Transcatheter closure of patent foramen ovale using the Cocoon occluder: A multicenter retrospective study.

BACKGROUND: The Cocoon patent foramen ovale (PFO) occluder is a new device especially designed for transcatheter closure of PFO. This occluder has some distinctive structural modifications aimed at reducing the risk of major complications of transcatheter PFO closure. In this report we present our initial experience to evaluate the efficacy and safety of the Cocoon PFO occluder in 253 patients who underwent transcatheter PFO closure. METHODS: The study cohort included 253 patients (median age 45 years) with embolic stroke of undetermined source who underwent attempted transcatheter closure of PFO for secondary prevention of paradoxical embolism. Patients were enrolled retrospectively from five sites in Greece and one in Romania between December 2016 and January 2021, and the median follow-up period was 28 months (range 12-48 months). Clinical and laboratory data from each participating center were sent to an electronic registry for evaluation and statistical analysis. RESULTS: The Cocoon PFO occluder was permanently implanted in all patients. At 6 months, complete occlusion of PFO was observed in 251/253 (99.2%) patients. Three (1.2%) patients had a trivial residual shunt. Thrombus formation on the device, which was successfully treated with recombinant tissue plasminogen activator infusion, was observed in one (0.4%) patient. No other complications occurred. During a median follow-up period of 28 months, 3 (1.2%) patients, aged 64-67 years, developed new onset paroxysmal atrial fibrillation. No neurologic events, cardiac erosions, allergic reactions to nickel, or thrombus formation occurred. CONCLUSION: The Cocoon PFO occluder is an effective and safe device that adds to our armamentarium for transcatheter closure of PFO.

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.

Medium-term results of percutaneous pulmonary valve implantation using the Venus P-valve: international experience.

AIMS: The aim of this study was to assess the international procedural and short-term to midterm experience with the new percutaneous Venus P-valve. METHODS AND RESULTS: Retrospective data of patient characteristics, clinical and imaging follow-up of Venus P-valve implantation outside China were collected. Thirty-eight patients underwent attempted Venus P-valve implantation between October 2013 and April 2017. Thirty-seven valves were successfully implanted during 38 procedures. There was one unsuccessful attempt and there were two valve migrations, one of which required surgical repositioning. The mean follow-up was 25 months with no short-term or midterm valve failure or deterioration in performance. Frame fractures occurred in 27% of patients. The cohort demonstrated a statistically significant reduction in pulmonary regurgitation fraction and indexed right ventricular diastolic volumes at six and 12 months. CONCLUSIONS: Implantation of the Venus P-valve has provided satisfactory short-term to midterm results with high success and low complication rates in an inherently challenging patient substrate.

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.

Catheter closure of atrial septal defects using the Cocoon septal occluder: preliminary results of a European multicenter study.

Despite its simplicity, device closure of atrial septal defects is still associated with rare but potentially lethal complications. In this prospective non-randomized multicenter study we investigated the safety and efficacy of the Cocoon septal occluder (CSO) for closure of atrial septal defects (ASDs) in 92 patients. Median age of the patients was 10.5 years (range 3-61 years) and median weight was 25 kg (range 13-65 kg). The device is an improved new generation double disc design made of Nitinol wire mesh that is coated with platinum using NanoFusion technology. The discs are connected by a waist with diameter ranging from 6mm to 40 mm with 2mm increments. All patients completed a 3-month follow-up. Mean ASD diameter was 21 ± 7 mm (range 10-35 mm), while the mean device diameter was 24 ± 8 mm (range 14-40 mm). The CSO was permanently implanted in all 92 patients. Complete echocardiographic closure of the defect immediately after the procedure or at the one month follow-up, was observed in all 92 patients (100%). No device-related complications were observed during the procedure or at short-term follow-up (range 3-12 months). Our preliminary results indicate that CSO is a promising device for transcatheter closure of ASDs. Further studies are required to document its efficacy, safety and long-term results in a larger patient population.

Transcatheter closure of large atrial septal defects with deficient aortic or posterior rims using the "Greek maneuver". A multicenter study.

OBJECTIVES: We report a modification ("Greek maneuver") of the standard atrial septal defect (ASD) closure technique using the Amplatzer septal occluder (ASO) to facilitate closure of large ASDs with deficient aortic or posterior rims. METHODS: 185 patients (median 10.8, range 3 to 52 years) with large ASDs (mean diameter 26±7 mm, range 20-40 mm) with a deficient aortic (134 patients) or posterior (51 patients) rim underwent catheter closure with the ASO using the "Greek maneuver" under transesophageal guidance. The Greek maneuver is applied when protrusion of the aortic edge of the deployed left disk of the device in to the right atrium is detected by echo. To circumvent this left disk is recaptured and the whole delivery system is pushed inward and leftward into the left atrium where the left disk and the 2/3 of right disk are simultaneously released. This maneuver forces the left disk to become parallel to the septum preventing the protrusion of the device into the right atrium. RESULTS: The ASO was successfully implanted and was associated with complete closure in 175/185 (95%) of the patients. There were no early or late complications related to the procedure during a follow-up period ranging from 6 months to 7 years. CONCLUSIONS: The "Greek maneuver" is a simple quite useful trick that facilitates closure of large ASDs associated with or without deficient aortic or posterior rims.

Initial and six-year results of stent implantation for aortic coarctation in children.

Although stenting has been used as a treatment option for aortic coarctation (CoA) at increasingly younger ages, limited information is available on the long-term follow-up of stent implantation for CoA in pediatric patients. A total of 74 patients with CoA (mean age 8 ± 3 years) underwent stent implantation; 42 were treated for isolated native CoA and 32 for recurrent CoA. A total of 87 stents were implanted (bare metal stents in 71 patients and covered stents in 3 patients). Redilation of a previously implanted stent was performed in 32 patients. Immediately after stenting, the peak systolic pressure gradient decreased from 68 ± 16 mm Hg to 8 ± 5 mm Hg (p <0.05), and the CoA diameter increased from 5 ± 3 mm to 16 ± 3 mm (p <0.05). The most important procedural complication was aneurysm formation in 1 patient that was successfully treated with implantation of a covered stent. No early or late deaths occurred and no evidence was found of late aneurysm formation during a follow-up period of 6 years. Late stent fracture was observed in 3 patients. At the end of follow-up, no cases of recoarctation were identified on multislice computed tomography or magnetic resonance imaging, and 67 (85%) of the 74 patients were normotensive, receiving no medications. In conclusion, stent implantation is an effective and safe treatment alternative to conventional surgical management for the treatment of CoA in selected pediatric patients.

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.

Usefulness of stenting in aortic coarctation in patients with the Turner syndrome.

We report our experience with stent implantation for treatment of aortic coarctation in patients with Turner syndrome. Ten consecutive patients with Turner syndrome and aortic coarctation (median age 12 years, range 9 to 24) underwent coarctation stenting. Of these, 6 patients were treated for isolated coarctation and 4 for recurrent coarctation (3 after balloon dilation and 1 after balloon dilation and surgical repair). Bare metal stents were implanted in 7 patients and covered stents in 3. Immediately after stent implantation, peak systolic gradient decreased from 46.1 ± 24.3 to 1.9 ± 2.1 mm Hg (p <0.001). Aortic diameter at coarctation site increased from 5.1 ± 3.2 to 15.3 ± 2.0 mm after stenting (p <0.001). There were no deaths or procedure-related complications. During a median follow-up of 30.5 months, no patient developed restenosis. Two patients developed late aortic aneurysms at the coarctation site. In conclusion, stent implantation for aortic coarctation in patients with Turner syndrome appears to be a safe and effective alternative to surgical repair. Larger cohorts and longer-term follow-up are required to determine the effects of the procedure on the aortic wall.

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.

Transcatheter closure of the patent ductus arteriosus using the new Amplatzer duct occluder: initial clinical applications in children.

BACKGROUND: In spite of recent advances in transcatheter management, the occlusion of certain anatomic types of patent ductus arteriosus (PDA), especially in infants and small children, remains a challenge. The aim of the study was to report initial human experience with transcatheter closure of PDA in 25 patients using the new Amplatzer duct occluder (ADO II) (AGA Medical, Golden Valley, MN). METHODS: The median age of the patients was 3.2 years (range 0.1-5 years), and the median weight was 10.5 kg (range 3-18 kg). The device used is a modified ADO II made of fabric-free fine Nitinol wire net into 2 very-low-profile disks with an articulated connecting waist. Both disks are 6 mm larger than the diameter of the connecting waist. Connecting waist diameters range from 3 to 6 mm. RESULTS: The mean PDA diameter was 3.6+/-1.3 mm (range 0.6-5 mm). The mean device diameter (waist diameter) was 4.3+/-1.4 mm (range 3-6 mm). Complete echocardiographic closure of the ductus at 1-month follow-up was observed in 24 (96%) of 25 patients. Immediately after the procedure, there was a mild left pulmonary stenosis (Doppler gradient of 15 mm Hg) in 2 of 25 patients. No other complications were observed. CONCLUSIONS: The ADO II is a promising addition to our armamentarium for PDA closure. Further studies are required to document its efficacy, safety, and long-term results.

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.

Severe hemolysis complicating transcatheter occlusion of a patent ductus arteriosus: the importance of elimination of residual flow.

Transcatheter closure of a patent ductus arteriosus (PDA) is an established technique that may rarely be complicated by severe intravascular hemolysis due to residual shunt. Although conservative management has been reported, the usual approach is to invasively eliminate the residual shunt. We report a case where misjudgment of PDA size and subsequent attempted closure with only one coil led to incomplete closure and residual shunt, which was complicated by severe intramuscular hemolysis. Effectively closing the PDA with an Amplatzer Duct Occluder resulted in immediate resolution of the hemolysis.

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.