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European Heart Journal Advance Access originally published online on March 28, 2006
European Heart Journal 2006 27(9):1085-1092; doi:10.1093/eurheartj/ehi842
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© The European Society of Cardiology 2006. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Early application of an implantable loop recorder allows effective specific therapy in patients with recurrent suspected neurally mediated syncope

Michele Brignole1,*, Richard Sutton2, Carlo Menozzi3, Roberto Garcia-Civera4, Angel Moya5, Wouter Wieling6, Dietrich Andresen7, David G. Benditt8, Panos Vardas9 for the International Study on Syncope of Uncertain Etiology 2 (ISSUE 2) Group

1 Department of Cardiology, Arrhythmologic Centre, Ospedali del Tigullio, Via don Bobbio 24, 16033 Lavagna, Italy
2 Department of Cardiology, Royal Brompton and Harefield Hospitals, London, UK
3 Department of Cardiology, Ospedale S Maria Nuova, Reggio Emilia, Italy
4 Department of Cardiology, H. Clínico, Valencia, Spain
5 Department of Cardiology, Hospital General Vall d'Hebrón, Barcelona, Spain
6 Department of Internal Medicine, Academisch Medisch Centrum, Amsterdam, The Netherlands
7 Department of Cardiology, Krankenhaus Am Urban, Berlin, Germany
8 Cardiac Arrhythmia Center, University of Minnesota Medical School, Minneapolis, MN, USA
9 Department of Cardiology, University Hospital of Crete, Herakleion, Greece

Received 5 November 2005; revised 26 January 2006; accepted 9 March 2006; online publish-ahead-of-print 28 March 2006.

* Corresponding author. Tel: +39 0185 329569; fax: +39 0185 306506. E-mail address: mbrignole{at}ASL4.liguria.it

Aims This prospective multicentre observational study assessed the efficacy of specific therapy based on implantable loop recorder (ILR) diagnostic observations in patients with recurrent suspected neurally mediated syncope (NMS).

Methods and results Patients with three or more clinically severe syncopal episodes in the last 2 years without significant electrocardiographic and cardiac abnormalities were included. Orthostatic hypotension and carotid sinus syncope were excluded. After ILR implantation, patients were followed until the first documented syncope (Phase I). The ILR documentation of this episode determined the subsequent therapy and commenced Phase II follow-up. Among 392 patients, the 1-year recurrence rate of syncope during Phase I was 33%. One hundred and three patients had a documented episode and entered Phase II: 53 patients received specific therapy [47 a pacemaker because of asystole of a median 11.5 s duration and six anti-tachyarrhythmia therapy (catheter ablation: four, implantable defibrillator: one, anti-arrhythmic drug: one)] and the remaining 50 patients did not receive specific therapy. The 1-year recurrence rate in 53 patients assigned to a specific therapy was 10% (burden 0.07±0.2 episodes per patient/year) compared with 41% (burden 0.83±1.57 episodes per patient/year) in the patients without specific therapy (80% relative risk reduction for patients, P=0.002, and 92% for burden, P=0.002). The 1-year recurrence rate in patients with pacemakers was 5% (burden 0.05±0.15 episodes per patient/year). Severe trauma secondary to syncope relapse occurred in 2% and mild trauma in 4% of the patients.

Conclusion A strategy based on early diagnostic ILR application, with therapy delayed until documentation of syncope allows a safe, specific, and effective therapy in patients with NMS.

Key Words: Neurally mediated syncope • Arrhythmias • Pacemaker • Loop recorder • Prolonged ECG monitoring • Diagnosis • Electrocardiography • Pacing


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