Implantation and Clinical Performance of an Entirely Leadless Cardiac Pacemaker

Abstract

Background: Entirely leadless pacemakers (LPMs) address limitations of conventional pacemakers that include complications related to the pacing leads, their connections, and pacemaker pockets. The aim of this study was to describe early implantation experience and clinical efficacy of LPM. Methods: A total of eight patients received an LPM (Micra™ Transcatheter Pacing System, Medtronic plc, Minneapolis, MN, USA). LPM was transvenously deployed using a 23 F sheath, and actively fixed by 4 nitinol tines. Results: On average, the patients were 74.3 ± 8.1 years, and 50% were female. All had indications for a ventricular demand (VVI) pacemaker, and ejection fraction was 66.4% ±7.4%. Except for one patient, all were implanted from the right femoral vein. The LPM was deployed either at the right ventricular apex (63%) or at the septum (37%). At implantation, pacing threshold at 0.24 ms was 0.69 ± 0.35 V, and R wave was 8.1 ± 2.9 mV. Successful pacing sites were reached at a median of 1 attempt (range 1–3), and the mean procedure and fluoroscopic times were 74 ± 19 min and 11.0 ± 5.8 min, respectively. 50% were on uninterrupted anticoagulation, and there were no acute complications including groin hematoma. Both pacing threshold and R wave improved at 1 month compared to acute implant value (0.46 ± 0.11 V and 14.5 ± 5.6 mV, respectively, P< 0.05 compared with implant). Between 1 and 3 months follow-up, there was no change in pacing or sensing threshold. The average percentage of ventricular pacing was 65% ± 26%. The intracardiac accelerometer was activated in 3/8 patients, and the satisfactory rate response profile during activity of daily living was achieved. Battery longevity was estimated to be more than 8 years in all patients. Conclusion This study documents excellent implantation success of the Micra™ LPM with stable pacing and sensing and satisfactory rate response profile.