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Right arrow Congenital - cyanotic

J Thorac Cardiovasc Surg 2008;135:1145-1152
© 2008 The American Association for Thoracic Surgery

Surgery for Congenital Heart Disease

Feasibility of the extracardiac conduit Fontan procedure in patients weighing less than 10 kilograms

Akio Ikai, MD, PhDa, Yoshifumi Fujimoto, MDb, Keiichi Hirose, MD, PhDb, Noritaka Ota, MDb, Yuko Tosaka, MDb, Tomohiro Nakata, MDb, Yujiro Ide, MDb, Kisaburo Sakamoto, MDb,*

a Department of Cardiovascular Surgery, Iwate Medical University Memorial Heart Center, Shizuoka, Japan
b Department of Cardiovascular Surgery, Shizuoka Children's Hospital, Shizuoka, Japan

Received for publication June 24, 2007; revisions received December 11, 2007; accepted for publication December 18, 2007.

* Address for reprints: Kisaburo Sakamoto, MD, Department of Cardiovascular Surgery, Shizuoka Children's Hospital, 860 Urushiyama, Aoi-ku, Shizuoka 420-8505, Japan. (Email: sakamoto{at}jun.ncvc.go.jp).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Discussion
 References
 
Objective: The extracardiac conduit Fontan procedure has led to improved outcomes. We performed the procedure in patients weighing less than 10 kg and evaluated its feasibility.

Methods: Since January 1999, 72 patients weighing less than 20 kg underwent extracardiac conduit Fontan procedure with polytetrafluoroethylene conduits. The patients were divided into 2 groups: 36 patients weighing less than 10 kg in group S and 36 weighing more than 10 kg in group L. Mean weight, median age, and median follow-up period in groups S and L were 8.5 ± 1.1 and 14.0 ± 3.0 kg, 18.9 and 42.0 months, and 29.2 (1.7–79.7) and 42.1 (2.8–94.2) months, respectively. Postoperatively, most patients received peritoneal drainage catheters. We reviewed data precatheterization and postcatheterization and postoperative course.

Results: Conduit sizes in groups S and L were 17.0 ± 1.3 and 17.9 ± 1.9 mm, respectively (P = .03). Five patients required fenestrations. There were 2 hospital deaths, 1 in each group, and 2 late deaths in group S. The postoperative course was identical in both groups, except for median length of stay in the intensive care unit and peritoneal drainage volume. Group S versus L: ventilator support, 11 versus 7 hours; pleural drainage, 9 days each; pleural drainage greater than 14 days, 6 versus 5 cases; peritoneal drainage, 8 versus 7 days; intensive care unit stay, 7 versus 4 days (P = .01), peritoneal drainage volume, 26.1 versus 14.1 mL · kg · d–1 (P = .0007).

Conclusions: The early outcome of the extracardiac conduit Fontan procedure was satisfactory in patients weighing less than 10 kg. However, the required size of the conduit remains debatable.

Abbreviations and Acronyms ECFP = extracardiac conduit Fontan procedure; ECMO = extracorporeal membrane oxygenation; IVC = inferior vena cava; LTFP = lateral tunnel Fontan procedure; PTFE = polytetrafluoroethylene


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Discussion
 References
 
The current surgical goal for most patients with a functional single ventricle is staged palliation culminating in a successful Fontan procedure. Since its introduction in 1971,1Go the Fontan procedure has undergone many modifications. Currently, two modifications are commonly used—the lateral tunnel and extracardiac conduit Fontan procedures (LTFP and ECFP, respectively).2-4Go The ECFP, introduced in 1990,5Go minimizes intratrial flow obstruction caused by intratrial partition. Moreover, the ECFP can be performed as a closed cardiac procedure without hypothermia, myocardial ischemia, or cardiopulmonary bypass.6Go The hemodynamic advantages of a tubular Fontan pathway have been convincingly demonstrated by hydrodynamic and computational modeling studies.7,8Go However, the ECFP has potential disadvantages related to the use of a prosthetic conduit, including the lack of growth potential, Fontan pathway obstruction, and thromboembolism. In particular, it is common practice to delay completion of Fontan circulation until the patient's body weight exceeds 15 kg to place an adult-sized conduit of at least 20 mm in diameter.9Go However, one final treatment goal in patients with single ventricle physiology is the elimination of cyanosis. To eliminate cyanosis as early in life as possible, we therefore performed the ECFP in patients weighing less than 10 kg and evaluated the feasibility of this strategy.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Discussion
 References
 
This study was approved by the ethics committee of Shizuoka Children's Hospital, and informed consent was obtained from all patients' parents. From January 1997 to November 2006, 72 consecutive ECFPs were performed at Shizuoka Children's Hospital in patients weighing less than 20 kg. During the same period, we performed a total of 152 ECFPs. To precisely evaluate the influence of body weight on the ECFP, we excluded 43 patients who weighed more than 20 kg, 18 patients who had undergone direct anastomosis between the inferior vena cava (IVC) and the main pulmonary artery stump, 18 patients who had undergone the LTFP, and 1 patient who had undergone an intracardiac conduit Fontan procedure. The remaining 72 patients were divided as follows into 2 equal groups on the basis of body weight: 36 patients weighing less than 10 kg (group S) and 36 weighing more than 10 kg (group L). Cardiac catheterization was performed in the midterm postoperative period at approximately 1 year after the operation. Follow-up was complete in all patients.

Surgical Techniques
All the ECFPs were performed via a median sternotomy and with cardiopulmonary bypass. Aortic crossclamping was used in 41 patients, including 17 (47%) group S and 24 (67%) group L patients. In crossclamped patients, myocardial protection was achieved with antegrade cold crystalloid cardioplegia. In small patients, the pulmonary artery incision was extended into the anterior wall of the superior vena cava to obtain enough space for anastomosis. As a conduit, we used polytetrafluoroethylene (PTFE; Gore-Tex; W. L. Gore & Associates, Inc, Flagstaff, Ariz) of 14 to 20 mm in diameter. Modified ultrafiltration was used in all patients. Fenestrations were not initially placed. In patients in whom Fontan pressure greater than18 mm Hg developed after modified ultrafiltration, a fenestration was placed by interposing a small PTFE graft 4 or 5 mm in diameter between the conduit and the atrium.

A total of 69 patients had undergone previous procedures. Newly developed intrapulmonary artery septation procedures,10Go which consist of unilateral cavopulmonary anastomosis, aortopulmonary shunt, and septation between two blood sources, were applied in both patient groups to promote growth in small pulmonary arteries.

The following procedures were concomitantly performed in 41 patients (17 group S and 24 group L patients): atrioventricular valve repair, branch pulmonary artery stenosis repair, atrial septectomy, main pulmonary artery division, pulmonary vein repair, Damus–Kaye–Stansel anastomosis, subaortic stenosis repair, and pacemaker-related procedures (see Table 3).


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  		Table 3 Operative data
 
Bilateral pleural drainage tubes were placed in all patients and removed when a drainage volume of less than 1 mL · kg · d–1 was achieved in each tube. Peritoneal drainage tubes were regularly used to remove peritoneal fluid and to reduce intraperitoneal pressure; they were removed when a drainage volume of less than 2 mL · kg · d–1 was achieved. In both patient groups, we routinely administered 5 mg/kg ticlopidine as antiplatelet therapy. Warfarin was not used.

Statistics
Data from groups were compared by the unpaired Student t test, Fisher exact test, or {chi}2 test, as appropriate. Serial data from postoperative catheterization were compared by the paired Student t test. Data are shown as mean ± standard deviation or median (range). The Kaplan–Meier method was used to determine the time from surgery to death or the last follow-up visit.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Discussion
 References
 
The preoperative age and body weight of patients in group S were significantly lower than in group L (Go Table 1). The number of patients having the morphologic features of hypoplastic left heart syndrome was higher in group S than in group L (group S vs group L: 11 vs 3; P = .03). Half of the patients in both groups had either hypoplastic left heart syndrome or heterotaxy syndrome. All patients underwent cardiac catheterization before ECFP. The mean values of the variables measured at catheterization were essentially identical in both groups. Pulmonary artery resistance was slightly higher in group S than in group L, but without significant difference (Table 1).


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  		Table 1 Preoperative patient profiles and cardiac catheterization data
 
Only 3 of the 72 patients underwent the ECFP as a primary procedure. Further, 10 patients underwent ECFP without previous cavopulmonary connection. The remaining 59 patients had an interim cavopulmonary connection as a staging procedure, including 14 patients with intrapulmonary artery septation, 1 patient with a hemi-Fontan procedure, and 1 patient with a Kawashima procedure (Go Table 2). Other operations conducted previously are listed in Table 2. A significantly greater number of group S patients had previously undergone the Norwood procedures (36% vs 8%), whereas group L patients had more frequently undergone isolated aortopulmonary or ventricular–pulmonary shunt procedures. Neither the mean cardiopulmonary bypass time nor the mean crossclamp time differed between the 2 groups. Fenestrations were placed in 3 group S and 2 group L patients. The size of the conduit used in group S was significantly smaller than that used in group L (17.0 ± 1.3 mm vs 17.9 ± 1.9 mm; P = .03) ( Table 3). However, we have recently used 18-mm conduits in an increasing number of group S patients (Go Figure 1).


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  		Table 2 Previous procedures
 

Figure 1
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  		Figure 1. Distribution of the size of extracardiac conduit in 72 patients for each year. The left bar indicates cases in group S and the right bar, in group L. The dotted bar indicates a 14-mm diameter conduit; white bar, a 16-mm diameter conduit; black bar, an 18-mm diameter conduit; and gray bar, a 20-mm diameter conduit. Since 2002, use of 18-mm diameter conduits has increased.

 
Early Outcome
The overall operative mortality was 2 (2.8%) of 72 patients. One group S patient with heterotaxy syndrome who had concomitantly undergone atrioventricular valve replacement died of contractile dysfunction resulting from supraventricular tachycardia. A group L patient who had heterotaxy syndrome without fenestration died of cerebral embolism. Extracorporeal membrane oxygenation (ECMO) was used in 2 group S patients. A patient with pulmonary atresia with intact ventricular septum, who had sinusoidal communication had hemodynamic instability owing to coronary malperfusion. The patient was supported by ECMO for 3 days and survived. Another patient with the heterotaxy syndrome and pulmonary vein stenosis, who had previously undergone repair of total anomalous pulmonary venous connection followed by atrioventricular valve repair as a concomitant procedure, had respiratory dysfunction and elevation of Fontan pressure on postoperative day 2. The patient was supported with ECMO for 5 days and successfully weaned after fenestration. No significant difference was observed between the groups with regard to the duration of ventilator support, pleural drainage, and peritoneal drainage. The number of patients requiring prolonged pleural drainage for more than14 days was not different between the groups (group S vs group L: 6 vs 5; P = .76). However, the median duration of stay in the intensive care unit was significantly longer for group S patients than for group L patients (group S vs L: 7 days vs 4 days; P = 0.01), and the average volume of peritoneal drainage was significantly greater in group S than in group L (group S vs group L: 26.1 ± 15.1 mL · kg · d–1 vs 14.1 ± 10.2 mL · kg · d–1; P = .0007) (Go Table 4). With regard to the prevalence of supraventricular dysrhythmia, 7 patients in group S and 9 patients in group L had supraventricular tachyarrhythmia. Three patients in both groups had sinus dysfunction. There was no difference in the prevalence of supraventricular dysrhythmia between the 2 groups.


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  		Table 4 Postoperative data
 
Follow-up
Follow-up was complete in all patients. Median follow-up periods were 29.2 (1.7–79.7) and 42.1 (2.8–94.2) months for groups S and L, respectively. Two group S patients with hypoplastic left heart and heterotaxy syndrome died of respiratory infection. The 5-year actuarial survival was 91% for group S and 97% for group L (P = .3, Go Figure 2). Protein-losing enteropathy developed in 3 patients (2 in group S and 1 in group L). All patients are currently responding to medical treatment. Postoperatively, no thromboembolic events occurred, and no patient required conduit replacement for obstruction. With regard to the prevalence of supraventricular dysrhythmia, patients with sick sinus syndrome, and grade I atrioventricular block, 1 in each group were treated with a pacemaker to maintain better synchronicity between the atrial and ventricular contractions. Only 1 patient with heterotaxy syndrome in group S had supraventricular tachyarrhythmia even though the patient was administered amiodarone prophylactically. One patient in group L was administered isoproterenol owing to atrioventricular dissociation. With regard to fenestration, 1 patient who underwent fenestration in group S died of respiratory infection as previously mentioned. We confirmed spontaneous closure of the fenestration in 2 patients in group L. The other two fenestrations were left open.


Figure 2
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  		Figure 2. Kaplan–Meier survival in 72 patients undergoing the ECFP. The number of patients at risk is indicated above the horizontal axis. There is no difference of survival between patients in groups S and L.

 
Follow-up Catheterization Data
We performed postoperative follow-up catheterization in 30 group S and 32 group L patients. The mean interval between the ECFP and follow-up was 9.8 ± 3.8 months for group S and 13.1 ± 4.2 months in group L. There was a significant difference between these 2 periods (P = .002).

No difference was observed between the groups with regard to IVC pressure, intraconduit pressure, superior vena cava pressure, bilateral pulmonary artery pressure, pulmonary capillary wedge pressure, pulmonary artery resistance, ejection fraction, cardiac index, and room air saturation (Go Table 5). There was a pressure gradient between precavopulmonary and postcavopulmonary anastomosis and there was also a statistically significant difference between the intraconduit pressure and the right and left pulmonary artery pressures; however, no pressure gradient had developed between the IVC and conduit.


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  		Table 5 Postoperative catheterization data
 

   Discussion
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Discussion
References
 
Since the introduction of the concept of total cavopulmonary connection,7Go the outcome of the Fontan completion has improved dramatically. Currently, the ECFP and LTFP are the two favored approaches for Fontan completion. However, the use of ECFP may be disadvantageous because of the use of an artificial graft that lacks growth potential and requires anticoagulation therapy to prevent thromboembolic events.9,11Go Generally, ECFP is performed in patients weighing more than15 kg so that an adult-sized conduit (generally 20 mm in diameter) can be used . Therefore, the patient age required for the ECFP is higher than that required for the LTFP.2-4Go The data on the LTFP12Go revealed that age at the time of operation was not a limiting factor for Fontan completion.

To eliminate cyanosis as early in life as possible, we performed the ECFP in patients who were approximately 1 year old and weighed less than10 kg. The operative mortality of the entire cohort of patients in this series was approximately 3%. This is similar to that reported in previous studies.2,6,13,14Go Numerous perioperative risk factors are associated with increased mortality after the ECFP. These include pulmonary artery resistance, pulmonary artery size, hypoplastic left heart syndrome, and heterotaxy syndrome. A direct comparison of the preoperative features of both patient groups revealed no differences in this study. In terms of morphologic features, especially, half of the patients in both the groups had hypoplastic left heart or heterotaxy syndrome. Moreover, pulmonary vascular resistance and Nakata index did not differ between the groups. Under well-controlled hemodynamic conditions for Fontan completion, the somatic size of patients might not be a limiting factor for performing the ECFP, even in patients weighing less than10 kg.

However, for performing ECFP in patients with low body weight, the size of the conduit, which lacks growth potential, might pose difficulties in the future.9,11Go The main problem concerning ECFP is the risk of late conduit obstruction. Amodeo and colleagues15Go have reported a mean reduction of the internal conduit diameter of 18% during the first 6 months with no further progression over the following 5 years. Marcelletti, Iorio, and Abella11Go from the same study group reported that they had never used a conduit less than 16 mm in diameter in their initial series. However, no cases of PTFE conduit replacement owing to obstruction were reported in the longest follow-up series. There have been numerous reports regarding the benefits of ECFP; however, no reports of conduit replacement owing to size mismatch affecting somatic development have been reported. Nakao and colleagues16Go have assessed the size of the IVC by means of echocardiography. In their study, mean diameters of the IVC were changed 17 mm in the left lateral position to 23 mm in the right lateral position in patients with right atrial pressures greater than 8 mm Hg. The study might suggest that a conduit 18 or 20 mm in diameter might be acceptable in adults. Initially, we used a conduit 16 mm in diameter; however, after gaining experience, we have recently increased the use of 18-mm diameter conduits. We administered 5 mg/kg of ticlopidine as antiplatelet therapy. We have not encountered any cases of conduit obstruction thus far; however, further studies are necessary for evaluating the fate of artificial tube grafts, particularly those less than 16 mm in diameter.

Persistent pleural effusion is one of the significant causes of morbidity in the postoperative period after ECFP.17Go Gaynor and colleagues13Go reported that fenestration and modified ultrafiltration are associated with a decrease in the duration of pleural effusions. In this series, we used modified ultrafiltration in all patients. Patients with fenestrations had to have cyanosis for a longer duration and had to undergo another intervention to close the fenestration. Therefore, we did not use fenestrations except in patients with a high Fontan pressure greater than 18 mm Hg. Only 5 (7%) of 72 patients in this series required fenestration. An alternative approach to reduce pleural effusion might be to minimize the use of cardiopulmonary bypass, thereby reducing the activation of inflammatory mediators.6Go If most of the mediastinal dissection is performed off-pump and no intracardiac procedures are necessary, then the average cardiopulmonary bypass time required for the superior and inferior anastomoses should be considerably decreased.

In this study, no difference in the duration of pleural drainage was noted between the groups. We speculated that peritoneal drainage might be helpful to reduce duration and volume of pleural drainage. Mainwaring, Lamberti, and Hugli18Go reported an increase in the concentration of the activated complement C3 and interleukin 6 after the ECFP. Bokesch and colleagues19Go reported a high concentration of proinflamatory cytokines in the peritoneal fluid. They suggested that peritoneal fluid may serve as a depot for harmful inflammatory cytokines after cardiopulmonary bypass, and removal of the peritoneal fluid could lower serum concentrations.

No difference was observed between the groups with regard to duration of peritoneal drainage and number of patients with prolonged peritoneal drainage; however, the peritoneal fluid drainage volume was higher in group S than in group L. In addition, cardiopulmonary bypass time was shorter in group S than in group L. No specific reason was found for the prolonged intensive care unit stay of group S as compared to group L. We speculated that the large volume of peritoneal drainage might require extensive fluid replacement to stabilize hemodynamics. We recognized that the hospital stay was considerably longer than that mentioned in any other previously published reports. Japan's lenient health insurance system might account for this.

This study has several limitations. It is a retrospective and nonrandomized study. There is a lack of reports on peritoneal drainage after the ECFP, and only a few patients in this study were operated on without peritoneal drainage. Therefore, it is very difficult to rule out any influence of peritoneal drainage on the postoperative course. In particular, the follow-up period in group S patients was relatively short inasmuch as they were growing; therefore, the inference regarding freedom from conduit obstruction and the need for reoperation in relation to outgrowth is uncertain. Further, a long-term follow-up study is essential.

In conclusion, we evaluated the technical feasibility of ECFP in patients weighing less than 10 kg. In terms of mortality and midterm results, the outcome of ECFP was acceptable in patients who weighed less than 10 kg. Currently, it may not be possible to consider ECFP as the standard procedure in patients weighing less than 10 kg. However, the procedure may be feasible in patients who, for instance, have severe cyanosis owing to pulmonary arteriovenous malformation. Further studies are required to assess the late hemodynamics of patients with small conduits when they achieve full somatic growth and the long-term outcome of these small conduits.


   Footnotes
 
Read at the Thirty-third Annual Meeting of The Western Thoracic Surgical Association, Santa Ana Pueblo, NM, June 27–30, 2007.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Discussion
 References
 

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  8. de Leval MR, Dubini G, Migliavacca F, Jalali H, Camporini G, Redington A, et al. Use of computational fluid dynamics in the design of surgical procedures: application to the study of competitive flows in cavo-pulmonary connections. J Thorac Cardiovasc Surg 1996;111:502-513.[Abstract/Free Full Text]
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  11. Marcelletti CF, Iorio FS, Abella RF. Late results of extracardiac Fontan repair. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu 1999;2:131-142.[Medline]
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  14. Hosein RB, Clarke AJ, McGuirk SP, Griselli M, Stumper O, De Giovanni JV, et al. Factors influencing early and late outcome following the Fontan procedure in the current era. The ‘Two Commandments’?. Eur J Cardiothorac Surg 2007;31:344-352.[Abstract/Free Full Text]
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