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Ann Thorac Surg 2003;76:1084-1088
© 2003 The Society of Thoracic Surgeons

Original article: cardiovascular

Early experience with a modified norwood procedure using right ventricle to pulmonary artery conduit

William T. Mahle, MDa,b*, Angel R. Cuadrado, MDa,b, Vincent K. H. Tam, MDa,c

a Sibley Heart Center, Children’s Healthcare of Atlanta, , USA
b Division of Cardiology, Emory University School of Medicine and Children’s Healthcare of Atlanta, Atlanta, Georgia, USA
c Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia, USA

Accepted for publication February 13, 2003.

* Address reprint requests to Dr Mahle, Division of Cardiology, Emory University School of Medicine, Children’s Healthcare of Atlanta, 1405 Clifton Road, Atlanta, GA 30322, USA.
e-mail: wmahle{at}emory.edu


   Abstract
Top
 Abstract
Introduction
 Material and methods
 Results
 Comment
 Conclusion
 References
 
BACKGROUND: A recent modification to the Norwood procedure involves the use of a right-ventricle (RV) to pulmonary artery (PA) conduit to provide pulmonary blood flow for patients with hypoplastic left heart syndrome (HLHS). This modification is thought to provide more stable hemodynamics by avoiding the diastolic "run-off" that occurs with a Blalock-Taussig shunt.

METHODS: We reviewed our experience with the first 11 patients undergoing the RV-PA conduit modification of the Norwood operation and compared their outcomes with those of the preceding 22 patients who underwent a conventional Norwood procedure.

RESULTS: Between July 1999 and March 2002, 33 patients with HLHS underwent the Norwood procedure at a median age of 5 days (range 1 to 31 days). Aortic atresia was present in 28 (85%). No significant difference was noted between the RV-PA (n = 11) and conventional Norwood (n = 22) groups with respect to measures of morbidity such as duration of mechanical ventilation or hospital stay. Patients who underwent the conventional Norwood procedure did have significantly lower diastolic blood pressure in the early postoperative period (38.4 ± 4.4 mm Hg versus 49.5 ± 4.3 mm Hg, p = 0.001). The operative and 1-year survival rates were 81% and 81%, respectively, for patients with the RV-PA modification, which was not significantly different from those of patients who underwent the conventional procedure, 81% and 73% (p = 1.00 and p = 0.36). Two patients developed a pseudoaneurysm of the RV infundibulum after placement of RV-PA conduit. Four sudden deaths occurred after hospital discharge, all occurring in the conventional Norwood group.

CONCLUSIONS: The RV-PA conduit modification of the Norwood procedure results in excellent early survival. By avoiding low diastolic blood pressure this modification may provide superior perfusion to the coronary vascular bed and potentially reduce the risk of sudden unexpected death.


   Introduction
Top
 Abstract
 Introduction
Material and methods
 Results
 Comment
 Conclusion
 References
 
Overall survival for children with hypoplastic left heart syndrome (HLHS) who have undergone the Norwood procedure has improved dramatically during the past 20 years [1–3]. Nonetheless, HLHS continues to be associated with a higher risk of early mortality than most other forms of complex congenital heart disease. The highest risk for mortality is in the early postoperative period [1, 4]. In addition, a number of infants die suddenly after hospital discharge [5]. Many of the early operative deaths and sudden unexpected deaths are thought to be related to poor myocardial perfusion, which in turn may be related to the difficulty of maintaining a proper balance of pulmonary and systemic blood flow with a Blalock-Taussig shunt [6].

Recently, investigators have suggested that establishment of a direct right ventricle to pulmonary artery (RV-PA) connection might provide more stable hemodynamics, especially in the early postoperative period [7, 8]. This surgical technique reduces "diastolic run-off" that occurs in the setting of a Blalock-Taussig shunt, and hence may improve myocardial perfusion. We review our initial experience with this surgical modification to the Norwood procedure.


   Material and methods
Top
 Abstract
 Introduction
 Material and methods
Results
 Comment
 Conclusion
 References
 
Patient population
Beginning in July 2001, a single surgeon (V.K.T.) began to use a RV-PA connection as part of the Norwood reconstruction. The outcome for the initial 11 subjects undergoing this modification of the Norwood procedure was compared with the outcome for the preceding 22 patients (case:control ratio of 1:2) with HLHS who underwent the conventional Norwood procedure by the same surgeon. The study period covered from July 1999 to April 2002.

Operative technique
Cardiopulmonary bypass (CPB) was established by cannulation of the main pulmonary artery and right atrial appendage. The branch pulmonary arteries were occluded and the patient was cooled to a temperature of 16° to 18°C. For 22 of 33 subjects a clamp was placed across the proximal transverse aortic arch such that CPB continued to perfuse the brain through the innominate artery and the heart through the native aorta. The duration of CPB for the entire cohort ranged from 75 to 225 minutes (median 160.5 minutes). Eleven subjects undergoing a conventional Norwood had arch reconstruction performed under circulatory arrest. The duration of circulatory arrest ranged from 26 to 71 minutes (median 54.5 minutes).

For patients undergoing an RV-PA conduit a 5-mm punch was used to create an opening in the right ventricular outflow tract. Looking through the pulmonary valve a thinned-out region was identified. This relatively avascular area was located between the conal branches of the left anterior descending coronary artery and the right coronary artery. An oblique cut was made in the graft in order to create a large elliptical anastomosis to the pulmonary artery confluence. The RV-PA conduit (saphenous vein or Gore-Tex [W.L. Gore and Assoc, Flagstaff, AZ]) was anastomosed to the pulmonary artery confluence and the right ventricle (Fig 1). In the initial experience, the RV-PA conduit passed to the right of the native aorta. However, in the latter part of the series the RV-PA conduit passed to the left of the native aorta to avoid an acute angle between the conduit and the right pulmonary artery.



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  		Fig 1. Norwood procedure using a right ventricle to pulmonary artery conduit. The origin of the conduit arises from an avascular area in the right ventricle outflow tract.

 
For patients undergoing a conventional Norwood procedure, a right modified Blalock-Taussig shunt ranging in diameter from 2.5 to 4 mm was used. A saphenous vein graft was used to for the shunt in 20 subjects and a Gore-Tex graft in 2 patients. Complete atrial septectomy was performed through the right atrial cannulation site. A patch of pulmonary homograft was used in the aortic arch reconstruction. Modified ultrafiltration was used in all cases.

Postoperative management
Delayed sternal closure was used in all patients. Inotropic support was commenced at the time of weaning from CPB. Standard inotropic support consisted of epinephrine and dopamine infusions. Mechanical ventilation was adjusted to maintain oxygen saturations of 70% to 80%.

Hemodynamic assessment
Complete transthoracic two-dimensional, Doppler, and color Doppler echocardiographic examinations were performed on all study patients on admission, before hospital discharge and before Glenn procedure. Atrioventricular valve regurgitation was graded on a scale from 1 to 4+ by measurement of the ratio of regurgitant jet area to the right atrial area [9]. Right ventricular systolic function was assessed qualitatively. Elective catheterization was performed in all patients before Glenn procedure.

Statistical analysis
Data are expressed as mean ± SD or median and range, where appropriate. Statistical analysis was performed by Fisher exact test, chi-square test, Wilcoxon rank sum test, Kaplan–Meier survival curve estimates, log-rank tests to compare survival curves, and Cox proportional hazards model for assessing associations between risk factors and freedom from death. Analysis was performed with STATA 6.0 (College Station, TX). Significance was determined at p values of less than 0.05. All p values are 2-sided and confidence intervals are 95%.


   Results
Top
 Abstract
 Introduction
 Material and methods
 Results
Comment
 Conclusion
 References
 
Patient population
The median age at presentation for the entire cohort was 1 day (range 0 to 37 days). A prenatal diagnosis of congenital heart disease had been made in 67% of cases. No significant difference was noted between patients undergoing the RV-PA modification and those undergoing conventional Norwood procedure with respect to preoperative variables (Table 1). The median age at the time of the Norwood procedure for both groups was 5 days (p = 0.83). The measures of postoperative morbidity were not significantly different between the 2 groups (Table 2). However, the diastolic blood pressure was significantly higher in the RV-PA group when compared with controls (49.5 ± 4.3 mm Hg versus 38.4 ± 4.4 mm Hg, p < 0.001).


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  		Table 1. Preoperative Data

 

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  		Table 2. Postoperative Data

 
Of the 33 patients included in the study, there were 27 operative survivors (81%). The operative survival for both groups was the same. The two operative deaths in patients who had undergone an RV-PA modification were attributed to sepsis (on the 29th postoperative day) and persistent pleural effusions (on the 39th postoperative day). Among the patients undergoing conventional Norwood 4 died within 24 hours of surgery. In addition, 4 patients had sudden unexpected death after hospital discharge following conventional Norwood. None of these patients were known to have impaired RV contractility or significant tricuspid insufficiency at hospital discharge. The 1-year survival for the entire cohort was 70% (95% confidence interval 51% to 82%). No significant difference was noted in 1-year survival (Fig 2).



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  		Fig 2. Kaplan-Meier survival plot for right ventricle to pulmonary artery (RV-PA) conduit and conventional Norwood groups (p = 0.36).

 
Pseudoaneurysm of the RV infundibulum at the site of the anastomosis of the RV-PA conduit developed in 2 patients. In 1 patient the pseudoaneurysm was identified on the 22nd postoperative day. The pseudoaneurysm continued to dilate to a maximal dimension of 3.2 cm (Fig 3). On the 27th postoperative day the patient underwent resection of the pseudoaneurysm and conversion to a modified Blalock-Taussig shunt. A second patient was found to have a smaller pseudoaneurysm in the RV infundibulum at routine follow-up, 4 months after the Norwood procedure. The pseudoaneurysm was resected at the time of the Glenn operation. At most recent follow-up the patient was found to have normal RV shortening without recurrence of the pseudoaneurysm. One patient was found to have elevated pulmonary artery pressures (mean pressure 24 mm) and persistent pleural effusions after initial palliation with a 5.5-mm saphenous vein RV-PA conduit. In an attempt to reduce pulmonary artery pressure, the RV-PA conduit was removed and a 3.5-mm right modified Blalock-Taussig shunt was placed.



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  		Fig 3. Transesophageal echocardiographic image of pseudoaneurysm of right ventricular infundibulum.

 
A cardiac catheterization was performed in 24 patients at a median age of 4.8 months. Data from the catheterization and echocardiographic studies are shown in Table 2.The mean pulmonary artery pressure was similar in both patient groups. To date, 22 patients have undergone a bidirectional Glenn procedure at a median age of 6.3 months (range 2.6 to 8.6 months). No hospital deaths were associated with the Glenn operation. One patient initially managed with conventional Norwood procedure, required removal of the Glenn anastomosis.


   Comment
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
Conclusion
 References
 
This retrospective study reports our early experience with an RV-PA conduit as the source of pulmonary blood flow in patients with HLHS undergoing the Norwood procedure. Operative survival after this modification (81%) was comparable to that after the conventional Norwood procedure. The theoretical advantage to this procedure is that diastolic run-off is avoided. This theory is supported by the observation of higher diastolic pressures in the RV-PA group compared with conventional Norwood patients.

A variety of techniques have been used to optimize postoperative hemodynamics for patients undergoing a conventional Norwood procedure. In patients with excessive pulmonary blood flow, inspired carbon dioxide and nitrogen have been used to increase pulmonary vascular resistance and improve cardiac output [10]. Pharmacological manipulation with phenoxybenzamine, an {alpha}-adrenergic receptor blocking agent, has also been used to lower systemic vascular resistance and increase systemic blood flow [11]. Manipulation of pulmonary and systemic vascular resistance is frequently required in patients after the conventional Norwood procedure because the Blalock-Taussig shunt allows for run-off in diastole. Use of an RV-PA conduit eliminates the diastolic run-off seen after the conventional Norwood. In this series the diastolic blood pressure measurements were significantly higher in the RV-PA group than in the conventional Norwood group.

Maintaining adequate diastolic blood pressure is of critical importance in patients with HLHS. Several previous investigators have shown that coronary blood flow is abnormal in patients after the conventional Norwood procedure. Fogel and colleagues [12] found that in patients with aortic atresia who have undergone a conventional Norwood procedure, the diastolic flow in the native aorta increased once a hemi-Fontan operation is performed and the Blalock-Taussig shunt is eliminated. Donnelly and colleagues [13] used positron emission tomography with nitrogen-13–labeled ammonia to measure myocardial perfusion at rest and with adenosine in infants with HLHS and other forms of congenital heart disease. These investigators found that infants with HLHS, who have undergone a conventional Norwood procedure, have significantly lower coronary flow reserve than patients with other forms of congenital heart disease. Optimizing coronary flow after the Norwood procedure is important because hemodynamics are often marginal in the early postoperative period. In an autopsy study of 122 patients with HLHS, Bartram and colleagues [6] found that impaired coronary perfusion accounted for 27% of all deaths after the Norwood procedure. In addition, impaired coronary perfusion may contribute to the relatively high incidence of sudden unexpected death that occurs following the Norwood procedure. Mahle and colleagues [5] reported that 4.1% of patients had sudden unexpected death after hospital discharge after the Norwood procedure. Our current series would agree with the published literature; 4 patients died suddenly at home after the conventional Norwood operation. To date, sudden deaths have not been reported among patients undergoing RV-PA modification, but the published literature is limited at present.

The operative survival for this series (81%) is comparable to recent reports from other large centers. Gaynor and associates [2] reported an operative survival of 78% in a series of 102 patients with HLHS. Poirier and coworkers [3] reported an early postoperative survival of 83% for 59 patients undergoing the Norwood operation using only autologous tissue to reconstruct the aortic arch. Importantly, in most series mortality risk is considerable even after hospital discharge. The overall survival in our series at 1 year was 70%. Other large series published in recent years have reported 1-year survival rates of 57% to 72% [2, 3, 14]. The present study did not demonstrate a significant difference in survival between the RV-PA modification and the conventional Norwood procedure. Longer follow-up and larger series will be required to determine if this modification confers a survival benefit.

Data from catheterization and echocardiography suggest that the RV-PA modification allows for adequate pulmonary artery growth and suitable hemodynamics for subsequent cavopulmonary surgery. The ratio of pulmonary to systemic blood flow is similar to that observed following the conventional Norwood procedure. Our initial experience in which the RV-PA conduit passed to the right of the neo-aorta resulted in some distortion of the right pulmonary artery. This finding may have been due in part to the acute angle between the conduit and right pulmonary artery. By altering the operation to direct the conduit to the left of the neo-aorta this distortion has been lessened.

Although the RV-PA modification of the Norwood operation clearly allows for satisfactory hemodynamics in the early postoperative period, concerns have been raised about the potential deleterious effect of an incision in the right ventricular outflow tract. Longer-term follow-up of patients with other forms of congenital heart disease suggests that a right ventricular incision may be a substrate for ventricular arrhythmias [15, 16]. In the present series pseudoaneurysm of the RV infundibulum at the proximal end of the RV-PA conduit developed in 2 patients. This complication has not been reported previously in the small number of cases in the literature with RV-PA modification [7, 8]. Some trials, however, do report pseudoaneurysm developing in the RV infundibulum in patients with pulmonary stenosis or atresia who have RV-PA conduits placed [17]. In addition, pseudoaneurysm has been described as rare complication of the Ross procedure [18]. Theoretical risk factors for the development of a pseudoaneurysm include distal stenosis and elevated RV pressure [19]. In general we have attempted to identify a thin portion of the RV infundibulum to place the punch infundibulotomy. This practice may have contributed to the development of RV pseudoaneurysms.


   Conclusion
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Conclusion
References
 
The RV-PA conduit modification of the Norwood procedure is an attractive alternative to the conventional use of a modified Blalock-Taussig shunt. In this small series early survival was comparable between the two techniques. The RV-PA modification results in significantly higher diastolic blood pressure, which may favorable impact coronary perfusion. Close follow-up of patients undergoing the RV-PA modification is warranted to assess RV function.


   References
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Conclusion
 References
 

  1. Mahle W.T., Spray T.L., Wernovsky G., Gaynor J.W., Clark B.J., 3rd Survival after reconstructive surgery for hypoplastic left heart syndrome: a 15-year experience from a single institution. Circulation 2000;102(Suppl 3):III136-141.
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  7. Imoto Y., Kado H., Shiokawa Y., Minami K., Yasui H. Experience with the Norwood procedure without circulatory arrest. J Thorac Cardiovasc Surg 2001;122:879-882.[Abstract/Free Full Text]
  8. Kishimoto H., Kawahira Y., Kawata H., Miura T., Iwai S., Mori T. The modified Norwood procedure on a beating heart. J Thorac Cardiovasc Surg 1999;118:1130-1132.[Free Full Text]
  9. Chopra H.K., Nanda N.C., Fan P., et al. Can two-dimensional echocardiography and Doppler color flow mapping identify the need for tricuspid valve repair?. J Am Coll Cardiol 1989;14:1266-1274.[Abstract]
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  13. Donnelly J.P., Raffel D.M., Shulkin B.L., et al. Resting coronary flow and coronary flow reserve in human infants after repair or palliation of congenital heart defects as measured by positron emission tomography. J Thorac Cardiovasc Surg 1998;115:103-110.[Abstract/Free Full Text]
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