Bryan H Goldstein1, Christopher J Petit2, Athar M Qureshi3, Courtney E McCracken2, Michael S Kelleman2, George T Nicholson4, Mark A Law5, Jeffery J Meadows6, Jeffrey D Zampi7, Shabana Shahanavaz8, Christopher E Mascio9, Paul J Chai2, Jennifer C Romano7, Sarosh P Batlivala10, Shiraz A Maskatia11, Ivor B Asztalos9, Alicia M Kamsheh9, Steven J Healan4, Justin D Smith7, R Allen Ligon2, Joelle A Pettus2, Sarina Juma2, James E B Raulston5, Krissie M Hock5, Amy L Pajk10, Lindsay F Eilers3, Hala Q Khan3, Taylor C Merritt8, Matthew Canter8, Stephan Juergensen6, Fatuma-Ayaan Rinderknecht6, Holly Bauser-Heaton2, Andrew C Glatz12. 1. Heart Institute, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA; Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA; The Heart Institute, Cincinnati Children's Hospital, Cincinnati, Ohio, USA; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA. Electronic address: bryan.goldstein@chp.edu. 2. Children's Heart Center, Children's Healthcare of Atlanta, Emory University School of Medicine, Atlanta, Georgia, USA. 3. The Lillie Frank Abercrombie Section of Cardiology, Texas Children's Hospital, Houston, Texas, USA; Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA. 4. Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville Tennessee, USA. 5. Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA. 6. Department of Pediatrics, University of California San Francisco, San Francisco, California, USA. 7. University of Michigan C.S. Mott Children's Hospital, Ann Arbor, Michigan, USA. 8. The Heart Center, St. Louis Children's Hospital, St. Louis, Missouri, USA. 9. Cardiac Center at the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA. 10. The Heart Institute, Cincinnati Children's Hospital, Cincinnati, Ohio, USA; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA. 11. Betty Irene Moore Children's Heart Center, Lucile Packard Children's Hospital, Palo Alto, California, USA; Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California, USA. 12. Cardiac Center at the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Pediatric Clinical Effectiveness, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Abstract
BACKGROUND: Neonates with tetralogy of Fallot and symptomatic cyanosis (sTOF) require early intervention. OBJECTIVES: This study sought to perform a balanced multicenter comparison of staged repair (SR) (initial palliation [IP] and subsequent complete repair [CR]) versus primary repair (PR) treatment strategies. METHODS: Consecutive neonates with sTOF who underwent IP or PR at ≤30 days of age from 2005 to 2017 were retrospectively reviewed from the Congenital Cardiac Research Collaborative. The primary outcome was death. Secondary outcomes included component (IP, CR, PR) and cumulative (SR): hospital and intensive care unit lengths of stay; durations of cardiopulmonary bypass, anesthesia, ventilation, and inotrope use; and complication and reintervention rates. Outcomes were compared using propensity score adjustment. RESULTS: The cohort consisted of 342 patients who underwent SR (IP: surgical, n = 256; transcatheter, n = 86) and 230 patients who underwent PR. Pre-procedural ventilation, prematurity, DiGeorge syndrome, and pulmonary atresia were more common in the SR group (p ≤0.01). The observed risk of death was not different between the groups (10.2% vs 7.4%; p = 0.25) at median 4.3 years. After adjustment, the hazard of death remained similar between groups (hazard ratio: 0.82; 95% confidence interval: 0.49 to 1.38; p = 0.456), but it favored SR during early follow-up (<4 months; p = 0.041). Secondary outcomes favored the SR group in component analysis, whereas they largely favored PR in cumulative analysis. Reintervention risk was higher in the SR group (p = 0.002). CONCLUSIONS: In this multicenter comparison of SR or PR for management of neonates with sTOF, adjusted for patient-related factors, early mortality and neonatal morbidity were lower in the SR group, but cumulative morbidity and reinterventions favored the PR group, findings suggesting potential benefits to each strategy.
BACKGROUND: Neonates with tetralogy of Fallot and symptomatic cyanosis (sTOF) require early intervention. OBJECTIVES: This study sought to perform a balanced multicenter comparison of staged repair (SR) (initial palliation [IP] and subsequent complete repair [CR]) versus primary repair (PR) treatment strategies. METHODS: Consecutive neonates with sTOF who underwent IP or PR at ≤30 days of age from 2005 to 2017 were retrospectively reviewed from the Congenital Cardiac Research Collaborative. The primary outcome was death. Secondary outcomes included component (IP, CR, PR) and cumulative (SR): hospital and intensive care unit lengths of stay; durations of cardiopulmonary bypass, anesthesia, ventilation, and inotrope use; and complication and reintervention rates. Outcomes were compared using propensity score adjustment. RESULTS: The cohort consisted of 342 patients who underwent SR (IP: surgical, n = 256; transcatheter, n = 86) and 230 patients who underwent PR. Pre-procedural ventilation, prematurity, DiGeorge syndrome, and pulmonary atresia were more common in the SR group (p ≤0.01). The observed risk of death was not different between the groups (10.2% vs 7.4%; p = 0.25) at median 4.3 years. After adjustment, the hazard of death remained similar between groups (hazard ratio: 0.82; 95% confidence interval: 0.49 to 1.38; p = 0.456), but it favored SR during early follow-up (<4 months; p = 0.041). Secondary outcomes favored the SR group in component analysis, whereas they largely favored PR in cumulative analysis. Reintervention risk was higher in the SR group (p = 0.002). CONCLUSIONS: In this multicenter comparison of SR or PR for management of neonates with sTOF, adjusted for patient-related factors, early mortality and neonatal morbidity were lower in the SR group, but cumulative morbidity and reinterventions favored the PR group, findings suggesting potential benefits to each strategy.
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