Introduction:

The Micra AV™ intracardiac leadless pacing system has been introduced recently and implemented into clinical routine. Size and composition of this second-generation leadless pacemaker are the same as the available MICRA VVI system. Feasibility, implantation safety and procedural success are assumed to be similar than proven in the setting of controlled studies with the first generation device. Therefore, we aimed to report our first single center follow-up (FU) data in comparison with the results of the prospective controlled Micra VR™ study and the results of our own Micra VR™ population.

Methods:

After MicraAV™ implantation pacemaker interrogation was performed one to seven days after implantation and during FU (one and three months, than every 6 six month). Data were assessed in a real-life setting and compared with existing data of a controlled prospective trial and the own data of the first generation VVI-device. Furthermore, we investigated the rate of AV-synchronous Stimulation (AVSR).

Results:

The MicraAV™ implantation was successful in 52/52 patients (67% male; mean age: 81±6) without procedure or device-related major complications.

The average acute thresholds, sensing and impedance after system release were: 0.65±0.55V@0.24ms; 9,2±4,7mV and 812±212Ohm

During follow up of up to 3 months, neither pacemaker failure nor infections were reported. Measurements were reevaluated for “long-term” thresholds, sensing and impedance: 0,46 ± 0,09V @ 0.24 ms; 15,6 ±5 mV and 603 ± 89 Ohm.

During FU of up to 15 month, no significant changes were detectable.  

During Follow up we detected a median AV-synchronous stimulation rate (AVSR) of 70%.

Conclusion:

In a real-life setting, the implantation of the leadless Micra AV™ system demonstrated a high rate of implantatiom success without major complications. We were also able to show stable system parameters in the clinical setting during short term follow up. We were able to reconfirm the positive results of the IDE trial in this clinical scenario.

After one year experience it is obvious that in MICRA AV-patients the focus has moved from implantation to patient-selection and follow-up. In real life the AV-synchronous stimulation rate seems to be the hardest challenge.