Occlusion Of Arterial Duct Research Articles

Percutaneous Closure of the Patent Ductus Arteriosus in Very Low Weight Infants: Considerations Following US Food and Drug Administration Approval of a Novel Device

Percutaneous Closure of the Patent Ductus Arteriosus in Very Low Weight Infants: Considerations Following US Food and Drug Administration Approval of a Novel Device

The new amplatzer ductal occluder for transcatheter arterial duct occlusion in children

Objective To describe early clinical experience with the new amplatzer ductal occluder Ⅱ(ADO Ⅱ) for transcatheter patent ductus arteriosus(PDA) in children. Methods Twelve children were diagnosed as PDA from Jan.2013 to Apr.2014 in Guangzhou Children and Women's Hospital.All the children who were treated with the ADO Ⅱ had the indication of a successful interventional therapy successfully.The size of device was chosen according to aortographic and transthoracic echocardiography(TTE) results and pulmonary pressure.The device was delivered in a consequent or reverse way depending on the type of PDA, the minimal diameter of PDA and the size of duct ampulla.The device was delivered in a reverse way in ten patients, and two in a consequent way before detaching the device.Another aortogram was performed in order to check the position and form of the device, the velocities of blood flow in left pulmonary artery and the descending aorta though TTE and whether there was a residual shunt.All patients were exa-mined by TTE in 24 hours after surgery and discharged without any complications 2 days later.The patients were programmed for the cardiologic consult including an TTE and electrocardiogram in 1, 3, 6 and 12 months after discharge. Results Twelve patients(7 male, 5 female) with a median age of(1.59±1.10) years(range 0.53-4.47 years), a median weight of (9.52±3.41) kg(range 5.5-18.3 kg), a median pulmonary blood flow/systemic blood flow(Qp/Qs)of 1.64±0.45(range 1.33-2.85), a median pulmonary artery systolic pressure (32.50±10.05) mmHg(range 23-58 mmHg, 1 mmHg=0.133 kPa), and the minimum (2.40±0.68)mm (1.6-3.8 mm), underwent transcatheter ductal closure with the ADO Ⅱ.Device sizes used were 3 mm×4 mm(n=7), 3 mm×6 mm(n=3), 6 mm×6 mm(n=2), respectively and delivered with 4 or 5 F delivery catheters.The median fluoroscopy time was (6.39±4.16) min(range 3.2-18.2 min). Complete ductal occlusion was achieved by the end of the procedure in 10 patients.The TTE showed good position of the occlusion and the velocities of blood flow in left pulmonary artery and the descending aorta were in a normal range.There was a trivial residual shunt after the surgery of 2 patients.No residual shunt was found after 24 hours in all 12 patients.In 1 case, the patient had a descending aortic obstruction with pressure gradient of 11 mmHg.Three months after surgery, the pressure descended to 10 mmHg by TTE.Complete ductal occlusion without aortic arch or left pulmonary artery stenosis had been identified in other 11 remaining patients on TTE follow-up of 6 months of 3 patients and 12 months of 6 patients. Conclusions The ADO Ⅱ achieves excellent ductal closure rates through low profile delivery systems in small infants and children with moderate and small PDA or morphologically varied PDAs.It is simple in use with few complications.Occlusion design allows closure with arterial or venous approach and delivery with 4 or 5 F delivery catheters.The children who used arterial approach, transthoracic echocardiography TTE is recommended to replace aortic angiography, so as to avoid puncturing the aorta and reduce vascular injury. Key words: Amplatzer ductal occluder Ⅱ; Patent ductus arteriosus; Transcatheter; Child

Early clinical experience with a modified amplatzer ductal occluder for transcatheter arterial duct occlusion in infants and small children

To describe early clinical experience with the amplatzer ductal occluder II additional sizes (ADO II AS) for percutaneous arterial duct occlusion in infants and small children. Pre-, intra- and postprocedural data analysis of all patients undergoing arterial duct occlusion with the ADO II AS from three tertiary referral centers. 17 patients (10 female) with a median age of 6 months (range 1.0-48.1 months) and a median weight of 5.7 kg (range 1.7-17.4 kg) underwent attempted transcatheter ductal closure with the ADO II AS. Retrograde arterial approach was used in eight patients with transvenous femoral approach used in nine. The mean minimal ductal diameter was 2.2 ± 0.7 mm with mean ductal length of 6.8 ± 1.7 mm. Device sizes used were 5/6 (n = 5), 3/4 (n = 4), 4/4 (n = 3), 4/6 (n = 3), and 5/4 (n = 2) with four French delivery sheaths used in all cases. The median fluoroscopy time was 5.7 ± 1.8 min. Two patients underwent delivery under exclusive echocardiography guidance. Complete ductal occlusion was achieved by the end of the procedure in 13 patients. Device embolization to the left pulmonary artery occurred in one patient with successful surgical removal and ligation of the arterial duct. Three patients required device resizing following deployment of the initial device. Complete ductal occlusion without aortic arch or left pulmonary artery stenosis has been identified in all 16 remaining patients on transthoracic echocardiographic follow-up at median of 4.2 months. The new amplatzer ductal occluder II AS achieves excellent ductal closure rates through low profile delivery systems in small infants and children with variable ductal anatomy.

Early clinical experience with a modified amplatzer ductal occluder for transcatheter arterial duct occlusion in infants and small children.

To describe early clinical experience with the amplatzer ductal occluder II additional sizes (ADO II AS) for percutaneous arterial duct occlusion in infants and small children. Pre-, intra- and postprocedural data analysis of all patients undergoing arterial duct occlusion with the ADO II AS from three tertiary referral centers. 17 patients (10 female) with a median age of 6 months (range 1.0-48.1 months) and a median weight of 5.7 kg (range 1.7-17.4 kg) underwent attempted transcatheter ductal closure with the ADO II AS. Retrograde arterial approach was used in eight patients with transvenous femoral approach used in nine. The mean minimal ductal diameter was 2.2 ± 0.7 mm with mean ductal length of 6.8 ± 1.7 mm. Device sizes used were 5/6 (n = 5), 3/4 (n = 4), 4/4 (n = 3), 4/6 (n = 3), and 5/4 (n = 2) with four French delivery sheaths used in all cases. The median fluoroscopy time was 5.7 ± 1.8 min. Two patients underwent delivery under exclusive echocardiography guidance. Complete ductal occlusion was achieved by the end of the procedure in 13 patients. Device embolization to the left pulmonary artery occurred in one patient with successful surgical removal and ligation of the arterial duct. Three patients required device resizing following deployment of the initial device. Complete ductal occlusion without aortic arch or left pulmonary artery stenosis has been identified in all 16 remaining patients on transthoracic echocardiographic follow-up at median of 4.2 months. The new amplatzer ductal occluder II AS achieves excellent ductal closure rates through low profile delivery systems in small infants and children with variable ductal anatomy. © 2012 Wiley Periodicals, Inc. © 147.

Pediatric cardiology Less invasive percutaneous closure of persistent arterial duct in children below 10 kilos

IntroductionThere is quite high risk of vascular complications connected with arterial puncture – mainly in the group of the smallest patients weighing less than 10 kg.AimTo evaluate a new method of percutaneous closure of persistent arterial duct (PDA) in small children.Material and methodsSix patients were enrolled in this method of PDA closure at the age of 10.67 ±1.97 months. The mean weight was 8.85 ±0.66 kg. The occluders were implanted using only venous access. The position of the occluder was determined by angiography in the pulmonary artery through the delivery system and by echocardiography.ResultsThe procedure was effective in all six cases but we managed to proceed in the planned transvenous method in five cases. There was one case of complete duct constriction after introduction of the catheter, so precise measurements were impossible. After removal of the catheter the constriction remitted completely. The duct was closed in the standard manner. During echocardiographic examination we found complete closure of all six arterial ducts directly after the procedures and in the follow-up (9.17 ±3.02 months). No stenosis within the pulmonary arteries or aorta were found.ConclusionsTranscatheter arterial duct occlusion without arterial puncture is an effective and safe method of treatment allowing one to reduce the complications connected with arterial puncture. A possible complication of this method may be a constriction of the duct walls as a result of a larger amount of manipulations.

Clinical evaluation of the new Amplatzer duct occluder II for patent arterial duct occlusion

Several devices such as coils and Amplatzer duct occluder (ADO) are used for catheter closure of patent arterial ducts (PDA). These carry a high success rate but residual shunts, suboptimal device orientation, and technical problems are encountered. The Amplatzer duct occluder II (ADO II) is designed to address these limitations. To evaluate the technical features of the new ADO II device for PDA closure and document the immediate/early closure rate, complications and device behavior during implantation. Prospective, two center study from February 2008 to January 2009. Twenty-seven patients (18 females) received the ADO II. The median age was 22 months (range: 7 months-68 years) and the median weight was 11.7 kg (range: 6.9-108). The median PDA diameter was 2.6 mm (range: 1-4.4). The approach was arterial in 13 and venous in 14 patients. Follow-up included echocardiography at 1 day and 1 month postimplantation. All implantations were technically successful with immediate complete angiographic closure in 21 and trivial contrast flow in six patients. The median procedure time was 43 min (range: 15-82) and the fluoroscopy time was 6 min (range: 2.2-26.5). Echocardiography confirmed no residual shunts on the following day. There were no complications. The new ADO II is a versatile and very effective device for closure of PDAs of various shapes, lengths, and up to diameters of 5.5 mm. The disc articulations, high early closure rate, arterial or venous approach options, and small diameter delivery catheter are all beneficial features.

Severe Mechanical Hemolysis after Complete Occlusion of Arterial Duct

Streptokinase was administered for femoral artery thrombosis in a 14-month-old girl after complete occlusion of an arterial duct with a Jackson coil. Hemoglobinuria started after femoral artery patency was achieved. Ductal shunting was unimpeded 35 hours after cessation of streptokinase. The problem was resolved by implantation of a second coil.

Transcatheter coil occlusion of the arterial duct; results of the European Registry.

To report on the data, collected by the Association for European Paediatric Cardiology (AEPC) Registry, on transcatheter coil occlusion of the arterial duct. A retrospective study was conducted of intention-to-treat data from 30 European and Middle Eastern tertiary referral centres which included an analysis of causes of suboptimal outcome. Since 1994, reports have been made on 1291 attempted coil occlusions of the arterial duct in 1258 patients. Median age at procedure was 4 years (range 0.1-52) and median weight was 29 kg (range 1.8-100). Following coil implantation, the immediate occlusion rate was 59%, which rose to 95% at 1 year. A suboptimal outcome occurred on 129 occasions (10% of procedures) and was defined as coil embolization, an abandoned procedure, persistent haemolysis, residual leak requiring a further procedure, flow impairment in adjacent structures and duct re-canalization. A number of clinical factors were chosen but only increasing duct size [odds ratio of 2.6:1 (CI 2-3.2)] and the presence of a tubular shaped duct [odds ratio 2.4:1 (CI 1.4-4)] were positively associated with an unfavourable outcome. The results of the European Registry support the view that transcatheter coil occlusion of the persistent arterial duct is a safe and effective procedure. Unfavourable outcomes are more likely when closing larger and/or tubular shaped ducts.

Comparison of two transcatheter closure methods of persistently patent arterial duct

A randomized trial of arterial duct occlusion with a double umbrella (DU) or wire coil (WC) was undertaken for patients <18 years of age, weighing >10 kg with isolated ducts ≤3 mm in diameter. Baseline, procedural, and outcome characteristics were compared in an intention-to-treat analysis according to randomization group. From 40 consecutively screened patients, 2 were not enrolled due to a ductal diameter of >3 mm on initial aortography, 38 patients were randomized to either the DU (n = 20) or WC (n = 18) groups. The groups did not differ significantly with respect to age, weight, gender, duct size, type, or branch pulmonary artery diameters. Crossover occurred only in the DU group, where 4 patients (20%) had a ductal diameter of ≤1 mm and could not be entered for umbrella placement. All remaining DU group patients had ductal diameters of ≥1.3 mm (p <0.0001). There were no embolizations or secondary implants in the DU group, but in the WC group there was 1 early and 1 late embolization, with 6 patients (33%) with ≥2 coils. Mean times for the procedure (DU 68 ± 19 minutes; WC 65 ± 27 minutes; p = 0.70) and fluoroscopy (DU 14 ± 4 minutes; WC 11 ± 6 minutes; p = 0.22) did not differ significantly. Angiographic duct closure was documented in 4 of 13 patients (31%) of the DU group and 4 of 18 patients (22%) of the WC group (p = 0.69). Combined with an echocardiogram, closure in 11of 17 patients with DU (65%) and 13 of 18 patients with WC (72%) (p = 0.64) was documented before hospital discharge. One WC group patient received thrombolytic therapy for a femoral artery thrombus. Follow-up at a median of 6.5 months (range 3.2 to 37) showed closure by Doppler echocardiography in 15 of 19 patients with DU (79%) versus 14 of 18 patients with WC (78%) (p = 1.0). Thus, with a tendency toward similar procedural characteristics and outcomes, the higher cost of the DU system compared with coil implants favors the use of coils for closure of the small arterial duct.

An evolving role of transesophageal echocardiography for the monitoring of interventional catheterization in children.

Transesophageal echocardiography (TEE) is increasingly utilized for the monitoring of interventional cardiac catheterization in children. The initial nondiscriminant use is giving way to a more selective approach. The current role and usefulness of this imaging modality are described. Between 1991 and 1995, 44 patients (mean age 7.4 +/- 5 years, weight 22.8 +/- 14.2 kg) underwent interventional cardiac catheterizations performed under TEE monitoring. The interventional procedures included (1) those involving creation, enlargement, or closure of an interatrial communication; (2) balloon dilatation of stenotic lesions; and (3) occlusion of arterial ducts. Transesophageal echocardiographic monitoring was judged to be either of great value, contributory, or of little use if the interventional procedure and choice of instrument relied heavily upon, was guided, or not affected by the information obtained from the ultrasonic investigation, respectively. Transesophageal echocardiography was judged to be of great value in the monitoring of 18 (40%) procedures involving either the creation, enlargement, or closure of interatrial communications. This included 4 transseptal punctures, 4 blade septectomies for relieving restrictive atrial septal defects (n = 3) and an enlargement of the communication between the superior and inferior chambers of the divided left atrium in cortriatriatum, and 11 closures of a secundum atrial septal defect. Only the ultrasonic monitoring could clearly visualize the interatrial partition to provide real-time guidance on the positioning of the instrument to carry out the invasive procedures. Transesophageal echocardiography provided clear images of the hinge points of the aortic and mitral valves, the dimension of the narrowed pulmonary venous pathway in patients after venous switch operation. This facilitated the choice of the correct size of the balloon for dilatation in 11 patients (24%) and provided immediate postdilatation hemodynamic assessment. As for balloon dilation of subvalvar ventricular outflow tract obstruction (n = 3), aortic coarctation (n = 6), and occlusion of persistent arterial duct (n = 7), TEE offered no obvious advantage over fluoroscopy with angiography. The monitoring was judged to be of little value for the 16 (36%) procedures. Transesophageal echocardiographic monitoring is of great value in interventional procedures involving the atrial septum and enhances interventional procedures involving obstructive lesions of the left heart in children.

Clinical results and radiographic appearance of the Rashkind double umbrella device in patients with occlusion of the ductus arteriosus.

The Rashkind double umbrella device for patent arterial duct occlusion has been used in many patients. Its radiographic appearance has not been sufficiently described. To present the varying radiographic appearances of the Rashkind double umbrella device on the chest X-ray. The chest radiographs of 69 patients (median age 60 months; median weight 17 kg), who underwent closure of their patent arterial duct between March 1990 and August 1994, were reviewed. The following parameters were evaluated: 1) the size of the heart (cardio-thoracic ratio) and pulmonary vessels, 2) the position of the device in AP/PA and lateral projections. The results of occlusion of the patent arterial duct were also reviewed. Sixty-two of 69 (90 %) patients had complete occlusion after a follow-up between 2 months and 3(1)/2 years. The cardio-thoracic ratio showed significant reduction at follow-up (P < 0.001). The two different size devices could be well differentiated in the AP and the lateral projection. In 14 patients (20 %) the device was in an asymmetrical position. There was no significant correlation between position of the device and success of occlusion in our material. Complete occlusion of the arterial duct using Rashkind double umbrella devices can be achieved in 90 % of our population. In 20 % the device will have an asymmetrical position. There is no correlation between asymmetrical position of the device in the chest radiograph and residual shunting.

Evolving use of embolisation coils for occlusion of the arterial duct.

To assess the outcome of arterial duct occlusion with coils chosen according to the duct morphology. Retrospective study. Paediatric cardiology centre. Coil occlusion was attempted in 57 patients aged 0.5 to 15 (median 3.7) years and weighing 5-59 (median 14) kg between January 1991 and December 1995. A residual leak was present in 8 patients after umbrella closure and in 4 patients after duct ligation. Coils of 4 different types were implanted through 4 or 5 F femoral artery catheters. Platinum or Interlocking Detachable 0.018 inch coils were deployed completely inside tubular ducts. Gianturco or PDA controlled release 0.038 inch coils were implanted to straddle short, post ligation and post umbrella ducts. Coil implantation was successful in 54/57 patients. At 1 year the cumulative occlusion rate was 53/57 ducts (93%) on an intention to treat analysis. A single coil was implanted in 37 (69%), 2 coils in 10 (19%), 3 coils in 3 (5%) and 4 coils in 4 (7%) of the 54 successful procedures. Duct occlusion was documented at the end of the procedure in 31%, by the following day in 83%, by 6 weeks in 87%, by 6 months in 96%, and by 1 year in 98%. Coil embolisation occurred in 6/58 procedures (10%), with a 50% rate in the first year of implantation (1/2 patients) falling to 7% in the last year (3/42 patients). All embolised coils were easily retrieved. Occlusion of small to moderate size arterial ducts, including residual post umbrella or post ligation ducts, was readily accomplished by coils selected according to the duct anatomy. This has both cost and practical benefits.

Transcatheter occlusion of arterial duct with new detachable coils

SummaryPercutaneous transcatheter embolization of the arterial duct, using new detachable coils, was performed in 19 patients aged from two to 16 years. The minimal ductal diameter ranged from 0.5 to 2.7 mm. We used a 5 mm diameter coil, 8 cm in length and/or an 8 mm diameter coil, which was 10 cm in length. The coil was connected to a delivery wire with a screw system, and could be detached by rotation of the delivery wire. The coil was straightened by inserting a mandril, with loops then being formed by withdrawal of the mandril. In all patients, the coil was advanced retrogradely and either one or two coils were successfully implanted. Implantation was performed in four patients without the catheter entering the pulmonary trunk across the arterial duct. The ductal ampulla was either absent or very small in five patients, so we implanted a coil which had been cut short. Angiography revealed no residual shunting in 14 patients (74%) and trace residual shunting in five patients. Migration of the coils to the pulmonary arteries, or to a systemic artery, did not occur in any patient. Follow-up using Doppler color flow imaging showed complete closure of the arterial duct in all patients (100%), and no turbulence either in the left pulmonary artery or in the descending aorta in any patient. The use of the new detachable coil may improve the accuracy of placement of the device and reduce the incidence of its migration.

Transcatheter occlusion of persistent arterial duct: REPORT OF THE EUROPEAN REGISTRY

Rashkind's "double umbrella" technique for percutaneous transcatheter occlusion of patent arterial duct (ductus arteriosus) has been used successfully in several centres. To assess its feasibility, safety, and efficacy in routine clinical practice, a European registry was established. In 642 of 686 patients entered into the study, the device was successfully implanted at the first attempt, and in a further 9 at a subsequent attempt. 491 patients (71% of all patients entered) had doppler-echocardiographic evidence of complete occlusion with a single device at the latest follow-up. Kaplan-Meier survival estimates indicated a complete occlusion rate of 82·5% (95% Cl 79·4 to 85·8) at one year after implantation of a single device. A second device was implanted in 41 patients with residual flow, and 37 of these had complete occlusion, giving an overall latest follow-up occlusion rate of 77% and an actuarial complete occlusion rate for one or two devices of 94·8% (95% Cl 92·9 to 96·7) at 30 months after implantation of the first device. 2 early deaths occurred (0·3%), both in patients with associated ventricular septal defect. Complications included embolisation of the device in 18 patients (2·4%), of whom 6 underwent catheter-retrieval of the device. Mechanical haemolysis occurred in a further 4 patients (0·5%). Transcatheter occlusion of the arterial duct is a safe and effective alternative to surgical closure. A second device is sometimes needed to achieve complete occlusion.