Long-term follow-up of percutaneous secundum-type atrial septal defect closure using Amplatzer Septal Occluder since 1995: a single-centre study.

INTRODUCTION: The goal of this single-centre study was to evaluate long-term results of percutaneous closure of secundum-type atrial septal defect using Amplatzer Septal Occluder with the follow-up to 25 years. METHODS: A retrospective analysis of patients who underwent percutaneous closure of secundum-type atrial septal defect between September 1995 and October 2012 in our institution was performed. All procedures were performed after fulfilling strict indication criteria. More than 5 years follow-up was reached in 651/803 patients (81%) with median follow-up time of 12 (5-25) years. RESULTS: The mean stretched defect diameter was 14,0 ± 5,2 mm. Early reintervention due to moderate or severe residual atrial septal defect had to be performed in 3/803 patients (0,03%). The incidence of long-term moderate or severe residual atrial septal defect was 0,0%. The complete closure rate at 10-year follow-up was 98,5%, as trivial residual shunts persisted in 8/508 patients (1,5%). A significant rate of the echocardiographic right ventricular end-diastolic diameter post-procedural normalisation (p < 0,05) was encountered. The rate of major complications was 0,5%. One device embolisation, one thrombus formation at the occluder surface, and one cardiac erosion in periprocedural or short post-procedural course were experienced. Only one late complication of infective endocarditis at the region of implanted occluder and the aortic valve was detected. The survival rate of all followed patients was 100%. CONCLUSIONS: Percutaneous closure of secundum-type atrial septal defect using Amplatzer Septal Occluder is a safe and effective procedure accounting for a very low incidence of major complications in the long-term follow-up.

Comparison of Non-Gated vs. ECG-gated CT Angiography of Fontan Circulation in Patients with Implanted Stents in Pulmonary Branches.

BACKGROUND: Motion artifacts may degrade CT examination of Fontan pathway and hinder accurate diagnosis of in-stent restenosis. PURPOSE: We retrospectively compared ECG-gated multi-detector computed tomography (CT) with non-ECG-gated CT in order to demonstrate whether or not one of the methods should be preferred. METHOD: The study included 13 patients with surgically reconstructed Fontan pathway. A total of 16 CT examinations were performed between February 2010 and November 2015.The incidence of motion artifacts in Fontan pathway and pulmonary branches were analysed subjectively by two readers. The effective dose for each examination was calculated. RESULTS: Just in one non-gated CT examination was evidence of motion artifact in distal part of left pulmonary artery. The mean normalized effective radiation dose was 2.33 mSv (±0.62) for the non-ECG-gated scans and 4.55 mSv (±0.85) for the ECG-gated scans (p ≤ 0.05). CONCLUSION: Non-gated CT angiography with single phase reconstruction significantly reduces radiation dose without loss of image quality compared with ECG-gated CT angiography.

First experience with AndraStent XL implantation in children and adolescents with congenital heart diseases.

OBJECTIVES: To present our experience with a new type of extra-large (dilatable up to 25 mm), balloon-expandable, nonpremounted, cobalt-chromium peripheral stent with semiopen designed cells: AndraStent. METHODS: Between December 2008 and August 2011, 21 AndraStents in 21 patients were implanted into vessel stenoses of varied localizations. AndraStents XL of 21, 30, and 39 mm in length were used. The median age and weight of patients at stent implantation were 11.6 years (range 2.1-19.1 years) and 36 kg (range 11-82 kg), respectively. The stent was implanted into the left pulmonary artery stenosis (n = 12), into the aortic isthmus (n = 7), into a stenosed aortopulmonary collateral artery (n = 1) and into a stenosed systemic venous tunnel postSenning operation (n = 1). RESULTS: All the implantations were successfully performed; there was one major vessel access complication necessitating vascular surgery. The diameter of the vessel stenosis increased significantly (P < 0.05) from a median of 5.7-11 mm. The stent foreshortening was only mild. CONCLUSIONS: Our initial results show that AndraStents are implantable and efficacious in different vascular stenoses and present a valuable alternative to the available large stents. With the application of a modified front-loading technique, they can also be implanted in smaller children.

The new Amplatzer duct occluder II: when is its use advantageous?

OBJECTIVES: To determine the safety and efficacy of the Amplatzer duct occluder and the Amplatzer duct occluder II in different types of arterial ducts, and to determine in which types of ducts the use of this new device can be advantageous. METHODS: All children with a device-based ductal closure between September, 2005 and February, 2010 were included. We retrospectively analysed the catheterisation and follow-up data. RESULTS: Between September, 2005 and February, 2010, 44 ducts were closed with the Amplatzer duct occluder - group Amplatzer duct occluder - and 52 ducts were closed with the Amplatzer duct occluder II - group Amplatzer duct occluder II. In the Amplatzer duct occluder group, the mean age was 3 years and 4 months, and the mean weight was 14.7 kilograms. Closure was successfully performed in all children. Complete closure at 24 hours was attained in 42 of 44 children (95.45%). No major complications occurred. In the Amplatzer duct occluder II group, the mean age was 6 years and 2 months, and the mean weight was 25.4 kilograms. Closure was successfully performed in all children, except in two children in whom the occluder protruded into the aortic isthmus and was replaced by the Amplatzer duct occluder. Complete closure at 24 hours was attained in 51 of 52 children (98.08%). No major complications occurred. CONCLUSION: In our experience, duct closure with the Amplatzer duct occluder II is a safe and effective method. The advantages of using it are the smaller sheath sizes and softer shape.

Percutaneous management of cyanosis in Fontan patients using Amplatzer occluders.

OBJECTIVES: To determine causes of cyanosis and to evaluate percutaneous management of cyanosis in a group of consecutive Fontan patients. BACKGROUND: A variety of communications allow a right-to-left shunt in Fontan circulation causing cyanosis and these communications are amenable to percutaneous closure. METHODS: Between November 1997 and November 2007, 45 consecutive patients ranging in age from 2.5 to 26 years (median 8 years) with Fontan circulation and cyanosis underwent cardiac catheterization and percutaneous closure of superfluous communications using different types of Amplatzer occluders. RESULTS: Altogether, 51 communications were detected and 50 of them were closed. In 5 patients (11.1%), multiple communications were present and were closed. Fenestration was detected in 37 of 41 patients (90.2%) after total cavopulmonary connection and all were closed by Amplatzer septal occluders. Five venous collaterals were revealed in 3 of 41 patients (7.3%) with total cavopulmonary anastomosis and were closed by Amplatzer vascular plugs. In 3 patients, lateral tunnel leaks were detected and were closed by Amplatzer PFO occluders. In 4 patients after Kawashima operation, 3 major pulmonary arterio-venous malformations and single venous collateral contributed to the cyanosis and all were closed using Amplatzer vascular plugs. CONCLUSIONS: Different communications cause cyanosis in Fontan patients. Progressive decline of percutaneous oxygen saturation is suggestive of development of venous collaterals or pulmonary arteriovenous malformations. Superfluous communications are amenable to percutaneous closure using various types of Amplatzer occluders. A novel use of an Amplatzer PFO occluder for the percutaneous closure of a lateral tunnel leak is described.

Utilisation of three-dimensional printed heart models for operative planning of complex congenital heart defects.

BACKGROUND AND AIM: To evaluate the accuracy of the three-dimensional (3D) printing of cardiovascular structures. To explore whether utilisation of 3D printed heart replicas can improve surgical and catheter interventional planning in patients with complex congenital heart defects. METHODS: Between December 2014 and November 2015 we fabricated eight cardiovascular models based on computed tomography data in patients with complex spatial anatomical relationships of cardiovascular structures. A Bland-Altman analysis was used to assess the accuracy of 3D printing by comparing dimension measurements at analogous anatomical locations between the printed models and digital imagery data, as well as between printed models and in vivo surgical findings. The contribution of 3D printed heart models for perioperative planning improvement was evaluated in the four most representative patients. RESULTS: Bland-Altman analysis confirmed the high accuracy of 3D cardiovascular printing. Each printed model offered an improved spatial anatomical orientation of cardiovascular structures. CONCLUSIONS: Current 3D printers can produce authentic copies of patients` cardiovascular systems from computed tomography data. The use of 3D printed models can facilitate surgical or catheter interventional procedures in patients with complex congenital heart defects due to better preoperative planning and intraoperative orientation.

Long-term outcome of transcatheter secundum-type atrial septal defect closure using Amplatzer septal occluders.

OBJECTIVES: The aim of this study was to assess long-term results of percutaneous closure of secundum-type atrial septal defect (ASD II) using Amplatzer septal occluders (ASO). BACKGROUND: Only immediate-, short-, and intermediate-term results of ASO implantation are known so far. METHODS: Between September 1995 and January 2000, 151 patients underwent a successful percutaneous closure of ASD II in our institution. All were included in the present study and were followed up until September 2004. RESULTS: This group of patients was followed up from 56 to 108 months (median 78 months). The mean stretched defect diameter was 15.9 +/- 4.8 mm. There were no deaths or significant complications during the study. At three years of follow-up, all defects were completely closed and remained closed thereafter. CONCLUSIONS: Since the first human implantations in September 1995, the Amplatzer septal occluder proved as a safe and effective device for percutaneous closure of ASD II.

Long-term outcome of transcatheter patent ductus arteriosus closure using Amplatzer duct occluders.

BACKGROUND: Immediate-, short-, and intermediate-term results of percutaneous patent ductus arteriosus (PDA) closure using Amplatzer duct occluders are excellent. However, long-term results have not yet been reported to date. METHODS: Between September 1996 and April 2002, 64 consecutive patients having isolated PDA with minimal diameter of > or =2 mm underwent percutaneous closure using Amplatzer duct occluders. All patients were included in this study and have been followed up until September 2005. RESULTS: Patients have been followed up from 40 to 108 months (median 58 months). The mean PDA diameter was 3.5 +/- 1.6 mm. There were no deaths or significant complications during the study period. At a 1-month follow-up, all PDA were completely closed and remained closed thereafter. CONCLUSIONS: Since the initial clinical experience in September 1996, the Amplatzer duct occluder has been proven as a safe and effective device for transcatheter PDA closure. Based on our experience, we believe that in patients having completely closed PDA with laminar blood flow pattern in the descending thoracic aorta and left pulmonary artery at a 1-year follow-up, there is no need for further evaluations. In contrast, few remaining patients need a careful follow-up until a complete normalization of all findings.

A complex pulmonary vein varix -- diagnosis with ECG gated MDCT, MRI and invasive pulmonary angiography.

A case of an asymptomatic 32-year-old male with a complex congenital pulmonary vein varix is reported herein. Chest X-ray incidentally revealed a tubular opacity passing from the periphery of the left lingula to the mediastinum. ECG gated multidetector computed tomography showed the opacity to be a vessel emptying into the left atrium via the left superior pulmonary vein. In addition, a second vascular structure was noted within the posterior mediastinum that was emptying into the same pulmonary vein. These findings were also confirmed by magnetic resonance imaging, 4D magnetic resonance angiography and invasive arterial angiography. Based on multimodality imaging findings the diagnosis of complex congenital pulmonary venous varix with posterior mediastinal extension was established.

Transcatheter occlusion of patent ductus arteriosus using a new angled Amplatzer duct occluder: initial clinical experience.

In the present study, we report the initial clinical experience with the new angled Amplatzer duct occluder (ADO) for the percutaneous closure of patent ductus arteriosus (PDA). Percutaneous closure of PDA using standard ADO in infants and in patients with small PDA ampulla is difficult, or even impossible, due to protrusion of the aortic disk into the descending thoracic aorta. The aortic disk of an angled ADO is angled at 32 degrees to the body of the device and concave toward the aorta to prevent protrusion of the disk into the aorta. Percutaneous closure of PDA was attempted in nine patients with a median age of 5.2 years (range, 0.5-12.7) and median weight of 20 kg (range, 4.9-55). Selection of the occluder and the implantation technique were similar to the standard ADO. The minimal PDA diameter ranged from 2.1 to 3.7 mm (median, 2.5 mm). Occluders were successfully implanted in all patients. Immediate complete PDA closure was achieved in all patients. There were no complications. The new angled ADO is a safe and effective device for PDA closure, particularly suitable for infants and patients with small PDA ampulla. Further studies and long-term follow-up are necessary to confirm our initial experience.

Transcatheter closure of double atrial septal defects with a single Amplatzer device.

Transcatheter closure of single secundum atrial defects has become the standard of treatment. The purpose of our study was to analyze the results of using a single Amplatzer device for closure of double atrial septal defects. Such defects were diagnosed in 41 out of 363 patients with atrial septal defects (ASDs) closed by transcatheter method. In 39, a single Amplatzer device was used. The size of the larger defect ranged from 5 to 18 mm, the smaller defect from 2 to 7 mm, with the distance between the borders of the communications ranging from 2 to 12 mm. We performed sizing and closure of only the larger defect. The mean size of implanted devices was 16.5 +/- 5.5 mm, equal to the stretched diameter of the main defect or 1-4 mm larger. The closure rate assessed by color Doppler flow examination was 61% after 24 hr, 78% after 1 month, 83% after 3 months, 86% after 1 year, and 95% after 2 years. If the distance between the two defects exceeded 7 mm, residual leaks were observed but tended to decrease and disappear with time. Selected patients with double atrial septal defects can be effectively treated with implantation of a single Amplatzer device.

Initial human experience with the Amplatzer perimembranous ventricular septal occluder device.

Transcatheter closure of perimembranous ventricular septal defects with coils or devices designed to close other lesions may be complicated by embolization or aortic insufficiency. A new asymmetric Amplatzer perimembranous ventricular septal occluder and delivery system was specifically designed for perimembranous defects. This report describes the first use of this device in 27 patients. Implantation was successful in 25 (93%), with 1 removed for device-related aortic insufficiency and inability to position the delivery sheath in another. Device orientation was excellent when the device was initially advanced through a standard delivery sheath positioned in the left ventricular apex. Twenty-three had complete occlusion within 1 week (92%), with a tiny (< 2 mm) residual shunt in the other two. In the 25 subjects with the device left in place, device-related aortic or tricuspid insufficiency, arrhythmias, and embolization were not observed. These excellent acute results need to be confirmed by long-term follow-up.

Percutaneous closure of perimembranous ventricular septal defects with the Amplatzer device: technical and morphological considerations.

Percutaneous closure of perimembranous ventricular septal defects (VSDs) has been feasible, safe, and effective with the new Amplatzer membranous septal occluder. We report further experience with this device with emphasis on morphological aspects of the VSDs and technical issues. Ten patients (median age and weight, 14 years and 34.5 kg, respectively) with volume-overloaded left ventricles underwent closure under general anesthesia and transesophageal guidance (TEE). The VSD diameter was 7.1 +/- 4.0 mm by angiography and 7.8 +/- 3.7 mm by TEE. Three patients had defects associated with aneurysm-like formations (two with multiple exit holes), four had defects shrouded by extensive tricuspid valve tissue, two had defects with little or no tricuspid valve involvement, and one had a right aortic cusp prolapse with trivial aortic regurgitation. Implantation was successful in all patients, although in two the initial device had to be changed for a larger one. Kinkings in the delivery sheath, inability to position the sheath near the left ventricular apex, and device prolapse through the VSD prompted modifications in the standard technique of implantation. Device orientation was excellent except in one case. Nine patients had complete occlusion within 1-3 months. Device-related aortic or tricuspid insufficiency, arrhythmias, and embolization were not observed. Two patients had slight gradients across the left ventricular outflow tract, normalizing after 3 months. The Amplatzer membranous septal occluder was suitable to close a wide range of perimembranous VSD sizes and morphologies with good short-term outcomes. Longer follow-up is required.

Percutaneous closure of perimembranous ventricular septal defects with the amplatzer device: technical and morphological considerations

Percutaneous closure of perimembranous ventricular septal defects (VSDs) has beenfeasible, safe, and effective with the new Amplatzer membranous septal occluder. Wereport further experience with this device with emphasis on morphological aspects of theVSDs and technical issues. Ten patients (median age and weight, 14 years and 34.5 kg,respectively) with volume-overloaded left ventricles underwent closure under generalanesthesia and transesophageal guidance (TEE). The VSD diameter was 7.1 4.0 mm byangiography and 7.8 3.7 mm by TEE. Three patients had defects associated withaneurysm-like formations (two with multiple exit holes), four had defects shrouded byextensive tricuspid valve tissue, two had defects with little or no tricuspid valve involvement,and one had a right aortic cusp prolapse with trivial aortic regurgitation. Implantationwas successful in all patients, although in two the initial device had to be changedfor a larger one. Kinkings in the delivery sheath, inability to position the sheath near theleft ventricular apex, and device prolapse through the VSD prompted modifications in thestandard technique of implantation. Device orientation was excellent except in one case.Nine patients had complete occlusion within 1–3 months. Device-related aortic or tricuspidinsufficiency, arrhythmias, and embolization were not observed. Two patients hadslight gradients across the left ventricular outflow tract, normalizing after 3 months. TheAmplatzer membranous septal occluder was suitable to close a wide range of perimembranousVSD sizes and morphologies with good short-term outcomes. Longer follow-upis required.