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Ductal Occluder (ductal + occluder)
Selected AbstractsLung perfusion studies after transcatheter closure of persistent ductus arteriosus with the Amplatzer duct occluder,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2010Tugcin Bora Polat MD Abstract Background: Reduced left lung perfusion has been described after transcatheter closure of the patent ductus arteriosus (PDA) with several prostheses. Although the Amplatzer ductal occluder (ADO) device is currently the most widely used occluder for closure of large-sized PDAs, the potential consequences of flow distribution to the lungs of this device have not been completely clarified. We evaluated lung perfusion following occlusion of PDA with the ADO device. Methods: Forty-seven patients underwent successful transcatheter PDA occlusion using the ADO device were included in this study. Lung perfusion scans were performed 6 months after the procedure. Results: Decreased perfusion to the left lung (defined as < 40% of total lung flow) was observed in 17 patients (36%), 5 of whom were low-weight symptomatic infants. Ductal ampulla length was significantly shorter and minimal ductal diameter to ampulla diameter ratio was significantly higher in patients with decreased left lung perfusion and correlated well with left lung perfusion values (r = 0.516 and r = ,0.501, respectively). A cut-off value of ,5.8 mm for the ductal ampulla length and ,1.9 for ampulla diameter to ampulla length ratio showed high sensitivity and specificity for reduced lung perfusion. Conclusions: The incidence of abnormal left lung perfusion is high 6 months after transcatheter closure of PDA with the ADO, more likely in the low weight symptomatic infants and in patients with a short duct or a relatively shallow duct having abrupt narrowing of a large ampulla. © 2010 Wiley-Liss, Inc. [source] Early clinical experience with the new amplatzer ductal occluder II for closure of the persistent arterial duct,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2009Jonathan Forsey MB, MRCPCH Abstract Objectives: To describe the early single-center clinical experience with the Amplatzer Ductal Occluder II (ADO II). Methods: All patients undergoing attempted transcatheter closure of persistent arterial duct (PDA) with the ADO II were included. Data collected included demographic, clinical, and echocardiographic parameters. Results: From March until September 2008, 29 procedures were undertaken in 27 patients (21 female). Median age was 1.4 years (range 0.4,76 years) with median weight 9.4 kg (range 4.7,108 kg). A transarterial approach was used in 2 patients. The median minimum ductal diameter was 2.7 mm (range 1.7,5). ADO II was released in 25 patients (92.5%). Two patients had significant residual shunting following deployment of ADO II and underwent closure with Amplatzer ductal occluder (ADO I). Postprocedural echocardiography identified one occluder had changed position with development of a significant leak and one occluder had embolized to the left pulmonary artery. Both occluders were retrieved successfully at a second catheter procedure. Complete occlusion was noted predischarge in 22 of the remaining 23 occluders (96%). One patient had mild flow acceleration in the left pulmonary artery which has resolved. Conclusions: The ADO II is highly effective at providing rapid occlusion of morphologically varied PDAs. Occluder design allows closure with arterial or venous approach and delivery with 4 or 5 F delivery catheters. Stable occluder position is dependent on correct positioning of both aortic and pulmonary discs. A larger range of sizes and configurations of this occluder may be required to successfully occlude all ductal sizes and morphologies. © 2009 Wiley-Liss, Inc. [source] Percutaneous closure of perimembranous ventricular septal defect associated with a ventricular septal aneurysm using the Amplatzer ductal occluderCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2005Christopher A. Tan MD Abstract Amplatzer ductal occluders were used for percutaneous closure of perimembranous ventricular septal defects with associated ventricular septal aneurysm in three patients. The device was well positioned and the ventricular left-to-right shunt was significantly decreased in all three patients. The procedure was tolerated well without complications in each case. © 2005 Wiley-Liss, Inc. [source] Pediatric Interventional Cardiology in the United States is Dependent on the Off-label Use of Medical DevicesCONGENITAL HEART DISEASE, Issue 1 2010Jamie S. Sutherell MD ABSTRACT Objective., A substantial unmet medical device need exists in pediatric care. As a result, the off-label use of approved devices is routine in pediatric interventional cardiology, but the extent and nature of this practice has not been previously described. The purpose of this study, therefore, is to evaluate the prevalence and nature of off-label cardiac device use in an active pediatric interventional program in the United States. Study Design., This study is a retrospective review of all interventional cardiac procedures performed at our institution from July 1, 2005 to June 30, 2008. Diagnostic (noninterventional) catheterizations, myocardial biopsies, invasive electrophysiology studies, and studies involving investigational devices were excluded. Interventions performed were compared with the manufacturer's labeled indications for each device. Results., During this 3-year period, 473 patients (median age 4.1 years) underwent 595 transcatheter interventions. An approved device was utilized for an off-label application in 63% of patients, and in 50% of all interventions performed. The most frequent off-label procedures were stent implantations (99% off-label), balloon dilations (78% off-label), and coil embolizations (29% off-label). In contrast, the off-label use of septal and ductal occluders was relatively uncommon. Conclusions., In our routine (noninvestigational) practice of pediatric interventional cardiology, 63% of patients underwent procedures utilizing medical devices for off-label indications. These data underscore the need to enhance cardiac device review and approval processes in the United States to include pediatric applications. [source] Percutaneous closure of perimembranous ventricular septal defect associated with a ventricular septal aneurysm using the Amplatzer ductal occluderCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2005Christopher A. Tan MD Abstract Amplatzer ductal occluders were used for percutaneous closure of perimembranous ventricular septal defects with associated ventricular septal aneurysm in three patients. The device was well positioned and the ventricular left-to-right shunt was significantly decreased in all three patients. The procedure was tolerated well without complications in each case. © 2005 Wiley-Liss, Inc. [source] |