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Background: Transcatheter closure of patent ductus arteriosus (PDA) in premature infants has been shown to be feasible in small series. Outcomes in larger series are currently lacking., Material: All premature infants (< 36 weeks GA) who underwent transcatheter PDA closure were included in a multicenter French national survey. Demographic data (gestational age [GA], birth weight [BW]) and procedural data (weight [PW], age at procedure [AP], procedural success, fluoroscopy time, and type of device) were collected. Outcomes and procedural complications were reviewed., Results: Between September 2013 and June 2017, 102 patients were included. In 71 cases, PDA pharmacological closure had been attempted. Mean GA was 27 ± 2.9 weeks. Mean BW and PW were 1,040 ± 715 g and 1,543 ± 698 g, respectively. Mean AP was 39 ± 26 days. Number of premature infants <1 kg, between 1 and 2 kg, and > 2 kg was 21, 59, and 22, respectively. Mean fluoroscopic time was 6.5 min. Success rate was 99%. Device- or procedure-related complications were reported in nine patients (8.9%) including three LPA stenoses (requiring surgery in two and balloon dilatation in one), two neo-coarctations (one requiring subsequent surgery), and three instances of tricuspid valve regurgitation at follow-up. Seven deaths were reported, none being related to the procedure. Mean follow-up was 39.75 ± 13.1 months., Conclusion: In this large series of premature infants undergoing transcatheter PDA closure, it was demonstrated that this procedure can be performed successfully in the vast majority of patients with an acceptable complication rate. Future efforts should focus on minimizing complications, particularly device-related vascular stenoses., (© 2019 Wiley Periodicals, Inc.)

Objectives: The aim of the study was to report the outcome of cardiac catheterisation in low-weight patients., Background: Data regarding cardiac catheterisation in infants weighing &lt;2500 g are scarce., Methods: We reviewed all cardiac catheterisations performed in infants weighing &lt;2500 g between January 2000 and May 2016. An analysis with respect to the type of procedure, the complexity of procedure (procedure type risk), and haemodynamic vulnerability index was finally carried out. We report the occurrence of deaths and complications using the adverse event severity score., Results: A total of 218 procedures were performed on 211 patients. The mean age and weight were, respectively, 15 ± 26 days (range, 0-152) and 2111 ± 338 g (range, 1000-2500). Procedures were interventional and diagnostic, respectively, in 174 (80%) and 44 (20%) patients. Out of 218, 205 (94%) were successful. Eleven complications (5%) occurred - six with an adverse event severity score of 4 and five with an adverse event severity score of 3. Ten patients (91%) showed a favourable outcome, and one died (stent thrombosis few hours after patent ductus arteriosus stenting). No correlation was found between lower weight and occurrence of death (p = 0.68) or complications (p = 0.23). The gravity scores (procedure type risk and haemodynamic vulnerability index) were not predictive of complications., Conclusions: Cardiac catheterisation in infants weighing &lt;2500 g appears feasible and effective with low risk. The weight should not discourage from performing cardiac catheterisation in this population.

Aims: The aim of this study was to compare the efficacy and safety of the Occlutech Figulla Flex II Occluder (OFFII) with the Amplatzer Septal Occluder (ASO) in patients > 8kg undergoing transcatheter ASD closure., Methods and Results: Randomized, controlled, multi-center prospective clinical trial with randomization 2:1 in favor of the OFFII. Primary efficacy endpoint was the rate of successful device placement and defect closure without major complications at hospital discharge. All data were assessed through a core laboratory. Interim analysis was performed when 70% of the patients were treated to evaluate for noninferiority. From a total of 176 randomized subjects, interim analysis was performed on the first 158 patients (65.2% female) (107 OFFII/51 ASO) undergoing device closure at a median weight of 42 kg (range 13-125 kg). Seventy-six percent (120 patients) completed 6-month follow-up. Successful device placement (first attempt) was achieved in 99.1% of the OFF group vs 90.2% of the ASO group (P < 0.05). Early efficacy success was achieved in 94.4% of the OFFII group vs 90.2% of the ASO group (P < 0.001). The incidence of major complications was 5.6% for the OFFII group compared to 9.8% for the ASO., Conclusions: The OFFII device was not inferior to the ASO with less complications and greater efficacy than the ASO., (© 2018 Wiley Periodicals, Inc.)

Background: Percutaneous coronary interventions (PCIs) are generally performed in adults with ischaemic heart disease, but reports of experience in the paediatric population are relatively limited., Aims: To report indications, interventional techniques and procedural outcomes for PCI in children treated in two French institutions., Methods: Medical records of all children in whom a PCI was attempted in two French tertiary institutions between 1998 and 2015 were systematically reviewed. Diagnostic procedures, including coronary angiograms, were excluded., Results: A total of 40 PCIs were attempted in 29 patients (median age 6.5 years, range three days to 17.9 years). Nineteen procedures (47.5%) were performed on an emergency basis. A total of 36/40 coronary obstructions were successfully treated, with no immediate residual postintervention stenosis. Initial balloon angioplasty was performed for all lesions, with subsequent stent placement in 23 lesions. There were two periprocedural and five late deaths. After a median follow-up of 12 months (range 1 week to 115 months), freedom from death and reintervention at 36 months were 79% and 60%, respectively. Age<1 month, emergency procedure and balloon angioplasty without stent implantation were associated with shorter survival., Conclusion: PCI can be used in the paediatric population in a wide range of anatomical conditions; it may be effective in selected patients, but remains challenging when performed in emergency and/or in neonates., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

Cardiac catheterisation has become an essential tool in the diagnosis and treatment of children with a wide variety of congenital and acquired forms of cardiovascular disease. Despite the clear clinical benefit to the patient, radiation exposure from paediatric cardiac catheterisation procedures (CCPs) may be substantial. Given children's greater sensitivity to radiation and the longer life span during which radiation health effects can develop, an epidemiological cohort study, named Coccinelle or 'Ladybird' (French acronym for 'Cohorte sur le risque de cancer après cardiologie interventionnelle pédiatrique'), is carried out in France to evaluate the risks of leukaemia and solid cancers in this population. A total number of 8000 included children are expected. Individual CCP-related doses will be assessed for each child included in the cohort. For each CCP performed, dosimetric parameters (dose-area product, fluoroscopy time and total number of cine frames) are retrieved retrospectively. Organ doses, especially to the lung, the oesophagus and the thyroid, are calculated with PCXMC software. The cohort will be followed up through linkage with French paediatric cancer registries., (© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background: Transcatheter valve-in-valve (VIV) implantation in failing bioprosthesis is an emerging field in cardiology., Aim: To report on a French multicentre experience and a literature review of tricuspid VIV implantation., Methods: We approached different institutions and collected 10 unpublished cases; a literature review identified 71 patients, including our 10 cases. Clinical aspects and haemodynamic data are discussed., Results: Among our 10 unpublished cases, the reason for implantation was significant tricuspid stenosis (n = 4), significant tricuspid regurgitation (n = 1) or mixed lesion (n = 5). Implantation was performed under general anaesthesia at mean age 28 ± 17 years. The 22 mm Melody valve was implanted in seven patients; the Edwards SAPIEN valve was implanted in three patients. The procedure succeeded in all cases, despite two embolizations in the right cardiac chambers; in both cases, the valve was stabilized close to the tricuspid annulus using a self-expandable stent, before implantation of a second Edwards SAPIEN valve. Functional class improved in all but one case. Mean diastolic gradient decreased from 9 ± 2.45 mmHg to 3.65 ± 0.7 mmHg (p = 0.007); no more than trivial regurgitation was noticed. Among the published cases, the Melody valve was implanted in 41 patients, the Edwards SAPIEN valve in 29 patients and the Braile valve in one patient. Short-term results were similar for our 10 cases, but mid-term results are not yet available., Conclusions: Tricuspid VIV implantation using the Melody or Edwards SAPIEN valves is a feasible and effective procedure for selected patients with failing bioprosthesis., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

Background: Percutaneous implantation of pulmonary valves has recently been introduced into clinical practice., Aim: To analyse data of patients treated in France between April 2008 and December 2010., Methods: Prospective, observational, multi-centric survey by means of a database registry of the Filiale de cardiologie pédiatrique et congénitale., Results: Sixty-four patients were included, with a median (range) age of 21.4 (10.5-77.3) years. The majority (60.9%) of the patients were New York Heart Association (NYHA) class II. The most common congenital heart disease was tetralogy of Fallot with or without pulmonary atresia (50%). Indication for valve implantation was stenosis in 21.9%, regurgitation in 10.9% and association of stenosis and regurgitation in 67.2%. Implantation was successful in all patients. Pre-stenting was performed in 96.9% of cases. Median (range) procedure time was 92.5 (25-250) minutes. No significant regurgitation was recorded after the procedure, and the trans-pulmonary gradient was significantly reduced. Early minor complications occurred in five cases (7.8%). Three patients died during a median follow-up of 4.6 (0.2-5.2) years, two from infectious endocarditis and one from end-stage cardiac failure. Surgical reintervention was required in three patients. Follow-up with magnetic resonance imaging demonstrated significant improvements in right ventricular volumes and pulmonary regurgitation in mixed and regurgitant lesions., Conclusions: Transcatheter pulmonary valve implantation is highly feasible and mid-term follow-up demonstrates sustained improvement of right ventricular function. Late endocarditis is of concern, therefore longer follow-up in more patients is urgently needed to better assess long-term outcome., Clinical Trial Registration: NCT01250327., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

Interventional cardiology (IC) procedures can be responsible for relatively high radiation doses compared to conventional radiology especially for young patients. The aim of this study was to assess current exposure levels in a French reference centre of pediatric IC. Dosimetric data including dose area product (DAP), fluoroscopy time (FT) and number of cine frame (NF) were analysed taking into account patient weight. Doses to the lungs, esophagus, breast and thyroid were evaluated using anthropomorphic phantoms and thermoluminescent dosimeters. Finally, effective doses (E) were calculated using DAP and conversion factors calculated with PCXMC 2.0 software. 801 IC procedures performed between 2010 and 2011 were analysed. Large variations were observed for DAP, FT and NF values for a given procedure and a given weight group. The assessment of organ doses showed high levels of dose to the lungs and esophagus especially in new-born babies. For diagnostic procedures, E varied from 0.3 to 23 mSv with a mean value of 4.8 mSv and for therapeutic procedures, values ranged from 0.1 to 48.4 mSv with a mean value of 7.3 mSv. The highest values were recorded for angioplasty procedures (mean 13 mSv, range 0.6-48.4 mSv). The increasing use of IC in pediatric population stresses the need of setting up reference levels and keeping doses to children as low as possible.

Objectives: Evaluate the incidence, diagnosis, and outcome of coronary compression (CC) during right-ventricular outflow tract interventions., Background: The incidence, risk factors, diagnosis, and outcomes of CC during percutaneous pulmonary valve implantation are poorly defined., Methods: One-hundred consecutive patients (May 2008 to January 2012) undergoing transcatheter right-ventricular outflow tract treatment in two institutions were studied., Results: CC occurred in six patients (6%) with a right ventricular outflow conduit stenosis, at a median age of 24.5 (13-49) years. It involved the left main coronary artery in four and the right coronary artery originating from the left anterior descending coronary artery in two patients. Conduit types were homograft (n = 3), bioprosthesis (n = 2), and a pericardial patch (n = 1). Median diameter was 23 (17-24) mm at surgical implantation. CC was diagnosed through a selective coronary angiogram during balloon dilation of the conduit in the first three patients and through an aortic root angiogram for the three next cases because we recognized that proximal compression could be masked during coronary artery cannulation. It was suspected on pre-procedure imaging (magnetic resonance imaging and/or computed tomography) in three cases. Patients with abnormal coronary anatomy tend to be at increased risk of CC (P = 0.0504). One institution had a higher incidence of CC (P = 0.04). CC resolved after balloon deflation. No patient underwent conduit stenting. Four patients underwent surgical reconstruction of right ventricular outflow tract., Conclusions: CC is accurately diagnosed during right-ventricular outflow tract interventions. We recommend an aortic root angiogram during dilation with a non-compliant balloon matching the diameter and length of the intended conduit implant., (Copyright © 2014 Wiley Periodicals, Inc.)

Background: Radiation can be used effectively for diagnosis and medical treatment, but it can also cause cancers later on. Children with congenital heart disease frequently undergo cardiac catheterization procedures for diagnostic or treatment purposes. Despite the clear clinical benefit to the patient, the complexity of these procedures may result in high cumulative radiation exposure. Given children's greater sensitivity to radiation and the longer life span during which radiation health effects can develop, an epidemiological cohort study is being launched in France to evaluate the risks of leukaemia and solid cancers in this specific population., Methods/design: The study population will include all children who have undergone at least one cardiac catheterization procedure since 2000 and were under 10 years old and permanent residents of France at the time of the procedure. Electronically stored patient records from the departments of paediatric cardiology of the French national network for complex congenital heart diseases (M3C) are being searched to identify the children to be included. The minimum dataset will comprise: identification of the subject (file number in the centre or department, full name, sex, date and place of birth), and characteristics of the intervention (date, underlying disease, type of procedure, technical details, such as fluoroscopy time and dose area product, (DAP), which are needed to reconstruct the doses received by each child). The cohort will be followed up through linkage with the two French paediatric cancer registries, which have recorded all cases of childhood leukaemia and solid cancers in France since 1990 and 2000, respectively. Radiation exposure will be estimated retrospectively for each child. 4500 children with catherizations between 2000 and 2011 have been already included in the cohort, and recruitment is ongoing at the national level. The study is expected to finally include a total of 8000 children., Discussion: This French cohort study is specifically designed to provide further knowledge about the potential cancer risks associated with paediatric cardiac catheterization procedures. It will also provide new information on typical dose levels associated with these procedures in France. Finally, it should help improve awareness of the importance of radiation protection in these procedures.

Background: Owing to the wide variety of surgical substrates used for right ventricular outflow tract (RVOT) reconstruction, the predictors of successful outcomes in such patients are unclear., Aims: To compare haemodynamic outcomes of percutaneous pulmonary valve implantation (PPVI) in patients with dysfunctional RVOT., Methods: This was a multicentre prospective study on all consecutive patients who underwent PPVI from May 2008 to December 2009. All patients underwent prestenting using a bare-metal stent. The patients were divided into two groups based on the surgical substrate used for RVOT reconstruction., Results: Baseline demographics, including right ventricle to pulmonary artery (RV-PA) pressure gradient and RV/aortic (Ao) pressure ratio, were similar in both groups. The mean RV-PA gradient and RV/Ao pressure ratio showed immediate and significant improvement after PPVI. At last follow-up, the RV-PA gradient and RV/Ao pressure ratio were significantly higher in patients with non-expandable conduits (P=0.002 and P=0.008, respectively). Patients with conduits greater than 20 mm showed better immediate and midterm outcomes compared with other patients. Patients with non-expandable conduits less or equal to 20 mm diameter showed good immediate outcomes but poor midterm haemodynamic outcomes compared with those with expandable conduits less or equal to 20 mm diameter (P=0.03)., Conclusions: PPVI is successful with a wide variety of surgical substrates used for RVOT reconstruction; there was immediate haemodynamic improvement in all patients. However, patients with non-expandable conduits less or equal to 20 mm had the worst outcomes. This information should be integrated into the decision-making process before selecting patients for PPVI., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

Adverse events related to vitamin K antagonist (VKA) therapy might be reduced by point-of-care international normalised ratio (POC INR) monitoring supported by an education program (EP). Our aim was to evaluate the efficacy of a non-selective VKA paediatric EP (regardless of the social, economic, educational or linguistic levels) by analysing the time spent in the therapeutic range (TTR), VKA adverse events and compliance to treatment, and INR control prescriptions. The EP was modified from the pediatric EP previously described but improved by a specifically devised child-focused game. One hundred four consecutive children (median age 8 years) receiving VKA were included in a standardised EP. Patients were in self-testing, and dose adjustments were made by a single physician for three tolerance ranges according to the underlying disease: [2.5-4], [1.8-3.2], and [1.5-2.5]. The median follow-up was 481 days [70-1,001]. The overall TTR was 81.4% [36-100]. The TTR were 74%, 85.6% and 89% for the ranges [2.5-4], [1.8-3.2], and [1.5-2.5], respectively. These results were sustainable during the study period. Only one serious VKA adverse event was recorded. The median number of POC INR tests was 2.5 [1.6-5.7] INR per patient and month. Patients/families performed POC INR when requested in 86.9% of the cases. More than 90% of the families found the EP supportive and wished to follow a long-term reinforcement program. In conclusion, this non-selective child-focused EP for VKA therapy, strongly supported by our dedicated game, is useful in maintaining efficacy, safety and compliance to anticoagulation and its monitoring.

Background: Neonatal aortic coarctation presenting with multiorgan failure is a life threatening condition., Objective: Our aim was to investigate whether emergency balloon dilation improved the prognosis of neonates with aortic coarctation who present with multiorgan failure., Methods: We studied all neonates referred over a period of 6 years with aortic coarctation and left ventricular dysfunction, with or without multiorgan failure. During the first half of the period, from January, 2001 to December, 2003, patients were treated surgically after regression of the multiorgan failure. During the second half, from January, 2004, to January, 2007, patients not responding to medical management were referred for balloon dilation of the coarcted segment., Results: Among 113 and 181 neonates, respectively, treated during the 2 periods, 40 and 36 had left ventricular dysfunction (p less than 0.01), and 11 and 23 had multiorgan failure (p less than 0.01). Prior to 2004, 6 deaths occurred before surgery. After 2004, 3 out of 14 patients (21%) treated by balloon angioplasty died in consequence of the procedure.During the period of the study, the global mortality of patients with left ventricular dysfunction diminished from 17.5 to 13.8%, this difference not being statistically significant. Mortality due to multiorgan failure, however, diminished from 54 to 13% (p less than 0.01). Multiorgan failure was reversed under medical treatment in 45% of patients, but in 87% under the regime of medical combined with interventional treatment (p less than 0.01)., Conclusions: To the best of our knowledge, this is the first series of neonates with aortic coarctation and multiorgan failure receiving a palliative treatment by balloon dilation. Although the prognosis of this condition remains severe, emergency balloon dilation can diminish mortality, providing a bridge to surgery in severely ill patients.

The advances of surgical and interventional treatment of congenital heart diseases have allowed a large number of patients with congenital heart disease to reach adult age. This population involves almost 0.3/1000 of total population in West Europe and North America and can be estimated around 200000 patients in France. Patients with operated Tetralogy of Fallot, benign forms of pulmonary atresia with ventricular septal defect, simple or complex transposition of the great arteries usually survive beyond childhood. These patients can need repeated interventions to treat lesions of native or reconstructed pulmonary arteries and/or aortic arch, to occlude residual shunts, to treat pulmonary incompetence. More complex heart diseases such as single ventricle, rarely allow survival until the adult age. The majority of these patients undergo heart transplant, often made difficult by multiple cardiac surgeries, anomalies of pulmonary arteries, chronic cyanosis, aorto-pulmonary shunts. Patients with relatively simple or complex congenital heart diseases need to be followed-up in specialized units, like those created more than twenty years ago in the United States, Canada, and United Kingdom. Interventional cardiac catheterisation play a major role in the management of this population. The results of 3 years of activity in a new centre treating GUCH patients are illustrated.