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(Chest. 2005;128:39S-47S.)
© 2005 American College of Chest Physicians

Pharmacologic Prophylaxis*

American College of Chest Physicians Guidelines for the Prevention and Management of Postoperative Atrial Fibrillation After Cardiac Surgery

David Bradley, MD; Lawrence L. Creswell, MD; Charles W. Hogue, Jr., MD; Andrew E. Epstein, MD; Eric N. Prystowsky, MD and Emile G. Daoud, MD

* From the Johns Hopkins Medical Institutions (Dr. Bradley), Baltimore, MD; the Division of Cardiothoracic Surgery (Dr. Creswell), University of Mississippi Medical Center, Jackson MS; the Department of Anesthesiology (Dr. Hogue), Washington University School of Medicine, St. Louis, MO; the Department of Internal Medicine (Dr. Epstein), University of Alabama, Birmingham, AL; The Care Group (Dr. Prystowsky), Indianapolis, IN; and Mid-Ohio Cardiology and Vascular Consultants (Dr. Daoud), Columbus, OH.

Correspondence to: Emile Daoud, MD, 3705 Olentangy River Rd, Room 100, Columbus, OH 43214; e-mail: edaoud{at}pol.net


   Abstract
TOP
 Abstract
Introduction
 Evidence Review and...
 Discussion
 Summary of Recommendations
 References
 
New-onset atrial fibrillation (AF) occurs frequently in patients after cardiac surgery. The purpose of this study was to review the published trials and to provide clinical practice guidelines for pharmacologic prophylaxis against postoperative AF. Trials of pharmacologic prophylaxis against AF after heart surgery were identified by searching MEDLINE, the Cochrane Controlled Trials Register, and the bibliographies of published reports. Evidence grades and clinical recommendation scores were assigned to each prophylactic drug based on published evidence. Ninety-one trials were identified. The primary study design was a randomized, controlled trial of one drug vs placebo/usual care. Pharmacologic therapies that are reviewed include Vaughan-Williams class II agents (ie, ß-receptor antagonists) [29 trials; 2,901 patients], Vaughan-Williams class III agents (ie, sotalol and amiodarone) [18 trials; 2,978 patients], Vaughan-Williams class IV agents (ie, verapamil and diltiazem) [5 trials; 601 patients], and Vaughan-Williams class I agents (ie, quinidine and procainamide) [3 trials; 246 patients], as well as digitalis (10 trials; 1,401 patients), magnesium (14 trials; 1,853 patients), dexamethasone (1 trial; 216 patients), glucose-insulin-potassium (3 trials; 102 patients), insulin (1 trial; 501 patients), triiodothyronine (2 trials; 301 patients), and aniline (1 trial; 32 patients). A consistent finding in this review is that antiarrhythmic drugs with ß-adrenergic receptor-blocking effects (ie, class II beta-blockers, sotalol, and amiodarone) demonstrated successful prophylaxis. Furthermore, those therapies that did not inhibit ß-receptors generally failed to demonstrate a decreased incidence in postoperative AF. While sotalol and amiodarone have been shown in some studies to be effective, their safety and the incremental prophylactic advantage in comparison with beta-blockers has not been conclusively demonstrated. On the basis of evidence that has been reviewed and graded for quality, it is recommended that strong consideration should be given to the prophylactic administration of Vaughan-Williams class II beta-blocking drugs as a means of lowering the incidence of new-onset post-cardiac surgery AF.

Key Words: atrial fibrillation • beta-blockers • guidelines • heart surgery • postoperative • prophylaxis • review


   Introduction
TOP
 Abstract
 Introduction
Evidence Review and...
 Discussion
 Summary of Recommendations
 References
 
New-onset atrial fibrillation (AF), atrial flutter (AFL), and other atrial tachyarrhythmias occur in 15 to 50% of patients after cardiac surgery.12345678910 Despite advances in surgery, anesthesia, and postoperative care, the incidence of new-onset postoperative AF has not decreased. Although postoperative AF is not associated with increased mortality, an irregular and rapid ventricular rate and the absence of organized atrial activity may result in hypotension and congestive heart failure, as well as symptoms of fatigue and palpitations. Postoperative AF has also been associated with an increased risk of stroke, prolonged hospitalization, and increased costs.3 Furthermore, AF arising de novo after cardiac surgery rarely requires long-term therapy. Because of these features, numerous studies since the 1960s have investigated the benefit of perioperative pharmacologic prophylaxis against atrial tachyarrhythmias occurring after cardiac surgery. The purpose of this analysis is to review the weight of evidence for each pharmacologic strategy and to provide clinical practice guidelines for the prevention of AF after cardiac surgery.

Data from two groups of published trials were combined to form the summary of evidence presented in this article. The first group of 70 trials121112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960616263646566676869707172737475767778 was identified by searching MEDLINE, the Cochrane Controlled Trials Register, and the bibliographies of published reports. A second group of 23 trials798081828384858687888990919293949596979899100101 was identified by reviewing the bibliographies of narrative reviews. Trials from both groups satisfied the same inclusion criteria, with two exceptions. The study by Yeatman et al100 was included even though it was published after the search time cutoff of 2001. A second study, by Wenke et al,98 was included even though the main body of the text was published in German (a detailed English-language abstract summarized the trial outcomes).

Of the combined 93 trials (ie, 70 plus 23), 2 were excluded because their data appeared to have been previously published.3459 This review, therefore, summarizes data from 91 studies. Of the 91 studies, 7 trials123070808194 had more than two study arms. For those trials in which more than one drug was studied, the data were analyzed in a pairwise manner comparing each drug to its appropriate control. For those trials investigating different dosing regimens for the same drug, the results are reported in a pairwise fashion by pooling data from the drug regimens and comparing these pooled data to data from the control arm. Evidence grades and clinical recommendation scores were assigned to each prophylactic drug regimen in accordance with previously defined criteria as described in the "Methodological Approach" article in this supplement.102


   Evidence Review and Recommendations
TOP
 Abstract
 Introduction
 Evidence Review and...
Discussion
 Summary of Recommendations
 References
 
ß-Receptor Antagonists (Vaughan-Williams Class II Agents)
From 1979 to 2001, 29 trials121116303738444546475766717475798081828788919293959698101 with 2,901 patients assessed the use of ß-adrenergic receptor antagonists, the administration of which was started in the preoperative, intraoperative, or postoperative period, vs control as prophylaxis for postoperative AF. The rationale for beta-blocker therapy as prophylaxis is that increased sympathetic tone is speculated to enhance the susceptibility of patients to postoperative dysrrhythmias. These studies have similar designs, but with important limitations. Patients who commonly require cardiac surgery were often excluded (eg, the presence of congestive heart failure, pulmonary disease or diabetes, valve surgery, or elderly patients). In addition to beta-blockers, patients were often prescribed other antiarrhythmic drugs, such as digitalis or calcium channel blockers, in an uncontrolled fashion. Nonetheless, 13 of 29 trials showed that prophylaxis with beta-blockers results in a statistically significant reduction in the incidence of post-cardiac surgery AF in comparison with placebo (Table 1 ). Patients who have received long-term therapy with beta-blockers up to the time of surgery and who did not receive postoperative beta-blockade (ie, beta-blocker withdrawal) have a high incidence of postoperative AF. Unless specifically contraindicated, the reinitiating of therapy with beta-blockers postoperatively should not be delayed.


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  		Table 1. Clinical Recommendations for Prophylactic Drug Therapies*

 
Two studies5094 randomized patients to receive beta-blockers plus digitalis vs control (Table 1). The combination therapy of beta-blockers and digitalis was more efficacious than the control therapy, but this benefit can probably be attributed largely to beta-blockade alone. Other trials compared therapy beta-blockers vs digitalis (three studies),1281 beta-blockers vs diltiazem (one study),80 and beta-blockers vs propafenone (one study)49 [Table 2 ]. Because of design limitations and small sample sizes, these studies did not provide firm conclusions about the relative efficacy of beta-blockers vs propafenone, digitalis, or diltiazem.


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  		Table 2. Clinical Recommendations for Comparative Prophylactic Drug Therapies

 
Sotalol (Vaughan-Williams Class III Agents)
The combination of ß-receptor and potassium channel blocking properties has made sotalol a promising drug for the prevention of AF after cardiac surgery. Eight randomized trials2024293048586872 with a total of 1,279 patients have shown that sotalol decreases the incidence of AF after cardiac surgery by 41 to 93% relative to placebo (Table 1). All but one trial29 among these eight trials yielded a statistically significant result in favor of sotalol. Although these findings are consistent and significant, there are some noteworthy limitations. First, in general, the study populations were small. Second, in six of the eight trials,202429485872 at least some patients had their preoperative beta-blocker regimen withheld after undergoing surgery, which may have biased the results in favor of sotalol. Third, only two of the trials5872 reported using intention-to-treat analysis. Further, sotalol trials, similar to class II beta-blocker trials, were limited because sick patients (ie, those with low left ventricular ejection fraction, bradycardia, emphysema, and renal insufficiency) were, in general, excluded. Finally, all but a few of the trials used an open-label study design, introducing potential bias into interpreting the results.

With regard to adverse events, sotalol was well-tolerated, and the frequency of side effects was comparable to that for beta-blockers. Sotalol therapy was discontinued mainly because of hypotension and/or bradycardia in 5.9% of sotalol-treated patients vs 2.9% of control subjects. In six sotalol trials242948586872 in which ventricular arrhythmias were reported, only two patients treated with sotalol developed a ventricular arrhythmia compared with no patients treated with placebo. Although these are encouraging results, it is important to note that the patients in these trials were carefully managed to minimize the risk of ventricular proarrhythmia and excessive QT-interval prolongation. The complications that may occur if sotalol is prescribed in a routine manner without these safeguards, therefore, are unclear. If prescribed, sotalol therapy should be initiated only in a monitored setting with daily measurement of the QT interval from a 12-lead ECG and should be used cautiously in the presence of renal insufficiency.

An important clinical issue is whether sotalol provides an incremental antiarrhythmic effect for postoperative AF compared with class II beta-blockers. If these therapies have equal efficacy, class II beta-blockers would be preferred because of the absence of ventricular proarrhythmia that can occur with sotalol therapy. Four trials30535567 with 801 patients compared sotalol with beta-blockers (ie, propranolol and metoprolol). Although two of the four trials5355 showed statistically significant reductions in postoperative AF among patients treated with sotalol, two trials,3067 including the largest of the four, did not find such a difference. These inconsistent results, combined with study design limitations, suggest that additional studies are needed before firm conclusions can be reached regarding the incremental benefit of therapy with sotalol vs class II beta-blockers for the prevention of AF after cardiac surgery. (Table 2).

Amiodarone
Amiodarone is a unique antiarrhythmic agent that inhibits multiple ion channels (ie, potassium and calcium) and adrenergic receptors ({alpha} and ß). Because of its low risk of proarrhythmia, amiodarone can be utilized as a prophylactic therapy in patients with structural heart disease. The ability of amiodarone to prevent AF following cardiac surgery has been gauged in 1,699 patients participating in 10 randomized controlled trials.12151822252741436070 In four trials,15222541 amiodarone prophylaxis was associated with a statistically significant reduction in AF after cardiac surgery. In the remaining six trials, amiodarone therapy did not significantly reduce AF. Overall, amiodarone prophylaxis was associated with an 8 to 72% relative reduction in postoperative AF. Oral amiodarone, started several days before surgery, is the only form of AF prophylaxis that has been reported to reduce the incidence of postoperative AF, the length of hospitalization, and hospital costs.15 A limitation of this protocol, however, is the requirement for a 7-day oral loading period before surgery, which is often not feasible. Because of conflicting findings, small study populations, and methodological limitations, the strength of evidence supporting the use of amiodarone for AF prophylaxis is diminished (Table 1).

Side effects resulting in the discontinuation of therapy with amiodarone were uncommon in the five trials reporting this outcome.1225274360 Amiodarone therapy was discontinued mainly because of bradycardia in 2.5% of patients vs 1.5% of control subjects. However, the small number of patients participating in these trials as well as the limited data regarding patient outcome after hospital discharge, precludes establishing the extent of side effects with amiodarone when prescribed as prophylaxis for postoperative AF.

Whether or not amiodarone is superior to beta-blockers in AF prophylaxis is unclear. In a subgroup analysis performed by Giri and colleagues,22 amiodarone provided no additional protection against AF after cardiac surgery among patients receiving beta-blockers. A direct comparison of amiodarone and propranolol showed a trend favoring amiodarone in the prevention of AF65 (Table 2). This trend, however, may be explained, in part, by the concurrent use of beta-blockers in 42% of the patients treated with amiodarone. No trials have compared amiodarone treatment with sotalol treatment. Based on the limited available data, the relative merits of beta-blockers in comparison with amiodarone are unclear.

Calcium Channel Antagonists (Vaughan-Williams Class IV)
Calcium channel antagonists like diltiazem and verapamil may decrease atrial ischemia and thereby reduce the incidence of postoperative AF. Four randomized trials17637686 with 541 patients compared the prophylactic administration of verapamil to control therapy. None of the four trials showed a statistically significant decrease in the incidence of postoperative AF among patients treated with verapamil (Table 1).

With regard to prophylaxis with diltiazem, only one randomized trial80 compared diltiazem with control therapy (n = 60 patients), and this trial concluded that diltiazem did not significantly reduce postoperative AF (Table 1). Among four trials26426185 comparing IV diltiazem with IV nitroglycerine, only one trial61 showed a statistically significant reduction in postoperative AF. A statistically nonsignificant trend favoring diltiazem was observed in the other three diltiazem-nitroglycerine trials (Table 2).

Magnesium
Intracellular magnesium depletion during cardiac surgery may predispose patients to postoperative arrhythmias. Fourteen trials13141921313352546264697081100 witha combined 1,853 patients have examined the potential benefit of magnesium chloride or magnesium sulfate supplementation in reducing AF after cardiac surgery in comparison with placebo or usual care. Only 169 of the 14 trials recorded a statistically significant reduction in postoperative AF among patients who were treated with magnesium. The remaining 13 trials produced inconclusive results regarding the incidence of postoperative AF. The limitations of these studies include postoperative beta-blocker withdrawal among some trial participants and methodological weaknesses (Table 1). Magnesium sulfate was directly compared with propranolol in one randomized trial with 134 patients.81 Patients receiving propranolol had a lower incidence of postoperative AF compared to those receiving magnesium sulfate (Table 2). Although magnesium sulfate does not appear to provide significant prophylaxis against postsurgical AF, serum magnesium levels should be maintained, perhaps with empiric supplementation, in patients undergoing cardiac surgery.

Digitalis
Digitalis was traditionally prescribed after heart surgery to enhance hemodynamics. Also, digitalis increases vagal tone and may therefore reduce the ventricular rate during atrial arrhythmias, although this benefit may be less pronounced perioperatively due to increased sympathetic tone. Ten controlled trials123256738183849497 with a total of 1,401 patients have yielded conflicting results about the potential benefits of digitalis for postoperative AF prophylaxis. All 10 of these trials have methodological limitations. For example, beta-blocker therapy was withdrawn postoperatively in four trials,56738184 and three trials were nonrandomized.838494 Because of these conflicting results and the availability of more efficacious prophylactic agents, digitalis should not be initiated solely as prophylactic therapy for patients undergoing cardiac surgery.

Other Therapies
Some prophylactic therapies have been evaluated in only a few small studies. Such therapies include dexamethasone78 and insulin-enhanced cardioplegia,28 as well as the administration of glucose-insulin-potassium solutions,408999 triiodothyronine,3651 procainamide,2339 alinidine,35 and quinidine.90 The study results and evidence grades are outlined in Table 1. Because of limited evidence, the merits of these drugs in the prevention of AF after cardiac surgery are unclear.


   Discussion
TOP
 Abstract
 Introduction
 Evidence Review and...
 Discussion
Summary of Recommendations
 References
 
A consistent finding in this analysis, as well as in a 2002 meta-analysis,103 was that antiarrhythmic agents with beta-blocking properties (ie, class II beta-blockers, sotalol, and amiodarone) have shown the most promise for successful AF prophylaxis. Furthermore, the contrary was also a consistent result. Those trials evaluating prophylactic therapy that did not inhibit ß-receptors (ie, class I and class IV antiarrhythmic agents, digitalis, magnesium, dexamethasone, insulin, and triiodothyronine) generally failed to demonstrate a decreased incidence of postoperative AF.

An equally important second observation is that there are no compelling data that sotalol or amiodarone provide an incremental prophylactic advantage in comparison with class II beta-blockers. Furthermore, sotalol and amiodarone are associated with potentially significant side effects. Sotalol therapy may result in life-threatening proarrhythmia, especially if prescribed for elderly patients with structural heart disease and with the concomitant use of diuretics in the setting of renal insufficiency. Studies that reported on adverse events related to amiodarone as prophylactic therapy included only a few patients and thus are underpowered to evaluate safety conclusively, especially when administered by IV methods. The recommendation of this committee, therefore, is that the preferred antiarrhythmic drugs for AF prophylaxis are class II ß-receptor antagonists. Sotalol and amiodarone cannot be favored over beta-blockers until conclusive evidence demonstrates that these agents offer an incremental antiarrhythmic effect above what can be achieved with a class II beta-blocker, and that this benefit outweighs the risk of the side effects. For some patients in whom therapy with beta-blockers is contraindicated, amiodarone therapy may be considered.

Study Limitations
This article has compiled and reviewed the results of 91 trials. There are multiple limitations with this type of evidence summary. Trials varied in patient inclusion and exclusion criteria as well as in the time of initiation of prophylactic therapy during hospitalization. Also, AF definitions differed. For example, among the sotalol trials, the minimum duration for an AF episode to be counted as an arrhythmic event was 30 s in one trial and 30 min in another. The methods used to detect arrhythmias also varied widely, including nurse evaluations, telemetry, telemetry with automatic alarms/recordings, and continuous Holter monitoring. Last, these trials were performed over several decades. Naturally, the knowledge base and technology progressed with each trial. These limitations, however, do not overshadow the lessons learned from prophylaxis studies.

Future Studies
The rationale for pharmacologic prophylaxis therapy is that the prevention of postoperative AF will reduce AF-induced symptoms and hemodynamic changes, and will minimize length of stay and hospital costs. However, rather remarkably, the impact of prophylaxis therapy on length of stay and hospital costs has not been a primary objective of any of the 91 trials examined. With regard to these end points, there are few data that support drug prophylaxis as being superior to heart rate control and anticoagulation therapy initiated only for those patients experiencing postoperative AF. A trial comparing these two strategies, with the primary end points of postoperative morbidity/mortality, length of stay, and hospital costs, would begin to fill an important gap in our knowledge regarding the prevention and management of post-cardiac surgery AF.


   Summary of Recommendations
TOP
 Abstract
 Introduction
 Evidence Review and...
 Discussion
 Summary of Recommendations
References
 
A number of antiarrhythmic drugs and classes of drugs have been found to demonstrate varying degrees of efficacy in preventing new-onset AF after cardiac surgery.

  1. In patients in whom prophylaxis against post-cardiac surgery AF is indicated, including those patients receiving long-term therapy with beta-blockers prior to surgery for whom therapy should be reinstated, we recommend the use of Vaughan-Williams class II beta-blockers (strength of recommendation, A; evidence grade, fair; net benefit, substantial).
  2. Sotalol (Vaughan-Williams class III agent) therapy may be considered for postoperative AF prophylaxis but is associated with increased toxicity (strength of recommendation, B; evidence grade, good; net benefit, intermediate).
  3. In individual patients for whom therapy with class II beta-blockers are contraindicated, therapy with amiodarone should be considered (strength of recommendation, B; evidence grade, good; net benefit, intermediate).
  4. To prevent AF/AFL in patients following cardiac surgery, we recommend against the use of calcium channel antagonists (ie, verapamil and diltiazem) (strength of recommendation, D; evidence grade, low; net benefit, none).
  5. For the prevention of AF/AFL in patients following cardiac surgery, we recommend against routine treatment with magnesium (strength of recommendation, D; evidence grade, low; net benefit, none).
  6. For reducing the incidence of postsurgical AF, we do not recommend digitalis for use as monotherapy (strength of recommendation, I; evidence grade, low; net benefit, none).

Table 1 provides the results and evidence grades for other prophylactic therapies evaluated in a few small studies. These therapies include dexamethasone, insulin-induced cardioplegia, triiodothyronine, procainamide, alinidine, quinidine, and glucose-insulin-potassium. The merits of these agents in preventing postoperative AF are unclear because of the limited evidence. Therefore, these agents, although cited in the text and in Table 1, were not included in the above summary of recommendations.


   Footnotes
 
Abbreviations: AF = atrial fibrillation; AFL = atrial flutter


   References
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 Abstract
 Introduction
 Evidence Review and...
 Discussion
 Summary of Recommendations
 References
 

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