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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

Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety

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  • Media type: E-Article
  • Title: Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety
  • Contributor: 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
  • imprint: Frontiers Media SA, 2023
  • Published in: Frontiers in Cardiovascular Medicine, 10 (2023)
  • Language: Not determined
  • DOI: 10.3389/fcvm.2023.1148052
  • ISSN: 2297-055X
  • Keywords: Cardiology and Cardiovascular Medicine
  • Origination:
  • Footnote:
  • Description: <jats:sec><jats:title>Background</jats:title><jats:p>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/m<jats:sup>2</jats:sup>] and normal-weight controls (BMI &amp;lt;30 kg/m<jats:sup>2</jats:sup>) in terms of R-wave amplitude and time in noise mode (noise burden) detected by a long-sensing-vector ICM.</jats:p></jats:sec><jats:sec><jats:title>Materials and methods</jats:title><jats:p>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 (<jats:italic>n</jats:italic> = 104) and unmatched (<jats:italic>n</jats:italic> = 268) and a nearest-neighbour propensity score (PS) matched (<jats:italic>n</jats:italic> = 69) normal-weight controls.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The average R-wave amplitude was significantly lower in obese (median 0.46 mV) than in normal-weight unmatched (0.70 mV, <jats:italic>P</jats:italic> &amp;lt; 0.0001) or PS-matched (0.60 mV, <jats:italic>P</jats:italic> = 0.003) patients. The median noise burden was 1.0% in obese patients, which was not significantly higher than in unmatched (0.7%; <jats:italic>P</jats:italic> = 0.056) or PS-matched (0.8%; <jats:italic>P</jats:italic> = 0.133) controls. The rate of adverse device effects during the first 90 days did not differ significantly between groups.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Although increased BMI was associated with reduced signal amplitude, also in obese patients the median R-wave amplitude was &amp;gt;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.</jats:p><jats:p><jats:bold>Registration</jats:bold>: URL: <jats:ext-link>https://www.clinicaltrials.gov</jats:ext-link>; Unique identifier: NCT04075084 and NCT04198220.</jats:p></jats:sec>
  • Access State: Open Access