100K patients: Wireless-enabled ICDs halve mortality rate

By Brian Dolan
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Dr. Leslie SaxonThe University of Southern California's Chief of Cardiology and Executive Director of USC's Center for Body Computing, Dr. Leslie Saxon authored a study published in the medical journal, Circulation. The study followed more than 100,000 patients across the US. who have implanted cardiac devices -- cardiac resynchronization therapy (CRT) devices and implantable cardioverter-defibrillator (ICD) devices. The study examined survival rates among those patients with wireless-enabled devices and those with no wireless-enabled tracking.

The study concluded that those patients whose ICD included wireless-enabled tracking faced half (50 percent) the mortality rate than those who only received follow-up care at device clinics. MobiHealthNews had a chance to interview Dr. Saxon about the study results.

MobiHealthNews: With efficacy studies today it seems like the press pans the entire connected health industry when there's a failure and celebrates the entire industry when a study proves to be a success. How would you contextualize the results of this study? Who do these results effect?

Saxon: This study's results effect hundreds of thousands of people today. The type of implantable device we looked at is going into upwards of 15,000 to 20,000 patients a month. These are patients that have incurred very high costs within the medical care system. That's because they have a very expensive piece of hardware inside them -- either a defibrillator or re-synchronization device -- because means they have heart failure. Heart failure is the number one diagnosis for patients admitted and discharged from hospitals today. It is extremely expensive to treat this type of advanced heart failure because the re-hospitalization rate is upwards of 40 percent.

In this study we followed these patients who have $20,000 to $30,000 devices implanted in them. We looked at survival rates of these 100,000 patients and the survivals are really good, which is gratifying because there is a lot of upfront costs to putting one of these devices in somebody. A lot of naysayers have said they don't want to use US healthcare dollars on these high tech devices in sick patients. Guess what? Over time it turns out to be very cost effective. It's a good bet. That is important for patients with heart failure, because the incidence is rising. This is the first study to show this is a worthwhile and durable therapy from an economic standpoint. We are in the process of doing some economic modeling on it, but it looks very good.

The second thing and the most profound is that for those patients who were followed remotely and actually engaged in a system that they would go and answer questions every week about their disease severity symptoms. For those patients that were transmitting their symptom data weekly and blood pressure data and everything stored in their implanted device had half the mortality of the patients who didn't do that. If you treat patients like this in a partnership model versus a traditional paternalistic "I'll tell you what to do, I'm a doctor" model, then you will get a continuous flow of information about patient symptoms that you can act on. So, if something changes on Sunday you are going to be able to see it and react to it quicker. I think that partnership and that continuous ability to react to change is what makes the remote monitoring work.

That is really profound, because right now half of the doctors putting in these devices are not offering the networked follow-up to their patients, which blows my mind, personally.

Did the connected device help patients self-manage?

Well, during the study we noticed the connected patients were suddenly looking and noticing things. They say: "If I take my drug at this time and drink enough water and see this improvement, maybe I can eat Chinese food on Sunday." They are able to give themselves rewards based on what they see, which is important. It is very hard to take six drugs and live your life like you are on a restricted diet constantly, which is how it feels for a lot people. Their ability to see what makes them feel better makes our work as doctors more efficient too.

Right, I was just going to ask. How much work is it for the provider to manage all the data coming in from these connected devices?

We can review this data very quickly -- in one or two minutes, really -- because the way it is presented is very efficient. It is exception based. The data only shows where there are changes or if there is an alert or alarm. Our advance nurse practitioners can spend just a half hour or so a day and review more than 400 or 500 patients. We find that we often never see these patients. We only bring up the ones that need our attention. Then we can bring those patients in or call them up. This allows us to keep more patients out of the clinic and keep the focus on those patients that need to be there. We have even intervened earlier to where we think we decreased hospital admissions.

What was really impressive about this study were the numbers of patients involved: More than 100,000. These are real patients not in clinical studies being treated across the US and we know how they are doing. That's particularly interesting data for everyone -- at least for this particular vendor's hardware.

What's next? What does this new data bring about?

We have to continue to grow out this field. We have to figure out important ways to enhance this system. I would like the patients to see the data that they are transmitting to the physician. They are currently blind to a lot of it. I would like patients to learn their own data. We should create interesting software applications to motivate and reward patients to further connect them to doctors. We can do this through a mobile device since a lot of this data is now liberated to a mobile device. These communicators are currently landline, but I think they should be cellular-based. Maybe the patients don't have a landline. They should be able to transmit the data from wherever they are. There are some privacy issues related to that but nothing that can't be overcome.

We always hear about the potential of telehealth for wellness or fitness, but I think the chronic condition side is just huge.

I think the potential is talked about all the time, you mentioned privacy, but what else is holding it back?

Making sure that the data going to a smartphone from a device -- well the FDA has something to say about that. The companies that own and collect and store this data are held to a very high standard for security and privacy. The FDA and FCC have to understand with telecom companies what the new standard is going to be for this type of medical data coming out of medical devices implanted in patients. It certainly needs to have a higher level of security than hockey scores, right?

Is the hold up with the FDA/FCC or are we waiting on these technologies?

No, I think the data has just got to emerge and when the first companies are ready they need to test it at the FDA. You need to get a dialogue going on between the FDA, telecoms and these device makers to determine these standards. This is starting to happen now and we are trying to help enable that at the Center for Body Computing.

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