Home Monitoring for Heart Failure: About TIME

Melissa K. Walton-Shirley, MD; Ileana L. Piña, MD, MPH; Clyde W. Yancy, MD, MSc


October 15, 2013

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Melissa K. Walton-Shirley, MD: Hi. I'm Dr. Melissa Walton-Shirley. I am here at the European Society of Cardiology Meeting 2013 with Dr. Ileana Piña and Dr. Clyde Yancy, and we are going to have a great discussion today about the IN-TIME trial. I wanted to speak a little about this trial. It is a German study of wireless monitoring of implantable devices for heart failure management, and Clyde, until now, we have mostly had negative or lackluster reviews for remote monitoring. I remember Bill Abraham presenting a trial that I had great hope for that really didn't amount to a mortality reduction. So what is different about this trial?

Clyde W. Yancy, MD, MSc: You know, I actually think this trial is more of the same. I recall DOT-HF in particular, which was yet another study that attempted to do telemetry of implanted devices, and it ended up giving us too much information, more alerts, more interventions, some of which didn't benefit patients nearly as well. It is not to say it is not a bad idea, though; it is simply to say that this is another bit of information in the global cascade. This does not answer the question. It doesn't tell us exactly what we should do. Moreover, we don't know exactly what pieces of information were uploaded to the central server, nor do we know, as Dr. Piña and I discussed, whether or not we understand what it is the physicians who were taking care of those patients did with that information. Until we see the quality of the data that were uploaded, until we understand the treatment algorithms, whether there were responses to those uploads, it is hard to interpret this in a context of anything but another one of the studies trying to identify a way to add this functionality to implanted devices.

Mortality Benefit

Dr. Walton-Shirley: Ileana, can you speculate as to why this trial drove a mortality benefit?

Ileana L. Piña, MD, MPH: That is, to me, one of the most interesting parts of this. I don't know what drove the mortality benefit. We have seen so often in heart failure surrogate factors that get better, but they don't translate into mortality benefits. We'd like to think that we are consistent, and so until this is published, I am going to reserve my opinions.

What I do think is pertinent -- Clyde alluded to it -- is who takes care of these patients? The majority of heart failure patients -- and we have gone through this before -- are not with us. They are in the primary care environment. They are with a general cardiologist. How do you process information that is coming to you remotely when, very often, even things like simple weight gains may be difficult to assess, to monitor, and to do something about it? So with 5 lb, do you do 20 mg of furosemide or do you do 40 mg of furosemide? We have no standardization of that type of care, so who monitors the monitor is always a question that I ask.

Dr. Yancy: Melissa, it actually goes a little bit deeper than that because what is different here is that it is not a trial of an implantable cardioverter-defibrillator; it is not a trial of an angiotensin-converting enzyme inhibitor or beta blocker. The intervention is a strategy, and so if lives had been saved just because the idea, the concept, the process of care is what was impactful, then that means we need to know specifically how this process was developed, with what information pieces and with what activities initiated after the data were uploaded. It is critical that we know those other pieces of information.


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