Miniaturized implantable cardiac monitor with a long sensing vector (BIOMONITOR III): Insertion procedure assessment, sensing performance, and home monitoring transmission success

Mariani, Justin A.; Weerasooriya, Rukshen; Brink, Olivier van den; Mohamed, Uwais; Gould, Paul A.; Pathak, Rajeev K.; Lin, Tina; Conradie, A.; Illéš, Peter; Pavia, S.; Rajamani, Kushwin; Lovibond, Sam; Matthews, Ian; DiFiore, David; Arumugam, Deepak; Schrader, Jürgen; Lau, Dennis H.

doi:10.1016/j.jelectrocard.2020.04.004

Cited by 28 publications

(41 citation statements)

References 31 publications

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“…In the present case, we used the BIOMONITOR III, a novel ICM device that combines a long sensing vector with a miniaturized profile. Previous studies have described visible P waves in >80% of cases 2 . In our case, there was no P wave in the subcutaneous ECG during AF compared with that during sinus rhythm (Figure 2A, B).…”

Section: Discussionsupporting

confidence: 47%

“…Previous studies have described visible P waves in >80% of cases. 2 In our case, there was no P wave in the subcutaneous ECG during AF compared with that during sinus rhythm (Figure 2A, B). In the subcutaneous ECG recorded by the sudden drop rate alarm, the P wave was not visible during AF, but appeared when the system returned to sinus rhythm.…”

Section: Discussionmentioning

confidence: 46%

“…P wave (arrow) can be clearly seen during the sinus rhythm the 3rd to the 6th intercostal space parallel to the cardiac shadow, using the provided insertion tools. 2 Because these tools are very simple and easy to use, complications of ICM (eg, bleeding or infection) are very rare. Previous report describes insertion of ICM in pediatric population to detect ventricular arrhythmia for syncope.…”

Section: F I G U R Ementioning

confidence: 99%

“…Insertable cardiac monitors (ICMs) combined with remote monitoring have been used in ESUS patients with mild symptoms (modified Rankin scale from 0 to 2) to detect CPAF and to prevent recurrent ischemic stroke. ICMs are usually implanted into the left margin of the sternum, from the 3rd to the 6th intercostal space parallel to the cardiac shadow, using the provided insertion tools 2 . Because these tools are very simple and easy to use, complications of ICM (eg, bleeding or infection) are very rare.…”

Section: Introductionmentioning

confidence: 99%

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Successful detection of covert paroxysmal atrial fibrillation due to insertable cardiac monitor in embolic stroke of undetermined source in a patient with situs inversus totalis

Kasai

Shakya

Miyaji

et al. 2021

Clinical Case Reports

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We describe a case of ICM implantation in a 74-year-old woman with SIT and ESUS for detection of AF. ICM implantation was performed successfully without any complications. AF was detected at 28 days after ICM insertion. ICMs can be safely implanted in patients with SIT, allowing successful detection of AF. Approximately, 25% of all ischemic strokes are cryptogenic. 1 Of these, a clinical entity of embolic stroke of undetermined source (ESUS) was recently established. ESUS is defined as a nonlacunar brain infarction without a proximal arterial steno-occlusive lesion or cardioembolic source. Thus, the pathogenesis of ESUS is varied and includes covert paroxysmal atrial fibrillation (CPAF), aorto/arteriogenic embolism, paradoxical embolism, and cancer-related embolism. CPAF is a major cause of ESUS. 1 However, detecting CPAF during hospitalization is often difficult, even with continuous electrocardiographic (ECG) monitoring. Insertable cardiac monitors (ICMs) combined with remote monitoring have been used in ESUS patients with mild symptoms (modified Rankin scale from 0 to 2) to detect CPAF and to prevent recurrent ischemic stroke. ICMs are usually implanted into the left margin of the sternum, from

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Section: Discussionsupporting

confidence: 47%

Section: Discussionmentioning

confidence: 46%

Section: F I G U R Ementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Successful detection of covert paroxysmal atrial fibrillation due to insertable cardiac monitor in embolic stroke of undetermined source in a patient with situs inversus totalis

Kasai

Shakya

Miyaji

et al. 2021

Clinical Case Reports

View full text Add to dashboard Cite

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“…Therefore, the most important goal of these devices is to obtain a clear and accurate sECG and to minimize false‐positive or ‐negative arrhythmic episodes caused by artefacts, oversensing, or undersensing of electric potentials 5 . The use of a long sensing vector has been proposed to increase the amplitude of the detected sECG 6,7 . Along with the design of the devices, several additional factors may significantly affect ICM signal quality, such as patient sex and weight or implant location, but data that may provide useful information to optimize sensing capability of ICMs are still scant.…”

Section: Introductionmentioning

confidence: 99%

Factors affecting signal quality in implantable cardiac monitors with long sensing vector

Forleo

Amellone

Sacchi

et al. 2021

Journal of Arrhythmia

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Purpose Electrical artefacts are frequent in implantable cardiac monitors (ICMs). We analyzed the subcutaneous electrogram (sECG) provided by an ICM with a long sensing vector and factors potentially affecting its quality. Methods Consecutive ICM recipients underwent a follow‐up where demographics, body mass index (BMI), implant location, and surface ECG were collected. The sECG was then analyzed in terms of R‐wave amplitude and P‐wave visibility. Results A total of 84 patients (43% female, median age 68 [58‐76] years) were enrolled at 3 sites. ICMs were positioned with intermediate inclination (n = 44, 52%), parallel (n = 35, 43%), or perpendicular (n = 5, 6%) to the sternum. The median R‐wave amplitude was 1.10 (0.72‐1.48) mV with P waves readily visible in 69.2% (95% confidence interval, CI: 57.8%‐79.2%), partially visible in 23.1% [95% CI: 14.3%‐34.0%], and never visible in 7.7% [95% CI: 2.9%‐16.0%] of patients. Men had higher R‐wave amplitudes compared to women (1.40 [0.96‐1.80] mV vs 1.00 [0.60‐1.20] mV, P = .001), while obese people tended to have lower values (0.80 [0.62‐1.28] mV vs 1.10 [0.90‐1.50] mV, P = .074). The P‐wave visibility reached 86.2% [95% CI: 68.3%‐96.1%] in patients with high‐voltage P waves (≥0.2 mV) at surface ECG. The sECG quality was not affected by implant site. Conclusion In ordinary clinical practice, ICMs with long sensing vector provided median R‐wave amplitude above 1 mV and reliable P‐wave visibility of nearly 70%, regardless of the position of the device. Women and obese patients showed lower but still very good signal quality.

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Revisiting where to apply preimplant mapping to improve P‐wave sensing of insertable cardiac monitors

Kasai

Sahashi

et al. 2022

Journal of Arrhythmia

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Background Insertable cardiac monitors (ICMs) are used for long‐term cardiac rhythm monitoring. They have proven useful in diagnosing arrhythmias. They are conventionally inserted at the 4th intercostal space without preimplant mapping. Method We develop a new method, VisP, that finds an optimal insertion position by applying the lightweight preimplant mapping to nine candidate positions beyond the conventional ones. We retrospectively analyze consecutive 60 patients who underwent ICM insertion (Reveal LINQ™) between April 2019 and March 2021 and compare the two groups with and without VisP. Results After 9 patients were excluded because of ectopic atrial rhythms or atrial fibrillation, 51 patients were analyzed. Thirty‐one patients underwent the conventional insertion (non‐mapping), whereas 20 patients underwent VisP. VisP achieved large P‐wave amplitudes while retaining the R‐wave amplitude for all patients; in contrast, P waves were not detected for 11 patients out of the 31 patients in the non‐mapping group (35%). On average, the P‐wave amplitude was 0.065 mV for VisP, compared to 0.029 mV for the non‐mapping group (p‐value< .001). The average R‐wave amplitude was 0.69 mV for VisP and 0.71 mV for non‐mapping (p‐value = .88), indicating the R‐wave difference is insignificant between the two groups. VisP selected the 4th, 3rd, and 2nd intercostal spaces for 7, 11, and 2 patients, respectively, meaning that 13 out of the 20 cases (65%) fell out of the conventional insertion location of the 4th intercostal space. Conclusions VisP improves the diagnostic ability of ICMs by finding an optimal position that yields reliable sensing of P waves while keeping high R‐wave sensing.

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Miniaturized implantable cardiac monitor with a long sensing vector (BIOMONITOR III): Insertion procedure assessment, sensing performance, and home monitoring transmission success

Cited by 28 publications

References 31 publications

Successful detection of covert paroxysmal atrial fibrillation due to insertable cardiac monitor in embolic stroke of undetermined source in a patient with situs inversus totalis

Successful detection of covert paroxysmal atrial fibrillation due to insertable cardiac monitor in embolic stroke of undetermined source in a patient with situs inversus totalis

Factors affecting signal quality in implantable cardiac monitors with long sensing vector

Revisiting where to apply preimplant mapping to improve P‐wave sensing of insertable cardiac monitors

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