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

BACKGROUND Adequate real-world safety and efficacy of leadless pacemakers (LPs) have been demonstrated up to 3 years after im-plantation. Longer-term data are warranted to assess the net clin-ical benefit of leadless pacing.OBJECTIVE The purpose of this study was to evaluate the long-term safety and efficacy of LP therapy in a real-world cohort. METHODS In this retrospective cohort study, all consecutive pa-tients with a first LP implantation from December 21, 2012, to December 13, 2016, in 6 Dutch high-volume centers were included. The primary safety endpoint was the rate of major procedure-or device-related complications (ie, requiring surgery) at 5-year follow-up. Analyses were performed with and without Nanostim bat -tery advisory-related complications. The primary efficacy endpoint was the percentage of patients with a pacing capture threshold ⠂2.0 V at implantation and without ⠃1.5-V increase at the last follow-up visit. RESULTS A total of 179 patients were included (mean age 79 & PLUSMN; 9 years), 93 (52%) with a Nanostim and 86 (48%) with a Micra VR LP. Mean follow-up duration was 44 & PLUSMN; 26 months. Forty-one major complications occurred, of which 7 were not advisory related. The 5-year major complication rate was 4% without advisory-related complications and 27% including advisory-related complications. No advisory-related major complications occurred a median 10 days (range 0-88 days) postimplantation. The pacing capture threshold was low in 163 of 167 patients (98%) and stable in 157 of 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.

Automated summary

This study evaluated the long-term safety and efficacy of leadless pacemakers in a real-world cohort. The results showed a low rate of major complications, with no complications occurring after the acute phase.