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Ambulatory ECG - cardioinhibitory response review

StudyParticipantDiagnostic tests
Brignole 2006b non-randomised comparative study; study held in Multinational.
Setting: Cardiology. multinational.
Funding: Medtronic Europe
TLoC population: patients with suspected neurally mediated syncope but 12-lead ECG normal. Prior tests: All patients had at least 1 prior test.
causes other than neurally mediated excluded (e.g. by carotid sinus massage, ECG)
Definition of TLoC: not defined.
Inclusion criteria: 3 or more clinically severe syncopal episodes in last 2 years without significant ECG or cardiac abnormalities (severe=high number of episodes or high risk of physical injury due to unpredictability).
Exclusion criteria: orthostatic hypotension, carotid sinus syncope; high likelihood of cardiac syncope; non-syncopal LOC, subclavian steal.
Patient characteristics: age: mean age 66 (14) years; sex: 55% female; some patients with existing heart disease (14% had heart disease);
TLoC history: median 6 events
Comorbidities: neurological disease 9%, diabetes 8%. Other details: see below
Other study comments: case series; same patients as Brignole 2006 (number 780); only comparative diagnostic yield given here versus tilt table
Index test: Reveal Plus (Medtronic); patient and automatic activation; time: mean 12 (8) months; device interrogated every 3 months or after event to maximum of 24 months (n=392)
Comparator test: no details given; time: 1 day (n=343).
for Target Condition/Outcome: suspected neurally mediated syncope; symptom/rhythm
correlation: asystolic pause over 3 seconds (AV block or sinus arrest); bradycardia; tachyarrhythmia (paroxysmal AF; paroxysmal SVT; VT)

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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