Acute Cardioversion versus Wait And See-approach for symptomatic atrial fibrillation in the emergency department (ACWAS-trial)

Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia and
is responsible for substantial morbidity, mortality and (subsequent) economic
costs. It is characterized by complety irregular heart rhythm, absent atrial
contraction, and no distinct P-waves on the electrocardiogram. AF can cause
heart failure and thrombus formation which explains the increased ischemic
stroke risk. The emergency department (ED) is often where (symptomatic) AF is
first detected and where patients present with recurrent attacks. Possible
symptoms are palpitations, fatigue, weakness, dizziness, dyspnea, angina, and
(pre)syncope. Current standard of care for patients with symptomatic AF in the
ED is aimed at urgent restoration of sinus rhythm (i.e. cardioversion). This is
usually achieved by pharmacological cardioversion, electrical cardioversion or
a combination of both. Electrical cardioversion is stressful for patients
because of the requirement of general anesthesia and the after-effects hereof.
It is furthermore costly as patients stay in the emergency department for a
prolonged period of time and presence of both a cardiologist, for the
conversion, and an anesthesiologist, for anesthesia, is required. Although
immediate cardioversion of patients is proven to be safe and effective in acute
restoration of sinus rhythm, one could question the need for immediate
cardioversion as AF is a condition that resolves spontaneously within 24 hours
in over 70% of the cases. In addition, its symptoms can succesfully be
alleviated with medication that lowers the heart rate (rate control). In this
age of rising health care costs, optimizing the use of available resources is
important. Based on the beforementioned considerations, a newly proposed
strategy would be to alleviate the symptoms of AF through adequate rate control
medication, thereby bridging the time to spontaneous conversion to sinus
rhythm. If sinus rhythm is not spontaneously achieved within 48 hours after
onset of symptoms, electrical cardioversion can still safely be performed. This
wait-and-see approach with delayed cardioversion as needed, would lower the
need for cardioversions in the emergency department. Obviously, this may lower
health care costs and decrease strain on the emergency department. Furthermore,
patient disease burden could be lowered and patient disease perception
improved. The latter relates to avoiding a burdensome intervention which is
potentially unnecessary, leading to less time spent in the hospital, less
adverse events and a lower psychosocial impact. This study aims to compare the
wait-and-see approach (symptom alleviation and delayed cardioversion when
necessary) to standard of care (immediate cardioversion). Outcome measures are
chosen to prove efficacy, safety, cost-effectiveness and improved quality of
life.

The objective of this study is to compare current standard of care for patients
with symptomatic recent onset atrial fibrillation, which consists of
pharmacological and/or electrical cardioversion, with a wait-and-see approach
which consists of symptom alleviation through rate control medication. All
patients will receive appropriate anti-thrombotic management. Primary outcome
measure is presence of sinus rhythm at 1 month after primary presentation.
Secondary outcome measures are safety indicators including biomarkers, quality
of life/patient perception and total cost of health care consumption during the
following year. Main goal is to assess the potential for lowering health care
costs, decreasing patient disease burden and stress on the emergency health
care system while maintaining optimal patient care.

Patients at the emergency department (ED) with recent onset atrial fibrillation
(AF) without signs of myocardial ischemia or hemodynamic instability are
eligible to participate. Patients will be informed about both treatment arms.
Upon signing of informed consent, patients will be randomized into two groups.
The control group will receive standard care. Pharmacological cardioversion
(PCV) will be performed. In case of contra-indications, history of failing PCV
or failure of PCV, electrical cardioversion (ECV) will be performed. The
intervention group will receive symptomatic treatment. All patients will
receive anti-thrombotic therapy as needed. Patients in the intervention group
will visit the clinic within 48 hours after onset of AF. Patients who still
have AF on ECG will undergo cardioversion (CV). In the following month, all
patients will use a MyDiagnostick device 3 times daily to check for recurrence
of AF. Patients will visit the outpatient clinic at 1 month to determine heart
rhythm on ECG. Quality of Life (QoL), costs and medical events will be assessed
at baseline, 1, 6, and 12 months.

The intervention consists of a wait-and-see approach (WASA) with symptom
reduction. A visit within 48 hours after onset of symptoms will be planned to
check for conversion to SR. If AF is still present, active cardioversion will
be performed.

The additional burden of the intervention arm of this trial versus standard of
care consists of:
- At presentation at the ED, additional blood will be collected during the
standard venapunction to determine biomarkers (in case the biomarkers are not
necessary for clinical care at that point in time). Risks are negligeble.
- An extra visit to the hospital at 48 hours with an extra ECG-recording. This
visit will take approximately 20 minutes if there has been spontenaous
conversion, and 240 minutes if there is still atrial fibrillation. It should be
kept in mind that the index visit was approximately 180 minutes shorter.

In both the intervention and control group, the additional burden consists of:
- During one month, three times daily, the use of a MyDiagnostick. This device
can be used discreetly and does not interfere with daily activity. Each
measurement takes 1 minute.
- At 1, 6 and 12 months after inclusion, patients will be asked to fill out
Quality-of-life questionnaires. This will take 30 minutes. Questions will focus
on quality of life, use of medical care and societal costs. The psychological
burden of these questionnaires is expected to be low.

Patients included at the MUMC are asked for an additional blood sample, drawn
during the visit at 1 month after index visit. For patients included in
Diakonessenhuis, in case of consent on the full informed consent form,
additional blood will be drawn by an additional venous puncture only for
DNA-analysis. For patients included in the other participated centers, in case
of consent on the additional informed consent form, additional blood will be
drawn by an additional venous puncture only for DNA-analysis.