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J Thorac Cardiovasc Surg 2008;135:863-869
© 2008 The American Association for Thoracic Surgery

Surgery for Acquired Cardiovascular Disease

Surgery for atrial fibrillation in patients with mitral valve disease: Results at five years from the International Registry of Atrial Fibrillation Surgery

Joao Melo, MD, PhDa,*, Teresa Santiago, MSca, Carlos Aguiar, MDa, Eva Berglin, MD, PhDb, Michael Knaut, MDc, Ottavio Alfieri, MD, PhDd, Stefano Benussi, MD, PhDd, Haw Sie, MDe, Mathew Williams, MDf, Fernando Hornero, MD, PhDg, Giuseppi Marinelli, MDh, Paul Ridley, MDi, Enrique Fulquet-Carreras, MDj, António Ferreira, MDa

a Hospital Sta Cruz, Carnaxide, Portugal
b Sahlgrenska University Hospital, Goteborg, Sweden
c Dresden University Hospital, Dresden, Germany
d San Raffaele Hospital, Milano, Italy
e Isala Klinieken, Zwolle, The Netherlands
f Columbia University Medical Center, New York, NY
g Hospital General Universitario de Valencia, Valencia, Spain
h Policlinico S. Orsola, Bologna, Italy
i North Staffordshire Royal Infirmary, Staffordshire, United Kingdom
j Hospital Universitario de Valladolid, Vallodolid, Spain

Received for publication April 28, 2006; revisions received June 25, 2007; accepted for publication August 30, 2007.

* Address for reprints: Joao Melo, MD, PhD, Hospital de Santa Cruz, Av. Prf. Reynaldo dos Santos, 2799-523 Carnaxide, Portugal. (Email: jmelo{at}hsc.min-saude.pt).


   Abstract
Top
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Objectives: We sought to assess the clinical and survival benefit of atrial fibrillation surgery in patients submitted to mitral valve surgery after stabilization of postoperative rhythm at 1 year.

Methods: One thousand seven hundred twenty-three patients were enrolled. Patients with follow-up of longer than 1 year (n = 972) were divided into 3 groups according to surface electrocardiographic rhythm during follow-up visits: stable sinus rhythm, stable atrial fibrillation, and intermittent rhythms. Adverse cardiac event incidence and predictors of long-term outcome were compared among the 3 groups.

Results: In-hospital mortality was 2.6%. Risk factors for mortality were the cut-and-sew technique (odds ratio, 8.92; 95% confidence interval, 1.71–46.50; P = .009) and isolated left atrial procedure (odds ratio, 0.16; 95% confidence interval, 0.04–0.56; P = .004). At 1 year, 63.4% patients were in stable sinus rhythm. Stable sinus rhythm was found to be associated with early and late survival (P = .01, log-rank analysis). Multivariate binary logistic regression analysis found that left atrial dimension (odds ratio, 0.97; 95% confidence interval, 0.96–0.99; P = .005) and concomitant coronary revascularization (odds ratio, 0.48; 95% confidence interval, 0.25–0.92; P = .027) were independent predictors of stable sinus rhythm at 1 year after surgical intervention. At 48 months' follow-up, predictors for stable sinus rhythm were biatrial surgical approach and absence of preoperative permanent atrial fibrillation (odds ratio, 3.56; 95% confidence interval, 1.62–7.83; P < .002). Left atrial size (each millimeter) has a borderline statistical significance (odds ratio, 0.97; 95% confidence interval, 0.93–1.00; P = .065). Thromboembolic events were found to be associated with absence of stable sinus rhythm (P = .010, log-rank analysis).

Conclusions: The achievement of stable sinus rhythm is a predictor of better survival and lower incidence of thromboembolic events. Predictors of stable sinus rhythm were smaller dimensions of the left atrium, biatrial approach, absence of preoperative permanent atrial fibrillation, and absence of concomitant coronary artery bypass grafting.

Abbreviations and Acronyms CI = confidence interval; OR = odds ratio; RAFS = International Registry for Atrial Fibrillation Surgery; sAF = stable atrial fibrillation; sSR = stable sinus rhythm


   Introduction
Top
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 References
 

See related editorial on page 727.

 

Recent reports of outcomes after atrial fibrillation treatment with mitral valve surgery have been limited by the lack of a clear definition of patient selection criteria and of consistent data on long-term results.1Go

Heart rhythm instability after these procedures is frequent. Nomenclature for these different rhythms is not uniform, and results are often described as "out of atrial fibrillation" or "regular rhythms," which have led to some misleading conclusions.1,2Go Long-term use of concomitant antiarrhythmic medication after surgical intervention is seldom reported.

The International Registry for Atrial Fibrillation Surgery (RAFS) covers a large cohort of patients submitted to atrial fibrillation surgery in different clinical contexts. RAFS uses a common nomenclature for clinical variables and a standardized reporting method for the surgical procedure and clinical outcomes.

The aim of this study was to assess the clinical and survival benefit, if any, of sinus rhythm recovery in the subset of patients submitted to mitral valve surgery included in the RAFS. Safety, efficacy, and benefits of atrial fibrillation surgery were evaluated on short- and long-term data. Late use of antiarrhythmic therapy was also assessed.

A classification based on heart rhythm stability after mitral valve surgery was used. The effect of recovery of stable sinus rhythm (sSR) on patient survival and on major adverse cardiac events was studied.


   Materials and Methods
Top
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 References
 
Of 2140 patients enrolled in the RAFS, 1723 were submitted to concomitant mitral surgery. Data from these patients were collected retrospectively from clinical reports between December 2003 and March 2006. Patients were submitted to surgical intervention in 10 hospitals located in Europe and America enrolled in the RAFS. Criteria used for the definition and classification of atrial fibrillation were those recommended by the European Society of Cardiology, American Heart Association, and American College of Cardiology.3Go

A total of 56 variables were included concerning demographic and clinical data at discharge and during follow-up. Common accepted nomenclature for the reported variables can be viewed at www.registryafsurgery.com, with the most significant ones being described in Go Table 1.


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  		Table 1 Data from all patients according to concomitant cardiac procedures
 
A standard protocol for valve or coronary surgery was used. All patients were operated on during cardiopulmonary bypass, according to local recommendations. Surgical techniques used to treat atrial fibrillation and left atrial appendage closure were at the physicians' discretion (Go Table 2). In 283 (16.4%) patients the left atrial appendage was left open.


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  		Table 2 AF procedures
 
Independent prognostic factors for in-hospital mortality were determined for the total group of patients. Follow-up outcomes are based on data from patients who have a minimum of 1 year's follow-up (n = 972). The average follow-up for these patients was 29.0 ± 21.4 months (median, 23 months; interquartile range 26.4 months).

In each of the 972 patients, rhythm was determined at every follow-up visit according to the institutional protocol. Three institutions used 24-hour Holter monitoring in the first 6 months and electrocardiography at each follow-up visit thereafter, 1 institution used either method throughout the follow-up period according to the case, and the remaining used 12-lead electrocardiographic recordings.

Patients were divided into 3 groups according to the rhythm documented during the first year: sSR, stable atrial fibrillation (sAF), and intermittent rhythms. sSR was defined as sinus rhythm at all follow-up visits during the first year.

A similar criterion was adopted for sAF. All other rhythms were described as intermittent rhythms. Atrial flutter rhythm was considered as sAF for analysis purposes.

Adverse cardiac event incidence and predictors of long-term outcome were compared in the 3 groups.

Summary statistics were presented as frequencies and percentages, means ± standard deviation, medians, and interquartile ranges. Missing data were not defaulted to negative, and denominators reflect only actual reported cases.

Associations of outcomes among nominal variables were compared by using the {chi}2 test with the Yates correction or the 2-sided Fisher exact test, when appropriate. Bivariate comparisons of continuous variables were investigated with the Student t test.

Survival analyses with Kaplan–Meier methods were performed to estimate survival and freedom from thromboembolic events. Cox proportional hazards models were used to identify the predictors of early and late mortality and the predictors of maintenance in sSR.

Iterative logistic modeling was performed for sSR by using the likelihood ratio test for model selection.


   Results
Top
 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 References
 
In-hospital mortality for the 1723 patients was 2.6% (n = 45; 99% confidence interval [CI], 1.7%–3.9%) Independent predictors for in-hospital mortality were the use of the cut-and-sew technique (odds ratio [OR], 8.92; 95% CI, 1.71–46.50; P < .009) and an isolated left atrial procedure (OR, 0.16; 95% CI, 0.04–0.56; P = .004).

In-hospital morbidity occurred in 153 (9%) patients (99 %CI, 7%–11%). These patients experienced 217 complications (Go Table 3), an average of 1.4 complications per patient.


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  		Table 3 Hospital morbidity
 
The mean hospital stay was 12.4 ± 10 days. At discharge, 59% of patients (n = 971) were in sinus rhythm, 34% (n = 554) were in atrial fibrillation, 2.6% (n = 42) were in atrial flutter, and the remaining 4.4% had other rhythms (n = 99; ie, nodal, sick sinus, and atrial heart rhythms). Of the 52 patients who required pacemaker implantation before discharge, 20 (1.4%; 95% CI, 0.9%–2.2%) were submitted to left-sided approaches, and 32 (6%; 95% CI, 4.0%–8.0%) were submitted to biatrial approaches (P < .001).

Patients with follow-up of less than 1 year were excluded from midterm analysis. Survival and embolic event analysis were performed in the remaining 972 patients.

Rhythm at 1 year was documented by means of electrocardiography in 869 patients by using Holter monitoring in 101 patients and by means of intracavitary recordings in 2 patients.

Biatrial approaches were used in 307 of 972 patients, and follow-up data at 1, 2, 3, and 4 years were available in 244, 104, 94, and 59 subjects, respectively.

At 1 year, 66% of patients were in sinus rhythm, 2.72% were in atrial flutter, 25% were in atrial fibrillation, and 6.3% had other rhythms (atrial, nodal, and pacing).

One hundred fourteen (6.6%) patients died during follow-up, and 144 adverse cardiac events were found in 120 (14.5%) patients. Considering the patient subset with long-term follow-up (>48 months, n = 181), the attrition rate for losing sSR was 3% per year.

sSR was found to be associated with higher early and late survival (P = .01, log-rank analysis) when compared with all other heart rhythms (Go Go Figures 1 and 2).


Figure 1
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  		Figure 1. Actuarial survival after the first year of follow-up for stable sinus rhythm (sSR) versus other rhythms.

 

Figure 2
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  		Figure 2. Actuarial survival after the first year of follow-up according to stable sinus rhythm (sSR) versus stable atrial fibrillation (sAF) versus "other."

 
The use of antiarrhythmic therapy was similar in both groups in early and long-term follow-up (Go Table 4). At 4 years, 34% of patients with sSR versus 21% of patients with sAF were taking antiarrhythmic medication.


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  		Table 4 Antiarrhythmic therapy
 
Multivariate binary logistic regression analysis (see Go Table 5) found that at 1 year after surgical intervention, left atrial dimension was an independent predictor for sSR at 1 year after surgical intervention (OR, 0.97 for each millimeter; 95% CI, 0.96–0.99; P = .005). Concomitant coronary revascularization was found to be an independent negative predictor of sSR (OR, 0.48; 95% CI, 0.25–0.92; P = .027).


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  		Table 5 Predictors for stable sinus rhythm at 1 and 4 years
 
In the subset of patients with more than 48 months' follow-up, multivariate analysis (see Table 5) identified the biatrial surgical approach (OR, 5.87; 95% CI, 1.94–17.74; P = .002) and the absence of permanent atrial fibrillation (OR, 4.00; 95% CI, 1.06–14.29; P = .041) as significant predictors for sSR at 4 years. Left atrial size had a borderline statistical significance when considered as a continuous variable (OR, 0.97 for each millimeter; 95% CI, 0.93–1.00; P = .065) but reached statistical significance when dichotomized (OR, 0.39 for left atrium >55 mm; 95% CI, 0.19–0.84; P = .015; the best cutoff value was determined by means of receiver operating curve analysis).

Twenty-five (3%) patients experienced thromboembolic events. Thromboembolic events were found to be associated with absence of sSR (P = .010, log-rank analysis; Go Figure 3).


Figure 3
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  		Figure 3. Survival free of thromboembolic events according to rhythm. sSR, Stable sinus rhythm.

 

   Discussion
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
References
 
Atrial fibrillation surgery in patients undergoing mitral valve operations has become very common in the last decade. Alternative techniques to the maze procedure were developed over the years in an attempt to avoid its complexity while retaining effectiveness.4Go Concomitantly, ablation techniques to create atrial scars were used as an alternative to the classic cut-and-sew technique.5-8Go Despite these advances, the clinical benefit of atrial fibrillation surgery and the best technique to perform it remain unclear.

It is well known that sinus rhythm recovery is not always achieved. Moreover, a significant number of patients can change rhythm over time, mainly in the first 6 months after surgical intervention, probably as a result of the healing process, neurohumoral modulation, or both.9-12Go Classifying these patients based on their discharge rhythms makes them behave as crossovers and creates confusion in outcome assessment.

The use of a clear definition of sSR in the first year after mitral surgery enabled us to assess the clinical outcome of atrial fibrillation surgery in those patients in whom it is truly effective (nearly two thirds in this registry) and identify sSR as a predictor for survival and decreased incidence of thromboembolic events. This finding emphasizes the importance of identifying those patients in whom the restoration of sinus rhythm is an achievable goal and who should be given the opportunity to attain it. Our results suggest that appropriate patient selection should take into account left atrial dimensions, concomitant coronary heart disease, and the type of atrial fibrillation.

Concomitant myocardial revascularization was a negative predictor of maintenance in sinus rhythm. This association might reflect a more advanced stage of myocardial disease and difficulties in controlling arrhythmia in the presence of ischemia. These results are in contrast with the ones published by Prasad and colleagues.13Go

As previously reported, left atrial dimension was an independent predictor of sSR 1 year after surgical intervention.14Go Our findings confirm that the likelihood of maintenance in sinus rhythm decreases as a continuum with increasing left atrial size, with a best cutoff point at 55 mm. The presence of preoperative permanent atrial fibrillation was a negative independent predictor of sSR at 4 years but not at 1 year, where it was surpassed by the short-term predictors left atrial size and concomitant revascularization. According to our findings, patients undergoing multiple valve procedures should not be excluded as candidates for atrial fibrillation treatment because concomitant non–mitral valve surgery was not associated with a decrease in effectiveness. This might reflect selection bias but also the fact that patients requiring multiple valve procedures currently receive surgical treatment at much earlier stages than a few years ago.

Interestingly, a biatrial approach was an independent predictor for staying in sSR but was also associated with increased in-hospital mortality and the need for a permanent pacemaker. Further studies will be needed to identify the patients in whom the apparent benefit of this approach outweighs its potential risks. The greater effectiveness of biatrial approaches is not surprising. The highest reported rates of conversion to sinus rhythm belong to the maze procedure,9Go a biatrial surgical technique. The importance of right atrial intervention is also underscored by the modest but instructive crude success rates (8%–12%) of previous studies on catheter ablation with right atrial compartmentalization.10Go

The high prevalence of antiarrhythmic therapy postoperatively might also have contributed to the preservation of sinus rhythm during follow-up. Although the use of antiarrhythmic drugs might reflect an effort to keep these complex patients in sinus rhythm, it is probably magnified by the use of β-blockers and digoxin in the treatment of concomitant hypertension and chronic heart failure.

Several limitations of this study must be acknowledged. First, despite the large number of patients included in the registry, the sample size of this study is still suboptimal because an important proportion of patients were lost to follow-up during the first postoperative year and were excluded from further analysis. Because the data were collected retrospectively into a registry, patient selection and surgical technique were largely unstandardized. The use of 12-lead electrocardiography to establish rhythm during follow-up reflects the rhythm at a given moment and overestimates the success rate of these surgical procedures. Because treatment options were not randomized, differences in outcome between a biatrial approach versus a left atrial approach only and cut-and-sew methods versus ablation methods might reflect selection bias rather than real differences in the safety and efficacy of surgical techniques. Before establishing a definite relationship between the achievement of sSR and improved outcomes, the effect of variables, such as cardiovascular risk factors that were not consistently recorded in this registry, should be taken into account.

In spite of the above limitations, these are encouraging results that require confirmation in large randomized controlled trials.


   Footnotes
 
Read at the Eighty-sixth Annual Meeting of The American Association for Thoracic Surgery, Philadelphia, Pa, April 29–May 3, 2006.

Stefano Benussi reports consulting fees from Estech; lecture fees from St Jude, Medtronic, and Cryocath; and an educational grant from Atricure.


   References
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 

  1. Geidel S, Ostermeyer J, Lass M, et al. Permanent atrial fibrillation ablation surgery in CABG and aortic valve patients is at least as effective as in mitral valve disease. Thorac Cardiovasc Surg 2006;54:91-95.[Medline]
  2. Bando K, Kasegawa H, Okada Y, et al. Impact of preoperative and postoperative atrial fibrillation on outcome after mitral valvuloplasty for nonischemic mitral regurgitation. J Thorac Cardiovasc Surg 2005;129:1032-1040.[Abstract/Free Full Text]
  3. Fuster V, Ryden LE, Asinger RW, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: executive summary. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation) Developed in Collaboration With the North American Society of Pacing and Electrophysiology. Circulation 2001;104:2118-2150.[Free Full Text]
  4. Cox JL, Schuessler RB, D'Agostino Jr. HJ, et al. The surgical treatment of atrial fibrillation: III. Development of a definitive surgical procedure. J Thorac Cardiovasc Surg 1991;101:569-583.[Abstract]
  5. Melo JQ, Adragão P, Neves J, et al. Surgery for atrial fibrillation using intra-operative radiofrequency ablation. Rev Port Cardiol 1998;17:377-379.[Medline]
  6. Knaut M, Spitzer SG, Karolyi L, et al. Intraoperative microwave ablation for curative treatment of atrial fibrillation in open heart surgery—the MICRO_STAF and MICRO_PASS pilot trial. Thorac Cardiovasc Surg 1999;47:379-384.[Medline]
  7. Sie HT, Beukema WP, Ramdat Misier AR, Elvan A, Ennema JJ, Wellens HJJ. The radiofrequency modified maze procedure. A less invasive surgical approach to atrial fibrillation during open-heart surgery. Eur J Cardiothorac Surg 2001;19:443-447.[Abstract/Free Full Text]
  8. Lee JW, Choo SJ, Kim KI, et al. Atrial fibrillation surgery simplified with cryoablation to improve left atrial function. Ann Thorac Surg 2001;72:1479-1483.[Abstract/Free Full Text]
  9. Melo J, Adragao P, Neves J, et al. Endocardial and epicardial radiofrequency ablation in the treatment of atrial fibrillation with a new intra-operative device. Eur J Cardiothorac Surg 2000;18:182-186.[Abstract/Free Full Text]
  10. Lima GG, Kalil RA, Leiria TL, et al. Randomized study of surgery for patients with permanent atrial fibrillation as a result of mitral valve disease. Ann Thorac Surg 2004;77:2089-2094.[Abstract/Free Full Text]
  11. Jessurun ER, van Hemel NM, Defauw JJ, et al. A randomized study of combining. The maze surgery for atrial fibrillation with mitral valve surgery. J Cardiovasc Surg 2003;44:9-18.[Medline]
  12. Akpinar B, Guden M, Sagbas E, Sanisoglu I, Ozbek U, et al. Combined radiofrequency modified maze and mitral valve procedure through a port access approach: early and mid-term results. Eur J Cardiothorac Surg 2003;24:223-230.[Abstract/Free Full Text]
  13. Prasad SM, Maniar HS, Camillo CJ, et al. The Cox maze III procedure for atrial fibrillation: long-term efficacy in patients undergoing lone versus concomitant procedures. J Thorac Cardiovasc Surg 2003;126:1822-1828.[Abstract/Free Full Text]
  14. Cappato R, Calkins H, Chen SA, et al. Worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation 2005;111:1100-1105.[Abstract/Free Full Text]

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