Transplant-Free Survival and Interventions at 6 Years in the SVR Trial
Top Cited Papers
- 22 May 2018
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Circulation
- Vol. 137 (21), 2246-2253
- https://doi.org/10.1161/circulationaha.117.029375
Abstract
Background: In the SVR trial (Single Ventricle Reconstruction), 1-year transplant-free survival was better for the Norwood procedure with right ventricle-to-pulmonary artery shunt (RVPAS) compared with a modified Blalock–Taussig shunt in patients with hypoplastic left heart and related syndromes. At 6 years, we compared transplant-free survival and other outcomes between the groups. Methods: Medical history was collected annually using medical record review, telephone interviews, and the death index. The cohort included 549 patients randomized and treated in the SVR trial. Results: Transplant-free survival for the RVPAS versus modified Blalock–Taussig shunt groups did not differ at 6 years (64% versus 59%, P=0.25) or with all available follow-up of 7.1±1.6 years (log-rank P=0.13). The RVPAS versus modified Blalock–Taussig shunt treatment effect had nonproportional hazards (P=0.009); the hazard ratio (HR) for death or transplant favored the RVPAS before stage II surgery (HR, 0.66; 95% confidence interval, 0.48–0.92). The effect of shunt type on death or transplant was not statistically significant between stage II to Fontan surgery (HR, 1.36; 95% confidence interval, 0.86–2.17; P=0.17) or after the Fontan procedure (HR, 0.76; 95% confidence interval, 0.33–1.74; P=0.52). By 6 years, patients with RVPAS had a higher incidence of catheter interventions (0.38 versus 0.23/patient-year, P<0.001), primarily because of more interventions between the stage II and Fontan procedures (HR, 1.72; 95% confidence interval, 1.00–3.03). Complications did not differ by shunt type; by 6 years, 1 in 5 patients had had a thrombotic event, and 1 in 6 had had seizures. Conclusions: By 6 years, the hazards of death or transplant and catheter interventions were not different between the RVPAS versus modified Blalock–Taussig shunt groups. Children assigned to the RVPAS group had 5% higher transplant-free survival, but the difference did not reach statistical significance, and they required more catheter interventions. Both treatment groups have accrued important complications. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00115934.This publication has 23 references indexed in Scilit:
- Transplantation-Free Survival and Interventions at 3 Years in the Single Ventricle Reconstruction TrialCirculation, 2014
- Cause, timing, and location of death in the Single Ventricle Reconstruction trialThe Journal of Thoracic and Cardiovascular Surgery, 2012
- 18 Years of the Fontan Operation at a Single Institution: Results From 771 Consecutive PatientsJournal of the American College of Cardiology, 2012
- Intermediate-term mortality and cardiac transplantation in infants with single-ventricle lesions: Risk factors and their interaction with shunt typeThe Journal of Thoracic and Cardiovascular Surgery, 2012
- Construction of the Right Ventricle-to-Pulmonary Artery Conduit in the Norwood: The “Dunk” TechniqueOperative Techniques in Thoracic and Cardiovascular Surgery, 2012
- Arrhythmias in a Contemporary Fontan Cohort: Prevalence and Clinical Associations in a Multicenter Cross-Sectional StudyJournal of the American College of Cardiology, 2010
- Comparison of Shunt Types in the Norwood Procedure for Single-Ventricle LesionsThe New England Journal of Medicine, 2010
- Design and rationale of a randomized trial comparing the Blalock–Taussig and right ventricle–pulmonary artery shunts in the Norwood procedureThe Journal of Thoracic and Cardiovascular Surgery, 2008
- A Proportional Hazards Model for the Subdistribution of a Competing RiskJournal of the American Statistical Association, 1999
- Hypoplastic left heart syndrome: Experience with palliative surgeryThe American Journal of Cardiology, 1980