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Ann Thorac Surg 2004;78:1965-1971
© 2004 The Society of Thoracic Surgeons

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Original Article: Cardiovascular

Midterm Ventricular Performance After Norwood Procedure With Right Ventricular–Pulmonary Artery Conduit

Department of Cardiovascular Surgery and Pediatric Cardiology, Fukuoka Children's Hospital Medical Center, Fukuoka, Japan

Accepted for publication June 2, 2004.

^* Address reprint requests to Dr Tanoue, Department of Cardiovascular Surgery, Kyushu University, 3–1–1 Maidashi, Higashi-ku, Fukuoka 812–8582, Japan (E-mail: tanoue{at}heart.med.kyushu-u.ac.jp).

	Abstract

Top Abstract Introduction Patients and Methods Results Comment References

 
BACKGROUND: Midterm and long-term results of patients who underwent a Norwood procedure with a right ventricular–pulmonary artery conduit remain unclear. This study aimed to compare the midterm ventricular performance of the Norwood procedure with right ventricular–pulmonary artery conduit and the Norwood procedure with systemic–pulmonary shunt.

METHODS: Twenty-one patients who underwent both a bidirectional Glenn procedure and a total cavopulmonary connection after Norwood palliation at Fukuoka Children's Hospital Medical Center were divided into two groups: the systemic–pulmonary shunt group (n = 11) and the right ventricular–pulmonary artery conduit group (n = 10). End-systolic elastance (contractility), effective arterial elastance (afterload), and ventriculoarterial coupling and the ratio of stroke work and pressure-volume area (ventricular efficiency) were measured on the basis of cardiac catheterization data before the bidirectional Glenn procedure, before and after the total cavopulmonary connection, and at approximately 1 year after total cavopulmonary connection.

RESULTS: After bidirectional Glenn procedure and total cavopulmonary connection, end-systolic elastance of the right ventricular–pulmonary artery conduit group was lower than that of the systemic–pulmonary shunt group, whereas effective arterial elastance of the right ventricular–pulmonary artery conduit group was lower than that of the systemic–pulmonary shunt group. Consequently, there was no difference in ventricular efficiency in both groups 1 year after total cavopulmonary connection.

CONCLUSIONS: The midterm ventricular performance of the right ventricular–pulmonary artery conduit group was comparable with the systemic–pulmonary shunt group in terms of ventricular efficiency. However, after bidirectional Glenn procedure and total cavopulmonary connection, contractility in patients who underwent a Norwood procedure with a right ventricular–pulmonary artery conduit was inferior to that of patients who underwent a Norwood procedure with a systemic–pulmonary shunt.

	Introduction

Top Abstract Introduction Patients and Methods Results Comment References

 
Clinical results of hypoplastic left heart syndrome (HLHS) have improved progressively and impressively [1–8]. The Norwood procedure with the use of a right ventricular–pulmonary artery conduit (Norwood RV–PA) has been revived in Japan [9, 10], and was recently accepted as a new operative strategy for the treatment of HLHS patients as an alternative to a Norwood procedure with systemic–pulmonary shunt (Norwood S–P) [11, 12]. Norwood RV–PA has been reported to produce stable systemic circulation and an adequate pulmonary blood flow, improve coronary perfusion, and provide a good clinical outcome. However, the influence of an incision in the right ventricle and diastolic regurgitation through the conduit on the midterm and long-term results of patients who underwent Norwood RV–PA remain unclear. Thus a comparative study of the midterm and long-term results of Norwood RV–PA and Norwood S–P was seen as necessary.

In the present study, we compared the ventricular performance after the bidirectional Glenn procedure (BDG) and a total cavopulmonary connection (TCPC) in HLHS patients who underwent Norwood RV–PA and Norwood S–P. The purpose of this study was to analyze the midterm (1 year after TCPC) ventricular performance (contractility, afterload, ventricular efficiency) of HLHS patients who had undergone Norwood RV–PA.

	Patients and Methods

Top Abstract Introduction Patients and Methods Results Comment References

 
Patient Information
Twenty-one patients of classic HLHS, including aortic atresia or stenosis, mitral atresia or stenosis with a poorly developed left ventricle, normally related great arteries, and an intact ventricular septum, 10 males and 11 females, underwent both BDG and TCPC after Norwood palliation at Fukuoka Children's Hospital Medical Center between April 1992 and August 2003. These patients were divided retrospectively into two groups: the S–P group (n = 11) and the RV–PA group (n = 10). Norwood S–P only has been performed until 1988, and Norwood RV–PA mainly has been performed since 1998 [10, 13]. The patients were consecutive, except for 2 children who died after BDG (1 Norwood S–P and 1 Norwood RV–PA) and were not included in the study. During the same period, 62 children underwent Norwood palliation (23 Norwood S–P and 39 Norwood RV–PA), and 49 patients survived this palliation and left the hospital (18 Norwood S–P and 31 Norwood RV–PA). After leaving the hospital, 11 children died before BDG (5 Norwood S–P and 6 Norwood RV–PA); presently 4 are waiting for BDG, and 11 are waiting for TCPC. Informed consent for both the operation and cardiac catheterization was obtained from all parents of the children.

In the S–P group, mean ages of all patients were 14.4 ± 5.6 days (range, 6 to 26 days) for Norwood palliation, 13.4 ± 8.1 months (range, 6 to 28 months) for BDG, and 35.8 ± 11.9 months (range, 17 to 58 months) for TCPC. Mean weights were 2.76 ± 0.23 kg (range, 2.44 to 3.20 kg) for Norwood palliation, 6.71 ± 1.59 kg (range, 4.44 to 9.05 kg) for BDG, and 11.10 ± 1.89 kg (range, 8.06 to 14.80 kg) for TCPC. In the RV–PA group, mean ages of all patients were 14.9 ± 6.8 days (range, 7 to 25 days) for Norwood palliation, 7.0 ± 2.1 months (range, 4 to 11 months) for BDG (p = 0.0267 versus the S–P group by Student's unpaired t test), and 24.2 ± 4.7 months (range, 17 to 32 months) for TCPC (p = 0.0095 versus the S–P group). The mean weight was 2.87 ± 0.47 kg (range, 1.72 to 3.42 kg) for Norwood palliation, 5.86 ± 0.85 kg (range, 4.82 to 7.63 kg) for BDG, and 10.06 ± 0.86 kg (range, 8.92 to 11.40 kg) for TCPC.

Operative Techniques
All operations were performed by the same cardiac surgeon (H.K.). Anesthesia was done using a standard technique with intravenous infusion of fentanyl, inhalation of sevoflurane, and muscle relaxation with pancuronium. The descending aorta cannulation technique combined with innominate artery perfusion and bicaval cannulations were performed thorough a standard median sternotomy [14, 15]. Cardiopulmonary bypass was instituted by a heart-lung machine consisting of a rotating pump and a membrane oxygenator. Circulatory arrest was avoided, and myocardial preservation was achieved using cold crystalloid cardioplegic solution [16, 17] combined with topical cooling.

NORWOOD PALLIATION
Norwood S–P was performed in 11 patients (S–P group), using a 3.5-mm polytetrafluoroethylene graft in 8 patients and a 4-mm polytetrafluoroethylene graft in 3 patients [15]. Norwood RV–PA was performed in 10 patients (RV–PA group), using a 5-mm polytetrafluoroethylene graft in 4 patients and a 6-mm polytetrafluoroethylene graft in 6 patients [9, 10]. The mean diameters of the ascending aorta were 3.0 ± 1.1 mm (range, 2.0 to 5.0 mm) in the S–P group and 3.2 ± 1.6 mm (range, 2.0 to 6.0 mm) in the RV–PA group. Regarding concomitant procedures, tricuspid valvuloplasty was performed in 3 patients of the RV–PA group (no patient in the S–P group).

BIDIRECTIONAL GLENN PROCEDURE
A bidirectional cavopulmonary shunt was made by direct end-to-side anastomosis between the superior vena cava and the pulmonary artery. Bilateral superior venae cavae were present in 2 children of the RV–PA group, and bidirectional cavopulmonary anastomoses were done in a separate fashion. Regarding concomitant procedures, tricuspid valvuloplasty was performed in 5 patients (2 in the S–P group and 3 in the RV–PA group), an augmentation of the pulmonary artery was performed in 10 patients (5 from each group), an enlargement of atrial septal defect was performed in 3 in the RV–PA group, and plasty of the aorta was performed in 3 in the S–P group. Additional pulmonary blood flow was maintained in 8 patients in the RV–PA group.

TOTAL CAVOPULMONARY CONNECTION
For inferior cavopulmonary anastomosis, the extracardiac conduit approach using a 16- to 18-mm polytetrafluoroethylene graft [18] was performed in all patients. Fenestration was created in 4 (1 in the S–P group and 3 in the RV–PA group). Regarding concomitant procedures, tricuspid valvuloplasty was performed in 6 (3 from each group), augmentation of the pulmonary artery was performed in 6 (1 in the S–P group and 5 in the RV–PA group), and an enlargement of atrial septal defect was performed in 1 in the S–P group.

Data Analysis
All patients underwent cardiac catheterization before BDG, before TCPC, and after TCPC, and 16 patients (9 in the S–P group and 7 in the RV–PA group) underwent cardiac catheterization at approximately 1 year after TCPC. The right ventricular (RV) volume was calculated according to Simpson's rule [19]. The calculation of the percent normal RV end-diastolic volume was based on the control data of patients who underwent follow-up cardiac catheterization after Kawasaki's disease with intact coronary artery at Fukuoka Children's Hospital Medical Center. The RV ejection fraction was calculated as follows: ejection fraction = (1 – minimal RV volume/maximal RV volume) x100 (%). The calculations of contractility (end-systolic elastance; Ees), afterload (effective arterial elastance; Ea), and ventricular efficiency (ventriculoarterial coupling; Ea/Ees, and the ratio of stroke work and pressure-volume area; SW/PVA) were performed based on the pressure and volume data of cardiac catheterization by the approximation method as previously described [20–22]. The approximation of Ees and Ea was performed as follows: Ees = mean arterial pressure/minimal RV volume, and Ea = maximal RV pressure/(maximal RV volume – minimal RV volume). The ventricular volume was divided by the body surface area. The ratio of Ea to Ees (Ea/Ees) and SW/PVA were calculated as indices of ventricular efficiency. The ratio Ea/Ees is the ventriculoarterial coupling between the left ventricle and the arterial system described by Burkhoff and Sagawa [23]. The SW/PVA was calculated as follows: SW/PVA = 1/(1 + 0.5Ea/Ees) x100 (%). This theoretical formula has previously been described by Nozawa and associates [24].

Statistical Analysis
The results are presented as mean ± standard deviation. Two-factor analysis of variance with repeated measures on one factor was used for the variables measured at four points (before BDG, before TCPC, after TCPC, and 1 year after TCPC). Student-Newman-Keuls test was used as a post hoc test.

	Results

Top Abstract Introduction Patients and Methods Results Comment References

 
Hemodynamic variables (mean pulmonary arterial pressure, mean aortic pressure, the pulmonary arterial index of Nakata and colleagues [25], systemic arterial oxygen saturation, and atrioventricular valve regurgitation) in cardiac catheterization before and after BDG and TCPC are shown in Table 1. Mean pulmonary arterial pressure significantly decreased after BDG in both groups. Pulmonary arterial index in the RV–PA group tended to be smaller than that in the S–P group after Norwood palliation (before BDG). Systemic arterial oxygen saturation significantly increased after both BDG and TCPC in both groups. Systemic arterial oxygen saturation in the RV–PA group was significantly lower than that in the S–P group after Norwood palliation (before BDG).

View larger version (19K): [in this window] [in a new window]   Fig 1. Time course of percent normal right ventricular end-diastolic volume (%N-EDV) (top) and ejection fraction (EF) (bottom). The percent normal right ventricular end-diastolic volume in the systemic–pulmonary shunt group (•) decreased after bidirectional Glenn procedure (BDG) and that in the right ventricular–pulmonary artery conduit group () decreased after total cavopulmonary connection (TCPC). The percent normal right ventricular end-diastolic volume in the right ventricular–pulmonary artery conduit group was significantly larger than that in the systemic–pulmonary shunt group before total cavopulmonary connection. Values shown are mean ± standard deviation.

	Comment

Top Abstract Introduction Patients and Methods Results Comment References

In our hospital, several strategies have been initiated to improve the clinical results of HLHS patients. The following strategies are pursued: (1) the complete avoidance of circulatory arrest throughout the Norwood procedure (the descending aorta cannulation technique combined with the innominate artery perfusion) [14, 15]; (2) the construction of a neoaorta without the use of any patching material [10, 15]; (3) a nonvalved RV–PA conduit instead of a systemic–pulmonary shunt for the prevention of hemodynamic instability [10]; and (4) a staged Fontan procedure with an extracardiac conduit under a beating heart in right heart bypass surgery [26, 27]. These various strategies have improved clinical outcomes for HLHS patients in our hospital. The excellent hemodynamic stability provided after Norwood RV–PA would be one of the most important factors for obtaining the improvement in clinical results.

Norwood RV–PA was recently accepted as a new operative strategy for the management of HLHS patients [9–12] and provides a stable systemic circulation with adequate pulmonary blood flow, as well as improves coronary perfusion. On the other hand, the influence of an incision in the right ventricle for the placement of the RV–PA conduit and diastolic regurgitation through the conduit on systemic RV function are of great concern. Systemic RV function after Norwood RV–PA evaluated by echocardiography or cardiac catheterization was reported to be acceptable [11, 12]. In the present study, systemic RV performance (Ees, Ea, Ea/Ees, and SW/PVA) of the RV–PA group was comparable with that of the S–P group after Norwood palliation (before BDG), but contractility (Ees) of the RV–PA group was inferior to that of the S–P group after BDG and TCPC. The size of the RV–PA conduit used was 5 mm in patients weighing less than 3 kg and 6 mm in the other patients in our hospital. There is no difference in RV performance and incidence of tricuspid regurgitation between patients receiving 5-mm conduits and those receiving 6-mm conduits in this study. The decline in contractility, however, would imply some influence from the ventriculotomy on systolic RV function.

It is not sufficient to assess the systemic morphologic RV function by measuring ordinary hemodynamic variables alone. In the present study, mean aortic pressure and ejection fraction did not significantly change before and after BDG and TCPC, and the difference between the two groups did not reach statistical significance. In contrast, the change and difference of the load-independent variables of systolic ventricular function, Ees, the factor of afterload, Ea, and the indices of ventricular efficiency, Ea/Ees and SW/PVA, were dramatic. We previously reported the approximation of Ees and Ea, and validated this approximation using a canine right-heart bypass model with a conductance catheter [21]. We combined this approximation of the Ees and Ea with the cardiac catheterization data of single-ventricle patients, and then compared the ventricular performance of the patients who underwent right heart bypass surgery [20, 21]. We then reported the minimization of the afterload mismatch by cavopulmonary anastomosis on TCPC [21], and the correction of the afterload mismatch during the interval between BDG and staged TCPC [20]. With this simple approximation of Ees and Ea, the systolic morphologic RV contractility, afterload, and efficiency of HLHS patients could be evaluated from the conventional cardiac catheterization data in the present study. The Ea of the RV–PA group was lower than that of the S–P group although the Ees of the RV–PA group was inferior to that of the S–P group after BDG and TCPC. Consequently, Ea/Ees and SW/PVA of the RV–PA group were comparable with those of the S–P group. It is conceivable that the overall systemic RV performance of the RV–PA group is acceptable in the midterm period.

The large percent normal RV end-diastolic volume after BDG and TCPC of the RV–PA group could be caused by volume overload by the additional pulmonary blood flow. The RV–PA conduit was left open to increase the oxygen saturation level and to promote pulmonary artery growth, and the additional flow was adjusted to elevate the superior vena cava pressure by 1 mm Hg. Although the role of the accessory pulmonary blood flow after BDG remains unclear [28], both pulmonary arterial index and systemic arterial oxygen saturation after the Norwood procedure (before BDG) of the RV–PA group were lower than those of the S–P group. The additional pulmonary blood flow is considered to be necessary for the children who underwent the Norwood RV–PA to avoid any problems from desaturation. One year after TCPC, the contractility of the RV–PA group was inferior to that of the S–P group, although ventricular efficiency of the RV–PA group was comparable with that of the S–P group. The long-term follow-up of RV performance in HLHS patients who underwent Norwood RV–PA is of critical importance.

The improvement in ventricular efficiency of the RV–PA group during the 1-year period after TCPC was related not only to the improvement of contractility but also to the reduction of afterload. Afterload-reducing therapies help to improve ventricular performance in HLHS patients. Long-term oral intake of angiotensin-converting enzyme inhibitor or ß-adrenergic blocker is adopted in our hospital. Home oxygen therapy is also performed for at least 6 months after the operation to decrease pulmonary vascular resistance. Furthermore, we have adopted the permanent use of anticoagulation with warfarin sulfate to prevent thromboembolism. We hope that this anticoagulant therapy prevents microembolism in peripheral vessels and also suppresses any increase in afterload.

The approximation of Ees and Ea described in this study has so far only been validated in an animal model [21], and does not amount to the measurement by a conductance catheter. The validation of this approximation should therefore not only be performed on normal hearts but also on diseased hearts in human studies. However, the present approximation enables us to evaluate contractility, afterload, and ventricular efficiency from the conventional cardiac catheterization data [20–22]. Correlation of tricuspid regurgitation and RV function should be analyzed. There is no difference in RV performance between the patients who required tricuspid valve repair or not throughout the assessment period. However, we cannot fully resolve this problem owing to the small number of patients. The influence of the RV–PA conduit size and the additional pulmonary blood flow after BDG also should be weighed. However, this analysis also could not be performed in this paper because of the small number of patients. The sufficiency of the 16- to 18-mm extracardiac conduit after growth remains unclear. We think that more than a 16-mm conduit can be applicable and that good long-term results can be expected. There is no case of the conduit replacement after TCPC with extracardiac conduit in our hospital [27]. Finally, the long-term changes of Ees, Ea, Ea/Ees, and SW/PVA will be the next interesting problem. Further studies of the long-term period after TCPC in HLHS patients are thus called for.

In conclusion, the midterm results of Norwood RV–PA are comparable with those of Norwood S–P in terms of ventricular efficiency. However, after BDG and TCPC, the contractility of patients who underwent Norwood RV–PA is inferior to that of patients who underwent Norwood S–P, whereas the afterload of patients who underwent Norwood RV–PA is lower than that of patients who underwent Norwood S–P. Further evaluations of patients who undergo Norwood RV–PA are thus called for to improve the long-term outcome of HLHS patients.

View larger version (21K): [in this window] [in a new window]   Fig 2. Time course of end-systolic elastance (Ees) (top) and effective arterial elastance (Ea) (bottom). End-systolic elastance improved in a stepwise fashion in both groups. Although end-systolic elastance and effective arterial elastance in the right ventricular–pulmonary artery conduit group () were the same as those in the systemic–pulmonary shunt group (•) after Norwood palliation (before bidirectional Glenn procedure [BDG]), end-systolic elastance in the right ventricular–pulmonary artery conduit group was lower than that in the systemic–pulmonary shunt group after bidirectional Glenn procedure and after total cavopulmonary connection (TCPC), whereas effective arterial elastance in the right ventricular–pulmonary artery conduit group was lower than that in the systemic–pulmonary shunt group. Values shown are mean ± standard deviation.

View larger version (19K): [in this window] [in a new window]   Fig 3. Time course of ventriculoarterial coupling (Ea/Ees) (top) and the ratio of stroke work and pressure-volume area (SW/PVA) (bottom). There is no difference in ventriculoarterial coupling and the ratio of stroke work and pressure-volume area in both groups. The ratio of stroke work and pressure-volume area in the right ventricular–pulmonary artery conduit group () improved during the 1-year period after total cavopulmonary connection (TCPC). Solid circles represent the systemic–pulmonary shunt group. Values shown are mean ± standard deviation. (BDG = bidirectional Glenn procedure.)

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