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The new Electrophysiology Laboratory of Policlinico San Donato, inaugurated in 2015, in the presence of the then President of the Lombardy Region Roberto Maroni, is a futuristic structure for the treatment of complex cardiac arrhythmias equipped with the most advanced technologies available today for the treatment of arrhythmias, even in complex contexts, with congenital or degenerative heart disease or heart failure.
The Electrophysiology Laboratory is a structure designed by Professor Carlo Pappone, Head of the Clinical Arrhythmology and Electrophysiology Unit of the IRCCS Policlinico San Donato to face the complex challenges of contemporary arrhythmology. The clinical characteristics of patients with indications for electrophysiological procedures have gradually changed in recent years: in addition to arrhythmias that depend on re-entry substrates (nodal re-entry tachycardias, Wolff-Parkinson-White syndrome), ablation interventions for arrhythmias in increasingly complex clinical contexts are occurring. For example, atrial fibrillation constitutes an epidemiologically relevant problem, both for the present and for the coming years, engaging a large part of the scientific and economic resources of our health system. The treatment of these pathologies represents a real challenge for the future and requires a huge investment effort to offer innovative biomedical strategies and equipment.
Our Electrophysiology Laboratory consists of three dedicated rooms: the Robotics Room, the Image Integration Room and the Hybrid Procedure Room.
Our Electrophysiology Rooms have been designed to provide an ideal environment dedicated to the development of an interdisciplinary approach for patients with complex arrhythmias in the context of congenital or degenerative heart disease, atrial fibrillation and heart failure. Their design, through the complete integration of all technological components, offers the possibility of performing hybrid procedures, of using alternative approaches and allows the treatment of hemodynamically unstable patients. Characterized by very specific features, the three rooms were built following common principles. Ergonomics, first of all, by limiting the installation of all equipment that can constitute an obstacle to the mobility of staff and patients. Then, the simplification of the operating interface – all the signals of the various equipment used converge on a single display whose setting is fully customizable by the operator – thus allowing you to focus the necessary information and limit the use of multiple monitors, avoiding dangerous distractions. The patient interface has been streamlined, and the acquisition of data useful for the procedure takes place via wireless systems, which is advantageous in terms of patient and staff comfort.
As far as audio-video connectivity is concerned, all the rooms are equipped with audio-video systems and connected to the most modern communication systems, thus facilitating their use for educational purposes and promoting the technological development of the equipment (collaboration with researchers and companies in real time). Another common principle is complete integration with the patient database: at any time the operator will be able to access the clinical information, including laboratory and imaging investigations, to which the patient has previously undergone. Finally, the wiring and connection spaces have been multiplied to facilitate easy installation of experimental medical equipment and easy technological upgrading, and a complete integration of the laboratory with remote monitoring systems has been created, allowing the patient to be managed remotely and intervene early on complex clinical situations.
The three Electrophysiology Rooms have a common technological platform. As for the radiological equipment, in addition to the fluoroscopic systems, we have an integrated system for rotational angiography that allows the three-dimensional reconstruction of the heart chambers, providing maximum anatomical detail. In the rooms we have the main and most updated non-fluoroscopic mapping systems. Each mapping system has its own peculiarities and is able to interface with others through integration systems, ensuring maximum information obtainable from each. Complete integration exists also for the remote connection of the laboratories: all the rooms are equipped with a system that enables the signals coming from the different parametric and mapping systems used during the procedure to be displayed on a single high definition panel. This system also enables the sharing of all the information relating to the procedure with other communication platforms, making the tool particularly suitable for scientific or educational purposes. Lastly, the continuous collaboration with the companies ensures the continuous hardware and software updating of the biomedical systems.
Room 1 – Robotics – It is dedicated to a series of activities, such as the development and validation of software protocols for the treatment of particular arrhythmias in patients with cardiac structural anomalies, with particular attention to congenital defects; the development and validation of new magnetic catheters for ablation and cardiac stimulation; the development of new applications for intravascular navigation and the selective positioning of cardiac stimulation catheters in the venous tributary system of the coronary sinus, in the context of cardiac resynchronization therapy; the development of protocols for epicardial navigation and combined endo-epicardial approaches for the treatment of transmural substrates. This laboratory is also dedicated to the development of magnetic navigation protocols for the positioning of intracardiac devices, for the correction of structural defects or for percutaneous occlusion of the left auricle; the development of extracardiac intravascular navigation protocols with particular attention to the cerebral district for interventional radiology maneuvers; finally, the development of protocols for the remote control of the system and remote patient care.
The Robotics room is equipped with a magnetic navigation system which has been extensively tested and developed by our team. This type of system offers indisputable advantages in terms of “operator-dependency” of the procedure, safety and reproducibility of the results. The maneuverability of the catheter and the stability of contact with the cardiac wall make this aid particularly suitable for the treatment of arrhythmias in patients with complex cardiac anatomies or in the pediatric population.
Room 2 – Image Integration – focuses on spatial recording of the image to improve the accuracy of the latter and to provide an accurate three-dimensional scheme. The present technology is used to develop devices equipped with sensors for the treatment of structural heart diseases such as, for example, aortic valve prostheses, where the GPRS system can be used for much more accurate positioning of the prosthesis and for the development of navigation protocols for some devices within rotational angiography images. Based on GPRS technology, installed inside the flat panel of the scopic system, this system, resulting from a military application, allows an extremely accurate spatial coding of the patient’s thoracic region positioned under the generator (detector). The system can identify the absolute spatial location of a dedicated miniaturized sensor that can be mounted on any intracardiac device, such as a catheter, an endoprosthesis or an intravascular stent. Through a continuous 3D spatial localization of the sensor, with an accuracy of 1 mm, it is possible to monitor in real time the position of the devices equipped with the sensor, and therefore position them precisely in the various structures within the patient’s chest and heart.
Room 3 – Hybrid Procedures –Designed in close collaboration with the Cardiac Surgery team, with Resuscitators and Interventional Cardiologists, it is based on the Artis Zeego system. This system has been designed to guarantee maximum accessibility to the patient and the medical team, allowing its use in different operator settings. The room has therefore been equipped to host hybrid procedures aimed at complex patients who require a multidisciplinary approach, such as patients with Brugada syndrome, for whom ablation of the arrhythmic substrate located on the anterior wall and outflow tract of the right ventricle is carried out by means of an epicardial approach, or patients with atrial fibrillation, who require an integrated endocardial approach, or those candidates for cardiac resynchronization therapy in which the positioning of the left ventricular lead is impossible percutaneously or, still, in patients with hemodynamic instabilities that require circulatory support and intensive care during the procedure. The clinical and research activity of the Hybrid Procedures Room is focused on creating an innovative multidisciplinary approach for the treatment of critically ill patients, in whom it is essential to face several problems at the same time, or in whom the procedural risk is such as to make the operative gesture difficult in a standard context. Particular attention is paid to the development of minimally invasive epicardial approaches, whether they contemplate the thoracic or subxiphoid pathway. As an “extension” of this room there is also a control room dedicated to remote procedures.
The last peculiarity of our Electrophysiology Laboratory is the presence of mobile Telemedicine platforms, the first to be used in Italy in the hospital setting and the first in Europe in Arrhythmology. The RP-Vita system is equipped with remote-controlled autonomous navigation, with the possibility of mapping a territory and fixing certain positions such as, for example, “room 1, bed A”. The doctor can remotely direct the robot to the patient’s bed, without the need for local staff to move the device. The auto-docking function automatically returns RP-VITA to a charging station after a consultation, in order to ensure its availability for a subsequent clinical session. RP-Vita is equipped with a very high resolution, panoramic, tilting camera with high zoom capabilities, which optimizes the visualization of patients and staff possibly present at the patient’s bed: the camera can be autonomously oriented by the specialist remotely.