Abstract
BackgroundPostoperative atrial fibrillation (POAF) is a frequent adverse event after thoracic surgery with associated morbidity, mortality, and healthcare costs. It has been shown to be preventable with prophylactic amiodarone, which is only recommended in high-risk individuals due to the potential associated side effects. Risk factors for POAF have been identified and incorporated into a prediction model to identify high-risk patients. Further evaluation in the form of a multicenter clinical trial is required to assess the effectiveness of prophylaxis specifically in this high-risk population. The feasibility of such a trial first needs to be assessed.MethodsThe PREP-AF trial is a double-blind randomized controlled feasibility trial. Individuals undergoing major thoracic surgery who are identified to be high-risk by the POAF prediction model will be randomized 1:1 to receive a short course of amiodarone vs. placebo in the immediate postoperative period. The primary outcome is feasibility, which will be measured by the number of eligible patients identified, consented, and randomized; intervention adherence; and measurement of future outcomes of a full trial.DiscussionThis study will determine the feasibility of a randomized controlled trial to assess the effectiveness of prophylactic amiodarone, in high-risk patients undergoing major thoracic surgery. This will inform the development of a multi-center trial to establish if prophylactic amiodarone is safe and effective at reducing the incidence of POAF. Preventing this adverse event will not only improve outcomes for patients but also reduce the associated health resource utilization and costs.Trial registrationClinicalTrials.gov NCT04392921. Registered on 19 May 2020.
Highlights
Background and rationale {6a} Postoperative atrial fibrillation (POAF) is the most commonly sustained arrhythmia after thoracic noncardiac surgery [1, 2]. We found it occurred in 17% of patients after lobectomy, 23% after pneumonectomy, and 12% after esophagectomy, making it the most common postoperative adverse event after thoracic surgery at our institution [3]
Prediction of POAF In reviewing the literature for risk stratification tools to predict POAF after thoracic surgery, we only identified one which was internally validated for all patients undergoing major thoracic surgery and contained factors obtainable in the preoperative period [4, 15, 16]
Objectives {7} This study aims to assess the feasibility of a blinded, randomized controlled trial where patients at increased risk of POAF who are undergoing major thoracic surgery are randomized to receive prophylactic amiodarone or placebo
Summary
Background and rationale {6a} Postoperative atrial fibrillation (POAF) is the most commonly sustained arrhythmia after thoracic noncardiac surgery [1, 2] We found it occurred in 17% of patients after lobectomy, 23% after pneumonectomy, and 12% after esophagectomy, making it the most common postoperative adverse event after thoracic surgery at our institution [3]. It is associated with increased postoperative morbidity, length of stay, ICU admission, and mortality [1, 2]. Postoperative atrial fibrillation (POAF) is a frequent adverse event after thoracic surgery with associated morbidity, mortality, and healthcare costs. Further evaluation in the form of a multicenter clinical trial is required to assess the effectiveness of prophylaxis in this high-risk population. The feasibility of such a trial first needs to be assessed
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