Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety.
Front Cardiovasc Med
; 10: 1148052, 2023.
Article
em En
| MEDLINE
| ID: mdl-37025684
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) ≥ 30â kg/m2] and normal-weight controls (BMI <30â kg/m2) in terms of R-wave amplitude and time in noise mode (noise burden) detected by a long-sensing-vector ICM. Materials andmethods:
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 0.46â mV) than in normal-weight unmatched (0.70â mV, P < 0.0001) or PS-matched (0.60â 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 >0.3â 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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Idioma:
En
Revista:
Front Cardiovasc Med
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Itália