Diagnostic Accuracy and Safety of Confirm Rx™ Insertable Cardiac Monitor in Pediatric Patients

Yoon, Justin; Fares, Maan; Hoyt, Walter J.; Snyder, Christopher S.

doi:10.1007/s00246-020-02463-3

Cited by 7 publications

(4 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Mariani et al [ 3 ] reported a mean R wave amplitude of 0.7 ± 0.37 mV with a median noise burden of 0.19% and good P wave visibility (89 ± 24%) after a mean follow-up period of 35.2 ± 18.5 days. Furthermore, our results appear to be satisfactory in light of recent reports in the literature evaluating the performance of other currently available next-generation ILRs in pediatric patients [ 14 – 16 ].…”

Section: Discussionsupporting

confidence: 76%

Implantable Loop Recorder with Long Sensing Vector: Safety, Acceptability, and Sensing Performance in Pediatric Patients

et al. 2022

View full text Add to dashboard Cite

Implantable loop recorders (ILRs) are effective tools for detecting arrhythmias by long-term continuous heart rhythm monitoring. Benefits have been demonstrated even in pediatric patients. ILR with a long sensing vector has recently been designed to improve signal quality in terms of P wave visibility and R wave amplitude. However, there are no data on its use in pediatric patients. We considered a series of pediatric patients implanted with a long sensing vector ILR. Sensing performance, including R wave amplitude and P wave visibility, device-related complications, and diagnostic yield were collected. During follow-up, each patient guided by his/her parents/guardians was also asked to complete a brief questionnaire to assess patient acceptability of the device. Twenty-five consecutive pediatric patients (mean age 11.3 ± 3.5 years, 72% male) were enrolled. The insertion success rate was 100% on the first attempt with no complications. The median amplitude of the R wave was 1.15 mV (interquartile range, 1.01–1.42) with no significant differences between patients aged ≤ or > 10 years ( p = 0.726) and between female and male ( p = 0.483). P wave was classified as ‘always visible’ in 24/25 patients (96%). ILR was generally well accepted and tolerated by all involved patients. During a median follow-up of 297 days (117–317), we achieved in 5 patients a correlation between symptoms and rhythm disorders (20%) and ruled out significant arrhythmias in 6 symptomatic children (24%). Long sensing vector ILR showed to be well accepted, with good signal quality and an excellent safety profile even in pediatric patients.

show abstract

Section: Discussionsupporting

confidence: 76%

Implantable Loop Recorder with Long Sensing Vector: Safety, Acceptability, and Sensing Performance in Pediatric Patients

et al. 2022

View full text Add to dashboard Cite

show abstract

“…Nevertheless, experimental and observational studies have demonstrated the potential for implementation in children experiencing loss of consciousness of unknown cause. The aim is to exclude or confirm potentially dangerous underlying arrhythmias [30][31][32][33][34][35][36].…”

Section: Guideline-based Indications For Ilr In Syncopementioning

confidence: 99%

Expert opinion of the Heart Rhythm Association of the Polish Cardiac Society and the Polish Neurological Society on evidence-driven implementation of implantable loop recorders in Poland

Karliński,

Grabowski,

Kempa

et al. 2024

Pol Heart J

View full text Add to dashboard Cite

Implantable loop recorders (ILR) are considered increasingly helpful in diagnosing cardio-neurological conditions, especially if arrhythmic events are of high clinical importance but are unlikely to be captured by standard methods of electrocardiogram recording due to the low frequency of events and short duration of a single event. The compelling evidence from randomized trials and observational studies strongly supports ILR utilization in patients after cryptogenic stroke or transient ischemic attack and in patients with recurrent transient loss of consciousness of unknown origin. These two groups of patients are expected to gain the most from initiating ILR-driven clinically effective management strategies. Stroke or transient ischemic attack survivors with detected subclinical atrial fibrillation can be switched from antiplatelets to anticoagulants, whilst patients with recurrent syncope may avoid severe injuries and/or substantial impairment of their quality of life. This joint opinion of the Heart Rhythm Association of the Polish Cardiac Society and experts from the Polish Neurological Society summarizes the up-to-date rationale for using ILR in everyday clinical practice and describes the road map for implementing this technology in Poland. Special emphasis is placed on the most recent guidelines issued by both cardiological and neurological scientific societies.

show abstract

“…The enhancements in the ILR algorithm were prompted by a higher rate of FP detection in the earlier studies [13,20,21]. Data for Confirm Rx TM in pediatric patients showed a reduction of FP from 55% to 0 with introduction of newer algorithms in a small number of patients receiving SCRM for variable indications [22]. A similar algorithm is used in other SCRMs [23].…”

Section: Af Diagnosticsmentioning

confidence: 99%

Subcutaneous cardiac rhythm monitors: state of the art review

Nadkarni

Devgun

Jamal

et al. 2021

Expert Review of Medical Devices

View full text Add to dashboard Cite

Introduction: Subcutaneous cardiac rhythm monitors (SCRMs) provide continuous ambulatory electrocardiographic monitoring for surveillance of known and identification of infrequent arrhythmias. SCRMs have proven to be helpful for the evaluation of unexplained symptoms and correlation with intermittent cardiac arrhythmias. Successful functioning of SCRM is dependent on accurate detection and successful transmission of the data to the device clinic. As the use of SCRM is steadily increasing, the amount of data that requires timely adjudication requires substantial resources. Newer algorithms for accurate detection and modified workflow systems have been proposed by physicians and the manufacturers to circumvent the issue of data deluge. Areas covered: This paper provides an overview of the various aspects of ambulatory rhythm monitoring with SCRMs including indications, implantation techniques, programming strategies, troubleshooting for issue of false positive and intermittent connectivity and strategies to circumvent data deluge. Expert opinion: SCRM is an invaluable technology for prolonged rhythm monitoring. The clinical benefits from SCRM hinge on accurate arrhythmia detection, reliable transmission of the data and timely adjudication for possible intervention. Further improvement in SCRM technology is needed to minimize false-positive detection, improve connectivity to the central web-based server, and devise strategies to minimize data deluge.

show abstract

Diagnostic Accuracy and Safety of Confirm Rx™ Insertable Cardiac Monitor in Pediatric Patients

Cited by 7 publications

References 10 publications

Implantable Loop Recorder with Long Sensing Vector: Safety, Acceptability, and Sensing Performance in Pediatric Patients

Implantable Loop Recorder with Long Sensing Vector: Safety, Acceptability, and Sensing Performance in Pediatric Patients

Expert opinion of the Heart Rhythm Association of the Polish Cardiac Society and the Polish Neurological Society on evidence-driven implementation of implantable loop recorders in Poland

Subcutaneous cardiac rhythm monitors: state of the art review

Contact Info

Product

Resources

About