Dr. Emanuela T. Locati (Cardiologist Consultant – Manager)
Dr. Luigi Giannelli (Cardiologist Consultant)
Dr. Elisa Ramondini (Electrophysiology technician)
Dr. Roberta Cotugno (Electrophysiology technician)
WHAT IS REMOTE MONITORING OF IMPLANTABLE CARDIAC DEVICES?
The remote telemetric control of implantable cardiac devices (defibrillator or ICD, pacemaker or PM, resynchronizer or CRT, implantable loop recorder or ILR) has the purpose of transmitting, through a dedicated Monitor (modem), the data stored in the directly implanted cardiac device to the Remote Monitoring Service of the Department of Arrhythmology and Physiology.
The Remote Monitoring is organized in order to obtain a flow of information from the implanted device to the Arrhythmology Center, to regularly check the operating parameters and any arrhythmias, so as to provide an answer as soon as possible to any technical or clinical problems, which can lead to the need for any optimization of the therapy or to carry out a clinical visit or a more or less urgent hospitalization.
|THE REMOTE MONITORING SYSTEM IS NOT AN EMERGENCY SERVICE, BUT RATHER IS ONLY INTENDED TO REGULARLY CHECK REMOTELY THE FUNCTIONING PARAMETERS AND HEART RANGE DETECTED BY THE DEVICE.
WHAT ARE THE ADVANTAGES OF REMOTE MONITORING?
The current guidelines for the management of patients with implantable cardiac devices recommend remote monitoring for the early recognition of clinical problems (i.e. ventricular tachyarrhythmias, atrial fibrillation …) and technical problems (electrode fracture, insulation breakdown, battery depletion …).
The use of remote monitoring has been shown to be effective in replacing frequent and repeated outpatient checks and avoiding unnecessary trips to the hospital.
According to the most recent clinical studies, adhering to the remote monitoring of implantable devices could bring benefits to the clinical evolution of heart disease.
In particular, remote monitoring is useful and extremely recommended in case of technical recalls by the manufacturing companies or in the management of the devices during the battery depletion phase.
WHAT IS THE EXPERIENCE OF OUR CENTER WITH REMOTE MONITORING?
Our center currently monitors over 3,500 patients with remote monitoring, including pacemakers (PM), implantable defibrillators (ICD), subcutaneous defibrillators (S-ICD), defibrillator or pacemaker resynchronizers (CRT-D and CRT-P), and implantable recorders (ILR). The experience of our center, which dates back over 10 years, represents one of the most significant in Italy with this method.
WHICH MONITORING SYSTEMS ARE ACTIVE IN OUR CENTER?
In our center, the implantable cardiac devices of the main Electromedical Companies are monitored: Each company has developed a Remote Monitoring system, with specific technical features for the individual systems, each of which uses a specific monitor, offered free of charge by the manufacturing companies:
Medtronic: Sistema CARELINK NETWORKTM
Medtronic DIRECT patient technical assistance service
TEL: 800 20 90 20
Monday – Friday 8:30 a.m. – 5:30 p.m.
Biotronik: System HOME MONITORINGTM with transmitter CARDIOMESSANGER https://www.biotronik.com/en-de/products/home-monitoring
Abbott-Dt. Jude: System MERLIN@HOME™ TRANSMITTERTM
Boston Scientific: System LATITUDETM COMUNICATORTM
HOW TO ACTIVATE THE REMOTE MONITORING?
The monitor dedicated to remote control will be delivered free of charge directly to the hospital, at the time of discharge after implantation or possibly later, by the staff of the Department of Arrhythmology.
To activate the operation, simply connect the transmitter to a socket and, if required, perform a first manual transmission according to the procedure that will be explained by the staff of the Department of Arrhythmology.
At the time of activation, the patient must sign the informed consent, after having read the dedicated information, and consent to the processing of the data according to the legislation on the protection of privacy currently in force.
In the monitor package, there is detailed documentation regarding the use of the monitor and its operation.
The transmissions will then generally be automatic, without the need for patient intervention, and only in specific cases, according to the communications from the dedicated health staff of the Department of Arrhythmology, will it be necessary to carry out manual transmissions.
HOW THE REMOTE MONITORING SERVICE WORKS?
The operating modes of the Remote Monitoring are as follows:
- The data from the cardiac device are sent automatically (or in some cases manually) through the monitor to a dedicated secure server, which makes them available via the web in a dedicated portal to which only authorized healthcare personnel of our center can access, via identification and password.
- The dedicated staff of our center programs the transmissions so that they are carried out automatically (or manually according to the technical characteristics of the devices), according to the timing considered optimal for the specific clinical problem.
- The timing of the transmissions may vary (therefore programming more frequent transmissions) in case specific technical or clinical problems emerge.
- Only if pathological elements are found, or in any case if deemed necessary, will the patient be contacted by the dedicated personnel of the Remote Monitoring Service to go to the hospital for an outpatient visit or for an eventual admission.
- In some cases, it is possible that the dedicated staff of the Department of Arrhythmology may request manual transmissions via the monitor, which does not necessarily imply that there are specific problems or risks, but only a further check is required for clinical or technical reasons.
WITHIN HOW MANY DAYS ARE THE SENT TRANSMISSIONS REVIEWED?
When the Remote Monitoring Service receives a transmission, the data sent will be reviewed by the dedicated staff within 5 (five) working days.
The patient is NOT routinely contacted every time the Monitoring Service receives a transmission, while the patient will be contacted by telephone only in the following cases:
- a) technical or clinical problems emerge from the control of the transmitted data.
- b) The Remote Monitoring Service does not receive any scheduled transmissions
WHAT HAPPENS IN CASE OF DEVICE FAILURE?
- For various and unpredictable technical reasons, it may happen that your monitor at the patient’s home is unable to contact the implanted cardiac device, and therefore is unable to send a transmission to the dedicated server.
- In this case, the Remote Monitoring Service may not receive transmissions, including, in some cases, even transmissions that could potentially contain important information.
- The Monitoring Service has no way of becoming aware of any missed transmissions in a short and certain time, but has information only on transmissions that have been correctly transmitted to the server and displayed on the website.
- The patient must regularly check that the monitor at home is regularly connected to the power supply and that no error messages appear (as indicated in the user manual that is delivered at the time of activation)
|In the event of non-transmission, the Remote Monitoring Service cannot in any way be held responsible for any clinical or technical problems relating to such failed transmissions.
FOR HOW LONG AND WHEN IS THE REMOTE MONITORING SERVICE SUSPENDED?
- In the absence of communications, participation in the Remote Monitoring program is renewed without time limits.
- The Department of Arrhythmology reserves the right to interrupt the Remote Monitoring Service, upon written notice with notice of not less than one month.
- The Department of Arrhythmology reserves the right to suspend the remote control service to patients who are not compatible with this service for any technical or logistical reasons.
- The patient can withdraw from the Remote Monitoring service at any time with immediate effect. You must provide written notice (by fax or e-mail) to the Remote Monitoring Service staff of this intention.
- In the event of termination of the Remote Monitoring service for any reason, the Service staff will indicate how to return or dispose of the used monitor.
HOW MUCH DOES IT COST TO TAKE PART IN THE REMOTE MONITORING SERVICE?
The Remote Monitoring service is currently provided free of charge by the Department of Arrhythmology and Electrophysiology.
The dedicated monitor (modem) will be provided free of charge by the manufacturing companies, and in case of failure it will be replaced free of charge by the companies and delivered to the patient by the staff of the Arrhythmology Department’s Remote Monitoring Service.
|The Remote Monitoring Service is not yet included in the services provided through the Health System, despite the importance of this control method. The Department of Arrhythmology has decided at least temporarily to provide this service for FREE.
WHAT ARE THE LIMITS OF REMOTE MONITORING?
Remote monitoring can replace some frequent and repeated outpatient checks and avoid unnecessary access to the hospital, but it cannot provide detailed information regarding some clinical problems (such as heart failure, breathlessness, dyspnea, precordialgia).
|In the case of such URGENT PROBLEMS, it is necessary to carry out a cardiological examination by the cardiologist specialist or to go to the emergency room.
In the event of NON-URGENT clinical problems, you can still contact the Remote Monitoring Service and, to the extent possible, we will provide you with advice and / or instructions based on the data available to us through monitoring and, if necessary, the we will ask you to make a manual transmission.
HOW PERSONAL DATA IS PROCESSED?
Legislative Decree No. 196 of June 30, 2003 provides for the protection of individuals with respect to the processing of personal data. Such treatment will therefore be based on the principles of correctness, lawfulness, transparency and protection of your privacy and the rights of the patient.
The data controller is the Department of Arrhythmology, IRCCS based in San Donato Milanese, Piazza Malan; The Data Processor is the dedicated monitor provider connected to the implantable device of the patient, with whom the Department of Arrhythmology has a contractual relationship and with which it will sign a specific declaration of consent and authorization to process its data.
The failure of the patient to authorize the processing of data, both to the staff of the Arrhythmology Department and to the company supplying the dedicated monitor connected to its implantable device, makes it impossible to activate the remote telemetry control program.
WHAT TO DO IN CASE YOU ARE AWAY FROM THE HOUSE?
The patient is obliged to always report to the Remote Monitoring Service any prolonged absences from home (for periods longer than a week) and in particular to notify the service in case of any admissions (both at our Hospital and at other Health Facilities).
The patient should carry the monitor with him even if he is traveling or on vacation. The monitor works for free throughout the Italian territory.
In the case of trips abroad, the patient should contact our service to find out about the coverage areas (which vary for different manufacturers).
IMPORTANT INFORMATION ON REMOTE MONITORING
In case of emergency or need for an URGENT medical check-up, the patient must call 118 or go to the emergency room. THE MONITOR MUST NOT BE USED IN AN EMERGENCY, as transmissions sent via Remote Monitoring are not viewed in real time.
COMMUNICATION METHOD WITH THE REMOTE MONITORING SERVICE
For any requests for information on the Remote Monitoring Service or on the use of the dedicated modem, you can contact us at the telephone number 02-5277-4293 on weekdays from 08:30 to 17:00 (Monday to Friday), where you can talk with Healthcare professionals from the Department of Arrhythmology dedicated to the Remote Monitoring Service, or by e-mail to firstname.lastname@example.org.
WE EMPHASIZE THAT WE DO NOT GUARANTEE THE PRESENCE OF AN OPERATOR AT THIS NUMBER, WHICH THEN SHOULD NOT BE USED FOR URGENT COMMUNICATIONS.
Renato Pietro Ricci, Emanuela T. Locati, Andrea Campana, Ciro Cavallaro, Massimo Giammaria, Maurizio Landolina, Maurizio Marzegalli, Donato Melissano, Controllo remoto dei dispositivi impiantabili: Health Technology Assessment, 2013 http://aiac.it/wp-content/uploads/2013/12/Ricci_AIAC_telecardiologia_HTA_finale-18.11.2013.pdf
Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, Parati G, Borghi G, Zanaboni P, Valsecchi S, Marzegalli M, Remote Monitoring Reduces Healthcare Use and Improve Quality of Care in heart Failure Patients With Implantable Defibrillators – The evolution of Management Strategies of Heart Failure Patients With implantable Defibrillators (EVOLVO) Study, Circulation 2012; 125:2985-2992
Slotwiner D, Varma N, Akar JG, Annas G, Beardsall M, Fogel RI, Galizio NO, Glotzer TV, Leahy RA, Love CJ, McLean RC, Mittal S, Morichelli L, Patton KK, Raitt MH, Ricci RP, Rickard J, Schoenfeld MH, Serwer GA, Shea J, Varosy P, Verma A, Yu CM. HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices. Heart Rhythm. 2015 Jul;12(7):e69-100.