Evaluation of insertable cardiac monitor placement and safety in the LUX-Dx PERFORM study

Abstract Funding Acknowledgements Type of funding sources: Private company. Main source(s): Boston Scientific Corporation Background The LUX-Dx PERFORM Study is designed to evaluate safety and performance the insertable cardiac monitor (ICM) in a general patient population. Enrollment device insertions are complete, all patients have completed 30 days follow-up. This abstract describes study population, characterizes insertion, reports on preliminary data for ICM system-related complications. Methods prospective, multi-center, single arm, post-market, observational study. complication-free rate (CFR) at post-insertion was calculated using Kaplan-Meier methodology 97.5% one-side lower confidence limit (LCL) compared prespecified target 94%. All adverse events were adjudicated by independent physician reviewers. Results 727 enrolled 24 centers United States from March 2021 May 2022. population 49% male, 91% white 66+/-14 years old. 717 had successfully registered LATITUDE Clarity management system. There 9 withdrawals prior insertion 1 aborted procedure due deployment difficulty. performed in-hospital 76% time (N=547) in-clinic 24% (N=171). 96% de novo insertions. A variety closure techniques used including surgical glue (62%), adhesive strips (45%), sutures (42%), staples (9%). Median 4 minutes (range - 37). complications first (CFR 99%, LCL 99%) which meets acute goal. include case difficulty, expulsion three post 2 infections that treated with oral antibiotics resolved without further mitigation. Conclusion can be inserted quickly, both hospital clinic settings, very low complication rate.