Comparison of amiodarone and esmolol for prevention of reperfusion ventricular fibrillation in individuals undergoing heart valve or aortic surgery: a study protocol for a randomized controlled clinical trial.
Trials
BACKGROUND:Amiodarone and esmolol can help to prevent and treat post-cardiac surgery reperfusion ventricular fibrillation. However, the relative efficacies of these two drugs remain unknown. The aim of the current trial is to compare the performances of amiodarone and esmolol for preventing reperfusion ventricular fibrillation following open heart surgery. METHODS/DESIGN:This is a single-center, prospective, double-blind, controlled clinical trial. A total of 260 patients undergoing heart valve or aortic surgery will be assigned randomly to treatment with prophylactic esmolol (intervention group) or amiodarone (control group). The main outcome is the incidence of reperfusion ventricular fibrillation following aortic opening during extracorporeal circulation. The secondary outcomes are the rate of automatic cardiac resuscitation, energy and frequency of electrical defibrillation, number of electrical defibrillations, and pacemaker use in the two groups of patients. Information on the patients' general condition and the durations of anesthesia, extracorporeal circulation, aortic occlusion, and operation time will be recorded. We will also compare the heart rate, mean arterial pressure, and central venous pressure between the two groups of patients at induction of anesthesia (T1), start of surgery (T2), start of extracorporeal circulation (T3), aortic block (T4), aortic opening (T5), after opening for 10 (T6), 20 (T7), and 30 min (T8), at cessation of extracorporeal circulation (T9), and at the end of surgery (T10) and compare blood gas analysis results at T1, T5, T9, and T10. DISCUSSION:This study will determine if prophylactic esmolol is more effective than amiodarone for reducing the incidence of reperfusion ventricular fibrillation in patients undergoing heart valve or aortic surgery. TRIAL REGISTRATION:China Clinical Trials Registry ChiCTR1900026429. Registered on 2019.10.9.
10.1186/s13063-023-07816-w
Esmolol: a review of its use in the short-term treatment of tachyarrhythmias and the short-term control of tachycardia and hypertension.
Drugs
Supraventricular tachyarrhythmia (including atrial fibrillation), hypertension and tachycardia in the perioperative setting, and acute ischaemic heart disease are generally agreed to require rapid attention and treatment. Prolonged tachyarrhythmia or hypertension can result in significant morbidity, such as cerebrovascular events, myocardial infarction and other end-organ damage. This article reviews the clinical efficacy and tolerability of intravenous infusions of esmolol for the short-term treatment of tachyarrhythmias and the short-term control of tachycardia and hypertension, and provides an overview of the pharmacological properties of the drug. Esmolol, a cardioselective β-blocker, has been proven effective in the control of elevated haemodynamic parameters in patients with supraventricular tachyarrhythmia, hypertension and tachycardia in the perioperative setting, and acute ischaemic heart disease, as well as being associated with a reduced risk of some clinical sequelae to increased haemodynamic parameters. Esmolol is, moreover, generally well tolerated; while it is associated with an increased risk of hypotension, this is rapidly reversible. Definitive conclusions on the efficacy of esmolol are difficult to reach, as most trials investigating esmolol have limitations such as small patient populations, and few studies investigate the same parameters. Ideally, several further studies would be beneficial; however, as esmolol is a well established, older drug, these are less likely to occur. Despite this, esmolol, as a fast-acting, rapidly reversible, easily titratable β-blocker, is an established option for the short-term treatment of tachyarrhythmias and the short-term control of tachycardia and hypertension.
10.2165/11208210-000000000-00000
Esmolol reduces perioperative ischemia in cardiac surgery: a meta-analysis of randomized controlled studies.
Zangrillo Alberto,Turi Stefano,Crescenzi Giuseppe,Oriani Alessandro,Distaso Francesco,Monaco Fabrizio,Bignami Elena,Landoni Giovanni
Journal of cardiothoracic and vascular anesthesia
OBJECTIVE:beta-Blockers were associated with a reduction of mortality and morbidity in noncardiac surgery until recently when the POISE trial showed that beta-blockers could be harmful in the perioperative period because of hypotension and bradycardia. Esmolol is an ultra-short-acting beta-blocker mostly used in emergency and high-risk patients. The authors performed a meta-analysis to evaluate the clinical effects of esmolol in cardiac surgery. DESIGN:Meta-analysis. SETTING:Hospitals. PARTICIPANTS:A total of 778 patients from 20 randomized trials. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULT:Three investigators independently searched BioMedCentral and PubMed. Inclusion criteria were random allocation to treatment and comparison of esmolol versus other drugs, placebo, or standard of care in cardiac surgery. Exclusion criteria were duplicate publications, nonhuman experimental studies, and no data on clinical outcomes. The use of esmolol was associated with a significant reduction of myocardial ischemia episodes (15/122 [12.2%] in the esmolol group v 36/140 [25.7%] in the control arm, odds ratio [OR] =0.42 [0.23-0.79], p = 0.007) and development of arrhythmias after cardiopulmonary bypass (15/65 [23.07%] v 23/64 [35.9%], OR = 0.42 [0.18-1.01], p = 0.05). The authors did not find a reduction in the use of inotropic drugs in esmolol-treated patients (29/153 [18.9%] v 48/146 [32.8%], OR = 0.43 [0.16-1.10], p = 0.08). Esmolol-treated patients had more episodes of bradycardia (19/129 [14.72%] v 3/133 [2.25%], OR = 5.49 [2.21-13.62], p = 0.0002) and hypotension (28/113 [24.77%] v 14/119 [11.76%], OR = 2.73 [0.83-9.04], p = 0.10). CONCLUSIONS:Esmolol reduces the incidence of myocardial ischemia and arrhythmias in cardiac surgery. An increase in bradycardia was noted as well.
10.1053/j.jvca.2009.01.003
The safety of perioperative esmolol: a systematic review and meta-analysis of randomized controlled trials.
Yu Savio K H,Tait Gordon,Karkouti Keyvan,Wijeysundera Duminda,McCluskey Stuart,Beattie W Scott
Anesthesia and analgesia
BACKGROUND:Although β blockers have been found to decrease perioperative myocardial infarction (MI), β-blocker-mediated hypotension is associated with postoperative stroke and mortality. In this systematic review we assessed the safety and efficacy of the β1-specific, adrenergic receptor antagonist esmolol in noncardiac surgery. Safety was assessed by analyzing the incidence of postoperative hypotension and bradycardia, and efficacy was assessed by analyzing the incidence of myocardial ischemia. METHODS:We searched electronic databases for randomized placebo-controlled trials of the perioperative use of esmolol in noncardiac surgery. We abstracted data on design, demographics, hemodynamic changes (planned or unplanned), myocardial ischemia, and MI. Heterogeneity was assessed via meta-regression. RESULTS:Our search identified 67 trials, which were well matched for study characteristics. The quality of the studies was limited by small sample size and poorly defined allocation concealment. Overall, the analysis demonstrates an increased incidence of unplanned hypotension (OR 2.13; 95% confidence interval [CI], 1.48 to 3.04), which was found to be dose related (R(2) = 0.408). An increased incidence of significant bradycardia was not demonstrated (OR 1.18; 95% CI, 0.69 to 2.02). Dose titration was shown to influence both the change in arterial blood pressure and heart rate. In comparison with placebo, esmolol decreased the frequency of myocardial ischemia in the 7 evaluating studies (OR 0.17; 95% CI, 0.02 to 0.45). We did not assess the effects of esmolol on the incidence of MI or stroke because the incidence of these events was too infrequent in the retrieved studies. CONCLUSION:This review suggests that titration of esmolol to a hemodynamic end point can be safe and effective. Safety data from studies in higher-risk patients are needed to establish a perioperative safety and efficacy profile of esmolol.
10.1213/ANE.0b013e3182025af7
New-onset atrial fibrillation: an update.
Omae Takeshi,Inada Eiichi
Journal of anesthesia
New-onset atrial fibrillation (NOAF) is the most common perioperative complication of heart surgery, typically occurring in the perioperative period. NOAF commonly occurs in patients who are elderly, or have left atrial enlargement, or left ventricular hypertrophy. Various factors have been identified as being involved in the development of NOAF, and numerous approaches have been proposed for its prevention and treatment. Risk factors include diabetes, obesity, and metabolic syndrome. For prevention of NOAF, β-blockers and amiodarone are particularly effective and are recommended by guidelines. NOAF can be treated by rhythm/rate control, and antithrombotic therapy. Treatment is required in patients with decreased cardiac function, a heart rate exceeding 130 beats/min, or persistent NOAF lasting for ≥ 48 h. It is anticipated that anticoagulant therapies, as well as hemodynamic management, will also play a major role in the management of NOAF. When using warfarin as an anticoagulant, its dose should be adjusted based on PT-INR. PT-INR should be controlled between 2.0 and 3.0 in patients aged < 70 years and between 1.6 and 2.6 in those aged ≥ 70 years. Rate control combined with antithrombotic therapies for NOAF is expected to contribute to further advances in treatment and improvement of survival.
10.1007/s00540-018-2478-8
Perioperative Amiodarone to Prevent Atrial fibrillation after Septal Myectomy in obstrUctive hypeRtroPHic cardiomyopathy.
Shalen Evan F,Heitner Stephen B,Al-Rashdan Lana,Akhavein Reyhaneh,Elman Miriam R,Fischer Katherine L,Lin Lucy Q,Mannello Meghan,Nazer Babak,Song Howard K,Masri Ahmad
ESC heart failure
AIMS:Amiodarone reduces the incidence of atrial fibrillation (AF) following coronary artery bypass surgery; however, the benefit of perioperative amiodarone in patients undergoing septal myectomy (SM) for obstructive hypertrophic cardiomyopathy (oHCM) has not been studied. We hypothesized that prophylactic amiodarone would reduce the incidence of postoperative AF (POAF) following SM for oHCM. METHODS AND RESULTS:A single-centre, pre-post intervention open-label study of oral amiodarone (200 mg twice daily starting 7 days preoperatively and 200 mg once daily continuing for 30 days postoperatively) in patients without prior AF undergoing SM for oHCM from 2014 to 2018. The primary outcome was incident AF within 30 days. Secondary outcomes were unplanned readmission, AF treatment, total and intensive care unit (ICU) length of stay (LOS), and pacemaker implantation for high-grade atrioventricular (AV) block. 61 patients met inclusion criteria with 34 (55.8%) in the pre-intervention (control) group and 27 (44.2%) in the post-intervention (amiodarone) group. The incidence of POAF was 11.0% in the amiodarone group compared with 38.2% in the control group (P = 0.017). After adjusting for age, amiodarone was associated with less POAF [adjusted odds ratio (aOR) 0.21; 95% confidence interval (CI) 0.05, 0.76; P = 0.016]. ICU (2 days [IQR 1, 4] vs. 3 days [IQR 2, 4]; P = 0.165) and total (6 days [IQR 5, 6] vs. 6 days [IQR 5, 7]; P = 0.165) LOS were similar, as was the rate of pacemaker implantation (7.4% vs. 8.3%, P > 0.999). There were no adverse events associated with amiodarone. CONCLUSIONS:Perioperative oral amiodarone is safe and was associated with lower incidence of POAF following SM for oHCM.
10.1002/ehf2.13662
Use and Outcomes Associated With Perioperative Amiodarone in Cardiac Surgery.
Atreya Auras R,Priya Aruna,Pack Quinn R,Pekow Penelope S,Stefan Mihaela,Lagu Tara,Lotfi Amir S,Lindenauer Peter K
Journal of the American Heart Association
Background In randomized controlled trials, perioperative administration of amiodarone has been shown to reduce the incidence of postoperative atrial arrhythmias and length of stay (LOS) among patients undergoing coronary bypass surgery. However, little is known about the use or effectiveness of perioperative amiodarone in routine clinical practice. Methods and Results We studied patients ≥18 years old without a previous history of atrial or ventricular arrhythmias who underwent elective coronary bypass surgery between 2013 and 2014 within a network of 235 US hospitals. Perioperative amiodarone was defined as receipt of amiodarone either on the day of or the day preceding surgery. We used covariate-adjusted modeling and instrumental variable methods to examine the association between receipt of amiodarone and the development of atrial arrhythmias, in-hospital mortality, readmission, LOS, and cost. Of 12 758 patients, 2195 (17.2%) received perioperative amiodarone, 3330 (26.1%) developed atrial arrhythmias postoperatively, and the average LOS was 6.4 days (±2.6 days). Instrumental variable analysis showed that receipt of perioperative amiodarone was associated with lower risk of atrial arrhythmias (risk difference -11 percentage points, 95% CI -19 to -4 percentage points; P=0.002) and a shorter LOS (-0.7 day, 95% CI -1.39 to -0.01 days; P=0.048). There was no association between receipt of perioperative amiodarone and in-hospital mortality, cost, or readmission. Conclusions Among patients undergoing coronary bypass surgery without previous arrhythmias, perioperative amiodarone is associated with a lower risk of atrial arrhythmias and shorter LOS. These findings are consistent with previous randomized trials and lend support to current guideline recommendations.
10.1161/JAHA.118.009892