Transcatheter closure of secundum atrial septal defects with complex anatomy

The aim of this study was to evaluate the feasibility, safety and efficacy of transcatheter closure of secundum atrial septal defects (ASD) in patients with complex anatomy. From September 1997 to July 2003, a total of 40 patients (median age, 34 years; 65% female) with complex ASDs, defined as the presence of a large defect (stretched diameter >26 mm) associated with a deficient rim (n=23); multiple defects (n=8); a multi-fenestrated septum (n=5); and defects associated with an aneurysmal septum irrespective of their size (n=4) underwent closure. The Helex device was used in 4 patients and the Amplatzer in the remaining. Two devices were implanted in 2 patients each. Implantation was unsuccessful in 5 patients, with 4 having large defects associated with a deficient anterior rim and a floppy posterior septum. Occlusion was observed in 22 of 35 patients (63%) immediately after implantation and in 31 (89%) at a mean follow-up of 18+/-9 months. No major complications occurred. Right ventricular end-diastolic dimensions (indexed for body surface area) decreased from 135+/-25% before closure to 124+/-15% 24 hours after closure, and to 92+/-12% after 12 months. Two patients with 2 distant defects and 2 patients with large defects remained with shunts (<4 mm) at the latest visit. Transcatheter closure of complex secundum ASDs was feasible, safe and effective; however, large defects associated with a deficient anterior rim and a floppy posterior septum may not be suitable for this approach.     

Clinical results of percutaneous closure of large secundum atrial septal defects in children using the Amplatzer septal occluder

We reviewed our experience using the Amplatzer septal occluder (AGA Medical, Golden Valley, MN, USA) to close large, secundum-type atrial septal defects (ASDs) in children. Between June 2002 and December 2005, 52 patients (mean age 13.5 +/- 8.7 years) underwent transcatheter closure of large (>/=25 mm), secundum ASDs with the use of the Amplatzer septal occluder (ASO). Groups 1 and 2 included patients with a retroaortic rim of <5 mm (n = 39) or >/=5 mm (n = 13), respectively. All procedures were performed with general anesthesia and transesophageal echocardiographic guidance except for 10 patients, which involved local anesthesia and three-dimensional transthoracic echocardiography. Successful device implantations, device sizes, approaches, complications, and closure rates were assessed. Device implantation was successful in 50 patients (96.1%), with no difference between groups (95% vs 100%, P>0.05). In 2 patients, implantation failed because of embolism or deployment failure. Device were larger in group 1 than in group 2 (29.7 +/- 4.2 vs 26.7 +/- 3.8 mm, P = 0.04). The right upper pulmonary-vein approach was more common in group 1 than in group 2 (P = 0.0001). Complications and closure rates did not differ between the groups (P > 0.05). Transcatheter closure of large, secundum ASD by using the ASO device was feasible, and complication rates were low. A deficient retroaortic rim did not preclude successful device implantation; however, a large device may be needed to close large ASD. Close long-term follow-up is necessary to determine the safety of transcatheter closure of large ASDs in children.     

Outcomes and alternative techniques for device closure of the large secundum atrial septal defect.

Outcomes of device closure of large and small secundum atrial septal defects (ASDs) as related to rim anatomy with the Amplatzer atrial septal occluder were compared. Rim adequacy (> or = 5mm) of the anterior, inferior, posterior, and superior rims was determined using transesophageal echocardiography. Balloon-stretched defect size defined patients into two groups: group 1, < or = 25 mm (n = 138); group 2, > 25 mm (n = 34). Rim deficiency (n = 62) was more frequent in group 2 compared to group 1 (50% vs. 33%; P = 0.07), especially inferior rim deficiency (35% vs. 2%; P = 0.005). Device deployment was successful in group 1 and group 2 (100% vs. 91%; P = 0.007). Unsuccessful deployment was associated with an ASD of > 25 mm (P = 0.007) and inferior rim deficiency (P = 0.001). At first follow-up (54 +/- 16 days), right ventricular systolic pressure had improved in both groups (P < 0.001). Closure of a large ASD associated with a lack of support in the inferior rim may warrant alternative strategies to position the device successfully.     

Comparison of transcatheter closure of secundum atrial septal defect using the Amplatzer septal occluder associated with deficient versus sufficient rims

To evaluate the feasibility of transcatheter closure of secundum atrial septal defects (ASDs) associated with deficient rims (<5 mm) using the Amplatzer septal occluder (ASO), 23 patients (median age 10.7 years) underwent an attempted transcatheter closure. The patients had a deficient anterior rim of 0 to 4 mm (n = 20), an inferior rim of 2 mm (n = 2), or a posterior rim of 4 mm (n = 1) as assessed by transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE). Forty-eight patients with sufficient rims (>5 mm) who underwent closure served as controls. There were no differences between the 2 groups in ASD stretched diameter and device size (p >0.05). Of 23 patients with deficient rims, 17 (74%) had immediate complete closure compared with 44 of 48 patients (92%) with sufficient rims (p <0.05). At 24-hour and 6-month follow-up, the complete closure rates were not significantly different between the 2 groups (91% for patients with deficient rims vs 94% for patients with sufficient rims at 24 hours and 100% vs 93% at 6 months, respectively). The fluoroscopic time and procedure time were longer in patients with deficient rims (13 +/- 7 and 72 +/- 26 minutes, respectively) compared with those with sufficient rims (10 +/- 4 and 61 +/- 22 minutes, respectively). No major complications were encountered either during or after the closure procedure in both groups. Thus, transcatheter closure of ASDs associated with small anterior, inferior, or posterior rims is feasible using an ASO. Long-term follow-up data are still needed to assess long-term safety and efficacy.     

Bioabsorbable atrial septal occluder for percutaneous closure of atrial septal defect in children

The BioSTAR bioabsorbable septal repair implant is a new transcatheter secundum atrial septal defect occlusion device that is absorbed and replaced by healthy native tissue. This retrospective analysis was designed to determine the most significant factors for its successful use in children. From October 2009 through December 2010, 33 children underwent catheterization to close secundum atrial septal defects by means of the BioSTAR. The mean age of the patients was 6.8 ± 3.4 years (range, 2.5-13 yr), and the mean body weight was 22.6 ± 11 kg (range, 11-55 kg). The device was successfully implanted in 91% of patients (30/33). In 2 patients, the attempt had to be abandoned because of deficient aortic rim. A 3rd patient had to be converted to surgery because the device embolized to the pulmonary artery. In 1 patient, 2 BioSTAR devices were used to occlude 2 separate holes. The mean maximum stretched diameter of the single-hole defects was 13.5 ± 2.5 mm (range, 8.5-18 mm). Twenty-five patients (76%) had a single-hole defect. The mean follow-up time was 7.7 ± 4.1 months (range, 0.8-15.6 mo). The occlusion rates were 77% after 24 hours and 97% at the end of follow-up. The BioSTAR septal occluder is best suited for small-to-moderate defects. Percutaneous closure of secundum atrial septal defects with the BioSTAR is safe and effective, yielding a high success rate at midterm outcome.     

Transcatheter occlusion of complex atrial septal defects.

Percutaneous device occlusion of secundum atrial septal defects (ASDs) is becoming an accepted alternative to surgical closure. This method allows us to evaluate patients with complex conditions for treatment. From a total of 70 patients with ASD evaluated for percutaneous closure, we selected for analysis 28 who had complex conditions. The mean age was 36+/-23 yr (range, 4-72). Six had heart failure, and of these six, three had atrial fibrillation. At cardiac catheterization, the pulmonary pressure was 47+/-24 mm Hg, and the QP/QS was 1.7+/-0.4; two patients had bidirectional shunt and systemic pulmonary pressure. Two patients received a buttoned device and 26 an Amplatzer septal occluder. The groups of patients with complex conditions were separated into the following groups. Group I (n = 4) underwent combined treatment of associated anomalies. Two patients had pulmonary stenosis, one had mitral stenosis, and one had an aortic root-left atrium fistula. They were treated in or during with the same procedure by combined transcatheter techniques (balloon valvuloplasty and fistula occlusion) before ASD occlusion. Group II (n = 9) had multiple defects (cribiform or two separate holes). They were treated with a single device in five instances and with two separate devices in four cases. Group III (n = 14) had large (32+/-3 mm) single defects. Nine of them underwent successful implantation using a device 33+/-3 mm in diameter; in the remaining five patients the device was removed because of instability. Group IV (n = 3) had residual defects after previous partial device occlusion. All three defects were successfully occluded with a second device. No movement or interference with the first device was observed. Group V (n = 6) had severe pulmonary hypertension (86+/-16 mm Hg). Immediately after ASD occlusion we observed significant relief in these patients (67+/-14 mm Hg; P<0.01). There were no major complications; all 23 patients with successful implants were discharged without symptoms 2-7 days later; one patient with atrial fibrillation recovered sinus rhythm. The follow-up (8+/-5 mo) Doppler echo study showed complete ASD occlusion in 22 patients and a peak pulmonary pressure of 30+/-14 mm Hg. We conclude that transcatheter occlusion of ASDs is an effective and safe treatment for patients with complex anatomic or physiopathologic conditions, as evaluated by short-term follow-up.     

Percutaneous closure of congenital and acquired ventricular septal defects--considerations on selection of the occlusion device

Nonsurgical closure of congenital and acquired ventricular septal defects (VSD) has become increasingly acceptable with the availability of various occlusion systems that allow percutaneous treatment of muscular and membranous defects. This study describes a series of 12 patients (0.2-74-years-old) who underwent defect closure with six different occlusion systems. Device selection according to anatomy and outcome is highlighted. Seven VSDs were located in the membranous part of the septum, five in the mid-muscular septum. Complex heart lesions were present in five postmyocardial infarction VSD in one and residual postsurgical defects in three patients. The size of the VSD ranged from 2.6 to 10 mm. The applied devices were: Amplatzer muscular VSD occluder (n=4), Amplatzer septal occluder (n=2), Amplatzer duct occluder (n=1), Amplatzer membranous VSD occluder (n=2), Nit-Occlud coil (n=2), and Cook PDA coil (n=1). The devices were implanted successfully in nine patients. There was complete VSD closure in eight patients within the first 24 hours. In one patient, a trivial residual shunt disappeared at 6 months follow-up. Because of device instability, two occluders were removed during catheterization. In two other cases, tricuspid valve tissue was entrapped in the occluder and had to be removed surgically, one of them during the consecutive Rastelli operation. Neither significant arrhythmia, nor thromboembolism or hemolysis occurred in out patients during follow-up. Transcatheter closure of VSD is an attractive alternative to surgery. In complex congenital heart disease, surgical-interventional hybrid therapy may improve morbidity and total outcome. The recently developed Amplatzer VSD devices allow closure of muscular and membranous VSDs. Implantation and short-term follow-up are superior to the formerly used devices. Long-term effects have to be evaluated in further studies.     

New echocardiographic diameter for Amplatzer sizing in adult patients with secundum atrial septal defect: preliminary results.

Anatomical atrial septal defect (ASD) diameter measured by transesophageal echocardiography (TEE) underestimates the Amplatzer septal occluder (ASO) size for ASD closure. The aim of this study is to investigate whether a new echocardiographic diameter (procedural ASD diameter) may enable precise measurements of ASO device size. Fifty adult patients with secundum ASD were evaluated by TEE for percutaneous closure. The procedural ASD diameter was measured using the steadier rim borders where thickness was 2.5 mm. Out of the 50 patients, 12 were considered unsuitable for Amplatzer device closure. The other 38 patients underwent percutaneous closure. The mean anatomical ASD diameter was 14.8 +/- 7.0 mm, the mean procedural ASD diameter measured 19.5 +/- 8.1 mm, and the mean stretched balloon diameter (SBD) was 20.0 +/- 8.0 mm. ASO device size was 20.1 +/- 8.0 mm. At linear regression analysis, a high correlation (r = 0.99) was found between procedural ASD diameter and SBD. Procedural ASD diameter correlates with SBD and may allow reliable prediction of Amplatzer device in an adult population undergoing percutaneous ASD closure.     

Percutaneous closure of large atrial septal defects

BACKGROUND: Percutaneous occlusion of secundum type atrial septal defect with an Amplatzer device is an effective treatment alternative. However, there is little information about the use of this treatment for large defects. PATIENTS AND METHOD: We retrospectively analyzed the initial and follow-up findings in 31 patients aged 41 18 years who had large atrial septal defects (>= 30 mm diameter). Mean defect diameter evaluated by the balloon occlusion method was 33.4 3.4 mm (range, 30-40 mm). In all patients we attempted the implantation of an Amplatzer septal occluder. RESULTS: The implant was successful in 23 patients (74%); 3 of whom had a double orifice. The size of the device was 34 3 mm diameter (range, 30-38 mm). Combined associated procedures were balloon pulmonary valvuloplasty in 3 patients and coronary stent implantation in 1. In 4 out of 8 patients where we failed, the implant was attempted but the device was unstable so we decided to retrieve it; in the remaining 4 patients, balloon measurement alone contraindicated the procedure. All patients did well, but one had cardiac tamponade during the procedure that was resolved in the catheterization laboratory. After 15 12 months of follow-up all 31 patients were alive and those who had functional limitation before treatment remained stable, with significant clinical improvement. CONCLUSIONS: Percutaneous device occlusion of large atrial septal defects is feasible and effective in most patients.     

经胸超声心动图监测下用Amplatzer封堵器治疗房间隔缺损

目的：评价在经胸超声心动图(TTE)监测下用Amplatzer封堵器介入治疗房间隔缺损(ASD)的可行性及实用价值。方法：全组共18例继发孔型ASD患者，均在常规C型臂X线机透视和TTE指导下经导管置入Amplatzer封堵器。结果：18例患者中有2例未放置成功而改为开胸手术；16例均成功置入Amplatzer封堵器，即刻完全堵闭，术后随访3个月至2年，TTE示ASD仍被完全封闭，未见残余分流。随访期间无任何并发症。结论：在TTE和X线透视指导下用Amplatzer封堵器治疗继发孔型ASD安全可行，具有一定实用价值。     

New technique for device closure of large atrial septal defects.

The objective of this study was to describe a new technique for transcatheter device closure of large atrial septal defects (ASDs) using the Amplatzer septal occluder and our experience with this technique in 14 patients. Transcatheter closure of large (> 25 mm) ASDs is challenging. We have developed a balloon-assisted technique (BAT) to facilitate device closure of large ASDs. The BAT consists of using a balloon catheter to support the left atrial (LA) disk of the Amplatzer septal occluder during device deployment. The balloon support prevents prolapse of the LA disk into the right atrium. Between April 2003 and February 2004, 14 patients with large ASDs (mean age, 25.71 +/- 15.71 years; mean weight, 51.21 +/- 23.78 kg) underwent device closure with the Amplatzer septal occluder using the BAT. The median balloon-stretched diameter of the ASD was 32 (range, 26-40) mm. The median device size used was 33 mm (range, 26-40 mm). All 14 patients had successful deployment of the device using the BAT. The mean follow-up period was 16.5 +/- 11.95 weeks. No major complications were noted during the procedure or on short-term follow-up. The BAT enables predictably successful closure of large ASDs using the Amplatzer septal occluder.     

Peratrial closure of atrial septal defects without cardiopulmonary bypass

The objective of this study was to introduce a new technique for occlusion of an atrial septal defect without cardiopulmonary bypass, using a modified Amplatzer device. Between October 2004 and November 2005, 96 secundum atrial septal defects in 83 patients were occluded by this method. A 3-cm incision in the right 4(th) intercostal space and a minithoracotomy were performed. Via this incision, the right atrium was exposed and the septal closure device was deployed under transesophageal echocardiographic guidance. The sizes of the defects ranged from 10 to 39 mm. The mean device size was 34.1 +/- 9 mm (12-46 mm). There was no operative mortality and no major morbidity on follow-up of 3-15 months. This new minimally invasive method of secundum atrial septal defect closure is safe and cosmetically superior to conventional surgery. Avoidance of cardiopulmonary bypass can reduce recovery time and complications. The indications are more extensive than percutaneous transcatheter closure, and the results are encouraging.     

Transcatheter closure of atrial septal defects with the Amplatzer septal occluder--a Japanese clinical trial.

This study reports the results of a Japanese clinical trial of transcatheter closure of atrial septal defects (ASD) using the Amplatzer septal occluder (ASO). Thirty-five patients with secundum ASD underwent transcatheter closure using the ASO at a median age of 12.9 years (range, 3.2-29.2 years) and a median weight of 39.2kg (range, 11.6-65.1 kg). The ASO was successfully implanted in 34 patients. The mean ASD diameter of the 34 patients measured by transesophageal echocardiography was 11.7 +/- 4.2mm (range, 5.0-20.8mm) and the mean balloon stretched diameter was 16.8 +/- 4.2 mm (range, 9-25 mm). The mean ASO size was 16.9 +/- 4.3 mm (range, 9-26mm). Complete closure rate at 1 day and 1 year after closure was 91% and 97%, respectively. One patient developed a transient second-degree atrioventricular block during the implantation procedure. No other complications occurred. Transcatheter closure of ASD using the ASO is effective and safe.     

Closure of a moderately large atrial septal defect with a self-fabricated fenestrated Amplatzer septal occluder in an 85-year-old patient with reduced diastolic elasticity of the left ventricle.

Percutaneous closure of an atrial septal defect (ASD) in the elderly with reduced diastolic elasticity of the left ventricle poses a significant management challenge. We report on the case of an 85-year-old patient who was admitted for percutaneous device closure of a moderately large secundum atrial septal defect. Hemodynamic evaluation documented an increase in left atrial pressure from a mean of 12 mm Hg to a mean of 32 mm Hg after balloon test occlusion of the ASD. Two months later, after adequate pretreatment with diuretics and afterload-reducing substances, he underwent successful closure of the ASD using a self-fabricated fenestrated Amplatzer septal occluder, which resulted in a postimplantation left atrial pressure of a mean of 18 mm Hg. Recovery was unremarkable and the fenestration has remained patent for 3 months since implantation of the device. This unique case highlights the feasibility of using a self-fabricated fenestrated Amplatzer septal occluder to close interatrial communications in elderly patients with diastolic dysfunction of the left ventricle.     

Transcatheter closure of congenital muscular ventricular septal defect

The success with occlusion devices for the closure of atrial septal defects and patent ductus arteriosus prompted the transcatheter closure of single and multiple muscular ventricular septal defects (VSD). The procedure for VSD was first attempted by Lock et al. in 1988 and devices originally designed for the closure of other intracardiac defects (Rashkind umbrella device, Lock clamshell, Cardioseal, coils, Sideris buttoned device etc.) were used with a variable success rate and a residual shunt. Recently, specially designed Amplatzer muscular VSD occluder and Sideris device are in use. The Amplatzer muscular VSD occluder has been undergoing clinical trial since 1998 after the animal experiments had shown 100% occlusion and complete endothelization at 3 months. The procedure was first attempted in August 1995 using the Rashkind umbrella device and since April 1998 only the Amplatzer muscular VSD occluder has been used. Of the149 patients who underwent transcatheter closure of VSD, 50 had muscular trabecular defects in various locations: mid-muscular, anterior, posterior, or apical. All cases were selected by detailed transthoracic and/or transesophageal echocardiography (TTE) and aneurysm of the muscular septum was observed in three of them. The age range was 3-28 years and the diameter of VSD was 4-11 mm. In all but one patient, the device was deployed from the venous side. Simultaneous TTE was done for proper positioning of the device and continuous electrocardiographic monitoring was also done for any arrhythmia/conduction defects. All patients were followed up every 3 months and received 3-5 mg/kg aspirin for 6 months. The procedure was successful in all patients. The Rashkind umbrella device (17 mm) was used in two and Amplatzer muscular VSD occluder (6-14 mm) in 48 patients. Forty-four devices were delivered by antegrade transvenous approach and six by the transjugular route. None had residual shunt, new aortic regurgitation, or tricuspid regurgitation. Transient complete heart block after 24 hours was noticed in one patient. On a follow-up of 2-90 months, the device was in position in all patients. There was no embolization of the device, and no late-conduction defects, infective endocarditis, or hemolysis. Transcatheter closure of muscular VSD is safe and efficacious, and should be considered as a procedure of choice as an alternative to surgery that avoids cardiopulmonary bypass.     

Three-dimensional reconstruction by transesophageal echocardiography of Amplatzer and CardioSEAL prosthetic devices after percutaneous closure and atrial septal defects

OBJECTIVE: The Amplatzer and cardioSEAL devices are currently used for percutaneous closure of atrial septal defects. The in vivo morphology of these devices is unknown and this is why we sought to describe their geometric profile by three-dimensional echocardiography. METHODS: Thirteen patients, aged 6 to 18, underwent transcatheter closure of a secundum type atrial septal defect with either the CardioSEAL (n = 8) or the Amplatzer (n = 5) device. Three-dimensional reconstructions of the defect were obtained from transoesophageal bidimensional echocardiographic views. RESULTS: In the Amplatzer group, the stretched diameter of the defect was larger than in the CardioSEAL group (22 +/- 2 vs 18 +/- 1 mm, p = 0.003), but ehocardiographic surfaces were the same (3.3 +/- 1 vs 3.6 +/- 1 cm2, p = 0.3). The surface of the CardioSEAL device was measured at 4.8 +/- 2 cm2 whereas the Amplatzer's surface was 6.8 +/- 2 cm2 (p = 0.03). The Amplatzer device had a volume of 9 +/- 1 cm3 while the CardioSeal's volume was 3.1 +/- 1 cm3 (p < 0.0001). CONCLUSIONS: The CardioSEAL device occupies a small volume but it covers less of the septal defect and this may result in a higher incidence of residual shunting. The Amplatzer device almost always occludes the septum, but it tends to bulge into the atria and may cause mechanical complications.     

Transcatheter closure of perimembranous ventricular septal defect with amplatzer membranous occluder

BACKGROUND: Use of trancatheter device closure for membranous ventricular septal defect is still in evolving phase. We report the early and mid-term results of our experience with the new asymmetric Amplatzer membranous ventricular septal defect occluder. METHODS AND RESULTS: We attempted, transcatheter closure of perimembranous ventricular septal defect using asymmetric Amplatzer occluder in 26 patients. The patients were selected on the basis of transthoracic and transesophageal echocardiographic assessment of the ventricular septal defect. The procedure was successful in 21 (81%) patients. The age ranged from 3 to 23 years, weight from 10 to 59 kg and defect size ranged from 3 to 9 mm (mean: 5 +/- 1.8 mm). One patient had situs inversus with dextrocardia: 11 had aneurysmal tissue partly occluding the defect and the device was deployed either across (n=6) or within the aneurysmal sac (n=5). Three patients developed high degree atrioventricular block on attempts to cross the defect with the sheath and the procedure was discontinued. In two patients it was not possible to place the sheath in left ventricle despite repeated attempts. There was a residual flow in 4 (19%) patients at 24 hours. Two patients developed bundle branch block and none had complete heart block. At follow-up (1-9 months, n=20), residual flow was seen in two patients. None developed late conduction defect, aortic regurgitation, infective endocarditis or hemolysis. CONCLUSIONS: Transcatheter closure of perimembranous ventricular septal defect can be performed safely and effectively with the new asymmetric Amplatzer occluder device in selected patients with good short- and midterm results. These devices can be deployed safely in and across and the aneurysmal sacs. In selected cases, this procedure is a satisfactory alternative to surgery.     

Percutaneous closure of perimembranous ventricular septal defects with the Amplatzer device: technical and morphological considerations.

Percutaneous closure of perimembranous ventricular septal defects (VSDs) has been feasible, safe, and effective with the new Amplatzer membranous septal occluder. We report further experience with this device with emphasis on morphological aspects of the VSDs and technical issues. Ten patients (median age and weight, 14 years and 34.5 kg, respectively) with volume-overloaded left ventricles underwent closure under general anesthesia and transesophageal guidance (TEE). The VSD diameter was 7.1 +/- 4.0 mm by angiography and 7.8 +/- 3.7 mm by TEE. Three patients had defects associated with aneurysm-like formations (two with multiple exit holes), four had defects shrouded by extensive tricuspid valve tissue, two had defects with little or no tricuspid valve involvement, and one had a right aortic cusp prolapse with trivial aortic regurgitation. Implantation was successful in all patients, although in two the initial device had to be changed for a larger one. Kinkings in the delivery sheath, inability to position the sheath near the left ventricular apex, and device prolapse through the VSD prompted modifications in the standard technique of implantation. Device orientation was excellent except in one case. Nine patients had complete occlusion within 1-3 months. Device-related aortic or tricuspid insufficiency, arrhythmias, and embolization were not observed. Two patients had slight gradients across the left ventricular outflow tract, normalizing after 3 months. The Amplatzer membranous septal occluder was suitable to close a wide range of perimembranous VSD sizes and morphologies with good short-term outcomes. Longer follow-up is required.     

Transcatheter closure of very large (>or= 25 mm) atrial septal defects using the Amplatzer septal occluder.

Between June 1999 and September 2002, 45 patients (age, 34 +/- 13 years; mean shunt ratio, 2.6 +/- 0.6) underwent transcatheter atrial septal defect (ASD) closure at our institution with the Amplatzer septal occluder (mean device size, 31.4 +/- 3 mm). Patients were selected by transesophageal echocardiography. The mean ASD dimension was 25.3 +/- 3.7 mm and 33 (73%) patients had deficient anterior rim. Specific procedural details included the use of 13 or 14 Fr introducer sheaths and the right upper pulmonary vein approach if the conventional approach failed. There were two procedural failures, with device embolization in both (surgical retrieval in one, catheter retrieval in one). During follow-up (3-30 months; median, 16 months), one patient (59 years) with previous atrial flutter had pulmonary embolism and was managed with anticoagulation. Two patients developed symptomatic atrial flutter. Fluoroscopy time was 31.6 +/- 19.5 min for the first 22 cases and 19.6 +/- 11.4 min for the rest (P = 0.04). Transcatheter closure of large ASDs is technically feasible but careful long-term follow-up is needed to document its safety.     

Percutaneous closure of atrial septal defect with the Amplatz device: initial result and mid-term follow-up

OBJECTIVES: Percutaneous device occlusion of atrial septal defects (ASD) is, although with some limitations, an alternative to surgical closure. The aim of this study was to evaluate the efficacy and safety of percutaneous ASD closure using the Amplatz device. PATIENTS AND METHODS: From October 1999 to March 2000, 25 children underwent transcatheter closure of ASD at a mean +/- SD age of 8.7 +/- 3.1 years (range 3-15 years) and a mean weight of 31.8 +/- 16.7 kg (range 11-84 kg). Device selection was based on the stretched diameter of the ASD using the PTA OS balloon. The device was implanted under ultrasonographic and radiological guidance. All patients showed signs of volume-overload of the right ventricle. The ASD was single (n = 21), with two separate holes (n = 2), or cribiform (n = 2). RESULTS: The median +/- SD size of the device used was 21.7 +/- 5.4 mm (range 15-36 mm). In twenty-two patients (88%) the device was successfully implanted. A repeat echocardiogram was performed the next day before discharge. Two patients underwent surgery after deployment of the device due to mitral valve dysfunction (n = 1) or residual leak (n = 1). In a patient with a two-hole ASD, another device was percutaneously withdrawn, while still attached to the delivery cable due to incomplete occlusion. CONCLUSION: a) Transcatheter occlusion with the Amplatzer device is an effective treatment for ostium secundum atrial septal defects; b) the low complication rate and the short hospitalization period makes this procedure the treatment of choice in these patients, and c) ASD which are too large, cribiform or with deficient rims may require a different approach.