Published online before print June 2, 2009, doi: 10.1161/CIRCEP.109.854828
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Original Articles |
Results of a Minimally Invasive Surgical Pulmonary Vein Isolation and Ganglionic Plexi Ablation for Atrial Fibrillation
Single-Center Experience With 12-Month Follow-Up
From the Department of Medicine (Cardiology) (F.T.H., M.K., R.K., G.K., R.K.S., M.A.W., K.A.E.) and Department of Medicine (Cardiac Surgery) (V.K., L.W.), Medical College of Virginia, Richmond, Va.
Correspondence to Kenneth A. Ellenbogen, MD, Medical College of Virginia, PO Box 980053, Richmond, VA 23298-0053. E-mail kellenbogen{at}mcvh-vcu.edu
Received February 2, 2009; accepted May 29, 2009.
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Abstract |
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Background— The Cox Maze procedure for treatment of medically refractory atrial fibrillation (AF) is limited by its complexity and requirement for cardiopulmonary bypass. Long-term follow-up and success using criteria established by the Heart Rhythm Society/European Heart Rhythm Association/European Cardiac Arrhythmia Society consensus statement have not been reported for surgical AF ablation. We describe the results of using a thorascopic approach and radiofrequency energy to perform bilateral pulmonary vein isolation and left atrial ganglionic plexi ablation for treatment of AF.
Methods and Results— Forty-five (33 paroxysmal; 12 persistent) consecutive patients underwent thorascopic bilateral radiofrequency pulmonary vein isolation, ganglionic plexi ablation, ligament of Marshall ablation, and left atrial appendage exclusion by a single surgeon. Forty-three patients were prospectively followed without antiarrhythmic drugs for a minimum of 1 year with a 30-day continuous event monitor or pacemaker interrogation at 6 and 12 months. Failure was defined as any atrial tachyarrhythmia of >30 seconds’ duration occurring >90 days after surgery. Mean follow-up was 516±181 days (202 to 858 days). Twenty-eight (65%) patients had no atrial tachyarrhythmia >30 seconds by 1 year, and 15 (35%) patients had atrial tachyarrhythmia recurrences by 1 year. Eight of 15 patients with recurrent AF had catheter ablation resulting in elimination and/or reduction of AF episodes in 7 of 8 patients. Four of 15 patients had AF elimination or reduction with antiarrhythmic drugs alone. Three patients did not benefit from surgery and received rate control only. There were no deaths; 1 phrenic nerve injury and 2 pleural effusions were the only major complications.
Conclusions— The single procedure success at 1-year follow-up for surgical pulmonary vein isolation and ganglionic plexi ablation is 65%. Atrial tachyarrhythmia recurrences after surgery are usually responsive to catheter ablation and/or antiarrhythmic drugs.
Key Words: atrial fibrillation • surgical ablation • cardiac monitoring • catheter ablation
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Introduction |
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Atrial fibrillation (AF) is the most common supraventricular arrhythmia seen in clinical practice, and catheter-based and surgical ablative approaches have been developed for patients with medically refractory symptomatic AF. Although the Cox Maze III surgery is the gold standard for surgical treatment of AF, this procedure has failed to achieve widespread adoption because of its complexity and highly invasive nature.1–5 As the electrophysiological mechanisms of AF have become better understood, ablation strategies have been refined to target the pulmonary vein antrum.
Clinical Perspective on p 370
The landmark work of Haissaguerre et al6–8 identified the pulmonary veins as sources of AF. Pulmonary vein isolation (PVI) has emerged as a successful technique for ablation of paroxysmal AF. In addition, Scherlag et al9–12 have demonstrated that the parasympathetic and sympathetic efferent neurons present in epicardial ganglionic plexi (GP) and the intrinsic cardiac autonomic nervous system may play an important role in triggering pulmonary vein firing. Several groups have incorporated GP mapping and ablation with pulmonary vein isolation in a minimally invasive approach to surgical AF ablation.13–15 The ligament of Marshall (LoM) may also play a role in triggering AF in some individuals.16–18 Nevertheless, results of long-term follow-up using standardized monitoring for AF recurrences after minimally invasive AF surgery have not been reported.
We report a prospective cohort study of patients who underwent minimally invasive bilateral PVI with GP and LoM ablation with 1-year follow-up.
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Methods |
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Patient Selection
We prospectively followed a cohort of 45 consecutive patients with AF who underwent minimally invasive surgical epicardial ablation with a minimum of 1-year follow-up. Definitions of paroxysmal and persistent AF, success and failure of ablation, major adverse events, and follow-up monitoring were based on the Heart Rhythm Society consensus statement for the catheter and surgical ablation of AF.5 Patients were enrolled consecutively by a single investigator’s (K.E.) referral of patients with symptomatic AF who had failed at least 1 antiarrhythmic drug (AAD). Patients were presented with the option of (1) continued AAD trials (when additional AAD trials were an option), (2) percutaneous catheter radiofrequency ablation, or (3) minimally invasive surgical ablation. Thirteen patients were preferentially referred for minimally invasive surgical ablation based on clinical factors, such as body habitus (eg, morbid obesity), recurrent bleeding on warfarin, or difficulty passing catheters from the femoral vein (inferior vena cava filter or trauma resulting in inferior vena cava occlusion). Twelve patients (27%) had a prior unsuccessful catheter ablation for AF.
The institutional review board approved the study, and all patients gave informed consent for inclusion in this prospective registry. The study was registered in clinicaltrials.gov (NCT00747838).
Surgical Procedure
A video of the surgical procedure is provided in the online supplemental data. The surgical procedure was performed under general anesthesia with double-lumen endotracheal tube placement for selective lung ventilation. The chest was entered in the third interspace using a non–rib-spreading mini-thoracotomy with thorascopic assistance. The right or left side was done first and then followed by the contralateral side. The pericardium was opened anterior to the phrenic nerve on the right and usually posterior to the phrenic nerve on the left. The rhythm was determined by placing a bipolar pen probe (Atricure Inc, Cincinnati, Ohio) on the left atrium, and recordings were made with a physiological recorder.18 Autonomic ganglia were identified by high-frequency stimulation to detect a vagal response at 20 predetermined epicardial sites around the pulmonary vein antra. GP mapping was performed by placing the bipolar pen at each site and stimulating with an 18-mV, 1.5-ms pulse width impulse at 1000 pulses per minute from a temporary external pacemaker. A positive response to GP stimulation was defined as prolongation of the sinus cycle or mean AF cycle length by 
50%. A lighted dissector was used to encircle the pulmonary venous antrum after fat was removed from the pulmonary vein trunk. Ablation of the antral area (not the pulmonary veins proper) was performed using a bipolar radiofrequency clamp (Atricure Inc). The end point for pulmonary vein antral ablation was complete entrance and exit block into and from the pulmonary veins. Entrance block was defined as failure to capture the pulmonary veins during pacing from the left atrium at 7.5 V and 1.5-ms pulse width. Exit block was defined by failure to capture the left atrium when pacing from the pulmonary veins distal to the radiofrequency lesions at 7.5 V and 1.5-ms pulse width. A proprietary algorithm terminated radiofrequency energy (maximum, 28 W) after impedance changes indicated transmural injury. Clamp applications were repeated a minimum of 2 to 3 times after bidirectional block was achieved.
The autonomic ganglia (GPs) were mapped before and after ablation of the pulmonary venous antrum. Bipolar radiofrequency energy at 15 W was delivered through the bipolar pen at sites demonstrating a vagal response. The end point for GP ablation was the elimination of a vagal response to stimulation. The LoM was ablated with radiofrequency energy or ligated proximally and distally and then ablated with radiofrequency energy. The left atrial appendage was stapled closed and excised after absence of flow was confirmed by intraoperative transesophageal echocardiography (Figure 1). A single chest tube was placed on each side, and multiple rib blocks with 0.25% bupivacaine and/or a subpleural catheter for continuous infusion of bupivacaine was used to supplement postoperative analgesia. When feasible, patients were extubated in the operating room. When possible, postoperative use of AADs was avoided and warfarin was resumed by discharge. Unless patients had a CHADS2 [Congestive heart failure, Hypertension, Age >70, Diabetes mellitus, previous Stroke or transient ischemic attack] score 2, warfarin was discontinued after the 6-month monitor confirmed the absence of atrial tachyarrhythmia (AT). If patients had a CHADS2 score 2, warfarin was continued indefinitely in the absence of contraindications. All procedures were performed by a single surgeon (V.K.) and followed by a single electrophysiologist (K.E.). Symptomatic recurrent AT that could not be controlled with β-blockers in the immediate postoperative state were preferentially treated with amiodarone for 4 to 8 weeks. All AADs were discontinued by the electrophysiologist by 8 weeks.
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Long-Term Follow-Up
Any patient not in sinus rhythm was cardioverted before the 3-month follow-up visit. With the exception of patients with a pacemaker, recurrent symptomatic palpitations occurring >3 months after surgery were further evaluated with a transtelephonic event monitor (TTM). Three patients had pacemakers, which were used to monitor for AF recurrence. All patients without a pacemaker underwent 30-day continuous monitoring at 6 months, 12 months, and then every 12 months after surgery. Monitoring was performed with an external loop recorder (Cardiolabs, Franklin, Tenn) with an automatically triggered algorithm to detect AF. Success was defined as no episode of AF, atrial flutter, or any AT lasting >30 seconds off AAD. AT was defined as any rhythm other than sinus with a rate >100 bpm.
Statistics
Data were prospectively entered into a database. Separate tables were created for demographic and preoperative data, surgical and in-hospital postoperative data, outpatient follow-up data, and home monitoring data. Statistical analyses were performed using SAS 9.13. Patients were compared by preoperative diagnosis, persistent or paroxysmal AF, and by the success or failure of the procedure. Failure was defined as any episode of AF, atrial flutter, or AT lasting >30 seconds detected after the 90-day postsurgical blanking period by follow-up ECG, pacemaker interrogation, or 30-day continuous event monitor performed at 6 and 12 months. Numeric data were compared using t tests or Wilcoxon rank tests, depending on the normality of the data distribution. Categorical data were compared using the Fisher exact test. Postoperative AF-free survival curves were calculated using the Kaplan–Meier method. Logistic regression was used to identify preoperative risk factors that were independent predictors of failure. Probability values <0.05 were considered statistically significant, and all statistical tests were 2-tailed.
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Results |
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Perioperative Results
Forty-five patients underwent successful minimally invasive surgery between June 1, 2006, to November 18, 2007. Patient characteristics are shown in Table 1. Mean follow-up was 516±181 days (202 to 858 days). There were 33 patients with paroxysmal AF and 12 with persistent AF (10/12 with long-standing persistent AF). Mean length of hospital stay was 5.9±2.6 days (range, 3 to 18 days). Mean ICU stay for postoperative recovery was 1.7±1.6 days (range, 1 to 10 days). The median length of the surgical procedure was 4.2 hours (range: 3 to 6.5 hours), which includes the time from initial skin incision to skin closure on the contralateral side. Complete information about the number of radiofrequency clamps and lesions delivered at the autonomic ganglia were available in 34 patients. The right pulmonary venous antrum was clamped a mean of 3.6±1.22 (range, 1 to 7) times and the left pulmonary venous antrum was clamped a mean of 3.3±1.41 (range, 1 to 8) times. Bidirectional block was achieved in all patients. A mean of 4.6±2.38 (range, 0 to 8) sites on the right side and 2.2±2.55 (range, 0 to 8) sites on the left side of the left atrium produced a vagal response. After GP ablation, no site produced a vagal response.
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No blood transfusions were needed, and no procedures required conversion to cardiopulmonary bypass. There were no deaths. Extubation was performed in the operating room in 84% of the patients, and 9% (4 of 45) of patients were extubated within 6 hours in the ICU. Three of 45 (7%) were extubated after 16 hours in the ICU. Twenty-three (51%) patients were discharged on AAD (amiodarone, 16/23; 70%). Thirty-seven (82%) patients were discharged on warfarin. Eleven (24%) patients were cardioverted within the 90-day blanking period.
Follow-Up
There was 100% compliance with the continuous 30-day monitors at 6 months and 96% compliance with TTM at 12 months. For the patients with recurrent AT (AF, atrial flutter, or any supraventricular tachycardia), information on whether or not the recurrent arrhythmias were persistent or paroxysmal, the longest duration of recurrent paroxysmal episodes, and management of recurrent episodes are included in Table 2. Of the 15 patients with recurrent AT, 4 patients had persistent AT. Complete follow-up was available in 96% of patients. Two of the 45 (4%) patients did not complete the 1-year monitoring and were lost to follow-up. The first patient had no arrhythmias on the 6-month TTM and the second patient had no AT recorded on pacemaker interrogation from the end of the blanking period to 8 months after surgery (Figure 2). These patients are not included in long-term follow-up.
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At 1 year, 28 of 43 (65%) patients were in sinus rhythm off AAD with no AT >30 seconds noted on office follow-up, on 30-day TTM, or on pacemaker interrogation (Figure 3). At 1 year, 29 of 43 (67%) patients were off warfarin. After catheter ablation for recurrent AF, 39 of 43 (91%) patients were off AAD (no AF recurrence after surgical ablation, 28; no AF recurrences after surgical plus catheter ablation, 4; paroxysmal AF controlled without AAD, 4; recurrent persistent AF, 3) (Figure 4 and Table 2). Four patients (2 with catheter ablation; 2 without) required AAD for control of recurrent paroxysmal AF after surgery. After catheter ablation, 26% (11/43) of patients were still on warfarin (compared with 82% before surgery).
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All recurrences and their management are shown in Figure 4 and Table 2. Fifteen of 43 (35%) patients had an AT recurrence occurring >90 days after surgery (Figure 4). The patients with recurrent AT had a mean of 57.5±44.5 (range, 2 to 137) AT-free days after the blanking period until documented AT. The last recurrence was detected 227 days after surgery; thus there were no new recurrences detected at the 12-month time point.
Eight of the 15 patients with recurrent AT underwent an electrophysiology study and catheter ablation (Figure 3 and Table 2). Mean time to catheter ablation after surgery was 252.5±73.0 days (range, 100 to 326 days). The 8 patients who underwent catheter ablation have been followed for a mean duration of 376.8±126.8 days (range, 172 to 544 days) after ablation. Five patients were found to have AF, and 3 patients were found to have atrial flutter (1 right atrial flutter, 1 right cavotricuspid isthmus–dependent flutter, 1 left atrial flutter). All 5 patients with recurrent AF had paroxysmal AF. Six months after catheter ablation, 4 of 5 patients (80%) were free of AF on TTM.
Four of 15 (27%) patients are treated with AAD for recurrent paroxysmal AF (2 with radiofrequency ablation, 2 without). Eight of 15 (53%) are maintained on anticoagulation. Three of 15 patients failed to receive any benefit from any intervention. One patient was treated with an atrioventricular node ablation and VVIR pacemaker implantation. The other 2 patients are on a rate control strategy for persistent AF with atrioventricular nodal–blocking drugs only. By managing recurrences with catheter ablation and medication, control of recurrent symptomatic AF increased to 93% (40/43 patients).
Univariate and multivariate analysis of variables that failed to predict recurrent AF include sex, diabetes, hypertension, ejection fraction, age, coronary artery disease, prior stroke, active tobacco use, preoperative AF duration, left atrium size, preoperative diagnosis of persistent versus paroxysmal AF, presence of AF at discharge, use of AAD at discharge, body mass index, ICU length of stay, total length of hospitalization, and previous cardiac surgery (all P>0.05). There was no statistically significant difference in the risk of failure between the paroxysmal (n=33) and persistent groups (n=12) (success: paroxysmal, 70%; persistent, 58%; P=0.50; Figure 3) or between no previous catheter ablation (n=33) and previous catheter ablation (n=12) (success: no previous catheter ablation, 67%; previous catheter ablation, 33%; P=0.28).
Complications
There were no deaths or conversion to cardiopulmonary bypass. There were 3 patients with hospitalizations >10 days. The first patient had bilateral pneumothoraces that required new chest tubes and mechanical ventilation >24 hours. The second patient required mechanical ventilation >24 hours for hypoventilation. The third patient had a pleural effusion (300 mL) requiring drainage before discharge. All 3 patients had a body mass index >37. One patient had permanent paralysis of the right phrenic nerve. One patient had a pleural effusion drained 1 month after surgery on office follow-up.
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Discussion |
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This report describes our experience with a minimally invasive surgical approach that combines pulmonary vein antral isolation with GP and LoM mapping and ablation. Our experience is important because it presents a single-procedure success rate for a consecutive cohort of patients with systematic 1-year follow-up. We have carefully applied the follow-up model and procedural success definitions proposed by the 2007 Heart Rhythm Society/European Heart Rhythm Association/European Cardiac Arrhythmia Society consensus statement on catheter and surgical ablation of AF.5
Our 1-year success (defined as freedom from AF/atrial flutter/AT off AAD) of 65% is based on ECG and home monitoring data from 96% of our subjects regardless of the presence or absence of symptoms. Previously published surgical and catheter ablation studies failed to use a rigorous follow-up strategy for documentation of AF recurrence and applied variable definitions of success (Table 3).13–15,19,20 These studies included 7.4% to 32% of patients who had failed at least 1 prior catheter ablation procedure. Despite having a higher proportion of patients with prior failed catheter ablation compared with 3 other studies, a more aggressive monitoring algorithm, a longer follow-up duration, and a stricter definition of success, we found a similar overall success rate to previously published surgical studies.13–15,19,20 If our study used a definition of failed ablation as recurrent AT/AF/atrial flutter greater than 10 minutes similar to other published studies of AF ablation, then our success rate would have been 79%.
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Our observations indicate that even with minimally invasive surgical ablation, a significant proportion (19%) of patients have asymptomatic AF (percentage free from symptomatic AF, 81%; percentage free from any AF, 62%) after ablation (Figure 5). Karch et al21 found that 28% and 47% (of patients with circumferential and segmental pulmonary vein ablation, respectively) had documented recurrence of an asymptomatic AT with a 7-day Holter monitoring at 6-month follow-up. Hindricks et al22 found that after circumferential PVI, 36% of patients had completely asymptomatic recurrences at 12-month follow-up using a continuous 7-day ECG monitor and an AF symptom log, compared with 22% immediately before ablation. Relying only on symptomatic episodes of AF overestimates the efficacy of AF interventional strategies.21
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Consistent with the observations by Hindricks et al,22 the mean number of AT episodes and the mean AT duration declined in our patients after catheter ablation and/or AAD (Table 2). Thus, surgical ablation in conjunction with AAD or catheter ablation for recurrent AT allowed us to achieve symptomatic relief from AF in 93% of our patients.
We did not pursue interventions other than direct current cardioversion and postoperative AAD for AT within the 90-day blanking period. Lellouche et al23 found that of 90 patients with AT 3 minutes within 1 month of the index catheter ablation, 91% had a late recurrence requiring an additional procedure. These early recurrences served as a marker for patients who were at risk of AT recurrence after the blanking period. In our cohort there were 4 patients (patients 2, 6, 10, and 15) whose AT recurrences were found within 2 weeks of the blanking period; 2 (patients 10 and 15) benefited from an atrial flutter ablation (Table 2). Patient 2 received an atrioventricular node ablation and a VVIR pacemaker for persistent AF; patient 6 has rare paroxysmal AF controlled with AAD (Table 2). However, since our TTM protocol was not designed for the purposes of early detection and catheter ablation of AT recurrences, the significance of these recurrences and their successful treatment remains to be determined.
Whether GP ablation improves the success rate of AF ablation compared with surgical PVI alone is unknown. Although canine models have shown an important role for GP ablation, long-term human data for GP ablation do not exist.9–12 Discrepant results regarding the inclusion of GP ablation from surgical studies fail to provide a definitive answer to this question.
Other studies have found a significant difference between the efficacy of catheter-based and surgical ablation for paroxysmal compared with persistent AF.13–15,19,20,24,25 Our experience found no significant difference in the success rate of patients with paroxysmal compared with persistent AF. Our success rate with persistent AF is high, probably because of the small sample size of persistent AF patients and the fact that left atrium size was not markedly enlarged in either group. However, the success rate with persistent AF could also represent modification of the atrial substrate: (1) Oral et al24 showed that 22% of patients with persistent AF had successful elimination of AF, (2) a large area of the left atrium cuffs are ablated with each radiofrequency clamp application, (3) ablation of the LoM and GPs eliminates the contribution of the autonomic ganglia to the triggering of pulmonary vein firing from the left atrial antrum, and (4) we performed extensive dissection in the interatrial areas to include as much left atrial tissue as possible. This improvement in the single-procedure success for treatment of persistent AF compared with catheter ablation will need to be validated as more patients undergo surgical ablation. Finally, it should be noted that in comparing our results with single-procedure success for catheter ablation, the mean age of our patients was 2 to 12 years older than that reported by Noheria et al26 in their systematic review of catheter AF ablation.
Limitations
Although we have noted a significant success rate and symptomatic improvement in patients, we did not conduct a formal assessment of quality of life. Although our success rate is less than that reported in other series, the lack of a previous consensus definition for single-procedure success and the varied definitions of success and follow-up probably account for this difference. This is supported by the high rate of symptomatic AF reduction/elimination with a combination of AAD/catheter ablation for AF recurrences after surgical ablation. As future studies emerge for both surgical and catheter-based AF ablation, application of the HRS consensus criteria for procedural success will improve the accuracy of comparing different ablation techniques.
Our study may be subject to referral bias based on a preference for surgery in patients with obesity, patients who could not tolerate or desired to discontinue warfarin, and patients who had abdominal or pelvic anatomy complicating catheter ablation. In addition, patients may have been biased in their decision to pursue surgical ablation when presented with the potential for repeat procedures after catheter ablation.
The limited numbers of patients in this single-center study prevent definitive conclusions from being drawn with univariate and multivariate regression analyses. As the number of patients undergoing minimally invasive PVI with GP and LoM ablation increase, the application of multivariate regression analyses will be critical to confirming the results of our analysis.
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Conclusions |
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A minimally invasive surgical approach using PVI combined with the mapping and ablation of autonomic GP for medically refractory AF has a single-procedure success rate of 65% at 1 year. Recurrences can be managed with catheter ablation and AAD.
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Acknowledgments |
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Sources of Funding
Dr Kasirajan received research support from Atricure Inc, and Dr Wood received research support from Atricure Inc.
Disclosures
Drs Kasirajan and Wood received honoraria and research support from Atricure Inc, and Dr Ellenbogen received honoraria and research support from Atricure Inc., Ablation Frontiers, Biosense Webster, Medtronic, Boston Scientific, and St. Jude Medical.
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References |
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Footnotes |
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Clinical trial registration information: www.ClinicalTrials.gov. ClinicalTrials.gov identifier: NCT00747838.
The online-only Data Supplement is available at http://circep.ahajournals.org/cgi/content/full/CIRCEP.109.854828/DC1.
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