finding a measure of device predictors of hospitalization. So that you can imagine that we're treating patients more often, we're treating them earlier, and we're preventing these costly heart failure hospitalizations that even our president talks about.

Dr. Hayes: And by the same token, we also looked at, in the CRT population, the percentage of biventricular pacing. Historically, if I saw a patient in the clinic, I would usually like to see, certainly 90% pacing, to know that we're going to get the benefit, and especially if I had a nonresponder, I want to know specifically how much they're pacing.

Then in more recent times, I'd really like 95% biventricular pacing, but we looked at this in the LATITUDE^® population as well, and what we found was that the cutpoint, in all of our CRT patients, was 97%, but the bottom line was that the closer you could get to 100%, the better they were. I've had people say, "Can you really tell though you're not looking specifically at every beat? Could some be fusion beats?" Granted, there are times you just can't answer all of those questions, but for me, this had made a difference, because now when I see the patient at 95%, I'm not automatically happy. If I can do anything to try and get them closer to 100% biventricular pacing, that's what I'm going to do.

Dr. Saxon: That's another major observation, because we may end up seeing a much higher response rate to CRT. That could really change the field and the value of CRT-D devices of patients, at least CRT devices, for patients a lot.

Dr. Hayes: I think this is just the tip of the iceberg of the things that we can go in and look at on either high voltage. I think neither of us have had a lot of experience yet with pacemaker remote monitoring data, but that's also going to become the gold standard.

Dr. Saxon: Absolutely, I think that more and more regulatory committees, in terms of device safety and safety surveillance, are going to be requiring. Monitoring. I know all 3 companies are now doing this, and it's been enormous to safety surveillance to be able to look in at these lead problems and not just depend on return product, and to look for trends across very large populations across the world.

Dr. Hayes: And watch it almost real-time.

Dr. Saxon: Yes, and that obviously will improve outcomes, which is informed product design and lots of other things. We've painted a pretty broad picture here. Is there anything you'd like to close with?

Dr. Hayes: In the very beginning, I was a bit skeptical as somebody who felt you always had to see the patient, that the transtelephonic monitoring for pacemakers, which have been around for multiple decades, pretty much gave us what we needed. I'm a complete convert, especially as we start to look at the population-based data that we're getting out of this. I just think it truly is, as you pointed out earlier, already revolutionizing the way you and I practice.

Dr. Saxon: I think you're right. We have to encourage our colleagues to get on the bandwagon here, because the patients are going to be demanding this information. We're not reaching back to them and letting them share in it. We need to do that. We need to open up LATITUDE^® to patients and families and Merlin and CareLink^®.

Dr. Hayes: You mentioned earlier the total numbers of patients in the ICD studies vs what we have here. We talked about how this validates what we've already seen. Do you see now that possibly going in the other direction? For example, we come upon some nugget of information in these 30, 40, 50,000 patients that perhaps we hadn't realized before, that then will send us back to do a clinical trial?

Dr. Saxon: I think it should go both ways and that'll be fantastic. We have to, as doctors, stop being afraid of sequestering the information, because it's really victimizing us. It's putting us on the hook for a lot more than we need to be and with development of mobile apps, it'll make our lives and our way of dealing with this information better. It frees up our staff to use them more effectively, and I think our patients will demand it and we need to give it to them, and we'll probably be appreciating better outcomes as a result of it.

Supported by an independent educational grant from Boston Scientific.

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