Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer

PRIMARY OBJECTIVE:

I. To evaluate the effect of prophylactic amiodarone on the rate of atrial fibrillation (AF) in patients undergoing minimally invasive esophagectomy (MIE).

SECONDARY OBJECTIVES:

I. In each subobjective, below, evaluations of the effects of prophylactic amiodarone on the following will be made:

• Ia. Postoperative (PostOp) rapid ventricular response;
• Ib. Postop pulmonary complications;
• Ic. Postop anastomotic leak;
• Id. Intensive care unit (ICU) readmission;
• Ie. ICU length of stay (LOS);
• If. Hospital LOS;
• Ig. 30-day readmission;
• Ih. Inpatient mortality;
• Ii. 30-day mortality;
• Ij. Adverse events;
• Ik. Time to AF;

Il. Evaluating the association between therapeutic (or serum levels and the development of AF in the experimental group only.

EXPLORATORY OBJECTIVE:

I. To evaluate the effect of prophylactic amiodarone administration on hospital cost of care.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive amiodarone hydrochloride intravenously (IV) for 4 days and then via a feeding tube for 3 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo (normal saline) IV for 4 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for 60 days following discharge from hospitalization after MIE.

Inclusion criteria

• All patients undergoing MIE will be evaluated for potential enrollment

• Indication of cancer, esophageal dysplasia or esophageal dysmotilities
• Age > 18 years
• Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

• History of chronic or paroxysmal AF, or atrial flutter
• Previous severe adverse reaction or contraindication to amiodarone (e.g., pulmonary toxicity/fibrosis, hepatotoxicity, thyroid dysfunction)
• Current preoperative use of amiodarone, as baseline home medication
• Development of AF intraoperatively
• Pregnancy

• Negative pregnancy tests are required for participants of childbearing potential (PCBP) on Day of Surgery (DOS)
• Breastfeeding/chest feeding
• Aborted MIE operation
• QTcF (Fridericia formula) > 500 for heart rate (HR) 60-100 within 30 days

• For patients with a heart rate (HR) of between 50-59 on their pre-operative screening electrocardiography (EKG), we will first review evidence of chronotropic cardiac response to exercise before inclusion in the study. If a patient's HR increases to ≥ 100 with exercise, the patient is eligible for inclusion of study. Exercise testing options may include a stair climb, a brisk walk, or supine leg-lifts prior to surgery. If exercise is not an option, we can review results of formal stress testing chronotropic response (ie. HR ≥ 100). HR monitoring can be collected by either pulse oximeter or EKG