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

Breeman, K.T.N.; Oosterwerff, E.F.J.; Graaf, M.A. de; Juffer, A.; Saleem-Talib, S.; Maass, A.H.; Wilde, A.A.M.; Boersma, L.V.A.; Ramanna, H.; Dijk, V.F. van; Erven, L. van; Delnoy, P.P.H.M.; Tjong, F.V.Y.; Knops, R.E.

doi:doi:10.1016/j.hrthm.2023.05.031

BackgroundAdequate real-world safety and efficacy of leadless pacemakers (LPs) have been demonstrated up to 3 years after implantation. Longer-term data are warranted to assess the net clinical benefit of leadless pacing.ObjectiveThe purpose of this study was to evaluate the long-term safety and efficacy of LP therapy in a real-world cohort.MethodsIn this retrospective cohort study, all consecutive patients 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 battery 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....Show moreBackgroundAdequate real-world safety and efficacy of leadless pacemakers (LPs) have been demonstrated up to 3 years after implantation. Longer-term data are warranted to assess the net clinical benefit of leadless pacing.ObjectiveThe purpose of this study was to evaluate the long-term safety and efficacy of LP therapy in a real-world cohort.MethodsIn this retrospective cohort study, all consecutive patients 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 battery 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.ResultsA total of 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 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%).ConclusionThe 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.Show less

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