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Over the past 50 years, the number and invasiveness of percutaneous cardiovascular procedures globally have increased substantially. However, cardiovascular interventions are inherently associated with a risk of acute brain injury, both periprocedurally and postprocedurally, which impairs medical outcomes and increases health-care costs. Current international clinical guidelines generally do not cover the area of acute brain injury related to cardiovascular invasive procedures. In this international Consensus Statement, we compile the available knowledge (including data on prevalence, pathophysiology, risk factors, clinical presentation and management) to formulate consensus recommendations on the prevention, diagnosis and treatment of acute brain injury caused by cardiovascular interventions. We also identify knowledge gaps and possible future directions in clinical research into acute brain injury related to cardiovascular interventions., (© 2024. Springer Nature Limited.)

Background: Post-myocardial infarction ventricular septal rupture (VSR) is a rare and severe complication of myocardial infarction. To find early mortality (<30 days) risk factors of device VSR closure and to evaluate its medium-term outcome., Methods: Multicenter retrospective analysis on all 46 consecutive patients with percutaneous (n = 43) or hybrid (n = 3) VSR closure in 2000-2020 with various nitinol wire mesh occluders. Medical records, hemodynamic data, procedure results, short- and mid-term follow-up were analyzed (4.8 ± 3.7 years, range: 0.1-15, available in 61.7% of patients). Of the patients, 34.8% underwent VSR closure in acute phase (<21 days after VSR occurrence), 17.4% underwent device closure due to significant residual shunt after previous VSR surgery., Results: Success rate was 78.3%. More than moderate residual shunt, major complications, and early surgical reintervention affected 18.9%, 15.2% (including 2 intra-procedural deaths), and 21.7% of patients, respectively. Early mortality was 26.1% (13.9% in successful vs. 70% in unsuccessful closure; p < 0.001). Older age, need for intra-aortic balloon counterpulsation, severe complications, and procedural failure were identified as risk factors for early mortality. Among patients who survived the early period, the 5-year survival rate was 57.1%. NYHA class improved in 88.2% patients at the latest follow-up., Conclusions: Procedure of VSR device closure demonstrates an acceptable technical success rate; however, the incidence of severe complications and early mortality is notably high. Older patients in poor hemodynamic condition and those with unsuccessful occluder deployment are particularly at a higher risk of a fatal outcome. The prognosis after early survival is promising., Competing Interests: Declaration of competing interest None declared., (Copyright © 2024 Elsevier Ireland Ltd. All rights reserved.)

Background: Percutaneous pulmonary valve implantation has become an attractive method of dysfunctional right ventricle outflow tract treatment., Case Presentation: We describe a unique case of a 20-year-old Caucasian male patient with a complex cyanotic heart defect, namely pulmonary atresia, with congenitally corrected transposition of the great arteries and ventricular septal defect after Rastelli-like surgery at the age of 5 years with homograft use. At the age of 20 years, the patient needed percutaneous pulmonary valve implantation owing to homograft dysfunction. Despite unusual course of the coronary arteries, balloon testing in the landing zone of the right ventricle outflow tract excluded potential coronary artery compression. Then, after presentation, a Melody valve was implanted successfully in the pulmonary valve position. The 8-year follow-up was uneventful., Conclusion: This is likely the first description of a percutaneous pulmonary valve implantation in such anatomy. Such a procedure is feasible; however, it requires exceptional caution owing to the anomalous coronary arteries course, which can be the reason for their compression., (© 2024. The Author(s).)

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.

Introduction: Balloon aortic valvuloplasty (BAV) is a common treatment method of aortic valve (AV) stenosis in neonates. Long-term BAV effects are suboptimal, and their predictors are not well acknowledged., Aim: To identify predictors of suboptimal short- and long-term BAV results., Material and Methods: The study group comprised forty-three neonates (8 females; weight 3.34 ±0.56 kg) who underwent BAV between 1998 and 2021. Seventeen patients (39.53%) had critical AV stenosis. AV was bicuspid in 22 patients, tricuspid in 12, unicuspid in 2, and undefined in 7 patients. The mean balloon/annulus ratio was 0.9 ±0.07. Catheterization, clinical, and follow-up data were analysed., Results: The peak-to-peak gradient decreased from 67.5 ±26.3 to 21.3 ±12.6 mm Hg. Twenty-eight patients (65.1%) had adequate early outcome. Aortic regurgitation (AR) occurred in 13 (30.2%) patients. No predictors of inadequate early outcome were found. Twenty-year survival was 90.7%. Eleven (35.5%) patients underwent reintervention at a median of 12 (1-215) months; BAV in 5 patients, surgical valvuloplasty in 2, Ross operation in 2, AV replacement in 1, and Norwood operation in 1 patient. Fifteen-year freedom from reintervention (FFR) was 48%. Adequate early outcome resulted in higher FFR (71% vs. 22%), and so did no significant AR (60% vs. 30%)., Conclusions: BAV provides satisfying early results. AR remains a significant aftermath of BAV. Risk factors and procedural techniques improving the outcome of BAV are unclear. Further research is needed to improve FFR., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2022 Termedia Sp. z o. o.)

We report a 15-year-old male with hypoplastic left heart syndrome (HLHS) after Fontan operation with recurrent, drug-resistant atrial tachycardia. With the use of electro-anatomical mapping system (EnSite) an atrial flutter (AFl) with reentry activation around the tricuspid valve was diagnosed. Successful radiofrequency catheter ablation (RFCA) was performed., Competing Interests: Ewa Jędrzejczyk‐Patej and Radosław Lenarczyk—consultant fees from Medtronic, Biotronik, Abbott, and Boston Scientific. Beata Średniawa—consultant: Medtronic, Zoll, Bayer, lectures fee for: Boehringer‐Ingelheim, Bayer, Pfizer., (© 2021 The Authors. Journal of Arrhythmia published by John Wiley & Sons Australia, Ltd on behalf of Japanese Heart Rhythm Society.)

Background: Transcatheter patent ductus arteriosus (PDA) closure has become the first‑choice method of treatment in the majority of patients. However, device selection poses a challenge., Aims: This study aimed to analyze periprocedural and 1‑year outcomes of PDA transcatheter closure performed with different devices throughout a 25‑year time period in a single center., Methods: All 1036 patients who underwent transcatheter PDA closure between 1993 and 2020 were included in retrospective analysis. Various devices were used: the Rashkind device (RD; n = 25), coils (n = 469), nitinol duct occluders type I (DO I; n = 300), type II (n = 32), type II additional sizes (ADO II AS; n = 209), as well as off‑label devices: vascular plugs and atrial septal and muscular ventricular septal defect occluders (n = 17). Data on 24‑hour and 1‑year follow‑up were available for 100% and 78.9% of the study patients, respectively., Results: The procedure was successful in 98.6% of the study patients, with a major complication rate of 0.2%. Complete PDA closure after a year was observed in 81.8% of the patients treated with RD, 93.7% of those with coils, and 100% of those with duct occluders. There were no differences between Amplatzer DO I (n = 159) and its DO I copies manufactured in China (n = 141) with regard to success, efficacy, and complication rates. Recently, ADO II AS has replaced coils and become the preferred device to close small‑to‑moderate PDA., Conclusions: Transcatheter PDA closure with all types of nitinol duct occluders is safe and effective, with no residual shunting at 1‑year follow‑up. Due to higher efficacy, ADO II AS has replaced coils in the treatment of smaller PDA.

Competing Interests: Marcin Demkow is a proctor for Edwards Lifesciences Inc. The other authors declare no conflict.

Objectives: Patent ductus arteriosus (PDA) in elderly patients is an uncommon anomaly, and the duct itself is often calcified and fragile; therefore, transcatheter closure is more difficult. The aim is to analyse periprocedural and one-year follow-up results of transcatheter closure of PDA in such patients. Methods and results . Retrospective analysis of 33 elective patients aged ≥55 years (median 63; 56-85; 29 women), in whom PDA was closed percutaneously between 2002 and 2018 in two tertiary centres. All but three patients were symptomatic, with most in NYHA II ( n  = 14) and III ( n  = 11) class; pulmonary hypertension ( n  = 22), arterial hypertension ( n  = 22), duct calcifications ( n  = 17), atrial fibrillation ( n  = 15), significant mitral regurgitation ( n  = 5), and decompensated renal failure ( n  = 2) were observed. Different devices were applied depending on PDA morphology; nitinol wire mesh occluders with symmetrical articulating discs have been the most used in recent years ( n  = 11). Follow-up was conducted at an outpatient clinic (28/33 patients). The procedure was successful in all patients. There was one embolisation, followed by implantation of a larger device. No major complications were noted. A small residual shunt was present in echocardiography in one patient after one year. NYHA class improved in all but two patients (with multiple comorbidities)., Conclusions: Transcatheter PDA closure in elderly patients is safe and efficient with a high complete closure rate and few complications. Amplatzer duct occluder type II is an attractive device in such patients., Competing Interests: The authors declare that there are no conflicts of interest regarding the publication of this paper., (Copyright © 2020 Michal Galeczka et al.)

Background: We aimed to evaluate medium- and long-term outcomes of transcatheter closure (TC) of ruptured sinus of Valsalva aneurysm (RSVA), which is a rare and mostly congenital heart disease., Methods: Retrospective analysis included 23 patients (14 males) aged 15-79 years (y; 39.9±18.5) selected for TC of RSVA between 2007 and 2017 in two tertiary centers in Poland and Ukraine. Fifteen patients were in New York Heart Association (NYHA) class III or IV before TC; 5 patients had acquired RSVA after previous cardiac surgery. We applied 22 duct, 3 muscular, and 1 atrial septal Amplatzer or Amplatzer-like occluders by the anterograde venous approach after arterio-venous loop creation in all but 1 patient. Mean follow-up conducted in outpatient clinic was 5.5±3.5 (1-11)y., Results: The procedure was successful in 19/23 patients (82.6%). Four procedures were abandoned and the device percutaneously retrieved due to coronary artery compression (1 patient), transient increase of aortic regurgitation (AR; 1 patients) or embolization (2 patients). New onset of significant AR was noted in one of the latter patients after device removal. NYHA class improved in all treated patients but 2, in whom it remained stable (p<0.05), with 10 patients in class I. Three patients needed percutaneous re-intervention during follow-up because of significant residual shunt in 1 and late recurrent RSVA in 2 patients. The follow-up of the remaining patients was uneventful. Neither erosion, embolization, new AR, nor death were observed., Conclusions: The percutaneous closure of RSVA is a safe and effective method of treatment with good clinical outcome. However, although not described previously, recurrent shunts after TC of RSVA are possible and can be treated successfully with another transcatheter intervention., (Copyright © 2019 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Competing Interests: The authors declare no conflict of interest.

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.

INTRODUCTION    Stent implantation has become the treatment of choice for native aortic coarctation (CoA) and postsurgical aortic recoarctation (reCoA) in adults and adolescents. OBJECTIVES    This study aimed to compare the immediate and long‑term outcomes of patients with native CoA and postsurgical reCoA who underwent stent implantation in our center. PATIENTS AND METHODS    The data of 136 patients with native CoA and reCoA who underwent stent implantation between May 1999 and December 2016 were retrospectively analyzed. The study population was divided into 2 groups: 108 patients with native CoA and 28 patients with reCoA. Clinical and procedural characteristics and immediate and long‑term outcomes after the intervention were compared between the groups. The use of antihypertensive drugs was analyzed in all patients. RESULTS    There were no significant differences in the clinical characteristics of the study groups. The gradient before the intervention was significantly higher in the native CoA than in the reCoA group (P = 0.011), and the diameter of stenosis before the intervention was smaller in the native CoA group compared with the ReCoA group (P = 0.003). Procedural treatment was successful in 77.8% of the patients with native CoA and 78.5% of those with reCoA. There were no differences in the immediate and long‑term outcomes between the groups. The antihypertensive treatment was tapered or discontinued in about 34% of the study population. CONCLUSIONS    Stenting is an effective and safe procedure in patients with native CoA and reCoA, with good late outcomes.

To date, there are no reported cases of the Amplatzer Duct Occluder II: Additional Sizes' use in percutaneous closure of an aortopulmonary window. We report a case of percutaneous closure of an aortopulmonary window in a 4.5-month-old, 6 kg child. Owing to the patient's low weight, high risk of damage to the pulmonary valve, as well as the possibility of aortic and pulmonary artery obstruction, classic implants were deemed unsuitable and a decision was made to use the Amplatzer Duct Occluder II: Additional Sizes. The implant performed very well - the soft waist filled the aortopulmonary connection and both retention discs were properly shaped and pressed against vessel walls. Echocardiogram performed 12 hours after the procedure confirmed a correct occluder position. Low-profile retention discs had no impact on pulmonary valve function, despite the defect's proximity to the valve. No obstruction of the aortic or pulmonary artery lumen was noted. The Amplatzer Duct Occluder II: Additional Size implant is a safe and useful device for percutaneous closure of an aortopulmonary window in a carefully selected group of patients.

Aims: The aim of this study was to present our experience with the AMPLATZER Duct Occluder II Additional Sizes (ADOIIAS) for the closure of different types of patent ductus arteriosus (PDA) in patients of various age groups., Methods and Results: A group of 103 patients, in whom the PDA (diameter below 3.5 mm) was closed using the ADOIIAS, was analysed. The median age of treated patients was 3.0 years (from 0.1 to 24 years), and 55 patients (53.4%) were older than three years. Ductal anatomy defined by angiography showed type A in 42 patients (40.8%), type C in six patients (5.8%), type D in 21 patients (20.5%), and type E in 34 patients (33.0%). In two cases, embolisation of the device occurred shortly after implantation. Both occluders were retrieved percutaneously. One death occurred in a neonate four days after ADOIIAS implantation (not related to the procedure: multi-organ failure). Total occlusion of PDA was confirmed in all patients the day after the procedure. No protrusion of the device into the aorta or pulmonary artery was observed in any patient during follow-up., Conclusions: The use of the ADOIIAS is a good therapeutic option for the treatment of selected PDA. The implant may be successfully substituted for coil implantation in all age groups.

Background: Results of stent implantation (SI) of postsurgical recoarctation of the aorta (ReCoA) are not frequently published., Aim: This study sought to retrospectively evaluate results of SI in ReCoA in older children and adults., Methods: Twenty-eight SIs were performed on 26 ReCoA patients with a median age of 23 (10-65) years. Dependent upon availability, the following stents were applied: Palmaz, Cheatham Platinum (CP), Andrastents XL/XXL (AS), Covered CP (CVCP) stents, and self-expanding stents (Smart). Generally, high-pressure balloons were applied to dilate stents., Results: The procedure was effective in 20/26 patients (77.7%). The mean peak systolic gradient reduced from 40.5 ± 18.7 mm Hg to 13.1 ± 12.1 mm Hg (p < 0.05), and the diameter of the stenosed segment increased from 7.5 ± 3.02 mm to 13.1 ± 3.32 mm (p < 0.05). In six cases (including a patient treated with a Smart stent) transaortic pressure gradient after SI remained > 20 mm Hg (stiff postsurgical lesion). For one patient (40-year-old male), an acute dissection of the aorta occurred during balloon predilatation. Immediate CVCP implantation resolved this problem. Two more CVCPs were used - one to close a small aortic aneurysm that appeared five years after a Palmaz SI and another to stabilise a broken CP bare metal stent. There were no deaths or aortic dissections during follow-up, and most patients were able to reduce or suspend their medication for systemic hypertension., Conclusions: Endovascular stenting of ReCoA in adults and adolescents appears to be an acceptable method of treatment in experienced hands. However, for some patients the presence of a stiff lesion can provoke suboptimal results. Considering the serious complications that can occur after SI, all patients should have regular follow-up (including an imaging study). Covered stents should always be available in the cathlab as a rescue device when implanting stents in coarctation of the aorta patients.

Background: Although currently used devices for interventional closure of patent foramen ovale (PFO) are widely used due to the minimally invasive nature of this technique and high success rate, there is still a need to look for new materials and designs in order to improve the treatment outcomes., Aim: To evaluate the safety, biocompatibility, temporal healing patterns, and coverage dynamics of the new Polish PFO occluder (Balton, Warsaw, Poland) in a swine model - an observation that may assist the decision with regard to its first-in-human use and duration of anticoagulation therapy., Methods: In total, 12 pigs were scheduled for 28-day (n = 6) and 90-day follow-up (n = 6). In each animal, using a standard femoral venous approach, one PFO occluder was implanted and subsequently, in order to verify device position stability, the Minnesota manoeuvre was performed. At follow-up, all devices underwent a comprehensive evaluation with the use of high-resolution radiography (Faxitron MX-20 system), scanning electron microscopy (SEM), and standard histopathological techniques., Results: All PFO occluders were implanted successfully with no complications. The Faxitron revealed that all nitinol portions of the frame appeared intact and breaks were not detected at both studied time points. Overall, the device appeared to be well deployed in the atrial septum. At 28 days the average neointimal coverage of the right side of the PFO occluder by SEM was 92%; while in contrast the left side had less coverage, at 63%. At 90 days, the coverage of the right side of the occluder was 96.8%, while the left side of the PFO occluder improved and had similar coverage of 93.3%. By histology the endothelialisation process was virtually complete at 90 days. At the early time-point the overall inflammatory infiltrate was moderate and subsequently it diminished and was only mild or occasionally moderate at 90-day follow-up. At both time points the inflammatory reaction was limited to the neointimal tissue surrounding the device., Conclusions: Our study confirmed safety and good overall biocompatibility of the new Polish PFO occluder, which is comparable to other devices available on the market - an observation that supports the decision with regard to its first-in-human application. Neoendothelialisation was virtually completed at 90 days, suggesting that similarly to other widely used devices a minimum of three to six months of anticoagulation therapy should be recommended.

Competing Interests: The authors declare no conflict of interest.

Introduction: Stent implantation is an effective therapy for aortic coarctation (CoA) in adolescents and adults., Aim: To present a unique group of patients with native coarctation of the aorta older than or equal to 46 years treated with bare metal or covered stents., Material and Methods: Since 2002 we have performed stent implantations by applying bare metal stents or covered stents using femoral access in 24 patients aged 46 and older., Results: We used the Mullins technique in all cases, implanting different stents: Palmaz, Cheatham-Platinum (CP), covered CP or Andrastents XL/XXL. Twenty-one procedures were elective and 3 were urgent. Eighteen bare metal stents (2 stents in one patient) and 7 covered stents were used. All procedures were effective (CoA gradient reduced < 20 mm Hg), despite 2 migrations of bare metal stents. Mean gradient was reduced from 50.6 ±15.3 to 6.8 ±6.5 mm Hg ( p < 0.001) and mean lumen diameter of stenosed aorta increased from 5.5 ±2.5 to 14.9 ±5.2 mm ( p < 0.001). One special case is discussed - a 49-year-old man with end staged heart failure and severe CoA, who underwent a rescue procedure with a bare metal stent. One serious complication - stroke of the central nervous system - was observed in a 53-year-old woman during covered stent implantation (symptoms resolved during rehabilitation process)., Conclusions: Stent implantation of native coarctation of the aorta is also a safe procedure in the eldest patients and is associated with persistent relief of aortic obstruction.

Competing Interests: The authors declare no conflict of interest.

Background: Transcutaneous pulmonary valve replacement (TPVR) has become an alternative to heart surgery for patients after previous right ventricular outflow tract (RVOT) or pulmonary artery (PA) surgical interventions. The objective was to present immediate and long-term outcomes of trans¬cutaneous pulmonary valve replacement., Methods: Between 06/2009 and 06/2016, 46 patients underwent TPVR. Initial diagnoses included tetralogy of Fallot, common arterial trunk, transposition of great arteries post Rastelli correction, left ventricle outflow obstruction after Ross operation, pulmonary atresia, and isolated dysplastic pulmonary valve stenosis. Thirty eight (78%) patients had previously implanted conduits in the pulmonary position, the rest had either RVOT patch reconstruction (n = 6; 13%) or biological valve implantation (n = 2; 4%). They presented primarily with pulmonary stenosis (n = 18; 39%) or regurgitation (n = 28; 60%)., Results: All procedures were successful - 44 Melody and 2 Edwards-Sapien valves were implanted. Before each procedure exclusion of potential coronary compression and RVOT prestenting was performed. Significant RVOT systolic gradient reduction (from 35.3 ± 19.5 to 13.5 ± 7.1 mm Hg; p < 0.001) and decrease of right to left ventricle systolic pressure ratio from 0.58 ± 0.18 to mean 0.37 ± 0.1 (p < 0.001) was achieved. Also, in every patient PA-RVOT competence was restored, with minor in¬competence in only a few patients. Post procedure follow-up ranged from 2 to 86 (mean 35.2) months. Follow-up fluoroscopy or chest X-ray revealed 6 stent fractures (2 stent defragmentation - with only 1 significant valve stenosis)., Conclusions: Transcutaneous pulmonary valve replacement is a safe procedure with encouraging results, it also enables deferring surgical reintervention in the majority of patients.

Aims: The aim of this study is to present our experience with a new type of extra-large stent, namely the AndraStent XL/XXL., Methods and Results: AndraStents were implanted in 46 patients, 38 with native coarctation of the aorta (CoA) and eight with recurrent coarctation of the aorta following previous surgery (ReCoA). All patients had arterial hypertension in the upper limbs, absent or weak femoral pulses, and continuous flow in the abdominal aorta on Doppler examination. The median age of patients was 25 years (range from nine to 65). The stents (cobalt-chromium with semi-open cell design) were manually mounted on balloon catheters and delivered through 10 to 14 Fr Mullins sheaths using a conventional femoral approach. All procedures were successful (no stent migration, proper expansion, no aorta dissection/rupture, major bleeding or major vessel injury). The systolic gradient across the aorta decreased from 40.6 mmHg before the procedure to 11.6 mmHg after the procedure (p<0.001). The mean fluoroscopy time was 5.7 minutes. Imaging examinations were scheduled and performed between six and 12 months after the initial procedure in 40 patients (angiography or angio CT or both). Procedural outcome remained favourable during a mean 2.4 years of follow-up. Neither stent fracture nor dislocation was observed in any patient at follow-up. In two patients, small aneurysm formation was observed six and eight months after the procedure -they were treated successfully with subsequent covered stent implantation. Re-dilatation of the implanted stent was performed between four and 26 months in 14 patients., Conclusions: Implantation of new large cobalt-chromium stents is a good therapeutic option for the treatment of native and recurrent CoA.

Introduction: Balloon angioplasty (BAP) and aortic or pulmonary balloon valvuloplasty (BAV, BPV) are well-established treatment options in congenital heart defects. Recently, significant technological progress has been made and new catheters have been implemented in clinical practice., Aim: To analyze the results of BAP, BAV and BPV with the new balloon catheter Valver and its second generation Valver II, which the company Balton (Poland) launched and developed. These catheters have not been clinically evaluated yet., Material and Methods: We performed 64 interventions with Valver I and Valver II. With Valver I the following procedures were performed: 17 BPV (including 9 in tetralogy of Fallot - TOF), 10 BAV and 27 BAP in coarctations of the aorta (CoA) - including 9 native and 18 after surgery. With Valver II ten interventions were done - 3 BPV, 2 pulmonary supravalvular BAP (after switch operations), 2 BAP of recoarctations and 3 other BAP. Age of the patients ranged from a few days to 40 years., Results: All procedures were completed successfully, without rupture of any balloon catheters. The pressure gradient drop was statistically significant in all groups: BPV in isolated pulmonary valvular stenosis 28.1 mm Hg (mean), BPV in TOF 18.7 mm Hg, BAV 32.8 mm Hg, BAP in native CoA 15.4 mm Hg and in recoarctations 18.6 mm Hg. In 3 cases during rapid deflation of Valver I, wrinkles of the balloons made it impossible to insert the whole balloon into the vascular sheath (all were removed surgically from the groin). No such complication occured with Valver II., Conclusions: Valver balloon catheters are an effective treatment modality in different valvular and vascular stenoses.

Background: Transcatheter closure has become the method of choice for treatment of many heart defects. Recently, Lifetech Scientific introduced the Cera occluder (CO), a self-expandable nitinol wire-mesh device covered with ceramic coating. We present our preliminary experience in transcatheter closure of atrial septal defect (ASD), patent foramen ovale (PFO), patent ductus arteriosus (PDA), and post-infarction ventricular septal defect (PIVSD) with the CO., Methods: The study population consisted of 25 patients (17 female) ages 1.1-82 years (median age, 34.0 years) with either ASD (n = 7), PFO (n = 11), PDA (n = 6), or PIVSD (n = 1). All patients were treated percutaneously with appropriate CO devices, without any preliminary patient selection. The implantation technique applied in these procedures was the same as previously described for Amplatzer occluders., Results: All procedures were performed successfully. Complete shunt closure was achieved in all but 1 patient with PIVSD. No complications were observed during procedures or during follow-up of 0.5-4 months., Conclusions: Our preliminary experience in the clinical application of COs for transcatheter closure of ASD, PFO, PDA, and PIVSD has confirmed their utility, feasibility, and safety, at least in the short-term follow-up.

We describe a patient who, at the age of 6 months (body weight 6.1 kg), was diagnosed with a large atrial septal defect (with diameter 10-11 mm) that had spontaneously closed in a 1-year period. The timing of transcatheter intervention in children should be considered individually, paying close attention to subsequent echocardiographic data.

Ventricular septal defects closure (VSD) depending on the anatomy and clinical setting can be performed surgically or by a hybrid and transcatheter approach. Two cases of children with VSD will be presented. Patients' defects were closed with various types of occluders made of nitinol wire mesh occluder, patent ductus arteriosus (PDA) type. The first case was a 2.5-year-old boy after cardiosurgical correction of tetralogy of Fallot (TOF). After the procedure, a significant haemodynamic residual VSD was observed, which was not successfully closed during the subsequent reoperation. Despite pharmacological treatment, symptoms of heart failure were observed in this patient. In echocardiographic images the residual VSD was presented as a tunnel-like dissection of the ventricular septum (length 6 mm and diameter 3.4 mm). The defect was closed via arterial access with an Amplatzer Duct Occluder II (ADO II). The procedure was successfully performed without any medical complications. In this child, a significant shunt reduction and a noticeable improvement in the patient's clinical status and diminished symptoms of heart failure were noticed. The second patient was a 4-year-old girl suffering from a multi-perforated perimembranous VSD accompanied by a ventricular septal defect with aneurysm. The defect was closed by a venous approach with a PDA Cardio-O-Fix occluder (very similar to ADO I). No short-term or long-term complications were visible during or after the procedure. Only a mild residual shunt through the VSD was observed 6 months afterwards. Transcatheter VSD closure with a proper morphology, with occluders of type Amplatzer Duct Occluder ADO I or ADO II, constitutes a safe and effective therapeutic alternative.

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.

Background: The complexity of ventricular septal defects in early infancy led to development of new mini-invasive techniques based on collaboration of cardiac surgeons with interventional cardiologists, called hybrid procedures. Hybrid therapies aim to combine the advantages of surgical and interventional techniques in an effort to reduce the invasiveness. The aim of this study was to present our approach with mVSD patients and initial results in the development of a mini-invasive hybrid procedure in the Gdansk Hybrid Heartlink Programme (GHHP) at the Department of Pediatric Cardiac Surgery, Pomeranian Centre of Traumatology in Gdansk, Poland., Material and Methods: The group of 11 children with mVSDs was enrolled in GHHP and 6 were finally qualified to hybrid trans-ventricular mVSD device closure. Mean age at time of hybrid procedure was 8.22 months (range: from 2.7 to 17.8 months, SD=5.1) and mean body weight was 6.3 kg (range: from 3.4 to 7.5 kg, SD=1.5)., Results: The implants of choice were Amplatzer VSD Occluder and Amplatzer Duct Occluder II (AGA Med. Corp, USA). The position of the implants was checked carefully before releasing the device with both transesophageal echocardiography and epicardial echocardiography. All patients survived and their general condition improved. No complications occurred. The closure of mVSD was complete in all children., Conclusions: Hybrid procedures of periventricular muscular VSD closure appear feasible and effective for patients with septal defects with morphology unsuitable for classic surgical or interventional procedures. The modern strategy of joint cardiac surgical and interventional techniques provides the benefits of close cooperation between cardiac surgeon and interventional cardiologist for selected patients in difficult clinical settings.

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.