Performance of the New BioMonitor 2-AF Insertable Cardiac Monitoring System: Can Better be Worse?
Pacing Clin Electrophysiol
; 40(5): 516-526, 2017 May.
Article
em En
| MEDLINE
| ID: mdl-28220938
BACKGROUND: Implantable loop recorders (ILR) are valuable tools for the investigation of patients with suspected arrhythmias. The BioMonitor 2-AF is a novel insertable ILR with enhanced atrial fibrillation (AF) detection algorithm and remote monitoring capability. OBJECTIVE: The objective of this first-in-human study with the BioMonitor 2-AF was to analyze course of P-wave sensing performance and R-wave amplitude, prevalence of false and correctly sensed and classified episodes, and effectiveness of remote monitoring. METHODS: All 19 patients who underwent ILR insertion were included in the BIOTRONIK Home Monitoring® system (BIOTRONIK GmbH, Berlin, Germany). Daily changes in P-wave and R-wave sensing were analyzed over 6 weeks. A breathing test (in- and expiration) was performed in two different body positions at baseline and during a 6-week in-house follow-up to investigate alterations of P-wave and R-wave sensing. RESULTS: R-wave amplitude and the high P-wave visibility (94.4%) remained unchanged during the follow-up period. In most patients both an increase and decrease of R-wave amplitude, and in some cases a complete R-wave vector change (31.6%), was documented during the "breathing test." Change of body position did not alter R-wave sensing amplitude mostly. "Breathing test" and change of body position had no effect on P-wave sensing performance. In 15.8% of the patients, misclassification of episodes as AF or high ventricular rates due to P-wave oversensing occurred. No ILR-related complication occurred. Automatic transmission via BIOTRONIK Home Monitoring® was successful 100% of the time. CONCLUSION: This study demonstrates that the BioMonitor 2-AF is a safe and effective tool for continuous cardiac monitoring.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Próteses e Implantes
/
Fibrilação Atrial
/
Diagnóstico por Computador
/
Eletrocardiografia Ambulatorial
/
Eletrodos Implantados
Tipo de estudo:
Diagnostic_studies
/
Observational_studies
/
Risk_factors_studies
Limite:
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article