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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: 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.

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: 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.

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.

An additional source of pulmonary blood flow in a patient with bidirectional Glenn procedure (BGD) may cause elevation of mean pulmonary artery pressure (MPAP), precluding safe completion of the Fontan operation. We present a case of single ventricle physiology after pulmonary artery banding (PAB) and Glenn procedure. At the age of six years, cardiac catheterisation revealed in the patient elevated MPAP (22 mm Hg). The PAB was closed through the right internal jugular vein with an Amplatzer Atrial Septal Occluder. After the procedure, MPAP remained at a similar level. Sildenafil oral therapy was applied for six months. Subsequent heart catheterisation confirmed complete closure of PAB and decrease of MPAP to 10 mm Hg. The abovementioned complex treatment of elevated MPAP pressure in a child after Glenn therapy allowed safe completion of the Fontan operation.

Background: The use of an Amplatzer Cribriform Septal Occluder (ACSO) for percutaneous patent foramen ovale (PFO) closure (especially in cases with atrial septal aneurysm) has been recently described as superior compared to that of an Amplatzer PFO Occluder (APFO)., Aim: To assess immediate and medium-term clinical outcomes of patients with PFO with paradoxical embolism event (EE) who underwent transcatheter PFO closure with an APFO or an ACSO., Methods: Overall, 56 consecutive patients underwent percutaneous closure of PFO with an APFO device; the results were compared to those in seven patients treated with ACSO. Deaths due to embolism, stroke or transient ischaemic attack (TIA) were considered recurrent EE. Pre- and 6 month post-intervention right to left shunting (RLS) were evaluated with intravenous contrast injection by transcranial Doppler examination of the middle cerebral artery during Valsalva manoeuvre., Results: The procedure was successfully completed in all patients in both groups. No procedure-related complications were observed during hospitalisation. Residual RLS was noted at six months in 14/56 (25%) patients in the APFO group and 4/7 (57%) patients in the ACSO group (p <0.05). Recurrent TIA was observed in three patients in the APFO group (one of them had small residual shunt immediately after procedure and at six-month follow-up). Another patient from that group experienced stroke one month after the procedure. No recurrence of EE was recorded in the ACSO group., Conclusions: Transcatheter PFO closure with both Amplatzer devices is a minimally invasive procedure with high success and low complication rates. Taking in consideration residual RLS in the medium-term period, the application of a Cribriform device is not superior to that of an Amplatzer PFO device. Results of randomised trials are necessary to confirm the effectiveness of transcatheter therapy in patients with PFO and a paradoxical thromboembolic event.

A large fistula from the left coronary artery to the right ventricle was successfully closed percutaneously in a 40 year-old patient using a patent ductus arteriosus occluder. The device was positioned and deployed via the venous system using a guidewire that had been advanced via the aorta, coronary artery and fistula to the venous circulation (arterio-venous loop creation). No complications were reported at follow-up.

The case of 61 year-old woman with congenital coronary artery fistula connecting left main coronary artery and the right atrium is presented. The patient was admitted to the Cardiology Department because of the first atrial fibrillation episode. During hospitalisation the congenital heart defect was diagnosed thanks echocardiography and multi-slice computed tomography. Three months later the percutaneous closure of the fistula with Amplatzer Duct Occluder was performed. The direct and 6-months results were very good.

We report the case of a 49 year-old-man with congenital coarctation of the aorta (CoA), admitted in a critical clinical condition due to advanced secondary cardiomyopathy and chronic heart failure. An Andrastent XL was implanted successfully in the CoA. The procedure resulted in an almost completely resolved CoA and prompt clinical improvement in the patient.

Transcatheter pulmonary valve implantation improves conduit haemodynamics without necessity of complex reoperation. Clinical experience with application of the Edwards-SAPIEN Transcatheter Heart Valve (THV) in pulmonary position is still limited. We present data of 2 patients (21 year-old woman and 26 year-old man) with a history of dysfunction of homograft in position of right ventricular outflow tract (RVOT), in whom the Edwards-SAPIEN THV was successfuly implanted.

Background: Major vessel stenoses are currently successfully treated with stent implantation. Recently, new cobalt-chromium stents (Andrastents XL and XXL, Andramed, Germany) have been introduced into clinical practice. This alloy combines high biocompatibility with radial strength and flexibility., Aim: To present our experience with the use of Andrastents XL and XXL for the dilatation of stenosed pulmonary arteries, coarctation of the aorta (CoA), and a stenosed superior vena cava (SVC)., Methods: The study group included 24 patients treated with 26 Andrastents. In 7 patients aged 23.3 (range 18-27) years, with the mean body weight of 64.7 (range 50-77) kg, prestenting of a calcified pulmonary homograft was performed using 9 Andrastents XL or XXL (length of 30, 39, or 48 mm) before the Melody valve implantation. In one patient with a long and stiff stenosis, 3 stents were necessary. In 12 patients with native CoA aged 30.1 (range 9-55) years, with the mean body weight of 60 (range 25-105) kg, twelve Andrastents XL or XXL (length of 30, 39, or 48 mm) were implanted. In 4 patients with the right or left pulmonary artery stenosis close to the bifurcation (age 8.5 [range 6-10] years, body weight 27.3 [range 17-33] kg), 4 Andrastents 30 XL were implanted. In one child (age 7.5 years, body weight 21.7 kg) with a iatrogenic SVC stenosis (after 2 venous cannulations necessary for 2 surgical corrections of his double-outlet right ventricle), the stenosed site was dilated using Andrastent 21 XL., Results: All procedures were performed successfully. No stent fractures were observed during the follow-up. The mean pressure gradient was reduced from 42.4 to 18 mm Hg (RVOT) in patients who underwent Andrastent and Melody valve implantation, from 54.1 to 13.2 mm Hg in patients with CoA, and from 49 to 21.7 mm Hg in patients with pulmonary artery stenosis. No aneurysm formation, stent migration, or rupture of the treated vessel during stent implantation were observed in any patient. The mean fluoroscopy time during stent implanatation was 6.6 min in CoA, 8.8 min in pulmonary artery stenosis, 24.8 min during implantation of Melody valve (with prestenting of RVOT with Andrastents) and 17.6 min during SVC dilation. Procedural outcomes (evaluated using noninvasive methods) remained favourable during the follow-up (0.5-21 months), with no complications observed., Conclusions: Implantation of Andrastents XL or XXL is a very good therapeutic option in the treatment of major vessel stenoses.

We present a case of a 21 year-old man who has had Fontan type correction 17 years ago with symptoms of severe heart insufficiency (III NYHA class, cahectic, with massive peripheral oedema and ascites) caused by increased pulmonary vascular resistance and increased pulmonary artery pressure. He was treated successfully with long term sildenafil medication.

We present 2 cases (4 and 17-year-old children) with aorta-vena azygos fistulae. In the fist child spontaneous closure was confirmed by clinical symptoms and aortography, in the second (with significant left-right shunt) successful closure with 10 x 8 mm Amplatzer Duct Occluder was obtained. These case reports show that the strategy of treatment of aorto-venous fistulae must be individualised.

Aim: To assess the early results of the pulmonary artery valve transcatheter implantation (PAVTI) in pts included into POL-PAVTI registry. Detailed medical and economic analyses were performed., Methods: Pulmonary artery valve implantation was performed in 14 pts (9 men), aged 16-31 (mean 24.6 +/- 4.8) years, with pulmonary homograft dysfunction after total repair of tetralogy of Fallot (4 pts), pulmonary atresia (2 pts), pulmonary stenosis (1 pt), common arterial trunk type I (1 pt), Ross procedure (3 pts) and TGA - Rastelli operation (3 pts). Eleven pts underwent in the past 2-5 surgical or/and catheter interventions. Indication for PAVTI was based on clinical evaluation and echocardiographic studies. Assessment of morphological and functional features of the right ventricle (RV) and homograft with the use of cardiac magnetic resonance (CMR) was performed in 10 cases. Pulmonary stenosis (max. pulmonary gradient 32-119, mean 72 +/- 28 mmHg) was observed in 13 pts and/or significant pulmonary regurgitation in 10 pts. The procedure was performed in general anesthesia. The deployment of a valved stent in the pulmonary valve position was preceded by a metal stent implantation. Results were evaluated by echocardiography two days after the procedure and one month later. Four patients were evaluated 6 months after procedure., Results: Time of the procedure varied 60-190 (mean 127 +/- 35) min, time of fluoroscopy ranged 12-31 (mean 21 +/- 11) min. PAVTI was successfully performed in all pts without serious complications. Patients were discharged from the hospital 48-293 (mean 120 +/- 71) h after procedure. Significant reduction of pulmonary gradient after the procedure assessed by echocardiography was observed on the second day (20-60, mean 38 +/- 12 mmHg, p < 0.0001) and one month (19-52, mean 34 +/- 9 mmHg, p < 0.0001). Mild pulmonary regurgitation was observed in 2 pts. In 5 pts evaluated 6 months after procedure haemodynamic parameters were unchanged; no late complications were observed. Average cost of the procedure including a price of the valve (82 000 PLN) was 98 000 PLN., Conclusions: Pulmonary artery valve transvascular implantation is an effective and safe method of non-surgical treatment for patients with homograft dysfunction. Cost-effectiveness is approvable.

Paravalvular leak (PVL) is a complication observed in patients after prosthetic valve replacement. The incidence of PVL is estimated as 2-3%. The cause of PVL may be paravalvular infection, suture continuity disruption, damage of tissues around the annulus or limitation of disc mobility by thrombus or vegetation. The preferable method of treatment of PVL is surgery. Recently, percutaneous closure of PVL became an alternative method. We present a case of successfully completed percutaneous closure of PVL with the use of Amplatzer occluder device in a patient with mitral PVL.

Transcatheter implantation of pulmonary valve became a big step forward in the field of interventional cardiology. It is especially important in the patients with defects of the right ventricular outlet tract, because they were usually candidates for multiple surgical operations. We present first transcatheter replacement of pulmonary valve in 23-years-old man. The 'Melody' valve was implanted successfully. There were no complications and the patient was discharged in good condition.