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Multi-center trial (2005 to 2008) examining 555 patients with HLHS or related HRHS single ventricle cardiac lesions undergoing a Norwood procedure were randomly assigned to receive either a MBT shunt or RV PA-conduit for pulmonary blood flow. (although choice of shunt in the end was surgical)

Patients with a RV PA-conduit had a greater transplant-free survival at 12mths (74% vs. 64%, P=0.01), although beyond this time frame this difference became less significant.

However, the RVPA shunt group had more unintended interventions (220 vs. 168 events per 100 infants, P=0.003) and complications (5.3 vs. 4.7 complications per infant, P=0.002)

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To date, outcomes with the MBT shunt and those with the RVPA shunt have been compared only in small, nonrandomized case series, with limited follow-up and conflicting results.
This study looks to examine outcome differences between the two groups.

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Inclusion criteria consisted of a diagnosis of hypoplastic left-heart-syndrome or a related single, morphologic right ventricular anomaly and a planned Norwood procedure. Exclusion criteria were the preoperative identification of cardiac anatomy that would render either the MBT shunt or the RVPA shunt technically impossible and any major congenital or acquired extracardiac abnormality that could independently affect the likelihood of transplantation-free survival (the primary outcome).

Infants were randomly assigned to either the MBT shunt or the RVPA shunt within strata according to the presence or absence of aortic atresia and obstructed pulmonary venous return, with dynamic allocation by the surgeon

www.nejm.org/doi/full/10....

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Norwood procedure with an RVPA shunt, as compared with an MBT shunt, was associated with a higher rate of transplantation-free survival 12 months after randomization

www.nejm.org/doi/full/10....

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Degree of tricuspid-valve regurgitation at discharge after the Norwood procedure, before stage II, and at the age of 14 months on the basis of echocardiograms interpreted by the core laboratory -

The incidence of moderate-to-severe tricuspid-valve regurgitation was similar in the two groups at 14 months (22% for the entire cohort).

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Morbidity during the Norwood and stage II hospitalizations -

Morbidity during hospitalizations for the Norwood and stage II procedures was similar for the two groups, except that fewer infants in the RVPA shunt group required cardiopulmonary resuscitation after the Norwood procedure

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On the basis of available intermediate-term data, there was no significant difference between the two groups with respect to transplantation-free survival beyond 12 months

www.nejm.org/doi/full/10....

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Right ventricular function -

The ejection fraction was greater in the RVPA shunt group after the Norwood procedure (P<0.001) but was similar in the two groups at 14 months (P=0.97).

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Right ventricular volume -

Median right ventricular end-diastolic and end-systolic volumes, adjusted for body-surface area, were lower in the RVPA shunt group than in the MBT shunt group on echocardiograms obtained before stage II procedures were performed, but there was no difference at 14 months

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The core laboratory interpretation of pulmonary-artery size by angiography before stage II -

On the basis of the Nakata index, the overall size of the pulmonary artery on angiography before the stage II procedure was smaller in the RVPA shunt group than in the MBT shunt group. When the individual pulmonary-artery branches were compared, the mean diameter of the distal right branch was smaller in the RVPA shunt group, whereas the mean diameters of the distal left branches were similar in the two groups

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The incidence of unintended cardiovascular interventions involving the shunt, pulmonary arteries, or neoaorta by 12 months -

Infants in the RVPA shunt group underwent more unintended cardiovascular interventions from the time of randomization to 12 months (92 vs. 70 per 100 infants, P=0.003).

This difference was largely attributable to the higher rate of balloon dilation or stent placement in the shunt or a branch of the pulmonary artery in the RVPA shunt group, particularly after discharge following the Norwood procedure

www.nejm.org/doi/full/10....

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Comparison of Shunt Types in the Norwood Procedure for Single-Ventricle Lesions

N Engl J Med 2010; 362:1980-1992

dx.doi.org/10.1056/NEJMoa...

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