Cardiology, in Italy the first wireless dual-chamber pacemaker system in the world

Italian cardiology and electrophysiology are experiencing their revolution thanks to technological innovation with increasingly less invasive procedures and increasingly sophisticated, miniaturized and connected implantable devices. The scope of this change was discussed during the event ‘Cardiology that beats to the rhythm of the future’, organized by Abbott with some of the leading Italian interventional cardiologists, during which the company announced the availability in Italy of Aveir* Dr, the first wireless dual-chamber pacemaker system in the world to address the needs of people with an abnormal or slower-than-normal heart rhythm. This is an unprecedented revolutionary innovation, which allows two pacemakers without electrocatheters to communicate and synchronize with each other at every single heartbeat thanks to the implant-to-implant communication technology (i2i*) patented by Abbott. The system expands the treatment options compared to single-chamber wireless pacemakers that can only treat 20% of patients.

The progressive increase in life expectancy and, with it, the prevalence of chronic diseases – as stated in a note – have favored a progressive increase in cardiac arrhythmias. It is estimated that approximately one third of the world’s population could develop a pathological arrhythmia, one of the most frequent causes of mortality, visits to the emergency room and hospitalizations. “Pacemaker technology – says Marcello Mestriner, Country Manager Cardiac Rhythm Management of Abbott Italy – has remained substantially unchanged over the years due to the significant technological challenges to allow effective atrioventricular synchrony between two pacemakers without wires. Aveir Dr responds to a substantial need of people with bradyarrhythmias by solving the technological challenge of dual-chamber stimulation without electrocatheters thanks to its revolutionary design system”.

The device uses a new dual-chamber therapy delivery method, being composed of two pacemakers, one that stimulates the right ventricle (Aveir Vr) and one that stimulates the right atrium (Aveir Ar). Each device is approximately 10 times smaller than a traditional pacemaker, less than an AAA battery. Just certified in Europe (CE Certificate, June 3, 2024, Notified Body 0123), the first implants have already been performed in Italy. As Claudio Tondo, director of the Department of Arrhythmology, Centro Cardiologico Monzino Irccs of Milan and associate professor of the Department of Biomedical, Surgical and Dental Sciences, University of Milan, explains, “the availability in Italy of the first wireless dual-chamber pacemaker in the world, which 2 years ago we were the first to validate in our country having participated in the international clinical study, will expand the possibilities of treatment of cardiac rhythm disorders and therefore the number of patients who will be able to benefit from wireless pacemakers, one of the greatest innovations in the world of pacemakers in the last 10 years”.

The procedure with Aveir Dr does not involve scars or the creation of a visible pocket in the chest, with a considerable reduction for the patient in recovery times from the implant procedure and risks associated with the electrocatheters and the pocket. “With this technological innovation – observes Antonio Curnis, head of the Laboratory of electrophysiology and electrostimulation, Spedali Civili di Brescia – the leadless pacemaker system is able to electrically stimulate the entire heart, like traditional systems, but with many more advantages for patients. It had never been done before with wireless pacemakers. I am convinced that leadless technology has the potential to gradually replace traditional implants”.

There are approximately 1,250,000 pacemaker implants worldwide each year. In Italy, over 50,000 pacemaker implants are performed each year, an average of 137 per day, with a growth of over 30% in the last 15 years. “We hospital cardiologists are called upon to face multiple challenges, including arrhythmias, which are rapidly increasing throughout the world,” underlines Stefano Guarracini, head of Cardiology and head of hemodynamics, Clinica Pierangeli in Pescara. “The great advantages of this technology derive from its miniaturized dimensions and the absence of wires, which allow the two small capsules to be inserted directly into the cardiac cavity with a less invasive procedure than traditional surgery. Once the patient has resumed daily activities, their movements are not limited.”