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“It is safe to use, has high efficacy and reduces healthcare burden”

“It is safe to use, has high efficacy and reduces healthcare burden”

Niraj Varma and Thomas Vogtmann both led studies on the Biotronik Home Monitoring System. They spoke to Cardiac Rhythm News at the ESC 2009 Congress in Barcelona, Spain.

Can you tell us about the TRUST and MoniC studies and what the results showed?

Niraj Varma: The Biotronik home monitoring system is different to other home monitoring because it is a fully automatic system. The patient does not have to be involved. My study was called the TRUST study and it examined the efficacy and safety of this system and also its ability for early detection. It was a one-year, randomised study. We brought patients without home monitoring in every three months for face-to-face consultations and in the home monitoring patients we brought them in at three months, but then we did not ask them to come to the hospital for a year. In between we tested them every three months online using the remote monitoring data. If necessary we asked them to come in to the hospital. The results show that, from a primary endpoint point of view this regime is safe – not seeing a patient for a year was safe, and did not compromise patient safety. It also reduced the burden of healthcare utilisation by almost 50%. At the same time it enabled early detection so we could detect significant events such as arrhythmias within 24 hours. So the major outcome of the TRUST study is that it shows that it is safe not to see the patient with remote monitoring for up to a year. It also reduces hospitalisation burden and provides early detection.

Vogtmann: We studied centralised home monitoring in the MONIC study. What we wanted to do is see, on the one side, how much time we need to spend analysing these data because a lot of people starting with home monitoring are afraid of a “flood” of data. To achieve that we had a daily transmission with many device parameters and clinical parameters, which acted as a filter structure to focus on the clinical relevance. We opened up a study centre where we analysed the data of 10 satellite clinics from university hospitals in Germany and Austria. We wanted to find out how much time we spent was spent on analysing the data and how effective it was. Ultimately, we wanted to find out if the centralisation of the data was feasible and how much time was needed to analyse the data on a daily basis. Also we looked at safety – is it safe if you just have access to the remote monitoring data or are you missing any predictable adverse events. We also looked at the effectiveness of the analysis: Is what we are passing on from the clinic of clinical value? We studied a mixed patient cohort with ICDs and pacemakers and some of the results show that the workload in the monitoring centre takes less than 30 minutes for the analysis of 100 monitored patients.

What have been the barriers to home monitoring so far?

Vogtmann: A lot of people do not know how to handle the data but if you take some time to discuss your own workflow in your clinic then the system can be adjusted to the needs of the patients, and tailored to the needs of the patient. You then have the most benefit and the time effort is very low. That is something that needs to be addressed in the very beginning because people are scared of handling so much data.

Varma: We have been waiting for the studies to show that the technology is robust. TRUST shows that remote monitoring is safe to use and has high efficacy. It also reduces healthcare burden. At the same time, it helps early detection, which can only enhance patient safety. TRUST will be published in the next few months; the results were shown at AHA last year. It is the first multi-centre study to assess home monitoring. The other thing to consider is reimbursement. In the US we are lucky because we have reimbursement for remote monitoring which applies very well to the TRUST design. Germany also has reimbursement.

From MONIC we are going to get some very critical data about how key personnel who use remote monitoring on a day-to-day basis – that is the nursing staff and the technical staff –can apply it and how they may have to change some aspects of their workflow patterns, because use of remote monitoring does affect this. We have adopted remote monitoring at the Cleveland Clinic and every ICD that we implant is capable of being monitored remotely, because we recognise its utility. Without it we simply could not function properly because we have a huge volume of patients and this is facilitated by the use of home monitoring. But it does mean we have to change workflow patterns and the MONIC study will provide data on how we should assess all these data and how we should configure our devices.

Once collected, how is the data accessed?

Vogtmann: You can adjust the system to your IT applications. With the remote monitoring device you can access the data from the worldwide web: that is the easiest way. You can access it from any computer that has access to the Internet. If not, the data are available in hard copy, by fax. Or you can get an SMS, or an email message, so there are many ways to access the data. The other nice thing this is you can access the data from wherever you are. For example if the patient calls and you are on the ward and not in your office you have easy access to the data from any computer, so I think that is a real benefit of the system.

Are the data from the remote monitoring device stored with patients’ medical record?

Varma: We have electronic medical records and we are still in the process of fully implementing connectivity so remote monitoring data can be directly uploaded to the electronic medical record. That is the ideal – all the companies working with remote monitoring are trying to configure this. At the moment in our hospital we have some interfaces that provide uploaded remote monitoring data for pacing systems which interact with our electronic medical records but the fact that we are using remote monitoring now is driving this need for connectivity between platforms. That is the stage we are at – we are still in a process of evolution.

What is the future for remote home monitoring?

Varma: We have established that home monitoring is a robust technology, now we need to apply it to wider and wider groups. We are looking at several outcome studies for atrial fibrillation and for heart failure management and I think there is a lot of potential for using remote monitoring in those groups because it provides early detection. If you can tell there is something going on so you can prevent hospitalisations in that group.

Vogtmann: The technology for using the device monitoring system is all there and I think the next step for the companies working on it is to develop remote monitoring to be used as a disease management programme so that it is not only looking at the device but at the whole disease of the patient. We are running telemedical projects in heart failure morbidity and mortality studies in our institute and a lot of the sensors that are used there are already integrated into the devices, and there will be more in the future, so I think that in the next five years the focus will be to change it from a device follow-up to a disease follow-up system.