Materials and Methods
Details on the BALKAN-AF survey have been formerly described [20]. In brief, data regarding consecutive subjects with electrocardiographically documented ‘non-valvular’ AF were collected prospectively. Cardiologist or an internal medicine specialist, where cardiologist was not available evaluated and examined patients. University, non-university hospitals and outpatient health centres (a total of 49 centres), localized around the Balkans, were sites in registry.
This 14-week, multicenter, observational snapshot registry was designed and performed by the Serbian Atrial Fibrillation Association (SAFA). This survey was presented to the National Cardiology Societies/ relevant Working Groups in particular Balkan countries. In the Balkan region the registry was approved by the National and/ or local Institutional Review Board. An informed consent form was gathered from all the patients before enrollment to the survey. The study protocol is in agreement with the ethical guidelines of the 1975 Declaration of Helsinki.
Patients younger than 18 years, with prosthetic mechanical heart valves, with moderate or severe mitral stenosis or any significant heart valve disease with indications to surgical treatment were excluded from the study.
SAFA designed classic electronic case report forms which were sent to collect data. Following information was obtained: patients’ clinical characteristics and characteristics of AF, health care location, patients’ physical findings and management at visit. Cardiovascular risk factors, diseases and risk scores were defined according to particular European Society of Cardiology guidelines, other guidelines, scientific statements and textbooks showed previously in Supplementary Information [21]. Diagnostic assessment and treatment associated with AF was collected at enrolling visit and previous 12 months. Stroke risk was evaluated based on CHA2DS2-VASc [congestive heart failure, hypertension, age ≥ 75 years, diabetes, stroke/ transient ischaemic attack (TIA), vascular disease, age 65-74 years, sex category (female)] score [22]. Bleeding risk was evaluated according to HAS-BLED [hypertension, abnormal renal/ liver function, stroke, bleeding history or predisposition, labile International Normalised Ratio (INR), elderly (>65 years), drugs or alcohol concomitantly] score [23].
Systematic monitoring of centres and follow-up visits were not performed. National coordinators and all investigators were responsible for consecutiveness of enrolled patients, correctness and completeness of data.
In this study, patients were assigned to rhythm or rate control as declared by the responsible physician/ investigator. This ‘real life’ registry contains data on the use of rate control management and rhythm control management, which are not ‘pure’.