Percutaneous closure of a patent foramen ovale: single-centre experience using different types of devices and mid-term outcome

INTRODUCTION: Patent foramen ovale (PFO) has been identified as a source of paradoxical embolism and cryptogenic stroke. Low recurrence rates of ischaemic stroke after percutaneous closure have been described. We report our single-centre experience using four different types of devices. METHODS: All patients, who underwent a percutaneous PFO closure in the University Hospitals Leuven between February 1999 and December 2003, were included. The primary end point was defined as reoccurrence of stroke, transient ischaemic attack (TIA), or a peripheral thrombo-embolic event. The periprocedural and mid-term complications were reported. RESULTS: One-hundred and twelve patients, mean age 52.1 +/- 12.5 years (63 men/49 women), were included in the study. Indications for closure were cryptogenic stroke (91.9%), peripheral embolism (4.5%), obligate right-to-left shunt in Ebstein anomaly (1.8%), platypnoea syndrome or brain abscesses (both 0.9%). The Cardioseal/Starflex was used in 12, the Amplatzer PFO occluder in 35, the PFO Star/CardiaStar in 64, and the Helex in one patient. The primary end point occurred in 1.8% for stroke and 2.8% for TIA during a median follow-up of 1.9 years, range 4.9 years. Periprocedural complications were dislocation of the device (0.9%), transient arrhythmias (15.5%), aspiration pneumonia (0.9%), inguinal haematoma (3.6%), and an allergic reaction to medication (1.8%). Mid-term complications were perforation of the device (0.9%), persistent transient arrhythmias (6.3%) and thrombus formation on the device (0.9%). No significant differences in outcome or the occurrence of any type of complication could be documented between the different types of devices. CONCLUSION: Percutaneous PFO closure seems to be a highly efficient and relatively safe procedure, independent of the type of device used for closure.     

Percutaneous closure of patent foramen ovale and atrial septal defect: procedure outcome and medium-term follow-up

Percutaneous closure of atrial septal defect (ASD) and patent foramen ovale (PFO) has become increasingly utilized. The indications and results of percutaneous closure are diverse. AIM: To assess the indications, results, and complications of percutaneous closure of ASD and PFO in our tertiary center. METHOD: Case note review and retrospective analysis of all consecutive patients undergoing percutaneous closure over a 3-year period from January 2003 to October 2005 with a mean follow-up of 19 months (4-36). Results: There were 185 consecutive patients. The mean age was 44.9 years (SD 12.9) and 53% (n = 98) were males. There was 59% (n = 109) PFO and 41% (n = 76) ASD. The predominant indication for PFO closure was cerebrovascular accident (CVA) (42.2%, n = 46)- and for ASD, dilated right ventricle (68.4%, n = 52). Of all procedures, 94.6% (n = 175) were first time and 5.4% (n = 10) were redo for residual shunt. Overall, the success rate was 96.8% (n = 179) with two patients referred for surgical closure due to the large size of ASD and unsuitability for percutaneous closure, two procedures abandoned due to pericardial effusion, and two abandoned because the PFO was too small to cross. The Amplatzer device was used in 92.7% (n = 166) and the Starflex in 7.3% (n = 13). Minor complications were recorded in 10 patients (5.4%), of which 4 (2.2%) had minor venous access bleeding, 1 patient (0.5%) had retroperitoneal hematoma, and 2 patients (1.1%) had transient atrial fibrillation. One patient (0.5%) had transient inferior ST elevation during the procedure, one patient (0.5%) reported chest pain postprocedure, and one patient (0.5%) developed septicemia 3 weeks postprocedure. Major complications were recorded in three patients (1.5%), one patient (0.5%) with retroperitoneal hematoma requiring blood transfusion and two patients (1%) with pericardial effusion following transseptal puncture, requiring aspiration. No death, stroke, or device embolization was recorded. CONCLUSION: Our experience with percutaneous closure in adults demonstrates excellent results and safety with few complications. Percutaneous device closure will replace surgical closure for many ASDs and PFOs.     

Transcatheter closure of perimembranous ventricular septal defects using umbrella devices.

There is only limited experience of interventional closure of perimembranous ventricular septal defects (pmVSDs), particularly on the long-term follow-up. This is a report on our long-term results after transcatheter closure of pmVSDs using the Cardioseal, Starflex, or Rashkind devices. PATIENTS: Between 1993 and 2005, we performed interventional occlusions of pmVSDs in 18 patients. The size of the defect ranged between 4 and 8.5 mm, Q(p)/Q(s) was calculated between 1.3 and 2.2. Except for two, the patients had no other structural heart defect. In the early days, we used the Rashkind PDA occluder (17 mm) in seven, followed by the Cardioseal device (17 mm) in nine, and the 23 mm Starflex device in two patients. RESULTS: Interventional closure of the defects was performed successfully in all patients without any complication during the procedure. Fluoroscopy times were 11.8-53.7 min (median 28.65 min). We achieved a complete closure in 13 patients, three patients with recently implanted devices still show minimal shunting. In two patients the occluder had to be removed surgically because of embolization into the pulmonary artery and significant residual shunting resulting in severe hemolysis in the second patient. In long- (mean 10.7 years) and short-term (mean 0.85 years) follow-up we have not observed any hemolysis, arrhythmias, device dislocations, or device-related aortic or tricuspid regurgitation. CONCLUSION: Transcatheter closure of small pmVSDs using non-selfcentering devices can be performed successfully. Long-term follow-up investigations show encouraging results. Complications like device-embolization and significant residual shunting occur in the presence of large defects and/or concomitant malformations.     

Percutaneous catheter closure of atrial septal defect. Short-term and mid-term results

INTRODUCTION: Percutaneous closure of atrial septal defects (ASD) is becoming more frequent. PATIENTS AND METHOD: From October 1997 to October 2002, 209 patients, age 0.4-70 (mean 19.5) years, were catheterized to close an ASD or patent foramen ovale (PFO). Transesophageal echocardiography was performed simultaneously in all patients. Two hundred and six patients had ASD (25 multiple ASDs) and 3 had PFO. Three devices were used, the Amplatzer Atrial Septal Occluder (ASO), CardioSeal (CS), and Starflex (SF). RESULTS: Device implantation was achieved in 181 patients (87%) but had to be abandoned in 28 patients, generally because the ASD was too large. One hundred and seventy-four ASOs were implanted in 172 patients with ASD (2 ASOs were implanted in 2 patients with double ASD) and CS/SF in 9 patients (3 patients with PFO and 6 with ASD). The procedure was effective in 166/172 (96%) ASO implantations and in 8/9 (89%) CS/SF implantations. The procedure was unsuccessful in 7 patients and the device had to be removed (6 ASO and 1 SF). The occlusion rate with ASO was 88% after 24 hours, 91% after 1 month, 95% after 1 year, 97% after 2 years, and 100% after 4 and 5 years. All defects treated with SF/CS were closed successfully after 24 hours. In one case the ASO device was embolized to the aorta. In the first month after ASO implantation, supraventricular tachycardia appeared in 2 patients and transient left ventricular failure in 2 patients. No late complications were observed. CONCLUSION: Percutaneous catheter closure of selected types of ASD using the Amplatzer Atrial Septal Occluder, CardioSeal, or Starflex should be offered to patients as non-surgical alternative. The type of device used depends on the defect size and morphology as well as the surgeon's experience. The presence of multiple defects does not exclude the possibility of a successful percutaneous catheter closure.     

Transcatheter closure of secundum atrial defect in small children.

OBJECTIVE: To assess safety and efficacy of transcatheter atrial septal defect (ASD) closure in small children. BACKGROUND: Percutaneous closure of ASD is a well accepted alternative to surgery. Reported experience in small children remains, however, scarce. METHODS: Fifty-two children underwent percutaneous ASD closure at a weight < or =15 kg, in four Belgian tertiary referral paediatric cardiology centers. Indication for treatment, device implantation rate, procedural details, complication rate, residual shunt on echocardiography, and impact of procedure on symptoms were retrospectively analyzed. RESULTS: Mean age at procedure was 36 months (7-60), mean weight 13 kg (4.7-15). Associated cardiac lesions were seen in 21% of the patients and noncardiac in 32.7%. Most patients (69.2%) were symptomatic. Mean ASD size was 12 mm (range 5-20 mm). A device could be inserted in 49 patients (94%). No major complications occurred. Minor complications occurred in 8 patients (15.4%) including device embolization in 2, successfully treated with transcatheter retrieval and second device insertion. Mean follow-up reached 27 months (0.03-61.2). Residual shunt was absent, trivial, or small in 93% (n = 42) at latest follow-up. Clinical improvement was noted in 91.7% of the symptomatic patients. Minor complications were more frequent in the presence of large ASDs (>15 mm) but not in smaller babies (<10 kg). CONCLUSION: Patients < or =15 kg requiring ASD closure form a special population with high incidence of associated anomalies and medical conditions. For this particular set of patients, percutaneous closure is a valid alternative. Asymptomatic or mildly symptomatic children should be treated at a later age.     

Long-term outcome of transcatheter secundum-type atrial septal defect closure using Amplatzer septal occluders

OBJECTIVES: The aim of this study was to assess long-term results of percutaneous closure of secundum-type atrial septal defect (ASD II) using Amplatzer septal occluders (ASO). BACKGROUND: Only immediate-, short-, and intermediate-term results of ASO implantation are known so far. METHODS: Between September 1995 and January 2000, 151 patients underwent a successful percutaneous closure of ASD II in our institution. All were included in the present study and were followed up until September 2004. RESULTS: This group of patients was followed up from 56 to 108 months (median 78 months). The mean stretched defect diameter was 15.9 +/- 4.8 mm. There were no deaths or significant complications during the study. At three years of follow-up, all defects were completely closed and remained closed thereafter. CONCLUSIONS: Since the first human implantations in September 1995, the Amplatzer septal occluder proved as a safe and effective device for percutaneous closure of ASD II.     

Retrograde use of the Cardioseal/Starflex occluder device.

The Cardioseal/Starflex septal occluder is usually deployed through a long transvenous sheath for closure of atrial septal defects, persistent foramen ovale, and, less commonly, ventricular septal defects. We describe two patients with residual left-to-right shunting after surgical palliation of congenital heart defects and illustrate the successful use of the double-umbrella device in these situations using a retrograde transarterial approach. This is exemplified by two previously not described interventions: retrograde closure of a large muscular ventricular septal defect in a patient after a palliative Mustard operation and a transcatheter closure of a Waterston-Cooley anastomosis. Effective and safe closure of left-to-right shunting can be achieved by retrograde use of the Cardioseal/Starflex device in selected adolescents and grown-ups with congenital heart disease.     

Percutaneous closure of ventricular septal defects in children aged <12: early and mid-term results

AIMS: The aim of the article is to study the safety, efficacy, and follow-up of percutaneous closure of muscular ventricular septal defect (mVSD) and perimembranous ventricular septal defect (pmVSD) in children. METHODS AND RESULTS: Between January 2000 and June 2005, among 140 patients who underwent percutaneous closure of an mVSD or a pmVSD, 88 were aged lt;12. Two different Amplatzer devices were used: the mVSD occluder and the pmVSD occluder. Mean age and weight at procedure were 4.5+/-3.3 years and 18.7+/-11.2 kg, respectively. Percutaneous closure was successfully achieved in 83 subjects (94%). No deaths occurred. Thirteen patients (14.7%) had early complications: device embolization (n=4), vascular complications (n=3), and rhythm abnormalities (n=6). These were transient complications in all but one case [1.1% complete atrioventricular block (cAVB) needing pacemaker implantation]. During a median follow-up of 24 months, three subjects treated for a pmVSD needed pacemaker implantation due to the occurrence of cAVB. Multivariable analysis using Cox's proportional hazard regression showed that age was the only risk factor associated with the occurrence of cAVB (P=0.028; relative risk: 0.25). CONCLUSION: Percutaneous closure of mVSD and pmVSD in children can be performed safely and successfully. The occurrence of cAVB is a major concern in young children with pmVSD.     

Atrial Septal Occluder Device Embolization to an Iliac Artery: A Case Highlighting the Utility of Three‐Dimensional Transesophageal Echocardiography during Percutaneous Closure

Percutaneous closure of secundum atrial defects has become an accepted treatment in part because it is minimally invasive and relatively low risk. Despite recent advances in implantation technique and device improvements, complications occur. Here, we report a case of device embolization during percutaneous repair of an atrial septal defect (ASD) with multiple fenestrations. We highlight the value of using live/real time three‐dimensional transesophageal echocardiography to help plan the percutaneous procedure and detect complications.     

Morphological variations of secundum-type atrial septal defects: feasibility for percutaneous closure using Amplatzer septal occluders.

The aim of the study was to assess the morphology of secundum-type atrial septal defects (ASD) with a view to percutaneous closure using Amplatzer septal occluders (ASO). One hundred and ninety patients who underwent closure of isolated secundum-type ASD between September 1995 and January 2000 were included. The morphology of the defects was studied using transthoracic and transesophageal echocardiography. Patients with defects of suitable morphology and size underwent percutaneous closure using ASO. The remaining patients underwent surgical closure. Centrally placed defects were observed in 46 patients (24.2%). Morphological variations of secundum-type ASD were detected in 144 patients (75.8%). One hundred and fifty-one patients (79.5%) underwent percutaneous closure using ASO. Thirty-nine patients (20.5%) underwent surgical closure. Centrally placed defects, defects with deficient superior anterior rim, multiple defects, and perforated aneurysms of the interatrial septum are morphological variations of secundum-type ASD suitable for percutaneous closure using ASO. Cathet Cardiovasc Intervent 2001;53:386-391.     

Early and late complications associated with transcatheter occlusion of secundum atrial septal defect

OBJECTIVES: The goal of this study was to report the early and late complications experienced in atrial septal defect (ASD) transcatheter closure. BACKGROUND: Atrial septal defect transcatheter occlusion techniques have become an alternative to surgical procedures. A number of different devices are available for transcatheter ASD closure. The type and rate of complications are different for different devices. METHODS: Between December 1996 and January 2001, 417 patients (mean age: 26.6 +/- 19 years) underwent transcatheter occlusion of secundum type ASD. Complications were categorized into major and minor. Two different devices were used: the CardioSEAL/STARFlex in 159 patients and the Amplatzer septal occluder in 258 patients. RESULTS: Thirty-four patients experienced 36 complications during the hospitalization (8.6%, 95% confidence interval: 6.1% to 11.1%). Ten patients underwent elective surgical repair because of device malposition (three patients) or device embolization (seven patients). Twenty-four patients experienced 25 minor complications: unsatisfactory device position or embolization. Devices were retrieved using a gooseneck snare and/or a basket; 11 patients experienced arrhythmic problems. Other complications were: pericardial effusion, thrombus formation on the left atrial disc, right iliac vein dissection, groin hematoma, hemorrhage in the retropharynx and sizing balloon rupture. Two patients had late complications: peripheral embolization in the left leg one year after implantation of an Amplatzer device and sudden death 1.5 year later. CONCLUSIONS: Our series of patients with ASD by transcatheter occlusion shows that the procedure is safe and effective in the vast majority of cases. To further reduce the complications rate, the criteria of device selection according to ASD morphology and some technical tips during implantation are discussed.     

Thrombus formation on an atrial septal defect closure device

Atrial septal defects (ASDs) are the most prevalent form of congenital heart disease presenting after childhood. Percutaneous closure has become a safe and effective strategy for managing adults with secundum-type ASDs. Reports on complications are rare. The present report discusses a case of rapid formation of a large thrombus on an ASD transcatheter closure device. The case highlights the importance of transesophageal echocardiography during the procedure and supports the role of periprocedural anticoagulation in transcatheter ASD closures.     

Early-mid term follow-up results of percutaneous closure of the interatrial septal defects with occlutech figulla devices: a single center experience

Background: Percutaneous closure of secundum type atrial septal defect (ASD) and patent foramen ovale (PFO) has gained widespread use in recent years. Herein, we evaluated the safety and efficacy of the Occlutech® Figulla devices for PFO and ASD closure in a reference tertiary center. Methods: All 143 patients (46.9% male, mean age 39.3 ± 12.2 years) who underwent transcatheter PFO (n = 85) and ASD (n = 58) closure with Occlutech® Figulla devices between February 2009 and October 2011 were included in this study. An echocardiographic follow‐up examination was performed at the 1st, 6th, and 12th month visits. Results: The devices were successfully implanted in all 143 patients (100%). In‐hospital periprocedural complications were device embolization (0.7%; 1 ASD patient), atrial fibrillation (1.4%; 1 ASD and 1 PFO patients), supraventricular tachycardia (0.7%; 1 PFO patient), and vascular access hematoma (0.7%; 1 ASD patient). Among ASD patients, 2 patients had trivial (jet width <1 mm in diameter) and 1 patient had small (1–2 mm) residual shunts before hospital discharge, which disappeared after the 6‐month visit. During the mean 15.4 ± 9.6 months follow‐up, all patients were asymptomatic and no ischemic stroke, cardiac perforation, device erosion, embolization, thrombus formation, or malposition of the device was observed. Conclusions: Percutaneous PFO and secundum type ASD closure with the novel Occlutech® Figulla Occluder devices without left atrial central pin and with significantly reduced meshwork was safe, feasible, and effective. (J Interven Cardiol 2012;25:375–381)     

Retrieval of an embolized amplatzer septal occluder

Percutaneous closure of secundum atrial septal defect (ASD) by various devices has been proven to be an effective and safe treatment modality for patients with congenital heart diseases. However, we have to be aware of the potential early and late complications like device embolization and formulate plan for rescue procedures. We have reported a case of successful closure of a large secundum ASD in a 23‐year‐old woman by a 40 mm Amplatzer septal occluder (ASO), which embolized into the right ventricle 4 hr after the procedure. This had caused palpitation and nonsustained ventricular tachycardia. Patient safety was our most important concern and after discussion with the cardiac surgeons and the patient, we would like to make a percutaneous stepwise attempt for retrieval. We first applied an endocardial biopsy forcep to grap the disk of the ASO to fix and stabilize the dislodged device. This would prevent the device from obstructing the inflow and outflow tract and causing catastrophic consequences. Then, a 15‐mm Amplatz gooseneck snare was used to catch exactly at the connecting hub of the ASO disk, and the whole apparatus could then be cautiously and safely retrieved out from her body without complications. This had saved her from an unplanned emergency open heart operation that carried significant bleeding complication. © 2009 Wiley‐Liss, Inc.     

Percutaneous closure of atrial septal defect type ostium secundum using the new Intrasept occluder: initial experience.

We report the first experience obtained with the new Intrasept device. We attempted to treat 35 patients with a mean age of 43 +/- 21 years. The mean size of the defect was 17/15 mm. It was successfully closed in 31 patients. In the remaining four the device could not be stabilized because of excessive defect size. A small residual shunt was present immediately following implantation in three patients. No complications occurred during the procedure and at 6 months, 31 patients had an uneventful outcome. Only one patient had a small residual shunt. No thrombus, embolization, or device fracture was documented during a mean follow-up of 17 +/- 11 months. Percutaneous closure of ASD ostium secundum is feasible with the Intrasept device with a high success rate and very good medium-term outcome. Our initial experience and results were excellent with small to medium size defects, however, large defects (>20 mm) remain challenging.     

Transcatheter closure of secundum atrial septal defect with a new self-expanding nitinol double disk device (Amplatzer device): experience in Nanjing

PURPOSE: Various devices have been developed for the transcatheter closure of secundum atrial septal defect (ASD II) to avoid the morbidity, discomfort, and thoracotomy scar associated with surgical closure. The purpose of this study was to evaluate the safety and efficacy of the Amplatzer septal occluder for transcatheter closure of ASD II. PATIENTS AND METHODS: Only patients who were clinically diagnosed with ASD II were selected. The anatomy of ASD had to meet certain echocardiographic criteria. Under the guidance of echocardiography and fluoroscopy, the implantation of the device was accomplished as recommended by the manufacturer. RESULTS: Thirty patients (median age 18.4 years) with an ASD II underwent transcatheter closure. Procedure time ranged from 30-200 minutes and fluoroscopy time from 10-50 minutes. The diameter of the ASD measured by echocardiography ranged from 13-25 mm, while both the stretched diameters of the ASDs and the sizes of the devices ranged from 18-34 mm. The successful placement rate was 100%. The residual shunt rate was 100% immediately after device implantation and 10% after 24 hours. After 3 months, 3.3% of the patients had a (trivial) residual shunt. The device did not affect the surrounding structures of ASD. No embolization of the device occurred. CONCLUSION: The Amplatzer device designed for the closure of ASD II can be implanted easily and also is retrievable. Due to a low ratio of residual shunt and few complications, this device is a good choice for transcatheter closure of ASD II. Long-term follow-up will be required for widespread clinical use.     

Embolization of Atrial Septal Occluder Device into the Pulmonary Artery: A Rare Complication and Usefulness of Live/Real Time Three-Dimensional Transthoracic Echocardiography

Percutaneous closure of atrial septal defects (ASD) in adults has emerged as an alternative to surgery. We report a rare complication of an atrial septal occluder device embolization into the pulmonary artery which was detected by fluoroscopy and echocardiography. The potential usefulness of live/real time three-dimensional transthoracic echocardiography in the management of patients undergoing percutaneous ASD occlusion is described.     

Surgical versus percutaneous occlusion of ostium secundum atrial septal defects: results and cost-effective considerations in a low-income country.

OBJECTIVES: We compared the effectiveness and cost of percutaneous occlusion using an Amplatzer septal occluder (ASO) (AGA Medical Corp., Golden Valley, Minnesota) device compared with surgical closure of an ostium secundum atrial septal defect (ASD II) in Guatemala. BACKGROUND: The percutaneous occlusion of ASD II in first-world nations seems to offer better clinical results and lower cost compared with surgical closure. METHODS: We reviewed the clinical course of 111 patients referred to our institution for closure of isolated ASD II. Successful closure was assessed immediately after the procedures and at 12 months. Actual hospital costs were calculated for every patient who underwent either of the two procedures. RESULTS: Eighty-three patients with ASD II (75%) were selected for percutaneous occlusion with the ASO device, and the remaining 28 patients (25%) underwent surgical closure. In the device group, in 72 patients (86.7%) devices were successfully deployed. At immediate and 12-month follow-up, the complete closure rate was 87.5% (63 of 72 patients) and 97.2% (70 of 71 patients), respectively. In the surgical group, all patients had successful closure immediately after the procedure and at 12 months. Surgical closure offered a 27% cost savings in comparison with percutaneous occlusion (U.S. 3,329.50 dollars +/- 411.30 dollars and U.S. 4,521.03 dollars +/- 429.71 dollars; p < 0.001, respectively). Cost of the device (U.S. 2,930.00 dollars) proved to be the main cause for this difference. CONCLUSIONS: We confirmed the clinical advantages of percutaneous occlusion over surgical closure of ASD II. However, percutaneous occlusion costs were higher compared with surgical closure. In Guatemala, where health care resources are limited, ASD II closure with the ASO device did not prove to be cost-effective.     

Embolization and retrieval of the Amplatzer septal occluder.

Embolization and percutaneous retrieval of the Amplatzer septal occluder (ASO) after release have been reported. However, the incidence, the causes of embolization, and the methods for effective retrieval have not been systematically described. In a survey of the ASO company-designated proctors, the incidence of ASO embolization in this group's experience was 0.55% (21 embolizations in 3824 device placements) with a wide range of patient demographics, atrial septal defect (ASD) sizes, and device sizes. Most embolizations occurred because of inadequate rim or undersized devices. Of the 21 embolizations, 15 of the devices were retrieved percutaneously with a gooseneck snare without morbidity or mortality. Six were retrieved at surgery. Of the 21 patients, 12 had ASO closure of their ASDs, and 9 had surgical ASD closure. In vitro, all devices could be retrieved with sheathes 2 Fr sizes larger than their recommended delivery sheath. Any device larger than 26 mm could be retrieved with its delivery sheath. The ability to pull the snared button into a sheath was variable and was assisted by pulling the device from above with a bioptome and by using a rigid notched sheath. Because the incidence of ASO embolization is about 1 in 200 in the most experienced hands, all operators should be prepared with the techniques and equipment required for percutaneous ASO retrieval.