19.03.2014 - 11:18
Barcelona’s Hospital Clínic has installed the ‘Micra’ 24mm pacemaker – similar to the size of a one euro coin – on 4 patients as part of a clinical trial involving 10 medical centers and 60 patients throughout the world. This innovative wireless system is minimally invasive since it does not require any surgical procedure but is implanted in the heart through the femoral vein, using a catheter. Such a procedure can be performed in a shorter time—under 30 minutes—and also reduces the patients’ risks of future infections. During the presentation of the pacemaker, the Hospital’s Head of Arrhythmia, Lluís Mont, said that the new ‘Micra’ device, manufactured by medical technology company Medtronic, represented a “sea change” in the field of cardiology. In addition, According to the Medical Director of the Hospital, Josep Brugada, if the clinical study is successful, it will involve a “paradigm shift”. Experts estimate it will reach hospitals within the next two or three years. The patients who will benefit from this new, faster and less invasive procedure are those who do not need the pacemaker continuously but who may require it for preventive use.
Currently, 10 medical centers around the world are participating in this global clinical trial to test the ‘Micra’ pacemaker, a wireless capsule that requires no surgery to be implemented, and whose battery can last for about 10 years. The medical trial is currently in its first stage with the pacemaker implanted on 60 patients. In the second phase, a total of 39 centers will be conducting similar procedures on 300 patients.
Barcelona’s Hospital Clínic will remain the only medical center in the Spanish State to participate in this trial. In Europe, four other centers have taken part in this first stage, in Austria, Hungary, the Netherlands and France, while hospitals in New York, Japan, Malaysia and India have also participated in the project.
A short procedure avoiding tissue damage and post-surgery complications
One tenth the size of current pacemakers, ‘Micra’ is implanted directly in the heart through a catheter inserted through the femoral vein. Once in place, the pacemaker is attached to the wall of the right ventricle and can be repositioned if necessary.
Thanks to its small size and its efficient fixing system through four flexible arms, ‘Micra’ allows for greater stability and avoids damaging heart tissue. Besides, it does not require the use of wires to connect the pacemaker to the heart.
Furthermore, in contrast to the current procedures for pacemaker implants, ‘Micra’ does not require any surgical incisions to the chest or the creation of any “pocket” under the skin. This innovation eliminates potential post-surgery complications as well as all visible traces, such as scars.
“The main risk of this procedure is that the pacemaker is not attached properly,” said the Hospital’s Head of Arrhythmia, Lluís Mont. However, he added that this would not be a “serious” problem since the device would move to the right lung and could easily be extracted.
The pacemaker should be available in two or three years
Although the doctors are very optimistic about this new procedure, which could lead to a “paradigm shift”, according to the Medical Director of the Hospital, Josep Brugada, they stressed that there was still a long way to go, and that the pacemaker would not be available on the market before at least two or three years.
