Findings of a retrospective cohort study assessing the long-term real-world safety and efficacy of leadless pacemakers implanted in patients throughout the Netherlands are “promising for longer-term data on leadless pacing”, the study’s authors suggest.
Writing in Heart Rhythm, Karel Breeman (Amsterdam UMC, Amsterdam, the Netherlands) and colleagues note that adequate real-world safety and efficacy of leadless pacemakers have been demonstrated up to three years, but add that longer-term data are warranted to assess the net clinical benefit of the treatment.
The study team gathered data from patients undergoing first leadless pacemaker implantation in six Dutch high-volume centres between December 2012 and December 2016. The primary safety endpoint was the rate of major procedure- or device-related complications at five-year follow-up. The primary efficacy endpoint was the percentage of patients with a pacing capture threshold ≤2V at implantation and without ≥1.5-V increase at the last follow-up visit.
A total of 179 patients were included in the analysis, 93 (52%) with a Nanostim (St Jude Medical) and 86 (48%) with a Micra VR (Medtronic), and patients had a mean follow-up duration of 44±26 months. Investigators report that 41 major complications occurred, of which seven were not advisory related.
The five-year major complication rate was 4% without advisory-related complications and 27% including advisory-related complications. No advisory-related major complications occurred at a median 10 days (range 0–88 days) post-implantation. The pacing capture threshold was low in 163 of 167 patients (98%) and stable in 157 of 160 (98%).
“The long-term safety (excluding advisory-related complications) and efficacy of leadless pacemakers were adequate,” Breeman et al report in their concluding remarks. “No complications occurred more than three months after implantation, which may be a specific benefit of leadless pacemakers. The pacing threshold of leadless pacemakers is stable over time, in contrast to the gradually rising threshold of transvenous pacemakers. Our study results confirm the findings of previous studies and are promising for longer-term data on leadless pacing.”
