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Eur J Cardiothorac Surg 2005;28:724-730
© 2005 Elsevier Science NL

Meta-analysis of clinical outcomes of maze-related surgical procedures for medically refractory atrial fibrillation

James T. Reston a , Jeffrey H. Shuhaiber b , *

a Department of Health Technology Assessment, ECRI, Plymouth Meeting, PA, USA
b Department of Surgery, University of Illinois at Chicago, 840 Southwood Avenue (Suite 518- E), 614-G Laflin, Chicago, IL 60612, USA

Received 11 May 2005; received in revised form 18 July 2005; accepted 20 July 2005.

* Corresponding author. Tel.: +1 312 404 871; fax: +1 708 327 2503. (Email: shuhaibr{at}uic.edu).


   Abstract
Top
 Abstract
1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 References
 
OBJECTIVE: Although maze-related surgical procedures have shown success at eliminating atrial fibrillation, published controlled studies have generally been too small to detect clinically significant differences in morbidity and mortality. We pooled available studies to determine whether a simultaneous maze procedure reduces the risk of stroke or death in patients with chronic or paroxysmal atrial fibrillation who receive mitral valve surgery. Secondary outcomes included post-operative bleeding and need for pacemaker.

METHODS: Our systematic review identified four randomized controlled trials and six retrospective comparative studies that met minimum quality criteria. We conducted meta-analyses of clinical outcomes using Cohen's h, a statistic appropriate for analysis of infrequent events.

RESULTS: The findings suggest that maze may reduce stroke risk but also increase the need for pacemaker implantation, as well as increase the risk of post-operative bleeding unless radiofrequency ablation is used. However, the statistically significant findings for stroke, need for pacemaker, and post-operative bleeding were overturned by sensitivity analysis, indicating that the findings are not robust.

CONCLUSION: The literature evaluating maze clinical outcomes suffers from several shortcomings, particularly small sample sizes and selection bias. However, weak evidence supports a reduction in stroke rates and an increase in need for pacemakers among patients receiving the maze procedure. Radiofrequency maze may avoid an excess risk of post-operative bleeding associated with maze incisions. Larger, well-designed RCTs are needed to confirm these findings and evaluate outcomes such as survival and quality of life.

Key Words: Maze procedure • Meta-analysis • Atrial fibrillation


   1. Introduction
Top
 Abstract
 1. Introduction
2. Materials and methods
 3. Results
 4. Discussion
 References
 
Atrial fibrillation (AF) is a common condition in patients with heart disease, and is believed to increase the risk of stroke and death. AF is classified as paroxysmal, persistent, or permanent [1]. While persistent AF can generally be terminated by pharmacologic therapy or cardioversion, both paroxysmal and permanent AF may be refractory to medical therapy in certain patients (i.e. medical therapy does not eliminate AF in these patients). These patients may be candidates for surgical procedures designed to eliminate AF.

Overall, the maze surgical procedure (including its many variants) has been shown to be highly successful at eliminating AF. However, other clinical benefits have yet to be established. These potential benefits include reduction in risk of various morbidities (e.g. heart failure, progression to another AF type, neurological events) and mortality.

The classic Cox-maze operation is relatively complex and time-consuming, which has prevented widespread diffusion of the procedure. Although the Cox-maze III procedure leads to a high freedom from AF, simpler modifications of this procedure and substitution of new energy sources (e.g. radiofrequency, microwave, cryosurgery and laser) that create ablation lines in place of surgical incisions are under study to determine if comparable results can be achieved.

Although different procedures are available for treatment of AF, clinicians do not know the type of patient or the type of arrhythmia that will benefit the most from a specific type of procedure. Published retrospective reviews of single-center data typically have limited applicability to other centers, and the validity of retrospective treatment comparisons is typically weakened by differential selection of patients to the experimental and control groups.

In this study, our aim was to determine whether the maze procedure (including variants with different incision patterns and energy sources) leads to improvement in patient-oriented outcomes from systematic analysis of randomized controlled trials (RCTs) and retrospective comparative trials. We hypothesized that variants of the maze procedure had a similar effect on clinical outcomes, and tested this assumption using meta-analysis.


   2. Materials and methods
Top
 Abstract
 1. Introduction
 2. Materials and methods
3. Results
 4. Discussion
 References
 
2.1 Identification of trials and exclusion criteria
We conducted a Medline search for all English language articles (up to June 2004) that presented a controlled comparison of the maze procedure (or variants) combined with mitral valve surgery to mitral valve surgery alone in patients with medically refractory AF. Article bibliographies were scanned to ensure that no studies were missed. Twelve relevant controlled studies were identified. Rates of stroke and mortality following maze were the primary outcomes of interest in this study. Secondary outcomes of interest included sinus rhythm restoration, need for permanent pacemaker, and post-operative bleeding.

2.2 Evaluation of study quality
Our evaluation of quality consisted of evaluating each study's internal validity. Certain study designs have potential for bias that can diminish one's ability to draw conclusions about the relationship between treatment and patients' outcomes. We evaluated whether the patients in the maze and control groups were similar by using each study's data in the context of three validated models for estimating risk of death during surgery (Parsonnet, EuroSCORE, and Society of Thoracic Surgery risk scores) [2–4]. Two methodologists, blinded from each other, reviewed each study and scored each treatment group based on the risk models. If one treatment group within a study scored higher than the comparison group, the study was potentially biased against finding better outcomes in the higher-scoring group. Each methodologist separately assigned a direction of potential bias; disagreements were resolved in conference and consensus achieved. Because these risk models only estimate a patient's risk of death, they may not predict the risk of certain morbidities that are often unrelated to a patient's baseline status (e.g. postoperative bleeding). Studies with greater potential for biased results were included in meta-analyses in only two instances. For one outcome (need for pacemaker), the evidence showed an effect that was in the opposite direction to that expected based on our quality analysis. In the other case, the outcome (post-operative bleeding) was considered independent of the patient's baseline risk. The above information was used to evaluate the quality of the evidence base. Inevitably, this type of judgment is subjective. Two methodologists, acting independently and blinded from each other, examined the quality evaluations and reached consensus.

2.3 Statistical analysis
We conducted meta-analyses using a fixed-effects model, which is described in detail elsewhere [5,6]. The method used to calculate effect size (Cohen's h, the arcsin transform of the difference between proportions) from dichotomous data was described by Snedecor and Cochran [7]. Compared to other measures of effect (e.g. odds ratios, relative risk), Cohen's h provides greater statistical power to detect between-treatment differences when event rates (such as mortality or stroke) are low.

We tested for the presence of statistically important differences between the results of different studies (heterogeneity) using the Q statistic and the I 2 statistic. A statistically significant Q-test would suggest that between-studies variations in study quality or differences in patient characteristics affected the results of some of the studies in our analysis. Because the Q statistic is conservative [8], we adopted a p value of 0.10 as the critical value for statistical significance [9]. I 2 represents the proportion of total variation in estimates of treatment effect due to differences between studies [10]. We adopted a criterion of I 2≥50% as representing substantial between-study differences. Thus, a judgment of consistency in the evidence for a given outcome required that the Q statistic have a p value of ≥0.10 and that the I 2 value be <50%. Since no evidence of heterogeneity was detected in any of our meta-analyses, summary estimates of treatment effect were based on all studies included in each of the meta-analyses.

The aim of sensitivity analysis is to test the robustness of the findings of our original meta-analysis. To accomplish this, we conducted a series of new analyses as recommended by Olkin [11]. This involved the systematic removal of each study to determine the effect of each study on the summary result, additional random-effects meta-analyses, and a repeat of the original meta-analysis using a different effect-size measure (Hedges' d instead of Cohen's h).


   3. Results
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
4. Discussion
 References
 
We identified four RCTs and six retrospective comparative studies that met minimum quality criteria [12–21]. Two other studies were excluded, one due to lack of reporting [22], the other because some patients may not have been medically refractory [23]. Table 1 lists the specific maze procedures used in the included studies. Most are modifications of the maze III procedure. Although these procedures differ in some details, the variations were designed to simplify the procedure, not to improve efficacy. Therefore, a reasonable assumption is that the outcomes of these different procedures should not differ to a significant degree. This hypothesis is testable in the context of meta-analysis. When studies are combined in a meta-analysis, tests of homogeneity will reveal whether the outcomes of the studies are consistent. Indeed, despite the variety of maze-related procedures, none of the meta-analyses described below detected statistically significant heterogeneity among the studies.


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  		Table 1. Maze procedures used in included studies
 
Table 2 compares the included studies in terms of the presence or absence of factors that may affect a study's potential for biased results. Of the seven factors deemed as most important to minimize the potential for bias, the four RCTs had at least six out of seven of these factors (two RCTs had all seven factors). In contrast, the best of the non-randomized studies had only five out of seven of these factors, and the worst had only two out of seven of these factors. Thus, the potential for biased results is much higher in the non-randomized studies.


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  		Table 2. Study design and quality
 
To more specifically identify the likely direction of bias in these studies, we examined patient characteristics that could potentially influence study results (Table 3 ). This table focuses on specific pretreatment differences between patients who did and did not receive maze. These differences could lead to over- or underestimation of the effectiveness of maze. We have indicated the probable direction of bias for studies that had the potential for bias. Six of the 10 studies were vulnerable (in different degrees) to potential biases that might favor better outcomes with the maze procedure. In the remaining four studies, two had no obvious bias and in two others the direction of bias (assuming bias was present) could not be determined.


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  		Table 3. Between-group differences in patient characteristics within individual studies
 
Because of the potential biases in the non-randomized studies, our meta-analyses for mortality, stroke and sinus rhythm restoration included only the four RCTs. Mortality did not show a statistically significant between-group difference (maze 8.4% vs control 5.8%, p = 0.35), but the difference in stroke rates was statistically significant and favored maze (maze 0% vs control 5.8%, p = 0.008). However, a sensitivity analysis removing one study reduced the difference to a non-significant level, indicating that the results are not robust.

Maze was clearly effective in restoring sinus rhythm compared to mitral valve surgery alone (maze 80.7% vs control 17.3%, p<0.000001) for patients with medically refractory atrial fibrillation. This finding was not overturned by sensitivity analyses. The question remains as to whether patients with paroxysmal AF require maze for sinus rhythm restoration. One retrospective study by Handa et al. [17] performed a subgroup analysis of the control patients to compare the percentage of sinus rhythm conversion among patients with paroxysmal AF and those with permanent AF. They found that the percentage of sinus rhythm conversion was much higher (91%) among those with paroxysmal AF than among those with permanent AF (31%) who received mitral valve surgery alone. Although this study suggests that patients with paroxysmal AF may not need maze surgery, a higher quality study is needed to confirm this observation.

We included all 10 studies (non-randomized as well as randomized) in a meta-analysis of need for pacemaker following surgery. Even the non-randomized studies showed a trend toward greater need for pacemaker among patients receiving maze, despite potential bias that would have favored better results in these patients. Therefore, although the magnitude of the effect may not be accurate, the direction of effect is accurate. In spite of potential bias that would have lowered the magnitude of effect, the effect was still statistically significant and favored reduced need for pacemakers in the control group (maze 3.9% vs control 1.5%, p = 0.02). However, a sensitivity analysis using a different summary statistic (Hedges' d) reduced the difference to a non-significant level, indicating that the findings are not robust.

We hypothesized that the post-operative bleeding rate of maze with surgical incisions would be elevated compared to the control surgery (mitral valve alone). Conversely, we hypothesized that the post-operative bleeding rate would not differ between radiofrequency maze and control surgery. We therefore performed two separate meta-analyses of trials evaluating maze with surgical incisions and trials evaluating radiofrequency maze. As expected, the post-operative bleeding rate was elevated when maze with surgical incisions was performed (3.9% vs 0% in control group, p = 0.007). However, the summary result was overturned in a sensitivity analysis removing the study with the largest between-group difference, indicating that the finding is not robust. The bleeding rate did not differ between radiofrequency maze and the control treatment (1.9% vs 2.9%, p = 0.52). However, this meta-analysis included lower quality studies, so the possibility that the lack of observed difference was due to bias cannot be ruled out.

The results of meta-analyses of clinical outcomes are shown in Table 4 and Fig. 1 . To interpret the effect sizes using Cohen's h in Fig. 1, an effect size of 0.2 roughly corresponds to a small effect, 0.5 is equivalent to a moderate effect, and 0.8 is roughly equivalent to a large effect. The outcomes for the different studies were highly consistent (none of the meta-analyses showed statistically significant heterogeneity) despite differences in procedures among the studies. In addition, for all outcomes the results of fixed-effects and random-effects meta-analyses did not differ. The findings suggest that maze-related procedures may reduce stroke risk but also increase the need for pacemaker implantation, as well as increase the risk of post-operative bleeding unless radiofrequency ablation is used. However, with the exception of sinus rhythm restoration, all of the statistically significant findings were overturned by sensitivity analysis, indicating that the findings are not robust. Thus, larger high-quality RCTs are needed to confirm these findings and evaluate other important outcomes such as survival and quality of life.


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  		Table 4. Summary of meta-analyses of maze outcomes
 

Figure 1
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  		Fig. 1. Summary of meta-analyses of maze outcomes. Outcomes are listed to the left of the summary effect sizes.

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
References
 
Maze-related surgery for AF has established itself as a new and well-defined group of surgical procedures. The modalities involved in conducting such procedures include a multitude of energy sources applied by the surgeon as either sole therapy or part of a concomitant procedure. The classical Cox-maze III with the cut and sew technique interrupts most of the arrhythmia circuits in the atria, sustaining prolonged freedom from AF. The Cox-maze cut and sew technique is dependent on the experience of the surgeon and permissible cardiopulmonary physiology that can safely extend the period of myocardial ischemia. These limitations have been noted before and have been the driving force to create a less complex modified operation. Several modifications have been created using the radiofrequency ablation tool applied around the pulmonary veins endocardially or epicardially. Other modifications include transmission of energy (e.g. cryoablation, microwave of sufficient magnitude to cause denaturation of the AF interruption lines). The modified Maze involves variations with ablation line extensions to at least one or more of the following: the mitral annulus, the area around each pulmonary vein(s) or each pair of veins, the coronary sinus and the atrial appendage.

Although Cox et al. performed the majority of maze surgery in patients with lone AF, surgeons currently tend to use the procedure primarily for patients who have drug-refractory AF and concomitant cardiac disease (usually valve-related) that requires open-heart surgery [24,25]. Patients with lone AF have a lower risk of thromboembolic events without treatment, and the risks of open-heart surgery in this patient subgroup seem less justifiable to some practitioners [24,25]. However, certain patients with lone AF may be willing to risk the maze procedure if their AF is associated with intolerable symptoms that are unrelieved by drug therapy. In contrast, patients with valvular disorders will generally require open-heart surgery regardless of whether they receive the maze procedure.

Some controversy exists as to whether certain patients with AF and mitral valve disease should receive a maze procedure. Surgeons who perform maze agree that maze is useful for AF patients who need mitral valve repair, because maze can eliminate their need for anticoagulants (and the associated risk of bleeding). However, others do not believe that the maze procedure is justified for most patients with chronic AF who require prosthetic mitral valve replacement, as these patients will require lifelong anticoagulation even after sinus rhythm restoration. In contrast, other practitioners routinely perform maze with mitral valve replacement because they believe that refractory AF poses an increased risk of stroke even in the presence of anticoagulation [16]. Because none of the available randomized trials separately evaluated these subgroups of patients, we could not compare these subgroups in our report.

Recent advances in understanding the mechanism of AF have led to further simplification of surgical techniques. Electrophysiological mapping of patients with paroxysmal AF have suggested a tendency for reentrant circuits or ectopic foci to exist in the left posterior atrial wall but the right atrium. Most recently, the left atrium has been identified as an electrical driving force and potential sole recipient for the maze procedure. Current thinking centers around the critical zone of the left atrium—the area identified between the region of junction between the left atrium and pulmonary veins in the vast majority of patients. The Bordoux group showed that ablation of beats inside the pulmonary veins with a radiofrequency catheter was effective for long-term elimination of arrhythmia [1].

This critical zone can now be targeted endocardially or epicardially with either incisional ablation or radiofrequency ablation. At the current time, randomized prospective studies have demonstrated that such success can be achieved with modified maze surgical techniques.

In the context of our current study, data from more patients is needed to confirm observations regarding stroke, need for pacemaker, antiarrhythmics and postoperative anticoagulation adjusted for patient risks and surgeon's protocol for anticoagulation and antiarrhythmic medication. We propose that a central registry needs to be kept of all known patient variables pre- and postoperatively for purposes of audit and quality control.

In this report, we assessed the quality of each study, combined acceptable studies in meta-analyses and tested for between-study differences in outcomes using heterogeneity statistics. This type of analysis has been underutilized in the surgical literature. Despite differences in the procedures used in the studies we evaluated, the meta-analyses showed consistent findings for clinical outcomes following maze-related procedures.

This study has notable limitations. Only four of the 10 included studies were RCTs. Although most of the meta-analyses were limited to the RCTs, two of these trials had a potential bias that might have favored better results among patients receiving maze. Another limitation is the small size of the evidence base. Because all of the studies were small, the results of all of the meta-analyzed outcomes except sinus rhythm restoration were overturned upon sensitivity analysis. Thus, future well-designed trials could overturn the results for most of the adverse outcomes we evaluated.

In conclusion, AF is a curable condition irrespective of its prior duration or underlying heart disease. The limited available evidence suggests that surgical eradication of chronic AF may reduce the incidence of stroke, with a small increased risk of need for permanent pacing. Use of energy sources such as RFA to create ablation lines minimizes the risk of bleeding associated with the cut-and-sew technique. Larger randomized trials are needed to confirm these findings and further evaluate survival and quality of life.

At present, the evidence suggests that experienced heart surgeons should continue treating medically refractory AF when feasible simultaneously with mitral valve surgery. Further well-designed clinical research is needed to determine if the benefits of the maze procedure for lone AF outweigh the risks of open-heart surgery. In addition, further randomized trials are awaited to establish the added benefit of maze despite anticoagulation in patients who need prosthetic mitral valve replacement. Future trials are also needed to determine whether patients with different types of arrhythmia (paroxysmal or permanent) benefit equally from the maze procedure. Finally, some potential benefits of maze may not become clear until long-term followup data from well-designed trials becomes available.


   Acknowledgments
 
The authors would like to thank Dr Charles Turkelson for helpful discussions and input during the course of this project.


   References
Top
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 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 References
 

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Jeffrey H. Shuhaiber
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