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’.