TY - JOUR
T1 - Five-year safety and efficacy of leadless pacemakers in a Dutch cohort
AU - Breeman, Karel T. N.
AU - Oosterwerff, Erik F. J.
AU - de Graaf, Michiel A.
AU - Juffer, Albert
AU - Saleem-Talib, Shmaila
AU - Maass, Alexander H.
AU - Wilde, Arthur A. M.
AU - Boersma, Lucas V. A.
AU - Ramanna, Hemanth
AU - van Dijk, Vincent F.
AU - van Erven, Lieselot
AU - Delnoy, Peter-Paul H. M.
AU - Tjong, Fleur V. Y.
AU - Knops, Reinoud E.
N1 - Publisher Copyright: © 2023 Heart Rhythm Society
PY - 2023/8
Y1 - 2023/8
N2 - Background: 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. 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 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. Results: 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%). 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.
AB - Background: 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. 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 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. Results: 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%). 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.
KW - Complications
KW - Efficacy
KW - Leadless
KW - Pacemaker
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85162884464&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.hrthm.2023.05.031
DO - https://doi.org/10.1016/j.hrthm.2023.05.031
M3 - Article
C2 - 37271354
SN - 1547-5271
VL - 20
SP - 1128
EP - 1135
JO - Heart Rhythm
JF - Heart Rhythm
IS - 8
ER -