Epicardial Application of Hydrogel with Amiodarone for Prevention of Postoperative Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting

Bockeria, O.L.; Kanametov, T.N.; Shvartz, Vladimir A.; Sokolskaya, Maria; Zhuginisov, D.Sh.; Санакоев, М.К.; Bockeriа, L.A.

doi:10.1007/s12265-019-09905-1

Cited by 13 publications

(36 citation statements)

References 20 publications

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“…However, amiodarone presents with serious cardiac and extracardiac adverse risks, such as bradycardia, increased liver enzymes, hyperthyroidism, thyrotoxicosis, and interstitial pneumonitis. Accumulation of the drug may also lead to longer lasting side effects after discontinuing the drug [ 7 ]. Local epicardial application of amiodarone hydrogel has been shown to reduce the adverse outcomes of amiodarone and have a decrease in POAF incidence from 22-37% to 3.3-8% [ 7 , 42 ].…”

Section: Methodsmentioning

confidence: 99%

“…Accumulation of the drug may also lead to longer lasting side effects after discontinuing the drug [ 7 ]. Local epicardial application of amiodarone hydrogel has been shown to reduce the adverse outcomes of amiodarone and have a decrease in POAF incidence from 22-37% to 3.3-8% [ 7 , 42 ]. While these studies were small in sample size (~ 60), they show promise for an effective therapeutic for POAF.…”

Section: Methodsmentioning

confidence: 99%

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Post-Operative Atrial Fibrillation: Current Treatments and Etiologies for a Persistent Surgical Complication

Lopes¹,

Agrawal²

2022

J Surg Res

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Post-operative atrial fibrillation (POAF) is a persistent and serious surgical complication that occur in 20-55% of cardiac surgery cases. POAF may lead to adverse health outcomes such as stroke, thromboembolism, cardiac arrest, and mortality, and may develop long-term. Patients have a 2-fold increase in mortality risk and spend about 3.7 more days in the hospital and $16,000 more in medical costs during their visit. The mechanisms and risk factors of POAF are still poorly understood, yet a strong foundation of how a disease process occurs is needed to provide the most effective treatment. Current mechanisms that are postulated to contribute to POAF include an increase in sympathetic tone, oxidative stress, local and systemic inflammation, a trigger that induces atrial substrate changes, a driver to sustain POAF, and electrolyte disturbances such as hypomagnesemia. While needing more research, current risk factors include age, male sex, history of myocardial infarction or heart failure, hypertension, diabetes, obesity, and COPD. Treatments mostly include prophylaxis of repurposed drugs such as beta-blockers, statins, oral anticoagulants, antiarrhythmics, and Vitamin D and electrolyte supplementation. Autonomic denervation has also been a promising preventative measure for patients undergoing cardiac surgery. This critical review article provides an up-to-date and comprehensive summary of the pathophysiology of POAF, current clinical risk factors and management for POAF and discusses new pathways for further investigation.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Post-Operative Atrial Fibrillation: Current Treatments and Etiologies for a Persistent Surgical Complication

Lopes¹,

Agrawal²

2022

J Surg Res

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“…In the studies by Feng et al 18 and Wang et al 15 7 of the 50 patients who received amiodarone hydrogel therapy also required temporary pacing for transient bradycardia. No cardiac pacing devices were required for the amiodarone study group in the study by Bockeria et al 16 despite the significantly lower average and minimum heart rates than in control group. Even though bradycardia was present, there was no significant overall effect on the cardiac safety profile of the amiodarone hydrogel or patch.…”

Section: Resultsmentioning

confidence: 99%

“…Three of the studies demonstrated that the epicardial administration of amiodarone to the heart during cardiac surgery was effective in reducing the risk of POAF. 15,16,18 Bockeria et al 16 investigated the effects of the amiodarone-releasing hydrogel in preventing POAF in 60 patients (30 control, 30 amiodarone interventions) who underwent CABG. Approximately 5-8 ml of amiodarone hydrogel (1 mg/kg bodyweight) were applied to the surfaces of both atrial.…”

Section: Efficacy Of Amiodarone In Preventing Poafmentioning

confidence: 99%

Effectiveness of intra‐operative topical amiodarone for prevention of postcardiac surgery new‐onset atrial fibrillation: A review of current evidence

Chen

Sartor

Zhang

et al. 2022

Journal of Cardiac Surgery

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Background: Postoperative atrial fibrillation (POAF) is one of the most common complications following cardiac surgery and is associated with increased morbidity.Intraoperative topical amiodarone application on epicardial tissue has been shown to reduce systemic concentrations while maintaining therapeutic myocardial concentrations, thereby, lowering the risk of extracardiac adverse effects associated with oral and intravenous amiodarone therapy. However, the efficacy and safety of topical amiodarone in preventing POAF is unclear.Objectives: This study summarizes the clinical studies to-date that have investigated the efficacy and safety of topical amiodarone administration in preventing POAF following cardiac surgery.Methods: A database search was conducted using Medline, Embase, and Cochrane Library to identify relevant studies. Abstracts were screened and data were extracted from relevant full-text articles that met the inclusion and exclusion criteria. Results:The search returned four studies with variable findings on the effect of topical amiodarone therapy on the incidence of POAF, cardiac effects, extracardiac effects, and hospital length of stay. Conclusion:Prophylactic topical application of amiodarone may be effective and safe for preventing post-operative new-onset atrial fibrillation. Further investigation is required to evaluate the efficacy and safety of topical amiodadrone therapy before it can be widely integrated into current practice.

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“…The risk of POAF was calculated using the Cox regression model ( Table 6 ). Only age ( p = 0.009) and the application of hydrogel with amiodarone ( p = 0.011) showed statistical significance among all clinical, laboratory, and instrumental parameters [ 12 ].…”

Section: Resultsmentioning

confidence: 99%

Local Use of Hydrogel with Amiodarone in Cardiac Surgery: Experiment and Translation to the Clinic

Shvartz

Kanametov

Sokolskaya

et al. 2021

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The objective of this study was to study the use of the hydrogel biopolymer based on sodium alginate (“Colegel”) with a drug substance—amiodarone—for the prevention of postoperative atrial fibrillation (POAF) in cardiac surgery. The experimental part of the study was performed on 46 rabbits. Five groups were formed: in the first group, the dose of amiodarone in hydrogel was 1 mg; in the second group—3 mg; in the third group—6 mg; in the fourth group, hydrogel was used without amiodarone; in the fifth group, 60 mg amiodarone was administered intravenously. The animals from each group were removed from the experiment for the pathomorphological study of the heart after 3, 7 and 14 days. The studied endpoints were: the heart rate control; the development of the blockades of the conduction system of the heart; and the development of inflammation according to laboratory pathomorphological studies. The translational clinical part involved a randomized clinical trial which included 60 patients, with an average age of 62 ± 8.5 years. All patients were randomized into two groups: the study group (n = 30, with the application of amiodarone hydrogel) and the control group (n = 30, without the application of amiodarone hydrogel). The dose of amiodarone in the hydrogel material was 60 mg for all patients. The heart rhythm was monitored during 5 days. The primary endpoint was the development of POAF. Secondary endpoints were: the dynamics of heart rate; the duration of the QT and PQ intervals; the development of blockades of the cardiac conduction system; as well as the dynamics of AST and ALT. According to the results of the experimental part, it was found that the method of the local epicardial delivery of amiodarone by the hydrogel material was safe. Hydrogel with amiodarone is effective for reducing the heart rate in the animal experiment in comparison to the control group and the group with the intravenous administration of the drug. The optimal dose of amiodarone in hydrogel was 1 mg per 1 kg. According to the results of the clinical part, it was found that the method of the local epicardial delivery of amiodarone as a hydrogel material proved its safety. Hydrogel with amiodarone at a dose of 60 mg was effective in preventing POAF in patients after coronary artery bypass grafting (CABG) operations in comparison to the control group (p < 0.001). The age and procedure of application of the amiodarone gel were significantly associated with POAF (p = 0.009 and p = 0.011, respectively). The use of hydrogel with amiodarone reduced the probability of developing POAF 18.9-fold. The method of the local epicardial delivery of amiodarone in the form of a hydrogel material is safe. The use of hydrogel with amiodarone after CABG reduced the probability of developing POAF.

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Epicardial Application of Hydrogel with Amiodarone for Prevention of Postoperative Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting

Cited by 13 publications

References 20 publications

Post-Operative Atrial Fibrillation: Current Treatments and Etiologies for a Persistent Surgical Complication

Post-Operative Atrial Fibrillation: Current Treatments and Etiologies for a Persistent Surgical Complication

Effectiveness of intra‐operative topical amiodarone for prevention of postcardiac surgery new‐onset atrial fibrillation: A review of current evidence

Local Use of Hydrogel with Amiodarone in Cardiac Surgery: Experiment and Translation to the Clinic

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