Transplantation-free survival and interventions at 3 years in the single ventricle reconstruction trial
Open accessAbstract
Background—: In the Single Ventricle Reconstruction (SVR) trial, 1-year transplantation-free survival was better for the Norwood procedure with right ventricle–to–pulmonary artery shunt (RVPAS) compared with a modified Blalock-Taussig shunt (MBTS). At 3 years, we compared transplantation-free survival, echocardiographic right ventricular ejection fraction, and unplanned interventions in the treatment groups. Methods and Results—: Vital status and medical history were ascertained from annual medical records, death indexes, and phone interviews. The cohort included 549 patients randomized and treated in the SVR trial. Transplantation-free survival for the RVPAS versus MBTS groups did not differ at 3 years (67% versus 61%; P =0.15) or with all available follow-up of 4.8±1.1 years (log-rank P =0.14). Pre-Fontan right ventricular ejection fraction was lower in the RVPAS group than in the MBTS group (41.7 ± 5.1% versus 44.7 ± 6.0%; P =0.007), and right ventricular ejection fraction deteriorated in RVPAS ( P =0.004) but not MBTS ( P =0.40) subjects (pre-Fontan minus 14-month mean, −3.25±8.24% versus 0.99±8.80%; P =0.009). The RVPAS versus MBTS treatment effect had nonproportional hazards ( P =0.004); the hazard ratio favored the RVPAS before 5 months (hazard ratio=0.63; 95% confidence interval, 0.45–0.88) but the MBTS beyond 1 year (hazard ratio=2.22; 95% confidence interval, 1.07–4.62). By 3 years, RVPAS subjects had a higher incidence of catheter interventions ( P <0.001) with an increasing HR over time ( P =0.005): <5 months, 1.14 (95% confidence interval, 0.81–1.60); from 5 months to 1 year, 1.94 (95% confidence interval, 1.02–3.69); and >1 year, 2.48 (95% confidence interval, 1.28–4.80). Conclusions—: By 3 years, the Norwood procedure with RVPAS compared with MBTS was no longer associated with superior transplantation-free survival. Moreover, RVPAS subjects had slightly worse right ventricular ejection fraction and underwent more catheter interventions with increasing hazard ratio over time. Clinical Trial Registration—: URL: http://www.clinicaltrials.gov . Unique identifier: NCT00115934.
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Recent evidence indicates that immediate reintervention for residual lesions leads to better outcomes than reoperation later in the postoperative period.
“Recent data suggests that immediate reintervention on residual lesions is associated with improved outcomes compared to reoperation in the postoperative period.20”
From Utility of a standardized postcardiopulmonary bypass epicardial echocardiography protocol for stage I Norwood palliation: STERN et al. (2017) · cites this paper as [20]
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References 21 · Cited by 206
- Authors
- Newburger, J. W., Sleeper, L. A., Frommelt, P. C., Pearson, G. D., Mahle, W. T., Chen, S., Dunbar-Masterson, C., Mital, S., Williams, I. A., Ghanayem, N. S., Goldberg, C. S., Jacobs, J. P., Krawczeski, C. D., Lewis, A. B., Pasquali, S. K., Pizarro, C., Gruber, P. J., Atz, A. M., Khaikin, S., Gaynor, J. W., & Ohye, R. G.
- Affiliations
- Children's Hospital of Wisconsin (US)
- From the Boston Children’s Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children’s Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children’s Hospital of New York–Presbyterian,...
- ORCID
- Venue
- Circulation
- Published
- 2014-05-20
- Volume
- 129
- Issue
- 20
- Pages
- 2013-2020
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- PMC
- PMC4029928
- OpenAlex
- W2065823779
- Cited by
- 206
- References
- 21
- Citations by year
- 2026: 10 · 2025: 5 · 2024: 12 · 2023: 19 · 2022: 19 · 2021: 8 · 2020: 17 · 2019: 11 · 2018: 23 · 2017: 27 · 2016: 23 · 2015: 23 · 2014: 9
- FWCI
- 20.64
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Circulation (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (2u01hl068281-06)
- National Heart, Lung, and Blood Institute (HL085057, U01HL068288, HL068281, U01-HL-068281, U10HL109816, U01HL068292, U10HL068270, U01HL068290, HL068270, U01HL068285, HL068290, U01HL085057, U10HL109737, HL068269, HL068285, U01HL068270, U10HL109778, HL068288, U01HL068279, U01HL068269, HL068279, HL068292)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (P30HD018655)
- Topics
- Health Sciences › Medicine › Epidemiology › Congenital Heart Disease Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Congenital heart defects research
- Health Sciences › Medicine › Surgery › Transplantation: Methods and Outcomes
- Keywords
- single ventricle reconstruction, Norwood procedure, right ventricle-to-pulmonary artery shunt, modified Blalock-Taussig shunt, transplant-free survival, right ventricular ejection fraction, interventional catheterization, Fontan procedure, congenital heart disease, single ventricle, non-proportional hazards
- MeSH terms
- Aorta, Thoracic, Child, Preschool, Female, Follow-Up Studies, Cardiac Catheterization, Heart Ventricles, Humans, Infant, Male, Prospective Studies, Pulmonary Artery, Risk Factors, Incidence, Logistic Models, Proportional Hazards Models, Heart Transplantation, Ventricular Function, Right, Treatment Outcome, Disease-Free Survival, Hypoplastic Left Heart Syndrome, Norwood Procedures, Blalock-Taussig Procedure
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