Case report: Transcatheter closure of a giant and tortuous right coronary artery to right ventricle fistula in an infant.

Congenital coronary artery fistulas (CAFs) are an uncommon congenital anomaly. While most patients are asymptomatic, life-threatening events including sudden death, myocardial ischemia, heart failure, infective endocarditis, and rupture of aneurysm may occur. Surgical ligation was once the standard choice of management of CAFs in the past. However, transcatheter closure of CAFs has become an emerging alternative to surgery in patients with suitable anatomy. We reported a 7-month-old infant with a giant and tortuous CAF that originated from the distal right coronary artery and drained into the right ventricle, and was successfully treated by transcatheter closure with an Amplatzer ductus occluder.

Wheezing caused by a patent ductus arteriosus (PDA) device occluder: Case report and review of the literature.

Wheezing often occurs in infants and young children with respiratory infections. For children with recurrent wheezing, after controlling their wheezing, they should be alert to rare diseases. Here, we report a case of wheezing following the application of the patent ductus arteriosus occlusion device ADO II (AGA Medical Corporation) with the occlusion device pressing against the adjacent left main bronchus. After the pressure end of the occluder was removed, the child's wheezing was effectively relieved.

Percutaneous management of a ruptured sinus of Valsalva aneurysm in an infant.

Ruptured sinus of Valsalva aneurysm is a rare entity in children. To our knowledge, this is the youngest child reported in the literature with a sinus of Valsalva ruptured aneurysm being successfully treated percutaneously using an AmplatzerTM Duct Occluder II Additional Sizes device.

Effect of transcatheter closure by AmplatzerTM Duct Occluder II in patients with small ventricular septal defect.

Transcatheter closure of ventricular septal defect (VSD) is an alternative treatment of surgery. However, because of the potential risk of the complete atrioventricular block (AVB) and the lack of available dedicated devices for VSD, this procedure rarely used most centers. Recently in Thailand, with distinct device design that may cause less clamp force and radial force, the AmplatzerTMDuct Occluder (ADO) II has become available for the closure of small VSDs. This is a retrospective review of 49 patients who underwent transcatheter VSD closure using ADO II at Songklanagarind hospital and Queen Sirikit National Institute of Child Health between January 2014 and December 2016 with an intention to report procedural success rate and 12-months-outcomes. Twenty-six cases were female. The median age and weight at treatment were 7.8 year (ranged from 1.9 to 25 year) and 25.1 kg (ranged from 11 and 57 kg). The majority (65.3%) of the VSD was a perimembranous defect. The mean diameter of LV entry was 5.2 ± 2.5 mm and the mean RV exit was 3.2 ± 0.8 mm. Four patients had more than 1 exit at RV orifice. The mean length of the VSD was 5.3 ± 1.8 mm. The mean aortic valve-VSD distance was 3.9 ± 2.0 mm. The mean tricuspid valve-VSD distance was 3.8 ± 2.5 mm. The procedural success achieved in all patients (100%), most of the implantations were performed in a retrograde approach (53.1%). The ADO II was successfully implanted in 2 cases (5%) who failed other devices in the first attempts. There were no major complications. There were no changes in the severity of tricuspid and aortic valve regurgitation immediate after implantation and at 12 months' follow-up. Three patients (6%) had tiny to small residual shunt at 12 months' follow-up. None of the patients had a complete heart block. However, new-onset of left bundle branch block and right bundle branch block occurred in 2 (5%) cases and 5 (10%) cases, respectively. With symmetrical double-disc design and softness of the device, the ADO II can be safely and effectively used for closure of the VSDs with the defect size less than 6 mm.

Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams.

OBJECTIVES: Characterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure. BACKGROUND: The presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature. METHODS: This was a single arm, prospective, multicenter, non-randomized study to evaluate the Amplatzer Piccolo Occluder to treat PDA in patients ≥700 g. From June 2017 to February 2019, 200 patients were enrolled at nine centers, with 100 patients weighing ≤2 kg. Primary effectiveness endpoint was the rate of PDA closure at 6-month follow-up. Primary safety endpoint was the rate of major complications through 6 months. Secondary endpoint was rate of significant pulmonary or aortic obstruction through 6 months' follow-up. RESULTS: The implant success rate was 95.5% (191/200) overall and 99% in patients ≤2 kg (99/100). The primary effectiveness endpoint was achieved in 99.4% of implanted patients. Four patients experienced a primary safety endpoint event (2 transfusions, 1 hemolysis, and 1 aortic obstruction). There were no branch pulmonary artery obstructions. Five patients, all ≤2 kg, were noted to have worsening of tricuspid regurgitation (TR) after the procedure. None of the TR incidences manifested clinically. The Amplatzer Piccolo Occluder received FDA approval in January 2019 and became the first device approved for PDA closure in patients ≥700 g. CONCLUSIONS: This study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700 g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier: NCT03055858.

Can transcatheter PDA closure be performed in neonates ≤1000 grams? The Memphis experience.

OBJECTIVE: Advancements in transcatheter technology have now made it possible to safely close patent ductus arteriosus (PDA) in extremely low birth weight (ELBW) infants. The objective of this article is to describe our technique for transcatheter PDA closure (TCPC) in ELBW infants. DESIGN: The techniques employed are very specific to this population and are drastically different when compared to the procedure performed in patients weighing >5 kg. SETTING: A multidisciplinary team approach should be taken to evaluate and manage ELBW infants in order to achieve success. It is important that specific techniques with venous-only approach outlined in this article be followed to achieve optimal results with low risk of complications. PATIENTS: To date, in Memphis, 55 ELBW infants have had successful TCPC at a weight of ≤1000 g with minimal procedure-related complications. INTERVENTIONS: It is important that specific techniques with venous-only approach outlined in this article be followed to achieve optimal results with low risk of complications. OUTCOME MEASURES: This procedure entails a steep learning curve and should be limited to specialized centers with expertise in these thanscatheter procedures. RESULTS: There has been 100% procedural success of performing TCPC in children ≤1000 g. There have been only two procedure-related complications which happened to the first two patients, ≤1000 g, that we performed TCPC on. CONCLUSIONS: It is feasible and probably safe to perform TCPC in children ≤1000 g. The techniques described in this article represent our institutional experience and have helped us improve clinical outcomes in ELBW infants.

New Patent Ductus Arteriosus Closure Devices and Techniques.

Patent ductus arteriosus (PDA) in extremely low-birth-weight infants puts this vulnerable population at high risks of morbidity and mortality. Inclusion of a multidisciplinary team and newly available transcatheter PDA occlusion devices in the management of these infants can mitigate those risks and promote better long-term outcomes. It is important that specific techniques with venous-only approach outlined in this article be followed to achieve optimal results.

Treatment of congenital non-ductal shunt lesions with the amplatzer duct occluder II.

Amplatzer Duct Occluder II (ADO II) is especially designed for closing long ducts in infants. The experience with off-label use of ADO II in non-ductal positions is limited. AIM: To evaluate feasibility of use of ADO II in non-ductal positions, incidence of complete heart block (CHB), advantages and disadvantages. MATERIAL AND RESULTS: Out of 79 defects closed with ADO II, 61 had perimembranous, 12 apical/mid-muscular ventricular septal defects (VSD), 4 Gerbode defects, one each of coronary arterio-venous fistula and aorto-right ventricular tunnel. Age ranged from 8 months to 21 years (mean 8.9 ± 4.02 years, median 9 years). The mean fluoroscopy time was 5.2 ± 1.1 min with range 4.2-9.2 min. Complete closure was achieved in all. Three cases developed transient junctional bradycardia, treated with steroids. One patient who developed CHB (1.3%) needed temporary pacing. DISCUSSION: ADO II is a low profile device. It can be easily delivered through a 5F guiding catheter and needs very short fluoroscopic time as arteriovenous loop is not needed. The cost is 1/3 of regular ventricular septal occluders. The CHB that is a major challenge for closure of VSDs is less common with soft, specially designed ADO II, which does not compress the conducting system. CONCLUSIONS: Use of the ADO II in non-ductal positions can be achieved with high success and low complication rates, especially CHB; its use is also associated with significantly reduced procedure time and device cost. Device size availability restricts use of the ADO II to defects up to 6 mm in diameter. © 2013 Wiley Periodicals, Inc.

Use of ADO II device in a large aorto-pulmonary collateral -an interesting case.

A 11month old girl was diagnosed to have a large aorto pulmonary collateral during evaluation for respiratory distress and seizures. Echocardiographic evaluation showed a large collateral from the descending aorta to left lung with ventricular dysfunction (left ventricular ejection fraction of 40%). This was confirmed on computed tomography angiogram (CT) scan. The collateral was closed with Amplatzer Ductal Occluder II device under fluoroscopic guidance. To the best of our knowledge, this is the first reported case of large aorto-pulmonary collateral closed successfully with an Amplatzer Ductal Occluder II device.