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- Titel:
Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety.
- Dokumenttyp:
- Journal Article
- Autor(en):
- Bisignani, Giovanni; De Bonis, Silvana; Pierre, Bertrand; Lau, Dennis H; Hofer, Daniel; Sanfins, Victor Manuel; Hain, Andreas; Cabanas, Pilar; Martens, Eimo; Berruezo, Antonio; Eschalier, Romain; Milliez, Paul; Lüsebrink, Ulrich; Mansourati, Jacques; Papaioannou, Georgios; Giacopelli, Daniele; Gargaro, Alessio; Ploux, Sylvain
- Abstract:
- BACKGROUND: Fat layers in obese patients can impair R-wave detection and diagnostic performance of a subcutaneous insertable cardiac monitor (ICM). We compared safety and ICM sensing quality between obese patients [body mass index (BMI) ≥ 30 kg/m2] and normal-weight controls (BMI <30 kg/m2) in terms of R-wave amplitude and time in noise mode (noise burden) detected by a long-sensing-vector ICM. MATERIALS AND METHODS: Patients from two multicentre, non-randomized clinical registries are included in the present analysis on January 31, 2022 (data freeze), if the follow-up period was at least 90 days after ICM insertion, including daily remote monitoring. The R-wave amplitudes and daily noise burden averaged intraindividually for days 61-90 and days 1-90, respectively, were compared between obese patients (n = 104) and unmatched (n = 268) and a nearest-neighbour propensity score (PS) matched (n = 69) normal-weight controls. RESULTS: The average R-wave amplitude was significantly lower in obese (median 0.46 mV) than in normal-weight unmatched (0.70 mV, P < 0.0001) or PS-matched (0.60 mV, P = 0.003) patients. The median noise burden was 1.0% in obese patients, which was not significantly higher than in unmatched (0.7%; P = 0.056) or PS-matched (0.8%; P = 0.133) controls. The rate of adverse device effects during the first 90 days did not differ significantly between groups. CONCLUSION: Although increased BMI was associated with reduced signal amplitude, also in obese patients the median R-wave amplitude was >0.3 mV, a value which is generally accepted as the minimum level for adequate R-wave detection. The noise burden and adverse event rates did not differ significantly between obese and normal-weight patients.Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04075084 and NCT04198220.
- Zeitschriftentitel:
- Front Cardiovasc Med
- Jahr:
- 2023
- Band / Volume:
- 10
- Volltext / DOI:
- doi:10.3389/fcvm.2023.1148052
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/37025684
- TUM Einrichtung:
- Klinik und Poliklinik für Innere Medizin I, Kardiologie (Prof. Laugwitz)
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