The continuous evolution of devices for the treatment of cardiac arrhythmias responds faster and faster to the needs of over 20 thousand people, in Italy alone, who use a pacemaker (data from AIAC 2018, number of first implants of a pacemaker).

Maria Cecilia Hospital in Cotignola (Ravenna), part of GVM Care & Research, is among the main national centers for the clinical application of the new discoveries, a High Specialty Hospital accredited with the National Health Service, which is a reference point for the treatment of cardiac and arrhythmic pathologies. This is where the MICRA AV Post Approval Study (PAS), a worldwide non-randomized study of the MICRA AV, the smallest wireless pacemaker ever made, was recently launched.

The study sees the involvement of 750 patients from about 80 centers around the world, located in the United States, Europe, the Middle East and Asia, for a recruitment period (clinical trial) of approximately 18 months; the patients will then be followed up for a minimum of 3 years during which the data recorded by the pacemaker implant will be studied for continuous medical-technological evolution.

“The introduction of the new mini-pacemaker (MICRA AV) in clinical practice represents a milestone in the history of cardiac electrostimulation – comments Dr. Saverio Iacopino, National Coordinator of the Arrhythmology Department of GVM Care & Research, and already in 2017, the first doctor in Italy to have implanted the smallest pacemaker available at the time (an older version of the Micra) -. All this represents a real technological challenge that has made it possible to change the patient’s perception of the procedure. In fact, the person to whom the new pacemaker is implanted does not suffer cuts and has no threads in the heart. We are proud to have participated in the entire clinical validation process of this device, in terms of efficacy in the treatment of arrhythmia and safety for the patient. Maria Cecilia Hospital was in fact involved in the worldwide multicenter study MARVEL, a long coordination work between electrophysiologists and engineers that led to the validation of the results that allowed the new MICRA AV mini pacemaker to receive the approval of the American FDA at the beginning of 2020 and the CE mark last month “.

At Maria Cecilia Hospital, the team led by Dr. Iacopino also recently performed one of the first emergency MICRA AV implants on a 75-year-old patient with a very complex clinical history as a wearer of a pacemaker dual chamber with right ventricular lead malfunction and complete atrioventricular block, a previous replacement of the aortic and mitral valves with mechanical prostheses requiring the implantation of a non-functioning epicardial pacemaker and coronary revascularization by bypass.

The application of the wireless pacemaker takes place thanks to an injection of the device through a femoral vein to reach the heart. The MICRA AV is particularly indicated for patients suffering from atrial fibrillation with low heart rate or pathological pauses of the heart or with atrioventricular blocks.

A successful operation allows patients to be discharged after only one night of observation.