Background Patients with single‐ventricle physiology who undergo the Fontan procedure are at risk for thrombotic events associated with significant morbidity and mortality. The UNIVERSE Study evaluated the efficacy and safety of a novel liquid rivaroxaban formulation, using a body weight–adjusted dosing regimen, versus acetylsalicylic acid (ASA) in children post‐Fontan. Methods and Results The UNIVERSE Study was a randomized, multicenter, 2‐part, open‐label study of rivaroxaban, in children who had undergone a Fontan procedure, to evaluate its dosing regimen, safety, and efficacy. Part A was the single‐arm part of the study that determined the pharmacokinetics/pharmacodynamics and safety of rivaroxaban in 12 participants before proceeding to part B, whereby 100 participants were randomized 2:1 to open‐label rivaroxaban versus ASA. The study period was 12 months. A total of 112 participants were enrolled across 35 sites in 10 countries. In part B, for safety outcomes, major bleeding occurred in one participant on rivaroxaban (epistaxis that required transfusion). Clinically relevant nonmajor bleeding occurred in 6% of participants on rivaroxaban versus 9% on ASA. Trivial bleeding occurred in 33% of participants on rivaroxaban versus 35% on ASA. For efficacy outcomes, 1 participant on rivaroxaban in part B had a pulmonary embolism (2% overall event rate); and for ASA, 1 participant had ischemic stroke and 2 had venous thrombosis (9% overall event rate). Conclusions In this study, participants who received rivaroxaban for thromboprophylaxis had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the ASA group. Registration URL: https://www.clinicaltrials.gov . Identifier: NCT02846532.

Secundum atrial septal defect closure can be safely and successfully performed with the Amplatzer septal occluder in children younger than 10 years old.

Nota: Estas diretrizes se prestam a informar e não a substituir o julgamento clínico do médico que, em última análise, deve determinar o tratamento apropriado para seus pacientes.

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Objective -Evaluation of the long-term clinical results of the Fontan operation in patients with tricuspid atresia. Methods -A retrospective analysis was made at the Instituto de Cardiologia do Rio Grande do Sul (Institute of Cardiology of Rio Grande do Sul), from August 1980 throughTricuspid atresia is a rare cardiac malformation, in which no communication exists between the right atrium and the right ventricle, bringing about complex physiological adaptations and culminating with high morbidity and mortality, thus requiring the utilization of an adequate surgical technique for its correction 1 . So, in 1971, Fontan and Baudet 2 introduced the basis for an operation that became the final palliative surgery for patients with tricuspid atresia. Basically, a communication is established between the systemic venous return and the pulmonary arterial circulation, bypassing the right ventricle flow 2,3 . As years went by, however, a number of changes were proposed to the classical Fontan operation, such as the Kreutzer technique 4 , the Björk technique 5 , and the total cavopulmonary shunt (TCPC) [6][7][8][9] , and very few studies deal with the long-term follow-up of patients who undergo these procedures [10][11][12][13][14][15][16][17][18] .Considering that Fontan surgery is a relatively recent therapeutic procedure and that, in addition to this, some important changes were added to the original surgical technique, this study aims at evaluating late survival, as well as the complications that occurred during the long-term follow-up of patients with tricuspid atresia who underwent Fontan surgery or its variants.

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