Importance:Controversies persist about management of the ductus arteriosus by nonsteroidal anti-inflammatory drugs in extremely preterm infants. Acetaminophen (paracetamol) appears to be a promising alternative with possibly fewer adverse effects. Objective:To evaluate whether prophylactic intravenous acetaminophen started within 12 hours of birth increases survival without neonatal severe morbidities at 36 weeks' postmenstrual age. Design, Setting, and Participants:A double-blind, randomized, placebo-controlled clinical trial was conducted among preterm infants born between 23 weeks 0 days and 28 weeks 6 days of gestation in 43 neonatal intensive care units of 14 European countries between October 2020 (October 2021 for infants born at 23-26 weeks' gestation, after the phase 2 study identified the optimal dose of acetaminophen) and April 2024. Data analysis was conducted from January to June 2025. Intervention:In the acetaminophen group, patients born at 27 to 28 weeks' gestation received a 20-mg/kg loading dose of acetaminophen followed by 7.5 mg/kg every 6 hours for 5 days, and patients born at 23 to 26 weeks' gestation received a 25-mg/kg loading dose of acetaminophen followed by 10 mg/kg every 6 hours for 5 days. In the placebo group, isotonic sodium chloride was administered. Main Outcomes and Measures:The primary outcome was survival without neonatal morbidity evaluated at 36 weeks' postmenstrual age. The secondary exploratory outcome was ductus arteriosus closure, assessed by echocardiography on day 7. Results:A total of 778 patients (median [IQR] gestational age, 26 [25-27] weeks; 375 [48.2%] female) were included in the study, with 391 in the acetaminophen group and 387 in the placebo group. Survival without severe morbidities at 36 weeks' postmenstrual age occurred in 259 infants (66.2%) in the acetaminophen group and 246 (63.6%) in the placebo group (absolute risk difference [ARD], 2.7 [95% CI, -4.0 to 9.3] percentage points; relative risk [RR], 1.04 [95% CI, 0.94 to 1.16]). The ductus arteriosus was considered closed on day 7 in 264 of 371 infants (71.2%) assigned to acetaminophen and 191 of 366 infants (52.2%) assigned to placebo (ARD, 19.0 [95% CI, 12.0 to 25.7] percentage points; RR, 1.36 [95% CI, 1.21 to 1.53]). In the safety analysis, adverse events were not different except for a higher cholestasis rate in the acetaminophen group (25 of 392 infants [6.4%]) vs the placebo group (10 of 386 infants [2.6%]) (ARD, 3.8 [95% CI, 0.9 to 6.9]) percentage points. Conclusions and Relevance:This study found that prophylactic acetaminophen treatment for patent ductus arteriosus did not increase survival without neonatal morbidities. Trial Registration:ClinicalTrials.gov Identifier: NCT04459117.
Neurodevelopmental disorders are a major non-cardiac source of morbidity in congenital heart disease (CHD), but families’ experiences of risk communication and developmental care remain insufficiently described. We aimed to characterize parental perspectives on neurodevelopmental risk communication, referral, care coordination, and unmet needs in France. We conducted a nationwide, anonymous, cross-sectional online survey of parents of children with CHD in France between May and June 2025. The questionnaire, co-developed with expert parents and a national patient organization, assessed timing and modalities of risk communication, access to follow-up pathways, coordination, and family impact. Of 667 invited families, 293 completed the survey (response rate 43.9 Conclusion: Parents described substantial gaps in neurodevelopmental risk communication, care coordination, and continuity of follow-up for children with CHD. Structured, family-centered pathways should begin at diagnosis and extend into school age.
Introduction Congenital heart disease (CHD) is the leading cause of fetal malformations and remains a major determinant of morbidity in childhood. Children with CHD are at increased risk of neurodevelopmental disorders (NDD). The severity of CHD strongly influences clinical management and long-term outcomes, including neurodevelopment. Adverse maternal environment may play a major role in CHD and NDD induction. Additionally, contribution of CHD severity to NDD remains unclear. Methods We analyzed obstetrical and pediatric data from a French multicenter retrospective cohort including 334 women who delivered infants with CHD between 2012 and 2023. Neurodevelopmental follow-up at 2, 5 or 7 years was available for a third of them. CHD severity was categorized as critical-complex, non-critical complex and non-complex according to the classification used by the French Reference Center for Complex Congenital Cardiac Malformations (M3C) and time to cardiac surgery. NDD were assessed using the Strengths and Difficulties Questionnaire (SDQ), the Ages and Stages Questionnaire (ASQ) and a standardized teacher-completed questionnaire. Multinomial multivariate logistic regression was used to evaluate associations between maternal environmental factors, CHD severity and NDD. Results Maternal psychological distress (OR 0.39, 95% CI [0.18–0.87]) and nulliparity (OR 1.77, 95% CI [1.08–2.90]) were associated with a lower probability of severe CHD. CHD severity was not significantly associated with NDD at 2, 5 or 7 years. Maternal age<25 years or>30 years, second parity and gestational weight gain<12kg were associated with a higher risk of combined CHD and NDD. Conclusion Our study is the first to demonstrate the associations between specific maternal environmental risk factors and NDD in CHD infants when considering CHD severity. We showed no difference in NDD occurrence regarding CHD severity. These results support systematic neurodevelopmental screening in all CHD patients during childhood regardless the severity of the cardiac pathology.
BACKGROUND:Percutaneous atrial septal defect (ASD) closure is an established alternative to surgical repair for patients with secundum ASD, offering minimally invasive treatment with high procedural success rates. Despite its widespread adoption, clinically significant complications such as device embolization and erosion may occur. Our Survey aims at providing a comprehensive, multicenter perspective on the incidence, features, and management strategies for these complications, in order to improve procedural outcomes and patient safety through collaborative data collection. METHODS:This is an international, multicenter survey collecting retrospective data from 30 centers performing transcatheter ASD closures between 2011 and 2021. Participating institutions contributed anonymous aggregate data on patient demographics, procedural details, and clinical outcomes, focusing on the incidence, anatomical and procedural risk factors, and management of device embolization or erosion. RESULTS:A total of 30 institutions participated, providing data on 13.155 procedures of transcatheter closure of ASD, with 40% of them in children. Amplatzer device was used in 58% of cases, with balloon sizing performed routinely in 62% of institutions, mainly with stop flow technique. A total of 17 erosions (0.13%) were reported, of which 10 in children (incidence 0.19%) and 7 in adults (incidence 0.09%). Surgical repair was performed in all these cases, one patient died. Embolizations were reported in 91 cases (incidence 0.7%), with 60% of them in children. Most (80%) occurred within 24 h. Surgical retrieval was carried out in 29% of cases. Irrespective of management, no fatal complications occurred. CONCLUSIONS:Complications such as embolization and erosion after transcatheter ASD closure in children and adults are exceedingly rare but still present in clinical practice and require careful monitoring for prompt recognition and timely intervention, in order to obtain favorable outcomes.
Transcatheter closure of sinus venosus defects (SVD) is an emerging alternative to surgery, however, concerns remain regarding growth potential in paediatric patients treated with fixed-diameter stents. This retrospective study included individuals younger than 18 years from 12 centres. SVD closure was performed using covered stents after demonstration of right upper pulmonary vein redirection during balloon interrogation. Complete closure without significant residual flow was defined as procedural success. Major complications were those necessitating surgical intervention, whereas minor complications were managed intraprocedurally. Among 54 patients < 18 years, 17 had bilateral superior vena cava and six had a high-draining vein. The majority (37) underwent single-stent placement; others required multiple stents. Procedural success was 98.1
INTRODUCTION:Extracorporeal membrane oxygenation (ECMO) is associated with neurological complications and potential long-term effects on health-related quality of life (HRQoL), when compared to healthy peers.1 This prospective cross sectional matched case control study evaluated HRQoL, as well as neurodevelopmental, motor and cognitive outcomes in pediatric ECMO survivors. METHODS:Forty-two ECMO survivors supported with ECMO (2014-2023) were matched with 42 pediatric intensive care unit (PICU) survivors. HRQoL was assessed using the PedsQL 4.0 Generic Core Questionnaire. RESULTS:HRQoL scores were slightly lower in the ECMO group, with a mean adjusted difference for HRQoL total score of -5.4, 95%CI -10.6 to -0.3, p = 0.040. Physical functioning was lower in the ECMO group, with a mean adjusted difference of -9.6, 95%CI -16.8 to -2.5, p = 0.009. Among other outcome measures reported, executive function complaints affected approximately one third of the cohort and were associated with impaired HRQoL. CONCLUSION:ECMO survivors show minor differences in HRQoL compared with matched PICU survivors except for physical functioning. Both groups demonstrate executive function impairments. ECMO survivors require structured post‑ICU follow‑up to address physical and cognitive needs. IMPACT:ECMO survivors show minor differences compared to matched PICU survivors, except for physical functioning. Both groups have a high rate of executive function impairments during later neuropsychological testing. ECMO survivors should be included in post-ICU follow-up programs. Long-term health-related quality of life in pediatric ECMO survivors: a prospective controlled study.
Introduction Transcatheter patent ductus arteriosus (PDA) closure is safe in<2kg infants and in≥6kg patients, but major safety concerns remain when applied to the intermediate weight range. We aimed to assess outcomes of transcatheter PDA closure in 2 to 6kg infants. Methods An international, multicentre, retrospective cohort study was conducted in 31 tertiary hospitals in 17 countries between 2000 and 2023, investigating all infants who underwent attempted transcatheter PDA closure with a procedural weight of 2 to 6kg. Results Attempted transcatheter PDA closure was performed in 1231 infants (median weight: 4747 grams Q1–Q3 [3700–5300]; median age: 132 days Q1–Q3 [83–194]; ex-preterm: n=581 [56.8%]) with a 95.0% success rate. A composite outcome of procedural failure or major adverse events was observed in 173 (14%) patients, including device embolization in 64 (3.7%), device-induced left pulmonary artery stenosis in 47 (2.7%) and procedural death in 2 (0.2%). Logistic regression model analysis identified a 2-to 3.9-kg procedural weight, increased pulmonary artery pressure, and window-type or tubular ductal morphologies as independent predictors of the composite outcome. Based on propensity score matching analysis, 2 to 3.9kg infants had a risk ratio of 2.19 (95%CI, 1.25–3.83) for experiencing the composite outcome, as compared to 4 to 5.9kg infants. Conclusion Transcatheter PDA closure in 2 to 6kg infants was feasible in most patients. Procedural failure or major adverse events occurred in 14% and several independent risk factors were identified, including the 2 to 3.9kg weight range identified as a higher-risk subgroup. These findings may improve risk stratification and decision-making process.
Newborns with congenital heart disease (CHD) and preterm newborns are at high risk for morbi-mortality. However, the extent to which CHD affects long-term outcomes, especially neurodevelopment, in preterm newborns remains unclear. Retrospective case control matched study. Preterm infants (< 37 weeks of gestation) born with CHD between January 2013 and December 2022 included in the LIFT cohort and followed up at 24 months (n = 35) were matched by gender, gestational age, year and place of birth and parental socio-professional status (n = 132). Severe to moderate neurodevelopmental impairment (NI) was more frequent for patients born preterm with CHD at 24 months of age (12/35 (34.29
Background Superior vena cava (SVC) thrombosis after Glenn palliation constitutes acute cavopulmonary circuit failure. Case Summary A 6-month-old boy with hypoplastic left heart syndrome developed SVC syndrome on postoperative day 13 after bidirectional Glenn, secondary to catheter-associated SVC-Glenn thrombosis with distal pulmonary embolisms. Alteplase infused in situ through the existing catheter (0.2 mg/kg/h, 72 hours) achieved complete recanalization without bleeding. Discussion Mediastinal hemorrhage and 4-day veno-arterial extracorporeal membrane oxygenation precluded thrombolysis and surgery, and mechanical disruption risked embolization into the compromised pulmonary bed. Take-Home Messages When an indwelling catheter traverses the thrombus, catheter-directed alteplase achieves complete recanalization, even after hemorrhage and extracorporeal support.
Introduction Among congenital heart diseases, aortic coarctation accounts for 5–8% of patients and is associated with significant morbidity and mortality from childhood to adulthood. Neonatal forms are considered critical congenital heart defects, requiring early management under optimal conditions to ensure a favorable cardiovascular prognosis. Among postoperative complications, aortic recoarctation is the most frequent early complication in these patients. However, to date, the predictive factors for this complication remain poorly understood. The objective of this multicenter study is to describe the morbidity and mortality of aortic coarctation operated on before 1 year of age in a large multicenter cohort and to identify predictive factors for aortic recoarctation. Methods This is a retrospective, multicenter, longitudinal observational study conducted in five French surgical centers. Patients who underwent surgery for aortic coarctation before the age of one year, between January 2011 and December 2025, were included. Patients with complex congenital heart disease and those who initially underwent cardiac catheterization were excluded. The primary endpoint was 6-year survival free from aortic recoarctation. Secondary endpoints were overall survival and survival free from arterial hypertension. Results A total of 908 patients were included (male-to-female ratio: 1.95), with a median follow-up of 4 years. The median age at surgery was 14 days. The surgical technique used was the Crafoord procedure in 35% of cases, extended Crafoord repair in 48%, and aortic arch plasty in 17%. Survival free from recoarctation was 81.5% at 6 years (Figure 1). Overall survival was 97% at 6 years. Survival free from hypertension was 60% at 6 years. Predictive factors for recoarctation identified in univariate analysis included demographic, clinical, and imaging outcomes. Multivariate analysis is ongoing. Conclusion Neonatal aortic coarctation remains a condition associated with substantial morbidity and mortality. The predictive factors for recoarctation identified may help guide surgical decision-making and follow-up strategies. Hypertension remains the main long-term morbidity, affecting up to 40% of children at 6 years of age, although only 8.5% receive treatment. Improving its detection and management is essential to reduce long-term cardiovascular impact in adulthood.
BACKGROUND AND AIMS:There is a paucity of data on arrhythmia burden in patients with congenitally corrected transposition of the great arteries (ccTGAs). The present study sought to quantify the incidence of atrial arrhythmia (AA), ventricular arrhythmia (VA), and complete atrioventricular block (CAVB) in patients with ccTGA and identify associated factors. METHODS:An international, multi-centre, retrospective cohort study was conducted in 29 tertiary hospitals (six countries) between 1990 and 2018. Primary analyses consisted of determining the incidence of a combined outcome consisting of AA, VA, or CAVB, along with its individual components. Factors associated with the different types of arrhythmias were assessed by uni-variable and multi-variable Cox regression analyses. RESULTS:A total of 1131 patients with ccTGA were followed for 9.0 (interquartile range 4.0-17.2) years. Cumulative rates of the primary endpoint at 10, 15, and 20 years were 44.5%, 51.0%, and 58.8%, respectively. AA, VA, and CAVB occurred in 2.1, 1.4, and 2.0 cases per 100 person-years, respectively. In multi-variable analyses, surgery/intervention conferred a greater than three-fold higher risk of AA [hazard ratio (HR) 3.01, 95% confidence interval (CI) 1.90-4.78, P < .001]. Furthermore, surgery/intervention was significantly associated with a greater risk of VA (HR 1.73, 95% CI 0.98-3.05, P = .003) and CAVB (HR 3.65, 95% CI 2.20-6.05, P < .001). The left bundle branch block was associated with a higher risk of VA (HR 4.03, 95% CI 1.59-10.23, P = .003) and the right bundle branch block with a higher risk of CAVB (HR 3.71, 95% CI 1.81-7.63, P < .001). CONCLUSIONS:The arrhythmia burden in patients with ccTGA is substantial, with a high incidence of AA, VA, and CAVB.
KEY POINTS:Children with CKD exhibit markedly lower cardiopulmonary fitness with an absolute maximal oxygen uptake deficit of 10 ml/kg per minute compared with reference values. More than half of the patients show impaired fitness as early as CKD stage 3, highlighting early functional vulnerability. Maximal oxygen uptake is independently associated with modifiable parameters commonly targeted by rehabilitation, supporting tailored intervention strategies. BACKGROUND:Children with CKD are at high cardiovascular risk, yet cardiopulmonary fitness is rarely assessed in routine care. Maximal oxygen uptake (VO 2 max) is a powerful prognostic marker, and Z -score-based evaluations may improve early risk stratification. METHODS:In this prospective multicenter study, children aged 6-17 years with CKD stages 2-5 (Kidney Disease Improving Global Outcome) underwent standardized cardiopulmonary exercise testing (CPET). VO 2 max was expressed as Z -scores using contemporary pediatric reference values. Impaired fitness was defined as VO 2 max Z -score <-1.64. Multivariable linear regression was used to identify independent determinants of VO 2 max. RESULTS:Among 88 enrolled patients (mean age 12±4 years, 67% male), 77 completed a valid CPET. Mean VO 2 max Z -score was -1.8±2.1, corresponding to 33.5±9.2 ml/kg per minute, that is, an absolute lowering of approximately 10 ml/kg per minute compared with age-matched and sex-matched reference values. Overall, 57% had impaired fitness. VO 2 max was progressively lower across higher CKD stages ( P < 0.001 ). In multivariable analysis, higher VO 2 max was independently associated with higher hemoglobin concentration, better pulmonary function (forced expiratory volume in 1 s), better ventilatory efficiency (VE/VCO 2 slope), and higher ventilatory anaerobic threshold, explaining 77% of VO 2 max variability. CONCLUSIONS:Cardiopulmonary fitness is markedly lower in children with CKD, with a clear stage-dependent decline that is already evident at early disease stages. The magnitude of VO 2 max impairment is substantial and related to potentially modifiable clinical and functional factors, supporting early CPET-based screening and the development of targeted, multidisciplinary rehabilitation in pediatric CKD. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER:Clinicaltrials.gov identifier NCT04897672 and Montpellier University Hospital Institutional Review Board (IRB 202100852).
Introduction Neurodevelopmental disorders (NDD) are the most common morbidity in congenital heart disease (CHD) patients across the lifespan. We aim to describe current clinical practice in neuromonitoring and neurodevelopmental follow-up strategies in France. Methods An audit using an online nationwide survey was distributed through appropriate healthcare networks and scientific societies. Results Replies from 100 professionals (25 centers) including 52 physicians working in one of the 10 French surgical CHD centers, were analyzed. Preoperative neuromonitoring is little performed (fetal brain imaging: 2/10 centers, baseline cerebral near-infrared spectroscopy [NIRS]: 2/10 centers, preoperative neurological examination: 4/10 centers). All centers use cerebral NIRS for intraoperative neuromonitoring and early postoperative neuromonitoring. Eighty percent of centers give access to a perinatal healthcare network for longitudinal follow-up up to the age of 7 years, whilst only 1/10 centers keep offering a specialized and multidisciplinary care pathway involving serial neurodevelopmental assessment after the age of 7. Conclusion Although all surgical CHD centers perform perioperative and early postoperative neuromonitoring, there is a huge heterogeneity in preoperative neuromonitoring and in the long-term follow-up modalities. This should encourage surgical CHD centers to standardize their practice for both clinical and research purposes.
Introduction Pulmonary branch stenting is a relatively recent technique, now widely used worldwide, but remains insufficiently studied, particularly regarding its long-term efficacy and tolerability. The objectives of our study were to assess long-term stent efficacy and survival in pulmonary branches, to evaluate the effectiveness of subsequent redilations, to document procedure-related complications, and to identify predictive factors associated with stent survival. Methods We conducted a retrospective, multicentre, observational study including all patients who underwent percutaneous or surgical implantation of a stent in one or both pulmonary artery (PA) branches. The primary endpoint was stent survival free from surgical removal, percutaneous re-stenting, branch occlusion, or cardiac-related death. Results Between 2004 and 2025, 159 patients (55% male; mean age 7.5±9.1 years) underwent 215 pulmonary branch stent implantations. The most frequent underlying congenital heart diseases were pulmonary atresia with ventricular septal defect (28%), tetralogy of Fallot (24%) and single ventricle physiology (14%). A genetic abnormality was identified in 19% of patients. Most stents were implanted percutaneously (65%), predominantly in paediatric patients (88%), and resulted in a significant increase in the pulmonary branch minimal diameter Z-score (from −5.0±2.6 to 0.0±1.7, P<0.001). Mean follow-up was 6.3±5.0 years, covering 206 stents (95%). The primary endpoint occurred in 24% of stents after a mean of 2.3±3.2 years. Stent survival free from the primary endpoint was 78% at 10 years. Factors associated with endpoint occurrence were younger age and lower weight at implantation, smaller baseline pulmonary artery diameter, and the use of non-redilatable stents. Long-term complications included 41 cases of in-stent proliferation (20%), 21 fractures (10%), 7 migrations (3%), and rarer events (PA–aortic fistula, aortic compression, dissection). During follow-up, 225 redilations were performed on 117 stents (1–5 per stent), increasing the initial diameter by 36±33% (mean gain 2.8±2.2mm). The last available stent Z-score was normal (0.1±1.4). Conclusion Pulmonary branch stenting achieves a significant and sustained increase in pulmonary artery diameter with an acceptable rate of complications. Larger-scale studies are required to refine patient selection and identify those at lower risk of long-term complications.
QuestionDoes early prophylactic treatment for patent ductus arteriosus with an appropriate dose of acetaminophen (paracetamol) increase survival without serious morbidity in preterm infants of 23 to 26 weeks of gestation?FindingsIn this randomized clinical trial among 778 preterm infants, early prophylactic treatment with acetaminophen did not increase survival without severe morbidity at 36 weeks' postmenstrual age, despite accelerated closure of the ductus arteriosus. This treatment was associated with an increased rate of cholestasis.MeaningProphylactic treatment for patent ductus arteriosus with acetaminophen should not be recommended in very preterm infants. ImportanceControversies persist about management of the ductus arteriosus by nonsteroidal anti-inflammatory drugs in extremely preterm infants. Acetaminophen (paracetamol) appears to be a promising alternative with possibly fewer adverse effects.ObjectiveTo evaluate whether prophylactic intravenous acetaminophen started within 12 hours of birth increases survival without neonatal severe morbidities at 36 weeks' postmenstrual age.Design, Setting, and ParticipantsA double-blind, randomized, placebo-controlled clinical trial was conducted among preterm infants born between 23 weeks 0 days and 28 weeks 6 days of gestation in 43 neonatal intensive care units of 14 European countries between October 2020 (October 2021 for infants born at 23-26 weeks' gestation, after the phase 2 study identified the optimal dose of acetaminophen) and April 2024. Data analysis was conducted from January to June 2025.InterventionIn the acetaminophen group, patients born at 27 to 28 weeks' gestation received a 20-mg/kg loading dose of acetaminophen followed by 7.5 mg/kg every 6 hours for 5 days, and patients born at 23 to 26 weeks' gestation received a 25-mg/kg loading dose of acetaminophen followed by 10 mg/kg every 6 hours for 5 days. In the placebo group, isotonic sodium chloride was administered.Main Outcomes and MeasuresThe primary outcome was survival without neonatal morbidity evaluated at 36 weeks' postmenstrual age. The secondary exploratory outcome was ductus arteriosus closure, assessed by echocardiography on day 7.ResultsA total of 778 patients (median [IQR] gestational age, 26 [25-27] weeks; 375 [48.2%] female) were included in the study, with 391 in the acetaminophen group and 387 in the placebo group. Survival without severe morbidities at 36 weeks' postmenstrual age occurred in 259 infants (66.2%) in the acetaminophen group and 246 (63.6%) in the placebo group (absolute risk difference [ARD], 2.7 [95% CI, -4.0 to 9.3] percentage points; relative risk [RR], 1.04 [95% CI, 0.94 to 1.16]). The ductus arteriosus was considered closed on day 7 in 264 of 371 infants (71.2%) assigned to acetaminophen and 191 of 366 infants (52.2%) assigned to placebo (ARD, 19.0 [95% CI, 12.0 to 25.7] percentage points; RR, 1.36 [95% CI, 1.21 to 1.53]). In the safety analysis, adverse events were not different except for a higher cholestasis rate in the acetaminophen group (25 of 392 infants [6.4%]) vs the placebo group (10 of 386 infants [2.6%]) (ARD, 3.8 [95% CI, 0.9 to 6.9]) percentage points.Conclusions and RelevanceThis study found that prophylactic acetaminophen treatment for patent ductus arteriosus did not increase survival without neonatal morbidities.Trial RegistrationClinicalTrials.gov Identifier: NCT04459117 This randomized clinical trial evaluates whether prophylactic intravenous acetaminophen started within 12 hours of birth, compared with placebo, for patent arteriosus ductus increases survival without neonatal severe morbidities at 36 weeks' postmenstrual age.
Introduction Transcatheter closure of patent ductus arteriosus (TC-PDA) has become a safe alternative to surgical ligation in premature infants. Current guidelines recommend an experienced onsite physician proctoring initial cases, as procedural complications may have catastrophic consequences. Appropriate onsite mentoring is difficult in remote centers. Methods La Réunion University Hospital is a French congenital heart disease (CHD) center located 10.000-km away from mainland France, without expert TC-PDA proctor within close distance. Cases were performed with the remote mentoring of an echographer and an interventionist proctor who were conferenced into the operating room using Medinbox, a secure platform allowing bidirectional audio communication and real-time high-quality streaming of imaging guidance modalities (Fig. 1). A retrospective study was conducted to report our experience in tele-proctored TC-PDA in<2000-grams infants between 2022 and 2025. Results Tele-proctored TC-PDA was performed in 11 symptomatic infants (median gestational age: 26 weeks [Q1–Q3: 25–27], birth weight: 850 grams [Q1–Q3: 715–920]), at a procedural age of 25 days [Q1–Q3: 22–27] and weight of 1200 grams [Q1–Q3: 1000–1450], including an 880-grams and a 950-grams infant under high-frequency jet ventilation. PDAs were large (diameter: 3.6mm [Q1–Q3: 2.9–3.8]), with a length of 7mm [Q1–Q3: 6–9], and hemodynamically significant according to clinical and echocardiographic criteria. They were closed using an 4/2 Amplatzer Piccolo Occluder (APO, Abbott, USA) in 5 patients, a 5/2 APO in 5, and a 6-mm Amplatzer Vascular Plug-II (Abbott, USA) in 1.Procedural success was achieved in 11/11 cases. Postprocedural echocardiography showed non-increased LPA and DAo flow velocities (Vmax: 1.6m/s [Q1–Q3: 1.4–1.8] and 1.1m/s [Q1–Q3: 1.0–1.3], respectively). Patients were extubated within 5 days [Q1–Q3: 2–7]. One patient died 2 months after the procedure because of a procedure/device unrelated sepsis. After a median follow-up of 14 months [Q1–Q3: 4–22], no late reintervention was required in the 10 survivors, who all had no residual shunt on last visit. Conclusion Our report demonstrates that tele-proctoring is feasible using an integrated digital operating room technology and may be safely applied for high-risk neonatal cardiac interventions. This carries major implications, including rapid dissemination and sharing of knowledge for innovative technical procedures helping patients across the globe.
Introduction Transcatheter patent ductus arteriosus (PDA) closure can be challenging in cases of large PDA, complex anatomy, and small patient size. We aimed to assess the feasibility, efficacy and safety of the off-label use of the multifunctional occluder (MFO) in transcatheter PDA closure. Methods A retrospective analysis was conducted on patients who underwent transcatheter PDA closure with the MFO in 14 pediatric cardiology centers (5 countries) from 2018 to 2025. Results A total of 77 procedures were performed on 75 patients, including 5 adults (6.7%). Among the 70 children (93.3%) [median age: 0.8 years (range: 0.1–10 years), median procedural weight: 6.9kg (range: 2.1–32.0kg)], 35 (50.0%) weighed 6kg or less [median procedural weight: 4.0kg (range: 2.1–5.9kg)]. The PDA was large, with a minimal ductal diameter of 3.8mm (range: 1.5–7.0mm), short in 54.5%, and unrestrictive with increased pulmonary artery pressures in 51.6% patients. The morphology was predominantly conical (Krichenko type A: 51.9%), with window-type or complex morphologies representing 26.7% (Type B: 18.2%, Type D: 7.8%). Both arterial and venous femoral accesses were obtained in 87.0% cases, with deployment being antegrade in 77.9% and retrograde in 22.1%. Successful device deployment and release were achieved in 74 cases (96.1%). The rate of major adverse events was 5.2% including 1 early (1.3%) and 3 late complications (3.9%). No other adverse events were reported. Conclusion The off-label use of the MFO device is a promising option for transcatheter PDA closure, demonstrating safety and efficacy in this series.
A neonate with common arterial trunk presented with severe cyanosis rather than pulmonary overcirculation. Echocardiography, cardiac CT, catheterisation, and surgery showed a pulmonary trunk arising from a truncal valvar sinus, with systolic obstruction by a dysplastic truncal cusp. Staged palliation restored antegrade pulmonary flow, allowed pulmonary arterial growth, and enabled successful complete repair.
Introduction Congenitally corrected transposition of the great arteries (ccTGA) with biventricular physiology is presumed to carry a favorable outcome. We aimed to better characterize the impact of prenatal diagnosis on conduction disorders, interventions, and mortality. Secondary objective was to examine outcomes in isolated ccTGA. Methods An international, multicenter, retrospective cohort study was conducted in 29 tertiary hospitals (6 countries) from 1990–2018. Patients with a single ventricle, heterotaxy syndrome, or valvar atresia were excluded. Results Of 331 ccTGA patients with a median follow-up of 8.6 years [IQR: 3.5–14.1], 128 (38.7%) were diagnosed prenatally at a median gestational age of 22 weeks. As compared to the postnatal group, prenatally diagnosed patients experienced earlier cardiac conduction disorders (median age at diagnosis of conduction disorders: 0.3 versus 2.7 years, P=0.010), earlier pacemaker implantation (median age at pacing: 6.5 years [2.5–11.6] versus 0.9 year [0.1–3.0], P<0.001) and earlier surgical intervention (intervention-free survival rate at 3 years: 50.3% versus 34.7%, P<0.001). The 3-year survival rate was significantly lower in patients diagnosed prenatally (91.1% versus 98.4%, P=0.002) and the median age at death was significantly younger among patients diagnosed prenatally (0.2 versus 7.0 years, P<0.001). In both groups, isolated ccTGA (n=63, 19%) was associated with superior outcomes with no intervention in 46.8% and only one death. Conclusion Prenatally diagnosed patients with ccTGA had earlier conduction disorders and interventions than postnatally diagnosed patients and died at a younger age. Outcomes were best in patients with isolated ccTGA.