3.8.8External event recorder versus telemetry

StudyParticipantDiagnostic tests
Rothman 2007
RCT; study held in USA.
Setting: Cardiology.
Multicentre.
Funding: Cardionet Inc
TLoC population: patients with a suspected cardiac cause. Prior tests: All patients had at least 1 prior test.
high clinical suspicion of malignant arrhythmia; syncope or presyncope; non-diagnostic 24 hour Holter or telemetry in last 45 days
Definition of TLoC: syncope or presyncope (transient dizziness, lightheadedness, unsteadiness or weak spells without LOC).
Inclusion criteria: high clinical suspicion of malignant arrhythmia; syncope or presyncope; non-diagnostic 24 hour Holter or telemetry in last 45 days.
Exclusion criteria: NYHA Class IV heart failure, MI in last 3 months, unstable angina, candidate for or recent valve surgery, sustained VT or VF, complex ectopy, below 18 years, other condition prohibiting completion of or compliance with protocol.
Patient characteristics: age: mean age 56 years; sex: around 30% male; some patients with existing heart disease (around 49% hypertension; 20% coronary artery disease; 5% MI, 5% congestive heart failure); TLoC history: not stated Comorbidities: not stated. Other details: non-diagnostic 24 hour Holter or telemetry in last 45 days. Other study comments: RCT
Index test: external loop event monitoring; patient or automatically activated; time: up to 30 days (minimum 25 days) (n=52)
Comparator test: mobile cardiac outpatient telemetry (MCOT; CardioNet): continual recording; time: up to 30 days (n=62).
for Target Condition/Outcome: prespecified: pauses; complete AV block; Mobitz type 2 2nd deg block; AF/flutter; rate over 120bpm + symptoms; over 150 - symptoms; brady below 40bpm + symptoms; sustained (over 10s)/symptomatic SVT over 120bpm; VT over 100bpm over 3 beats

From: Appendix D1, Included studies characteristics

Cover of Transient Loss of Consciousness (‘Blackouts’) Management in Adults and Young People
Transient Loss of Consciousness (‘Blackouts’) Management in Adults and Young People [Internet].
NICE Clinical Guidelines, No. 109.
National Clinical Guideline Centre for Acute and Chronic Conditions (UK).
Copyright © National Clinical Guideline Centre for Acute and Chronic Conditions, 2010.

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