Five-year safety and efficacy of leadless pacemakers in a Dutch cohort.

BACKGROUND: Adequate real-world safety and efficacy of leadless pacemakers (LPs) has been demonstrated up to three years after implantation. Longer-term data is warranted to assess the net clinical benefit of leadless pacing.

OBJECTIVE: To evaluate the long-term safety and efficacy of LP therapy in a real-world cohort.

METHODS: In this retrospective cohort study, all consecutive patients were included with a first LP implantation from December 21, 2012 to December 13, 2016 in six Dutch high-volume centers. The primary safety endpoint was the rate of major procedure- or device-related complications (i.e., requiring surgery) at five-year follow-up. Analyses were performed with and without Nanostim battery advisory-related complications. The primary efficacy endpoint was the percentage of patients with a pacing capture threshold of ≤2.0V at implantation and without ≥1.5V increase at the last follow-up visit.

RESULTS: 179 patients were included (mean age 79±9 years), 93 (52%) with a Nanostim and 86 (48%) with a Micra VR LP. Mean follow-up duration was 44±26 months. Forty-one major complications occurred, of which seven not advisory-related. The five-year major complication rate was 4% without advisory-related complications and 27% including advisory-related complications. Not advisory-related major complications occurred median 10 days (range 0-88 days) post-implantation. The pacing capture threshold was low in 163/167 (98%) and stable in 157/160 (98%).

CONCLUSION: The long-term major complication rate without advisory-related complications was low with LPs. No complications occurred after the acute phase and no infections occurred, which may be a specific benefit of LPs. The performance was adequate with a stable pacing capture threshold.