First Implant of Dual-Chamber Leadless Pacemaker

A pacemaker is a small battery-powered device implanted in the chest that delivers electrical impulses via cardiac leads, thereby helping to restore normal heart rhythm. It is meant for the treatment of abnormally slow heart rhythm disorders, including sinus node dysfunction. Pacemakers also treat heart block (when the electrical signals from the top chambers don’t conduct properly to the bottom chambers of the heart). Such arrhythmias can cause difficulty in breathing, dizziness, fainting, and sometimes, even sudden cardiac death. In the case of traditional pacemakers, a power generator is placed under the skin near the collarbone via an incision, which connects to wires stretched through veins and attached to the heart muscle. With this type of pacemaker, one in six patients have been found to suffer a complication over a three-year period, such as bleeding and infection, dislodgement, fracture, or blood clots around the wires.

Now, Abbott has announced a clinical trial of the world’s first patient implants of a dual-chamber leadless pacemaker system, Aveir™ DR, which is a milestone in leadless pacing technology. Leadless pacemakers are implanted directly into the heart and eliminate the need for cardiac leads, thus reducing lead-related complications, as well as recovery time due to the minimally invasive catheter-based implant procedure. The system used in the trial (one leadless pacemaker for the right ventricle and one for the right atrium) is retrievable, so it can be replaced or retrieved as therapy needs evolve. About 550 patients from up to 80 sites in Canada, USA, Europe, and Asia-Pacific are planned to be enrolled in the trial. The first implant was performed at Na Homolce Hospital in Prague, Czech Republic.

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