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Randomized Controlled Trial
. 2014 Oct;148(4):1467-74.
doi: 10.1016/j.jtcvs.2013.10.057. Epub 2013 Dec 12.

Impact of pre-stage II hemodynamics and pulmonary artery anatomy on 12-month outcomes in the Pediatric Heart Network Single Ventricle Reconstruction trial

Ranjit Aiyagari  1 , John F Rhodes  2 , Peter Shrader  3 , Wolfgang A Radtke  4 , Varsha M Bandisode  5 , Lisa Bergersen  6 , Matthew J Gillespie  7 , Robert G Gray  8 , Lin T Guey  3 , Kevin D Hill  2 , Russel Hirsch  9 , Dennis W Kim  10 , Kyong-Jin Lee  11 , Andrew N Pelech  12 , Jeremy Ringewald  13 , Cheryl Takao  14 , Julie A Vincent  15 , Richard G Ohye  16 ; Pediatric Heart Network Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Impact of pre-stage II hemodynamics and pulmonary artery anatomy on 12-month outcomes in the Pediatric Heart Network Single Ventricle Reconstruction trial

Ranjit Aiyagari et al. J Thorac Cardiovasc Surg. 2014 Oct.

Abstract

Objective: To compare the interstage cardiac catheterization hemodynamic and angiographic findings between shunt types for the Pediatric Heart Network Single Ventricle Reconstruction trial. The trial, which randomized subjects to a modified Blalock-Taussig shunt (MBTS) or right ventricle-to-pulmonary artery shunt (RVPAS) for the Norwood procedure, demonstrated the RVPAS was associated with a smaller pulmonary artery diameter but superior 12-month transplant-free survival.

Methods: We analyzed the pre-stage II catheterization data for the trial subjects. The hemodynamic variables and shunt and pulmonary angiographic data were compared between shunt types; their association with 12-month transplant-free survival was also evaluated.

Results: Of 549 randomized subjects, 389 underwent pre-stage II catheterization. A smaller size, lower aortic and superior vena cava saturation, and higher ventricular end-diastolic pressure were associated with worse 12-month transplant-free survival. The MBTS group had a lower coronary perfusion pressure (27 vs 32 mm Hg; P<.001) and greater pulmonary blood flow/systemic blood flow ratio (1.1 vs 1.0, P=.009). A greater pulmonary blood flow/systemic blood flow ratio increased the risk of death or transplantation only in the RVPAS group (P=.01). The MBTS group had fewer shunt (14% vs 28%, P=.004) and severe left pulmonary artery (0.7% vs 9.2%, P=.003) stenoses, larger mid-main branch pulmonary artery diameters, and greater Nakata indexes (164 vs 134, P<.001).

Conclusions: Compared with the RVPAS subjects, the MBTS subjects had more hemodynamic abnormalities related to shunt physiology, and the RVPAS subjects had more shunt or pulmonary obstruction of a severe degree and inferior pulmonary artery growth at pre-stage II catheterization. A lower body surface area, greater ventricular end-diastolic pressure, and lower superior vena cava saturation were associated with worse 12-month transplant-free survival.

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Figures

Figure 1
Figure 1
Location of Branch Pulmonary Artery Measurements. Diamonds mark the mid-main pulmonary artery measurement location, and circles mark the proximal lower lobe pulmonary artery measurement location. Abbreviations: MBTS, modified Blalock-Taussig shunt; RVPAS, right ventricle-to-pulmonary artery shunt.
Figure 2
Figure 2
SVR Trial Subjects’ Outcomes and Subgroup with Acceptable Pre-stage II Angiography Abbreviations: MBTS, modified Blalock-Taussig shunt; RVPAS, right ventricle-to-pulmonary artery shunt.
See this image and copyright information in PMC

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