AUTHOR=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 

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

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=10

YEAR=2023

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2023.1148052

DOI=10.3389/fcvm.2023.1148052

ISSN=2297-055X

ABSTRACT=<sec><title>Background</title><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<sup>2</sup>] and normal-weight controls (BMI &lt;30 kg/m<sup>2</sup>) in terms of R-wave amplitude and time in noise mode (noise burden) detected by a long-sensing-vector ICM.</p></sec><sec><title>Materials and methods</title><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 (<italic>n</italic> = 104) and unmatched (<italic>n</italic> = 268) and a nearest-neighbour propensity score (PS) matched (<italic>n</italic> = 69) normal-weight controls.</p></sec><sec><title>Results</title><p>The average R-wave amplitude was significantly lower in obese (median 0.46 mV) than in normal-weight unmatched (0.70 mV, <italic>P</italic> &lt; 0.0001) or PS-matched (0.60 mV, <italic>P</italic> = 0.003) patients. The median noise burden was 1.0% in obese patients, which was not significantly higher than in unmatched (0.7%; <italic>P</italic> = 0.056) or PS-matched (0.8%; <italic>P</italic> = 0.133) controls. The rate of adverse device effects during the first 90 days did not differ significantly between groups.</p></sec><sec><title>Conclusion</title><p>Although increased BMI was associated with reduced signal amplitude, also in obese patients the median R-wave amplitude was &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.</p><p><bold>Registration</bold>: URL: <ext-link ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">https://www.clinicaltrials.gov</ext-link>; Unique identifier: NCT04075084 and NCT04198220.</p></sec>