Chronic Performance of a Leadless Cardiac Pacemaker
Key result
Leadless cardiac pacing maintains stable electrical performance with zero device-related complications through 12 months.
- n=31
Why the study?
Long-term results of leadless cardiac pacemaker systems are unknown, necessitating assessment of complication incidence and electrical performance.
Does a leadless cardiac pacemaker demonstrate stable safety and electrical performance over 12 months of follow-up in patients requiring single-chamber pacing?
Study Design
Type
Cohort (n=31)
Structured PICO
Does a leadless cardiac pacemaker demonstrate stable safety and electrical performance over 12 months of follow-up in patients requiring single-chamber pacing?
P
Population
31 older adults (mean age 76) with an indication for single-chamber pacing who received a leadless cardiac pacemaker, evaluated retrospectively at 12 months.
E
Exposure
Leadless cardiac pacemaker (LCP) system implantation
O
Outcome
Complication incidence, electrical performance (pacing threshold, R-wave amplitude, and impedance), and rate response characteristics within the first year of follow-upsafety
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The data available for both leadless pacemaker systems are promising and show that safety is similar to transvenous pacemakers. However, data across a larger patient population with longer term follow-up will be key in order for leadless pacemakers to fully replace transvenous pacemakers, which have been around for over 50 years and have vast amounts of data to support their safety profile.”
“With a leadless pacemaker design, lead and pocket complications can be eliminated, potentially resulting in lower complication rates.”
MRMichael R. GoldCardiologist, Medical University of South Carolina
“these early results are very encouraging.”
Implication
A leadless cardiac pacemaker demonstrates stable electrical performance and no intermediate-term pacing-related adverse events during the first year of follow-up.
Abstract
BACKGROUND: A leadless cardiac pacemaker (LCP) system was recently introduced to overcome lead-related complications of conventional pacing systems. To date, long-term results of an LCP system are unknown. OBJECTIVES: The aim of this study was to assess the complication incidence, electrical performance, and rate response characteristics within the first year of follow-up of patients implanted with an LCP. METHODS: We retrospectively assessed intermediate-term follow-up data for 31 of 33 patients from the LEADLESS trial cohort who had an indication for single-chamber pacing and received an LCP between December 2012 and April 2013. RESULTS: The mean age of the cohort was 76 ± 8 years, and 65% were male. Between 3 and 12 months of follow-up, there were no pacemaker-related adverse events reported. The pacing performance results at 6- and 12-month follow-up were, respectively, as follows: mean pacing threshold (at a 0.4-ms pulse width), 0.40 ± 0.26 V and 0.43 ± 0.30 V; R-wave amplitude 10.6 ± 2.6 mV and 10.3 ± 2.2 mV; and impedance 625 ± 205 Ω and 627 ± 209 Ω. At the 12-month follow-up in 61% of the patients (n = 19 of 31), the rate response sensor was activated, and an adequate rate response was observed in all patients. CONCLUSIONS: The LCP demonstrates very stable performance and reassuring safety results during intermediate-term follow-up. These results support the use of the LCP as a promising alternative to conventional pacemaker systems. Continued evaluation is warranted to further characterize this system. (Evaluation of a New Cardiac Pacemaker; NCT01700244).
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Cite This Study
Knops et al. (2015) conducted a cohort in Indication for single-chamber pacing (n=31). Leadless cardiac pacemaker (LCP) was evaluated on Complication incidence, electrical performance, and rate response characteristics. A leadless cardiac pacemaker demonstrated stable pacing performance (mean pacing threshold 0.43 V at 12 months) and zero pacemaker-related adverse events between 3 and 12 months of follow-up.