Ranjit Aiyagari1, John F Rhodes2, Peter Shrader3, Wolfgang A Radtke4, Varsha M Bandisode5, Lisa Bergersen6, Matthew J Gillespie7, Robert G Gray8, Lin T Guey3, Kevin D Hill2, Russel Hirsch9, Dennis W Kim10, Kyong-Jin Lee11, Andrew N Pelech12, Jeremy Ringewald13, Cheryl Takao14, Julie A Vincent15, Richard G Ohye16. 1. Division of Pediatric Cardiology, University of Michigan Medical School, Ann Arbor, Mich. Electronic address: ranjita@umich.edu. 2. Duke University Medical Center, Durham, NC. 3. New England Research Institute, Watertown, Mass. 4. Nemours Cardiac Center, Wilmington, Del. 5. Department of Pediatrics, Medical University of South Carolina, Charleston, SC. 6. Department of Cardiology, Children's Hospital Boston, Boston, Mass. 7. Division of Pediatric Cardiology, Children's Hospital of Philadelphia, Philadelphia, Pa. 8. Division of Pediatric Cardiology, University of Utah, Salt Lake City, Utah. 9. Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. 10. Children's Healthcare of Atlanta, Emory University, Atlanta, Ga. 11. The Hospital for Sick Children, Toronto, Ontario, Canada. 12. Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wis. 13. Division of Cardiology, All Children's Hospital, St Petersburg, Fla. 14. Division of Pediatric Cardiology, Children's Hospital Los Angeles, Los Angeles, Calif. 15. Division of Cardiology, New York-Presbyterian Morgan Stanley Children's Hospital, New York, NY. 16. Section of Pediatric Cardiovascular Surgery, University of Michigan Medical School, Ann Arbor, Mich.
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.
RCT Entities:
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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