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Ann Thorac Surg 2006;81:1529-1535
© 2006 The Society of Thoracic Surgeons

Review

Physiologic Versus Anatomic Repair of Congenitally Corrected Transposition of the Great Arteries: Meta-Analysis of Individual Patient Data

Abdullah A. Alghamdi, MD * , Brian W. McCrindle, MD, Glen S. Van Arsdell, MD

Division of Cardiac Surgery and Congenital Cardiac Surgery Program, Department of Surgery, University of Toronto, Toronto, Ontario, Canada

Accepted for publication September 15, 2005.

* Address correspondence to Dr Alghamdi, Division of Cardiac Surgery and Congenital Cardiac Surgery Program, The Hospital for Sick Children, 555 University Ave, Suite 1525, Toronto, ON, Canada M5G 1X8 (Email: abdullah.alghamdi{at}utoronto.ca).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 Conclusion
 References
 
The objective of this meta-analysis of individual patients' data was to compare the immediate outcomes of anatomic and physiologic repair of congenitally corrected transposition of the great arteries. Eleven nonrandomized studies, involving 124 patients, met the inclusion criteria for this review. The Rastelli type anatomic repair and the era of surgery were significantly related to the outcome in different tested models. Entering all variables into the logistic regression model showed a significant protective effect of the Rastelli type anatomic repair (odds ratio = 0.05, 95% confidence interval: 0.01, 0.50, p = 0.02).


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 Conclusion
 References
 
Congenitally corrected transposition of the great arteries (CCTGA) is a congenital cardiac anomaly that is characterized by atrioventricular (AV) and ventriculoarterial (VA) discordant connection [1]; thus, physiologically corrected. It accounts for less than 1% of congenital heart diseases [2] and is almost always associated with coexistent cardiac anomalies [3]. Ventricular septal defect (VSD) is the most common coexisting anomaly and is present in about 80% of the cases [1]. Other coexisting anomalies include the following: pulmonary valve stenosis or atresia, atrial septal defect, systemic (tricuspid) valve abnormalities, and heart block [2, 4].

The classical surgical approach to CCTGA has been to repair the associated lesions without addressing the AV and VA discordance. In this approach, the morphologically right ventricle remains as the systemic ventricle and the morphologically right AV valve (tricuspid) remains as the systemic AV valve [5]. Concerns about the long-term function of the morphologic right ventricle and the systemic AV valve (tricuspid) have led to the concept of anatomic repair that incorporates the morphologically left ventricle and morphologically left AV valve (mitral) in the systemic circulation [6].

To date, there are no studies comparing the immediate outcomes of these surgical approaches. Reports of small, single-center studies assessing immediate results of either anatomic or physiologic surgical approaches were encouraging so that it appeared to be of scientific and practical importance to collect the individual patients' data into one large database. Such an approach may yield a more precise estimate of the effect of each surgical approach on immediate outcomes over a wide range of the spectrum of CCTGA patients. The objective of this review was to meta-analyze individual patients' data to compare the immediate outcomes of anatomic and physiologic repair of CCTGA.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 Conclusion
 References
 
Inclusion and Exclusion Criteria
All published studies that included patients with CCTGA who underwent a definitive repair procedure were included. The intervention was the definitive repair of CCTGA (defined as physiologic or anatomic repair). Physiologic repair entails utilizing the morphologic right ventricle (RV) as a systemic ventricle and addressing the associated intracardiac lesions such as a VSD. Anatomic repair entails addressing the anatomic correction of CCTGA; therefore, the morphologically left ventricle supports systemic circulation. In the anatomic repair, the atrial switch procedure (Senning or Mustard) is combined with either an arterial switch or ventricular (Rastelli) level repair. The primary outcome was the incidence of postoperative all-cause in-hospital mortality. Studies that met any one of the following criteria were excluded: failure to measure the outcome of interest (ie, in-hospital mortality), unspecified period of follow-up, insufficient patients' data, and inability to extract individual patients' data (eg, when a study provides aggregate data only).

Literature Search and Data Extraction
Studies were identified by searching MEDLINE, EMBASE, and the Cochrane controlled trial register (CCTR) on the Cochrane library from the earliest achievable date of each database to May 2005, supplemented by manual search of reference lists of retrieved studies. The following terms and keywords were used: [transposition of great vessels OR congenitally corrected transposition of the great arteries OR CCTGA OR (corrected AND transposition)]. The highly sensitive search strategy for identifying clinical controlled trials in MEDLINE was also used [7]. No language restrictions were applied.

The studies retrieved by the search strategy were reviewed by one reviewer (AA) and relevant studies were selected according to the definitions in the inclusion and exclusion criteria. A bibliographic software (Reference Manager V.10; Thomson Scientific, Philadelphia, PA) was used to download all references and ensure the absence of duplication of references. Data were extracted by the above reviewer. Data collected from each study included individual patients' data on the following: age at the time of definitive repair, type of repair, presence of ventricular septal defect, preoperative pulmonary valve abnormality, preoperative tricuspid valve abnormality, preoperative arrhythmia, preoperative shunting procedures, and in-hospital mortality. Reason(s) for exclusion were documented for all excluded studies. Data were extracted onto predesigned data abstraction forms.

Data Analysis
The statistical software package SAS (version 8.2, SAS Institute, Cary, NC) was used for all statistical analyses. Categorical variables were summarized as frequencies and percentages, and continuous variables as means and standard deviations. Categorical variables were compared using the Pearson {chi}2 test for independent proportions, and the Student t test was used to compare continuous variables. The sample population was divided into three groups: physiologic repair, anatomic repair (Rastelli type), and anatomic repair (with arterial switch procedure).

For comparison of surgical approaches for the primary outcome, the logistic regression statistical technique was used. The reference group was selected to be protective compared with other categories for each variable under consideration. To adjust for the fact that the patient population was different between studies, the study era was entered into the model as a binary variable (before 1995 and 1995 or after).

Due to the large number of covariates and the small number of events, a main model containing surgical approach and study era was designed; subsequently, the covariates age at definitive repair, preoperative pulmonary valve abnormality, preoperative tricuspid valve abnormality, preoperative arrhythmia, and preoperative shunt procedures were entered one at a time. Thereafter, the full model including the main model and all other covariates was built. Results were expressed in odds ratios with physiologic repair as a reference category. The final model was assessed by quantifying the area under the receiver operating characteristic (ROC) curve and the probability associated with Hosmer-Lemeshow goodness of fit. An area under ROC curve of 0.5 indicates no predictive discrimination (equivalent to chance alone) and an area of 1.0 indicates perfect separation of patients with different outcomes [8, 9]. Hosmer-Lemeshow goodness-of-fit statistics compares the predicted probability with actual probability within population subgroups; ie, the larger the p value the better the fit [10].


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 Conclusion
 References
 
Sixty-five references were identified from the search strategy. There were no randomized studies. Fifty-four studies were excluded after examining the entire manuscripts. The reasons for exclusion were the following: outcome of interest (in-hospital mortality) was not measured (five studies) [11–15], different target population (eleven studies) [3, 16–25], insufficient patients' data (four studies) [6, 26–28], patients' data were presented in an aggregate form (twenty-four studies) [29–52], and multiple reasons (ten studies) [2, 53–61].

Eleven studies, involving 124 patients, met the inclusion criteria for this review. In these studies, sample sizes ranged from 2 to 27 patients. In total, 69 patients underwent anatomic repair (Rastelli type), 25 patients underwent anatomic repair (with arterial switch), and 30 patients underwent physiologic repair. All studies were from single centers: France (1), India (1), Japan (3), Italy (1), United Kingdom (3), and United States (2). Table 1 summarizes the characteristics of the included studies.


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  		Table 1. Characteristics of Included Studies
 
The age of included patients at the time of surgery ranged from 0.25 to 55 years. One hundred and twelve (90%) patients had an associated ventricular septal defect, 80 (65%) had an associated pulmonary valve abnormality (stenosis or atresia), 53 (43%) underwent a previous shunt procedure, 51 (46%) had a preoperative tricuspid valve abnormality, and 13 (12%) had a preoperative arrhythmia. Fifty-one (41%) patients underwent the definitive repair procedure before 1995, whereas 73 (59%) patients underwent the definitive repair in 1995 or after. The characteristics of the included patients in each surgical approach are summarized in Table 2.


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  		Table 2. Characteristics of Included Patients in Each Surgical Approach
 
In total, 13 patients died during their hospitalization. Of those, 7 (23%) patients were in the physiologic repair group, whereas 3 (4%) and 3 (12%) were in the anatomic (Rastelli type) and anatomic (with arterial switch), respectively. Unadjusted mortality difference was statistically significant ({chi}2 = 8.11, degrees of freedom [df] = 2, p = 0.01).

The results of multivariable logistic regression of the main model (surgical approach and era of surgery), and the main model with other covariates (age of the patient at the time of surgery, preoperative pulmonary valve abnormality, preoperative tricuspid valve abnormality, preoperative arrhythmia, and previous shunting procedure) entered one at a time are summarized in Table 3.


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  		Table 3. Statistical Details of the Multivariable Logistic Regression
 
In the main model, anatomic repair (Rastelli type) was associated with a significant reduction in the in-hospital mortality (odds ratio [OR] = 0.20, 95% confidence interval [CI]: 0.05, 0.85, p = 0.02), and era 1 (operations before 1995) was associated with a significant risk of mortality (OR = 5.70, 95% CI: 1.30, 24.70, p = 0.02). Entering the other covariates into the main model did not dramatically change the estimates or level of significance of the effect of era. Similarly, the estimates and levels of significance of the protective effect of anatomic (Rastelli type) repair did not change with the addition of the other covariates into the main model with the exception of preoperative pulmonary valve abnormality (OR = 0.24, 95% CI: 0.05, 1.20, p = 0.16).

Entering all variables into the final model revealed findings similar to the main model with a significant protective effect of the anatomic repair (Rastelli type), and significant increased risk with era 1 (before 1995); (OR = 0.05, 95% CI: 0.01, 0.50, p = 0.02) and (OR = 9.66, 95% CI: 1.54, 60.4, p = 0.01), respectively (Table 4). The area under the receiver operating characteristics curve of the final (all variables) model was 0.87 and the probability associated with Hosmer-Lemeshow goodness of fit statistics = 0.54.


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  		Table 4. Statistical Details of the Multivariable Logistic Regression of the Full Model
 

   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
Conclusion
 References
 
The pathological anatomy of CCTGA was first described by Rokitansky in 1875 [1]. The clinical features were recognized later. In CCTGA, the systemic venous blood enters into the right atrium, which drains through a bicuspid mitral valve into a left ventricle, which ejects blood into the pulmonary artery. Pulmonary venous blood returns to a left atrium, which drains through a tricuspid valve into a morphological right ventricle that ejects into the aorta. This double anatomical discordance is physiologically corrected.

Only 1% to 2% of CCTGA patients have no coexisting anomalies [3]. A few studies reported that such patients can live up to 80 years without surgical intervention [12, 24, 25]. However, in these reports patients with isolated CCTGA presented with heart failure and varying degrees of AV valve regurgitation. In a series of 111 patients with CCTGA with a follow-up reaching up to 20 years, Lundstrom and colleagues [43] reported that 20 patients of the series who were over the age of 20 years did not require surgical intervention [43]. Three women among them became pregnant and gave birth to four healthy babies and one miscarriage [43].

Surgical intervention is indicated when CCTGA is associated with clinically important intracardiac anomalies such as a VSD or pulmonary valve abnormalities. The classical surgical approach has been to repair the associated intracardiac anomalies without addressing the anatomic discordance (ie, physiologic repair). However, a number of studies have demonstrated depressed right ventricular function, especially during exercise [11, 14, 34, 46]. Concerns about the right ventricular function, along with frequent dysfunction of the tricuspid valve have led to the concept of anatomic repair, which was originally suggested by Ilbawi and colleagues [6] in 1990 for patients with CCTGA, VSD, and pulmonary stenosis. In this setting, the atrial switch procedure (Senning or Mustard) is combined with either an arterial switch or ventricular (Rastelli) level repair.

The focus of this review of individual patients' data was to address the following question: Which surgical approach is superior in reducing the incidence of in-hospital mortality in patients with CCTGA? This study addresses this question in a systematic way. Our results were derived from 11 studies encompassing 124 patients, of whom 56.65% underwent anatomic (Rastelli) level repair, 20.16% underwent anatomic (with arterial switch) repair, and 24.19% underwent physiologic repair.

The results of this study suggest that the Rastelli type anatomic repair is probably superior to the other surgical approaches in terms of the in-hospital mortality. This finding could be explained in part by the technical advantages of the Rastelli type anatomic repair approach which includes the following: first, closing the VSD through the right ventriculotomy allows a more ready accessibility to the right ventricular aspect of the septum and tricuspid valve than the other approaches, which is important in avoiding the conduction system and addressing tricuspid valve abnormalities [6, 62, 63]. In our included patients, the Rastelli type anatomic repair was associated with the lowest incidence of postoperative heart block compared with the anatomic repair with arterial switch and the physiologic repair (8%, 19%, and 65%, respectively; p < 0.001). Additionally, the Rastelli type repair was associated with a lower incidence of postoperative systemic AV valve regurgitation compared with the physiologic repair (6% and 53%, respectively; p < 0.001). These two variables were not included in the logistic regression models as the proportions of missing values were high; 22% and 31% for the postoperative heart block and postoperative AV valve regurgitation, respectively.

Second, there is no coronary transfer in the Rastelli type anatomic repair, which decreases coronary-related complications. Some reports have shown that the coronary pattern and technique of transfer are related to postoperative mortality [64, 65]. Furthermore, coronary artery stenosis or obstructions are concerns after coronary transfer. Some studies showed that 3% to 8% of patients develop coronary stenosis or occlusion after arterial switch procedure [66].

Another potential explanation of our finding is related to the changes in hemodynamics after anatomic repair. In the physiologic repair approach the morphologic RV supports the systemic circulation, which leads to progressive ventricular dilatation, failure, and subsequent tricuspid valve regurgitation [35]. The basic mechanism is probably related to the progressive increase in the morphologic RV (systemic RV) pressure, which leads to a commitment of the ventricular septum rightward leading to tricuspid valve (systemic AV valve) regurgitation [67]. Deterioration of the RV function with tricuspid valve regurgitation is associated with worse clinical outcomes in patients with CCTGA [35]. Anatomic repair, on the other hand, utilizes the morphologic LV as the systemic ventricle; as a result, the LV pressure will increase and the ventricular septum will shift from a rightward to a midline position. Subsequently, an appreciable improvement of the RV pressures and tricuspid valve function will be noticed [67].

Kreutzer and colleagues [68] reviewed a cohort of 101 consecutive patients who underwent Rastelli repair for a simple transposition of the great arteries (TGA) between 1973 and 1998. Of this cohort 73 patients had pulmonary stenosis and 18 had pulmonary atresia. The early mortality (defined as death within 30 days after operation) was 7%. In our included patients, 4% of the Rastelli repair group died within the hospital stay.

The focus of this individual patients' data meta-analysis was on the in-hospital mortality. Data was not available to address the long-term benefits or risks of different surgical approaches. However, there are suggested long-term benefits of the Rastelli repair. These benefits may include the avoidance of the neoaortic valve incompetence (ie, maintenance of the aortic valve integrity) and an apparent lower incidence of heart block. In the arterial switch procedure, the pulmonary valve will form the new aortic valve. Reports have indicated that an appreciable percentage of patients develop neoaortic valve regurgitation after the arterial switch procedure which might reach up to 30% [69]. Another long-term complication that is of concern is the development of surgically induced arrhythmias as suture line and suture load may be related to the development of postoperative arrhythmias. Gandhi and colleagues [70] demonstrated that atrial arrhythmias were related to the suture line in an animal model that underwent a modified Fontan procedure. This concept may be important in avoiding the suture sites that are associated with the development of arrhythmias.

This meta-analysis does not answer the question of which patients' subgroups may benefit from one surgical approach or another. In the earlier time cohort (before 1995), the proportion of patients who underwent the physiologic repair was 63%, which dropped to 37% after 1995. This may indicate increased adoption of the anatomic surgical approach. Rastelli type anatomic repair might not be the optimal approach in all patients with CCTGA. Reports have indicated that anatomic repair in patients with right ventricular or tricuspid valve dysfunction offers the greatest immediate benefits, in the form of improved systemic ventricular and AV valve function [5, 71].

This meta-analysis of individual data is not a substitute for well-designed large studies that compare different surgical approaches with regard to the immediate and long-term clinical outcomes. The optimal means of comparing anatomic and physiologic surgical approaches of CCTGA would be a randomized clinical trial. However, given the paucity of this condition and individualized nature of its complex repairs, such a trial is unlikely to be performed. Well-designed large multicenter cohort studies that address early and late outcomes would be the most practical and feasible study designs.


   Conclusion
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Conclusion
References
 
This review revealed that the anatomic (Rastelli) repair of CCTGA was associated with a significant improvement in the incidence of the in-hospital mortality. Further studies are warranted to confirm the result of meta-analysis, to explore late outcomes, and to define patients' subgroups that could benefit from other surgical approaches.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Conclusion
 References
 

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