Researchers from the Hospital Clínic-IDIBAPS, in Barcelona, have participated in an international study that has demonstrated the effectiveness of a new device consisting of a pacemaker and a defibrillator that communicate with each other by radio frequency, without cables, which prevents infections in the people suffering from heart problems.
In this international study, published in the New England Journal of Medicine (NEJM), Dr. Lluís Mont, head of the Atrial Fibrillation Unit and the Pathobiology and Treatment of Cardiac Arrhythmias group at IDIBAPS, and the Dr. José Tolosana, from the same team, who this Thursday held a press conference to explain this medical advance.
For ten years, researchers and doctors from Europe, Asia and the United States, including the Barcelona Clinic group, have worked on the new device, consisting of a subcutaneous defibrillator and a very small pacemaker, which work without cables and communicate with each other. them by radiofrequency, in patients with ventricular arrhythmias at risk of sudden death.
The trial has been tested on 162 patients, of whom twenty have been treated at the Hospital Clínic, with a subsequent follow-up of no less than six months.
Among them is David Andújar, who had the defibrillator and wireless pacemaker implanted last year 2023, after suffering a massive heart attack in October 2022, and who this Thursday also explained his experience as a patient.
Andújar wore a defibrillator for eight months to prevent his sudden death in the event of a new attack and the Clínic proposed that he be part of the international study.
After undergoing surgery and receiving the new device, this patient, who was 48 years old at the time of the attack, has not recorded any cardiac complications and can live a much more normal life, although he must connect to a machine at home every day. to which the pacemaker and defibrillator send information about the activity of your heart.
This information is sent to the doctors and health workers at the hospital, who monitor the evolution of Andújar, who ended up with 31% cardiac function and who today expressed satisfaction and gratitude for having been part of this study.
“At first, you feel strange wearing the devices but I got very tired,” explained this patient, who worked in construction and was diagnosed with anxiety when he reported that he was getting tired and couldn’t do what he normally did. Andújar had a blocked femoral vein and waited for three hours while he had the heart attack because he believed what was happening to him was an anxiety attack.
Dr. Mont has considered that the study will allow “to change the treatment paradigm of patients with ventricular arrhythmias and risk of sudden death, since they will be able to benefit from both types of stimulation – defibrillator and pacemaker -, avoiding the complications that are observed with cable systems a few years after their implementation.”
Currently, the treatment given to patients with ventricular arrhythmias who are at risk of sudden death is the defibrillator, which is implanted under the skin in the area a little below the armpit and which carries a cable to the area. from the heart.
This defibrillator monitors the heart rhythm and delivers shocks when it detects a dangerous arrhythmia or small impulses when the heart is too slow.
These devices can cause complications due to infections, electrode displacement, and adverse reactions, which increase over time, although subcutaneous defibrillators are less invasive and have improved these complications. However, defibrillators do not allow stimulation for slow heart rhythms or stimulation of fast rhythms to stop tachycardia, avoiding electrical ‘shock’.
For their part, pacemakers use low-energy electrical impulses to control the frequency and rhythm of the heartbeat, and while traditional pacemakers send electrical impulses through wires, wireless ones do so without them.
New research has shown that if both devices communicate, they work effectively and without complications, which benefits patients who suffer from ventricular arrhythmias at risk of sudden death.
Arrhythmias are alterations in the normal rhythm of the heart, which can beat too fast (tachycardia), too slowly (bradycardia) or irregularly, situations that can be benign and without symptoms, or cause serious symptoms such as dizziness, lack of breath, chest pain, or fainting.
Among the most dangerous are ventricular fibrillation and ventricular tachycardia, which can lead to sudden death if not treated quickly.
The new device now requires approval from the FDA (United States Government agency responsible for regulating foods, medicines, cosmetics and medical devices, among other things) and the European Medicines Agency (EMA). acronym in English) to be able to begin its commercialization, Dr. Mont has specified.