Preoperative Amiodarone as Prophylaxis against Atrial Fibrillation after Heart Surgery
Emile G. Daoud, M.D., S. Adam Strickberger, M.D., K. Ching Man, D.O., Rajiva Goyal, M.D., G. Michael Deeb, M.D., Steven F. Bolling, M.D., Francis D. Pagani, M.D., Cynthia Bitar, R.N., Marc D. Meissner, M.D., and Fred Morady, M.D.
Background Atrial fibrillation occurs commonly after open-heartsurgery and may delay hospital discharge. The purpose of thisstudy was to assess the use of preoperative amiodarone as prophylaxisagainst atrial fibrillation after cardiac surgery.
Methods In this double-blind, randomized study, 124 patientswere given either oral amiodarone (64 patients) or placebo (60patients) for a minimum of seven days before elective cardiacsurgery. Therapy consisted of 600 mg of amiodarone per day forseven days, then 200 mg per day until the day of discharge fromthe hospital. The mean (±SD) preoperative total doseof amiodarone was 4.8±0.96 g over a period of 13 ±7 days.
Results Postoperative atrial fibrillation occurred in 16 ofthe 64 patients in the amiodarone group (25 percent) and 32of the 60 patients in the placebo group (53 percent) (P = 0.003).Patients in the amiodarone group were hospitalized for significantlyfewer days than were patients in the placebo group (6.5 ±2.6 vs. 7.9 ± 4.3 days, P = 0.04). Nonfatal postoperativecomplications occurred in eight amiodarone-treated patients(12 percent) and in six patients receiving placebo (10 percent,P = 0.78). Fatal postoperative complications occurred in threepatients who received amiodarone (5 percent) and in two whoreceived placebo (3 percent, P = 1.00). Total hospitalizationcosts were significantly less for the amiodarone group thanfor the placebo group ($18,375±$13,863 vs. $26,491±$23,837,P = 0.03).
Conclusions Preoperative oral amiodarone in patients undergoingcomplex cardiac surgery is well tolerated and significantlyreduces the incidence of postoperative atrial fibrillation andthe duration and cost of hospitalization.
Postoperative atrial fibrillation occurs in 10 to 40 percentof patients undergoing cardiac surgery.1,2,3,4,5,6,7,8,9,10,11,12Although prophylactic therapy with beta-adrenergic blockersreduces the incidence of postoperative atrial fibrillation,8,11,13,14,15,16,17this arrhythmia remains an important cause of increased hospitalstays and expenses after heart surgery.18 Amiodarone is a classIII antiarrhythmic drug that is effective for atrial fibrillation19,20,21,22,23,24,25and that can be begun safely on an outpatient basis in patientswith structural heart disease.26,27 The purpose of this studywas to assess the use of oral amiodarone as prophylaxis againstatrial fibrillation after heart surgery.
Methods
Patient Population
From June 1, 1995, to September 30, 1996, 373 patients for whomcardiac surgery was scheduled at least one week in advance werescreened in the cardiac-surgery clinics of the University ofMichigan Hospital and Harper Hospital for participation in thisstudy. To be included, patients had to give informed consent,be more than 18 years old, be scheduled for elective heart surgeryrequiring cardiopulmonary bypass, have at least one week beforesurgery was scheduled, and have normal sinus rhythm. Patientswere excluded if they were allergic to amiodarone; had usedamiodarone within four months of enrollment; had a history ofamiodarone toxicity; had participated in another investigationalprotocol; required the use of antiarrhythmic therapy other thanbeta-receptor antagonists, calcium-channel antagonists, or digitalis;had untreated thyroid disease; had serum aspartate aminotransferaseor alanine aminotransferase concentrations four times the upperlimit of normal; were pregnant; had a resting heart rate ofless than 50 beats per minute in the absence of medical therapyknown to slow the sinus rate; or had uncontrolled heart failure.One hundred forty-five patients (39 percent) were excluded becausethey had participated in another investigational protocol (77patients), had chronic atrial fibrillation (33), used antiarrhythmicmedication (13), had resting heart rates of less than 50 beatsper minute (11), were less than 18 years old (5), had untreatedthyroid disease (2), had uncontrolled heart failure (2), orhad an elevated aspartate aminotransferase concentration (2).Among the remaining 228 eligible patients, 131 (57 percent)consented. Surgery was canceled for seven patients after randomization,however, and these patients were not included in the study.Therefore, 124 patients (118 at the University of Michigan Hospitaland 6 at Harper Hospital) were randomly assigned in a double-blindfashion to either oral amiodarone (64 patients) or placebo (60patients). The characteristics of the patients are summarizedin Table 1. There were no significant differences between thepatients who received amiodarone and those who received placebo.
The study protocol was approved by the University of Michiganand Harper Hospital human-research committees. The patientswere interviewed on the day of their initial evaluations inthe cardiac-surgery outpatient clinic. The patients who consentedwere randomly assigned in a double-blind fashion to begin oraltherapy on the same day. Patients were enrolled a mean (±SD)of 13±7 days before surgery. Amiodarone (Cordarone, Wyeth–AyerstLaboratories, Philadelphia) was prescribed at a dosage of onetablet (200 mg) three times a day for seven days, then one tableteach day while the patient was hospitalized. Amiodarone wasdiscontinued on the day of hospital discharge. The placebo tabletswere identical in appearance to the amiodarone tablets. Forthe patients being treated with digitalis or warfarin, the dosesof these drugs were halved, and the prothrombin time was measuredone week later. Other medical therapy was unchanged. Outpatientcompliance was monitored by pill count and was 96 percent. Toscreen for outpatient complications, a telephone interview wasconducted with each patient one week after enrollment.
The patients were hospitalized on the day of surgery. All patientswere placed on cardiopulmonary bypass. Coronary-artery bypassgraft surgery was performed in 52 patients (42 percent), valvularsurgery in 41 (33 percent), both coronary-artery bypass andvalvular surgery in 22 (18 percent), and other surgical proceduresin 9 (7 percent). Myocardial protection was provided by coldcardioplegia in 116 patients and retrograde perfusion in 8 patients.
After surgery, each patient was admitted to an intensive careunit and was subsequently transferred to a monitored unit. Aninvestigator evaluated the patients daily. Three-lead telemetricmonitoring (Marquette Series 7500, Milwaukee) was performedcontinuously for a mean of 7.2±3.6 days after surgery.The electrocardiographic data were stored for 24 hours and reviewedon a daily basis. An episode of atrial fibrillation was countedif it persisted for more than five minutes. Management of atrialfibrillation was directed by the cardiac-surgery team.
The study agent was discontinued on the day of hospital discharge.A home-nurse evaluation was performed 7±2 days afterthe patients were discharged and included measurements of vitalsigns in all the patients and single-lead electrocardiographyin 84 patients (68 percent). At the routine postdischarge evaluationin the cardiac-surgery clinic, a 12-lead electrocardiogram wasrecorded, and patients were queried about intercurrent hospitalizationsor emergency-room evaluations. These medical records were reviewedby an investigator.
Cost Data
Data on hospitalization costs for the study population wereprovided through the use of a commercially available decision-supportinformation software system (Model 204, Transition Systems,Boston), operated by the University of Michigan Budget Office.These data represent the sum of variable direct costs, fixeddirect costs, and indirect costs. Professional-service feeswere not included in these costs. Cost data were collected for114 patients (58 given placebo and 56 given amiodarone) whounderwent surgery at the University of Michigan and were hospitalizedno more than 21 days from the day of surgery. The cost of amiodaronetherapy was estimated at $2.61 per tablet.28
Statistical Analysis
Data were analyzed on the basis of the intention-to-treat principle.Continuous variables were expressed as means ±SD. Continuousvariables were compared by means of Student's t-test, and categoricalvariables were compared by Fisher's exact test. Kaplan–Meieranalysis with the log-rank test was used to compare the probabilityof atrial fibrillation in the amiodarone and placebo groups.After an episode of atrial fibrillation or after the postdischargeclinic evaluation, the patient was withdrawn from further analysis.A P value of less than 0.05 was considered to indicate statisticalsignificance.
Results
Outpatient Therapy and Surgical Data
The mean number of preoperative days of therapy was significantlygreater for the patients randomly assigned to receive placebo(15.0±8.7) than for those randomly assigned to receiveamiodarone (12.0±5.0, P = 0.02). The mean total outpatientamiodarone dose was 4.8±0.96 g (median, 5.0; range, 0.6to 7.0). Except for two patients who elected to stop outpatienttherapy because of minor gastrointestinal side effects (onereceiving placebo and one receiving amiodarone, P = 1.00), nopatients had side effects or adverse reactions during outpatienttherapy. There was no significant change in the serum concentrationof aspartate aminotransferase or alanine aminotransferase onthe day of surgery as compared with the day of enrollment ineither group (Table 2).
Table 2. Surgical and Postoperative Clinical Data.
Other than fewer defibrillations per patient to restore sinusrhythm after release of the aortic cross-clamp in the amiodaronegroup, there were no significant differences in surgical databetween the amiodarone and placebo groups (Table 2).
Postoperative Atrial Fibrillation
The percentages of patients remaining free of atrial fibrillationin the amiodarone and placebo groups are shown in Figure 1.When episodes of atrial fibrillation that occurred during andafter hospitalization are considered, the incidence of atrialfibrillation was 25 percent (16 of 64 patients) in the amiodaronegroup and 53 percent (32 of 60 patients) in the placebo group(P = 0.003).
Figure 1. Kaplan–Meier Analysis of the Percentages of Patients Remaining Free of Atrial Fibrillation after Surgery in the Amiodarone and Placebo Groups.
The asterisks indicate the mean days of hospital discharge.
The prevalence of atrial fibrillation occurring during hospitalizationin the amiodarone group was 23 percent (15 of 64 patients),as compared with 42 percent (25 of 60 patients) in the placebogroup (P = 0.03). Atrial fibrillation occurred a mean of 2.5±1.7days after surgery in the patients assigned to amiodarone and2.7±1.6 days after surgery in the patients assigned toplacebo (P = 0.79). The maximal ventricular rate during atrialfibrillation was significantly lower in the amiodarone groupthan in the placebo group (112±21 vs. 135±31 beatsper minute, P = 0.03); however, there was no significant differencebetween the groups in the duration of atrial fibrillation (13.8±13.4vs. 9.3±10.3 hours, P = 0.27 by Student's t-test) (Table 3).
Symptoms attributable to atrial fibrillation were reported by13 of 15 patients (87 percent) in the amiodarone group and 21of 25 patients (84 percent) in the placebo group (P = 1.00).Atrial fibrillation was initially managed by an antiarrhythmicmedication in 10 patients (67 percent) assigned to amiodaroneand in 14 patients (56 percent) assigned to placebo (P = 0.74).Spontaneous conversion without antiarrhythmic medication occurredin five patients receiving amiodarone (33 percent) and in ninereceiving placebo (36 percent, P = 1.00). Electrical cardioversionwas performed on no patients in the amiodarone group and twoin the placebo group (13 percent, P = 0.52).
Patients were evaluated 7±2 days after hospital dischargeby a home nurse and at 24±9 days in the cardiac-surgeryoutpatient clinic. Sinus rhythm was present in each patientat the home-nurse visit and the outpatient-clinic visit. Afterdischarge from the hospital, 7 patients who had received amiodarone(14 percent) and 11 who had received placebo (31 percent) wereevaluated for acute symptoms by their physicians (P = 0.10).Atrial fibrillation was diagnosed in one patient who had receivedamiodarone (2 percent) and seven patients who had received placebo(12 percent, P = 0.03) a mean of 12±5 days after discharge.The medical therapy at the time of these episodes of atrialfibrillation is summarized in Table 4.
Table 4. Medical Therapy When Episodes of Atrial Fibrillation Occurred after Hospital Discharge.
The use of beta-blockers did not influence the prevalence ofatrial fibrillation in either study group. In the placebo group,the incidence of atrial fibrillation was 61 percent (11 of 18patients) among the patients receiving beta-blockers and 33percent (14 of 42 patients) among those not receiving beta-blockers(P = 0.09). The incidence of atrial fibrillation among the amiodarone-treatedpatients receiving beta-blockers (27 percent [7 of 26]) wasnot significantly different from that among the amiodarone-treatedpatients not receiving beta-blockers (21 percent [8 of 38],P = 0.76).
The incidence of atrial fibrillation was significantly higheramong patients who had valvular surgery (46 percent [33 of 71])than among patients who underwent only coronary-artery bypasssurgery (29 percent [15 of 52], P = 0.04).
Length of Hospital Stay and Total Costs
The patients in the amiodarone group were hospitalized for significantlyfewer days than those in the placebo group (6.5 ±2.6vs. 7.9±4.3 days, P = 0.04). In the amiodarone group,the mean length of stay was 7.9±4.6 days for the patientswith atrial fibrillation and 6.1±1.3 days for those withoutatrial fibrillation (P = 0.02). In the placebo group, the patientswith episodes of atrial fibrillation were also hospitalizedfor significantly more days (9.4±3.6 vs. 6.8±4.5days, P = 0.02). The mean total cost of hospitalization forthe amiodarone group was $18,375±$13,863, as comparedwith $26,491±$23,837 for the placebo group (P=0.03).
Morbidity and Mortality in the Hospital
There was no significant difference in the incidence of intraoperativecomplications between the amiodarone and placebo groups (P =0.12) (Table 5). Postoperative complications occurred in 19patients (8 in the placebo group and 11 in the amiodarone group,P = 0.62). Six patients in the placebo group and eight in theamiodarone group had major morbidity (P = 0.78) (Table 6). Deathoccurred in two patients assigned to placebo (3 percent) andin three patients assigned to amiodarone (5 percent, P = 1.00)(Table 6).
Table 6. Postoperative Major Morbidity and Mortality.
When both intraoperative and postoperative events were considered,malignant ventricular arrhythmias occurred in five patientsin the placebo group (8 percent) and one in the amiodarone group(2 percent, P = 0.11).
Discussion
Main Findings
The use of prophylactic oral amiodarone for at least one weekbefore elective heart surgery reduced the incidence of postoperativeatrial fibrillation by approximately 50 percent, significantlyreduced the length and total cost of hospitalization, and reducedthe number of symptomatic episodes of atrial fibrillation occurringafter discharge. Amiodarone was well tolerated and did not increasethe risk of intraoperative or postoperative complications. Amiodaronetherapy was not associated with proarrhythmia or serious adversereactions, even among patients with severe coronary and valvularheart disease. Among the patients who did have atrial fibrillation,amiodarone reduced the ventricular rate more significantly thandid placebo.
In this study, unlike previous ones that included only patientsundergoing coronary-artery bypass graft surgery, 57 percentof the population had valvular surgery. Valvular surgery wasassociated with a higher incidence of atrial fibrillation, whichprobably explains the high incidence of atrial fibrillationin the placebo group. This study's heterogeneous populationhighlights the efficacy of amiodarone for patients undergoingnot only bypass but also valvular surgery.
Complications of Outpatient and Inpatient Therapy
Noncardiac toxic effects of amiodarone include dose-relatedand non–dose-related effects.29,30 The low-dose amiodaroneregimen used in this study did not result in important sideeffects, and there were no complications related to outpatientadjustment of digitalis or warfarin dosages. Also, in this study,unlike previous ones,31,32,33 there were no acute pulmonarytoxic effects after surgery in the patients randomly assignedto amiodarone.
Cardiac toxicity due to amiodarone is uncommon.19,20,21,22,23,24,25The incidence of amiodarone-induced ventricular proarrhythmiais low,25 even in the setting of structural heart disease.34Furthermore, amiodarone has little or no negative inotropiceffect, rarely exacerbates heart failure, and can reduce congestivesymptoms.35 In this study, the low complication rate in theamiodarone group confirms the results of other studies thathave demonstrated safe initiation of amiodarone treatment inoutpatients with coronary artery disease and congestive heartfailure.26,27
Complications Occurring after Hospitalization
Although the assigned medical therapy was discontinued on theday of discharge, the incidence of atrial fibrillation was significantlylower in the amiodarone group than in the placebo group duringthe period immediately following discharge. The half-life ofamiodarone is 13 to 103 days.36 It is likely that the lowerincidence of atrial fibrillation after discharge in the amiodaronegroup is attributable to a persistent antiarrhythmic effect.
Hospitalization Costs
Unlike previous trials of prophylaxis against postoperativeatrial fibrillation, this study demonstrated a reduction inthe total cost of hospitalization for the patients assignedto amiodarone therapy. These data probably underestimate thecost savings attributable to amiodarone therapy, because professionalfees were not included in the cost analysis and cost data foronly the initial hospitalization were examined. Atrial fibrillationafter discharge was more frequent in the placebo group, andhospitalization costs related to the management of these episodesof atrial fibrillation were not analyzed.
Previous Studies
Hohnloser et al. performed a placebo-controlled study of intravenousamiodarone as prophylaxis against atrial fibrillation occurringafter heart surgery in 77 patients.37 The total intravenousdose — 4.5 g — was similar to the total outpatientdose of amiodarone in our study. The amiodarone infusion beganafter the completion of the surgical procedure and significantlyreduced the incidence of atrial fibrillation. However, electrocardiographicmonitoring was performed only during the first 48 hours aftersurgery, and amiodarone was discontinued in 18 percent of patientsbecause of side effects.
Some clinical trials using beta-adrenergic antagonists havedemonstrated prophylactic benefit against postoperative atrialfibrillation8,11,13,14,15,16,17; other studies, however, cameto conflicting conclusions.38,39,40 A possible reason for thisdifference may be that in some studies, patients randomly assignedto placebo were treated with beta-adrenergic blockers untilthe time of surgery.41 Therefore, these patients may have experiencedbeta-blocker withdrawal, which is associated with an increasein the incidence of postoperative atrial fibrillation.11,42,43A second drawback of the studies investigating prophylacticbeta-blocker therapy is the exclusion criteria. In most trials,the factors calling for exclusion have included a history ofasthma, chronic obstructive lung disease, or diabetes mellitusrequiring medical therapy; the presence of a left ventricularaneurysm; the fact that concomitant or primary valvular surgerywas to be performed; and the presence of congestive heart failure.These characteristics requiring exclusion are common among patientsundergoing cardiac surgery and limit the clinical utility ofprophylaxis with beta-blockers.11,18
Prophylactic oral amiodarone circumvents some of the limitationsof intravenous amiodarone and beta-adrenergic antagonists. Short-termlow-dose oral amiodarone is not associated with the complicationsof intravenous administration. Also, because it is well toleratedin patients with poor left ventricular function and unlikelyto exacerbate preexisting medical conditions, prophylactic low-doseoral amiodarone can be used for patients who are not candidatesfor beta-blockade.
Limitations of the Study
A limitation of this study is that Holter monitoring was notperformed to screen for postoperative atrial fibrillation orother arrhythmias during outpatient therapy. The primary goalof the study, however, was to address the clinical utility ofprophylactic oral amiodarone. Failure to detect brief, asymptomaticepisodes of atrial fibrillation or asymptomatic arrhythmiaswas unlikely to influence patient care or affect it adverselyand does not detract from the clinical implications of thisstudy.
A second limitation is that the management of atrial fibrillationwas directed by the attending cardiac surgeon. It is possiblethat a uniform protocol of atrial-fibrillation management mighthave reduced the length of hospital stay; however, since randomizationwas blinded, it is improbable that the longer average hospitalstay in the placebo group was attributable to a more protractedtreatment regimen for atrial fibrillation.
Clinical Implications
Prophylactic low-dose oral amiodarone used in patients undergoingopen-heart surgery was well tolerated and significantly reducedthe incidence of postoperative atrial fibrillation, as wellas the length and cost of hospitalization. Furthermore, unlikeclass I or other class III antiarrhythmic agents, oral amiodaronewas not associated with an increased risk of adverse events,particularly ventricular proarrhythmia. A primary limitationto the widespread use of oral amiodarone prophylaxis, however,is the requirement of a seven-day preoperative treatment period.Whether an accelerated loading regimen of amiodarone over aperiod of one to two days before surgery might be effectiveand safe in preventing postoperative atrial fibrillation remainsto be determined.
Supported in part by a grant from Wyeth–Ayerst Laboratories.
Source Information
From the Division of Cardiology, Department of Internal Medicine (E.G.D., S.A.S., K.C.M., R.G., C.B., F.M.), and the Division of Thoracic Surgery, Department of Surgery (G.M.D., S.F.B., F.D.P.), University of Michigan Hospital, Ann Arbor; and the Division of Cardiology, Department of Internal Medicine, Harper Hospital, Wayne State University, Detroit (M.D.M.).
Address reprint requests to Dr. Daoud at the Midwest Cardiology Research Foundation, Riverside Methodist Hospital, 3545 Olentangy Rd., Rm. 325, Columbus, OH 43214.
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