Leadless pacemaker – safety and performance in clinical trials
Bári Zsolt1, Vámos Máté1, 2, Bógyi Péter1, Kiss Róbert Gábor1, Duray Gábor Zoltán1
1MH Egészségügyi Központ, Kardiológiai Osztály, Budapest
2University Hospital Frankfurt – Goethe University, Department of Cardiology, Frankfurt am Main
Leadless pacemakers were developed to eliminate the most common complications associated with coventional transvenous pacemaker therapy. The device is implanted in the right ventricle by using a femoral percutaneous approach and located totally in the right ventricular cavity after removal of the introducer sheath. The new technology is now available in the everyday practice after the favourable results of large clinical trials completed in the last years. Leadless pacemaker could be primarily utilized in patients with indication for conventional single-chamber right ventricular pacemaker (VVI and VVIR) implantation. Besides the better cosmetic result, decline of the complications related to the pacemaker pocket and the transvenous pacemaker leads used for decades is likely by the spread of leadless pacemakers. Similar complication rates can be expected at both presently manufactured leadless devices. The chance of dislodgement can be different depending on the various fixation mechanisms however the incidence of cardiac perforation and vascular complications was similar in clinical trials. The implanter learning curve for this new procedure is not negligible in the occurrence of complications therefore reduction is expected by the spread and the development of the technology in the future. No long-term outcome data are yet available for leadless pacemakers. Further randomized studies are warranted for direct comparison with conventional pacing systems and to define the proper clinical role.