A Prospective Pilot Study on the Combination of CardiaMend and Amiodarone for the Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Open Heart Surgery by Median Sternotomy (CAMP POAF Trial)

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Abstract
Background: Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery and is associated with high rates of morbidity. Oral or intravenous administration of amiodarone is commonly used for treatment and prophylaxis; however, systemic delivery of amiodarone is associated with significant, well-known extracardiac side effects. Therefore, this study aimed to evaluate the effectiveness of combining a pericardial reconstruction matrix (CardiaMend) with amiodarone to prevent POAF in patients undergoing isolated coronary artery bypass grafting (CABG) or valve surgery. Methods: This was a single-center, prospective, pilot study that enrolled patients undergoing CABG or valve surgery via complete median sternotomy. The amiodarone-soaked CardiaMend patch was applied intraoperatively. The primary outcome was the incidence of POAF up to patient discharge. Secondary outcomes were time until discharge and burden of atrial fibrillation. Results: A total of 29 patients were included, all undergoing CABG, of whom 10% (3/29) had concomitant valve replacements. POAF was experienced by 10 patients (34%). All patients were discharged in sinus rhythm, and none required a wearable rhythm monitor. Conclusion: The use of a pericardial reconstruction matrix for local amiodarone delivery during cardiac surgery is a safe, potential prophylactic treatment for POAF. The clinical results of this pilot study showed a trend toward reduced POAF following cardiac surgery. These results, in combination with prior research, suggest that a more targeted application of amiodarone-eluting patches could be used to treat the atria and further improve outcomes. Clinical Trial Registration: NCT05681182, https://clinicaltrials.gov/study/NCT05681182.

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