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Eur J Cardiothorac Surg 2000;17:117-124
© 2000 Elsevier Science NL
InCor-Heart Institute, University of São Paulo Medical School, São Paulo, SP, Brazil
Corresponding author. Av. Dr. Enéas Carvalho de Aguiar 44, Divisão Cirúrgica, 05403-000 São Paulo, SP, Brazil. Tel.: +55-11-3069-5432; fax: +55-11-3069-5415
e-mail: mjatene{at}sherwood.com.br
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Abstract |
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 Top Abstract 1. Introduction2. Materials and methods3. Results4. DiscussionAppendix A. Conference...References |
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Key Words: Atrial fibrillation • Mitral valve disease • Rheumatic fever • Maze procedure • Mitral valve surgery
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1. Introduction |
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TopAbstract1. Introduction2. Materials and methods3. Results4. DiscussionAppendix A. Conference...References |
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As a consequence of the continuation of atrial fibrillation, the risk of thromboembolic events must not be ignored. Prophylactic oral anticoagulation medication is necessary in most patients [1,3].
To find an effective solution for controlling atrial fibrillation in patients with mitral valve disease, a surgical treatment, the maze procedure, proposed by Cox et al. [4–7], has been in use since 1991 in association with the surgical treatment of the mitral valve in a specific group of patients.
The purpose of this study was to evaluate the efficacy of the Cox maze procedure in the treatment of rheumatic atrial fibrillation associated with surgical treatment of the mitral valve, in consecutive patients, and to compare the immediate and mid-term results with a group of patients with atrial fibrillation and mitral valve disease who underwent surgical treatment of the mitral valve only, during the same period.
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2. Materials and methods |
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TopAbstract1. Introduction2. Materials and methods3. Results4. DiscussionAppendix A. Conference...References |
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Patients with previous cardiac surgery, other heart diseases or associated valve dysfunctions were excluded, except for patients with tricuspid regurgitation secondary to the mitral valve disease and one patient with an asymptomatic 50% occlusion in the left anterior descending artery. All patients underwent preoperative echocardiography so that the anatomical features of the cardiac valves, intracavitary thrombus, left atrium diameter and ventricular function could be studied and analyzed.
The study was retrospective. Before the development of the Cox maze procedure, all patients with atrial fibrillation and mitral valve disease were assigned for operation of the mitral valve only, according to previous recommendations of the cardiologist responsible for the patient. After general acceptance of the Cox maze procedure as a method for treating atrial fibrillation, we decided to begin using it in July 1991 to treat a group of patients with rheumatic mitral valve disease and atrial fibrillation, with surgical indication for treating the mitral valve. Most of the patients continued to receive the routine treatment for mitral valve disease and atrial fibrillation, which was to treat only the mitral valve, respecting the patient's cardiologist's recommendation. The other patients were selected to be part of the initial group for the application of the Cox maze procedure, as an institutional protocol to investigate this surgical technique.
Two groups of patients were identified: group I (GI) – patients who underwent concomitant mitral valve repair and atrial fibrillation treatment with the Cox maze procedure and group II (GII) – patients who underwent only the treatment of the mitral valve, with no specific approach used for treating the atrial fibrillation. The two groups were compared later for clinical evolution, echocardiogram parameters and arrhythmia control. GI was composed by 20 patients, ranging in age from 33 to 67 years (50.5±9.7 years), 17 being females. Isolated mitral stenosis was present in 14 patients while six had double mitral dysfunction. GII consisted of 35 patients, ranging in age from 16 to 74 years (51.6±14.7 years), 30 being females. Isolated mitral stenosis was present in 21 patients, double mitral dysfunction in 13 and mitral regurgitation in one.
The information related to preoperative clinical and echocardiographic parameters in the two groups as well as the statistical analysis of the comparison between the groups are presented on Tables 1 and 2.
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2.1. Surgical technique
All patients were operated upon by median sternotomy with cardiopulmonary bypass. In all patients, myocardial protection was performed with moderate hypothermia (25°C), topical hypothermia with cold saline solution in the pericardium and the induction of cardiac arrest with St. Thomas crystalloid cardioplegic solution, repeated every 25–30 min.
In GI patients, extensive and careful isolation of the entire heart commenced with the release of all vessels from extracardiac tissues, pericardial reflections and anatomical grooves. Then heparinization was carried out (4 mg/kg), and separate cannulation of both vena cava and aorta was performed.
Cox maze I [4–7] was used, as originally described, on the first 13 patients, and beginning in September 1993 Cox maze III [8] was used in the remaining seven patients.
In all cases, ventricular pacemaker wire was used, connected to the generator in the cases of bradycardia (less than 70 b.p.m.). Dopamine was administered in all patients in dopaminergic doses (<3mg/kg) to try to improve chronotropic response. Dobutamine was used as an inotropic drug in all cases.
2.2. Statistical analysis
The comparative analysis of the groups was divided into two parts: (1) Comparison of the groups in relation to the pre and postoperative characteristics: Student's t-test for independent samples [9] or Wilcoxon Rank Sum Test [9] for the quantitative variables, and for the qualitative variables the Fisher's [9] exact test was employed; and (2) The evolution data were analyzed with the statistical methods described in part 1, in addition to the Kaplan–Meier [10] method and the Profile Analysis [11], which was used to evaluate the pre and postoperative echocardiograms. A significance level of 5% was used. For the data analysis, the SAS (Statistical Analysis System) was used. Kaplan–Meier [10] method and log rank test were used to estimate and compare survival and embolic free probability in GI and GII.
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3. Results |
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TopAbstract1. Introduction2. Materials and methods3. Results4. DiscussionAppendix A. Conference...References |
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3.2. Mortality rate
Mortality during the first 30 days was 5.4% (three patients), one death in GI (low cardiac output syndrome in a 57-year-old female with isolated mitral stenosis, preoperative CHF functional class IV). The other two deaths occurred in GII patients (low cardiac output in a 50-year-old female patient with double mitral dysfunction and CHF functional class IV); the second death occurred on the 28th postoperative day after acute respiratory insufficiency, a pulmonary embolism being verified soon after the readmission to the hospital.
3.3. Complications
Low cardiac output syndrome was the most common complication. It was reported in two patients in GI and three in GII. One patient in GI was re-operated upon to control bleeding and another patient was re-operated upon to replace an infected bioprosthesis (Enterococcus faecalis). Both made a good recovery.
3.4. Postcardiopulmonary bypass and mid-term rhythm evaluation
The postcardiopulmonary bypass cardiac rhythm evaluation demonstrated that all GI patients reverted from atrial fibrillation to regular rhythm, 15 (75%) being in sinus and five (25%) being in junctional rhythm. In GII, 13 (37.1%) patients remained in atrial fibrillation after cardiopulmonary bypass and 22 (62.9%) reverted to sinus rhythm (P<0.0001). In the ICU, it was observed that 4 (20%) patients from GI had atrial fibrillation, but all reverted to regular rhythm. In GII, 28 (80%) patients experienced atrial fibrillation in the ICU (P=0.0001) and only four reverted to sinus rhythm. When analyzing the evolution of atrial fibrillation in the patients, it was observed that 5.3% of GI patients had atrial fibrillation compared with 76.5% in GII (P<0.0001) (Table 4). No differences in postoperative heart rhythm was observed between patients with mitral valve repair, compared with those with mitral valve replacement.
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3.6. Postoperative clinical findings
In the preoperative period, all patients had CHF functional class III or IV. In the postoperative period, CHF functional class I occurred in 73.7% of the patients in GI and 64.7% of those in GII (P=0.143).
With regard to the use of medication after surgery, 50% of the patients in GI were using no medication in comparison with 9.1% in GII (P=0.0001); 35% of patients in GI were receiving two or more drugs (digitalis or diuretic and/or oral anticoagulant) compared with 79.6% in GII (P=0.0001). Anticoagulant (dicumarol) was not used for patients in sinus rhythm. For those in AF the anticoagulant regimen was variable, depending on the cardiologist opinion. Most of the patients were receiving dicumarol, some cases only aspirine and few cases with no medication.
During follow-up (median of 38.5 months in GI and 41.1 months in GII), four deaths occurred, two in GI (pulmonary infection on the 40th postoperative day and renal failure 3 years after surgery) and two in GII (CHF progression and gynecological neoplasia, both 3 years after surgery). The survival curve of the two groups was not significantly different statistically (P=0.7291), with a survival probability of 84% in 36 months for GI and 87.7% in 36 months for GII.
In the same follow-up period, the patients underwent echocardiographic evaluation. No difference occurred in the diameter of the left atrium in the postoperative period (GI and GII, 4.85 cm and 5.0 cm, respectively; P=0.2013). No differences were observed in ejection fraction in the postoperative period, being 0.72 in GI and 0.70 in GII (P=0.9913). Atrial contraction was demonstrated in all GI patients with regular rhythm, being more effective in the right atrium in comparison with the left atrium. No marked difference in outcome occurred among patients regardless of the surgical technique used (Cox maze I, 13 patients; Cox maze III, last seven patients).
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4. Discussion |
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TopAbstract1. Introduction2. Materials and methods3. Results4. DiscussionAppendix A. Conference...References |
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Mitral valve disease is the disease that occurs most frequently in association with atrial fibrillation. Jatene et al. [14], Gregori Jr. et al. [15], Kosakai et al. [16,17] and Sandoval et al. [18] have reported on the treatment of atrial fibrilation associated with mitral valve disease. The clinical symptoms caused by valvular heart disease are frequent indications for surgery; however, in our study, 55% of the patients in GI experienced frequent tachycardiac palpitations.
Another issue to be considered is previous history of thromboembolic events, which were present in four GI patients. In our opinion, these cases have a clearer indication for the Cox maze procedure, because of the occurrence of possible new thromboembolic events, despite the use of anticoagulation therapy [16].
Analyzing mid-term follow-up of GI patients, we observed satisfactory control of heart rhythm, which is the same finding as that of our initial experience with the Cox maze procedure and mitral valve treatment [14]. Similar results in the control of atrial fibrillation in patients with valvular heart disease were reported by Gregori Jr. et al. [15] and Kosakai et al. [16,17] in a series of 62 patients with mitral valve disease, with successful control of atrial fibrillation in 84% of these patients. The control of atrial fibrillation in GI patients in our study may be considered satisfactory, with reversion to regular rhythm in all cases after cardiopulmonary bypass, and maintenance of the results in 95% of patients.
4.1. Mortality rate
The hospital mortality rate was 5.4%, being 5.0% in GI (one patient) and 5.7% in GII (two patients). The literature shows mortality ranging from 0 to 7.0% in the initial series of patients with isolated atrial fibrillation [8,12,19,20]. Mortality ranged from 0 to 5.8% in the patients treated with the Cox maze procedure in association with other surgical procedures, such as mitral valve treatment [14,15,17,18]. We did not observe a difference in hospital mortality between GI and II, allowing us to conclude that the association of the Cox maze procedure with mitral valve treatment does not increase hospital mortality.
4.2. Low cardiac output
Low cardiac output occurred in five patients in our study, two patients in GI and three in GII; its treatment was carried out with the use of inotropic drugs in all the cases or with circulatory support with an intra-aortic balloon pump. Kosakai et al. [17] and Sandoval et al. [18] reported the same approach and similar results. Low cardiac output was also observed in patients who underwent treatment for valvular heart disease only, which was present in 4.1% of the patients with previous atrial fibrillation, as Chua et al. [3] demonstrated.
4.3. Complications from the Cox maze procedure
The Cox maze procedure is a complex surgical operation that requires a careful surgical technique, several incisions and the potential for bleeding, which, however, is not a frequently observed complication. Only the first patient in the series needed to be re-operated upon due to bleeding. Cox et al. [8,20] reported a 7% incidence of reoperation and in a more recent study 9.7%. Kosakai et al. [16,17] showed an incidence of reoperation around 8.0% in a group of patients who underwent surgical treatment of atrial fibrillation and of the mitral valve.
One of the complications directly related to the Cox maze procedure, which was reported earlier by Cox et al. [20] in 71% of treated patients, is the tendency toward fluid retention with pulmonary congestion during the immediate postoperative period, specially in patients with isolated atrial fibrillation. However, in other patients with mitral valve disease and atrial fibrillation in whom the two diseases were treated concomitantly, fluid retention with pulmonary congestion was rare [14,16–18].
4.4. Surgical aspects
No differences were observed in GI patients who underwent the Cox maze I or Cox maze III procedures. The original technique (Cox maze I) was employed in the first 13 patients and the modified technique (Cox maze III) in the subsequent seven patients. No statistical differences were observed between patients who underwent Cox maze I vs. Cox maze III with regard to preoperative clinical and echocardiographic findings, ECC and clamping time, cardiac rhythm, and postoperative clinical and echocardiographic evolution. The P-value was always greater than 0.05. Total time of the surgery took a median of 480 min for those who underwent the Cox maze I procedure and 375 min for the Cox maze III procedure (P=0.0078).
The Cox maze procedure performed in association with the mitral valve approach proved to be difficult, requiring greater cardiopulmonary bypass and anoxic arrest times. In patients in GII the average time of cardiopulmonary bypass, aortic clamping and total surgery time were, respectively, 64.9, 46.5 and 269.1 min. In GI, however, these times were longer: 158.6, 125.9 and 450 min, respectively. Long times of cardiopulmonary bypass were described by Cox et al. [20] and McCarthy et al. [12], who reported average times of 184 and 143 min in a group of patients who underwent the Cox maze procedure alone without associated procedures. Kosakai et al. [17] reported an average ECC time of 226 min and average aortic clamping time of 142 min in patients similar to the those in our study. Such results demonstrate that the Cox maze procedure requires a longer operating time, not only when it is performed in association with surgical treatment for the mitral valve but also when performed as an isolated procedure.
4.5. Embolic events
The occurrence of embolic events in the preoperative period in patients with mitral valve disease, although more frequently associated with atrial fibrillation, occurs also frequently in patients with sinus rhythm [21]. A variable incidence of embolic events occurred in the postoperative period. Montoya et al. [22] reported that 4% of the patients operated upon for isolated mitral stenosis had postoperative emboli at different time intervals, despite anticoagulation therapy. Herrera et al. [23] reported an incidence of 9.7% of central and peripheral emboli, during a time interval ranging from 1 to 189 months, 60% with atrial fibrillation, and half of the patients receiving oral anticoagulation.
In GII patients in our study, the incidence of embolic events was 21.2% during a period of time that ranged from 1 day to 46 months after surgery. Six of these patients were in atrial fibrillation, one was in sinus rhythm prior to the embolic event, and two were receiving oral anticoagulation medication. No patients in GI showed any signs of embolic events during the study period, which reinforces the idea that the maintenance of regular rhythm, decrease in left atrium dimensions and treatment of valvular lesions are factors that together may prevent such events.
4.6. Control of rhythm
Even in the patients who underwent the Cox maze procedure, atrial fibrillation occurred in the immediate postoperative period. Cox et al. [8] reported an incidence of atrial arrhythmias greater than 34% with 6.3% of patients being in atrial fibrillation. Kosakai et al. [17] reported an occurrence of atrial fibrillation or atrial flutter of 43.5% in the first 2 weeks of the postoperative period in patients with atrial fibrillation and mitral valve disease. Atrial fibrillation occurred in 20% of GI patients, with restoration to sinus rhythm and mid-term regular rhythm maintenance in all patients, except one who continued to have atrial fibrillation. After this initial period, the tendency toward maintaining regular rhythm was clearly observed and reported in the GI patients’ evaluations and in reports by Cox et al. [8,20] and Kosakai et al. [16,17].
4.7. Clinical information
Both GI and GII patients achieved a significant improvement in NYHA functional class in the postoperative period. We believe that treatment of the valvular lesion is the main reason for the clinical improvement. A report with up to 18 years of postoperative follow-up of isolated mitral valve operations [24] demonstrated that most patients progress to CHF functional class I and II, a clinical worsening, during the follow-up that is related to the recurrence of the valvular lesion. Clinical decompensation caused by atrial fibrillation is less frequently reported.
4.8. Postoperative medication
Fifty percent of GI patients had not been using any kind of medication during the study period, but 35% had been using two or more drugs. In contrast, in GII most of the patients (79.6%) were using two or more drugs. Similarly, Kawaguchi et al. [25] reported that 73% of patients who underwent the Cox maze procedure and mitral valve disease correction no longer needed to use anticoagulation medication, in addition to 15% who discontinued all medications.
4.9. Late mortality
Two patients in GI and two in GII died. In only one patient in GII did death have a cardiac origin (progressive ventricular dysfunction, without valvular dysfunction). The other patients died of pulmonary infection, chronic renal failure and gynecological neoplasia. Herrera et al. [23] report an incidence of late mortality of 9.5–15% in patients who underwent surgical treatment of the mitral valve. The causes were both cardiac (valvular dysfunction, thromboembolism, ventricular dysfunction and sudden death) and non-cardiac in origin and some causes were unknown.
In conclusion, the Cox maze procedure is effective for controlling atrial fibrillation and is considered a consistent therapeutic option for patients with atrial fibrillation associated with rheumatic mitral valve disease. It's not absolutely clear that it could prevent thromboembolic events, but they were less frequent in GI patients. It was also observed that less medication was used in GI patients during mid-term evolution, in comparison with GII patients.
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Footnotes |
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Appendix A. Conference discussion |
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TopAbstract1. Introduction2. Materials and methods3. Results4. DiscussionAppendix A. Conference...References |
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Dr M. Jatene: These 20 patients in group I were the first patients, and we chose these first 20 patients to have a longer follow-up period. We have now almost 100 patients in the Maze group and many others as the patients in GII. To come to these 55 patients we exclude some patients, including the patients with no previous surgery, no aortic valve disease, only mitral valve patients in first operation. And about the first question?
Dr Melo: Regarding contractility, because what concerns me on the maze operation is that if you do so many incisions on the atria it is difficult to believe that the atria will be contractile.
Dr M. Jatene: We can see contractility by echo and by NMR, and from these 20 patients, the 13 first patients were operated with the maze I procedure, and after September 1993, all patients were operated with maze III. What we saw is that the right atrial contraction with maze I is much better than the left, because there was a delay in the conduction of the stimuli by the roof of the left atrium, and with the change of the technique we are now observing in all patients with maze III a similar contraction; in right atrium and left atrium. We could see this contraction; about 87–90% of the patients we could observe very clearly the contraction despite the number of incisions.
Dr J. Defauw (Wyk by Duurstede, The Netherlands): Did you see any relation between the time of duration of atrial fibrillation and the return to sinus rhythm?
Dr M. Jatene: We tried to see these. There were not so many patients to do this study. But all patients had atrial fibrillation more than 18 months of duration preoperatively, and we have a lot of papers in the literature that said that the two main risk factors to maintain the atrial fibrillation is the duration of the atrial fibrillation and the left atrium size. Only one patient in the maze group remained in atrial fibrillation, and we couldn't compare this one patient to the other 18 or 19 patients. There was no statistic possibility to do this and we couldn't give this answer just now.
Dr G. Rizzoli (Padua, Italy): I would like to know how important is it, in the presence of a dilated left atrium, to reduce the size of the left atrium together with this operation to interrupt the circulation to the stimulus?
Dr M. Jatene: Yes, this is an important point. We agree with you. There are many techniques. I think the common goal is to reduce the left atrium size, and as Dr. Cox said, the critical mass concept as an electrophysiological basis is very important, and reducing the left atrium size, I think most of the patients could control the atrial fibrillation.
Dr M. Sarsam (Belfast, UK): We have a much smaller series of Maze III procedure than yours. We have found that in patients with primary AF or AF in association with ASD, they all go back into sinus rhythm. In contrast, only two thirds of patients with chronic AF in association with mitral valve disease, are reverting into sinus rhythm and remain in sinus rhythm a year after surgery. Since we are doing the same operation, it appears that these are two different pathologies. Among the mitral patients, as the last speaker had mentioned, we have identified a large left atrium and age over 70 to be negative factors. Can you explain the discrepancy between our results and yours and also the results coming from Japan that only two thirds of mitral patients are really going back into sinus rhythm after the maze procedure?
Dr M. Jatene: I think the results are similar. This is not a large number of patients. These are the first initial patients and a selected group. But I agree that between 75, 80 to 90% is what we could reach in mitral valve patients, not more. It depends on many factors, as we've talked before. One reasonable factor must be a histological pathology in atrium walls, due to the mitral disease, especially in rheumatic patients. But I think that the idea is the same. For isolated atrial fibrillation and atrial fibrillation with ASD or with CABG associated, I think we are very close to 100%, but with mitral valve patients this number decreased to 85, 90%. I agree with you.
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References |
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TopAbstract1. Introduction2. Materials and methods3. Results4. DiscussionAppendix A. Conference...References |
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