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In aged patients, the most frequent indications for anticoagulation are atrial fibrillation (AF) and venous thromboembolism for stroke and systemic embolism prevention. Despite systemic anticoagulation recommended by current guidelines for patients over 65 years, in clinical practice up to 50 % of elderly patients do not receive maintenance anticoagulation therapy. This is particularly evident in frail subjects at risk of syncopal and not-syncopal fall, fearing intracranial bleeding following a fall. As the risk of bleeding associated with falls is still debated, the boards of the Academy of Emergency Medicine and Care (AcEMC) and the Italian Multidisciplinary Working Group on Syncope (GIMSI), in order to write a consensus document, submitted to a panel of experts eight statement which could represent as many controversial topics for anticoagulant prescription in patients over 75 years. The Delphi method was used to obtain consensus between 15 physicians from different medical specialties; some of them were expert in syncope management and worked in a Syncope Unit. All had experience in prescribing oral anticoagulation. A questionnaire was sent on the appropriateness of oral anticoagulation in eight clinical situations where the risk of fall is present (frailty, cognitive impairment, previous falls, absence of caregiver, chronic renal impairment, nonvalvular AF with HAS-BLED score ≥3 or CHA2DS2-VASc score ≥3). All experts completed the questionnaire within three rounds and the consensus was reached on many but not all statements, leaving room for debate on some clinical situations. The consensus document gives useful advice for elderly patients’ management, who need oral anticoagulant therapy but are at risk of syncopal or not-syncopal fall. Nonetheless, there are some unresolved issues where an individual decision should be taken by the physician in agreement with the patient.

Abstract Background The efficacy of dual-chamber cardiac pacing in neuro-mediated reflex syncope with a cardio-inhibitory response to the Tilt-Table test (TT) has not been definitively assessed so far. The lack of reproducibility of results from previous studies may be partially explained by discrepancies in subject selection and some weaknesses in design and methods. The European Society of Cardiology (ESC) has set a class IIb indication to pacemaker implantation in this population recommending further research. Methods/design The BIOSync study is a multicenter, patient- and outcome-assessor-blind, randomized, parallel-arm, placebo-controlled trial with the objective of assessing the clinical benefit of cardiac pacing in patients with frequently recurrent reflex syncope, suspected (but not proven) to be triggered by asystolic pauses as showing a VASIS 2B response to the TT (>3-s pause regardless of blood pressure drop). The primary and secondary endpoints are time to first post-implantation recurrence of syncope or the combination of pre-syncope or syncope, respectively. One hundred and twenty-eight consenting patients will be 1:1 randomized to dual-chamber cardiac pacing ‘on’ or ‘off’ after pacemaker implantation, and followed up until the first adjudicated primary endpoint event for a maximum of 2 years. The so-called Closed Loop Stimulation function on top of dual-chamber pacing is the pacing mode selected in the study active arm. Participating patients are asked to self-report syncopal symptoms at least every 3 months with self-administered questionnaires addressed to an independent Adjudication Committee. Patients and members of the Adjudicating Committee are blinded to randomization. The study is designed to detect a 40% relative reduction in the 2-year incidence of syncopal recurrences with 80% statistical power. Discussion The BIOSync study is designed to definitively assess the benefit of pacing against placebo in reflex syncope patients with a cardio-inhibitory response to the TT. The study will also provide important information on the efficiency of the TT in appropriately selecting reflex syncope patients for cardiac pacing. Trial registration ClinicalTrials.gov, identifier: NCT02324920 (27 October 2016, date last accessed).

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