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Background: Transcatheter closure of atrial septal defect (ASD) has become the treatment of choice for most patients. About 5% of them suffer from transient headache episodes (THE) after the procedure, whose etiology is unclear., Aims: To evaluate risk factors for THE occurrence after transcatheter closure of ASD in the pediatric population., Methods: Eight hundred and forty patients, after transcatheter ASD closure with nitinol devices, from a single center, were included in retrospective analysis. THE was defined as occurring up to 24 hours after the procedure. A logistic regression model including age, weight, ASD diameter, device size, presence of nitinol coating on the device, fluoroscopy time, application of balloon calibration, device oversizing, and residual shunt after 24 hours was created to evaluate risk factors for THE occurrence., Results: There were 40 patients with THE (4.8%), 70% female and 30% male. The median age was 13 (7.35-16) years. In patients with headache, balloon calibration (BC) was performed more frequently (82.5% vs. 43.3%; P <0.001). The balloon waist median (interquartile range [IQR]), 19 (16-22) mm vs. 15 mm (12-18) mm (P <0.001), and device size median (IQR), 18 (13.5-22) mm vs. 14 (11-17) mm (P <0.001) were larger, and residual shunt after 24 hours (12.5% vs. 4.9%; P = 0.03) and a year (7.5 vs. 1.0%; P <0.001) were more frequent. ASD size and the prevalence of double/multiple ASD were similar in both groups. Age, BC application, no nickel release protection, duration of fluoroscopy, and device oversizing were predictors of THE (P <0.001)., Conclusions: BC during percutaneous ASD closure and the lack of a protective layer against nickel release on the device are risk factors for headache occurrence in the early postprocedural period.

Background: Atrial septal defect (ASD) type 2, according to current standards, is closed percutaneously usually after the child has reached the age of four to five years. There are limited data regarding such treatment in younger infants., Aim: We sought to evaluate the feasibility, safety, and efficacy of percutaneous ASD closure in children under three years of age., Methods: The research group consisted of 157 children less than three years old with haemodynamically significant ASD, who underwent effective transcatheter ASD closure in a single tertiary centre between 1999 and 2014. The mean procedural age of the treated children was 2.2 years and mean weight was 12.5 kg. In all cases nitinol wire mesh devices were applied (mostly Amplatzer Septal Occluders). ASD was closed using standard technique (except a few cases wherein the left disc of the implant was inserted initially into the right pulmonary vein to prevent oblique position of the device). Procedure-related complications were divided into major and minor ones., Results: Atrial septal defect was closed in 149 children: 97 with a single ASD and 52 with double/multiple ASD. The procedure was abandoned in eight patients (three with single and five with double/multiple ASD). No death or implant embolisation occurred during the procedure or follow-up, and there was one case of major postprocedural complications. Normalisation of the right ventricular diameter occurred in all patients during one-year follow-up. In the majority of children acceleration of physical development and resolution of accompanying morbidity were observed in follow-up., Conclusions: Percutaneous ASD closure can be performed safely in children under three years of age with low risk of peri- or postprocedural complications.

Background: Transcatheter closure of atrial septal defect (ASD) in older children and adults is currently considered the first-choice therapeutic option. This approach remains challenging in younger children. The aim of the study was to evaluate feasibility, safety and midterm efficacy of percutaneous ASD closure in symptomatic infants ≤10 kg body weight in our institution., Methods: There were 28 children up to 10 kg of body weight, who were qualified for transcatheter closure of ASD. All patients but one showed overload of right atrium and right ventricle. Mean weight of patients who underwent transcatheter closure was 9.2 ± 0.88 kg and age 1.59 ± 0.58 years, respectively. Transcatheter closure of ASD was conducted using Amplatzer occluders (ASO)., Results: The devices were implanted successfully in 26/28 patients (93%). In 2 (7%) children the device repeatedly straddled the septum in relatively big ASD and the procedure was abandoned. Mean ASD diameter in patients, who underwent transcatheter closure, was 9.08 ± 2.9 mm (transthoracic echocardiography) and mean implant size/weight ratio was 1.07 ± 0.31. In the child with right-left shunt through ASD normalization of saturation occurred. Mean fluoroscopy time was 4.16 min. In 3 children minor complications occurred: transient arrhythmias (n = 1), fever after procedure (n = 2). The follow-up time was 6.1 (range 1.2-11) years. At follow-up, clinical condition and/or growth improved in all patients except 4 children with coexisting comorbidity. No arrhythmia nor conduction disturbances were observed during follow-up., Conclusions: In selected patients weighing less or equal to 10 kg, percutaneous closure of ASD is a safe and effective procedure.

Atrial septal defect (ASD) was closed percutaneously in an 18-year-old boy with a 27 mm nitinol wire mesh occluder according to standard procedures. Three hours after the procedure, he presented anxiety attacks, aggression, a vacant stare and a verbal/speaking disorder. Small ischaemic stroke localised in the right temporal/parietal region of the central nervous system was confirmed by computed tomography examination. Activated partial thromboplastin time was then 54 s despite continuous heparin infusion. Heparin dose was increased and symptomatic treatment was introduced (mannitol, furosemide, propofol, haloperidol). The next day, all symptoms disappeared. He remained in good clinical condition, without neurological disorders 1.5 months after the procedure. Complications related to transcatheter ASD closure still exist despite the fulfillment of standard procedural criteria. Frequent coagulogical examinations during and after the procedure are necessary. Close observation and follow-up of treated patients is mandatory.

Background: Transcatheter treatment has become the method of choice for treating many heart defects. Recently, Cardio-O-Fix occluder (COF) - a new, self-expandable nitinol wire-mesh device very similar to the Amplatzer device - has been introduced into clinical practice. To the best of our knowledge, this is the first publication related to its application., Methods: Five patients aged from six months to 69 years were included in the study: two with atrial septal defect (ASD), one with patent foramen ovale (PFO) after cryptogenic stroke, and two with patent ductus arteriosus (PDA). These latter two comprised one six month old infant with co-existent hypertrophied cardiomyopathy, and a 53 year-old woman with recanalized PDA after previous ligation. All were treated percutaneously with COF. There was no preliminary patient selection. The only limitation was the size of the devices in our possession (16 and 22 mm ASD COF, 25 PFO COF, 4/6 and 6/8 PDA COF). The implantation technique was the same as previously described for Amplatzer occluders., Results: All procedures were finished successfully with complete closure of the shunt. No complications were observed during a six month follow-up. In the child with PDA, we observed decrease of gradient from 80 to 60 mm Hg in hypertrophied left ventricular outflow tract, although a small protrusion of PDA-COF device was noted in the descending aorta (8 mm Hg gradient in ECHO). In the patient with recanalized PDA, the procedure was performed after arterio-venous loop creation. Mean fluoroscopy time was 4.4 (range from 1.6 to 11) minutes., Conclusions: Our preliminary experience indicates that the application of Cardio-O-Fix devices is safe and effective.