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Background: The Amplatzer™ Trevisio™ Intravascular Delivery System (Trevisio DS; Abbott Laboratories, Chicago, IL, USA) facilitates the delivery of Amplatzer™ Occluders and features an ultraflexible tip, which improves assessment of occluder position before release., Aims: To assess the safety and efficacy of the Trevisio DS for transcatheter closure of patent foramen ovale and atrial septal defect., Methods: The Amplatzer™ Trevisio™ Intravascular Delivery System Post-Approval Study was a prospective, postmarket, single-arm, multicentre, observational study of the Trevisio DS. Enrolled patients were indicated for transcatheter closure of patent foramen ovale or atrial septal defect. In all procedures, the Trevisio DS was used to deliver Amplatzer™ Occluders. Technical success was defined as successful deployment and release of at least one occluder. Device- or procedure-related serious adverse events were tracked until discharge or day 7, whichever occurred earlier., Results: The study enrolled 144 patients with patent foramen ovale and 107 patients with atrial septal defect at 22 European sites; 53 patients with atrial septal defect (49.6%) were aged<18years. The rate of technical success was 98.4% (97.2% for atrial septal defect, 99.3% for patent foramen ovale). There was one serious adverse event (0.4%), an acute periprocedural device embolization that occurred after occluder release in a patient with atrial septal defect; the device was retrieved percutaneously. This was determined by the implanter to be unrelated to the performance of the Trevisio DS., Conclusions: The Trevisio DS exhibited a high rate of technical success and an excellent safety profile during transcatheter closure of patent foramen ovale and atrial septal defect., (Copyright © 2023 Abbott Laboratories. Published by Elsevier Masson SAS.. All rights reserved.)

Stroke remains one of the greatest health challenges worldwide, due to a high mortality rate and, despite great progress in its treatment, the significant disability that it causes. Studies conducted around the world show that the diagnosis of stroke in children is often significantly delayed. Paediatric ischaemic arterial stroke (PAIS) is not only a problem that varies greatly in frequency compared to the adult population, it is also completely different in terms of its risk factors, clinical course and outcome. The main reason for the lack of a rapid diagnosis of PAIS is a lack of access to neuroimaging under general anaesthesia. The insufficient knowledge regarding PAIS in society as a whole is also of great importance. Parents and carers of children should always bear in mind that paediatric age is not a factor that excludes a diagnosis of stroke. The aim of this article was to develop recommendations for the management of children with acute neurological symptoms suspected of ischaemic stroke and further treatment after confirmation of the ischaemic aetiology of the problem. These recommendations are based on current global recommendations for the management of children with stroke, but our goal was also to match them as closely as possible to the needs and technical diagnostic and therapeutic possibilities encountered in Poland. Due to the multifactorial problem of stroke in children, not only paediatric neurologists but also a neurologist, a paediatric cardiologist, a paediatric haematologist and a radiologist took part in the preparation of these recommendations.

Background: Despite extensive knowledge about the quality of life of people suffering from rare diseases, data on patients with Marfan syndrome (MFS) are scarce and inconsistent. Hence, the problem of assessing the quality of life (QOL) and its relationship with the assessment of which ailments are the most burdensome for these patients is still open. Aim: Comparison of the quality of life of patients with MFS and determination as to which of the reported complaints in patients with MFS are related to the QOL of patients. Methods: The study included 35 patients with MFS and 35 healthy controls, matched for gender and age. In the study, the questionnaire of quality of life assessment SF-36 was used to assess the level of health-related quality of life, as well as an interview of the most severe symptoms reported by patients with MFS. Results: The level of the physical dimension of the QOL (p < 0.001) and limiting of roles due to physical health (p = 0.002), as well as the level of general index of the QOL (p < 0.001), were statistically significantly lower in MFS patients when compared to controls. People from both studied groups do not vary in the scope of pain, vitality, social functioning, limiting the roles due to emotional problems, and state of mind but also in the mental dimension of the health-related quality of life (HRQL). Additionally, there has been a correlation between HRQL and the subjective assessment of the effects of orthopedic, ophthalmic, and cardiological problems in life, as well as lower exercise tolerance in the evaluation of people with MFS and QOL in most areas. Conclusions: Patients with MFS present a reduced QOL in the areas of physical functioning, limiting roles due to physical health, general feeling of general health, the physical dimension of the HRQL, and the general index of the QOL; in these areas, they require careful evaluation, as well as medical and psychosocial assistance.

Competing Interests: The authors declare no conflict of interest.

Restrictive cardiomyopathy (RCM) has a poor prognosis and limited treatment options apart from heart transplantation (HTx). We report on the first-in-human interventional atrial flow regulator (AFR) implantations in 3 children with RCM, leading to marked clinical and hemodynamic improvement. We propose the AFR as bridge to HTx or destination therapy in RCM. ( Level of Difficulty: Advanced. )., Competing Interests: This report was funded by a grant from the German Research Foundation (DFG KFO311, HA4348/6-2 to Dr Hansmann). Dr. Hansmann has received funding from the Federal Ministry of Education and Research (BMBF; 01KC2001B, 03VP08053) and the European Pediatric Pulmonary Vascular Disease Network (www.pvdnetwork.org). Dr. Sabiniewicz is a consultant for Occlutech, the producer of the atrial flow regulator device. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2022 The Authors.)

As a result of the COVID-19 pandemic, telemedicine has become an important branch of healthcare worldwide. Apart from their undeniable advantages, the virtual visits lack physical examination, which can lead to important diagnostic mistakes. We hereby present a case of a pediatric patient whose weight gain, initially attributed to a sedentary lifestyle was, in fact, due to sub-acute right heart failure in the context of a ruptured sinus of Valsalva aneurysm. The condition was not diagnosed until the patient presented at the emergency. The boy was successfully treated with two percutaneous interventions and returned to his previous stature., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Sabiniewicz, Lubocka and Sabiniewicz.)

Medicine is a rapidly-evolving discipline, with progress picking up pace with each passing decade. This constant evolution results in the introduction of new tools and methods, which in turn occasionally leads to paradigm shifts across the affected medical fields. The following review attempts to showcase how 3D printing has begun to reshape and improve processes across various medical specialties and where it has the potential to make a significant impact. The current state-of-the-art, as well as real-life clinical applications of 3D printing, are reflected in the perspectives of specialists practicing in the selected disciplines, with a focus on pre-procedural planning, simulation (rehearsal) of non-routine procedures, and on medical education and training. A review of the latest multidisciplinary literature on the subject offers a general summary of the advances enabled by 3D printing. Numerous advantages and applications were found, such as gaining better insight into patient-specific anatomy, better pre-operative planning, mock simulated surgeries, simulation-based training and education, development of surgical guides and other tools, patient-specific implants, bioprinted organs or structures, and counseling of patients. It was evident that pre-procedural planning and rehearsing of unusual or difficult procedures and training of medical professionals in these procedures are extremely useful and transformative.

Marfan Syndrome (MFS) is a systemic disorder caused by mutations in fibrillin-1. The most common cause of mortality in MFS is dissection and rupture of the aorta. Due to a highly variable and age-dependent clinical spectrum, the diagnosis of MFS still remains sophisticated. The aim of the study was to determine if there exist phenotypic features that can play the role of "red flags" in cases of MFS suspicion. The study population included 306 patients (199 children and 107 adults) who were referred to the Department of Pediatric Cardiology due to suspicion of MFS. All patients underwent complete clinical evaluation in order to confirm the diagnosis of MFS according to the modified Ghent criteria. MFS was diagnosed in 109 patients and marfanoid habitus in 168 patients. The study excluded 29 patients with other hereditary thoracic aneurysm syndromes. Comparative analysis between patients with Marfan syndrome and marfanoid habitus was performed. Symptoms with high prevalence and high positive likelihood ratio were identified (pectus carinatum, reduced elbow extension, hindfoot deformity, gothic palate, downslanting palpebral fissures, lens subluxation, myopia ≥ 3 dioptres remarkably high stature). The differentiation between patients with MFS and marfanoid body habitus is not possible by only assessing external body features; however, "red flags" could be helpful in the screening phase.

Background: The study was conducted to investigate the implications of anthropometry in school-aged children on the degree of respiratory sinus arrhythmia observed in clinical settings., Methods: In a cohort study, 626 healthy children (52% male) aged 10.8 ± 0.5 years attending primary school in a single town underwent a 12-lead electrocardiogram coupled with measurements of height, weight and blood pressure. Indices of respiratory sinus arrhythmia (pvRSA, RMSSD, RMSSDc) were derived from semi-automatic measurements of RR intervals. Height, weight, BMI, blood pressure as well as waist and hip circumferences were compared between subjects with rhythmic heart rate and respiratory sinus arrhythmia, and correlations between indices of sinus arrhythmia and anthropometry were investigated., Results: Respiratory sinus arrhythmia was recognized in 43% of the participants. Subjects with sinus arrhythmia had lower heart rate ( p < 0.001), weight ( p = 0.009), BMI ( p = 0.005) and systolic ( p = 0.018) and diastolic ( p = 0.004) blood pressure. There were important inverse correlations of heart rate and indices of sinus arrhythmia (r = -0.52 for pvRSA and r = -0.58 for RMSSD), but not the anthropometry., Conclusion: Lower prevalence of respiratory sinus arrhythmia among children with overweight and obesity is a result of higher resting heart rate observed in this population.

Background: In patients following complete repair of the tetralogy of Fallot, the duration of the QRS complex is associated with the size and mechanical function of the right ventricle, which are contemporarily assessed by cardiac magnetic resonance (CMR)., Methods: 38 patients aged 18.0-54.9 years (median age 24.9 years) who had undergone complete repair of the tetralogy of Fallot were examined using CMR and concomitant 24 h ambulatory electrocardiography monitoring. We used statistical analysis to investigate the correlations between electrocardiographic parameters (heart rate, HR; PQ interval, PQ; QRS duration, QRS; and corrected QT interval, QTc) and CMR results (right ventricular ejection fraction, RVEF; right ventricular end-diastolic volume index, RVEDVI; and right ventricular end-systolic volume index, RVESVI) for patients after early and late repair., Results: The ECG-based parameters were not correlated with time since repair. There were significant correlations between QRS duration and RVEF (r = -0.61), RVEDVI (r = 0.56), and RVESVI (r = 0.54) for early operated patients but not for late-operated patients. No other substantial correlations were reported., Conclusion: Despite its role in screening for arrhythmias, electrocardiography has a limited role as a predictor of morphology and function of the right ventricle in patients after repair of the tetralogy of Fallot.

Objectives: The purpose of the study was to analyze the functioning of afamily as perceived by a person with Marfan syndrome and to look for relationships between the characteristics of the system and the overall quality of life of the ill., Methods: Participants included 33 individuals with Marfan syndrome and 33 individuals without chronic illness. We used the Family Evaluation Scale - the Polish adaptation of the FACES-IVby D.H. Olson and the Satisfaction with Life Scale (SWLS) by Diener, Emmons, Larson and Griffin., Results: People with Marfan syndrome perceive their families as significantly less coherent and significantly more disengaged than people without chronic illness. This family system of people with Marfan syndrome can be characterized by low scores on the "Cohesion" and "Flexibility" and high scores on the other four scales showing the level of imbalance of the family as a system, which makes this family profile similar to an ‛unbalanced' system. Life satisfaction of people with Marfan syndrome correlated positively with "Cohesion", "Flexibility" and "Family Satisfaction" as features of family system perceived by them., Conclusions: The obtained results confirm the importance of supporting families of people with Marfan syndrome and specialist help aimed at dealing with emotional burden related to the health of the patient.

Pericarditis is a rare, but severe cause of chest pain in children that can easily be overlooked during routine diagnostics. Fibrinous pericarditis was recognized in a 5-year old patient who presented with fever and chest pain. Despite thorough diagnostics, no evident etiological factor was found. Furthermore, the disease was unresponsive to broad-spectrum antibiotics and NSAIDs, however oral prednisone was found to cause rapid improvement in the patients' condition. It was presumed that the patient's condition was caused by a blunt trauma to the chest experienced 3 days prior to the onset of symptoms. In an 8-month follow-up the patient remains in good overall condition and no recurrences were observed., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Lubocka and Sabiniewicz.)

Background: Respiratory sinus arrhythmia (RSA) is associated with better health in children. Aim: The study was conducted to analyze the trajectory of RSA in 10-year-olds. Methods: A follow-up study on 120 healthy children (62 boys) aged 10.7 ± 0.5 years consisted of a standard 12-lead electrocardiogram, measurements of height, weight and blood pressure. The protocol was repeated after 3 years. Assessment of RSA based on semi-automatic measurements of RR intervals included: the difference between the longest and shortest RR interval duration (pvRSA), the root mean square of differences between successive RR intervals (RMSSD), the standard deviation of the RR interval length (SDNN) and their equivalents corrected for heart rate (RMSSDc and SDNNc). Results: A the first visit 61.7% of children presented with RSA; 51.7% 3 years later. 23.3% of them had RSA only on the first examination; 13.3% only on the second one. The pvRSA, RMSSD, and SDNN measured in 2019 did not differ significantly from their 2016 equivalents ( p > 0.05). The decline in RSA defined by RMSSD was noted in 52.5% of children and in 54.2% when defined by SDNN. The corrected values decreased in 68.3 and 64.2% of the participants for RMSSDc and SDNNc, respectively. The students with RSA at both visits had lower heart rate ( p < 0.001) and systolic blood pressure ( p = 0.010) compared to those with rhythmic electrocardiograms. Conclusions: RSA in children is changeable, though its measurable indices should be adjusted to heart rate., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Lubocka and Sabiniewicz.)

Competing Interests: The authors declare no conflict of interest.

Atrial septal defect is the most common congenital heart lesion in adults. Although atrial septal defect closure is recommended in those with right heart enlargement or paradoxical embolism, data informing such indications in adults are quite limited. This population has many unique characteristics and needs. In recent years, significant progress has been made with regard to diagnostic modalities that facilitate the diagnostic workup of these patients. However, the decision‑making process, especially in selected adult patients population (advanced age, various concomitant diseases, poor LV function [both systolic and diastolic], pulmonary hypertension, concomitant arrhythmias or multiple defects, or deficient rims) is still not easy. Available data are predominantly focused on imaging endpoints and short‑term morbidity and mortality rather than long‑‑term. The evidence base for outcomes with or without defect closure comes from various studies with different observation periods. Moreover, the clinical experience in diagnosing and treating that subgroup of patients is inhomogeneous between individual physicians (cardiologists, imaging specialists, operators) and between small and large experience centers. In the view of the above, the joint group of experts from the Association of Cardiovascular Interventions and the Grown‑Up Congenital Heart Disease Section of the Polish Cardiac Society developed the following consensus opinion in order to standardize the principles of diagnosis, indications for treatment, methods of performing procedures, and tenets of postoperative care in Poland.

Pulmonary arteriovenous malformations are rare congenital vascular anomalies. They are usually associated with congenital hemorrhagic hemangioma. The hemodynamic effect of fistulas depends on their size, as well as the location. The most common manifestations include central cyanosis, ischemic stroke, murmur over the lung fields, cardiomegaly and, less often, heart failure. We present the case of a child who was admitted to the Department of Pediatric Cardiology and Congenital Heart Defects due to central cyanosis and heart murmur., (© 2020 Wiley Periodicals LLC.)

One of the roles of a pediatric cardiologist who suspects or diagnoses a genetically determined connective tissue disease (e.g., Marfan, Ehlers-Danlos, and Loeys-Dietz syndromes) is to assess whether the aortic root is dilated. The aortic root diameter is affected by the patient's age, sex, and body surface area. Therefore, the aortic root diameter needs to be determined and expressed as a z-score. Calculation of the z-score is time-consuming and problematic if used infrequently. This study aimed to introduce a simple screening method for identifying aortic root dilation in children. The study population consisted of 190 children who were diagnosed with Marfan syndrome or Marfan-like disorders. The aortic root ratio (ARr) was formulated. The value of the ARr was compared in each patient with the results in z-scores, which were obtained using on-line calculators based on the most widespread nomograms. The optimal cut-off value of the ARr was ≥ 18.7. At this cut-off point, the sensitivity of the ARr ranged from 88.3% to 100% and the specificity ranged from 94% to 97.8%. All of the patients in whom the ARr failed to identify aortic root dilation were also divergently classified by different nomograms. At the ARr cut-off point of ≥ 18.0, a sensitivity of 100% was achieved for all nomograms with minimal reduction in specificity. The ARr allows for rapid and precise screening for aortic root dilation in children. Unlike classic analysis, the ARr does not require nomograms or on-line calculations.

The presence of patent foramen ovale (PFO) was found to be associated with a number of medical conditions, including embolic stroke and recurrent transient neurological defects. The closure of PFO remains controversial; however, in recently published guidelines from the European Association of Percutaneous Cardiovascular Interventions in collaboration with 7 other European societies, which extensively refer to the latest randomized clinical trials, it is explicitly recommended to perform percutaneous PFO closure in the prevention of recurrent thromboembolic events. In connection with the above facts and expected increasing number of PFO closure procedures, the joint expert group of the Association of Cardiovascular Interventions and the Grown‑Up Congenital Heart Disease Section of the Polish Cardiac Society developed the following consensus opinion in order to standardize the principles of diagnosis, indications, methods of performing procedures, and postoperative care in relation to Polish conditions and experiences.

Marfan syndrome (MFS) is a connective tissue disorder characterized by a broad range of clinical manifestations. Cardiovascular involvement is the most life-threatening aspect of the syndrome. Although abnormalities within the cardiovascular system in adults are well documented, there is still a paucity of data regarding manifestation of MFS in childhood. The aim of the study was to compare cardiovascular manifestation of MFS between children and adults. The study population consisted of 236 patients (144 children and 92 adults), who were referred to our department with suspicion of MFS. All patients underwent complete clinical evaluation in order to confirm the diagnosis of MFS according to the modified Ghent criteria. MFS was diagnosed in 101 (44 children and 57 adults) out of the 236 patients. The other patients were diagnosed with Ehlers-Danlos syndrome, Loeys-Dietz syndrome, MASS phenotype, ectopia lentis syndrome, marfanoid habitus and other rare syndromes. The most common cardiovascular abnormality was aortic root dilatation (81.19% of patients). It was found that both adults and children had similar high rates of aortic root dilatation. Similarly, there was no significant difference with regard to the prevalence of aortic valve regurgitation and mitral valve prolapse among children and adults. These findings equivocally indicate that the aforementioned abnormalities develop in early childhood, therefore, they may be used in the early identification of patients with MFS. Other assessed abnormalities, which included mitral valve regurgitation, pulmonary artery dilation, aneurysms of aortic arch, descending thoracic aorta and abdominal aorta were found mostly in adults, and thus, are of less use in the early detection of MFS.

Objectives: This study sought to evaluate the feasibility, safety, and efficacy of the Ultraseal device for left atrial appendage closure (LAAC) (Cardia, Eagan, Minnesota) in patients with nonvalvular atrial fibrillation at high bleeding risk., Background: The Ultraseal device is a novel bulb-and-sail designed LAAC device, with an articulating joint enabling conformability to heterogeneous angles and shapes of appendage anatomy., Methods: This was a multicenter study including consecutive patients undergoing LAAC with the Ultraseal device at 15 Canadian and European sites. Periprocedural and follow-up events were systematically collected, and transesophageal echocardiography at 45 to 180 days post-procedure was routinely performed in all centers but 3., Results: A total of 126 patients (mean age 75 ± 8 years; mean CHA 2 DS 2 -VASc score 5 ± 2; mean HAS-BLED score 4 ± 1) were included. The device was successfully implanted in 97% of patients. A major periprocedural adverse event occurred in 3 (2.4%) patients (clinically relevant pericardial effusion [n = 1], stroke [n = 1], device embolization [n = 1]). Ninety percent of patients were discharged on single or dual antiplatelet therapy. Follow-up transesophageal echocardiography was available in 89 (73%) patients, with no cases of large (>5 mm) residual leak and 5 (5.6%) cases of device-related thrombosis (all successfully treated with anticoagulation therapy). At a median follow-up of 6 (interquartile range: 3 to 10) months, the rates of stroke and transient ischemic attack were 0.8% and 0.8%, respectively, with no systemic emboli. None of the events occurred in patients with device-related thrombosis., Conclusions: In this initial multicenter experience, LAAC with the Ultraseal device was associated with a high implant success rate and a very low incidence of periprocedural complications. There were no late device-related clinical events and promising efficacy results were observed regarding thromboembolic prevention at midterm follow-up. Larger studies are further warranted to confirm the long-term safety and efficacy of this novel device., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: The study involved preparing and implementation a model of complex screening programme for adolescents and comparison of anthropometric examinations between the population of the SOPKARD-Junior programme and representative sample of Polish children in the same age., Material and Methods: The screening programme in 14-15 year old pupils ( n = 282) included: anthropometric, blood pressure, echocardiographic, electrocardiographic, carotid arteries, kidney and thyroid ultrasound examinations, as well as respiratory, dental and masticatory system, orthopaedic, psychological and psychiatric assessment. Blood and urine tests were also performed. The results of anthropometric examinations from the SOPKARD-Junior and OLAF programmes were used for comparative analysis., Results: Statistically significant ( p < 0.001) differences between young people from Sopot and their peers in the general Polish population were found in height (+3.61 cm for boys), body mass (+5.19 kg for boys and +3.99 kg for girls), body mass index (+0.99 kg/m 2 for boys and +1.33 kg/m 2 for girls), waist circumference (+4.52 cm for boys and +4.52 cm for girls) and hip circumference (+2.51 cm for boys). The highest attendance rate was achieved for examinations performed in school (e.g. anthropometric and blood pressure measurements - n = 268; 95%) and the lowest for the echocardiograpy performed in local hospital ( n = 133; 47%). The mean score of the programme quality (scale 1-6) assessed by children was 4.63., Conclusions: The SOPKARD-Junior programme represents an attempt to develop a model of screening assessments for teenagers in Poland. Preliminary results of the SOPKARD-Junior programme indicate small differences in the biological development of Sopot youth in comparison with their peers from Polish population of the OLAF programme. The high attendance rate on research conducted at the school indicate that proposed health examinations in adolescents are acceptable and feasible., Competing Interests: The authors declare no conflict of interest.

Objectives: To report an over decade-long experience with percutaneous post-infarction ventricular septal defect (PIVSD) closure., Background: PIVSDs remains a major clinical challenge with extremely high mortality. Data concerning interventional closure of PIVSD is scarce., Methods: All percutaneous PIVSD closures performed between 2003 and 2016 in 8 participating centres were identified. Data concerning patients and procedures was acquired. Patients were divided into two groups, based on the time interval between VSD diagnosis and closure (≤14 days-acute phase, >14 days-non-acute phase)., Results: Twenty-one percutaneous PIVSD closures were performed on 20 patients (9 females, mean age: 70 years). Mean interval between the diagnosis and the procedure was 182.6 ± 500 days (range: 7-2228). Defects were mostly located in apical (55%) segments of the septum. In 7 cases (33%) the procedure was performed in the acute phase. The closure was technically successful in 17 cases (81%). Four patients died within 48 hours after the procedure. 30-days survival rate of the entire cohort was 70%. Univariate analysis revealed impact of technical success of the procedure (HR 0.13, CI 0.03-0.68 P = 0.016) and white blood cell count (HR 1.36 per unit increase, CI 1.1-1.69, P = 0.005) on 30-day mortality., Conclusions: In a selected population of patients percutaneous PIVSD closure is feasible and provides satisfactory survival rate. Procedural success has a protective impact on survival. Timing of the closure remains controversial. Procedure in the non-acute phase carries lower mortality, but at the same time introduces a selection bias. Larger registry-based studies are required., (© 2017, Wiley Periodicals, Inc.)

Three-dimensional (3D) printing has attracted a huge interest in recent years. Broadly speaking, it refers to the technology which converts a predesigned virtual model to a touchable object. In clinical medicine, it usually converts a series of two-dimensional medical images acquired through computed tomography, magnetic resonance imaging or 3D echocardiography into a physical model. Medical 3D printing consists of three main steps: image acquisition, virtual reconstruction and 3D manufacturing. It is a promising tool for preoperative evaluation, medical device design, hemodynamic simulation and medical education, it is also likely to reduce operative risk and increase operative success. However, the most relevant studies are case reports or series which are underpowered in testing its actual effect on patient outcomes. The decision of making a 3D cardiac model may seem arbitrary since it is mostly based on a cardiologist's perceived difficulty in performing an interventional procedure. A uniform consensus is urgently necessary to standardize the key steps of 3D printing from imaging acquisition to final production. In the future, more clinical trials of rigorous design are possible to further validate the effect of 3D printing on the treatment of cardiovascular diseases. (Cardiol J 2017; 24, 4: 436-444).

Background: The Occlutech Figulla ASD device series (OFSO) shows an improved device design for interventional ASD closure, larger follow-up series are missing., Methods: We retrospectively reviewed the feasibility, safety, implantation properties, results, and follow-up of ASD closure using Occlutech devices over a 5 year period by establishing a multi-institutional collaborative result registry with 16 contributing centers from 11 countries (IRFACODE)., Results: In 1315 patients of all age groups (female 66.9%), successful (98%) ASD closure was performed (mean age 28.9 years, weight 52 kg, height 148.6 cm). Of the defects, 47.9% showed no or only a deficient aortic rim; in 11.9%, there was more than one defect; a septum aneurysm was present in 21.5%; and the mean implanted device size was 20.5 mm. Immediate closure was achieved in 78.6%, at discharge in 83.1%, and 96.4% and 97.3% at 6 and 12 months follow-up, respectively. During a mean follow-up of 2.7 years (in total 3597 patient years), significant complications were minimal (total = 8, <1%) with secondary device embolizations in five and AV-blocks in three patients. No erosion or death was reported., Conclusion: ASD closure using OFSO is feasible in a large variety of patients, safe with only a minimal risk of severe side effects and especially without any aortic erosions despite a large percentage of large and complicated defects. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)