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Ann Thorac Surg 2000;70:157-161
© 2000 The Society of Thoracic Surgeons

Original articles: Cardiovascular

Intravenous amiodarone for prevention of atrial fibrillation after coronary artery bypass grafting

Shih-Huang Lee, MDa, Che-Ming Chang, MDa, Ming-Jen Lu, MDb, Ren-Jen Leea, Jun-Jack Cheng, MDa, Chi-Ren Hung, MDb, Shih-Ann Chen, MDa,b

a Divisions of Cardiology and Cardiovascular Surgery, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan
b National Yang-Ming University, Taipei, Taiwan

Address reprint requests to Dr Shih-Huang Lee, Division of Cardiology, Shin Kong Wu Ho-Su Memorial Hospital, 95 Wen Chang Rd, Shih Lin, Taipei, Taiwan
e-mail: ufae0061{at}ms7.hinet.net


   Abstract
Top
 Abstract
Introduction
 Material and methods
 Results
 Comment
 References
 
Background. Atrial fibrillation occurs in 10% to 40% of patients who undergo coronary artery bypass grafting. This prospective study assesses the safety and efficacy of low-dose intravenous amiodarone in the prevention of atrial fibrillation after coronary artery bypass grafting.

Methods. One hundred forty patients were randomly divided into two groups: an amiodarone group (n = 74) receiving intravenous amiadarone in a loading dose of 150 mg and maintenance dose of 0.4 mg · kg-1 · h-1 for 3 days before and 5 days after operation and a control group (n = 76) receiving matching infusions of 5% glucose solution.

Results. Atrial fibrillation occurred in 9 (12%) of the amiodarone group patients and in 26 (34%) of the control group patients during hospitalization (p < 0.01). The maximum ventricular rate during atrial fibrillation was significantly slower in the amiodarone group (107 ± 21) than in the control group (138 ±24 beats per minute, p < 0.01). The duration of atrial fibrillation in the amiodarone group (1.1 ± 1.2 hours) was significantly shorter than that in the control group (3.2 ± 1.3 hours, p = 0.01). The two groups had no significant differences in incidence of major morbidity (8 of 74 versus 8 of 76 in amiodarone and control groups, respectively) or mortality (4 of 74 versus 5 of 76). However, the control group had significantly longer intensive care unit stays (132 ± 24 versus 111 ± 19 hours, p < 0.01).

Conclusions. Perioperative low-dose intravenous amiodarone significantly reduces the incidence, ventricular rate, and duration of atrial fibrillation after coronary artery bypass grafting. Furthermore, low-dose intravenous amiodarone is well tolerated and does not increase the risk of intraoperative or postoperative complications.


   Introduction
Top
 Abstract
 Introduction
Material and methods
 Results
 Comment
 References
 
Atrial fibrillation (AF) occurs in 10% to 40% of patients who undergo coronary artery bypass grafting (CABG) [1–5]. Although this arrhythmia is usually benign, it may occasionally result in severe symptoms [1, 2, 4–7]. A variety of pharmacologic agents, including propranolol, timolol, digoxin, and verapamil, has been used to prevent the occurrence of AF after CABG; none of those agents, however, has been uniformly accepted as a routine treatment [8–11]. This prospective study assesses the safety and efficacy of low-dose intravenous amiodarone in the prevention of AF after CABG.


   Material and methods
Top
 Abstract
 Introduction
 Material and methods
Results
 Comment
 References
 
Study patients
This study included 150 patients who underwent elective CABG at Shin Kong Wu Ho-Su Memorial Hospital. Exclusion criteria were age less than 20 years, history of previous AF; concomitant operations such as valve replacement and aneurysmectomy; preoperative use of antiarrhythmic therapy other than digitalis, calcium-channel blockers and ß-blockers; history of amiodarone side effects; use of amiodarone within 6 months of enrollment; concomitant thyroid disease; abnormal liver function test results; pregnancy; preexisting bradycardia (defined as heart rate less than 55 beats per minute at rest); and uncontrolled severe heart failure. History, physical examination, laboratory data, chest roentgenogram, and two-dimensional, Doppler, and color echocardiograms were obtained for all patients.

Study protocol
Patients were randomized to receive amiodarone or placebo starting 3 days before CABG. The amiodarone group received intravenous amiodarone in a loading dose of 150 mg followed by a maintenance dose of 0.4 mg · kg-1 · h-1 for 3 days before and 5 days after operation. The control group received matching 5% glucose infusions. Medical records were reviewed to complete clinical data forms. Physicians prospectively collected clinical data on cardiac history and presence of standard comorbid conditions.

Operative techniques
As we have described in a previous study [12], after initiation of cardiopulmonary bypass, cardiac arrest was induced using a cold cardioplegia solution containing 30 mEq of potassium/L. The delivery of cardioplegia was by either antegrade or combination of antegrade and retrograde perfusion. Systemic hypothermia was maintained at 28°C, and saline ice flush was poured into the pericardial cavity for topical hypothermia. Conduits for bypass included sapheneous veins or internal mammary artery or a combination of the two. After successful graft anastomosis, body temperature was raised gradually to 36°C and patients were then weaned off of cardiopulmonary bypass.

Data collection
Intraoperative and postoperative data, including complications and adverse events, were assessed through a medical record review. The major outcome measured for this study was the occurrence of postoperative AF. After the operation, patients were continuously monitored in the intensive care unit by individual bedside electronic monitors (HP 78560A, Hewlett Packard, Waltham, MA). After patients were transferred to ordinary wards, they were monitored by telemetry (WEP-8430, Nihon Kohden, Tokyo, Japan). A centralized arrhythmia monitoring and detection center staffed by specially trained nurses was employed for continuous electrocardiographic monitoring. All persistent arrhythmias were confirmed with 12-lead electrocardiograms. The occurrence of AF was confirmed by an experienced cardiologist. Atrial fibrillation was defined as atrial activity that was either not discernible or completely unorganized, accompanied by an irregularly irregular ventricular rate. In this study we included episodes of AF lasting longer than 10 minutes. Management of AF was directed by the cardiac surgery team.

Statistical analysis
All continuous variables are expressed as mean ± SD. The {chi}2 test with Yates’ correction or Fischer’s exact test was used to assess nonparametric data, and a t test or Wilcoxon signed rank test was used to assess differences between the two groups incontinuous variables. A p value of less than 0.05 was considered statistically significant.


   Results
Top
 Abstract
 Introduction
 Material and methods
 Results
Comment
 References
 
Baseline patient characteristics
Mean patient ages were 66 ± 7 years in the amiodarone group and 65 ± 8 years in the control group. New York Heart Association functional classes and incidences of smoking, diabetes mellitus, chronic lung disease, hypertension, prior myocardial infarction, congestive heart failure, stroke and prior percutaneous transluminal coronary angioplasty were similar in the two groups. There was no significant difference between the two groups in preoperative usage of digitalis, calcium-channel blockers, ß-blockers, aspirin, nitrate, or diuretics. Furthermore, the groups did not differ significantly in left atrial dimension, left ventricular end-diastolic dimension, left ventricular ejection fraction, or extent of coronary artery disease. These data are summarized in Table 1.


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  		Table 1. Baseline Characteristics of Study Patients

 
Operative variables
Use of internal mammary artery, number of grafts per case, cross-clamp time, cardiopulmonary bypass time, and need of operative intraaortic balloon pumping were similar in the two groups (Table 2).


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  		Table 2. Operative Variables

 
Postoperative complications
The two groups had no significant difference in the incidence of gastrointestinal bleeding, cerebrovascular accident, persistent renal function exacerbation, wound problems, or ventricular tachycardia. The causes of death in the amiodarone group were ventricular arrhythmia in 2 patients and sepsis in 2 others. In the control group, the causes of death were ventricular arrhythmia in 2 patients, sepsis in 1 patient, and cerebrovascular accident in 2 patients. In the amiodarone group, amiodarone administration was stopped in 2 patients at the third day after CABG because of sinus bradycardia; AF did not occur in either of them. No patients had other significant side effects or adverse reactions; no significant change in serum concentration of aspartate aminotransferase or alanine aminotransferase was noted within the 2 weeks following CABG. The control group had significantly longer intensive care unit stays (132 ± 24) than did the amiodarone group (111 ± 19 hours, p < 0.01). In the control group, the mean intensive care unit stay was 158 ± 21 hours for patients with AF and 118 ± 26 hours for those without AF, respectively (p < 0.01). In the amiodarone group, patients with AF also had significantly longer intensive care unit stays: 147 ± 20 versus 106 ± 17 hours, p < 0.01. The mean hospital stay was 17 ± 6 days in the amiodarone group and 19 ± 7 days in the control group (p = NS). These data are summarized in Table 3. The mean cost per patient was $15,875 ± $7,234 United States dollars in the amiodarone group and $16,942 ± $9,438 United States dollars in the control group (p = NS).


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  		Table 3. Postoperative Complications

 
Postoperative atrial fibrillation
Atrial fibrillation occurred in 9 patients (12%) in the amiodarone group and 26 patients (34%) in the control group during hospitalization (p < 0.01). Atrial fibrillation occurred at a mean of 3.6 ± 1.5 days after CABG in the amiodarone group and 3.3 ± 1.3 days after surgery in the control group (p = NS) (Fig 1). The maximum ventricular rate during AF was significantly slower in the amiodarone group than in the control group (107 ± 21 versus 138 ± 24 beats per minute, p < 0.01). Symptoms attributable to AF were reported by 5 of the 9 patients (56%) in the amiodarone group and 21 of the 26 patients (81%) in the control group (p = NS). In the amiodarone group, AF converted to sinus rhythm spontaneously in 2 patients, and the other 7 patients were managed by an antiarrhythmic medication in 2 patients and digitalis in 5 patients. In the control group, AF converted to sinus rhythm spontaneously in 4 patients and the other 22 patients were managed by antiarrhythmic medication in 12 patients, digitalis in 6, calcium-channel blockers in 2, and ß-blockers in 2. The duration of AF in the amiodarone group (1.1 ± 1.2 hours) was significantly shorter than that in the control group (3.2 ± 1.3 hours, p = 0.01) (Table 4). Electrical cardioversion was not performed on any patient in either of the two groups. None of the patients in either group had symptomatic AF within 2 weeks of discharge.



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  		Fig 1. Time of occurrence of postoperation atrial fibrillation (AF = atrial fibrillation).

 

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  		Table 4. Duration of Atrial Fibrillation

 

   Comment
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
References
 
Major findings
We believe that this study demonstrates that perioperative low-dose intravenous amiodarone significantly reduces not only the incidence of postoperative AF but also the ventricular rate and duration of AF among patients who experience postoperative AF. Furthermore, we show that low-dose intravenous amiodarone therapy is well tolerated and does not increase the risk of intraoperative or postoperative complications in the patients receiving CABG.

Comparison with previous studies
Previous studies of the efficacy and safety of amiodarone in preventing AF after CABG are limited, and their results are controversial. Redle and colleagues randomized 127 patients to receive oral amiodarone (2 g/d in divided doses given for 1 to 3 days before and 400 mg/d given for 7 days after CABG) or placebo; they found that prophylactic oral amiodarone did not significantly reduce the incidence of AF after CABG [13]. Hohnloser and colleagues performed a placebo-controlled study of intravenous amiodarone as prophylaxis against AF after CABG in 77 patients; the amiodarone infusion, given after surgery in a loading bolus of 300 mg for 2 hours followed by 1200 mg every 24 hours for 2 days and 900 mg every 24 hours for the next 2 days, significantly reduced the incidence of postoperative AF [14]. Electrocardiographic monitoring was, however, performed only during the first 48 hours after surgery, and amiodarone was discontinued in 18% of patients because of sinus bradycardia and excessive QT prolongation. Daoud and colleagues recently reported a double-blind study of oral amiodarone as prophylaxis against AF after CABG or valvular heart surgery or both in 124 patients; the results showed that the use of prophylactic oral amiodarone at least 1 week before elective heart surgery reduced the incidence of postoperative AF [15]. However, Daoud’s study included a heterogeneous group of patients who had undergone CABG, valvular heart surgery, both CABG and valvular heart surgery, or other procedures. The authors concluded that amiodarone benefited both patients undergoing CABG and those undergoing valvular surgery without providing data for each group. In the present study, the homogenous patient population highlights the efficacy and safety of low-dose intravenous amiodarone for patients undergoing CABG.

Complications of low-dose intravenous amiodarone prophylaxis
The noncardiac toxic effects of amiodarone include dose-related and nondose-related effects [16–17]. In Hohnloser and colleagues’ study, intravenous amiodarone infusion was discontinued in 18% of patients because of side effects [14]. However, the oral amiodarone regimen used in Daoud’s study did not produce important side effects [15]. In the present study no acute pulmonary toxic effects occurred after CABG among patients randomly assigned to low-dose intravenous amiodarone. In addition amiodarone had little or no adverse effect on the post-CABG status of patients with chronic lung disease or diabetes mellitus. Previous studies have demonstrated that low-dose amiodarone does not cause significant depressant effect on hemodynamic function or proarrhythmias in patients with structural heart disease [18–20]. The present study confirmed the safety of low-dose intravenous amiodarone in patients receiving CABG.

Clinical implications
Unlike high-dose intravenous amiodarone, low-dose amiodarone was not associated with increased risk of adverse events after CABG. A primary advantage of intravenous amiodarone prophylaxis is the shorter preoperative treatment period compared with that needed for oral amiodarone prophylaxis. Several investigators have reported that 7 to 20 days of therapy are necessary for arrhythmia control by oral amiodarone [17, 21]. The effectiveness and safety of an accelerated loading regimen of intravenous amiodarone given 1 to 2 days before CABG to prevent postoperative AF remains to be determined, however.

Study limitations
Although some clinical trials demonstrate that prophylactic ß-blockers have benefits against postoperative AF [1, 8, 9], other studies have conflicting conclusions [15, 22, 23]. Redle and colleagues demonstrated that prophylactic oral amiodarone combined with ß-blockade worked effectively to prevent AF after CABG [24]. In the present study, few patients received ß-blockers; the reduction in the incidence of postoperative AF can thus be attributed to the effect of amiodarone. A limitation in applying our study results is that in some countries it may be not feasible for patients to receive intravenous amiodarone 3 days before and 5 days after CABG because of the length of hospital stay and the cost of amiodarone. Further study is needed to determine which oral amiodarone regimens will prevent AF after CABG as effectively as the intravenous regimens used in the present study.

Perioperative low-dose intravenous amiodarone significantly reduces the incidence, ventricular rate, and duration of postoperative AF after CABG. Furthermore, low-dose intravenous amiodarone is well tolerated and does not increase the risk of intraoperative or postoperative complications.


   Acknowledgments
 
Supported in part by grants from the National Science Council (NSC 88-2314-B010-094 and 88-2314-B-341-002) and Shin Kong Wu Ho-Su Memorial Hospital (SKH-8302-86-0126-01).


   References
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 

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Accepted for publication December 21, 1999.




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J. M. Bailey, K. A. Tanaka, and J. H. Levy
Cardiac Surgical Pharmacology
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L. Yazicioglu, S. Eryilmaz, M. Sirlak, M. B. Inan, A. Aral, R. Tasoz, and H. Akalin
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E. Crystal, S. J. Connolly, K. Sleik, T. J. Ginger, and S. Yusuf
Interventions on Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Heart Surgery: A Meta-Analysis
Circulation, July 2, 2002; 106(1): 75 - 80.
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C. K. Haan and S. A. Geraci
Role of amiodarone in reducing atrial fibrillation after cardiac surgery in adults
Ann. Thorac. Surg., May 1, 2002; 73(5): 1665 - 1669.
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Amiodarone versus digoxin and metoprolol combination for the prevention of postcoronary bypass atrial fibrillation
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