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(Circulation. 2000;102:761.)
© 2000 American Heart Association, Inc.

Clinical Investigation and Reports

Randomized, Double-Blind Trial of Simultaneous Right and Left Atrial Epicardial Pacing for Prevention of Post–Open Heart Surgery Atrial Fibrillation

Emile G. Daoud, MD; Reza Dabir, MD; Michelle Archambeau, RN; Fred Morady, MD; S. Adam Strickberger, MD

From the Divisions of Cardiology, University of Michigan Medical Center, Ann Arbor, and Oakwood Hospital, Dearborn, Mich (E.G.D., M.A., F.M., S.A.S.), and the Division of Cardiothoracic Surgery, Oakwood Hospital, Dearborn, Mich (R.D.).

Correspondence to Emile Daoud, MD, 3545 Olentangy River Rd, Room 325, Columbus, OH 43214. E-mail egd{at}mocc.cc

	Abstract

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Background—The purpose of this study was to assess simultaneous right and left atrial pacing as prophylaxis for postoperative atrial fibrillation.

Methods and Results—In a double-blind, randomized fashion, 118 patients who underwent open heart surgery were assigned to right atrial pacing at 45 bpm (RA-AAI; n=39), right atrial triggered pacing at a rate of 85 bpm (RA-AAT; n=38), or simultaneous right and left atrial triggered pacing at a rate of 85 bpm (Bi-AAT; n=41). Holter monitoring was performed for 4.8±1.4 days after surgery to assess for episodes of atrial fibrillation lasting >5 minutes. The prevalence of postoperative atrial fibrillation was significantly less in the patients randomized to biatrial AAT pacing when compared with the other 2 pacing regimens (P=0.02). An episode of atrial fibrillation occurred in 4 (10%) of 41 patients in the Bi-AAT group compared with 11 (28%) of 39 patients in the RA-AAI group (P=0.03 versus Bi-AAT) and 12 (32%) of 38 patients in the RA-AAT group (P=0.01 versus Bi-AAT). There was no difference in the occurrence of atrial fibrillation between the right atrial AAI and AAT groups (P=0.8). There was no significant difference among the 3 groups with regard to the number of postoperative hospital days (7.3±4.2 days), morbidity (5.1%), or mortality rate (2.5%).

Conclusions—Simultaneous right and left atrial triggered pacing is well tolerated and significantly reduces the prevalence of post–open heart surgery atrial fibrillation.

Key Words: valves • bypass • surgery • arrhythmia

	Introduction

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Postoperative atrial fibrillation occurs in 10% to 40% of patients undergoing open heart surgery.^{1 2 3 4 5 6 7} Although prophylactic therapy with ß-adrenergic antagonists amiodarone and sotalol reduces the incidence of postoperative atrial fibrillation,^{7 8 9 10 11} atrial fibrillation remains an important cause of increased hospital length of stay and expense after heart surgery.¹² Chronic, simultaneous dual-site atrial pacing may reduce the recurrence rate of atrial fibrillation,^{13 14 15} and thus the hypothesis tested in this study was that triggered, biatrial pacing would reduce the frequency of new-onset atrial fibrillation occurring after open heart surgery.

	Methods

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Patient Population
From January 1997 to October 1998, 234 patients were screened for participation in this study within 3 days before open heart surgery at Oakwood Hospital. Inclusion criteria consisted of informed consent, age >18 years, elective heart surgery requiring cardiopulmonary bypass, and normal sinus rhythm. Exclusion criteria included participation in another investigational protocol, pregnancy, presence of a permanent pacemaker, or use of a class I or III antiarrhythmic medication. Fifty-six (24%) patients were excluded, and, among the remaining 178 eligible patients, 118 (66%) patients consented. Coronary artery bypass graft surgery was performed in 100 (85%) patients, both coronary artery bypass and valvular surgery were performed in 12 (10%) patients, and valvular surgery alone was performed in 6 (5%) patients. Patient characteristics and surgical data are summarized in Table 1. There were no identifiable differences in clinical characteristics between the 3 treatment groups.

View this table: [in this window] [in a new window]   Table 1. Patient Characteristics

Study Protocol
The study design was approved by the Oakwood Hospital Human Research Committee and was a double-blind protocol in which the surgical staff and principal investigators and the patient were unaware of the assigned pacing modality. Clinical data, lead parameters, and Holter data were collected and recorded into the database by independent blinded investigators.

Patients were randomly assigned in a double-blind fashion immediately after surgery to 1 of 3 pacing modes: (1) right atrial pacing with an inhibited mode at a rate of 45 bpm (RA-AAI; n=39); (2) right atrial pacing with a triggered mode at a rate 10 beats greater than the patient’s intrinsic sinus rate but not <85 bpm (RA-AAT; n=38); or (3) simultaneous right and left atrial pacing (biatrial pacing) with a triggered mode 10 beats greater than the patient’s sinus rate but not <85 bpm (Bi-AAT; n=41). Triggered pacing with relatively rapid rates was selected to suppress atrial ectopy and dispersion of refractoriness. Atrial ectopy or an increase in dispersion of refractoriness is frequently associated with induction of atrial fibrillation.^{16 17 18 19 20} After completion of the surgical procedure, 2 temporary unipolar epicardial leads (model 6500, Medtronic, Inc) were attached to the anterior-superior aspect of the right atrium, and a second pair of epicardial leads was attached to the posterior-inferior aspect of the left atrium between the coronary sinus and the right inferior pulmonary vein (Figure 1). The lead was a multifilament, braided, stainless steel, insulated conductor that terminated in an uninsulated 3-mm (surface area 7.5 mm²) stainless steel electrode. This electrode was attached to a curved needle with polypropylene suture, and the proximal end of the suture was coiled to reduce dislodgment. In patients assigned to either RA-AAI or RA-AAT pacing, the right atrial pair of unipolar leads was connected to an external pacemaker generator (Pacesetter, Inc), and the proximal ends of the left atrial epicardial pacing electrodes were taped to the chest wall. Biatrial pacing was achieved by simultaneous bipolar pacing of the right and left atria (Figure 1). Pacing was performed at 3 times the capture threshold, and the sensitivity was set at 0.25 mV. Pacing was initiated within 12 hours after surgery and continued until 24 hours before discharge, at which time the pacing leads were removed. There were no complications related to removal of the leads.

View larger version (16K): [in this window] [in a new window]   Figure 1. Diagram shows position of atrial pacing electrodes and their connection to external pacemaker generator. Electrodes were positioned along anterior-superior aspect of right atrium and posterior-inferior aspect of left atrium, near coronary sinus (CS).

After surgery, each patient was admitted to an intensive care unit and was subsequently transferred to a monitored unit. An investigator evaluated patients daily. Two-lead telemetric monitoring was performed continuously until the day of hospital discharge or for 7 days after surgery. Electrocardiographic data were stored for 24 hours and reviewed on a daily basis. Arrhythmia detection and assessment of pacemaker function were also screened through daily 3-lead Holter monitors obtained for up to 5 days after surgery. Right and left atrial capture threshold, sensitivity, and lead impedance were measured with a portable pacing analyzer (Ventritex, Inc). An episode of atrial fibrillation was counted if it persisted for >5 minutes. After an episode of atrial fibrillation, atrial pacing was discontinued, and the patient was withdrawn from further analysis. The cardiac surgery team directed management of atrial fibrillation. Patients were reevaluated in the cardiac surgery outpatient clinic 6 weeks after surgery.

Statistical Analysis
Data were analyzed on an intention-to-treat basis. Continuous variables are expressed as mean±1 SD. Continuous variables were compared by means of a paired or unpaired t test as appropriate. Multiple continuous variables were compared by means of ANOVA. Categoric variables were compared by means of ² analysis. Analysis of repeated measures was used to compare daily measurement of the right and left atrial capture threshold, sensitivity, and lead impedance. The time to first occurrence of atrial fibrillation and the survival of pacing electrode function were assessed by Kaplan-Meier analysis. A value of P < 0.05 was considered significant.

	Results

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Postoperative Atrial Fibrillation
The prevalence of postoperative atrial fibrillation was significantly less in the patients randomized to biatrial AAT pacing when compared with the other 2 pacing regimens (P=0.02; Figure 2). An episode of atrial fibrillation occurred in 4 (10%) of 41 patients in the Bi-AAT group compared with 11 (28%) of 39 patients in the RA-AAI group (P=0.03 versus Bi-AAT), and 12 (32 of 38 patients in the RA-AAT group (P=0.01 versus Bi-AAT). There was no difference in the occurrence of atrial fibrillation between the right atrial AAI and AAT groups (P=0.8). The first postoperative episode of atrial fibrillation occurred 2.7±1.4 days in the RA-AAI group, 2.6±1.7 days after surgery in the RA-AAT group, and 2.9±0.9 days after surgery in the Bi-AAT group (P=0.5). The mean duration of atrial fibrillation was 7.8±6.1 hours. There was no significant difference between the duration of atrial fibrillation between the 3 groups (P=0.3) (Table 2).

View larger version (16K): [in this window] [in a new window]   Figure 2. Kaplan-Meier analysis of percentage of patients remaining free of atrial fibrillation (AF) after surgery in 3 pacing groups.

View this table: [in this window] [in a new window]   Table 2. Duration of Atrial Fibrillation1

ß-Receptor antagonists were prescribed in 101 (86%) of 118 patients. ß-Blocker therapy did not have a statistically significant impact on the prevalence of atrial fibrillation in any group (P=0.4).

Sinus rhythm was present in each patient when evaluated in the cardiac surgery outpatient clinic 6 weeks after hospital discharge.

Hospital Length of Stay and Morbidity and Mortality Rates
The length of hospitalization was not significantly different among patients assigned to Bi-AAT (7.0±5.3 days), RA-AAI (6.6±2.6 days), and RA-AAT (7.7±3.8 days) pacing (P=0.6). The frequency of major postoperative complications and deaths were similar between treatment groups (P=1.00 and P=0.3, respectively; Table 3).

View this table: [in this window] [in a new window]   Table 3. Complications

Lead Analysis
The duration of successful pacing was significantly less for biatrial pacing (3.1±1.2 days) compared with right atrial pacing in an inhibited mode (4.1±1.4 days, P=0.003) and with right atrial pacing in a triggered mode (3.8±1.2 days, P=0.04). There was no significant difference in the duration of successful pacing when comparing RA-AAI with RA-AAT pacing (P=0.3). The mean atrial rate was 92.4±8.2 bpm for the Bi-AAT group, 95.4±8.2 bpm for the RA-AAT group (P=0.10 versus Bi-AAT), and 69.8±14.2 bpm in the RA-AAI group (P<0.0001 versus RA-AAT and Bi-AAT). The mean amplitude of the measured P wave was 1.5±0.8 mV and was not statistically different between groups (P=0.4). Survival of right atrial leads was substantially greater than left atrial leads (P<0.001; Figure 3).

View larger version (16K): [in this window] [in a new window]   Figure 3. Kaplan-Meier analysis of lead survival. Right atrial lead survival was significantly greater than left atrial lead survival (P<0.001).

	Discussion

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Main Findings
The main findings of this study are that prophylactic, simultaneous, right and left atrial pacing in a triggered mode after open heart surgery reduces the prevalence of postoperative atrial fibrillation by 60%, is well-tolerated, and is not associated with increased postoperative complications. Additionally, right atrial pacing by itself has no significant antiarrhythmic effect.

Although biatrial pacing reduced episodes of postoperative AF, there was no reduction in the length of hospitalization. Since the safety of placing and removing left atrial active fixation leads was uncertain, patients were observed for complications for 1 day after lead removal. Therefore, patients without AF remained hospitalized an additional day but, for patients with AF, the leads were often removed while management of AF was ongoing. The absence of complications after removing the 4 leads implies that in future studies, patients can be discharged on the day that pacing wires are removed.

Possible Mechanisms
Two mechanisms may explain how simultaneous right and left atrial triggered pacing at a rate faster than the patient’s sinus rate prevented atrial fibrillation. The first is that dispersion of atrial refractoriness is reduced with biatrial pacing. Clinical studies have demonstrated that premature atrial contractions result in dispersion of atrial refractoriness and establish nonuniform anisotropic conduction, particularly near the coronary sinus and posterior triangle of Koch.^{16 17 18 21 22} These regional differences in atrial electrophysiology are essential for reentry, which facilitates initiation of atrial fibrillation. In this study, a triggered pacing mode was chosen to assure early activation of the atrial myocardium near the coronary sinus in response to premature atrial contractions sensed in either the right or left atria and hence reduce atrial dispersion.

A second possible mechanism by which simultaneous biatrial triggered pacing may prevent atrial fibrillation is through the suppression of atrial ectopy. Atrial fibrillation is often initiated by a premature atrial beat, especially during periods of sinus bradycardia. Biatrial pacing at a relatively rapid rate may result in overdrive suppression of atrial ectopy that may have otherwise initiated atrial fibrillation.^{23 24} This latter mechanism seems less likely because overdrive suppression of atrial ectopy would also be expected with RA-AAT pacing. However, in the present study, AAT pacing from the right atrium had no effect on the prevalence of atrial fibrillation.

Previous Studies
Short- and long-term clinical trials have investigated the effect of dual-site atrial pacing.^{13 14 15 18 21 22} The results of these trials suggest that dual-site pacing, in combination with antiarrhythmic therapy, increases the arrhythmia-free interval and the percentage of patients who remain free of an atrial fibrillation recurrence. The current study confirms these findings and demonstrates that triggered biatrial pacing reduces the prevalence of postoperative atrial fibrillation in patients not receiving class I or III antiarrhythmic medications.

Two studies have assessed the effect of temporary epicardial atrial pacing for the prevention of post–open heart surgery atrial fibrillation.^{25 26} Neither study found biatrial pacing to be beneficial. However, both of these studies differ from the present study in several important ways. Neither of the earlier studies performed biatrial triggered pacing at a rate that was always faster than the patient’s intrinsic rate. Triggered pacing provides the theoretical advantage of reduced atrial dispersion and overdrive suppression of atrial ectopy. Next, in one of the earlier studies, adequate atrial sensing was difficult to achieve, and atrial undersensing may have initiated atrial fibrillation.²⁵ In the current study, atrial sensing was set at 0.25 mV, thus reducing the likelihood of sensing failure. Finally, the present study enrolled 118 patients, whereas the previous studies only included 21 and 61 patients.^{25 26}

Preliminary studies from other centers have demonstrated that biatrial pacing reduces postoperative atrial fibrillation.^{27 28 29 30} Three of these studies, however, did not control for the effect of placement of epicardial left atrial leads and/or the effect of continuous high-rate pacing.^{27 28 29} The fourth study³⁰ had a design comparable to the current study and reported a similar degree of reduction (69%) in atrial fibrillation with biatrial pacing versus no pacing

Pacing Electrode Performance
Previous studies have reported that temporary atrial epicardial electrodes are prone to failing.^{31 32} Although the lead used in this study is reported to perform reasonably well,^{33 34} >60% of right and 80% of left atrial electrodes failed by the fifth postoperative day. In the present study, the incidence of atrial fibrillation was greatest in the first 3 days after open heart surgery. Hence, later lead failure may not have had a substantial impact on prevention of atrial fibrillation.

Surgical Technique
To optimize pacing parameters and to achieve consistent positioning of the epicardial leads in a secure fashion, only 1 surgeon participated in this study. Right atrial lead placement was in a conventional position; however, the position of the left atrial leads was chosen to preexcite the posterior-inferior region of the left atrium near the coronary sinus. Achieving a stable position in this area did not result in excessive bypass pump times or complications.

ß-Blocker Therapy
The results of this study may reflect an additive effect of biatrial pacing and ß-blockade, since 86% of patients were administered ß-blockers. However, this seems unlikely because the prevalence of atrial fibrillation among the 3 groups was unaffected by ß-blocker therapy.

Clinical Implications
An ideal prophylactic approach is one that is effective in a diverse patient population and that is associated with minimal expense and risk. Biatrial pacing for prevention of atrial fibrillation after open heart surgery may be such a technique. Unlike class I or class III antiarrhythmic agents, biatrial pacing is not associated with a risk of ventricular proarrhythmia, bradycardia, or hypotension, nor does biatrial pacing need to be initiated before surgery.¹⁰ Whether future advances in electrode technology and pacing algorithms³⁵ or hybrid therapies, such as biatrial pacing in conjunction with antiarrhythmic therapy, may further reduce the prevalence of postoperative atrial fibrillation remains to be determined.

	Acknowledgments

 
This study was supported in part by a research grant from Pacesetter, Inc.

Received December 20, 1999; revision received March 2, 2000; accepted March 10, 2000.

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