Midterm Safety and Performance of a Leadless Cardiac Pacemaker
3-Year Follow-up to the LEADLESS Trial (Nanostim Safety and Performance Trial for a Leadless Cardiac Pacemaker System)
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Leadless cardiac pacemakers (LCPs) have been introduced to decrease lead- and pocket-related complications. Initial studies have shown short-term complication rates of 4% to 6.7% and adequate electric performance in up to 12 months of follow-up.1–3 However, to fully appreciate the clinical impact and the robustness of this novel technology, additional follow-up is required to determine the long-term safety and performance. In this study, we report the longest clinical follow-up to date: the 3-year results of the LEADLESS trial (Nanostim Safety and Performance Trial for a Leadless Cardiac Pacemaker System).4
Patients implanted with an LCP (Nanostim, St. Jude Medical/Abbott) were retrospectively assessed to evaluate the safety and performance of this device with a minimum of 3 years of follow-up. No patients were lost to follow-up. Medical records were analyzed from June 2014 until May 2016 and evaluated for (1) serious adverse device effects (SADEs) and (2) electric performance of the LCP. The primary outcome was freedom from SADEs (Kaplan-Meier estimate) at 40 months of follow-up. Categorical variables are presented as frequencies and continuous variables as means (±SD). Permission of the local institutional review boards was obtained for this retrospective analysis, and all participants gave written informed consent.
Thirty-three patients (age 77±8 years, 67% male) were enrolled and were followed for a median duration of 38 months (range, 21–41 months). Two patients were …