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Randomized Controlled Trial Multicenter Study
ELectrophysiological mechanisms underlying the Inhibitory CArdiac syncope without asystolic significant pause: Therapeutic and prognostic implications. The ELICA randomized trial.
- Celestino Sardu, Raffaele Marfella, Gianluca Testa, Matteo Santamaria, Cosimo Sacra, Alfredo Ranauro, Giuseppe Paolisso, Maria Rosaria Rizzo, and Michelangela Barbieri.
- Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania "Luigi Vanvitelli", Naples Department of Medicine and Health Sciences, University of Molise Cardiovascular and Arrhythmias Department, John Paul II Research and Care Foundation, Campobasso, Italy.
- Medicine (Baltimore). 2018 Aug 1; 97 (31): e11757e11757.
BackgroundThe aim of this study was to investigate syncope recurrence in patients with a 2A cardioinhibitory response to the head up tilt testing (HUT).MethodsIn this study, we enrolled 72 consecutive patients affected by syncope with cardioinhibitory response without asystolic significant pause to HUT (2A type). In these patients, we randomly performed electrophysiological study (ES). In case of sino-atrial node, atrio-ventricular node dysfunction, and sustained arrhythmias induction, the ES resulted positive. ES was positive in 9 patients (group A), then treated by catheter ablation, and/or by devices implants. Otherwise, ES resulted negative (group B), and these patients did not receive an interventional treatment. However, after ES, we evaluated syncope recurrence during 360 days follow-up.ResultsThere was a lower statistical significant syncope recurrence at follow-up, comparing group A to group B of patients [n of events 9 (40.9%) vs 8 (57.1%), P < .05]. At multivariate analysis, ES result was the only factor predicting syncope recurrence at follow-up (hazard ratio = 27.63, 95% confidence interval = 1.02-54.24, P < .005).ConclusionThe positivity to ES study, and successful interventional therapies may reduce the burden of syncope recurrence at 360 days follow-up in 2A HUT subjects.Clinical trial number: NCT02861274.
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