10 questions and answers on remote monitoring of implantable devices

Answers the Dr. Andrea Bernardini, Electrophysiologist at the Cardiology of the SMNuova Hospital, Florence, USL Toscana Centro

1. What is remote monitoring of implantable devices?

Remote monitoring is a service intended for patients with implantable devices, namely cardiac defibrillators (ICD or CRT-D), Loop Recorder (ILR) or some models of pacemakers (PM). The monitoring takes place through the transmission of data through a dedicated modem, directly to the Remote Monitoring Service of the available hospital center and allows remote control of the correct functioning of the devices. In particular, it is possible to check the possible onset of arrhythmias, the operating status of the device and some useful indices to check the patient's condition.

2. What are the benefits of remote monitoring?

The advantages are represented by the possibility of early identification of any technical problems with the device and above all monitoring the possible onset of arrhythmias (for example atrial fibrillation), reducing checks at the hospital. These advantages are particularly useful for patients who have access difficulties due to problems of distance, transport or infirmity.

3. Can it be considered an emergency service?

Remote monitoring is not an emergency service! It is used exclusively to remotely and not in real time control the operating parameters of the device and any arrhythmias detected. In case of emergency or the need for an urgent medical check-up, the patient must still call 112 or 118 or go to the nearest emergency room. In fact, transmissions sent via Remote Monitoring are not viewed immediately after their transmission.

4. How does remote service activation work?

The transmitter dedicated to remote control is delivered to the hospital, after the implant or during hospitalization or for subsequent checks. Given that each manufacturing company has its own activation mode and type of transmitter, generally to activate the operation it is necessary to connect the transmitter to a power outlet and, if required, carry out a first manual transmission as explained in the package leaflet. Some Loop Recorders (ILR) connect directly to the patient's smartphone via a dedicated app. The transmitter package always contains detailed documentation regarding the use and operation of the transmitter. Once the first transmission has been made, the transmissions will then be automatic, programmed according to a predefined frequency, without the need for patient intervention.

5. How does the Remote Monitoring service work?

The data from the cardiac device is sent automatically (or in some cases manually) via the transmitter to a dedicated secure server, which can only be accessed by healthcare personnel authorized by the Center, who will examine the data sent by the device relating to its operation and any recorded arrhythmias. Transmissions are usually reviewed within a week of the Center, but in some centers the assessment intervals may be longer, even a few months. The patient is contacted only if technical problems or any recorded arrhythmias emerge or if scheduled transmissions are not received.

6. Are all devices compatible with the service?

Almost all ICD devices (single-chamber, dual-chamber, biventricular defibrillators) and IRLs are equipped with remote monitoring, while for PMs, on the other hand, only the most modern devices allow it. You can contact the Center where the PM has been implanted to ask if it is possible to activate remote monitoring.

7. What are the limitations of remote monitoring?

Monitoring cannot provide detailed information on some clinical problems (such as breathlessness, feeling faint, chest pain or palpitations). In the event of urgent problems (eg device discharge) or feeling unwell, it is necessary to go to the nearest emergency room or to make a cardiological examination. On the other hand, in the case of non-urgent problems, the patient can contact the Remote Monitoring Service to ask for information, instructions and / or advice.

8. What is the current status of the monitoring service in Italy?

Over the past 10 years, the number of PM implants has doubled, while that of ICDs has even multiplied nearly twenty times. The population of patients who regularly access periodic monitoring and remote monitoring services has literally exploded in a very short time, with a consequent significant increase in the workload for doctors and personnel dealing with remote monitoring. However, in the meantime, the human and professional resources of the health structures have not grown proportionally and only recently has the Remote Monitoring Service been included among the services provided by the Health System. This means that in the Italian territory there is a wide heterogeneity of efficiency and management in the Hospital Centers with remote monitoring service. But the patient can request to be followed by a center other than the implantation center, in another center where the remote monitoring service is more organized to carry out the evaluation of the transmitted data.

9. What to do in case of prolonged absences from home?

The patient should always carry the transmitter with him in case of prolonged absence from home, for example on a vacation; the transmission of information works free of charge throughout the Italian territory. In case of trips abroad, the patient should contact the assistance service of the manufacturing companies to inquire about the coverage areas of the service.

10. What can I do if my monitoring system does not seem to be working properly or gives an error?

The first step is to contact the After-Sales Service of the manufacturer of the device. The telephone addresses of the main implantable device companies are listed below:

Abbott: +39 02 3596 1070 or mail to supportmerlin@abbott.com

Medtronic: +39 800 20 90 20 or mail adirecto.italia@medtronic.com

Biotronik: +39 02 274394200 or fill out the form on https://www.biotronik.com/it-it/contact

Microport+ 39 0235964500

Boston Scientific+ 39 848781164