Evaluation of insertable cardiac monitor placement and safety in the LUX-Dx PERFORM study
| Autor: | M Richards, C Stolen, T Simon, T Stoltz, H Manyam, J W Dukes, V Bavikati, J Rosman, J D Rogers, J Garner |
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| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | Europace. 25 |
| ISSN: | 1532-2092 1099-5129 |
| Popis: | Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Boston Scientific Corporation Background The LUX-Dx PERFORM Study is designed to evaluate safety and performance of the LUX-Dx insertable cardiac monitor (ICM) in a general patient population. Enrollment and device insertions are complete, and all patients have completed 30 days of follow-up. This abstract describes the study population, characterizes device insertion, and reports on preliminary data for ICM system-related complications. Methods The LUX-Dx PERFORM study is a prospective, multi-center, single arm, post-market, observational study. The ICM system-related complication-free rate (CFR) at 30 days post-insertion was calculated using Kaplan-Meier methodology and the 97.5% one-side lower confidence limit (LCL) was compared to the prespecified performance target of 94%. All ICM system-related adverse events were adjudicated by independent physician reviewers. Results 727 patients were enrolled at 24 centers in the United States from March 2021 to May 2022. The study population was 49% male, 91% white and 66+/-14 years old. 717 patients had device insertions and were successfully registered in the LATITUDE Clarity data management system. There were 9 withdrawals prior to insertion and 1 aborted procedure due to deployment difficulty. ICM insertion was performed in-hospital 76% of the time (N=547) and in-clinic 24% of the time (N=171). 96% were de novo device insertions. A variety of closure techniques were used including surgical glue (62%), adhesive strips (45%), sutures (42%), and staples (9%). Median procedure time was 4 minutes (range 1 - 37). There were 4 ICM system-related complications in the first 30 days (CFR 99%, LCL 99%) which meets the acute safety performance goal. The system-related complications include 1 case of ICM deployment difficulty, 1 case of device expulsion three days post insertion, and 2 infections that were treated with oral antibiotics and resolved without further mitigation. Conclusion The LUX-Dx ICM can be inserted quickly, in both hospital and clinic settings, with a very low complication rate. |
| Databáze: | OpenAIRE |
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