Performance of the New BioMonitor 2‐AF Insertable Cardiac Monitoring System: Can Better be Worse?

Lacour, Philipp; Dang, Phi Long; Huemer, Martin; Parwani, Abdul Shokor; Attanasio, Philipp; Pieske, Burkert; Boldt, Leif‐Hendrik; Haverkamp, Wilhelm; Blaschke, Florian

doi:10.1111/pace.13059

Cited by 28 publications

(23 citation statements)

References 27 publications

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“…Investigators chose to utilize prophylactic antibiotics, primarily post-procedure, for 38% of the study patients. Pre-procedure antibiotics have frequently been used in similar studies (31-100%) [5,11,12], though guidance for prophylactic antibiotic usage during ICM insertion has not been established [13].…”

Section: Discussionmentioning

confidence: 99%

BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study

Awad¹,

Weiss²,

Yunus³

et al. 2020

BMC Cardiovasc Disord

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Background: Insertable cardiac monitors are utilized for the diagnosis of arrhythmias and traditionally have been inserted within hospitals. Recent code updates allow for reimbursement of office-based insertions; however, there is limited information regarding the resources and processes required to support in-office insertions. We sought to determine the safety and feasibility of in-office insertion of the BioMonitor 2 and better understand in-office procedures, including patient selection, pre-insertion protocols, resource availability, and staff support.Methods: Patients meeting an indication for a rhythm monitor were prospectively enrolled into this single-arm, non-randomized trial. All patients underwent insertion in an office setting. Two follow-up visits at days 7 and 90 were required. Information on adverse events, device performance, office site preparations, and resource utilization were collected.Results: Eighty-two patients were enrolled at six sites. Insertion was successful in all 77 patients with an attempt. Oral anticoagulation was stopped in 20.8% of patients and continued through insertion in 23.4%, while prophylactic antibiotics were infrequently utilized (37.7% of study participants). On average, the procedure required a surgeon plus two support staff and 35 min in an office room to complete the 8.4 min insertion procedure. The mean R-wave amplitude was 0.77 mV at insertion and 0.67 mV at 90-days with low noise burden (2.7%). There were no procedure related complications. Two adverse events were reported (event rate 2.7% [95% CI 0.3, 9.5%]). Conclusions:In-office insertion of the BioMonitor 2 is safe and feasible. Devices performed well with high R-wave amplitudes and low noise burden. These results further support shifting cardiac monitor insertions to office-based locations.

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Section: Discussionmentioning

confidence: 99%

BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study

Awad¹,

Weiss²,

Yunus³

et al. 2020

BMC Cardiovasc Disord

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“…The short purported V-V intervals are in fact PR intervals (or, less often, intervals between the R-wave and oversensed T-wave), while long V-V intervals correspond to intervals between the R-wave and oversensed subsequent P-wave. The P-wave will be detected if its amplitude exceeds the target sensing threshold nominally set to a 25% limit of the maximum sensed R-wave amplitude [1] . There are some actions available to prevent PWOS (and TWOS).…”

Section: Discussionmentioning

confidence: 99%

“…While being undoubtedly useful, ICMs are responsible for a significant number of incorrectly analysed impulses, mostly due to oversensing. This may lead to misclassification of sinus rhythm as ventricular arrhythmia or atrial fibrillation [1] .…”

Section: Introductionmentioning

confidence: 99%

“…An implantable cardiac monitor (ICM) is a valuable tool for diagnosis of various disorders including unexplained syncope, palpitations, suspected bradyarrhythmia and tachyarrhythmia [1,2] . The device is implanted subcutaneously in the precordial area with battery longevity up to three years and has much higher effectiveness than classic diagnostic methods such as a single electrocardiogram (ECG) and shortor long-term Holter monitoring, especially in cases of rare episodes of syncope or arrhythmia.…”

Section: Introductionmentioning

confidence: 99%

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Inadequate high ventricular rate (HVR) diagnosis with BioMonitor 2-AF implantable cardiac monitor due to P-wave oversensing – case report and programming solutions.

Małecki¹,

Januszkiewicz²,

Michalak³

et al. 2018

Heart Beat

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Implantable cardiac monitors (ICMs) are valuable tools for diagnosis of syncope and arrhythmia. However, ICMs may be responsible for a significant number of misclassified records due to artefacts and/or imperfections of diagnostic algorithms. P-wave oversensing (PWOS) is one of the plausible causes of inappropriate automatic analysis. In this report, a case of a free diver with recurrent syncope is investigated. The patient had undergone the implantation of a Biomonitor 2-AF of Biotronik GmbH. Soon after implantation, high ventricular rhythm (HVR) was registered. Manual analysis of the incident report revealed mild bradycardia and repetitive P-wave and periodic T-wave oversensing misclassified as HVR. The mechanism of PWOS and management options are discussed.

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“…It has been recommended by Medtronic that the MyCareLink TM monitor should be within 6 feet of the patient during the 0200-daily download [8][9][10]. This reliance on using an external monitor to transmit data is also used in other companies of ICMs including Biotronik's Home Monitoring, Abbot's Merlin@home TM transmitter and Boston Scientific's Latitude Home Monitoring [11][12][13].…”

Section: Introductionmentioning

confidence: 99%

Data Transmission Delay in Medtronic Reveal LINQ<sup>TM</sup> Implantable Cardiac Monitor: Clinical Experience in 520 Patients

Chokesuwattanaskul¹,

Safadi²,

Ip³

et al. 2019

JBiSE

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Background: The Implantable Cardiac Monitor (ICM) is an invaluable tool for detecting cardiac arrhythmias by providing physicians. Critical to the success of ICMs depends on how quickly and accurately the data can be transmitted to a physician's office after an arrhythmic event. Then, the clinical event can be analyzed and the treatment will be provided accordingly. However, no reports have been published as to how efficiently the ICM data is transmitted. Methods: There is a retrospective review of 520 patients who received a Medtronic Reveal LINQ TM between 2/01/2015 and 6/01/2017. The time from the arrhythmic event to the time of physician notification was calculated and reason for delay was noted. Results: One hundred and twenty patients out of 520 patients (23%) had arrhythmic events

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Performance of the New BioMonitor 2‐AF Insertable Cardiac Monitoring System: Can Better be Worse?

Abstract: This study demonstrates that the BioMonitor 2-AF is a safe and effective tool for continuous cardiac monitoring.

Cited by 28 publications

References 27 publications

BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study

BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study

Inadequate high ventricular rate (HVR) diagnosis with BioMonitor 2-AF implantable cardiac monitor due to P-wave oversensing – case report and programming solutions.

Data Transmission Delay in Medtronic Reveal LINQ<sup>TM</sup> Implantable Cardiac Monitor: Clinical Experience in 520 Patients

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Performance of the New BioMonitor 2‐AF Insertable Cardiac Monitoring System: Can Better be Worse?

Abstract: This study demonstrates that the BioMonitor 2-AF is a safe and effective tool for continuous cardiac monitoring.

Cited by 28 publications

References 27 publications

BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study

BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study

Inadequate high ventricular rate (HVR) diagnosis with BioMonitor 2-AF implantable cardiac monitor due to P-wave oversensing – case report and programming solutions.

Data Transmission Delay in Medtronic Reveal LINQ&lt;sup&gt;TM&lt;/sup&gt; Implantable Cardiac Monitor: Clinical Experience in 520 Patients

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Data Transmission Delay in Medtronic Reveal LINQ<sup>TM</sup> Implantable Cardiac Monitor: Clinical Experience in 520 Patients