Prevention of Atrial Fibrillation Following Esophagectomy

Thousands of patients undergo major esophagectomy surgery in the United States each year,
during which all or a portion of the esophagus is removed. A major complication of these
surgeries is the occurrence of an irregular heartbeat known as atrial fibrillation (AF),
which develops in up to 40% of patients undergoing these procedures. AF is characterized by
rapid, irregular, chaotic beating of the two smaller chambers of the heart (the atria),
leading to rapid, irregular beating of the two larger chambers (the ventricles). The average
time to occurrence of post-surgical AF is 2-3 days following surgery. AF occurring following
esophagectomy can result in extremely rapid heart rates, as fast as 150-200 beats per
minute, and may be associated with serious consequences, including severely low blood
pressure and potentially debilitating stroke. Further, the risk of death following
esophagectomy is significantly higher in patients who develop AF compared with those who do
not. Therefore, the occurrence of this irregular heartbeat following esophagectomy is
associated with severe, potentially life-threatening consequences. Prevention of this
irregular heartbeat in these patients may therefore be very important.

Amiodarone is a medication that is known to be effective for prevention and treatment of AF
that occurs in patients who have not undergone surgery. In addition, amiodarone has been
shown to be effective for prevention of AF following open-chest heart surgery. However, the
use of medications for prevention of AF following esophagectomy has not been well studied,
and amiodarone has not been studied in a controlled trial for the prevention of AF in this
population. In addition, amiodarone is associated with side effects, and it is important to
determine the safety of this medication when used in this patient population.

Inclusion Criteria:

- Males or females over the age of 40

- Scheduled to undergo esophagectomy

Exclusion Criteria:

- History of atrial fibrillation

- Prior severe side effects from amiodarone

- Elevated liver enzymes >3 times the upper limit of normal (UNL)

- QTc interval > 450 ms

- Receiving class Ia or class III antiarrhythmics