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Background: The Single Ventricle Reconstruction (SVR) trial compared survival after Norwood procedure with either modified Blalock Taussig shunt (MBTS) or right ventricle pulmonary artery shunt (RVPAS).
Methods: Data from all 549 participants in the SVR trial were used to develop the MBTS TFSA algorithms, which predict the transplantation-free survival advantage (TFSA) after MBTS vs RVPAS at 1 and 6 years after Norwood procedure. Linear regression analysis of the MBTS TFSA values was performed to identify factors related to more optimal outcomes with MBTS at each timepoint. The impact of discordant management (ie, predicted shunt type did not equal the one actually received) on outcomes and the extent of inconsistencies between predictions were evaluated.
Results: The MBTS TFSA algorithm favored MBTS over RVPAS for only 6.2% of participants at 1 year and for 27.0% at 6 years. In terms of both 1- and 6-year outcomes, MBTS was favored with younger age at Norwood procedure and pre-Norwood intubation, while RVPAS was favored with younger gestational age and metrics indicating larger right ventricle size in the parasternal echocardiographic views. Other predictors were timepoint-specific. MBTS TFSA based allocation could have led to an absolute risk reduction in heart transplantation and mortality of 8.0% at 1 year and 16.8% at 6 years, mostly by preventing discordant MBTS management. Notably, separate predictions from the 1-year and 6-year algorithms produced discordant predictions for 136 participants (24.8%).
Conclusions: The incorporation of data-derived patient-specific factors for selection of shunt type for the Norwood procedure may produce more optimal transplantation free survival. These precision medicine algorithms require prospective validation.
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http://dx.doi.org/10.1016/j.athoracsur.2024.09.020 | DOI Listing |
J Physiol Sci
December 2024
Department of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Fenestration has been reported to enhance Fontan hemodynamics in several cases of Fontan circulation. However, the indication criteria for fenestration remain under discussion. To assess the effectiveness of fenestration in Fontan circulation, we conducted a theoretical analysis using a computational model of the fenestrated Fontan circulation.
View Article and Find Full Text PDFJ Extra Corpor Technol
December 2024
Department of Pediatrics, Division of Cardiology, Stanford University School of Medicine, Lucile Packard Children's Hospital, Stanford, CA, USA.
Background: Patients requiring extracorporeal life support (ECLS) support post-Norwood operation constitute an extremely high-risk group.
Materials And Methods: We retrospectively aimed to evaluate the relationship of hyperoxia with mortality and other clinical outcomes in patients who required ECLS following Norwood operation between January/2010 and December/2020 in a large volume center.
Results: During the study period 65 patients required ECLS post-Norwood.
Biometrics
October 2024
Department of Statistical Science, Duke University, 214 Old Chemistry, Box 90251, Durham, NC 27708-0251, United States.
Response-adaptive randomization (RAR) has been studied extensively in conventional, single-stage clinical trials, where it has been shown to yield ethical and statistical benefits, especially in trials with many treatment arms. However, RAR and its potential benefits are understudied in sequential multiple assignment randomized trials (SMARTs), which are the gold-standard trial design for evaluation of multi-stage treatment regimes. We propose a suite of RAR algorithms for SMARTs based on Thompson Sampling (TS), a widely used RAR method in single-stage trials in which treatment randomization probabilities are aligned with the estimated probability that the treatment is optimal.
View Article and Find Full Text PDFEur J Cardiothorac Surg
November 2024
Adult Congenital Heart Diseases Unit, Royal Brompton and Harefield Hospitals, Part of Guy's and St Thomas's NHS Foundation Trust, London, UK.
Objectives: There is dearth of data on long-term outcomes of systemic semilunar (SS) or atrioventricular (AV) valve operation in adult patients with a Fontan circulation. We describe a single-centre experience of adults who underwent valve surgery late after a Fontan procedure.
Methods: We retrospectively reviewed all patients with a Fontan circulation who had a reoperation for severe valve disease during adulthood in our centre.
J Am Heart Assoc
December 2024
Children's Health & Exercise Research Centre (CHERC) Public Health and Sports Sciences, Faculty of Health and Life Sciences, University of Exeter Exeter United Kingdom.
Background: Peak oxygen consumption (peak O) is traditionally scaled by body mass, but it is most appropriately scaled by fat-free mass. However, it is unknown whether peak O scaled by fat-free mass is associated with mortality and morbidity in people with a Fontan circulation. The aim of this study was to assess the associations between different expressions of peak O with mortality and morbidity in people with a Fontan circulation.
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