Impact of device length on electrogram sensing in miniaturized insertable cardiac monitors

Pitman, Bradley M.; Kadhim, Kadhim; Tarone, Rachel; Jones, Esther; Linz, Dominik; Lim, Matthew; Heath, Kyle; Scanlan, Nicholas; Roberts‐Thomson, Kurt C.; Young, Glenn D.; Wong, Christopher X.; Sanders, Prashanthan; Mariani, Justin A.; Lau, Dennis H.

doi:10.1016/j.jelectrocard.2022.05.008

Cited by 7 publications

(6 citation statements)

References 22 publications

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“…To obtain large R-wave amplitudes, the ICM model investigated in the present study was designed with an extended sensing vector using a flexible antenna that increases the inter-electrode spacing up to approximately 70 mm, very close to the optimal distance suggested by experimental research ( 15 ). A recent study directly comparing long- and standard- (<50 mm) sensing-vector ICMs confirmed that the long vector can be a good solution to obtain large sECG amplitudes ( 8 ).…”

Section: Discussionmentioning

confidence: 98%

“…The impact of body composition on sensing amplitude detected by the ICM was among the secondary endpoints of several previous studies. Although data from short-sensing-vector devices (Reveal LINQ) suggested an inverse relationship between R-wave amplitude and BMI ( 17 ), studies with long-sensing-vector ICMs were less conclusive ( 8 , 10 , 18 – 22 ) ( Table 5 ). Lacour et al ( 18 ) did not observe such relationship in a small cohort of 19 patients implanted with a previous device version (BioMonitor 2).…”

Section: Discussionmentioning

confidence: 99%

“…In a larger population with the same device (n = 84), Forleo et al (19) showed a tendency to lower values in obese people (P = 0.074). More recently, Pitman et al (8) found a significant but weaker negative correlation between BMI and R-wave amplitudes in BIOMONITOR III as compared to standard-sensing-vector devices. While using a PS-matching method to reduce uncontrolled confounders, we confirmed a negative but not critical impact of BMI on R-wave amplitude detected by the long-sensing-vector ICM and relatively unaffected noise levels by BMI.…”

Section: Comparison With Previous Studiesmentioning

confidence: 98%

“…This is even more important as obesity was found to be an independent clinical predictor of pacemaker implantation and atrial arrhythmia in patients with ICM ( 6 , 7 ). Recently, devices with long sensing vectors have been designed to obtain larger P - and R-wave amplitudes and thus improve sECG quality compared to standard sensing vectors ( 8 ). However, there are still no data on the ICM sensing performance and the safety of ICM insertion in obese vs. non-obese patients.…”

Section: Introductionmentioning

confidence: 99%

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

Bisignani

Bonis²,

Pierre³

et al. 2023

Front. Cardiovasc. Med.

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BackgroundFat 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 methodsPatients 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.ResultsThe 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.ConclusionAlthough 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.

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Section: Comparison With Previous Studiesmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Bisignani

Bonis²,

Pierre³

et al. 2023

Front. Cardiovasc. Med.

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“…The provides larger amplitudes of the sECG on average compared with the standard sensing dipole of less than 50 mm. 15 Improvements in ICM algorithms could also have played a role. For instance, in line with a recent report, 16 we observed that the RhythmCheck feature showed…”

Section: Discussionmentioning

confidence: 99%

Remote monitoring of implantable cardiac monitors in patients with unexplained syncope: Predictors of false‐positive alert episodes

Russo,

Covino,

De Pasquale

et al. 2023

Pacing Clinical Electrophis

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BackgroundRemote monitoring is recommended for patients with implantable cardiac monitors (ICMs), but compared to other cardiac implantable devices, ICMs are less accurate and transmit a higher number of alerts.ObjectiveThe aim of this study was to investigate the predictors of false‐positive (FP) arrhythmic alerts in patients with unexplained syncope who were implanted with ICM and followed by an automatic remote monitoring system.MethodsWe retrospectively evaluated all consecutive patients who received a long‐sensing vector ICM for unexplained syncope between January 2019 to September 2021 at our Syncope Unit. The primary endpoint was the incidence of the first FP episode. The secondary endpoints included assessing the incidence of FP episodes for all types of algorhythms and indentifying the reasons for the misdetection of these episodes.ResultsAmong 105 patients (44.8% males, median age 51 years), 51 (48.6%) transmitted at least one FP alert during a median follow‐up of 301 days. The presence of pre‐ventricular complexes (PVCs) on the resting electrocardiogram was the only clinical characteristic associated with an increased risk of FP alerts (adjusted Hazard ratio [HR] 5.76 [2.66–12.4], p = 0.010). The other significant device‐related variables were a low‐frequency filter at 0.05 Hz versus the default 0.5 Hz (adjusted HR 3.82 [1.38–10.5], p = 0.010) and the R‐wave amplitude (adjusted HR 0.35 [0.13–0.99], p = 0.049).ConclusionPatients who have PVCs are at higher risk of inappropriate ICM activations. To reduce the occurrence of FP alerts, it may be beneficial to target a large R‐wave amplitude during device insertion and avoid programming a low‐frequency filter at 0.05 Hz.

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Malfunction of an insertable cardiac monitor with a long-sensing vector attributed to a mechanical failure: A case report

Takahashi,

Aoki,

Sato

et al. 2023

HeartRhythm Case Reports

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Impact of device length on electrogram sensing in miniaturized insertable cardiac monitors

Cited by 7 publications

References 22 publications

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

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

Remote monitoring of implantable cardiac monitors in patients with unexplained syncope: Predictors of false‐positive alert episodes

Malfunction of an insertable cardiac monitor with a long-sensing vector attributed to a mechanical failure: A case report

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