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Ann Thorac Surg 2007;84:894-899
© 2007 The Society of Thoracic Surgeons

Original Articles: Cardiovascular

Nonfenestrated Extracardiac Total Cavopulmonary Connection in 132 Consecutive Patients

Christian Schreiber, MD, PhD*, Jürgen Hörer, MD*,*, Manfred Vogt, MD, PhD, Julie Cleuziou, MD, Zsolt Prodan, MD, Rüdiger Lange, MD, PhD

Clinic for Cardiovascular Surgery, and Department of Paediatric Cardiology and Congenital Heart Disease, German Heart Center Munich, Technical University Munich, Munich, Germany

Accepted for publication April 11, 2007.

* Address correspondence to Dr Hörer, Clinic of Cardiovascular Surgery, German Heart Center Munich, Technical University Munich, Lazarettstrasse 36, Munich, 80636, Germany (Email: hoerer{at}dhm.mhn.de).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Footnotes
 References
 
Background: The study was conducted to assess the need for fenestration for completion of a total cavopulmonary connection (TCPC) with the most recent modification of an extracardiac conduit.

Methods: The extracardiac approach was introduced to our institution in January 1999. Between June 2000 and June 2006, 132 consecutive patients were treated without a fenestration. At the time of TCPC, the median age was 31 months (range, 16 251), with 93 patients (70%) being younger than 48 months. Median patient weight was 12.5 kg (range, 9 to 66 kg). A previous partial cavopulmonary connection (PCPC) was accomplished in 117 patients (88.6%), without additional pulmonary blood flow.

Results: Thirty-day-mortality was 1.5%. Median time to extubation was 14 hours (range, 3 hours to 126 days). Initial pulmonary artery pressure value was 16.5 ± 2.2 mm Hg, and 13.1 ± 1.8 after extubation. Median drainage requirement was 4 days (range, 1 to 45), and median duration of hospitalization was 20 days (range, 5 to 128). Thirty-one (24%) required repeat drainage insertion. No subsequent fenestration was performed, and at hospital discharge no significant repeat effusions were observed. Multiple covariate logistic regression revealed longer time interval from PCPC to extracardiac TCPC (p = 0.006) as a significant predictor of pleural drainage lasting longer than 4 days, and older age at the time of extracardiac TCPC (p = 0.040) as a risk factor for hospitalization more than 20 days. Higher pulmonary artery pressure 3 hours postoperatively was a significant predictor for both outcome variables in the multivariate model (p = 0.013, p = 0.001).

Conclusions: In general, an extracardiac TCPC can be performed without fenestration. Early staging of patients with functional single ventricle physiology may be one of the keys for these findings.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 Footnotes
 References
 
Since 1988, separation of systemic and pulmonary venous return has been accomplished by means of a total cavopulmonary connection (TCPC) [1]. Creation of an extracardiac TCPC was initially proposed for patients with anomalies of the intra-atrial anatomy, such as pulmonary and systemic venous return, an atretic or dysplastic left atrioventricular valve, or complex malformations with common atrioventricular valve [2]. In recent years, many groups have moved to this approach, avoiding usually myocardial ischemia (aortic cross-clamping), atriotomy and intra-atrial suture lines, and allowing for a shorter duration of cardiopulmonary bypass. The feasability of early fenestration is reported [3]; however, we and others have raised the question whether routine fenestration applying this extracardiac modification is at all necessary [4, 5]. Within a time interval of 6 years, 132 consecutive patients were treated without a fenestration. The endpoints "hospitalization duration" and "pleural drainage" were entered into both a univariate and multivariate outcome analysis.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Footnotes
 References
 
In January 1999, we introduced the extracardiac TCPC at our institution. Gradually, construction of an intracardiac tunnel was abandoned, and since August 2001, we have performed only extracardiac completions [6] until June 2000, even those patients with an extracardiac connection received an additional fenestration, which was done at the discretion of the individual surgeon. In total, only 9 of the patients received a fenestration. Between June 2000 and June 2006, however, 132 consecutive patients were treated without a fenestration. The preoperative characteristics are summarized in Table 1. At the time of extracardiac TCPC, the median age was 31 months (range, 16 to 249), with 93 patients (70%) being younger than 48 months. Median patient weight was 12.5 kg (range, 9 to 66 kg). Only tubes of at least 18 mm in diameter were implanted. A previous partial cavopulmonary connection (PCPC) was accomplished in 117 patients (88.6%), without additional pulmonary blood flow. Patients undergoing revision of a cavopulmonary connection were excluded.


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  		Table 1 Anatomic and Hemodynamic Characteristics of 132 Patients Undergoing Extracardiac Total Cavopulmonary Connection Without Fenestration
 
This study has been approved by the Ethics Committee of the Technical University Munich (1740/07). The Ethics Committee waived the need for individual patient consent for this study.

All patients received heparin in the early postoperative period, with the aim of establishing a partial thromboplastin time of 40 to 60 seconds. Oral anticoagulation was eventually commenced, aiming to achieve an international normalized ratio of 2.0 to 3.0. Patients, or parents, were generally taught to use a self-testing apparatus (CoaguCheck; Roche Diagnostics, Mannheim, Germany). Total cavopulmonary completion was always performed on cardiopulmonary bypass. A nonringed polytetrafluoroethylene graft (Gore-Tex, W. L. Gore & Assoc, Flagstaff, Arizona) was used in all cases. Only tubes of at least 18 mm in diameter were implanted. Unless concomitant intracardiac procedures were required, aortic cross-clamping was not used. For additional intracardiac procedures, antegrade crystalloid cardioplegia, at 40 mL/kg body weight, was applied and the patients cooled to 28°C. At weaning from bypass, we aimed at a haemoglobin of approximately 10 g/dL, and after routine modified ultrafiltration at a hemoglobin of about 12 g/dL. Oxygen saturations were checked, and transesophageal echocardiography was always performed. A cell-saving device and aprotinin at 30.000 IU/kg were used in all cases. Drains were removed as soon as the effusions were serous and when the drainage loss was less than 5 mL/kg body weight per day. Repeat drainage insertion was performed when effusions, despite fluid restriction and administration of loop diuretics, increased and led to respiratory impairment.

Statistical Analysis
Frequencies are given as absolute numbers and proportions. Continuous data are expressed in terms of the mean and standard deviation or as medians with ranges when appropriate. The endpoints of hospitalization length and pleural drainage were dichotomized according to medians. The outcome analyses were performed excluding patients who died within the first 30 postoperative days. For univariate analysis, a total of 28 single covariate logistic models were tested for each outcome, with values of p below 0.05 as the criterion for statistical significance. For multivariate analysis, multiple covariate models were specified and tested using variables from the single covariate models with values of p below 0.10. All data were analyzed using SPSS 14 (SPSS, Chicago, Illinois).


   Results
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 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Footnotes
 References
 
The perioperative and postoperative characteristics are summarized in Table 2. Myocardial ischemia was avoided in 101 patients, with a mean cardiopulmonary bypass time of 64 ± 33 minutes in those. In the remainder, cardiopulmonary bypass time was 111 ± 37 minutes (p < 0.001). Either as single procedure or in combination, aortic cross-clamping was needed for atrioventricular valve plasty in 17 patients, atrioventricular valve replacement in 4, atrioventricular valve closure in 6, complex pulmonary artery patch plasty in 8, ventricular septal defect enlargement in 1, isolation of hepatic veins in heterotaxy syndrome in 1, and explantation of intravenous pacing leads in 1.


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  		Table 2 Demographic Characteristics at Time of Extracardiac Total Cavopulmonary Connection (TCPC) and Surgical Variables of 132 Patients Undergoing Completion Without Fenestration a
 
Two patients (1.5%) died within the first 30 postoperative days. One of them, 23 months old, presenting with congenitally corrected transposition of the great arteries, hypoplastic left ventricle, restrictive ventricular septal defect, and moderate atrioventricular valvar insufficiency, died at the first postoperative day in cardiac failure. Previous operations included a systemic to pulmonary artery shunt with subsequent PCPC. The other patient, 17 years old, with transposition of the great arteries, total anomalous pulmonary venous connection, and hypoplastic right ventricle, died on the ninth postoperative day of multiorgan failure. Previous operations included correction of total anomalous pulmonary venous connection, with repeat relief of pulmonary venous obstructions and systemic to pulmonary artery shunts. Both patients were excluded from further analysis of the two endpoints of length of hospitalization and pleural drainage. There were 2 hospital deaths at 48 and 128 days after the operation. Both patients (6 and 17 years old) presented with hetorotaxy syndrome. One of them succumbed to multiorgan failure after sepsis. The other patient, with severely impaired ventricular function, required atrioventricular valvar replacement at the time of TCPC and died after 128 days in multiorgan failure and sepsis. These 2 patients were included in the outcome analysis.

Mean pulmonary artery pressure 3 hours after the operation was 16.5 ± 2.2 mm Hg, and decreased significantly to 13.1 ± 1.8 mm Hg after extubation (p < 0.001).

The median duration of hospitalization among the 30 days survivors was 20 days (range, 5 to 128). Among 8 variables with values of p below 0.10 in single covariate models, the multiple covariate model revealed older age at the time of extracardiac TCPC (p = 0.040), and higher pulmonary artery pressure 3 hours postoperatively (p = 0.013) as risk factors for prolongued hospitalization (Table 3).


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  		Table 3 Univariate and Multivariate Analysis of Risk Factors for Hospitalization More Than 20 Days
 
The median duration of pleural drainage among the 30 days survivors was 4 days (range, 1 to 45). Among 12 variables with values of p below 0.10 in single covariate models, the multiple covariate model revealed longer time interval from PCPC to extracardiac TCPC (p = 0.006), and higher pulmonary artery pressure 3 hours postoperatively (p = 0.001) as a significant predictors of pleural drainage lasting longer than 4 days (Table 4).


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  		Table 4 Univariate and Multivariate Analysis of Risk Factors for Pleural Drainage More Than 4 Days
 
No subsequent fenestration was performed, and after hospital discharge, no significant repeat effusions were observed.


   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Footnotes
 References
 
The idea of a right-to-left "pop-off" communication was introduced in the late 1980s. It soon became routine at a number of centers, and remains so today [7–15]. But has the advent of the extracardiac approach, and the early staging likewise, not made a routine fenestration irrelevant? Our results on 132 consecutively treated patients over a period of 6 years confirm this.

Indication not to fenestrate was certainly not biased. We simply continued our previously reported approach [4], where we studied 84 patients. If more than 1 risk factor among ventricular function being more than moderately impaired, atrioventricular valvar regurgitation more than moderate, mean pulmonary arterial pressure more than 15 mm Hg, mean atrial pressure higher than 12 mm Hg, pulmonary arterial distortion, or other than sinus rhythm was present preoperatively, the patient was considered a "high risk" candidate. There were no differences between groups of patients having one or more risk factors in regard to need for intubation (p < 0.511), pulmonary arterial pressures after extubation (p < 0.817), and duration of chest drainage (p < 0.650). This time, the endpoints of hospitalization duration and pleural drainage were dichotomized according to medians. Univariate and multivariate analyses were performed.

Of the 132 patients, the majority was relatively young at time of extracardiac TCPC, with a median age of 31 months. Our required weight at this stage is around 10 kg. In these patients, the pulmonary arteries usually have a diameter of around 6 to 8 mm. In our experience, this is large enough to accommodate a tube of 18 mm [6]. In case of a mismatch with the inferior caval vein, we found that the use of an adequate cuff of atrial tissue permits an undistorted anastomosis with the Gore-Tex tube. Our surgical experience, therefore, differs from other studies that demanded a weight of at least 15 kg for insertion of a tube of at least 18 mm, or where conduits with diameters of less than 18 mm were implanted in small children [17–19]. In the short term, however, our clinical experience has not substantiated the generally supported claim, that the diameter of the tube should not be oversized by more than one fifth of the diameter of the inferior caval vein [17, 20]. Interestingly, Gupta and coworkers [14] studied a large cohort of 100 consecutive patients in which 33 were treated with a conduit smaller than 18 mm in diameter. In half of their patients with conduits smaller than 18 mm, they encountered persistent pleural effusions, compared to only a quarter of patients having conduits larger than 18 mm.

It is furthermore of note that a previous partial cavopulmonary connection (PCPC) was accomplished in 117 patients (91%), without additional pulmonary blood flow in any of them. Median patient age at this stage was 9 months. Controversy continues over whether additional sources of pulmonary blood flow are beneficial in combination with a PCPC. Additional pulmonary artery flow through either an aortopulmonary shunt or the main pulmonary artery may raise upper central venous pressure, expose the patient to a higher risk of persistent pleural effusions, or may less effectively reduce the volume load on the single ventricle [21]. Berdat and colleagues [22], however, have concluded that additional pulmonary artery flow has no adverse effect on outcome. They have included 106 patients from 1996 to 2000, and compared isolated PCPC patients with those who had additional pulmonary blood flow through the pulmonary artery and those with an additional Blalock-Taussig shunt. In our view, several issues remain. Firstly, exclusion of all other sources of pulmonary blood flow at the time of PCPC aims at volume unloading the functional single ventricle, preventing potential functional deterioration and reducing atrioventricular valve regurgitation [21]. Secondly, pulmonary artery pressures may remain high. In the Berdat study [22], collective mean pulmonary artery pressures were as high as 12 mm Hg, whereas in our cohort, left and right pulmonary artery pressure were lower at time of extracardiac TCPC, with a mean of 9 mm Hg. Thirdly, even though patients are less prone to hypoxia with an additional blood source to the lungs, patients are simply older at the time of an extracardiac TCPC. Berdat and colleagues [22] reported that 17 of 47 patients (36.2%) from the PCPC group, 8 of 26 patients (30.8%) with additional flow through the main pulmonary artery, and 3 of 17 patients (17.7%) with additional aortopulmonary shunt underwent completion after 30.9 ± 45.8 months, 49.7 ± 35.4 months, and 24.9 ± 18.4 months, respectively. In our collective, the interval from PCPC to TCPC was rather short, with a mean of 25.8 ± 25.4 months. Equally, our statistical analysis therefore supports our strategy of early staging, since higher pulmonary artery pressure 3 hours postoperatively was a significant predictor for both outcome parameters in the multivariate model (p = 0.013, p = 0.001).

Routine fenestration is controversial. Thompson and colleagues [5] were among the first to question it. They stated that a fenestration not only leads to subnormal systemic arterial oxygenation, but that among potential drawbacks are exposure of the patient to risk, and the costs of subsequent interventions to close the fenestration. The long-term risks associated with chronic right-to-left shunting, formation of thrombus, and potential paradoxical embolism, have been the major concerns associated with fenestration. In addition, there is the decrease in exercise tolerance, and consequently quality of life in patients suffering arterial desaturation subsequent to fenestration [23–25]. As far as we are aware, there is only one prospective and randomized trial assessing the clinical utility of fenestration [26]. Whereas, in this trial, fenestration was shown to be associated with clinical benefits, the authors stated that not every patient undergoing Fontan palliation requires fenestration to achieve a good outcome.

Prolonged pleural effusions represent a clinically important cause of morbidity. In our cohort, median drainage requirement was 4 days (range, 1 to 45) and median duration of hospitalization was 20 days (range, 5 to 128). Thirty-one (24%) had repeat drainage insertion. Meyer and colleagues [16] reviewed their recent experience in 169 patients operated on between January 2000 and December 2004. Fifty-seven percent were extracardiac completions; however, fenestrations were performed in 144 patients. Overall, pleural drainage was necessary in 35% for more than 3 days, and in 10% for more than 10 days. In addition, they state that 23 patients (15%) had to be readmitted to the hospital, most commonly for pleural effusions. Apposed to our approach, in which we perform the extracardiac TCPC usually at a temperature between 32°C and 34°C (unless intracardiac procedures are required), they applied a strategy of deep hypothermic arrest in most cases (83%).

A very recent publication on another large cohort, 221 patients operated on between November 1988 and November 2003, equally does not report any beneficial effect of fenestrating the extracardiac TCPC [15]. For 52 patients, their main indication for a fenestration was the size of the pulmonary arteries, even though the mean age was 72.2 months (range, 13.1 to 131.3). Despite their relative frequency, the basis for the development of pleural effusions after the Fontan procedure remains unexplained [27]. In our series, multiple covariate logistic regression revealed a longer time interval from PCPC to extracardiac TCPC as a significant predictor of pleural drainage lasting longer than 4 days. This finding would support our current approach of early unloading and extracardiac completion regardless of the patient’s age but recommending weight of around 10 kg.

Our findings differ from the findings of McGuirk and coworkers [13], who studied 103 patients in whom a lateral TCPC had been created in 19 and an extracardiac TCPC in the remainder. Among these patients, they created 53 fenestrations. Prolonged pleural drainage was necessary in two fifths. Multivariate analysis identified increased postoperative pulmonary arterial pressure and abnormal pulmonary venous drainage as independent risk factors for the prolonged pleural drainage. However, as mentioned earlier in the Meyers series [16], in which the overall median time on cardiopulmonary bypass even reached 66 minutes (range, 41 to 274), as opposed to 61 minutes (range, 29 to 187) in our cohort, prolonged periods of cardiopulmonary bypass were significantly associated with increased postoperative volumes of pleural drainage in previous studies. Gupta and colleagues [14] discussed the exposure to inflammatory sequels. Gentles and associates [7] report even an increased risk of early death and failure in combination with prolonged periods of cardiopulmonary bypass. They state that every effort should be made to limit the duration of cardiopulmonary bypass when completing a Fontan circulation. If intracardiac procedures (ie, atrioseptectomy, atrioventriclaur valve plasty) are performed at earlier stages, the placement of the extracardiac tube can usually be performed within 35 to 45 minutes of cardiopulmonary bypass. We then routinely use modified ultrafiltration to eliminate the crystalloid priming volume and the volume substitution during cardiopulmonary bypass. That has been reported to significantly reduce the incidence of postoperative pleural and pericardial effusions, requirement of blood products, and hospital stay after the Fontan procedure [28]. A minimized cardiopulmonary bypass circuit, together with modified ultrafiltration, allows even for extracardiac total cavopulmonary completion in small children without administration of blood products [29].

We have shown that conduits of at least 18 mm diameter can safely be placed in children weighing 10 kg. That means that completion of the cavopulmonary connection can be performed at a young age. In our collective, 42 patients (32%) had a PCPC and subsequent TCPC below the age of 24 months. Seventy-six (58%) had a PCPC and subsequent TCPC below the age of 36 months. We continue to stage patients at early intervals. Statistical analysis supports our current strategy of early unloading without additional pulmonary blood. It is, furthermore, our belief that routine fenestration is dispensable in the majority of patients treated with an extracardiac TCPC.


   Footnotes
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 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Footnotes
References
 
* Both authors contributed equally to the study. Back


   References
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 Abstract
 Introduction
 Patients and Methods
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 Comment
 Footnotes
 References
 

  1. De Leval MR, Kilner P, Gewillig M, Bull C. Total cavopulmonary connection: a logical alternative to atriopulmonary connection for complex Fontan operations J Thorac Cardiovasc Surg 1988;96:682-695.[Abstract]
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