Role of New Generation Implantable Loop Recorders in Managing Undiagnosed Pediatric Cardiac Symptoms

doi:10.21203/rs.3.rs-4655922/v1

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Research Article

Role of New Generation Implantable Loop Recorders in Managing Undiagnosed Pediatric Cardiac Symptoms

https://doi.org/10.21203/rs.3.rs-4655922/v1

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Journal Publication

published 19 Aug, 2024

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Importance: Pediatric cardiac symptoms such as palpitations, syncope, or seizure-like episodes pose diagnostic challenges for general pediatricians. These symptoms, though often benign, may reveal underlying arrhythmias or inherited cardiac conditions (ICCs), affecting the quality of life and limiting activity participation.

Purpose: To determine the effectiveness and safety of implantable loop recorders (ILRs) in diagnosing and managing arrhythmias in pediatric patients.

Methods: A retrospective cohort study conducted over an 8-year period from January 2016 to December 2023 in a single pediatric cardiology center. A cohort of 155 pediatric patients (median age 11.4 years) who underwent ILR implantation, selected based on symptoms such as palpitations, chest pain, or syncope, and those with previously recorded arrhythmias or high-risk ICCs. The primary outcomes were the diagnostic yield of ILRs for arrhythmias and subsequent changes in patient management. Diagnostic yield was defined as the detection of relevant arrhythmias, such as pauses of 3 seconds or longer, high-degree AV block, sinus node dysfunction, supraventricular tachycardia, ventricular tachycardia or inappropriate sinus tachycardia.

Results: The median follow-up period was 2.3 years (845 days). Diagnostic arrhythmias were recorded in 60% of patients with symptom-activated transmissions and 80% of device-activated transmissions. Sinus pauses (37.5%) and VT (30%) were the most common arrhythmias detected. In patients with syncope (n = 76), 30% had relevant arrhythmias. In the palpitations group (n = 20), 35% had relevant arrhythmias. Approximately 80% of patients with ILR-diagnosed arrhythmias underwent targeted management, including medication changes and additional procedures. No significant complications were observed; minor complications occurred in 2.5% of patients.

Conclusions: New generation ILRs are effective and safe for diagnosing and managing pediatric arrhythmias, providing significant reassurance to patients and families. Further studies are needed to evaluate the impact of ILRs on quality of life and sports participation in high-risk young patients.

Pediatric arrhythmias

implantable loop recorder

inherited cardiac conditions

congenital heart disease

Pediatric Cardiac Symptoms: Symptoms like palpitations, syncope, and seizure-like episodes in pediatric patients pose significant diagnostic challenges.
Diagnostic Tools: Traditional diagnostic tools such as ECG, Holter monitors, and external loop recorders often have low diagnostic yields due to the sporadic nature of symptoms.
Implantable Loop Recorders (ILRs): ILRs have been shown to improve the diagnostic yield for arrhythmias in adults and provide long-term rhythm monitoring.

What is New

Effectiveness in Pediatrics: This study demonstrates that new generation ILRs significantly enhance the diagnostic yield for arrhythmias in pediatric patients with undiagnosed cardiac symptoms.
Safety and Efficacy: The study confirms that ILRs are both safe and effective in the pediatric population, with minimal complications and high diagnostic accuracy.
Targeted Management: Findings show that ILR-diagnosed arrhythmias lead to targeted management changes in approximately 80% of cases, including medication adjustments and additional procedures.
Long-term Monitoring: ILRs provide continuous long-term monitoring, offering reassurance to patients and families, and potentially improving quality of life and participation in activities for high-risk young patients.

In pediatric care, addressing cardiac symptoms such as palpitations, syncope, or seizure-like episodes presents unique challenges for general pediatricians and physicians. While these symptoms are typically benign in children and adolescents, they may unveil underlying arrhythmias, inherited cardiac conditions (ICCs), or exert a considerable psychological burden, limiting sport and activity participation and significantly impacting the quality of life. A comprehensive evaluation is essential to establish a diagnosis, assess risk, and formulate an appropriate management plan. Unfortunately, conventional cardiology screening methods often prove inadequate in identifying the root cause of these symptoms due to their sporadic and unpredictable nature, resulting in a low diagnostic yield with non-invasive strategies such as electrocardiogram (ECG), Holter monitoring, or external loop recorders (ELR).

The advent of implantable loop recorders (ILRs), also known as implantable cardiac monitors (ICMs), marks a significant advancement in long-term and effective monitoring for paroxysmal arrhythmias and infrequent cardiac symptoms. (1) ILRs are subcutaneous devices that provide long-term rhythm surveillance and allow documentation of the cardiac rhythm by recording electrocardiograms, both in an automatically activate modality and in a patient-activate modality. (2)

An ILR system consists of three main components: the loop recorder itself, an external device to manually activate recordings during symptomatic events, and a home monitor or mobile device that transmits data to a centralized system using satellite technology. The device works by continuously monitoring heart activity and automatically records tracings when abnormal heart rhythms are detected, such as irregular, fast, or slow heart rhythms or pauses, according to predefined parameters. The settings can be customized to meet the needs and clinical characteristics of each patient, with zones set to record above the maximum normal heart rate (tachycardia zone), below the minimal heart rate (bradycardia zone), and pauses determined according to age and clinical situation. (3) Additionally, new generation ILRs can monitor and quantify the percentage (burden) of ventricular premature beats. (4) Recordings can be activated by the system when a tracing falls outside the preset "normal parameters" or manually by patients using an external device during symptomatic periods. These recordings are then transmitted wirelessly to the physician for analysis, either in person through the device programmer or remotely via a home monitor or mobile device to a web-based network.

Long-term monitoring using an ILR is recommended in highly symptomatic children when other investigations are inconclusive, due to infrequent events or the inability to complete a diagnostic protocol. (5) ILRs provide the most effective method for establishing a diagnosis when arrhythmogenic syncope is suspected but not proven despite a comprehensive evaluation. (6–7) They are useful in documenting symptomatic arrhythmias, correlating them with clinical symptoms, detecting occult arrhythmias in asymptomatic patients with potentially lethal cardiac diseases, and monitoring changes with medical management in high-risk patients.

Recent technological advancements have led to a significant reduction in the size of these devices, making them more comfortable and less invasive for pediatric patients. The safety profile and efficacy of ILRs have earned them a place in the latest syncope and pediatric device guidelines. (8) However, ILRs not been specifically tested for pediatric use, and there is scarce data on benefits in children and adolescence. This study seeks to bridge this knowledge gap by providing valuable insights into patient characteristics, indications for implantation, diagnostic yield, and subsequent medical management choices. Our findings are derived from a consecutive cohort of young patients who underwent Reveal LINQ ILR implantation at a single pediatric center over a 7-year period.

Hypothesis

The new generation of ILR contribute to significantly improve the diagnostic yield and management of undiagnosed cardiac symptoms in pediatric patients compared to conventional non-invasive methods.

This retrospective cohort study was conducted at a single pediatric cardiology center from January 2016 to December 2023. This study was conducted in accordance with the Declaration of Helsinki and the ethical standards of Bristol Royal Hospital for Children's Institutional Review Board, including ethics approval obtained from the Institutional Review Board. The study aimed to evaluate the effectiveness and safety of the Reveal LINQ ILR in diagnosing and managing undiagnosed cardiac symptoms in pediatric patients. Inclusion criteria: patients under 18 years of age who presented with unexplained cardiac symptoms such as palpitations, syncope, or seizure-like episodes, or those with a high risk of arrhythmias, that had a Reveal LINQ ILR implantation and had a follow-up of at least 12 months post implantation. Exclusion criteria included patients with known diagnoses that could fully explain their symptoms or those who were unable to undergo ILR implantation due to medical contraindications. The participation rate was 95%, with 158 patients initially enrolled and 155 completing the study.

Pre-implantation management

The pre-implantation cardiac screening approach was tailored to each case by the primary healthcare provider, following an individualized assessment. As a baseline, all patients underwent a minimum screening comprising a 12-lead ECG, a 24-hour Holter monitoring, and echocardiography. For certain cases, additional investigations were conducted based on presenting symptoms, with options including an exercise stress test (EST), cardiac magnetic resonance imaging (CMRI), electrophysiology study (EPS), and/or electroencephalogram (EEG). The decision to pursue more extensive investigations was made on an individual basis.

Indications for Implantable Loop Recorder (ILR)

ILR indications encompassed a spectrum ranging from the diagnosis of infrequent or unexplained cardiac symptoms such as palpitations, chest pain, or seizure-like episodes to the follow-up of patients with previously recorded cardiac arrhythmias or those at high risk, such as those with ICCs. The diverse range of ILR indications reflects the need to address various clinical scenarios and underscores the importance of personalized and targeted monitoring strategies.

Essential features of ILR implantation t

Reveal LINQ ILRs (Medtronic Inc., Minneapolis, MN, USA) were implanted following standard sterile precautions in a dedicated cardiac catheterization laboratory. The procedures were performed under general or local anesthesia, depending on the patient’s age, cooperation, and preference. The implantation site was subcutaneous in the left parasternal region for all patients, except for one case where an axillary region implantation was chosen for aesthetic reasons. After sterile field preparation, the skin was infiltrated with local anesthetic, and the device was injected into the subcutaneous layer. The skin wound was closed with a resorbable single suture. Antibiotics were not routinely administered.

Device Programming and Standardized Follow-up

Following implantation, patient-specific programming of tachycardia and bradycardia detection zones was conducted, taking into consideration the patient’s age, underlying heart disease, medication, and clinical history. After recovering from anesthesia, patients and their family members were instructed on how to activate the monitor and transmit data, and were advised to contact the cardiology department in the event of symptoms. Patients were typically discharged on the same day following a 3 to 4-hour observation period.

All patients performed a test download at home to ensure connectivity to the CareLink website. Test downloads were not included in the analysis. Transmissions were reviewed by dedicated pediatric cardiac rhythm physiologists, who forwarded them to pediatric electrophysiologists for evaluation in cases of potentially abnormal or diagnostic recordings. Elective follow-up was scheduled annually for patients with non-pathological transmissions, or more frequently as needed for those with positive or pathological findings.

For the purposes of this manuscript, relevant arrhythmias are defined as pauses of 3 seconds or longer, high-degree (type IIb or type III) atrioventricular (AV) block, evidence of sinus node dysfunction (SND) based on age-related definitions, as well as supraventricular tachycardia (SVT), ventricular tachycardia (VT), or inappropriate sinus tachycardia (IST). (9–10) Non-relevant arrhythmias are defined as sinus bradycardia (SB), sinus pauses of less than 3 seconds, sinus tachycardia (ST), supraventricular ectopy (SVE), and ventricular ectopy (VE).

Data collection

A retrospective chart review was conducted at our center following institutional review board approval. All patients under 18 years of age who underwent ILR implantation from January 2016 to December 2023 were included. Medical records were reviewed, and data were collected on patient demographics, family history, presence of congenital heart disease or genetic diagnosis, treatment, and ILR implantation indications. Device-related data collected included patient-activated and device-activated transmissions, recorded rhythm abnormalities, time from implantation to diagnostic transmission, patient management changes, and complications.

Statistical analysis

The results of this study are predominantly descriptive and are expressed as percentages, with mean values and standard deviations (SD) for continuous variables. A p-value of less than 0.05 was considered to indicate statistical significance. All statistical analyses were performed using the IBM SPSS Statistics 25.0 software (SPSS Inc., Chicago, IL, USA).

Differences between groups were evaluated using the chi-squared test and Fisher's exact test for categorical variables. For continuous variables with a normal distribution, an unpaired Student's t-test was used. For continuous variables without a normal distribution, the Mann-Whitney U test was applied. The Wilcoxon rank-sum test was employed for skewed continuous variables, and ANOVA was used for comparisons among more than two groups.

A total of 158 ILRs were implanted at a single center over a 7-year period. However, three patients were transferred to other institutions and subsequently lost to follow-up, resulting in a final cohort of 155 patients.

The baseline characteristics of the patients and the indications for implantation are detailed in Table 1. The median age at implantation was 11.4 ± 5 years, ranging from 7 days to 17.9 years, with 7 patients under the age of 1 year. Gender distribution showed no significant difference. Among the patients, half (n = 84) had a known baseline diagnosis, including an ICC, congenital heart disease, genetic syndrome, or a previously recorded cardiac arrhythmia. Table 2 details the specific distribution of the population as per the correlation of symptoms with tracings (positive in 63%) and the identification of relevant arrhythmias (42% of those with symptom-tracing correlation). Genetic testing conducted as part of their overall cardiac evaluation was performed in 56 patients (36%), with a positive yield in 43 cases (28% of the total population). The pathogenic/likely pathogenic genetic variants are outlined in Online Supplemental Table A.1. A comparison between subgroups of patients with relevant vs. non-relevant arrhythmias did not reveal any statistically significant differences in patients' characteristics, treatment at implantation, or personal and/or family histories (Table 1).

Table 1. Demographic characteristics of patients with ILR implants
	Total (n = 155)	Relevant arrythmia (n = 41)	No/non-relevant arrythmia (n = 114)	p value
Age (years)	10.3 ± 5.0	10.6 ± 5.1	10.3 ± 5.1	0.75
Sex (female)	74 (47.7%)	21 (51.2%)	53 (46.5%)	0.60
Weight (kg)	40.6 ± 21.6	42.8 ± 22.3	39.8 ± 21.3	0.44
Family history of SCA	18 (11.6%)	4 (10.0%)	14 (12.3%)	0.78
Family history	30 (19.4%)	3 (7.3%)	27 (23.7%)	0.02
ICC	21 (13.6%)	2 (4.9%)	19 (16.7%)
CHD	3 (1.9%)	1 (2.4%)	2 (1.7%)
Arrhythmia	3 (1.9%)	0 (0.0%)	3 (2.6%)
Syndrome	3 (1.9%)	0 (0.0%)	3 (2.6%)
Personal history	84 (54.2%)	21 (51.2%)	63 (55.3%)	0.65
ICC	31 (20.0%)	4 (10.0%)	27 (23.7%)
CHD	18 (11.6%)	5 (12.2%)	13 (11.4%)
Arrhythmia	28 (18.1%)	11 (26.8%)	17 (14.9%)
Syndrome	12 (7.7%)	2 (4.9%)	10 (8.8%)
Genetics	56 (36.1%)	13 (31.7%)	43 (37.7%)	0.49
Positive	43 (27.7%)	6 (14.6%)	37 (32.5%)
Antiarrhythmic drugs	50 (32.5%)	15 (36.6%)	35 (30.7%)	0.49
Basal ECG (pathological)	33 (21.3%)	6 (14.6%)	27 (23.7%)	0.22
Holter (pathological)	20 (12.9%)	7 (17.1%)	13 (11.4%)	0.35
EPS	25 (16.2%)	7 (17.1%)	18 (15.8%)	0.74
Ablation	15 (9.7%)	5 (12.2%)	10 (8.8%)
Indication				0.17
Symptoms	100 (64.5%)	30 (75.0%)	70 (61.4%)
Syncope	76 (49.0%)	24 (58.5%)	52 (45.6%)
Palpitations	20 (12.9%)	6 (14.6%)	14 (12.3%)
Seizure-like	4 (2.6%)	0 (0.0%)	4 (3.5%)
High risk of arrhythmia	55 (35.5%)	11 (26.8%)	44 (38.6%)
Known arrhythmia	35 (22.6%)	10 (24.4%)	25 (21.9%)
ICC	12 (7.7%)	1 (2.5%)	11 (9.6%)
Syndrome	5 (3.2%)	0 (0.0%)	5 (4.3%)
SCA	3 (1.9%)	0 (0.0%)	3 (2.6%)

CHD = congenital heart disease; ECG = electrocardiogram; EPS = electrophysiology study; ICC = inherited cardiac condition; ILR = implantable loop recorder; SCA = sudden cardiac arrest.

Table 2. Personal history of patients with ILR implants (supplementary)
ICC	31 (20%)	CHD	18 (12%)	Arrhythmia	28 (18%)	Syndromes	12 (8%)
Long QT	18 (12%)	Complete AVSD	4 (2.6%)	VT	17 (11%)	Muscular dystrophy	3 (2.0%)
Brugada	6 (4.0%)	Tumor	3 (2.0%)	SVT	6 (2.6%)	Episodic ataxia syndrome	2 (1.3%)
DCM	2 (1.3%)	ASD	2 (1.3%)	AV block	3 (2.0%)	Tuberous sclerosis syndrome	2 (1.3%)
ARVC	2 (1.3%)	TGA	2 (1.3%)	SVT + VT	2 (1.3%)	Lennox syndrome	1 (1.3%)
CPVT	2 (1.3%)	Truncus	2 (1.3%)			Proteus syndrome	1 (1.3%)
Short QT	1 (0.7%)	PS	1 (0.7%)			Gorlin syndrome	1 (1.3%)
		AS	1 (0.7%)			Dravet syndrome	1 (1.3%)
		ToF	1 (0.7%)			Ehlers-Danlos syndrome	1 (1.3%)
		Ebstein anomaly	1 (0.7%)
		CoA with AAH and VSD	1 (0.7%)
No relevant personal history 66 (42%)
AHH = aortic arc hypoplasia; ARVC = arrhythmogenic right ventricle cardiomyopathy; AS = aortic stenosis; ASD = atrial septal defect; AVSD = atrioventricular septal defect; CoA = coarctations of the aorta; CPVT = catecholaminergic polymorphic ventricular tachycardia; DCM = dilated cardiomyopathy; ICC = inherited cardiac condition; PS = pulmonary stenosis; SVT = supraventricular tachycardia; TGA = transposition of the great arteries; ToF = tetralogy of Fallot; VSD = ventricular septal defect; and VT = ventricular tachycardia.

During the follow-up period, 98 (63%) patients activated recordings during symptoms, resulting in 41 (42%) transmissions revealing diagnostic arrhythmia recordings. Examples of different relevant transmissions are illustrated in Fig. 1. Patient-activated transmissions accounted for 78 (50% of the total cohort), with 17 (21%) displaying relevant arrhythmia traces. Conversely, device-activated transmissions, constituting 33 (21% of the total cohort), showed 79% relevant arrhythmia traces. Among patients without a diagnosed arrhythmia (n = 57), 70% of the transmissions exhibited normal sinus rhythm, while the remaining recordings showed minor findings such as sinus bradycardia or tachycardia, and isolated supraventricular or ventricular ectopy.

The median time from device implantation to a diagnostic transmission was 175 days, with a total median follow-up of 845 days (2.3 years). Among patients with relevant arrhythmias, the most common abnormality was sinus pauses (n = 15, 37.5%), with a length ranging from 4 to 30 seconds (10.7 ± 7.3 seconds), and 73% being both patient- and device-activated. The second most frequent arrhythmia was ventricular tachycardia (VT) (n = 12, 30%), of which 83% were non-sustained VT (Fig. 2).

In the subgroup of patients presenting with syncope (n = 76), 30% (n = 23) had relevant arrhythmias (14 significant pauses, 4 VT, 2 SVT, 2 IST, and 1 AV block). Within the palpitations group (n = 20), 35% (7 cases) involved relevant arrhythmias (3 SVT, 2 IST, 1 VT, 1 pause). In the group of patients with an ICC (n = 12), where the monitor was implanted due to their high risk, one (8%) presented with an episode of VT.

Approximately 80% of patients diagnosed through ILR monitoring experienced the advantage of targeted arrhythmia management, incorporating medication adjustments, device implantation, and EPS (Fig. 2).

Throughout the device implantation and follow-up duration, no significant complications were recorded. Minor complications, observed in four patients (2.5%), included skin erosion in a 4-month-old infant (Fig. 3), device dysfunction, and an allergic reaction, necessitating device removal. It's important to note that one patient passed away during the follow-up period, with no discernible connection to cardiac symptoms or arrhythmia.

The present study sheds light on the role of ILRs in elucidating arrhythmias and guiding management in the pediatric patients. Arrhythmia-related symptoms, such as palpitations, chest pain, and syncope, are often difficult to interpret and diagnose in this population. Traditional diagnostic tools, including ECGs and Holter monitors, often yield around 5% diagnostic success due to the brief and self-limited nature of the episodes. (11–12) The integration of ILRs, external loop recorders (ELRs), and remote telemetry in a novel technology strategy has significantly increased the diagnostic yield to 50% and 80% at 2 and 4 years, respectively. (13)

The 2021 Pediatric and Congenital Electrophysiology Society (PACES) Expert Consensus Statement on the indications and management of cardiovascular implantable electronic devices in paediatric patients underscores the growing importance of ILR in pediatric cardiology and electrophysiology. (8) Class I recommendations advocate for ILR implantation in high-risk patients with syncope, while Class IIa recommendations include cases of recurrent syncope of uncertain origin, infrequent symptoms suspected to be due to an arrhythmia, or for guiding the management of patients with ICC (also referred to as channelopathies), or structural heart diseases.

Advancements in ILR technology, such as smaller size, lighter weight, MRI compatibility, and extended longevity, have significantly enhanced diagnostic capabilities. (14) Our study aligns with previous data, affirming ILRs as a strategic tool for guiding management and offering reassurance to patients and physicians. (15–17) Moreover, the options of remote programming and mobile applications are particularly helpful for teenagers.

Our study demonstrated a symptom-to-tracing correlation in 63% of implanted patients, with a diagnostic yield for arrhythmias in 60% of this cohort. The differences in diagnostic yield across pediatric studies can be attributed to the varying definitions and criteria for the nomenclature of arrhythmias.

New ILR algorithms exhibit remarkable efficacy in detecting abnormal heart rhythms in children, as evidenced by an 80% positive diagnostic yield in device-activated transmissions. Notably, only 22% of patient-activated transmissions demonstrated relevant arrhythmias, with 85% of patients activating transmissions during symptomatic episodes. Moreover, in patients without arrhythmia identification, excluding abnormal rhythms during symptoms has a positive psychological impact, providing reassurance to patients and their families. Further investigation is warranted to assess the impact of heart monitoring on the quality of life using ILRs.

Nearly 80% of patients with ILR-related diagnoses benefited from targeted arrhythmia management, involving medication changes, device implantation, and electrophysiological studies (EPS). ILRs also helped to elucidate and continuously monitor patients who had experienced recovered sudden cardiac arrest, allowing diagnoses of severe breath-holding spells, seizures, and catecholaminergic polymorphic ventricular tachycardia (CPVT). The latter patient subsequently received an implantable cardioverter-defibrillator.

Our experience is in accordance with previous research, (18–22) proving the safety of the implantation procedure with a low rate of complications.

Limitations:

This study is limited by its retrospective design, analysis of only one ILR vendor, the variety of ILR indications and patient characteristics, and the ongoing follow-up of some patients who may develop arrhythmic events at any moment.

Implantable loop recorders (ILRs) have proven to be both effective and safe in the diagnosis and management of pediatric arrhythmias. The latest advancements in device miniaturization and new arrhythmia detection algorithms offer significant benefits to the pediatric population. Even when a pathological ECG tracing is not demonstrated, ILRs provide reassurance to patients, families, and physicians. Further studies are needed to assess the impact of ILRs on the quality of life and sport participation in high-risk young patients.

CMRI

cardiac magnetic resonance imaging

ECG

electrocardiogram

EEG

electroencephalogram

ELR

external loop recorder

EPS

electrophysiology study

EST

exercise stress test

ICC

inherited cardiac conditions

ICM

implantable cardiac monitors

ILR

implantable loop recorder

Funding:

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Author Contribution

P.A.-M. and C.G.-C. conceptualized the study and designed the research. G.S., D.W., and G.S. collected the data and performed the analyses. P.A.-M. and R.S. wrote the main manuscript text. G.S. prepared figures 1-3. C.G.-C. and D.W. reviewed the manuscript and provided critical revisions. All authors reviewed and approved the final version of the manuscript.

Competing Interests

Authors disclose no financial or non-financial interests directly or indirectly related to the work submitted for publication.

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No competing interests reported.

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Role of New Generation Implantable Loop Recorders in Managing Undiagnosed Pediatric Cardiac Symptoms

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Abstract

Figures

What is Known

Introduction

Materials and Methods

Pre-implantation management

Indications for Implantable Loop Recorder (ILR)

Essential features of ILR implantation t

Device Programming and Standardized Follow-up

Data collection

Statistical analysis

Results

Discussion

Limitations:

Conclusions

Abbreviations

Declarations

Funding:

Author Contribution

Competing Interests

References

Additional Declarations

Supplementary Files

Status:

Journal Publication

Version 1