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 ofamiodarone-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.
RCT Entities:
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: Ann C Gaffey; Minna H Chen; Chantel M Venkataraman; Alen Trubelja; Christopher B Rodell; Patrick V Dinh; George Hung; John W MacArthur; Renganaden V Soopan; Jason A Burdick; Pavan Atluri Journal: J Thorac Cardiovasc Surg Date: 2015-07-17 Impact factor: 5.209
Authors: Victor Segura-Ibarra; Francisca E Cara; Suhong Wu; David A Iruegas-Nunez; Sufen Wang; Mauro Ferrari; Arturas Ziemys; Miguel Valderrabano; Elvin Blanco Journal: J Control Release Date: 2017-07-09 Impact factor: 9.776
Authors: Jose R Garcia; Peter F Campbell; Gautam Kumar; Jonathan J Langberg; Liliana Cesar; Juline N Deppen; Eric Y Shin; Neal K Bhatia; Lanfang Wang; Kai Xu; Frank Schneider; Brian Robinson; Andrés J García; Rebecca D Levit Journal: Circ Arrhythm Electrophysiol Date: 2018-05
Authors: Vladimir Shvartz; Teymuraz Kanametov; Maria Sokolskaya; Andrey Petrosyan; Tatyana Le; Olga Bockeria; Leo Bockeria Journal: Gels Date: 2021-03-10