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Early outcomes of children with univentricular circulation undergoing Fontan surgery: the EuroFontan registry
Massimo A Padalino1,2, Andrew Constantine3,4, Emma Bergonzoni1
1Pediatric and Congenital Cardiac Surgery, Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128 Padova, Italy.
Insights
Fontan surgery in children with single ventricle physiology has low early mortality and complications. However, specific heart morphologies, excluding tricuspid atresia, increase the risk of adverse outcomes, necessitating careful pre-operative assessment.
Area of Science:
- Pediatric Cardiology
- Congenital Heart Disease
- Cardiac Surgery
Background:
- The Fontan operation is a critical palliative surgery for functional single ventricle physiology in children.
- Despite improvements, peri-operative complications remain a concern following Fontan completion.
- Assessing early outcomes in a large, contemporary European cohort is essential.
Purpose of the Study:
- To evaluate early outcomes and complications after Fontan completion in a large international European cohort.
- To identify predictors of early adverse outcomes following Fontan surgery.
- To assess the impact of evolving surgical practices on Fontan outcomes.
Main Methods:
- Retrospective analysis of the EuroFontan registry data from 21 European centers (1990-2023), focusing on the last 15 years.
- Inclusion of 2075 patients who underwent Fontan completion, with analysis of a composite early adverse outcome.
- Multivariable mixed-effects logistic regression used to identify predictors, with multiple imputation for missing data.
Main Results:
- The study analyzed 2075 patients with a median age of 4.2 years at Fontan completion.
- Low early mortality (1.0%) and a composite adverse outcome rate of 5.1% were observed.
- Heart morphology other than tricuspid atresia was the sole significant predictor of adverse outcomes (OR 2.2, P = .01).
Conclusions:
- Contemporary Fontan surgery demonstrates low peri-operative morbidity and mortality.
- Pre-operative risk stratification is crucial, particularly for patients with morphologies other than tricuspid atresia.
- The findings underscore the importance of tailored surgical approaches based on patient-specific anatomy.
Background And Aims:
The Fontan operation and its modifications have transformed the management of children with functional single ventricle physiology. While outcomes have improved, peri-operative complications remain common. This study aimed to assess early outcomes and complications following Fontan completion in a large international European cohort.
Methods:
The EuroFontan registry is a multicentre retrospective study involving 21 congenital heart disease and transplant centres across Europe. Data were collected on patients who underwent Fontan surgery from January 1990 to January 2023. Analyses focused on the most recent 15-year period. A composite early adverse outcome (death within 30 days or in-hospital, low cardiac output syndrome, stroke, or Fontan takedown) was used. Predictors were assessed using multivariable mixed-effects logistic regression, with centre included as a random effect. Missing data were handled using multiple imputation with Rubin's rules, and sensitivity analyses were performed to assess robustness.
Results:
Of 3510 patients, this analysis focused on 2075 individuals from the past 15 years, with a median age of 4.2 [interquartile range 3.2-6.2] years at Fontan completion. Early mortality was 1.0% (95% confidence interval .66%-1.54%). The composite adverse outcome occurred in 5.1% (95% confidence interval 4.2%-6.1%). On multivariable analysis, morphology other than tricuspid atresia was the only significant predictor of the composite outcome (odds ratio 2.2, 95% confidence interval 1.21-3.99, P = .01).
Conclusions:
Fontan surgery has evolved and, in contemporary practice, has low peri-operative morbidity and mortality. Morphology other than tricuspid atresia was associated with increased risk of early adverse outcomes, highlighting the importance of pre-operative risk stratification.
