Clinical evaluation of a small implantable cardiac monitor with a long sensing vector

Piorkowski, Christopher; Busch, Mathias; Nölker, Georg; Schmitt, J; Roithinger, Franz Xaver; Young, Glenn D.; Táborský, Miloš; Herrmann, Gundula; Schmitz, Dietmar

doi:10.1111/pace.13728

Cited by 21 publications

(35 citation statements)

References 18 publications

(25 reference statements)

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“…As expected, patients with higher P‐wave voltage at surface ECG (≥0.2 mV) have higher chances to have a well‐visible P wave at ICM signal. The above findings confirmed on a large and multicenter population the excellent sensing performance of the long vector ICM already found in previous smaller and single‐center experiences 8‐12 . In addition, as a novelty, we explored subgroups of patients where there are concerns about ICM signal quality, such as females and obese subjects.…”

Section: Discussionsupporting

confidence: 80%

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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Section: Discussionsupporting

confidence: 80%

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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“…The sensitivity for shorter regular episodes of atrial fibrillation is lower, but it is unlikely that the device will miss longer lasting (e.g., hours to days) episodes of atrial fibrillation. Hence, the sensitivity to identify patients with arrhythmias is very good [28]. Due to their subcutaneous positioning, they cause a very low risk, and they do not limit the patient’s activities.…”

Section: Discussionmentioning

confidence: 99%

“…The BioMonitor 2 (Biotronik SE & Co. KG, Berlin, Germany) or successor devices will be used [28]. It is a subcutaneous ICM that continuously monitors the heart rhythm.…”

Section: Methodsmentioning

confidence: 99%

The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial

Jøns

Søgaard

Behrens

et al. 2019

Trials

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Background The increasing use of implantable cardiac monitors (ICMs) allows early documentation of asymptomatic cardiac arrhythmias that would previously have gone unnoticed. The addition of remote monitoring to cardiac devices means that physicians receive an early warning in cases of new-onset arrhythmias. While remote monitoring has been suggested to increase survival in heart failure patients with implantable defibrillators, trials using ICMs for continuous electrocardiographic monitoring of cardiac arrhythmias in the postmyocardial infarction setting have shown that patients who experienced cardiac arrhythmias such as atrial fibrillation, bradycardia, and ventricular tachyarrhythmia have an increased risk of major adverse cardiac events. Methods The Biomonitoring in patients with preserved left ventricular function after diagnosed myocardial infarction (BIO-GUARD-MI) study is designed to investigate and clarify whether the incidence of major adverse cardiac events can be decreased by early detection and treatment of cardiac arrhythmias using an ICM in patients after myocardial infarction. In addition, the study will allow us to describe the interplay between baseline characteristics, arrhythmias, and clinical events to improve the treatment of this high-risk patient population. The study will enroll and randomize a cohort of high-risk postmyocardial infarction patients with CHA2DS2-VASc score ≥ 4 and left ventricular ejection fraction > 35% to an ICM or conventional treatment. Physicians are provided with suggestions on how to respond to ICM-documented arrhythmias. An estimated 1400 patients will be enrolled and followed until 372 primary endpoints have occurred. In this paper, we describe the literature and rationale behind the design and interventions towards new-onset arrhythmias, as well as future perspectives and limitations for the use of ICMs. Discussion Remote monitoring may improve clinical outcome if it uncovers conditions with low symptom burden which cause or indicate an increased risk. A simple and easily implementable response to the information is important. Cardiac arrhythmias frequently start as asymptomatic, shorter lasting, and nightly events. The BIO-GUARD-MI trial represents the first attempt to simplify the response to the rather complex nature of heart arrhythmias. Trial registration Clinical Trials, NCT02341534. Registered on 19 January 2015.

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“…The probability of AF detection was calculated based on sensitivity and specificity estimates for the monitoring methods. BIOMONITOR estimates were derived from the BioMonitor 2 Master Study 16 and we assumed that all ICMs were successfully planted. SoC was taken to consist of the same mix of monitoring methods as reported for CRYSTAL-AF.…”

Section: Af Detectionmentioning

confidence: 99%

“…An alternative for patients with a history of cryptogenic stroke and suspected AF is the use of an insertable cardiac monitor (ICM), such as BIOMONITOR 16,17 . All ICMs are inserted under the skin in the left pectoral area.…”

Section: Introductionmentioning

confidence: 99%

Use of insertable cardiac monitors for the detection of atrial fibrillation in patients with cryptogenic stroke in the United States is cost-effective

Maervoet¹,

Bossers²,

Borge

et al. 2019

Journal of Medical Economics

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Objectives: Atrial fibrillation (AF) is the most common arrhythmia and a major marker of ischemic stroke risk. Early detection is crucial and, once diagnosed, anticoagulation therapy can be initiated to reduce stroke risk. The aim of this study was to assess the cost-effectiveness of employing an insertable cardiac monitor (ICM), BIOMONITOR, for the detection of AF compared to standard of care (SoC) ECG and Holter monitoring in patients with cryptogenic stroke, that is, stroke of unknown origin and where paroxysmal, silent AF is suspected. Materials and methods: A Markov model was developed which consisted of five main health states reflecting the potential lifetime evolution of the AF disease: post cryptogenic stroke (index event), subsequent mild, moderate and severe stroke, and death. Sub-states were included to track a patient's AF diagnostic status and the use of antiplatelet or anticoagulant therapy. AF detection was assumed to result in a treatment switch from aspirin to anticoagulants, except among those with a history of major bleeding. Detection yield and accuracy, clinical actions and treatment effects were derived from the literature and validated by an expert clinician. All relevant costs from a US Medicare perspective were included. Results and conclusions: An ICM-based strategy was associated with a reduction of 37 secondary ischemic strokes per 1000 patients monitored compared with SoC. Total per-patient costs with an ICM were higher (US$90,052 vs. US$85,157) although stroke-related costs were reduced. The use of an ICM was associated with a base-case incremental cost-effectiveness ratio of US$18,487 per life year gained compared with SoC and US$25,098 per quality-adjusted life year gained, below established willingness-to-pay thresholds. The conclusions were found to be robust over a range of input values. From a US Medicare perspective the use of a BIOMONITOR ICM represents a cost-effective diagnostic strategy for patients with cryptogenic stroke and suspected AF. ARTICLE HISTORY

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Clinical evaluation of a small implantable cardiac monitor with a long sensing vector

Cited by 21 publications

References 18 publications

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

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

The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial

Use of insertable cardiac monitors for the detection of atrial fibrillation in patients with cryptogenic stroke in the United States is cost-effective

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