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. 2023 Mar 21:10:1148052.
doi: 10.3389/fcvm.2023.1148052. eCollection 2023.

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

Giovanni Bisignani  1 , Silvana De Bonis  1 , Bertrand Pierre  2 , Dennis H Lau  3 , Daniel Hofer  4 , Victor Manuel Sanfins  5 , Andreas Hain  6 , Pilar Cabanas  7 , Eimo Martens  8 , Antonio Berruezo  9 , Romain Eschalier  10 , Paul Milliez  11 , Ulrich Lüsebrink  12 , Jacques Mansourati  13 , Georgios Papaioannou  14 , Daniele Giacopelli  15   16 , Alessio Gargaro  15 , Sylvain Ploux  17
Affiliations

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

Giovanni Bisignani et al. Front Cardiovasc Med. .

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.

Keywords: implantable loop recorder; insertable cardiac monitor; long-sensing vector; obesity; r-wave amplitude; signal quality.

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Conflict of interest statement

DG and A G are employees of BIOTRONIK Italia. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Box-whiskers plot of the 3-month average R-wave amplitude by study groups, in the unmatched and propensity score (PS) matched cohorts.
Figure 2
Figure 2
Plot of average 3-month R-wave amplitudes vs. inverse BMI values and linear fit (blue line) with 95% confidence interval (CI) in unmatched and propensity score (PS) matched cohorts.
Figure 3
Figure 3
Distributions of 3-month average daily noise burden (percentage of 24 h) by study groups, in the unmatched and propensity score (PS) matched cohorts.
See this image and copyright information in PMC

References

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