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Ann Thorac Surg 2009;88:1541-1545. doi:10.1016/j.athoracsur.2009.07.081
© 2009 The Society of Thoracic Surgeons
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Original Articles: Pediatric Cardiac

Ring-Enforced Right Ventricle-to-Pulmonary Artery Conduit in Norwood Stage I Reduces Proximal Conduit Stenosis

Christian Schreiber, MD, PhDa,*,*, Jelena Kasnar-Samprec, MD, PhD*,a, Jürgen Hörer, MD, PhDa, Andreas Eicken, MD, PhDb, Julie Cleuziou, MDa, Zsolt Prodan, MDa, Rüdiger Lange, MD, PhDa

a Clinic for Cardiovascular Surgery, German Heart Center Munich at the Technical University Munich, Munich, Germany
b Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich at the Technical University Munich, Munich, Germany

Accepted for publication July 10, 2009.

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


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Footnotes
 References
 
Background: An increasing number of surgeons prefer to place a conduit from the right ventricle to the pulmonary artery at the time of the Norwood stage I procedure. Proximal conduit stenoses have led us to modify this technique by using ring-enforced polytetrafluoroethylene conduits.

Methods: Angiograms of 24 patients with conventional conduits (CC) and 28 patients with ring-enforced conduits (RC) before partial bidirectional cavopulmonary anastomosis were analyzed. The degree of conduit stenosis on three different levels—proximal anastomosis, substernal part of the conduit, and distal anastomosis—was compared between the two groups.

Results: In the RC group, the extent of conduit stenosis at the level of proximal anastomosis and within the substernal proximal third of the conduit was minimized (23% ± 22% vs 45% ± 22%, p = 0.001, and 7% ± 6% vs 49% ± 26%, p < 0.001, respectively). At the level of the anastomosis with the pulmonary arteries, results were similar in the RC group (24% ± 14%) vs CC group (31% ± 15%, p = 0.103). Significantly fewer patients in the RS group required urgent intervention (dilatation ± stenting) or early stage II operation (1 vs 6 patients, p = 0.034).

Conclusions: The use of a ring-enforced polytetrafluoroethylene conduit between the right ventricle and the pulmonary artery in Norwood stage I palliation effectively prevents substernal compression and reduces interstage morbidity.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 Footnotes
 References
 
The classic Norwood I procedure provides pulmonary blood flow through a modified Blalock-Taussig shunt (mBTS). A modification of this procedure involves placing a conduit from the right ventricle to the pulmonary artery (RV-PA) [1]. The theoretic advantage of the RV-PA conduit is a more stable postoperative course, most likely because of an increased coronary arterial flow due to lack of the usual aortic diastolic runoff and resulting lower diastolic blood pressure [2, 3]. Potential disadvantages of the RV-PA conduit may be ventricular dysfunction, aneurysm formation, and arrhythmias after ventriculotomy, as well as ventricular dilation due to backflow through the shunt [4, 5]. However, the results from a randomized study that compared the outcomes of individuals undergoing a Norwood I procedure with the RV-PA conduit or mBTS [6] are still pending.

To overcome a potential drawback of proximal conduit compression [7–13], our group modified the RV-PA technique by using a 5-mm stretch vascular graft (Gore-Tex, W. L. Gore and Associates, Flagstaff, AZ) with removable rings [14]. To determine the benefit of ring-enforced grafts, we analyzed angiograms of patients with conventional RV-PA conduits and ring-enforced conduits before partial bidirectional cavopulmonary anastomosis (PCPC) with respect to shunt stenoses at three different levels.


   Patients and Methods
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 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Footnotes
 References
 
This study was approved by The Ethics Committee of the Technical University Munich as Project No. 2448/09.

As a part of Norwood I procedure, 28 consecutive patients were treated with conventional RV-PA conduits (CCs) from November 2002 to December 2005, and 38 consecutive patients were treated with ring-enforced conduits (RCs) beginning in January 2006. All patients had a primary diagnosis of hypoplastic left heart syndrome (HLHS). Patients with other diagnoses who required a Norwood I procedure were not included in this study.

We analyzed 24 angiograms of patients who have received CCs and 28 angiograms of patients with RCs. Four patients from the CC group, who were not evaluated in this study, died before the pre-PCPC angiogram was performed. Of 10 patients in the RS group who were not evaluated, 6 died before the pre-PCPC angiogram, 3 underwent the examination in another clinic and angiograms were not available, and 1 patient did not undergo angiography before the second-stage operation.

Surgical Technique
Cardiopulmonary bypass was instituted in all operations and then we proceeded to induce hypothermia. At the time the heart stopped ejecting, a ventriculotomy was performed, appreciating the course of coronary arteries and keeping a distance of at least 0.5 cm to the pulmonary valvar plane. Conduit size was 5 mm in all patients. After myectomy and trimming of the conduit in an oblique fashion—usually, only one of the conduit rings needed to be removed at this site—the conduit was anastomosed with the RV. The stitches fixing the conduit starting from the epicardium reached half way through the muscle. Conduits were directed towards the right-hand side of the augmented aorta (Fig 1).


Figure 1
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  		Fig 1. (A) Schematic drawing depicts the ring-enforced right ventricle to pulmonary artery conduit directed towards the right of the augmented aorta. (B) Intraoperative image shows the ring-enforced conduit after the procedure.

 
At the area of the pulmonary bifurcation, autologous pericardium or homograft material was used as a patch covering the tissue defect after excision of the pulmonary trunk. The conduit was inserted either into the pulmonary tree at the cranial part of this patch or into the right PA. At the level of distal anastomosis, only the rings adjacent to the anastomotic site were removed.

Thorax was left open in all patients after the procedure and secondarily closed at the intensive care station.

Cardiac Catheterization
Angiographies were performed after Norwood I and before PCPC. We have looked at a possible age difference of the patients at the time of angiography, time of the second-stage operation, as well as the time between angiography and the following PCPC.

The size of the conduit was measured in pixels at 4 points: proximal anastomosis to the right ventricle (Fig 2, "a"), substernal part of the conduit at its minimal diameter (Fig 2, "b"), distal anastomosis to the pulmonary arteries (Fig 2, "c"), and the maximal diameter of the conduit, mostly measured in the distal half—which was designated as the normal conduit diameter. We have assumed that the maximal shunt diameter seen in the angiograms is the real shunt diameter (ie, equal to 5 mm).


Figure 2
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  		Fig 2. Angiographic images show the (A) conventional and (B) the ring-enforced right ventricle-to-pulmonary artery conduit before the bidirectional cavopulmonary anastomosis (a = proximal anastomosis, b = substernal part of the conduit, and c = distal anastomosis).

 
The degree of conduit stenosis on each level was calculated using the formula:


Formula

Where Stenosis X is the degree of conduit stenosis at X, in percentage, X is the diameter at proximal anastomosis (a), substernal part of the shunt (b) or distal anastomosis (c) in pixels, and Norm is the maximal diameter of the conduit in pixels.

From 24 patients in CC group, 24 values were obtained for proximal and distal anastomosis and 23 for substernal part of the shunt. In the RC group, all 28 values were collected for each part of the conduit.

We have noted the oxygen saturation in RV and aorta at time of angiography, as well as red blood cell count, hemoglobin concentration, and hematocrit at time of admission for PCPC. The need for an urgent intervention (dilatation ± stenting of the conduit, urgent PCPC) was monitored for all patients in each group. Early and interstage mortality were compared between the two groups.

Statistical Analysis
Frequencies are given as absolute numbers and percentages. Continuous data are expressed in terms of the mean ± standard deviation. The Fisher exact test was performed to detect significant differences between groups. For comparison of continuous variables between two groups, the t test was used (2-tailed tests were used for all analyses). Statistical analysis was performed using SPSS 16.0 software (SPSS Inc, Chicago, IL).


   Results
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 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Footnotes
 References
 
The angiography in the CC group occurred when the patients were an average age of 129 ± 41 days. The average time from this evaluation to PCPC was 8.0 ± 9.8 days. The angiogram was done in 3 patients at 27, 27, and 37 days before the second-stage operation, and one of these patients required shunt dilatation and stenting at the time of angiography. The average time between angiography and PCPC for the rest of the patients in this group was 4.4 ± 3.5 days. The CC group underwent the second-stage operation at a mean age of 138 ± 39 days.

The angiography in the RC group occurred when the patients were an average age of 103 ± 32 days. Average time from this evaluation to PCPC was 15.7 ± 32.0 days. The angiogram was done in 4 patients at 140, 100, 58, and 29 days before the second-stage operation, and one of these patients required shunt dilatation and stenting at the time of angiography. The average time between angiography and PCPC for the rest of the patients in this group was 4.9 ± 4.0 days. The RC group underwent the second stage operation at the mean age of 123 ± 25 days.

On the angiogram, a significantly higher rate of conduit stenosis was observed in the CC group (45% ± 22%) at the level of proximal anastomosis compared with the RC group (23% ± 22%, p = 0.001, Fig 3). The difference in conduit stenosis at the substernal level was even more pronounced: compared with the normal conduit size, there was an average of 49% ± 26% stenosis in the CC group and 7% ± 6% stenosis in the RC group (p < 0.001). Qualitatively, conduit stenosis at the substernal level in CC group was mostly observed as flattening of the conduit due to compression by the sternum. The difference in conduit stenoses at the level of the distal anastomosis was 31% ± 15% in the CC group vs 24% ± 14 % in the RC group, which was not statistically significant (p = 0.103).


Figure 3
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  		Fig 3. Degree of stenosis within the right ventricle-to-pulmonary artery conduit before the bidirectional cavopulmonary anastomosis stratified by type of conduit and location. The horizontal line shows the median, the top and lower box edges show the 25th and the 75th percentile, and the whiskers are the minimum and the maximum.

 
We found no statistical difference in oxygen saturation in the RV (CC group, 71% ± 8.2%; RC group, 70.0% ± 6.6%) or aorta (CC group, 70.4% ± 7.9%; RC group, 69.8 ± 6.7%) between two groups at the time of angiography.

At the time of admission for PCPC, the red blood cell count was 5.8 ± 0.8 x 1012/L in the CC group and 5.7 ± 0.7 x 1012/L in the RC group, the hemoglobin concentration was 15.9 ± 2.1 g/dL in CC group and 15.6 ± 1.6 g/dL in the RC group, and the hematocrit was 0.5 ± 0.1 in the CC group and 0.5 ± 0.1 in the RC group.

Significantly fewer patients in the RC group required an urgent intervention (dilatation ± stenting) or early stage II procedure (1 patient in the RC group vs 6 in the CC group, p = 0.034).

Secondary chest closure was possible in all patients early in postoperative course. At time of closure, no signs of coronary malperfusion were observed.

Early mortality was 3 of 28 patients (10.7%) in the CC group and 5 of 38 (13.2%) in the RC group. Interstage deaths included 4 patients who died at 116 days (2 patients) and at 136 days (2 patients) after the Norwood I procedure, of whom one was in the RC group.


   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Footnotes
 References
 
Treatment of patients with HLHS varies in practice. Wernovsky and coworkers [15] sent a survey to 55 international centers in 2007 to evaluate admission and management of neonates with HLHS. Of the 51 centers that responded to the questionnaire, 13 were participating in the only randomized clinical trial comparing mBTS with RV-PA conduit [6]. Of the remaining 38 centers, 18 "usually" placed a conduit from the RV to the PA, 14 "usually" placed a mBTS, and the decision at 6 centers was made "based upon the preference of the surgeon and/or the cardiologist." Significant variability in practice was also evident in preoperative management, other surgical strategies, postoperative medical support, monitoring, and discharge planning.

Results from the only randomized study, which compares the outcomes of patients undergoing a Norwood I procedure with either the RV-PA conduit or mBTS [6], may give important guidance to whether the PA blood supply ought to be tailored more to patient characteristics.

Between November 2002 and January 2006, we palliated 32 patients with HLHS and its variants using the conventional RV-PA conduit. To overcome a potential risk of proximal conduit compression, we used a ring-enforced conduit only after January 2006. Therefore, the present study describes consecutive patients. A certain era effect cannot be ruled out, especially because our institutional policy for identifying patients for the second stage of the palliation changed within the study period. We now tend to perform the PCPC at a younger age. The conventional RV-PA conduit group, whose operations occurred from 2002 through 2005, underwent the second-stage operation at an older mean age of 138 ± 39 vs 123 ± 25 days for the RC patients, who were operated on beginning in January 2006.

Interestingly, another study also showed a trend to a younger age at presentation for the second-stage palliation in the RV-PA group [3] of 4.5 months vs 5.8 months at the time of the PCPC. In 2006 McGuirk and coworkers [16] examined their 12-year institutional experience. Between December 1992 and June 2004, 333 patients with HLHS underwent a Norwood I procedure. Pulmonary blood flow was established with a mBTS in 77% or RV-PA conduit in 22%. In 203 patients, the PCPC was done at a median age of 4.9 months (range, 27 days to 22.8 months) and median interval of 4.7 months (range, 18 days to 22.6 months) after the Norwood procedure. There was a continued attrition before stage II with an actuarial interstage mortality rate of 15% at 6 months after the Norwood procedure. This was consistent with previous reports in which interstage mortality rates were 9% to 16% [17–19]. Interstage causes of death have not been fully elucidated, and a substantial proportion of deaths remain sudden and unexpected [20]. Advantages of an early PCPC are early elimination of volume load and shortening of the evident high-risk interstage period. Jaquiss and colleagues [21] reported the results of PCPC in 85 consecutive patients. Group I (33 patients) was younger than 4 months old at operation and group II (52 patients) was older than 4 months. Hospital survival was 100% in both groups. They concluded that early PCPC after the Norwood operation was safe, but that younger patients were more cyanotic initially after the operation and required a longer duration of mechanical ventilation, pleural drainage, intensive care unit stay, and hospitalization.

Our institution has investigated results in a subgroup of patients aged younger than 6 months. Between 2001 and 2006, 124 patients underwent PCPC, followed by an extracardiac total cavopulmonary connection (TCPC) [22]. Review of 84 angiograms before PCPC and before TCPC allowed for analysis of hemodynamic findings and measurement of the diameters of the PAs. At the time of PCPC, 28 patients (group 1) were aged younger than 6 months, whereas 56 were older than 6 months (group 2). The most common diagnosis was HLHS in 16 patients (19%). The percentage of patients with HLHS was higher in group 1 than in group 2 (p = 0.006). There were no early deaths after PCPC. We found no differences in hemodynamic data, especially in the postoperative oxygen saturation in patients aged younger than 6 months.

In 2007 we reported our early experience, emphasizing the complications related to the placement of the conventional RV-PA conduit [23]. We have retrospectively reviewed the records and angiograms from these patients. Hospital survival after Norwood I operation was 89.3%. There were 3 interstage deaths, 2 of which were likely due to severe obstruction of the conduit. Stents were implanted into the proximal or medial portions of the conduits of 3 patients. Revision of the distal anastomosis and shortening of the conduit were performed early postoperatively in 2 patients. We concluded that stenosis of the conduit accounted for a certain interstage morbidity.

Others have also described the need for transcatheter shunt or conduit interventions [24]. Of 149 patients who had a Norwood I procedure, 3 required transcatheter interventions. In addition, 24% of the RV-PA group and 12% of the mBTS group had surgical revisions. Patient age at time of PCPC was 5.6 ± 1.7 months in the RV-PA group and 6.5 ± 2.5 months in the mBTS group. Overall mortality, however, was not influenced.

As stated earlier, in an effort to overcome a potential risk of proximal conduit compression, beginning in 2006 we started implanting the ring-enforced conduits only. By using a ring-enforced polytetrafluoroethylene conduit between the RV and the PA artery in Norwood stage I palliation, substernal compression was successfully avoided in our series of patients. We also observed a statistically significant reduction in proximal anastomosis stenosis. The described modification is easily reproducible. Our data support our initial presumption [14] that using a ring-enforced conduit would reduce the likelihood of compression and therefore positively influence interstage morbidity.

Optimal conduit placement remains one of the keys for success. Whereas we tend to sew the conduit, cut in an oblique fashion, more or less to the epicardium, one could discuss other modifications. Placement of the conduit into the ventriculotomy, even projecting into the ventricular cavity, might further reduce the development of proximal stenosis. Together with our proposed ring-enforced conduit, this modification might be another treatment option. A slightly leftward incision into the RV below the infundibulum, as well as a more generous resection of the subendocardial muscle, together with full thickness bites, might diminish conduit stenoses at the level of proximal anastomosis. Groups who are using this technique usually direct the conduit towards the left of the augmented aorta [1, 24, 25]. In our experience, directing the conduit to the right of the aorta makes the reoperation, such as a stage II procedure, technically easier: dealing with any stenosis at the distal site of the conduit insertion in most of these patients does not require extensive mobilization of the augmented aorta due to favorable position of the anastomosis between the superior vena cava and the aorta.

In summary, we found a reduced incidence of proximal conduit stenosis and interstage morbidity in the RC group in this study. We are encouraged by our results of using a ring-enforced conduit between the RV and the PA in Norwood stage I palliation and can conclude that it effectively prevents substernal compression and reduces interstage morbidity.


   Footnotes
Top
 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
 Results
 Comment
 Footnotes
 References
 

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  3. Lai L, Laussen PC, Cua CL, et al. Outcomes after bidirectional Glenn operation: Blalock-Taussig shunt versus right ventricle-to-pulmonary artery conduit Ann Thorac Surg 2007;83:1768-1773.[Abstract/Free Full Text]
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  22. Cleuziou J, Schreiber C, Cornelsen JK, Hörer J, Eicken A, Lange R. Bidirectional cavopulmonary connection without additional pulmonary blood flow in patients below the age of 6 months Eur J Cardiothorac Surg 2008;34:556-561.[Abstract/Free Full Text]
  23. Kostolny M, Hoerer J, Eicken A, Dietrich C, Schreiber C, Lange R. Impact of placing a conduit from the right ventricle to the pulmonary arteries as the first stage of further palliation in the Norwood sequence for hypoplasia of the left heart Cardiol Young 2007;17:517-522.[Medline]
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  25. Pizarro C, Malec E, Maher KO, Januszewska K, Gidding SS, Murdison KA, Baffa JM, Norwood WI. Right ventricle to pulmonary artery conduit improves outcome after stage I Norwood for hypoplastic left heart syndrome Circulation 2003;108(suppl 1):II155-II160.[Medline]



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