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Ann Thorac Surg 2004;78:1959-1964
© 2004 The Society of Thoracic Surgeons
Nemours Cardiac Center, Alfred I. duPont Hospital for Children, Wilmington, Delaware, and Polish-American Children Hospital, Krakow, Poland, USA
Accepted for publication June 4, 2004.
* Address reprint requests to Dr Pizarro, 1600 Rockland Rd, PO Box 269, Wilmington, DE19899 (E-mail: cpizarro{at}nemours.org).
Presented at the Fortieth Annual Meeting of The Society of Thoracic Surgeons, San Antonio, TX, Jan 26–28, 2004.
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Abstract |
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METHODS: Data collection of 96 consecutive hospital survivors after stage 1 Norwood surgery was undertaken. The source of pulmonary blood flow was a modified right Blalock-Taussig shunt in 46 (BTS) and a right ventricle to pulmonary artery conduit in 50 patients. The same follow-up protocol was used in both groups. Data analysis was performed to identify variables associated with interim mortality.
RESULTS: Analysis of patient-related and procedure-related variables revealed no differences in age, weight, diagnosis, presence of aortic atresia, lowest perioperative pH, duration of cardiopulmonary bypass, circulatory arrest, length of mechanical ventilation, or hospital stay at the time of stage 1 Norwood between groups. Respiratory rate and systolic blood pressure were the only differences detected between groups at the time of discharge. Interim mortality was higher in the Blalock-Taussig shunt group. Statistical analysis identified aortic atresia, a modified Blalock-Taussig shunt, and the presence of perioperative dysrhythmias to be associated with interim mortality.
CONCLUSIONS: The use of a right ventricle to pulmonary artery shunt decreases the incidence of interim mortality among hospital survivors after stage 1 Norwood for hypoplastic left heart syndrome. Aortic atresia, the use of a modified Blalock-Taussig shunt, and perioperative dysrhythmias are independently associated with a higher mortality before superior cavopulmonary connection.
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Introduction |
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TopAbstractIntroductionMaterial and MethodsResultsCommentDiscussionAcknowledgmentsReferences |
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On the basis of reports of greater circulatory stability associated with the use of right ventricle to pulmonary artery conduit (RV–PA) as part of the Norwood procedure in comparison with a modified Blalock-Taussig shunt (BTS) [3, 4, 10], the potential influence between two physiologically different sources of pulmonary blood flow on interim mortality among hospital survivors after stage 1 reconstruction for hypoplastic left heart syndrome was investigated.
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Material and Methods |
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TopAbstractIntroductionMaterial and MethodsResultsCommentDiscussionAcknowledgmentsReferences |
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The source of pulmonary blood flow was a modified BTS in 46 patients and an RV–PA in 50 patients. The two groups in this study were consecutive and nonrandomized, which reflects the change of strategy regarding the use of a different source of pulmonary blood flow during the study period. Recognizing the limitations of the study design, a specific effort was made to maintain all other aspects of patient care unchanged; therefore, no changes occurred regarding primary surgeons, patient selection, or perioperative management protocol. Data collection included demographic, preoperative, operative, and postoperative variables, as well as follow-up information obtained during office visits (Appendix).
The end points of the study included (1) interim deaths before second stage and (2) hemi-Fontan procedure.
The anatomic diagnosis of hypoplastic left heart syndrome was based on two-dimensional echocardiography and required the presence of aortic valve atresia or hypoplasia, hypoplasia or absence of the left ventricle, and a ductus arteriosus–dependent systemic circulation with retrograde flow in the aortic arch.
The operative technique used during the initial Norwood reconstruction has been described elsewhere [1]. Tricuspid valve function and right ventricular function were evaluated qualitatively using two echocardiographic views (subcostal and apical four-chamber views) by two independent observers. Right ventricular and tricuspid valve dysfunction were considered significant if graded moderate or greater. Obstruction of pulmonary venous return was considered significant if a velocity greater than 2 m/s was present on Doppler interrogation at the level of the interatrial septal communication or anomalous pulmonary venous connection.
The operative management strategy used in these patients included routine use of a period of deep hypothermic circulatory arrest, without use of 
-adrenergic blockade, aprotinin, or modified ultrafiltration during the stage 1 Norwood procedure.
At the time of hospital discharge, all patients had a physical examination, 12-lead electrocardiogram, chest roentgenogram, and echocardiographic assessment. Criteria for hospital discharge included appropriate oral intake (
120 cal · kg–1 · d–1) and weight gain for 3 consecutive days. All patients were discharged on 10 µg/kg digoxin twice daily and 1 mg/kg furosemide twice daily.
Follow-up protocol consisted of office visits scheduled at 2 weeks, 4 to 6 weeks, 3 months, and 5 to 6 months in preparation for hemi-Fontan, unless inadequate oral intake, poor weight gain, or increased cyanosis was detected.
Autopsy reports were reviewed in cases of interim death when available.
Data collection was performed following the guidelines of the Institutional Review Board.
Comparisons were made on the basis of source of pulmonary blood flow (RV to PA conduit versus systemic to pulmonary artery shunt). Patient and operative variables were evaluated for their influence on interim mortality. Data analysis included descriptive statistics, 
2, Mann-Whitney U test, Pearson correlation, and logistic regression. In all instances interim death served as the criterion. A p value less than 0.05 was considered significant.
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Results |
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Analysis of cardiac variables demonstrated a higher incidence of significant preoperative tricuspid valve regurgitation in the RV–PA group (Table 2).
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During the study period (2000 to 2003) the hospital mortality for stage 1 Norwood was 27% in the BTS group and 8% in the RV–PA group. The time to achieve the conditions for hospital discharge was similar in both groups (RV–PA median, 14 days [range, 5–70 days]; BTS median, 12 days [range, 5–37 days]).
Physical examination at the time of discharge revealed a higher systolic blood pressure and respiratory rate among patients in the BTS group (Table 3).
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Autopsy data in the subgroup of patients who received a modified BTS documented evidence of myocardial infarction in 2 patients, and was unrevealing in another 4. The timing and relevant clinical information around the time of death is presented in Figure 1. Aortic atresia was present in all patients who died before hemi-Fontan.
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Comment |
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TopAbstractIntroductionMaterial and MethodsResultsCommentDiscussionAcknowledgmentsReferences |
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Although the presence of hemodynamically important residual lesions, shunt thrombosis, and cardiac dysrhythmia have been reported in association with some deaths before the second-stage procedure, the majority of deaths appear to be related to inadequate myocardial perfusion or remain unexplainable [8, 9]. A similar incidence of interim mortality among patients without hypoplastic left heart syndrome who received a systemic to pulmonary artery shunt during the initial management for other forms of single ventricle supports the notion that patients with a physiology characterized by a systemic and pulmonary circulation connected in parallel at the arterial level are vulnerable to sudden changes in the systemic to pulmonary resistance ratio and the potential influence these changes have on myocardial perfusion [11].
Moreover, the abnormal coronary flow patterns and the diminished coronary flow reserve described in patients after stage 1 Norwood with a systemic arterial to pulmonary artery shunt support the conjecture that inadequate myocardial perfusion may play a role in these deaths [12, 13].
Several strategies introduced to assist in the perioperative management of patients at the time of the stage 1 Norwood have resulted in improved operative outcomes. However, none of them have addressed directly the challenging physiology exhibited by these patients. In recent years several centers have adopted the use of an RV–PA conduit as the source of pulmonary blood flow in patients undergoing stage 1 Norwood and have noted an important degree of increased circulatory stability associated with improved clinical outcomes [1, 3, 4]. The elimination of diastolic runoff into the pulmonary circulation with the use of an RV–PA conduit compared with a modified BTS is an important surgical modification that results in a more favorable physiology by virtue of eliminating the connection of the systemic and the pulmonary circulation at the arterial level, allowing a reduction of the volume load on the single ventricle, a higher diastolic pressure, and the potential for a favorable impact on coronary perfusion, irrespective of the size of the BTS used for comparison [4, 14, 15].
This study demonstrates a significant reduction in interim mortality among hospital survivors who received an RV–PA conduit during the stage 1 Norwood. Analysis of the cohort revealed no demonstrable differences in perioperative variables between the two groups, except for a higher incidence of associated noncardiac pathology and important preoperative tricuspid valve insufficiency in the RV–PA group. These conditions, which have been reported to be associated with decreased hospital survival after stage 1 Norwood [5, 16], did not appear to have any influence on interim mortality in this cohort.
Analysis of data obtained at the time of hospital discharge did not relate statistically with interim mortality. Although the hemodynamic variables obtained at the time of discharge did not support the notion of improved circulatory physiology and coronary perfusion demonstrated when these patients were studied in the cardiac catheterization laboratory [14], it should be noted that these measurements were obtained by noninvasive methods under less-than-well-controlled conditions at the time of discharge, perhaps rendering this assessment more susceptible to measurement error.
The use of a modified BTS and the presence of perioperative dysrhythmias were associated with a higher likelihood of interstage death independently and when both variables coexisted in the same patient. Although all the patients who died in the interstage period had a diagnosis of aortic atresia, this variable could not be included in the logistic regression model because of its distribution. These variables associated with a higher likelihood of interim death seem clinically relevant given their perceived physiologic effect, and are consistent with the speculation on the role of coronary perfusion imbalance on interim mortality as reported by Fogel and associates [12] and Donnelly and colleagues [13].
The unrelenting occurrence of interstage deaths has prompted the implementation of different strategies among several centers aimed at diminishing interim mortality after a Norwood procedure. Some have chosen to perform the second-stage intervention at a younger age, thus reducing the period of time the patients remain vulnerable to the challenging physiology after stage 1 Norwood. Alternatively the institution of a home-surveillance monitoring program has gained increasing application with the hope that subtle changes will be detected before an irreversible event occurs [17]. A more physiologically oriented approach has aimed to reduce the potential for diastolic runoff in the pulmonary circulation by decreasing the size of the systemic to pulmonary artery shunt, at the expense of a potential increase in the incidence of shunt thrombosis. This has been documented in up to a third of unexpected deaths among patients who received a 3.5- to 3.0-mm systemic to pulmonary artery shunt for the management of different forms of single ventricle [11]. Additionally, although the use of antiplatelet agents have been though to be protective of these events, no proven benefit has been definitively shown.
The fact that there was no difference in age at the time of hemi-Fontan and the absence of specific measures to neutralize the risk of interstage death in this cohort puts in evidence that the reduction on interim mortality observed in this study was not influenced by the timing of the second stage or the management strategy used in these patients but most likely the improved circulatory physiology exhibited by the patients who received an RV–PA conduit.
Considering the timing of interim deaths, there was an even distribution of these events between the time of hospital discharge and hemi-Fontan. It is difficult to speculate on the timing of these events; however, it appears that these patients remain vulnerable to unexpected interstage mortality as long as the circulatory physiology and particularly the myocardial perfusion depends on a delicate balance between systemic and pulmonary resistance ratio. Moreover, the autopsy data available documented myocardial ischemia in two cases and excluded residual anatomic lesions or shunt thrombosis in the remaining patients, which points to the possibility of an acute coronary insufficiency or cardiac dysrhythmia as the most likely culprit for these deaths.
In conclusion, these data show that the use of the RV–PA conduit as part of stage 1 Norwood reconstruction has a favorable impact on the circulatory physiology that extends beyond the immediate perioperative period and appears to be a significant contribution to decrease the likelihood of unexpected interstage mortality.
This study has several limitations. The retrospective nature of the review, the lack of randomization, the sample size, and incomplete autopsy data make inferences from the study prone to error. Although the surgical reconstruction and perioperative and postdischarge management strategies remain unchanged during the study, the noncontemporary nature of the groups compared could raise questions about the validity of the comparison. Additionally, the distribution of the data precluded the inclusion of certain variables in the analysis of potential factors related to interstage death.
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Appendix |
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Selected Characteristics Related to Hemi-Fontan
Age, weight, gestational age, and weight percentile.
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Discussion |
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TopAbstractIntroductionMaterial and MethodsResultsCommentDiscussionAcknowledgmentsReferences |
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I am very interested in your future results.
I think from your presentation it is now very clear that the cause of interim deaths after the right ventricle to pulmonary artery conduit (RV–PA) shunt is cyanosis related to the shunt obstruction, which may occur 4 to 5 months after surgery. Our 2 late deaths also occurred because of shunt obstruction from our initial series.
I would like to ask you, what is your protocol of postoperative follow-up in outpatient clinic?
Our protocol is echocardiographic check 1 and 3 months after surgery. If the shunt flow is decreased at any time or saturation is low, we perform a catheterization and a second-stage operation at any time.
DR MROCZEK: Thank you, Dr Sano, for your question. The reason of death in the patient with RV–PA conduit is unclear to us. It was a patient with very poor hemodynamics before operation who underwent pulmonary artery banding and afterward a Norwood procedure 2 weeks after pulmonary artery bandings. This patient developed necrotizing enterocolitis and underwent hemicolectomy. However, he was discharged in quite good condition. The patient was from Mexico. Unfortunately, there was no autopsy, so it is unclear whether there was shunt obstruction or other events.
Regarding your second question, the patients in both groups underwent the same follow-up protocol. They were controlled 2 weeks after operation, 6 weeks, 3 months, and 4 or 5 months of age. If some of these patients developed cyanosis earlier or had poor weight gain, they were admitted to our hospital and taken to the catheterization lab. If the reason for hypoxemia was elucidated, and if hemodynamics measurements were good for hemi-Fontan, they underwent the hemi-Fontan procedure.
DR JOHN HAWKINS (Salt Lake City, UT): I just have one quick question, and maybe you can answer this very quickly.
What size was your modified Blalock-Taussig shunt (BTS) in your comparison group of 46 patients that underwent the BTS?
DR MROCZEK: All patients except 2 received a 4-mm BTS.
DR HAWKINS: So my question is this. I do not know about you, but I think that I am better, and my hospital is better, at taking care of hypoplastic left heart syndrome in the year 2004 than we were in the year 2000. So given the fact that this is a historical group, dating back to 2000 to 2001, and you were using a 4-mm shunt, which, at least for me, is a very high-risk situation, how do you know that your results are not just because of the fact that it was a 4-mm shunt and you have learned how to take care of children with hypoplastic left heart syndrome better?
DR MROCZEK: There was no difference in management strategies between groups. There was no difference in perioperative management variables. And there was only slight difference in catheterization before hemi-Fontan.
DR CHRISTIAN PIZARRO (Wilmington, DE): I just want to offer a comment to help answer that question. It is true that we have a historical control in this series, and that is far from ideal. However, I would say that probably the experience of the entire team taking care of these patients goes beyond a decade, and I do not think that we have just gotten better in the last year or so. On the contrary, after reaching a "comfort zone" managing patients who received a modified BTS, if there was any learning curve, this was with the more recent group of patients who received an RV–PA conduit, in whom the circulatory physiology is a little different. Additionally, Dr Mair from Austria recently reported experience in the management of patients who actually received a 3.5-mm shunt versus a 5-mm RV–PA conduit as part of the stage 1 Norwood. Despite the conscious effort to limit the amount of pulmonary blood flow by using a smaller shunt in patients with a modified BTS, a significant increase in diastolic blood pressure as well as a reduction in volume load of the single ventricle was observed in patients who received an RV–PA conduit. This was associated with an improvement in operative survival and significant decrease in interim mortality before the second-stage procedure, which reaffirms the concept that the beneficial effect observed with the RV–PA conduit is more fundamental and transcends the size of the BTS used in the control group.
DR JOHN E. MAYER (Boston, MA): Well, I think the only other outstanding issue that nobody has brought up at this point is the issue about right ventricular function and aneurysm formation at the proximal anastomosis of the RV–PA shunt. I think it would be of interest for the audience to hear from each of the authors of these several papers on this Sano procedure, whether that has been a problem or not. What is the incidence of either right ventricular dysfunction or aneurysm formation at the proximal end of the shunt?
DR MROCZEK: Thank you for your question. We did not observe any aneurysm formation in RV–PA patients. In some of the patients we observed narrowing of the proximal aspect of the RV–PA conduit. But we usually observed this shunt narrowing in the distal part. So in most of our patients who have demonstrated cyanosis, the reason for that was narrowing of the distal part of the RV–PA conduit. But there was no difference in ventricular ejection fraction assessment by echocardiography between RV–PA patients and the BTS group.
DR MAYER: I guess I should clarify. I think it is regional wall problems, particularly in the area of the origin of the shunt.
DR MROCZEK: Yes, but total global function of the right ventricle seems to be similar.
DR VINCENT TAM (Fort Worth, TX): I just want to answer Dr Mayer's question. In my personal experience, early on, when I started to do this, we had 2 patients, 1 had developed what was probably a true aneurysm, and it was sort of discovered on echocardiography probably about 3 or 4 months postoperatively. And that child, when he came back for a second-stage palliation, we simply resected the aneurysm and closed the ventriculotomy. And as far as I know, he still has very good right ventricular function.
The second patient, I believe, developed a septic-mediated aneurysm. It was a child who had 2 weeks of positive blood cultures despite appropriate antibiotics.
And I think early on, in that first patient, probably it came from maybe cutting the muscle a little bit too much. Since then, we have not seen that problem.
The other point I want to make is that I want to reinforce Dr Sano's comment. We now routinely catheterize outpatients at about 3 to 4 months of age because occasionally we will see patients who have systolic obstruction of the shunt at about that age.
DR BACKER: From the right ventricular muscle?
DR TAM: Yes.
DR BACKER: Thank you.
Scott, maybe you could tell us, any aneurysms in your patients?
DR SCOTT M. BRADLEY (Charleston, SC): No.
DR CHRISTIAN: How about proximal obstruction that develops over time?
DR BRADLEY: No.
DR BACKER: All right. Thank you very much.
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Acknowledgments |
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TopAbstractIntroductionMaterial and MethodsResultsCommentDiscussionAcknowledgmentsReferences |
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TopAbstractIntroductionMaterial and MethodsResultsCommentDiscussionAcknowledgmentsReferences |
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