Pilot safety and efficacy trial of amiodarone-infused biologic acellular biatrial patches to prevent new-onset postoperative atrial fibrillation

Objective New onset post operative atrial fibrillation (POAF) occurs in approximately 25-40% of patients undergoing heart surgery and is associated with increased perioperative morbidity and mortality. We evaluated the safety and exploratory efficacy of amiodarone-infused CardiaMend™ biatrial patches for POAF prevention. Methods A single-center pilot clinical trial enrolled 40 patients after applying inclusions and exclusion criteria, randomized, in 1:1 fashion. Patients in the treatment group received the CardiaMend™ patch, a porous acellular matrix derived from fetal bovine dermis, infused with 70 mg amiodarone, placed on both atria, while the control group received standard of care. The primary endpoint was safety, defined as major adverse cardiovascular and cerebrovascular events (MACCE). Secondary endpoints included POAF, length of hospital stay (LOS), 30-day readmission, and POAF duration. Results The two randomized groups had similar baseline characteristics. There were two MACCE events: one patient in the control group had an embolic stroke with full recovery prior to discharge, and one in the treatment group died from an acute abdominal event following IABP removal, deemed unrelated to the study device. The incidence of POAF (4 patients, 20% vs. 8 patients, 40%, p=0.30) and mean AF duration (2.5 +/- 2.4 vs. 3.8 +/- 4.1 days) were lower in the treatment group. Mean LOS was shorter in the treatment group (5.8 +/- 1.2 vs. 9.3 +/- 7.5 days, p=0.07). At 30-day follow-up, Holter monitoring revealed no AF in the treatment group and 3 (15%) patients in the control group (p=0.23), and readmission rates were also lower in the treatment group (5% vs. 15%, p=0.6). Conclusion This pilot randomized clinical trial showed that amiodarone-infused CardiaMend™ biatrial patches were safe, with no evidence of systemic amiodarone toxicity. Treatment with amiodarone-infused CardiaMend™ patches was associated with a clinically noticeable reduction in POAF, length of stay, and post-discharge AF.