Transcatheter closure of patent ductus arteriosus in children and adults

AIM: To describe the initial New Zealand experience of transcatheter patent ductus arteriosus closure in adults and children. METHODS: Twenty-three children beyond infancy and four adults with isolated patent ductus arteriosus were selected for transcatheter umbrella closure. Rashkind umbrellas were placed across the patent ductus arteriosus through a percutaneously inserted long venous sheath using the Mullins technique. RESULTS: In 25 of the 27 patients a Rashkind umbrella was placed accurately. In two patients the umbrella could not be placed accurately: in one the procedure was abandoned uneventfully and in one the umbrella embolised to the right pulmonary artery necessitating surgical removal of the device and patent ductus arteriosus closure. There were no other significant complications. A second umbrella insertion is planned in two children for a significant residual leak at 1-year follow up. CONCLUSIONS: Transcatheter patent ductus arteriosus closure is a low risk and usually effective alternative to surgical closure for the majority of patients beyond infancy.     

Controllable graded cerebral ischaemia in the gerbil: studies of cerebral blood flow and energy metabolism by hydrogen clearance and 31P NMR spectroscopy

Patent ductus arteriosus is an uncommon anomaly in adult patients. Surgical closure of patent ductus arteriosus in this age group presents difficult problems to the surgeon. We report our experience of 21 adult patients (19-62 years of age, mean 40 years) who underwent closure of the ductus by transfemoral implantation of a Rashkind double umbrella device. The patients came to light because of atrial fibrillation, congestive heart failure, residual flow after surgical ligation of the duct or because of incidental diagnosis made during physical examination or chest X-ray. In ten patients the pulmonary arterial pressure was normal (systolic pressure < 30 mmHg), in eleven it was elevated (systolic pressure from 30 to 100 mmHg, mean 50 mmHg). In seven patients the duct was clearly calcified and the size of the duct varied from 3 to 9 mm (mean 4.3 mm). In 16 patients the ductus resulted perfectly closed after implantation of the first double umbrella device, two patients had minimal residual aortopulmonary flow, whereas in three patients the residual shunt was significant; two of these also developed haemolysis and went to surgery, in the latter the shunt was completely abolished after implantation of a second 17-mm device 16 months later. In conclusion transcatheter closure of patent ductus arteriosus in adults is feasible, even in the presence of calcifications and/or pulmonary hypertension; taking into account the significant surgical risk, PDA umbrella closure should be considered the first choice procedure in this group of patients.     

Residual shunts after application of the Rushkind occlusion system in closure of persistent ductus arteriosus. Insertion of a second device

From May 1991 to August 1994, we performed transcatheter closure of patent ductus arteriosus with Rashkind umbrella system in 25 patients. In one, the device had embolism, to the right pulmonary artery and was operated 24 hs afterwards without complications. Seven had residual shunts, two had subsequent surgery, two are being followed (one for mild and one for moderate residual shunt). In the other three cases we inserted a second device. We used a 12 mm device in two cases and a 17 mm device in the other. Two cases had total occlusion 24 hrs after and in one had mild residual shunt without clinical repercussion. There were no complications. All had electrocardiographic and clinical improvement, take no medication, and their cardiomegaly had decreased (Cardiac index pre 61 vs post 54%). In conclusion the insertion of a second device is safe and effective alternative for residual shunt after first Rashkind occluder.     

Multicentric Castleman''s disease in HIV infection: a clinical and pathological study of 20 patients

Techniques of transcatheter device placement for treatment of pediatric congenital heart disease have developed substantially since their introduction 20 years ago. Patent ductus arteriosus occlusion can be accomplished by umbrella deployment or coil placement. Intracardiac defects can be closed with umbrella or buttoned devices. Stenoses of vessels or conduits that are only temporarily relieved with balloon dilation can be effectively expanded with intravascular stents. Recent procedural modifications have been introduced in an attempt to minimize the size of the delivery sheath and reduce complications that can arise from device embolization. Transcatheter device placement can be an important adjunct to surgery for correction or palliation of congenital heart lesions.     

Transcatheter closure of residual atrial septal defect following implantation of buttoned device

We report a case in which residual shunting after a buttoned device occlusion of atrial septal defect (ASD) was eliminated by transcatheter retrieval of a portion of the device, followed by implantation of a second device. This method may be helpful for those patients with residual ASDs who decline surgical device retrieval and defect closure.     

Closure of atrial septal defects with the Amplatzer occlusion device: preliminary results

OBJECTIVES: This study reports our clinical experience with transcatheter closure of secundum atrial septal defects (ASDs) in children, using the Amplatzer, a new occlusion device. BACKGROUND: None of the devices previously used for transcatheter closure of interatrial communications has gained wide acceptance. METHODS: We examined the efficacy and safety of the Amplatzer, a new self-centering septal occluder that consists of two round disks made of Nitinol wire mesh and linked together by a short connecting waist. Sixteen patients with secundum ASD met established two- and three-dimensional echocardiographic and cardiac catheterization criteria for transcatheter closure. The Amplatzer's size was chosen to be equal to or 1 mm less than the stretched diameter. The device was advanced transvenously into a 7F long guiding sheath and deployed under fluoroscopic and ultrasound guidance. Once its position was optimal, it was released. RESULTS: The mean ASD diameter by transesophageal echocardiography was 14.1+/-2.3 mm and was significantly smaller (p < 0.001) than the stretched diameter of the ASD (16.8+/-2.4 mm). The mean device diameter was 16.6+/-2.3 mm. No complications were observed. After deployment of the prosthesis, there was no residual shunt in 13 (81.3%) of 16 patients. In three patients there was trivial residual shunt immediately after the procedure that had disappeared in two of them at the 3-month follow-up. CONCLUSIONS: The Amplatzer is an efficient prosthesis that can be safely applied in children with secundum ASD. However, a study including a large number of patients and a longer follow-up period are required before this technique can be widely used.     

Transcatheter closure of a residual postmyocardial infarction ventricular septal defect with the Amplatzer septal occluder

Acute ventricular septal rupture following myocardial infarction carries a high mortality. Early surgery improves survival but long term outcome depends on residual shunting and left ventricular function. Residual shunting is common despite apparently successful closure and may require reoperation. Transcatheter closure is an established method of treating selected congenital defects but clinical experience of transcatheter closure in postinfarction ventricular septal rupture is minimal. Transcatheter closure of a residual ventricular septal defect was successfully done using a new device, the Amplatzer septal occluder, in a 50 year old Indian man who had previously undergone emergency surgical repair for postinfarction acute ventricular septal rupture. The technique is described and its potential as a treatment in postinfarction ventricular septal rupture, its possible complications, and the important aspects of case selection and device design are discussed.     

Per-catheter ASD closure

Per-catheter devices for atrial septal defect (ASD) closure have been evolving since 1974. The four major devices available for use on a limited basis in early 1997 are reviewed. These include (in alphabetical order) the Angel Wing device, the ASDOS device, the Buttoned device, and the CardioSeal device (successor to the Clamshell). Sufficient data have been collected to indicate that transcatheter ASD closure is a viable alternative to surgery in selected patients. The advantages of the concept of per-catheter closure over surgical closure should lead to the continued development of devices and techniques for per-catheter treatment of ASD and other septal defects in the years to come.     

Transcatheter closure of atrial septal defects within the oval fossa: medium-term results in children using the 'ASDOS'-technique

OBJECTIVES: The purpose of this study was to evaluate the safety and efficacy of the ASDOS-technique (Sulzer-Osypka GmbH, Germany) for transcatheter closure of atrial septal defects within the oval fossa. BACKGROUND: Although several attempts have been made to occlude defects within the oval fossa by transcatheter techniques, none of these has gained general acceptance. METHODS: Patients with a defect in the oval fossa measuring equal to or less than 20 mm diameter, with a residual septal rim of 5 mm or greater, body weight greater than 10 kg, with clinical indications for surgical closure were considered for transcatheter closure. Follow-up investigations were performed at discharge, after 1, 3, 6 and 9 months, as well as after 1 and 2 years. RESULTS: Of 78 patients considered for closure, a device was inserted in 41 patients (53%), with success being achieved in 40 patients (98%). The ages ranged from 1.1 to 15 years (7.8 +/- 1.92 years), the 'stretched' diameter of the defect from 10 to 20 mm (14.7 +/- 2.60 mm), and the diameters of the inserted devices from 25 to 45 mm (33.2 +/- 5.43 mm). Transient impairment of atrioventricular conduction occured in 4 patients. During the follow-up of 23.0 +/- 5.6 months elective surgical closure of a residual shunt was performed 26 months after insertion of the device in one patient. None of the other patients required surgery, hospitalisation or medical treatment, and none is requiring further treatment of the defect within the oval fossa. Fracture of one arm of the device occurred in 4 patients, but the fractured arms are in an unchanged and stable position after a period of at least 19 months. CONCLUSIONS: Our medium-term data show that transcatheter closure in children of defects within the oval fossa can be performed with a high efficacy and safety using the ASDOS-device.     

Occlusion of patent ductus using the Rashkind system. Initial experience]

Three patients were submitted to the Rashkind device technique for closure of a patent ductus arteriosus. The percutaneous transvenous technique was employed in every cases. A 12 mm prosthesis was utilized in one case and 17 mm prostheses in the other two cases. In the first case, after temporary occlusion of the ductus arteriosus, the prostheses was removed due to the technical impossibility of evaluation of the proximal umbrella position. In the second and third cases, the prostheses were duly liberated in the proper position, thus occluding the defects. This technique does not require general anesthesia, is indicated in patients over 6 kgs of body weight, and is a therapeutic alternative to the habitual surgical procedure.     

Occlusion of large atrial septal defects with a centering buttoned device: early clinical experience

A feasibility clinical study was conducted for the transcatheter occlusion of large ostium secundum atrial septal defects with the centering buttoned device. The centering buttoned device is a modification of the regular buttoned device in which a centering counter-occluder is sutured at the central 40% portion of the occluder. During centering it is stretched, forming a parachute-shaped structure and pulling the occluder over the center of the defect. During buttoning, the counter-occluder forms a double figure eight, opposing the right atrial side of the atrial septum. Occlusion was performed in 12 patients aged 6 to 56 years. All had been rejected for transcatheter occlusion by the regular buttoned device, because of either their defect size or the lack of adequate septal rim. The defect size varied between 23 and 31 mm, and the device size varied between 45 and 60 mm. Nine had immediate effective occlusions of their defects and three residual shunts. One patient with unbuttoning had hemolysis at 2 weeks and underwent surgery. Early results of the transcatheter occlusion of large atrial septal defects are promising, and larger clinical trials are justified.     

Transcatheter closure of atrial septal defect

Isolated secundum atrial septal defect is one of the most common congenital heart defects. Surgical closure is the treatment of choice but is associated with a chest scar, some morbidity and a relatively long recovery and the use of cardiopulmonary bypass. Transcatheter closure of secundum atrial septal defect is therefore an attractive approach. 3 children, aged 5-10 years, underwent successful transcatheter closure of moderate to large central atrial septal defects with the Cardioseal device. The procedures were performed under x-ray and transesophageal echocardiographic guidance. Our initial experience, and that of others, indicates that transcatheter occlusion of secundum atrial septal defects is safe and effective and can be an appropriate alternative in approximately 60% of patients.     

Transcatheter closure of patent ductus arteriosus using controlled-release coils

Controlled-release coils have become available recently for the closure of patent ductus arteriosus (PDA). Transcatheter closure of patent arterial ducts was attempted in 13 patients, ranging in age from 5 months to 15 years, mean 4.1 years. Implantation of controlled-release PDA coils was attempted via the femoral artery through 5 Fr catheters in all cases except one, in whom both the femoral arterial and venous routes were used. The procedure was successful in 10 of the 13 patients. In these, the pulmonary artery systolic pressure ranged between 25 and 42 mmHg and the duct diameter varied from 1.5 to 6 mm at its narrowest point. Six of the patients received a single coil. Two coils were inserted in three patients and three coils in one patient. In three patients the ducts were too large for safe release of the coils, despite attempted implantation of up to three coils simultaneously. These coils were easily withdrawn into the catheter. Immediately at the end of the procedure, the duct was completely occluded in nine of the 10 patients, and in one patient there was a small residual flow. The procedure time varied between 35 min and 2.5 h, mean 81 min and the fluoroscopy time varied from 5 to 78 min, mean 25 min. None of the patients experienced hemorrhage, diminished lower extremity pulse, hemolysis or infection. In one patient, a 5 mm coil embolized into the right pulmonary artery soon after release. It was retrieved with a snare, then 8 mm and a 5 mm coil were implanted satisfactorily in the arterial duct. At follow-up by color Doppler echocardiography, the duct was completely occluded in all patients. Transcatheter closure of patent arterial ducts by controlled-release PDA coils is effective and safe. Even when more than one coil is inserted, it is still cheaper than transcatheter umbrella closure. This method is therefore of great value, particularly in less affluent countries.     

Closure of the ductus arteriosus in premature infants by inhibition of prostaglandin synthesis

Inhibition of prostaglandin synthesis constricts the ductus arteriosus in fetal lambs in utero. We administered the inhibitors, aspirin or indomethacin to 18 premature infants with patent ductus arteriosus, and assessed the effects clinically and by echocardiography (left atrial/aortic-root ratio). After aspirin (20 mg per kilogram, every six hours for four doses) the ductus closed permanently in one infant within 24 hours; in another, constriction occurred with clinical improvement, and the third did not respond. In five infants given 0.3 mg per kilogram of indomethacin, complete closure occurred within one day; two of them, who received three doses had an elevated serum creatinine for one week. In one infant the ductus reopened, requiring a second dose of indomethacin 11 days after the first. Ten infants received 0.1 mg per kilogram of indomethacin, and closure occurred within 24 to 30 hours in eight. One had a soft murmur for four days, and one did not respond to two doses of indomethacin. A murmur reappeared after three to seven days in three infants but only one required further treatment. In infants receiving a single dose of 0.3 mg per kilogram, or one or more doses of 0.1 mg per kilogram, renal function was unaltered.     

Pharmacokinetics of mefenamic acid in preterm infants with patent ductus arteriosus

The pharmacokinetics of mefenamic acid (MA), 2 mg/kg, were studied in 17 preterm infants with symptomatic patent ductus arteriosus. They were given this dosage orally at 24 h intervals. There were marked inter-individual differences in some of the pharmacokinetic parameters after the first dose; peak plasma concentration (Cmax) varied from 1.2 to 6.1 micrograms/mL with a mean of 3.8 micrograms/mL, time to reach Cmax (tmax) varied from 2 to 18 h with a mean of 7.7 h and plasma half-life (t1/2) varied from 3.8 to 43.6 h with a mean of 18.7 h. The group of infants (10/17) who had ductus closure after the first dose had significantly lower clearance (P < 0.01), longer t1/2 (P < 0.01) and higher 24 h plasma concentration (P < 0.001) compared to the group of infants (7/17) who had no ductus closure after the first dose. It appeared that the plasma concentration of MA had to be above 2.0 micrograms/mL and maintained at this concentration for at least 12 h for MA associated with ductus closure in preterm infants to take effect. In view of the inter-individual variation of plasma MA concentration and the effective plasma concentration, we suggest that measurement of the plasma concentration should be done 24 h after the first dose. This might be useful for safe and effective therapy for infants with ductus closure failure after the first dose.     

Coil on the loop and selectively enhanced stiffness for improved control: feasibility study in the neonatal ovine model of the large patent ductus arteriosus

RATIONALE AND OBJECTIVES: Several devices have been suggested and tested for interventional closure of the persistent ductus arteriosus. Coils were found effective only in small ducts due to their lack of maneuverability and physical limitation of grip forces leading to risk of embolization. The authors evaluated the feasibility to place single coils with selectively enhanced stiffness into high shunting ductus arteriosus, the coils being deployed and controlled through a veno-arterial loop in a bovine model. METHODS: "Double-cone" shaped, stainless steel coils with enhanced stiffness of the outer rings were mounted on either end on a nitinol core wire. A snap-in mechanism attaches the coil to this delivery wire and is freed by a pusher system of coiled steel wire that is advanced over the core wire. Forming a veno-arterial loop across the patent ductus allows for repositioning into the pulmonary artery or aortic catheter. A chronic lamb model of large patent ductus arteriosus (PDAs) (> or = 9 mm) was used in which ductus patency was secured by a protocol of repetitive angioplasties. Different systems (n = 10) were placed having retrieved the previous coil by a snare after definitive release. RESULTS: Placement of coils was possible in all 10 attempts. The coils were pulled back into the catheters between five and eight times before definitive release. CONCLUSIONS: The device allows controlled placement of single coils in our model of large PDAs and may lead the way to overcome previous limitations of coils. Clinical trials are warranted.     

Patch testing in children

Indomethacin is a very effective tocolytic agent. However, concern about its possible constrictive effect on fetal ductus arteriosus has limited the use of this medication in pregnancy. A 29-year-old woman was treated with indomethacin at 27 weeks of gestation for preterm labor and polyhydramnios. She received a dose of 75 mg/day for 5 weeks. At 35 weeks of gestation, she had a cesarean delivery due to fetal distress, and a hydropic baby was delivered. The infant died shortly after. Nonimmune hydrops fetalis and closed ductus arteriosus were the only pathological findings at autopsy. In utero, irreversible, complete closure of the ductus arteriosus is very rare. In the case presented, prolonged use of indomethacin during pregnancy was associated with complete closure of the ductus arteriosus that developed most probably after discontinuation of therapy. This case emphasizes the need for frequent fetal echocardiography examinations during as well as after maternal indomethacin treatment.     

Closure of the patent ductus arteriosus by means of cardiac catheterization

Authors report their results with transcatheter closure of patent arterial duct during a period of 1 year. Thirty patients underwent the procedure at the mean age of 5.22 yrs (range 5 mos-22.3 yrs) and mean bodyweight of 19.1 kg (range 5.8-73 kg). There were 9 males and 21 females. The diagnosis of the patent arterial duct was established by physical examination and noninvasive techniques. The procedures were attempted in all patients above 5 kg bodyweight with patent arterial duct and normal pulmonary artery pressure, irrespective of the shunt-size. All procedures were performed under general anesthesia in one session with the diagnostic cardiac catheterisation. Transcatheter closure was successful in 29 patients. In one patient the device embolized into the left pulmonary artery, snaring was unsuccessful, surgical closure of the patent duct and removal of the device took place uneventfully. Control aortography 15 minutes after the coil placement showed insignificant residual shunt through the patent duct in 8 patients (27%), while echocardiography at 1 month proved complete closure in all. The patients were followed by noninvasive methods. No mortality was observed. Authors emphasize the low risk and cost-effectiveness of the procedure. They stress the importance of the patients selection. Authors applied the technique for the first time and introduced it to the regular patient-care practice in Hungary.     

Expression of hepatocyte low-density lipoprotein receptor-related protein is post-transcriptionally regulated by extracellular matrix

A clinical trial was conducted to assess the feasibility, safety, and efficacy of the atrial septal defect (ASD) occlusion system for transcatheter closure of secundum ASD and patent foramen ovale (PFO) after episodes of cerebral embolism. Occlusion was attempted in 200 patients aged 1 to 74 years (mean 32). The procedure failed in 26 patients (13%); the device was retrieved through a catheter in 20 and through surgery in 6 patients. Procedure-related complications necessitating surgical removal of the device included device embolization in 2, device entrapment within the Chiari network in 1, frame fracture in 1, and perforation of atrial wall in 2. All 6 patients experienced an uneventful postoperative course. An additional 11 patients (6%) underwent surgical removal of the device during follow-up. There were 163 patients (81%) with an implanted ASD occlusion system at follow-up of from 6 to 36 months (mean 17). Thrombus formation around the device was detected by transesophageal echocardiography in 9 patients 1 to 4 weeks after implantation. One of these patients (who had a coagulation factor XII deficiency) suffered a cerebral thromboembolism. Late atrial wall perforation (5, 6, and 8 months after implantation) occurred in 3 adult patients. Infectious endocarditis developed in 2 adult patients (1%). No late device embolization and no atrioventricular valve injury occurred. An asymptomatic device frame fracture was found in 14% and frame deformity in 4% of all patients during the follow-up period of >230 patient-years. Immediately after closure, a moderate/large residual shunt remained in 8% and a small shunt in 29% of patients. After 1 year, a moderate/large shunt was present in 2% and a small one in 26% of patients. During a total follow-up of 49 patient-years, only 1 of 46 patients with PFO had a transient neurologic event after the closure. The study indicates that patients with centrally situated secundum ASD and those with PFO after cerebral embolism can be treated with this system with a high success rate and an acceptable morbidity.