title: Effectiveness of biatrial epicardial application of amiodarone-releasing adhesive hydrogel to prevent postoperative atrial fibrillation.
abstract: OBJECTIVE
  Postoperative atrial fibrillation (POAF) is the most frequent complication arising after cardiac surgery, occurring in 30% of cases. Amiodarone is the most effective drug for prophylaxis and treatment. However, because of significant extracardiac side effects, only high-risk patients are eligible for prophylactic amiodarone therapy. We performed a randomized prospective study of 100 patients undergoing cardiac surgery with epicardial application of amiodarone-releasing hydrogel to determine the effectiveness of preventing POAF.
  
  
  METHODS
  After institutional review board approval, 100 patients, from January 2012 to July 2013, who had undergone cardiac surgery, were randomized to 2 equal groups. The study group received poly-based hydrogel with amiodarone sprayed diffusely over the epicardium. The control group underwent the procedure without the spray. Continuous telemetry monitored for POAF, and amiodarone levels in the atria, plasma, and tissue were measured postoperatively. Daily electrocardiographic parameters were measured until postoperative day 14.
  
  
  RESULTS
  The incidence of POAF was significantly less in the study group, with 4 of 50 patients (8%) incurring atrial fibrillation compared with 13 of 50 patients (26%) in the control group (P < .01). The mean amiodarone concentrations in the atria (12.06 ± 3.1) were significantly greater than those in the extracardiac tissues (1.32 ± 0.9; P < .01). The plasma amiodarone levels remained below the detection limit (<8 μg/mL) during the 14 days of follow-up. Bradycardia was observed less in the study group (76 ± 29) than in the control group (93 ± 18; P < .01).
  
  
  CONCLUSIONS
  Epicardial application of amiodarone-releasing adhesive hydrogel is a less invasive, well-tolerated, quick, and effective therapeutic option for preventing POAF at minimal risk of extracardiac adverse side effects.
authors.affiliation: Shanghai Eastern Hospital, Shanghai, China.
authors.forename: Xiao Dong
authors.initials: XD
authors.lastname: Feng
authors.affiliation: ShanXi Cardiovascular Hospital, TaiYuan, Shanxi, China.
authors.forename: Xue Ning
authors.initials: XN
authors.lastname: Wang
authors.affiliation: Changzhi Peace Hospital, Changzhi, ShanXi, China.
authors.forename: Xin Hiu
authors.initials: XH
authors.lastname: Yuan
authors.affiliation: Scripps Memorial Hospital, La Jolla, Calif. Electronic address: wangmd100@gmail.com.
authors.forename: William
authors.initials: W
authors.lastname: Wang
mesh_terms: D000328:Adult; D000638:Amiodarone / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D001919:Bradycardia / Q000139:chemically induced / Q000175:diagnosis; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D002681:China; D015716:Electrocardiography, Ambulatory; D005260:Female; D006801:Humans; D020100:Hydrogels; D008297:Male; D008875:Middle Aged; D010496:Pericardium; D011446:Prospective Studies; D013686:Telemetry; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents; D020100:Hydrogels; D000638:Amiodarone