BACKGROUND: Few studies have compared conventional testing with prolonged monitoring using an implantable loop recorder (ILR) following the first syncope episode in patients with bundle branch block (BBB) and negative workup. OBJECTIVES: To compare two syncope evaluation strategies-primary use of an ILR (Group 1) versus conventional testing (Group 2)-and to estimate the prevalence of significant arrhythmias in the ILR patient subset. METHODS:From January 2005 to December 2010, 78 patients admitted after one syncope episode were randomized to ILR (n=41) or conventional follow-up (n=37). Mean follow-up was 27 ± 12 months. RESULTS:Mean age was 76 ± 8 years and 30 patients were women (38.5%); 18 presented cardiomyopathy (23%) and 12 had a history of atrial fibrillation (15.4%). Mean left ventricular ejection fraction was 56.5 ± 11% and mean His-to-ventricle interval was 55 ± 6ms based on negative electrophysiological study (EPS). Electrocardiogram abnormalities involved: 34 left bundle branch blocks (BBBs); 11 right BBBs; and 33 bifascicular blocks. Overall, 21 patients (27%) developed significant arrhythmic events: ventricular tachycardia (n=1; 1.3%); sudden death (n=2; 2.6%); third-degree atrioventricular (AV) block (n=14; 18%); sick sinus syndrome (n=4; 5.1%). In 19 (24.4%) patients, relevant arrhythmias were detected, with a significant difference between the ILR group (n=15/41; 36.6%) and the conventional follow-up group (n=4/37; 10.8%) (P=0.02). Eighteen patients were implanted with pacemakers; one received an implantable defibrillator. No predictors of AV block were identified in the ILR group. CONCLUSIONS: In this randomized prospective study, the ILR strategy proved largely superior to conventional follow-up in detecting recurrent events, with a potential impact on therapeutic management. This observation highlights the usefulness of early monitoring in patients with BBB and negative EPS even after the first syncope episode but an empiric pacemaker strategy remains to be validated in this selected population.
RCT Entities:
BACKGROUND: Few studies have compared conventional testing with prolonged monitoring using an implantable loop recorder (ILR) following the first syncope episode in patients with bundle branch block (BBB) and negative workup. OBJECTIVES: To compare two syncope evaluation strategies-primary use of an ILR (Group 1) versus conventional testing (Group 2)-and to estimate the prevalence of significant arrhythmias in the ILR patient subset. METHODS: From January 2005 to December 2010, 78 patients admitted after one syncope episode were randomized to ILR (n=41) or conventional follow-up (n=37). Mean follow-up was 27 ± 12 months. RESULTS: Mean age was 76 ± 8 years and 30 patients were women (38.5%); 18 presented cardiomyopathy (23%) and 12 had a history of atrial fibrillation (15.4%). Mean left ventricular ejection fraction was 56.5 ± 11% and mean His-to-ventricle interval was 55 ± 6ms based on negative electrophysiological study (EPS). Electrocardiogram abnormalities involved: 34 left bundle branch blocks (BBBs); 11 right BBBs; and 33 bifascicular blocks. Overall, 21 patients (27%) developed significant arrhythmic events: ventricular tachycardia (n=1; 1.3%); sudden death (n=2; 2.6%); third-degree atrioventricular (AV) block (n=14; 18%); sick sinus syndrome (n=4; 5.1%). In 19 (24.4%) patients, relevant arrhythmias were detected, with a significant difference between the ILR group (n=15/41; 36.6%) and the conventional follow-up group (n=4/37; 10.8%) (P=0.02). Eighteen patients were implanted with pacemakers; one received an implantable defibrillator. No predictors of AV block were identified in the ILR group. CONCLUSIONS: In this randomized prospective study, the ILR strategy proved largely superior to conventional follow-up in detecting recurrent events, with a potential impact on therapeutic management. This observation highlights the usefulness of early monitoring in patients with BBB and negative EPS even after the first syncope episode but an empiric pacemaker strategy remains to be validated in this selected population.
Authors: Monica Solbiati; Giorgio Costantino; Giovanni Casazza; Franca Dipaola; Andrea Galli; Raffaello Furlan; Nicola Montano; Robert Sheldon Journal: Cochrane Database Syst Rev Date: 2016-04-19