International experience with the use of Cocoon septal occluder for closure of atrial septal defects.

BACKGROUND: The Cocoon septal occluder (CSO) is a new generation double disk occluder device for catheter closure of the secundum atrial septal defect (ASD). Initial clinical evaluations with the use of this device have shown quite satisfactory results but large follow-up studies are missing. In this international multicenter study, we present procedural and follow-up data from 4008 patients with secundum ASD who underwent catheter closure with the use of CSO. METHODS: The study cohort consisted of 1853 pediatric and 2155 adult patients with secundum ASD treated with the CSO. Patients were enrolled retrospectively from 11 international centers and were followed for a mean period of 43 months (range 12-84 months), postprocedural. Clinical, electrocardiographic, echocardiographic, procedural, and follow-up data were collected from each collaborating hospital. RESULTS: The CSO was permanently implanted in 3983 patients (99.4%). Echocardiographic evaluation at one month follow-up revealed complete closure in 99.6% of those patients who had a device implanted. Thrombus formation in one adult patient was the only major device related to procedural complication. During the follow-up period, no patient developed cardiac erosions, allergic reactions to nickel, or other major complications. CONCLUSIONS: Implantation of CSO provided satisfactory procedural and follow-up results with high success and no device-related cardiac erosions and nickel allergy.

Catheter Closure Through a Venous Approach of Patent Ductus Arteriosus in Small Pediatric Patients Using Combined Angiographic and Echocardiographic Guidance.

The standard technique of catheter closure of patent ductus arteriosus (PDA) may be associated with arterial complications particularly in small pediatric patients. The aim of this study was to evaluate whether catheter closure of PDA in small children using an exclusive venous approach is a safe and effective alternative to closure with the standard technique. One hundred-twelve patients, aged 2 to 24 months, were randomly assigned in a 1:1 ratio to catheter closure of PDA using the standard technique (group 1) and an exclusive venous approach (group 2), respectively. In group 2, the procedure was guided using hand injections of contrast media through the delivery sheath and 2-dimensional and color Doppler echocardiography. Group 1: the PDA diameter ranged from 2 to 5.5 mm and the device diameter ranged from 4 to 8 mm. The PDA occluders were permanently implanted in all patients. Five losses of the arterial pulses that were restored with intravenous infusion of heparin and recombinant tissue plasminogen activator (rtPA), and 4 groin hematomas were the main complications of the procedure. Group 2: the mean PDA diameter ranged from 2.5 to 6 mm and the device diameter ranged from 3 to 8 mm. The PDA occluders were permanently implanted in all but 2 patients. There were no complications. Complete echocardiographic closure of PDA at 1-month follow-up was observed in all 110 patients. Exclusive transvenous PDA occlusion is an effective and safe technique that prevents the arterial complications of the standard approach in small children.

Percutaneous pulmonary valve implantation in the native right ventricular outflow tract.

Percutaneous pulmonary valve implantation into dysfunctional right ventricular (RV) to pulmonary artery conduits is being increasingly performed in many European and North American centers with satisfactory results and low-complication rates. We report the first application of this elaborate technique in the native RV outflow tract of a young patient who developed severe supravalvular pulmonary stenosis following an arterial switch operation for transposition of the great arteries. The procedure may be used as an alternative to surgical repair for the treatment of selected patients with supravalvular pulmonary stenosis complicating congenital heart surgery.

Further experience with catheter closure of patent ductus arteriosus using the new Amplatzer duct occluder in children.

The aim of the present study was to report our additional experience with transcatheter closure of the patent ductus arteriosus in 65 consecutive patients using the new Amplatzer duct occluder. The median patient age was 3.6 years (range 0.2to 12), and the median weight was 10.5 kg (range 4 to 38). The device was a modified Amplatzer duct occluder made of fabric-free fine Nitinol wire net in to 2 very low profile disks with an articulated connecting waist. It is delivered through a 4Fr to 5Fr delivery sheath. The device was permanently implanted in 62 of 65 patients. The mean patent ductus arteriosus diameter (at the pulmonary end) was 3.6 +/- 1.3 mm (range 0.5 to 5.5). The mean device diameter (waist diameter) was 4.2 +/- 1.5 mm (range 3 to 6). Complete echocardiographic closure of the PDA at 1 month follow-up was observed in 61 (98%) of 62 patients. Immediately after the procedure, mild left pulmonary stenosis (peak pressure gradient of 8, 10, and 12 mm Hg) in 3 of 63 patients. Device embolization in 1 patient was the main complication of the procedure. No other complications were observed. In conclusion, catheter closure using the Amplatzer duct occluder II is an effective and safe therapy for most patients with patent ductus arteriosus. Additional studies are required to document its efficacy, safety, and long-term results in a larger patient population.

Comparison and results of transcatheter closure of patent ductus arteriosus using the swivel-disk device versus plug occluder in children.

The transcatheter closure of certain types of patent ductus arteriosus (PDA) remains a challenge. The investigators report initial clinical experience with 25 patients who underwent PDA occlusion with the use of a swivel-disk device (SDD) or a plug occluder (PO). The patients were divided into 2 groups: in the SDD group, 12 patients aged 1 to 2 years with type A PDA underwent attempted closure using the SDD, a modified Amplatzer duct occluder with a very low profile retention disk that can adapt itself at different PDA insertion angles. The mean PDA diameter was 4.8 +/- 1.5 mm (range 3.8 to 8). In the PO group, 13 patients aged 0.5 to 3 years with type C, D, or E PDA underwent attempted occlusion with the PO, a tubular occluder made of Nitinol wire mesh. The mean PDA diameter was 4.2 +/- 3.5 mm (range 1.2 to 9). The 2 occluders are filled with Dacron patches. The mean device diameters were 6.5 +/- 1.2 and 6.8 +/- 2.2 mm (range 4 to 11) in the SDD and PO groups, respectively. Complete angiographic closure was seen in 24 of 25 patients. The deployment of 4 5-PDA5 coils abolished a residual shunt associated with hemolysis in a 5-month-old patient with a large type C PDA after the implantation of an 11-mm PO. No other complications were observed. In conclusion, the SDD and the PO are promising additions to the armamentarium for PDA closure.

Transcatheter closure of perimembranous ventricular septal defects in infants and children using the Amplatzer perimembranous ventricular septal defect occluder.

There are very few published reports of the transcatheter closure of perimembranous ventricular septal defects (PMVSDs) using the Amplatzer PMVSD occluder with encouraging initial results. This report presents initial and 1-year results from 54 patients with PMVSDs who underwent transcatheter closure at 5 different institutions with the Amplatzer PMVSD occluder. Sixty-five patients with PMVSDs were enrolled at 5 European centers. Eleven of the 65 patients did not fulfill the patient selection criteria at the initial echocardiographic evaluation or at cardiac catheterization. As a result, a total of 54 patients underwent attempted transcatheter closure using the Amplatzer PMVSD occluder. The median age of the patients was 5.1+/-3.6 years (range 0.3 to 13), and the median weight 18.5+/-10.3 kg (range 5 to 45). Devices were permanently implanted in 49 of 54 patients. Complete occlusion of the communication at 1-year follow-up was observed in 46 of 49 patients (94%). Main early procedural complications included (1) device embolization (2 patients), (2) severe bradycardia with hemodynamic compromise (2 patients), and (3) Mobitz II (2:1) heart block (1 patient). Late procedural complications included complete heart block (1 patient). No other complications were observed during follow-up. In conclusion, the Amplatzer PMVSD occluder is promising device that can be used for transcatheter closure in selected patients with PMVSDs. Further studies and long-term follow-up are required before this technique enters routine clinical practice.

Transcatheter closure versus medical therapy of patent foramen ovale and cryptogenic stroke.

OBJECTIVES: The purpose of this study was to evaluate the efficacy and safety of device closure of patent foramen ovale (PFO) versus antiplatelet therapy in patients with cryptogenic stroke (CS). BACKGROUND: There are no controlled data to support the therapeutic value of PFO closure with a device compared to medical treatment in patients with CS. METHODS: We performed a nonrandomized, prospective, patient preference case series comparing the recurrence rate in 92 patients with PFO and CS who were treated either with antiplatelet agents (44 patients) or underwent catheter closure (48 patients) using the Amplatzer PFO occluder (APFOO). All patients completed a 2-year follow-up. RESULTS: PFO closure group. Immediate complete closure (CC) was observed in 44/48 (91%) patients. Four (9%) patients had a minimal residual shunt immediately after the procedure. One patient developed hemopericardium that was successfully managed by pericardiocentesis. No other complication was observed. Follow-up. PFO closure group. Contrast bubble study at 6-month follow-up confirmed CC in all 48 patients. No complications were observed. Antiplatelet therapy group. Three (6%) and 6 (13%) patients had a major and minor hemorrhagic event, respectively. The average incidence of embolic events/year was 0 and 14.75% for the PFO closure group and the antiplatelet therapy group, respectively (P < 0.001). CONCLUSIONS: PFO closure using the APFOO is a rational alternative to medical treatment in patients with CS. Larger randomized clinical trials are required to support the use of this device over the other PFO occluders and medical therapy.

A novel use of the Amplatzer muscular ventricular septal defect occluder.

We report a case of a 12-month-old-infant with double outlet right ventricle and pulmonary stenosis who presented with signs of superior vena cava syndrome secondary to a dysfunctioning bidirectional Glenn shunt. The patient was successfully treated with transcatheter obstruction of an accessory pulmonary blood flow using the Amplatzer muscular ventricular septal defect occluder.