Cited by 65ECG Monitoring and AnalysisCardiac electrophysiology and arrhythmiasCardiac pacing and defibrillation studies

Incidence and timing of potentially high-risk arrhythmias detected through long term continuous ambulatory electrocardiographic monitoring

Open access
Solomon, Matthew D., Yang, Jingrong, Sung, Sue Hee, Livingston, Martha L., Sarlas, George, Lenane, Judith C., Go, Alan S.·2016·BMC Cardiovascular Disorders

Abstract

BACKGROUND: Ambulatory electrocardiographic (ECG) monitoring is the standard to screen for high-risk arrhythmias. We evaluated the clinical utility of a novel, leadless electrode, single-patient-use ECG monitor that stores up to 14 days of a continuous recording to measure the burden and timing of potentially high-risk arrhythmias. METHODS: We examined data from 122,815 long term continuous ambulatory monitors (iRhythm ZIO® Service, San Francisco) prescribed from 2011 to 2013 and categorized potentially high-risk arrhythmias into two types: (1) ventricular arrhythmias including non-sustained and sustained ventricular tachycardia and (2) bradyarrhythmias including sinus pauses >3 s, atrial fibrillation pauses >5 s, and high-grade heart block (Mobitz Type II or third-degree heart block). RESULTS: Of 122,815 ZIO® recordings, median wear time was 9.9 (IQR 6.8-13.8) days and median analyzable time was 9.1 (IQR 6.4-13.1) days. There were 22,443 (18.3%) with at least one episode of non-sustained ventricular tachycardia (NSVT), 238 (0.2%) with sustained VT, 1766 (1.4%) with a sinus pause >3 s (SP), 520 (0.4%) with a pause during atrial fibrillation >5 s (AFP), and 1486 (1.2%) with high-grade heart block (HGHB). Median time to first arrhythmia was 74 h (IQR 26-149 h) for NSVT, 22 h (IQR 5-73 h) for sustained VT, 22 h (IQR 7-64 h) for SP, 31 h (IQR 11-82 h) for AFP, and 40 h (SD 10-118 h) for HGHB. CONCLUSIONS: A significant percentage of potentially high-risk arrhythmias are not identified within 48-h of ambulatory ECG monitoring. Longer-term continuous ambulatory ECG monitoring provides incremental detection of these potentially clinically relevant arrhythmic events.

AI snapshot

Written from the paper’s full text.

TL;DR

In 122,815 long-term continuous ambulatory ECG records, potentially high-risk ventricular and bradyarrhythmias were common, and many were first detected after 48 hours of monitoring. Extending monitoring toward 14 days increased detection of these events beyond traditional 24- or 48-hour Holter strategies.

Key findings

  • Among 122,815 eligible records, median wear time was 9.9 days (IQR 6.8–13.8) and median analyzable time was 9.1 days (IQR 6.4–13.1). Detected arrhythmias included non-sustained VT in 22,443 (18%), sustained VT in 238 (0.2%), sinus pause >3 s in 1,766 (1.4%), AF pause >5 s in 521 (0.4%), and high-grade heart block in 1,468 (0.4%).
  • Median time to first arrhythmia was 74 h (IQR 26–149) for non-sustained VT, 22 h (IQR 5–73) for sustained VT, 22 h (IQR 7–64) for sinus pause, 31 h (IQR 11–82) for AF pause, and 40 h (SD 10–118) for high-grade heart block.
  • Cumulative detection increased with longer monitoring: sustained VT was 52.5% detected at 24 h, 65.5% at 48 h, and 92.9% by 7 days, with an additional 7.1% detected between 7 and 14 days. Non-sustained VT was 23.4%, 38.0%, and 79.4% detected by 1, 2, and 7 days, respectively.
  • For sinus pauses >3 s, 31.7% were detected within 1 day, 46.6% within 2 days, and 83.1% within 3 days. Diagnostic yields at 2 days versus 7 days for ventricular arrhythmias and bradyarrhythmias were significantly different in the overall populations (P < 0.01).

Methods

  • Retrospective analysis of all ZIO® Service long-term continuous ambulatory ECG monitors prescribed from November 2011 to December 2013 (N = 128,401), cleaned to 122,815 eligible records from 122,454 unique patients; exclusions included age <18 years, wear or analyzable time <24 h, heart rates >300 or <20 beats/min, and start times outside study dates.
  • The ZIO® Patch is a leadless, single-patient-use monitor that records up to 14 days of continuous single-channel ECG. Outcomes were categorized as ventricular arrhythmias (non-sustained and sustained VT >30 s) and bradyarrhythmias (sinus pauses >3 s, AF pauses >5 s, and high-grade heart block including Mobitz Type II or third-degree heart block); symptomatic pauses occurred within 45 s of a patient trigger.
  • Analyses used SAS 9.3 and calculated proportions with 95% confidence intervals, cumulative yield per additional day of monitoring, and chi-squared tests comparing high-risk arrhythmia detection at 1, 2, and 7 days versus 14 days.

Limitations

  • The paper states: no data on changes in clinical management or patient outcomes after monitoring; incomplete information on all symptomatic triggers; limited demographic data and no comorbidity data; some bradyarrhythmias such as asymptomatic sinus and AF pauses may occur nocturnally in normal subjects; clinical indications for monitor ordering were not validated; and at least 25% of patients wore the device <7 days (25th percentile 6.8 days), artificially reducing observed yield from days 7 to 14, so actual yield may be higher.
  • Evident from the text: this is an observational analysis without a control or comparison monitoring strategy, and arrhythmia identification relied on manufacturer algorithms and Certified Cardiac Technician review.
  • Evident from the text: there are minor numerical inconsistencies between the abstract and results/table for AF pause >5 s (520 vs 521) and high-grade heart block (1,486 vs 1,468).

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1186/s12872-016-0210-x

Cites

16 of 16 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 17 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    The diagnostic yields at 2 days versus 7 days for ventricular arrhythmias and bradyarrhythmias were significantly different from each other in the overall populations (P < 0.01).

    “The diagnostic yields at 2 days versus 7 days for ventricular arrhythmias and bradyarrhythmias were significantly different from each other in the overall populations (P < 0.01).”
    Quote in the paperSubstantial claim
  • Findingown data

    For sustained VT, 65.5% were identified by 48 h.

    “For sustained VT, only 52.5 % of the total identified arrhythmias were identified at 24 h, and approximately two-thirds (65.5 %) were identified by 48 h.”
    Quote in the paperSubstantial claim
  • Findingown data

    Additional 7 days of monitoring between 7 and 14 days yielded an additional 7.1% of sustained VT arrhythmias.

    “Most arrhythmias were identified by 7 days (92.9 %), but the additional 7 days of monitoring between 7 and 14 days yielded an additional 7.1 % of these potentially lethal arrhythmias.”
    Quote in the paperSubstantial claim
  • Findingown data

    There were 22,443 (18%) recordings with nonsustained VT.

    “Of the 122,815 eligible records, there were 22,443 (18 %) with nonsustained VT, 238 (0.2 %) with sustained VT, 1766 (1.4 %) with sinus pauses >3 s, 521 (0.4 %) with AF pauses >5 s, 249 (0.2 %) with symptomatic pauses and 1468 (0.4 %) with high-grade heart block (Table 1).”
    Quote in the paperNot a substantial claim
  • Findingown data

    For non-sustained VT, 38.0% identified by 2 days.

    “A similar trend was seen for the more common non-sustained VT, with 23.4, 38.0, and 79.4 % of all non-sustained VT being identified by 1, 2, and 7 days respectively.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim. 9
  • May combine two claims. 17
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    More than half (53%) of the recorders were worn by women.

    “More than half (53 %) of the recorders were worn by women; but for nearly all arrhythmias except symptomatic pauses, there were more detected arrhythmias among men than women.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    25% of recorders contained greater than 13 days of analyzable time.

    “Analyzable time was similar, with 25 % of recorders containing greater than 13 days of analyzable time.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Although nearly half (49.8%) of analyzed patients were aged less than 65 years old, the majority of all detected arrhythmias were among patients aged 65 years or older.

    “Although nearly half (49.8 %) of the analyzed patients were for patients aged less than 65 years old, the majority of all detected arrhythmias were among patients aged 65 years or older.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Overall, ventricular arrhythmias were more prevalent than bradyarrhythmias, driven by the large burden of episodes of nonsustained VT.

    “Overall, ventricular arrhythmias were more prevalent than bradyarrhythmias, although this was driven by the large burden of episodes of nonsustained VT.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    For ventricular arrhythmias, although the majority are identified in the first 7 days, a significant proportion were still detected in the 7 to 14-day monitoring window.

    “For ventricular arrhythmias, we found that although the majority of arrhythmias are identified in the first 7 days, a significant proportion of arrhythmias were still detected in the 7 to 14-day monitoring window.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Similar trends were observed for the other bradyarrhythmias, and these trends were consistent for both genders and across age categories.

    “Similar trends were observed for the other bradyarrhythmias, and these trends were consistent for both genders and across age categories.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    During the study period, 122,815 eligible ZIO Patch records were identified, contributed by 122,454 unique patients.

    “During the study period, we identified 122,815 eligible ZIO® Patch records contributed by 122,454 unique patients (Fig. 1).”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    These trends were similar for both men and women and across all age ranges, although sustained VT was detected earlier among very elderly patients (aged 80 years and older).

    “These trends were similar for both men and women and across all age ranges, although sustained VT was detected earlier among very elderly patients (aged 80 years and older).”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    We did not validate the data on the clinical indication for the ordered monitors, and differences among providers' thresholds for ordering the monitors could have an impact on patient selection and arrhythmia yield.

    “Further, we did not validate the data on the clinical indication for the ordered monitors, and differences among providers’ thresholds for ordering the monitors could have an impact on patient selection and arrhythmia yield.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationown data

    Patient compliance with extended monitoring was high, with at least 25% of patients achieving greater than 13 days of continuous monitoring.

    “Patient compliance with extended monitoring was high, with at least 25 % of patients achieving greater than 13 days of continuous monitoring.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim.

    Premisecitation

    Prior research suggests that traditional 24-h Holter monitoring is not sufficiently long enough to detect many types of arrhythmias.

    “Prior research suggests that traditional 24-h Holter monitoring is not sufficiently long enough to detect many types of arrhythmias [10–13]”
    Quote in the paperSubstantial claim0 of 4 sources checked
    • cites [10] Seet RC, Friedman PA, Rabinstein AA. Prolonged rhythm monitoring for the detection of occult paroxysmal atrial fibrillation in ischemic stroke of unknown cause. Circulation. 2011;124(4):477–86. source

      Not checked in the free run.

    • cites [11] Higgins P, MacFarlane PW, Dawson J, McInnes GT, Langhorne P, Lees KR. Noninvasive cardiac event monitoring to detect atrial fibrillation after ischemic stroke: a randomized, controlled trial. Stroke. 2013;44(9):2525–31. source

      Not checked in the free run.

    • cites [12] Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for discharged emergency department patients with possible cardiac arrhythmias. West J Emerg Med. 2014;15(2):194–8. source

      Not checked in the free run.

    • cites [13] Rothman SA, Laughlin JC, Seltzer J, Walia JS, Baman RI, Siouffi SY, et al. The diagnosis of cardiac arrhythmias: a prospective multi-center randomized study comparing mobile cardiac outpatient telemetry versus standard loop event monitoring. J Cardiovasc Electrophysiol. 2007;18(3):241–7. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The consideration of therapeutic interventions such as permanent pacemaker implantation is recommended by the joint ACC/AHA/HRS guidelines for the high-risk bradyarrhythmias evaluated in our study.

    “The consideration of therapeutic interventions such as permanent pacemaker implantation is recommended by the joint American College of Cardiology, American Heart Association, and Heart Rhythm Society guidelines for the high-risk bradyarrhythmias evaluated in our study [15].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [15] Epstein AE, DiMarco JP, Ellenbogen KA, Estes III NA, Freedman RA, Gettes LS, et al. ACC/AHA/HRS 2008 Guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation. 2008;117(21):e350–408. source

      Not checked in the free run.

  • May combine two claims.

    Interpretationown data

    The relatively high wear and analyzable time for the longer term continuous monitors suggests that outpatient ECG monitoring using this approach is feasible and can have significant yield of clinically important arrhythmias beyond atrial fibrillation.

    “The relatively high wear and analyzable time for the longer term continuous monitors suggests that outpatient ECG monitoring using this approach is feasible and can have significant yield of clinically important arrhythmias beyond atrial fibrillation.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    We did not have data on any changes in clinical management or patient outcomes following monitoring, so we were unable to delineate the direct clinical impact from the detection of arrhythmias found from the monitors in our study.

    “We did not have data on any changes in clinical management or patient outcomes following monitoring, so we were unable to delineate the direct clinical impact from the detection of arrhythmias found from the monitors in our study.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Study design and conductnone given

    Patient information was limited to demographic characteristics, and data were unavailable on patients' comorbidities.

    “Patient information was limited to demographic characteristics, and data were unavailable on patients’ comorbidities, which could potentially help further risk stratify patients and allow for predictive modeling to help identify those most at-risk for high-risk arrhythmias.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Interpretationreasoning

    Our study examined a more recent time period than prior investigations of long-term continuous monitors and suggests that changes in the device technology and accumulated operator experience may have resulted in improved patient compliance.

    “Our study examined a more recent time period than prior investigations of long-term continuous monitors [5, 9] and suggests that changes in the device technology and accumulated operator experience may have resulted in improved patient compliance.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [5] Barrett PM, Komatireddy R, Haaser S, Topol S, Sheard J, Encinas J, et al. Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. Am J Med. 2014;127(1):95. e11-97. source

      Not checked in the free run.

    • cites [9] Turakhia MP, Hoang DD, Zimetbaum P, Miller JD, Froelicher VF, Kumar UN, et al. Diagnostic utility of a novel leadless arrhythmia monitoring device. Am J Cardiol. 2013;112(4):520–4. source

      Not checked in the free run.

  • May combine two claims.

    Study design and conductown data

    At least a quarter of patients wore the device for less than 7 days (25th percentile of 6.8 days), thus artificially reducing the yield of detected arrhythmias from 7 to 14 days.

    “Finally, while average wear time was high, at least a quarter of patients wore the device for less than 7 days (25th percentile of 6.8 days), thus artificially reducing the yield of detected arrhythmias from 7 to 14 days.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    We did not have information on all symptomatic triggers, and thus did not analyze the proportion of all symptomatic triggers that correlate to true arrhythmias.

    “We did not have information on all symptomatic triggers, and thus did not analyze the proportion of all symptomatic triggers that correlate to true arrhythmias.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationown data

    Longer term monitoring up to 14 days resulted in high patient compliance, and greater detection of high-risk arrhythmias than 24- or 48-h monitoring strategies.

    “In sum, our study suggests that longer term monitoring up to 14 days resulted in high patient compliance, and greater detection of high-risk arrhythmias than 24- or 48-h monitoring strategies.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationown data

    Although the bulk of arrhythmias were detected within the first 7 days, longer-term monitoring between 7 and 14 days yielded a significant number of likely clinically meaningful, potentially high-risk arrhythmias.

    “Although the bulk of arrhythmias were detected within the first 7 days, longer-term monitoring between 7 and 14 days yielded a significant number of likely clinically meaningful, potentially high-risk arrhythmias.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    Mobitz II heart block and third degree heart block were identified by the manufacturer according to their FDA-cleared algorithms and 100% data curation and quality review by CCTs trained in advanced arrhythmia detection.

    “Mobitz II heart block and third degree heart block were identified by the manufacturer according to their FDA-cleared algorithms and 100 % data curation and quality review by CCT’s trained in advanced arrhythmia detection.”
    Quote in the paperSubstantial claim
21 of 21
  • The paper relies on this without support.

    There is limited empirical evidence on the impact and diagnostic yield of longer continuous monitoring for clinically meaningful arrhythmias outside of atrial fibrillation.

    “Although there has been very limited evaluation of this approach outside of detecting the presence of atrial fibrillation, longer monitoring periods are emerging as a new standard of care for selected patients.”
    “Although conventional wisdom suggests that longer monitoring may be useful for detecting rarer, potentially high-risk arrhythmias, such as ventricular arrhythmias and bradyarrhythmias, there is little empirical evidence on the impact and diagnostic yield of longer continuous monitoring for other clinically meaningful arrhythmias outside of atrial fibrillation.”
1 of 1

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Some large-scale population-based studies (11/179, 6.1%) relied on secondary data collected with mobile apps or web-based wearable platforms or provided through a wearable company.

    “Some large-scale population-based studies (11/179, 6.1%) relied on secondary data collected with mobile apps [87] or web-based wearable platforms [153] or provided through a wearable company [189].”

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • High-grade heart-block percentage is understated

    Major

    The reported 1,468 high-grade heart-block records are approximately 1.2% of 122,815 eligible records, not 0.4%.

    Reported 0.4 · recomputed 1.195294

  • Sinus-pause median conflicts with the one-day detection rate

    Major

    A median time to first sinus pause of 22 hours means at least half of first sinus pauses occurred by 22 hours. That conflicts with the statement that only 31.7% were found within one day.

  • Atrial-fibrillation pause counts differ

    Minor

    The abstract reports 520 recordings with an atrial-fibrillation pause, while the Results section reports 521.

  • High-grade heart-block counts differ between abstract and table

    Minor

    The abstract reports 1,486 recordings with high-grade heart block, whereas Table 1 reports 1,468.

4 of 4

Cites

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Authors
Solomon, M. D., Yang, J., Sung, S. H., Livingston, M. L., Sarlas, G., Lenane, J. C., & Go, A. S.
Affiliations
  • Kaiser Permanente (US)
  • iRhythm (United States) (US)
Corresponding author
Solomon, Matthew D.
Venue
BMC Cardiovascular Disorders
Published
2016-02-17
Volume
16
Issue
1
Pages
35-35
ISSN
1471-2261 (ISSN-L)
OpenAlex
W2276194925
Cited by
65
References
16
Citations by year
2026: 3 · 2025: 5 · 2024: 6 · 2023: 5 · 2022: 11 · 2021: 11 · 2020: 6 · 2019: 10 · 2018: 4 · 2017: 3 · 2016: 1
FWCI
4.95
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • BMC Cardiovascular Disorders (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
iRhythm, Inc
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › ECG Monitoring and Analysis
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
Keywords
non-sustained ventricular tachycardia, sustained ventricular tachycardia, sinus pause, arrhythmia incidence
MeSH terms
Aged, Aged, 80 and over, Arrhythmias, Cardiac, Bradycardia, Female, Heart Block, Humans, Male, Middle Aged, Retrospective Studies, Time Factors, Cohort Studies, Electrocardiography, Ambulatory, Incidence, Tachycardia, Ventricular, Sinus Arrest, Cardiac, Atrioventricular Block

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