Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients

Approximately 1900 transplants are performed in the US annually. Lung transplantation remains
the gold standard treatment for patients with end stage lung disease. This includes patients
with range of etiologies such as Idiopathic Pulmonary Fibrosis, COPD and Cystic Fibrosis. One
of the more common post-operative complications in patients undergoing lung transplantation
is the development of atrial fibrillation. Recent studies have demonstrated that
approximately 1/3 of patients will develop atrial fibrillation during their post-operative
course. While it is uncertain if the development of post-operative atrial fibrillation
affects survival, it does significantly increase length of hospital stay. Importantly, a
portion of the patients that develop atrial fibrillation post-operatively will require
cardioversion prior to discharge.

Currently one of the main stays of treatment for post-operative atrial fibrillation is
systemic (oral or intravenous) amiodarone, which is a class III antiarrhythmic agent. While
this particular drug is effective, it does carry the risk of several known complications. Due
to the drug's pharmacokinetics, amiodarone concentrates in organs with high lipid content
such as the thyroid, liver and lung. Amiodarone has several known adverse effects on the lung
ranging from acute respiratory distress syndrome to more chronic disease such as Interstitial
pulmonary fibrosis. Amiodarone can have detrimental effects on the liver which in rare cases
could lead to cirrhosis. Additionally, amiodarone can cause thyrotoxicosis as early as a few
weeks after the initiation of amiodarone.

The adverse events listed above are related to the cumulative dose of amiodarone. Typically,
when amiodarone is initiated, patients receive a loading dose of 600-800mg daily until the
cumulative dose reaches 10 grams, after which patients will receive 200mg daily as a
maintenance dose. Minimizing the cumulative dose of amiodarone by using a local application,
could mitigate the potential adverse drug toxicities. In a previous study, the application of
an amiodarone releasing hydrogel performed intraoperatively was shown to significantly
decrease the rates of post-operative atrial fibrillation in patients undergoing coronary
artery bypass. Currently for patients undergoing lung transplantation, there is not a safe
and effective measure available to prevent post-operative atrial fibrillation.

The Investigators aim to study the intraoperative application of an amiodarone containing
hydrogel for prevention of post-operative atrial fibrillation in lung transplant patients.

In patients undergoing lung transplantation, post-operative atrial fibrillation is common and
leads to prolonged hospital course and increased healthcare expenditures. Amiodarone is a
main stay of therapy for atrial fibrillation, however this drug does have potential serious
complications when administered systemically. The local application of amiodarone, could
potentially decrease the rates of atrial fibrillation, while avoiding the systemic
complications. This has the potential to decrease length of stay and decrease additional
procedures (ie. Cardioversion) in patients undergoing lung transplantation.

Inclusion Criteria:

- Subject or legal representative has signed Informed Consent Form (ICF)

- Undergoing lung transplant at the Jewish Hospital

- Age ≥ 18 years

- Subjects willing and able to comply with the follow up requirements of the study

Exclusion Criteria:

- Patients with previous history of atrial fibrillation.

- Patients with previously documented allergy or adverse reaction to amiodarone.

- Patients with previous ablation for atrial fibrillation

- Patients with an implantable pacemaker.