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J Thorac Cardiovasc Surg 2002;124:575-583
© 2002 The American Association for Thoracic Surgery

Surgery for Acquired Cardiovascular Disease (ACD)

Impact of Cox maze procedure on outcome in patients with atrial fibrillation and mitral valve disease

From the Departments of Cardiovascular Surgery^a and Cardiology,^c National Cardiovascular Center, Osaka, and Takarazuka Municipal Hospital,^b Takarazuka, Japan.

Read at the Eighty-first Annual Meeting of The American Association for Thoracic Surgery, San Diego, Calif, May 6-9, 2001.

Received for publication May 15, 2001. Revisions requested July 27, 2001; revisions received Dec 20, 2001. Accepted for publication Dec 27, 2001. Address for reprints: Ko Bando, MD, Department of Cardiovascular Surgery, National Cardiovascular Center, 5-7-1, Fujishirodai, Suita, Osaka, 565-8565, Japan (E-mail: kobando{at}hosp.ncvc.go.jp).

	Abstract

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 
Objective: We sought to determine whether the Cox maze procedure provides additional benefit to patients with atrial fibrillation undergoing mitral valve operations.
Methods: Between May 1992 and August 2000, we performed 258 Cox maze procedures with mitral valve replacement (n = 147) or mitral valve repair (n = 111). We compared the outcomes of these patients with those of 61 control patients with preoperative atrial fibrillation who underwent mitral valve replacement alone during the same interval. The three cohorts were similar in age, sex, and proportion of patients in preoperative New York Heart Association functional class 3 or 4.
Results: Although 5-year survivals were similar among the groups (94% for mitral valve replacement alone, 95% for mitral valve replacement plus maze, and 97% for mitral valve repair plus maze), freedoms from atrial fibrillation at 5 years were significantly higher in the mitral valve replacement plus maze group (78%) and the mitral valve repair plus maze group (81%) than in the mitral valve replacement group (6%, P < .0001). Freedoms from stroke at 5 years were 97% for the mitral valve replacement plus maze group, 97% for the mitral valve repair plus maze group, and only 79% for mitral valve replacement group (P < .0001). Multivariable analysis with Cox hazard model revealed that the most significant risk factor for late stroke was the omission of the Cox maze procedure (P = .003).
Conclusions: The addition of the Cox maze procedure to mitral valve repair and replacement was safe and effective for selected patients. Elimination of atrial fibrillation significantly decreased the incidence of late stroke.

	Introduction

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 

View larger version (125K): [in this window] [in a new window]   Dr Bando

	Patients and methods

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 
Between May 1992 and September 2000, we performed 258 Cox maze procedures combined with mitral valve replacement (MVR/maze, n = 147) or repair (MVP/maze, n = 111) at the National Cardiovascular Center, Osaka, Japan. We compared the outcomes of these patients with those of 61 patients with preoperative atrial fibrillation who underwent MVR alone during the same interval.

We retrospectively reviewed the data from operative notes, anesthesia records, clinical case histories, and laboratory investigations, including electrocardiograms, echocardiograms, and cardiac catheterization reports. Follow-up data were collected from National Cardiovascular Center records of outpatient visits and correspondence with referring physicians. A total of 319 clinical hemodynamic, electrocardiographic, and echocardiographic variables were entered into a computerized database and analyzed. Follow-up data for more than 6 months after the operations were available for all patients. Morbid events were analyzed for both the early (in hospital) and late (after discharge) periods. Stroke was defined as cerebral thromboembolism and was clearly differentiated from transient ischemic attack.

Patients
Demographic data and preoperative cardiac information are given in Table 1. Although the proportions of patients with left atrial thrombus were similar in all groups, the MVR/maze group had a higher incidence of previous stroke. Patients who underwent MVR alone had a higher incidence of previous heart surgery (Table 1). With respect to preoperative heart rhythm, most patients in each group had chronic atrial fibrillation. A maze procedure combined with mitral valve repair (MVP/maze; n = 4) or replacement (MVR/maze; n = 3) was performed for 7 patients who had multiple episodes of paroxysmal atrial fibrillation necessitating long-term anticoagulation. The duration of preoperative atrial fibrillation was significantly longer among patients with MVR alone than among patients who underwent MVP/maze or MVR/maze (Table 1). Patients undergoing MVR without a maze procedure had the maze procedure omitted primarily because of multiple previous heart operations, duration of preoperative atrial fibrillation longer than 20 years, f-wave in V₁ leads less than 0.1 mV, left atrial dimension larger than 70 mm, and emergency surgery.

View larger version (54K): [in this window] [in a new window]   Fig. 1. Techniques of maze procedure performed in this study. A, Cox maze III procedure; B, Kosakai maze procedure; C, Cryomaze procedure. SVC, Superior vena cava; RAA, right atrial appendage; LAA, left atrial appendage; LSA, left sinus node artery; RSA, right sinus node artery; SN, sinus node, PSA, posterior sinus node artery; IVC, inferior vena cava; MV, mitral valve; TV, tricuspid valve; FO, foramen ovale.

	Results

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 
Pathophysiologic characteristics of mitral valve disease and operative findings
The pathophysiologic characteristics of the mitral valve disease and the concomitant procedures are depicted in Table 2. There were no significant differences between the groups in terms of the incidence of associated procedures. All patients underwent surgery with mild hypothermia and combined antegrade and retrograde blood cardioplegia. The aortic crossclamp times and cardiopulmonary bypass times were not significantly different among the groups. The proportions of patients who underwent concomitant ligation of the left atrial appendage were similar among the groups (MVR, n = 45/61, 74%, MVR/maze, n = 102/147, 69%, and MVP/maze, n = 77/111, 70%, P = .79).

Survival and late outcomes
All patients were observed for at least 6 months after the operation. Although the actuarial 5-year survival of the patients with MVR alone (94%) was lower than those of the MVR/maze (95%) and MVP/maze (97%) groups, this difference did not reach statistical significance (P = .18; Figure 2). There were 10 late deaths. In the MVR alone group, 2 patients died of unknown causes, 1 had intracerebral bleeding, 1 had cerebral infarction, and 1 died of an arrhythmia. In the MVR/maze group, 4 late deaths were due to intracerebral bleeding (n = 1), arrhythmia (n = 1), left ventricular rupture (n = 1), and pneumonia (n = 1). In the MVP/maze group, 1 late death was caused by liver cancer.

View larger version (16K): [in this window] [in a new window]   Fig. 2. Actuarial survival curves for MVP/maze (solid line, n = 111), MVR/maze (long and short dashed line, n = 147), and MVR (dotted line, n = 61) groups. Error bars indicate 95% confidence interval. P = .1762 by log-rank test.

View larger version (16K): [in this window] [in a new window]   Fig. 3. Freedom from recurrence of atrial fibrillation (AF) curves for MVP/maze (solid line, n = 111), MVR/maze (long and short dashed line, n = 147), and MVR (dotted line, n = 61) groups. Error bars indicate 95% confidence interval. P < .0001 by log-rank test.

View larger version (17K): [in this window] [in a new window]   Fig. 4. Freedom from late stroke curves for MVP/maze (solid line, n = 111), MVR/maze (long and short dashed line, n = 147), and MVR (dotted line, n = 61) groups. Error bars indicate 95% confidence interval. P < .0001 by log-rank test.

Preoperative and postoperative medications
The spectra and intensities of preoperative antiarrhythmic drugs were comparable among the three cohorts, but after the operation the number of antiarrhythmic agents decreased with time in the combined MVR/maze and MVP/maze groups. At most recent follow-up, 35% of the patients in the MVR/maze group and 48% of the patients in the MVP/maze group needed no antiarrhythmic agents, whereas only 13% of those in the MVR group did not need these medications (P < .0001). The vast majority of patients in the MVR group continued to receive ß-blockers and digoxin for heart rate control.

With respect to warfarin, 100% of the patients in the MVR group and 97% of the patients in the MVR/maze group were receiving warfarin at most recent follow-up, whereas only 35% of the patients in the MVP/maze group required warfarin (P < .0001). In the MVP/maze group, warfarin administration was continued for patients who had at least one episode of postoperative atrial fibrillation.

Risk factors for recurrence of atrial fibrillation
Risk factors for recurrence of atrial fibrillation were analyzed by univariate and multivariable analyses. According to univariate analysis, omission of the maze procedure and duration of chronic atrial fibrillation for longer than 20 years were significant risk factors for recurrence of atrial fibrillation. According to multivariable analysis, the omission of a maze procedure and longer duration of chronic atrial fibrillation were risk factors for recurrent atrial fibrillation (Table 4).

Risk factors for late stroke
According to univariate analysis, the omission of a maze procedure and recurrence of atrial fibrillation 1 month after surgery or at the time of discharge were risk factors for late stroke (Table 5). According to multivariate analysis, the omission of a maze procedure was the most significant risk factor for late stroke (Table 5). Except for 2 of the patients in the MVR group, all patients had adequate anticoagulation with warfarin at the time of any strokes.

	Discussion

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

In our study more than 97% of patients who underwent a combined maze procedure and mitral valve operation survived the operations, and 95% to 97% of those patients are still alive 5 years later (Figure 2). Furthermore, the addition of maze procedures to the mitral valve operations did not increase the number of morbid events in the immediate postoperative period. These results confirm the safety of a maze procedure as an adjunct to MVP or MVR.

Maintenance of normal sinus rhythm after a maze procedure improves atrial function. ¹² However, the most important potential benefit of the maze procedure is prevention of late stroke. ⁷ Our results indicated that a maze procedure combined with a mitral valve operation restored regular rhythm in 84% to 85% of patients at 3 years after surgery (Figure 3), whereas only 6% of patients with MVR alone avoided recurrent atrial fibrillation at 3 years after surgery. Accordingly, 97% of these patients were free from late stroke at 5 years after surgery, compared with only 79% of patients who underwent MVR alone.

Some surgeons do not perform maze procedure in addition to MVR with mechanical valves because these patients receive systemic anticoagulation after surgery. In our study, however, 8 of the 10 late strokes among patients receiving optimal anticoagulation with warfarin occurred after MVR with mechanical valves. These results indicate that although anticoagulation is beneficial, it does not abolish the risk of stroke associated with atrial fibrillation. ^13-15 Furthermore, these results indicate that the current anticoagulant strategy of warfarin alone may not be adequate to prevent late strokes among these patients. ¹⁶

Risk factor analysis for late stroke revealed that the omission of a maze procedure and recurrent atrial fibrillation at discharge were significant risks according to univariate analysis (Table 5). According to multivariate analysis, the omission of a maze procedure was the most significant risk for the development of late stroke (Table 5). Moreover, in the MVR/maze and MVP/maze groups, late strokes occurred in 4 patients in whom atrial fibrillation recurred after an unsuccessful maze procedure. These findings confirm that the restoration of sinus rhythm after mitral valve surgery by a maze procedure is the most effective means of preventing late strokes.

The major limitation of our study is that it was not randomized, and there were significant differences between the baseline characteristics of patients in the MVR group and the combined maze procedure groups. The decision for or against an adjunct maze procedure reflected the surgeon's experience. As previously mentioned, however, we omitted the maze procedure for most patients who had multiple previous heart operations, preoperative atrial fibrillation for longer than 20 years, f-wave in V₁ leads less than 0.1 mV, severely enlarged left atrial dimension greater than 70 mm, or emergency surgery. Thus, the patients who underwent MVR alone may have been at higher risk than those who underwent combined procedures. This may be the primary reason for a somewhat lower late survival among the patients with MVR alone than among the patients in the other two groups. Another limitation of this study is that only some of the patients in each group underwent preoperative and postoperative cardiopulmonary exercise tests. Although most patients in each group were in New York Heart Association functional class I or II after the operation, further study to assess the late functional outcomes should be conducted. Although this study confirms the importance of maintaining sinus rhythm in the prevention of late strokes, the precise mechanism behind this process remains unclear. A prospective study would be needed to differentiate the roles of arrhythmia, cardiac function, microbubbles, and other factors in the occurrence of stroke and to determine the most effective regimen of anticoagulation and antiplatelet agents to minimize the risk of late bleeding and stroke.

We conclude that the addition of the Cox maze procedure to MVP and MVR is safe and effective for selected patients. The incidence of late stroke was significantly decreased in patients undergoing combined maze and mitral valve procedures.

	Appendix: Discussion

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 
Dr Renee Hartz (New Orleans, La). Although Bando and coworkers have clearly demonstrated a marked reduction in morbidity after mitral valve surgery when a maze procedure or a variant of the maze procedure was added to the operation, the validity of referring to a "control" group in this series can be questioned. Perhaps statistical comparisons have been meaningful or more valid if the groups had been referred to as "treatment" and "nontreatment" groups.

Specifically, Dr Bando, please address the following issues. First, in the MVR/maze group, did you consider simply ligating the atrial appendage, with or without adding a reduction in atrial size? With closely monitored anticoagulation, might you not have observed the same freedom from stroke at 5 years as you did with the maze procedure itself?

Second, in the MVP/maze group, the incidence of chronic atrial fibrillation was very high (95%), yet 85% of this cohort had pure mitral regurgitation and therefore presumably degenerative pathophysiology. Yesterday we learned from Carpentier and colleagues that 60% of the patients in their group with degenerative disease were in normal sinus rhythm after the operation. Can you reconcile this difference? Are you seeing patients later in the course of the disease than are surgeons in some our countries?

By extension, why was your freedom from stroke in this group, the MVP/maze group, only 78% at 5 years? In your article, you refer to "periods of inadequate anticoagulation." Who monitors your patients, and what is your chosen target international normalized ratio?

Finally, did you consider routine appendage ligation in all cases, even in your supposed control group? And did you consider ablation only with mapping techniques in extremely high-risk cases, ablating the site of origin, which we know can be determined before or during the operation?

It has been stated at this meeting and elsewhere that the maze procedure is the criterion standard for the curative treatment of atrial fibrillation. It has been a privilege to discuss this work, especially at a meeting where several presentations have documented expanding indications for this important operation and at which the presidential address was delivered by its inventor. You and your group should be commended for reducing the incidence of stroke by any means available in a large group of patients with valvular heart disease who are therefore at high risk for stroke.

Dr Bando. Regarding your first question, part of the answer is that it may not be appropriate to call the MVR alone group a "control" group. As you are aware, this was a nonrandomized retrospective study, and the background characteristics of these three cohorts were different. However, the key message in my presentation is that if you do not do a maze procedure and chronic atrial fibrillation continues, that is the most significant risk factor for late stroke, and in that regard I believe that our observation is valid.

Your second question is whether simple ligation of appendage and the reduction of left atrial size may result in the same effect as the maze operation of preventing late stroke. I think that the answer is no. As indicated in my presentation, 2 patients in the maze group had late strokes after unsuccessful maze procedures, although these patients had left atrial appendage ligation and were receiving adequate anticoagulation at the time of the stroke. Thus, the maintenance of a regular rhythm and re-establishment of atrial contraction is important in preventing stroke.

The third question relates to the MVP in the maze group. As you mentioned, 85% of this group had mitral regurgitation, but this included predominant mitral regurgitation, and some patients had a component of mitral stenosis as well. Therefore, this does not represent pure mitral regurgitation. In this group 45% of the patients had rheumatic changes, and this probably resulted in the difference between the Western population and the Japanese population. That may be the reason for the difference between our data and those of Carpentier and colleagues.

Our target international normalized ratio, which is monitored by our cardiologists at the National Cardiovascular Center and by a local physician, is 2.0 to 3.0. This is somewhat lower than the Western standard, but it is based on the preparing guidelines of the Japanese Circulation Society and American College of Chest Physicians.

Finally, would I ligate all atrial appendages? As I mentioned before, I preserve the appendage to maintain the production of atrial natriuretic peptide, but I tie from the outside if I do not have enough time or close from the inside while preserving the appendage.

Dr Lawrence Cohn (Brookline, Mass). I assume these were the classic surgical interruptions of the tracts in the atrium. Do you have experience with the newer radiofrequency techniques? Do you use these at all?

Dr Bando. Actually, we have just started and have done 1 case.

	Acknowledgments

 
We thank Drs Toshihiko Sato, Kanshi Komatsu, and Hiroyuki Konishi for their assistance with statistical analysis and Drs Kazuo Niwaya and Osamu Tagusari for allowing us to include their patients. We also thank Drs. Thomas Sharp and Noel Mills for their constructive comments.

	References

Top Abstract Introduction Patients and methods Results Discussion Appendix: Discussion References

 

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