The Micra Leadless Transcatheter Pacemaker. Implantation and Mid-term Follow-up Results in a Single Center

Abstract

Introduction and objectives: Currently, studies on the leadless pacemaker (Micra) have mostly been limited to clinical trials with less than 6 months' follow-up and they often fail to reflect real population outcomes. We sought to evaluate electrical parameters at implantation and chronologically during follow-up, as well as the safety of this new technique.

Methods: This prospective, observational study included 30 consecutive patients, all ≥ 65 years, with an indication for single-chamber pacemaker implantation.

Results: Successful implantation was accomplished in all patients referred for leadless implantation. The mean age was 79.4±6.4 years (range, 66-89 years); 20 (66.6%) were men and 28 had permanent atrial fibrillation (93.3%); 1 had atrial tachycardia and 1 had sinus rhythm. Concomitant atrioventricular node ablation was performed immediately after implantation in 5 patients (16.6%), and implantation was performed after transcatheter aortic valve implantation in 2. The procedure was performed under an uninterrupted anticoagulation regimen (maximum INR 2.4) in 23 patients (76.6%). With the exception of 1 moderate pericardial effusion without tamponade, there were no severe complications. The mean follow-up was 5.3±3.3 months and 4 patients had more than 1 year of follow-up. Sensing and pacing parameters were stable both at implantation and during the short- to mid-term follow-up.

Conclusions: Implantation of leadless pacemakers is feasible, safe and provides advantages over the conventional system. Further studies with longer follow-up periods will be needed before these devices become widely used in routine clinical practice.

Keywords: Atrial fibrillation; Cardiac pacing; Estimulación cardiaca; Fibrilación auricular; Leadless pacemaker; Marcapasos percutáneo sin cable.