Details

Autor(en) / Beteiligte

• Breeman, Karel T.N.
• Oosterwerff, Erik F.J.
• de Graaf, Michiel A.
• Juffer, Albert
• Saleem-Talib, Shmaila
• Maass, Alexander H.
• Wilde, Arthur A.M.
• Boersma, Lucas V.A.
• Ramanna, Hemanth
• van Dijk, Vincent F.
• van Erven, Lieselot
• Delnoy, Peter-Paul H.M.
• Tjong, Fleur V.Y.
• Knops, Reinoud E.

Titel

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

Ist Teil von

• Heart rhythm, 2023-08, Vol.20 (8), p.1128-1135

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2023

Link zum Volltext

Quelle

Elsevier ScienceDirect Journals

Beschreibungen/Notizen

• Adequate 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. The purpose of this study was to evaluate the long-term safety and efficacy of LP therapy in a real-world cohort. In 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. A 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%). 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.