Preliminary results from the LUX-Dx insertable cardiac monitor remote programming and performance (LUX-Dx PERFORM) study.
ICM
arrhythmia
cryptogenic stroke
device programming
remote monitoring
Journal
Clinical cardiology
ISSN: 1932-8737
Titre abrégé: Clin Cardiol
Pays: United States
ID NLM: 7903272
Informations de publication
Date de publication:
Jan 2023
Jan 2023
Historique:
revised:
15
09
2022
received:
22
03
2022
accepted:
20
09
2022
pubmed:
9
10
2022
medline:
21
1
2023
entrez:
8
10
2022
Statut:
ppublish
Résumé
Despite the wide adoption of insertable cardiac monitors (ICMs), high false-positive rates, suboptimal signal quality, limited ability to detect atrial flutter, and lack of remote programming remain challenging. The LUX-Dx PERFORM study was designed to evaluate novel technologies engineered to address these issues. Here, we present preliminary results from the trial focusing on the safety of ICM insertion, remote monitoring rates, and the feasibility of remote programming. LUX-Dx PERFORM is a multicenter, prospective, single-arm, post-market, observational study with planned enrollment of up to 827 patients from 35 sites in North America. A preliminary cohort consisting of the first 369 patients who were enrolled between March and October 2021 was selected for analysis. Three hundred sixty-three (363) patients had ICM insertions across inpatient and outpatient settings. The mean time followed was 103.4 ± 61.8 days per patient. The total infection rate was 0.8% (3/363). Interim results show high levels of remote monitoring with a median 94% of days with data transmission (interquartile range: 82-99). Thirteen (13) in-clinic and 24 remote programming sessions were reported in 34 subjects. Reprogramming examples are presented to highlight signal quality, the ability to detect atrial flutter, and the positive impact of remote programming on patient management. Interim results from LUX-Dx PERFORM study demonstrate the safety of insertion, high data transmission rates, the ability to detect atrial flutter, and the feasibility of remote programming to optimize arrhythmia detection and improve clinical workflow. Future results from LUX-Dx PERFORM will further characterize improvements in signal quality and arrhythmia detection.
Identifiants
pubmed: 36208096
doi: 10.1002/clc.23930
pmc: PMC9849434
doi:
Types de publication
Observational Study
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
100-107Subventions
Organisme : Boston Scientific Corporation
Informations de copyright
© 2022 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.
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