(en) [The leadless pacemaker or pacemaker without a lead system] Over four million people worldwide have a pacemaker, defibrillator, or another implantable cardiac rhythm management device. The “traditional” pacemaker (PMK) has been used for several decades in order to correct hearts beats that are too slow and associated with the risk of syncope. The traditional PMK used for bradycardia is primarily composed of two major elements: the leads that are placed in cardiac right chambers through the venous system and the pacemaker itself containing the battery and multiple electronic circuits. The implantation procedure requires a surgical incision below the clavicle in order to create a pocket under the skin where the PMK will eventually be placed. The overall risks associated with the implantation procedure include severe complications, such as pneumothorax (3%), severe bleeding (2%), infections (1%), and lead displacement (2-3%). Recently two US companies, Medtronic and St. Jude Medical, have developed a new cardiac pacing concept consisting of a small cylindrical self-contained leadless pacemaker (MICRA™ for Medtronic, and NANOSTIM™ for St Jude). The procedure is performed by means of a minimally invasive access through the femoral vein with an introducer containing the PMK guided under fluoroscopy to the right atrium and through the tricuspid valve. The catheter is then pushed into the right ventricle and screwed to the septal wall. Major advantages of this approach include the short time needed to carry out the procedure that may be performed under local anesthesia, along with the use of a self-contained device positioned in the right ventricle, without requiring a lead or surgical pocket. The PMK battery life is equivalent to that of similar conventional VVI pacemakers. The indications of this new technology concern only patients for whom a single-chamber VVIR pacemaker is indicated. The first-in-human implantation of a NANOSTIM™ was conducted with success in September 2013.
Scavée, C. (2015). Le «Leadless» pacemaker ou pacemaker sans sonde. Louvain médical, 134(4), 161-165. https://hdl.handle.net/2078.5/184775 (Original work published 2015)