Visits and Outpatient Diagnostics page Archivi - AF-ABLATION

TEAM:

Dr. Emanuela T. Locati (Cardiologist Consultant – Manager)

Dr. Luigi Giannelli (Cardiologist Consultant)

Dr.ssa Alessandra Colombo (Electrophysiology Technician)

Dr. Gaetano Giudice (Electrophysiology Technician)

Dr.ssa Debora Taranto (Electrophysiology Technician)

Dr. Roberto Manuello (Electrophysiology Technician)

Dr. Flavio Mastrocinque (Electrophysiology Technician)

Dr. Alberto Totta (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.

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 about 6.000 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 NETWORK^TM 

https://www.medtronic.com/it-it/pazienti.html

Medtronic DIRECT patient technical assistance service

TEL: 800 20 90 20
Monday – Friday 8:30 a.m. – 5:30 p.m.

directo.italia@medtronic.com

Biotronik: System HOME MONITORINGTM with transmitter CARDIOMESSANGER https://www.biotronik.com/en-de/products/home-monitoring

Abbott-Dt. Jude: System MERLIN@HOME™ TRANSMITTER^TM 

https://www.cardiovascular.abbott/us/en/hcp/products/cardiac-rhythm-management/merlin-home-transmitter.html

Boston Scientific: System LATITUDE^TM COMUNICATOR^TM 

https://www.bostonscientific.com/en-US/patients/about-your-device/latitude-home-monitoring.html

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)

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.

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).

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).

BIBLIOGRAPHICAL REFERENCES

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.

LINK to:

• Remote Monitoring Information
• Consent to Remote Monitoring 

What is the standard 12-lead electrocardiogram?

The standard 12-lead electrocardiogram (ECG) is the most frequently used diagnostic test in cardiology practice, which enables the electrical activity of the heart to be recorded and displayed graphically. The ECG can be performed either at rest, while the patient is lying on the couch, or during exertion, while the patient walks on a treadmill or rides on an exercise bike.

For what is the 12-lead electrocardiogram used?

The electrocardiogram at rest enables the measurement of the frequency and rhythm of the heart, as well as some parameters of heart muscle function. In particular, the ECG enables the detection of possible cardiac rhythm disorders (called cardiac arrhythmias). The ECG also makes it possible to detect any disturbances in cardiac muscle spraying (myocardial ischemia) or changes in the size of the heart chambers (for example myocardial hypertrophy). On the other hand, the electrocardiogram under stress can help in the diagnosis of latent heart disease.

What are the preparation rules and the risks of the 12-lead ECG?

The electrocardiogram procedure does not require any preparation. There are no contraindications for performing the standard electrocardiogram. The exam is safe and painless, and can be performed at any age, even in the newborn, and repeated whenever necessary. The only collaboration required of the patient is to remain still and relaxed at the time of the execution of the exam.

How does the 12-lead electrocardiogram work?

The ECG is performed by applying to the chest skin some electrodes (which can be adhesive or simple to contact), connected through electric wires to a device called an electrocardiograph. The electrodes and wires capture the electrical activity of the heart and transmit it to the electrocardiograph, which processes the cardiac signals and prints the signals on paper in the form of a graphic trace called the “electrocardiogram”.

To evaluate the activity of the heart in a three-dimensional way, in order to better localize the origin of the anomalies in certain parts of the heart, 12 derivations are recorded simultaneously, each of which preferentially explores a specific cardiac region. The derivations are divided into precordials (directly detected by the electrodes placed on the chest, in the area facing the heart) and peripherals, for which the signals are recorded starting from the limbs.

In our center, all the electrocardiographic traces are acquired through new generation electrocardiographs (Mortara Instruments Europe, Italy, Eli 350 or Eli 380 systems), which acquire and archive all the traces in digital form in a centralized archive, in order to make subsequent comparisons or processing with new specialized programs.

How should the electrodes be positioned to highlight the Brugada pattern in the 12-lead electrocardiogram?

In the case of suspicion of Brugada Syndrome, to identify the possible presence of spontaneous Brugada type 1 patterns, it may be necessary to place the precordial derivations in the so-called high precordial derivations, or in the 2nd and 3rd intercostal space instead of in the classical 4th intercostal space.

In the case of the Brugada pattern, sometimes the typical ECG alteration in the right precordial derivations is absent or barely mentioned (called pattern type 2 or 3), but appears or becomes accentuated if the exploring electrodes are placed one or two intercostal spaces higher. This happens because the phenomenon of Brugada, in basal conditions, occurs in a very limited portion of the right ventricular region, whose potentials are detected only if the electrodes are placed practically above the region concerned.

What are the bureaucratic procedures for implementing the standard 12-lead ECG?

The 12-lead ECG is generally performed in conjunction with the arrhythmological examination or when checking implanted cardiac devices.

The test can be carried out in agreement with the national health system (SSN). It must be requested by your general practitioner or referral specialist with the wording “dynamic Holter electrocardiogram”, with the indication of the clinical question.

The test can be performed privately. In this case, it is not mandatory to be in possession of the medical prescription of a specialist.

Remember to always bring the previous health records 

If you need to book an ECG 12 leads -> Request information and / or Exam

What is a stress test?

The stress test (or ergometric test) is a diagnostic test during which the electrocardiogram (ECG) is continuously recorded while the patient performs a controlled and gradual increase in physical effort, walking on an inclined platform, called a treadmill, or pedaling on a special exercise bike (cycle ergometer).

What is the stress test for?

The stress test is used to evaluate any ECG disturbances and / or modifications produced by the effort. In patients with known or suspected ischemic heart disease, it mainly provides information about the correct flow of blood through the vessels that supply the heart (coronary), while in patients with heart failure the functional capacity of the cardiovascular system and rhythm disturbances (bradycardias or tachycardias) are assessed.

In the arrhythmological context, the examination is useful for assessing the behavior of the heart rate, atrioventricular conduction, ventricular repolarization and, in particular, the onset of any atrial or ventricular arrhythmias during or after exertion.

How is the stress test performed?

During preparation, electrodes (adhesive metal plates) are applied to the patient’s chest and back and a first reference ECG is recorded at rest. Then the patient begins physical exertion, pedaling on an exercise bike (cycle ergometer) or walking on a treadmill.

The effort is progressive and is increased by constantly increasing the resistance opposed by the pedals of the cycle ergometer or the speed of the treadmill. During the examination, cardiac activity is continuously monitored through the monitor. Furthermore, blood pressure is detected during the various workloads. This enables the evaluation of both the exercise tolerance and the recovery capacity of a subject, simultaneously evaluating moment by moment the presence or absence of any anomalies.

During the execution of the examination, which lasts about 30 minutes, much attention is paid to the symptoms that the patient may experience and their relationship with any changes in the electrocardiogram.

What are the risks associated with the stress test?

The stress test does not expose the patient to particular risks, as the examination is carried out by trained personnel and in a suitable and equipped laboratory to deal with any complications or emergencies that may occur during the test.

What is the preparation for the stress test?

The stress test does not require particular preparation, but some conditions must be respected:

• The exam is performed with a patient fasting for at least 3 hours.
• The patient must not have had tea or coffee or smoked on the day of the exam.
• The suspension of any therapies is at the discretion of the doctor who requests the examination.
• Clothing suitable for performing physical exercise (tracksuit, sneakers, etc.) is required.
• Remember to always bring previous health documentation.

What are the bureaucratic procedures for performing the stress test?

Before the test is performed, acceptance of the exam must be carried out.

The stress test can be performed in agreement with the national health system (NHS). In this case, it must be requested from your general practitioner or specialist with a prescription stating “exercise electrocardiogram”, with an indication of the clinical question.

The stress test can also be performed privately. In this case, it is not mandatory to have a specialist’s prescription.

If you need to book a Stress Test -> Information request and / or exam

What is the high resolution ECG for the study of late potentials?

The high resolution ECG with recording (called SAECG, or “signal averaging ECG”) consists of a particular electrocardiographic recording that enables the identification of low voltage signals in the terminal part of the QRS complex of the electrocardiogram. This method is used in order to detect abnormal electrical activity in the heart muscle, especially at the ventricles, known as Late Ventricular Potentials (LVP, or “Ventricular Late Potentials”).

What are the Ventricular Late Potentials?

Late ventricular potentials are high frequency and low amplitude electrical signals, generally invisible on the standard electrocardiogram, but which can be detected thanks to electrocardiographic signal amplification techniques. The presence of late potentials on the path indicates the existence, in the ventricles, of an area in which electrical conduction is altered. The presence of late potentials identifies patients susceptible to develop serious ventricular rhythm disorders.

How are late potentials recorded and measured?

The search for LVPs is carried out with a special electrocardiograph that records about 1600 consecutive heart beats (for about 30 minutes) and analyzes cardiac activity with particular amplifications and filters in search of late potentials.

In our center the SAECG is carried out with ELI 350 SAECG System devices (Mortara Instruments Europe, Italy). The analysis is based on the acquisition of high resolution signals (1000 Hz) of the three orthogonal derivations (x, y, z) and the calculation of their average vector. The signals are then filtered with special filters to reduce noise (Band-pass filter frequency at 40–250 Hz bilateral filtering).

The SAECG algorithm automatically measures the following parameters:

1. duration filter (f-QRSd);
2. voltage of the quadratic root medium (root mean square voltage) of 40 ms QRS terminals filtered (RMS40)
3. duration of low amplitude signals (<40 mV) in the terminal component of the filtered QRS (LAS40).

LVPs are considered present (pathological) when both of these conditions are present:

>> RMS40 < 20 mV & LAS40 > 38 ms

Under what conditions are late potentials sought after?

LVPs are sought in patients at risk for malignant ventricular arrhythmias. The positivity of late potentials indicates a greater degree of risk and can predict the inducibility of ventricular fibrillation. LVPs can be positive in particularly the following diseases:

• Brugada syndrome
• Arrhythmogenic Cardiomyopathy (or Dysplasia) of the right ventricle
• Idiopathic dilated cardiomyopathy
• Heart attack
• Congenital heart disease, for example Tetralogy of Fallot

Can the research for late potentials be useful in Brugada syndrome?

Our center recently published a study on LVP research in Brugada Syndrome. The results of this study show that LVPs were highly correlated with the arrhythmogenic substrate of Brugada syndrome, which is identified through epicardial mapping.

Therefore, the LVPs registered with a non-invasive method could be a useful tool to identify subjects at risk of malignant ventricular arrhythmias, as an expression of an altered electrical activity at the epicardial level.

Therefore, VPTs discovered with a non-invasive method could be a useful tool to identify subjects at risk of malignant ventricular arrhythmias, as an expression of an altered electrical activity at the epicardial level.

Does the exam to detect late potentials carry some risk?

The examination, like standard electrocardiography, is painless, free of side effects and does not require hospitalization. The duration of the exam is approximately 30 minutes. The exam does not require any preparation. The only collaboration required of the patient is to remain still and calm during the acquisition of the ECG trace.

If you need to book a Late Potential -> Request information and / or Exam

Follow the link for our recent article on late potentials in Brugada syndrome 2019 Europace Ciconte LP Brugada

If you need to book a Late Potentials click here -> Request for information