Lympho-hematopoietic malignancies risk after exposure to low dose ionizing radiation during cardiac catheterization in childhood.

Pediatric patients with congenital heart disease (CHD) often undergo low dose ionizing radiation (LDIR) from cardiac catheterization (CC) for the diagnosis and/or treatment of their disease. Although radiation doses from a single CC are usually low, less is known about the long-term radiation associated cancer risks. We aimed to assess the risk of lympho-hematopoietic malignancies in pediatric CHD patients diagnosed or treated with CC. A French cohort of 17,104 children free of cancer who had undergone a first CC from 01/01/2000 to 31/12/2013, before the age of 16 was set up. The follow-up started at the date of the first recorded CC until the exit date, i.e., the date of death, the date of first cancer diagnosis, the date of the 18th birthday, or the 31/12/2015, whichever occurred first. Poisson regression was used to estimate the LDIR associated cancer risk. The median follow-up was 5.9 years, with 110,335 person-years. There were 22,227 CC procedures, yielding an individual active bone marrow (ABM) mean cumulative dose of 3.0 milligray (mGy). Thirty-eight incident lympho-hematopoietic malignancies were observed. When adjusting for attained age, gender and predisposing factors to cancer status, no increased risk was observed for lympho-hematopoietic malignancies RR/mGy = 1.00 (95% CI: 0.88; 1.10). In summary, the risk of lympho-hematopoietic malignancies and lymphoma was not associated to LDIR in pediatric patients with CHD who undergo CC. Further epidemiological studies with greater statistical power are needed to improve the assessment of the dose-risk relationship.

Prevalence and Associated Factors of Long-term Growth Failure in Infants with Congenital Heart Disease Who Underwent Cardiac Surgery Before the Age of One.

Long-term growth failure can have negative impact on health (by increasing morbidity and mortality) and on neurodevelopmental outcomes. Its prevalence among children with congenital heart disease (CHD) is not well described. The aim of our study was to evaluate the prevalence of growth failure in a population of infants with CHD away from cardiac surgery and identify associated factors. We conducted a retrospective and multicentric study that included infants from the North of France who underwent cardiac surgery before the age of one, between January 2013 and December 2017. 331 infants were included among which 48% had a prenatal diagnosis, 15% had a genetic syndrome, and 15% were premature infants. Mean birth weight was 3 ± 0.6 kg. At surgery, 35% presented feeding difficulties (need for enriched formula and/or feeding tube) and 14% had growth failure (defined by Z-score weight for age < -2SD). 6-12 months after surgery, 16% still presented growth failure. Several associated factors were identified: prenatal diagnosis, genetic syndrome association, birth weight ≤ 3 kg, complex CHD (≥ 2 significative lesions, or double outlet right ventricle or single ventricle physiology), surgery after 30 days, and need for diuretic drug before surgery and/or still needed 1 month after surgery. Growth failure persists between 6 and 12 months after surgery in 16% of infants with CHD. More studies are needed to link growth failure and neurodevelopment, which is the new challenge for this aging population.

Exposure to low-dose ionising radiation from cardiac catheterisation and risk of cancer: the COCCINELLE study cohort profile.

PURPOSE: The COCCINELLE study is a nationwide retrospective French cohort set up to evaluate the risk of cancer in patients who undergone cardiac catheterisation (CC) procedures for diagnosis or treatment of congenital heart disease during childhood. PARTICIPANTS: Children who undergone CC procedures from 1 January 2000 to 31 December 2013, before the age of 16 in one of the 15 paediatric cardiology departments which perform paediatric CC in mainland France were included. The follow-up started at the date of the first recorded CC procedure until the exit date, that is, the date of death, the date of first cancer diagnosis, the date of the 18th birthday or the 31 December 2015, whichever occurred first. The cohort was linked to the National Childhood Cancer Registry to identify patients diagnosed with cancer and with the French National Directory for the Identification of Natural Persons to retrieve the patients' vital status. FINDINGS TO DATE: A total of 17 104 children were included in the cohort and followed for 110 335 person-years, with 22 227 CC procedures collected. Among the patients, 81.6% received only one procedure. Fifty-nine cancer cases were observed in the cohort. Standardised incidence ratios (SIRs) were increased for all-cancer (SIR=3.8, 95% CI: 2.9 to 4.9), leukaemia (SIR=3.3, 95% CI: 2.0 to 5.4), lymphoma (SIR=14.9, 95% CI: 9.9 to 22.5) and solid cancers excluding central nervous system (CNS) tumours (SIR=3.3, 95% CI: 2.0 to 5.5) compared with the general population. FUTURE PLANS: Dose reconstruction is currently underway to estimate individual cumulative doses absorbed to relevant organs, including red bone marrow and brain for respectively haematologic disorders and CNS tumours risk estimation. A dose-response analysis will be conducted with consideration to confounding factors such as age at exposure, gender, predisposing factors to cancer and other sources of medical diagnostic low-dose ionising radiation.

Preventing the risk of coronary injury in posteroseptal accessory pathway ablation in children: different strategies and advantages of fluoroscopy integrated 3D-mapping system (CARTO-UNIVU™).

PURPOSE: To evaluate various strategies in order to minimize the risk of coronary injury during posteroseptal accessory pathways ablation in children. METHODS: We retrospectively reviewed 68 posteroseptal accessory pathways ablation procedures (20 decremental and 48 typical accessory pathways) performed in 62 pediatric patients at our institution between July 2009 and December 2016. Only posteroseptal accessory pathways targeted near or within the coronary sinus were included and ablation was mostly performed using irrigated tip radiofrequency. RESULTS: Median patient age was 11 years with a median body weight of 39 kg. Thirty patients underwent a coronary angiogram, 21 were coupled to the 3D navigation system CARTO-UNIVU™. The coronary angiogram showed a distance of less than 5 mm between the coronary artery and the ablation site in 40% of our cases; 3 patients had a coronary injury related to RF ablation, 6 patients were switched for cryoablation, 3 patients received limited RF energy (20 W). There were no demographic data predicting the proximity of the coronary artery to the ablation site. CONCLUSION: Ablation of posteroseptal accessory pathways specifically in children carries a risk of coronary artery injury which is probably underestimated. The use of merged 3D images and coronary angiograms, the reduction of RF energy or the switch to cryoablation are possible alternatives to limit the risk of coronary injury.

French national survey on infective endocarditis and the Melody™ valve in percutaneous pulmonary valve implantation.

BACKGROUND: Percutaneous pulmonary valve implantation (PPVI) is a routine treatment for dysfunctional right ventricular outflow tract. Infective endocarditis (IE) is a major concern. AIM: To report French experience with the Melody™ valve (Medtronic Inc., Minneapolis, MN, USA). METHODS: All patients who underwent PPVI were recorded in a multicentre French national survey. Demographic and procedural data were collected from patients with IE. Bacterial identification, diagnostic tools and outcome were recorded. RESULTS: Forty-five cases of IE were diagnosed in 43 patients. The cumulative IE incidence was 11.8% (95% confidence interval [CI] 8.5-15.9). The annualized IE incidence was 3.6% (95% CI 0-4.8). Freedom from IE was 96.3% and 85.8% at 12 months and 60 months, respectively. IE incidence did not change during the study period. The mean interval between PPVI and IE was 2.6±2.1 years (range, 5 days to 7.3 years). Fifteen patients with IE required intravenous antibiotics only. Seven patients had early interventional cardiac catheterization to relieve severe right ventricular outflow tract obstruction. Twenty-four patients had surgical valve replacement (six urgently; nine semi-urgently; nine electively). Staphylococcus aureus IE required surgery in all but one patient. Three patients died before any treatment. Three additional patients died, giving a mortality rate of 14%. Global survival in the total cohort of patients who received a Melody valve was excellent (96.5% at 5 years). When comparing survival curves between the IE and non-IE groups, death and cardiovascular events were statistically significantly higher in the IE group (log-rank P<0.0001). CONCLUSION: Melody valve IE is a severe complication following PPVI. The annualized IE incidence in this cohort was similar to rates reported in other studies. With rapid diagnosis and adequate treatment, outcome has improved, and unfavourable outcome is mainly associated with S. aureus.

Percutaneous coronary artery interventions in the paediatric population: Periprocedural and late outcome.

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.

Short and long-term outcomes of alcohol septal ablation with the trans-radial versus the trans-femoral approach: A single center-experience.

BACKGROUND: Although the trans-radial approach (TR) has been applied to various subsets of patients in percutaneous coronary intervention, the feasibility, efficacy, acute procedural and long-term outcomes of TR versus trans-femoral approach (TF) for alcohol septal ablation (ASA) have not yet been determined. OBJECTIVES: The aim of this study was to compare the short and long-term outcomes of ASA with the TR approach compared to the TF approach. METHODS: We retrospectively analyzed 240 patients who underwent an ASA procedure at our institution from November 1999 to November 2015. The TR approach was performed in 172 cases and the TF approach in the remaining 68 cases. RESULTS: The use of TR approach progressively increased from 62% in 1999-2005 to 91% in 2011-2015 (p=0.0001). The TF and TR group had similar age, baseline NYHA class (NYHA 3 or 4) and mean left ventricular outflow tract peak gradient before ASA. Total contrast used (TR: 73.2±47.2ml; TF: 88.7±49.3ml, p=0.11), total radiation Air kerma area product (TR: 43.7±48.0Gycm(-2); TF: 55.9±48.2Gycm(-2); p=0.39) and peak left ventricular outflow tract gradient immediately after ASA (TR: 19.1±19.6mmHg; TF: 20.4±18.0mmHg, p=0.63) were similar in both groups. Procedural success was 91.9% and 91.2% in the TR and TF groups, respectively (p=0.53). At 30days, there was 2 intra-hospital death (1 in TF and 1 in TR), 1 major stroke in the TF group and 1 coronary artery dissection in the TR group. Vascular complications were less frequent in the TR group (0.58% vs. 7.3%; p=0.002). The mean length of follow-up was 4.56±4.34years (IQR 0.69-8.2; median 2.92years; maximum: 15.5years). By Kaplan-Meier estimate, the observed survival in the overall cohort was comparable to the expected survival for a sex and age-matched comparable general French population at 10years (86.9 vs. 83.6%, p=0.88). Survival was similar between the TR and TF group (92.1% vs. 89.7% at 6years, respectively; p=0.71). CONCLUSIONS: Alcohol septal ablation from the radial approach can be performed with similar acute and long-term success, but with lower vascular complications compared to the femoral approach.

Stenting in paediatric and adult congenital heart diseases: A French multicentre study in the current era.

BACKGROUND: Many stents are used "off-label" during the management of congenital heart diseases (CHD). AIMS: To describe indications for, results of, and adverse events associated with stenting in CHD in current practice. METHODS: Participation in this study was proposed to all catheterization laboratories that specialize in CHD in France (M3C network). All paediatric and adult CHD cases with stent implantation in 2013 were included retrospectively. RESULTS: Overall, 207 stents were implanted in 151 patients across 11 centres. Median age was 13.7 years (range, 5 days to 70.1 years). Main procedure indications were branch pulmonary artery angioplasty (n=46, 29.1%), aortic (re)coarctation stenting (n=43, 27.2%), percutaneous pulmonary valve implantation (n=32, 20.2%) and ductus arteriosus stenting (n=14, 8.9%). The main stents implanted were the CP Stent™ (n=61, 29.5%), the Max™ LD stent (n=43, 20.8%), the Valeo(®) stent (n=28, 13.5%) and valved stents (n=30, 14.5%). Procedures were considered successful in 96.8% of cases (95% confidence interval [CI] 92.8-99.0%). Adverse events were observed in 23 procedures (14.7%, 95% CI 9.5-21.0%). Ductus arteriosus stenting (odds ratio 12.4, 95% CI 2.0-77.5; P<0.01) and pulmonary revalvulation (odds ratio 5.9, 95% CI 1.1-32.3; P=0.04) were risk markers for stent-related adverse events. CONCLUSIONS: Stents are used in various CHD catheterization procedures, from infancy to adult age. The adverse events rate is significant and is related to the type of procedure.

Melody ® transcatheter pulmonary valve implantation: results from a French registry.

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.

Safety and performance of the Spider™ patent foramen ovale occluder.

OBJECTIVES: The aim of this clinical trial was to assess safety, efficacy, and technical handling of a novel ceramic-coated double-disc patent foramen ovale (PFO) occluder. BACKGROUND: Though percutaneous PFO closure is performed with increasing frequency worldwide, certain risks such as thrombus formation and incomplete endothelialization remain. The Spider™ PFO occluder was designed to minimize these risks. METHODS: The Spider™ PFO occluder is a self-expandable double-disc device with a ceramic coated nitinol wire mesh and an integrated expanded polytetrafluoroethylene (ePTFE) membrane on the right atrial side and ceramic coated nitinol anchors and ePTFE patch on the left atrial side. Study patient assessments were conducted at baseline, periprocedure, and discharge and at 1-, 6- and 12-month follow-up. RESULTS: Fifty-one patients (mean age 52 ± 14 years; 63% male) were enrolled in the prospective, multicenter clinical trial. Implantation was successful in all patients. Mean procedural time was 30.0 ± 8.6 min. No periprocedural or in-hospital complications occurred. Four patients (8%) had paroxysmal atrial fibrillation (AF) at 1-month follow-up. Otherwise, no procedure or device related adverse events occurred. Importantly, there were no recurrent embolic events. At 1-month follow-up 63% (32/51) of patients had no residual shunt with contrast transesophageal echocardiography during Valsalva maneuver. Of all patients who underwent 6-month echo follow-up to date, 78% (39/50) had no residual shunt during Valsalva maneuver. CONCLUSION: Initial results with the novel Spider™ PFO occluder show that the device is safe and easy to use for percutaneous closure of PFO. The overall complication rate was low. The rate of AF needs further investigation.

Assessment of left ventricular ejection fraction using the wall motion score index in cardiac magnetic resonance imaging.

BACKGROUND: Left ventricular ejection fraction (LVEF) is an important indicator of left ventricular function and of the severity and prognosis of ischaemic heart disease. Assessment of regional function using the wall motion score index (WMSI) is an alternative means of evaluating left ventricular function. AIM: We attempted to evaluate LVEF by a method using the WMSI with cardiac magnetic resonance imaging (MRI). METHODS: One hundred and twenty-two patients referred for evaluation of heart disease had rest WMSI evaluation by cardiac MRI. The WMSI was evaluated using the 16-segment model and score proposed by the American Society of Echocardiography. In our first group of 80 patients, a correlation between WMSI and cardiac MRI LVEF was established and a regression equation was derived. This regression equation was then used in 42 consecutive patients to compare WMSI LVEF with the gold standard MRI LVEF. RESULTS: In the first 80 patients, MRI LVEF and WMSI correlated very well (r=0.93). Similarly, in the second group of 42 patients, WMSI LVEF derived from the regression equation correlated very well with MRI LVEF (r=0.94). CONCLUSION: An objective evaluation of LVEF can be easily made using the WMSI with cardiac MRI, which correlates very well with standard MRI planimetric methods.

PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in non-anticoagulation eligible atrial fibrillation patients: results from the European PLAATO study.

AIMS: The European PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) study was performed to determine the safety and efficacy of left atrial appendage occlusion by catheter technique. Embolic stroke due to atrial fibrillation is a common observation, especially in the elderly. Most thrombi in atrial fibrillation form in the left atrial appendage (LAA), its occlusion may therefore reduce the incidence of stroke in these patients. METHODS AND RESULTS: One hundred and eighty patients with non-rheumatic atrial fibrillation and contraindication to warfarin therapy were enrolled in the PLAATO study. Patients were eligible if they had a?history of transient ischaemic attack (TIA) or stroke or at least two independent risk factors for stroke such as age > or =75 years, hypertension, congestive heart failure or diabetes. The primary endpoint was LAA closure as determined by transesophageal echocardiography (TEE) two months after the procedure and stroke rate at 150 patient years. Left atrial appendage occlusion was successful in 162/180 patients (90%, 95% CI 83.1% to 92.9%). Two patients died within 24 hours of the procedure (1.1%, 95% CI 0.3% to 4%). Six cardiac tamponades were observed (3.3%, 95% CI 1.5% to 7.1%). In two cases, surgical drainage of the tamponade was necessary (1.1%, 95% CI 0.3% to 4%). In one patient, the device that was chosen was too small and embolised into the aorta after its release (0.6%, 95% CI 0.1% to 3.1%). It was snared and replaced without further complications. Successful occlusion of the LAA was achieved in 126/ 140 (90%, 95% CI 83.5% to 94.2%) of patients as noted by TEE at the two months follow-up. In a follow-up time of 129 documented patient years, three strokes occurred (2.3% per year). The expected incidence of stroke according to the CHADS2-Score was 6.6% per year. The trial was halted prematurely during the follow-up phase for financial considerations. CONCLUSIONS: Left atrial appendage closure is relatively safe and effective. However, severe complications can occur. It might become an alternative for atrial fibrillation patients who are ineligible for long-term anticoagulation therapy.

Significant persistent ductus arteriosus in infants less or equal to 6 kg: percutaneous closure or surgery?

BACKGROUND: Percutaneous closure of large persistent ductus arteriosus using the Amplatzer duct occluder is an alternative to surgery. However, this device is not recommended in infants weighing less than 6 kg. AIM: To evaluate the safety and effectiveness of this procedure in low-body-weight infants. METHODS: We reviewed retrospectively data for infants weighing less or equal to 6 kg who underwent percutaneous closure of significant persistent ductus arteriosus using the Amplatzer duct occluder in France between 1998 and 2007. RESULTS: Data for 58 patients (mean weight: 5 kg, range: 3.4-6; mean age: 5.5 months, range: 2.1-15.3) were reviewed. Mean angiographic persistent ductus arteriosus minimal diameter was 3.7 mm (range: 1-7.5). Implantation of the Amplatzer duct occluder was successful in 89.7% of cases. In six (10.3%) patients, the device was not implanted because it would have led to significant aortic obstruction. One procedure-related death occurred in a 4 kg infant (1.7%). Major and minor complications occurred in 6.9 and 31.0% of patients, respectively. Persistent ductus arteriosus diameter greater than 3.7 mm, type C (tubular shape) and diameter/patient weight ratio greater than 0.91 were significantly associated with an unsuccessful procedure and/or major complications. During a median 10-month follow-up, no late device embolization occurred. CONCLUSIONS: Although percutaneous closure of significant persistent ductus arteriosus with the Amplatzer duct occluder is effective in low-body-weight infants, the level and severity of complications indicate surgery as first-line treatment, at least until further studies are done to assess the safety and effectiveness of the new Amplatzer duct occluder II in low-body-weight infants.

Transcatheter closure of patent foramen ovale with radiofrequency: acute and intermediate term results in 144 patients.

AIMS: Currently available devices for transcatheter closure of patent foramen ovale (PFO) which rely on a permanent implant have limitations, including late complications. The study objective was to evaluate the safety, feasibility, and effectiveness of the PFx Closure System, the first transcatheter technique for PFO closure without an implantable device. METHODS AND RESULTS: A prospective study of 144 patients was conducted at nine clinical sites from October 2005 through August 2007. All patients had a history of cryptogenic stroke, transient ischemic attack, migraines, or decompression illness. The mean balloon stretched diameter of the PFO was 7.9 +/- 2.5 mm. Technical success (successful application of radiofrequency energy) was achieved in 130 patients. One patient required a transfusion as a result of blood loss during the procedure. There were no other major procedural complications. There were no recurrent strokes, deaths, conduction abnormalities, or perforations following the procedure. At a mean follow-up of 6 months, successful closure was achieved in 79 patients (55%). In PFOs with balloon sized or stretched diameters less than 8 mm, the closure rate was 72% (53/74). CONCLUSION: This study demonstrates that transcatheter closure of a PFO without a permanent implant is technically feasible and safe. Further technique and device modifications are required to achieve higher closure rates.

Efficiency of transcatheter closure of atrial septal defects in small and symptomatic children.

OBJECTIVES: We report the multicentric French experience with transcatheter closure in children weighing 15 kilograms or less, with the aim of assessing the efficacy of the procedure in this age group. PATIENTS: We included all children weighing 15 kilograms or less, and seen between January, 1997, and June, 2004, who had successful transcatheter closure of an interatrial communication within the oval fossa. RESULTS: Transcatheter closure was performed in 35 patients weighing 15 kilograms or less, of whom 14 were male and 21 female. The procedures were undertaken in 8 different centres, the patients having a median age of 3 years, with a range from zero to 6.2 years, and a mean weight of 13 kilograms, with a range from 3.6 to 15 kilograms. All the patients were symptomatic, with associated cardiac malformations present in 4 cases, and extracardiac anomalies in 4 patients, including Down's syndrome in 3, and Adams Oliver syndrome in the other case. In 1 patient, emergency cardiac surgery was needed 24 h after the procedure to correct a previously undiagnosed divided right atrium. No other complication occurred. After a median follow-up of 2 years, with a range from 0.5 to 5.2 years, all the patients are asymptomatic, except for one long-standing patient with bronchodysplasia. In 1 other patient, a small residual bidirectional shunt was detected by echocardiography. No patient presented significant arrhythmia. In the patients followed-up for more than 12 months, we found a significant gain in weight gain. CONCLUSION: Transcatheter closure of an interatrial communication within the oval fossa is efficient in children weighing 15 kilograms or less, and can be proposed as a first line of treatment in symptomatic patients. Children with retarded growth tend to have complete recovery within one year of closure.

Transcatheter closure of congenital ventricular septal defects: results of the European Registry.

AIM: To report the experience of 23 tertiary referral European Centres on transcatheter closure of congenital ventricular septal defects (VSD). METHODS AND RESULTS: Implantation of transcatheter devices was attempted in 430 patients (pts) with congenital VSDs until July 2005. The following anatomic types were present: 119 muscular, 250 perimembranous, 16 multiple, 45 residual post-surgery. Median VSD size was 7 mm (range 3-22), fluoroscopy time 33 min (range 3-146). Devices implanted were Amplatzer muscular or membranous devices in 364, PDA devices in 12, ASD devices in seven, Starflex in seven, and coils in nine patients. Procedure was successful in 410 cases (95%). COMPLICATIONS: device embolization in five cases (surgery in two, catheter retrieval in three), aortic regurgitation in 14 cases (two of which requiring surgery), tricuspid regurgitation in 27 cases (no surgery was necessary), minor rhythm disturbances in 10 pts, death in one patient, complete heart block (cAVB) in 16 pts [perimembranous 12 of 250 (5%), muscular one of 119 (0.8%), residual post-surgery VSD three of 45 (6.7%)]. CAVB was transient in six patients, requiring permanent pace-makers in 10 cases (3.8%) (six early, four late). In the multivariate analysis, the only variable associated with a risk of the occurrence of complication was age (P=0.012) and weight (P=0.0035). In the univariate analysis, risk factors for the development of cAVB were, device type (P=0.03) and VSD location (P=0.05). After the multivariable Cox proportional hazards analysis, no risk factor was found. CONCLUSION: Transcatheter closure of congenital VSDs offers encouraging results. COMPLICATIONS are limited; the most relevant one seems to be the device related to cAVB in perimembranous VSD. More experience and long-term follow-up are mandatory to assess safety and effectiveness of this procedure as an alternative to conventional surgery.