Incidence and clinical course of thrombus formation on atrial septal defect and patient foramen ovale closure devices in 1,000 consecutive patients

OBJECTIVES: The purpose of this study was to investigate the incidence, morphology, and clinical course of thrombus formation after catheter closure of intra-atrial shunts. BACKGROUND: Post-procedure detailed information about thrombotic material on different devices for transcatheter closure is missing. METHOD: A total of 1,000 consecutive patients were investigated after patent foramen ovale (PFO) (n = 593) or atrial septal defect (ASD) (n = 407) closure. Transesophageal echocardiography (TEE) was scheduled after four weeks and six months. Additional TEEs were performed as clinically indicated. RESULTS: Thrombus formation in the left atrium (n = 11), right atrium (n = 6), or both (n = 3) was found in 5 of the 407 (1.2%) ASD patients and in 15 of the 593 (2.5%) PFO patients (p = NS). The thrombus was diagnosed in 14 of 20 patients after four weeks and in 6 of 20 patients later on. The incidence was: 7.1% in the CardioSEAL device (NMT Medical, Boston, Massachusetts); 5.7% in the StarFLEX device (NMT Medical); 6.6% in the PFO-Star device (Applied Biometrics Inc., Burnsville, Minnesota); 3.6% in the ASDOS device (Dr. Ing, Osypka Corp., Grenzach-Wyhlen, Germany); 0.8% in the Helex device (W.L. Gore and Associates, Flagstaff, Arizona); and 0% in the Amplatzer device (AGA Medical Corp., Golden Valley, Minnesota). The difference between the Amplatzer device on one hand and the CardioSEAL device, the StarFLEX device, and the PFO-Star device on the other hand was significant (p < 0.05). A pre-thrombotic disorder as a possible cause of the thrombus was found in two PFO patients. Post-procedure atrial fibrillation (n = 4) and persistent atrial septal aneurysm (n = 4) had been found as significant predictors for thrombus formation (p < 0.05). In 17 of the 20 patients, the thrombus resolved under anticoagulation therapy with heparin or warfarin. In three patients, the thrombus was removed surgically. CONCLUSIONS: The incidence of thrombus formation on closure devices is low. The thrombus usually resolves under anticoagulation therapy.     

Percutaneous treatment of atrial septal aneurysm

Among a total number of 203 patients with atrial septal defects (ASD) or patent foramen ovale (PFO) who were treated by percutaneous closure, we selected 29 (19 with ASD and 10 with PFO) who fulfilled the criteria for atrial septal aneurysm. Eight patients had functional class II or III dyspnea, and 12 had a history of previous cerebrovascular accident (38%). Seven of the patients with ASD, had a single defect and 12 had multiple defects; 14 received a single occluder and 5 patients needed 2 or 3 devices. Follow-up transthoracic ultrasound study at 6 months showed the defect to be successfully closed in all 29 patients. After a mean follow-up time of 31 +/- 19 months, all patients were alive and symptom-free. Patients with atrial septal aneurysm and associated ASD or PFO can be successfully treated with Amplatzer septal occluders.     

Incidence of atrial fibrillation following transcatheter closure of atrial septal defects in adults

Transcatheter closure of secundum atrial septal defect (ASD) and patent foramen ovale (PFO) has become a routine procedure. Little is known about the effect of atrial septal device implantation on the occurrence of atrial fibrillation (AF). We evaluated the frequency of AF occurring after transcatheter PFO and ASD closure in a large population. From 1994 until 2007 a total of 1,062 patients underwent transcatheter closure of an interatrial communication. New-onset AF was defined by 12-lead electrocardiogram or Holter monitoring in patients without a history of AF at baseline. Of the 1,062 patients, 822 had a PFO and 240 had an ASD. During a median follow up of 20 months, new-onset AF was documented in 8% of patients. New-onset AF occurred in 7% of patients after PFO closure and in 12% of patients with underlying ASD. The annual incidence of new-onset AF was 2.5% and 4.1% in patients with PFO and ASD, respectively. Generally, patients with new-onset AF were older than those without AF. Device type or size did not influence the occurrence of AF. In the group of patients with PFO, residual shunt was more common in patients with AF compared with the non-AF group. In conclusion, AF is more common after PFO and ASD closure compared with the general population; although device type or size did not impact the occurrence of AF, residual shunt may influence the occurrence of AF after intervention in patients with underlying PFO.     

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.     

Atrial and ventricular septal defects can safely be closed by percutaneous intervention

Various transcatheter devices and methods to close congenital heart defects are currently available. Devices have been designed specifically for atrial septal defect (ASD), patent foramen ovale (PFO), and ventricular septal defect (VSD) closure. The trend in interventional treatment of intracardiac shunts shows toward defect-specific systems. The PFO is a tunnel defect requiring occluders that adapt to its length while common ASD strongly vary in their diameter, making a large scale of device sizes indispensable. VSDs are predominantly sealed by coils or tissue-adapted devices like muscular or perimembranous occluders. Since VSDs may occur with an aneurysm (VSA), a multi-perforated septum, an instable myocardial situation (postinfarction) or a high interventricular pressure gradient, closure of these defects is regarded sometimes as complicated. But during the last 30 years (since King and Mills implanted the first double-umbrella occluding system) several studies have proven procedure efficacy and safety of both ASD and VSD closure. This article reviews a large scale of studies and includes our single center data on 1,609 PFO, ASD, and VSD patients.     

The role of transesophageal echocardiography in transcatheter closure of secundum atrial septal defects by the Amplatzer septal occluder

BACKGROUND: Our purpose was to determine the role of transesophageal echocardiography (TEE) in the closure of atrial septal defects by the Amplatzer septal occluder (ASO) (AGA Medical, Golden Valley, Minn). METHODS: A total of 240 patients with atrial septal defect (ASD) secundum were examined by transthoracic 2-dimensional echocardiography (TTE) and TEE to determine the ASD morphologic features, diameter, and rims. During transcatheter closure TEE was used for determination of the ASD diameter and guidance of the ASO implantation. RESULTS: Sixteen (6%) patients were found not suitable for transcatheter closure with TTE, 35 (14%) with TEE, and 2 during catheterization. Twenty-eight patients (18%) had partial or total deficiency of the posterior, inferoanterior, or inferoposterior rim, 54 (27%) had a centrally positioned ASD, 92 (46%) had insufficient superoanterior rim, and 9 had multiple ASDs, whereas 8 had a septal aneurysm associated with a single defect and 4 a multiperforated aneurysm. A total of 170 patients underwent implantation of ASO. The ASO was correctly positioned in 144 at the first attempt. In the remainder TEE revealed unstable position of the left atrial disk (12), opening of both atrial disks in the left atrium (5), deployment of the device through the smaller defect in patients with multiple ASDs (3), and, in 1 patient, the device was too small and had to be replaced by a larger one. CONCLUSIONS: Morphologic variations of the ASD are common. TEE is crucial for the determination of the ASD morphologic features, diameter, and rims, which are crucial for proper patient selection. TEE allows precise guiding and positioning of the ASO, which is essential for safe and effective transcatheter ASD closure.     

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)     

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.     

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.     

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.     

Role of intracardiac echocardiographic guidance in transcatheter closure of atrial septal defects and patent foramen ovale using the Amplatzer device

Transesophageal echocardiography (TEE) has been successfully used for guiding transcatheter device closure of secundum atrial septal defect (ASD) and patent foramen ovale (PFO). However, the use of TEE for device closure requires general anesthesia. Experience with intracardiac echocardiographic (ICE) guidance to close ASD and PFO is limited. One hundred eleven patients (76 female/35 male) with secundum ASD (82 patients) and PFO (29 patients) associated with a stroke underwent an attempt of transcatheter closure of their defects under ICE guidance using the new AcuNav catheter. The median age of patients was 40 years (range 2.5-80.7) and the median weight was 66 kg (range 12.7-128 kg). The median two-dimensional size of secundum defects as measured by ICE was 17 mm (range 3-32 mm). The median balloon stretched diameter of the ASDs was 22 mm (range 4-36 mm). Five patients had more than one defect that required placement of two devices to close the defects. The median Qp/QS ratio for patients with secundum ASD was 2.1 (range 1-18). ICE provided adequate views of the defects and surrounding structures and the various stages of device deployment. All patients had successful device placement, including the patients who received simultaneous two devices with immediate complete closure of the defects in 100 patients, whereas four and seven patients had trivial and small residual shunt, respectively. The median fluoroscopy time was 10.2 minutes (range 3.7-38.4 minutes) and the median total procedure time was 60 minutes (range 28-180 minutes). There were no complications related to the use of the AcuNav catheter. We conclude that ICE provided unique images of the atrial communications and facilitated device closure of secundum ASD and PFO in children and adults. We believe ICE should replace TEE as a guiding imaging tool for ASD and PFO device closure, thus eliminating the need for general anesthesia.     

介入治疗房间隔缺损600例临床分析

目的:探讨介入治疗房间隔缺损(ASD)的疗效及并发症。方法:1998年11月至2011年2月应用双盘伞ASD封堵器治疗600例继发孔ASD,其中男性235例,女性365例;年龄1.3~72岁,体质量10~107kg。术前均经体检、心电图、胸X线片及超声心动图确诊,术后行心脏超声及临床检查随访。结果:手术成功率98.8%(593/600),5例因缺损较大或边缘不足试封堵失败,1例术中出现Ⅲ°房室传导阻滞放弃介入治疗,1例释放封堵器后即发现移位,即刻通知外科及时开胸取出封堵器并修补缺损;选择封堵器直径6~40mm,35例多孔ASD,有33例置入1个封堵器,2例应用2个封堵器。手术近期并发症包括:封堵器移位(1例),脑梗死(1例),心律失常(2例),空气栓塞(3例),平均5年随访中没有严重并发症。结论:ASD的介入治疗其技术成功率高,近期和远期疗效均满意,已成为治疗ASD的首选方法。     

Improvements in cardiac form and function after transcatheter closure of secundum atrial septal defects

OBJECTIVES: We set out to study the effect of transcatheter closure of atrial septal defect (ASD) on right ventricular (RV) and left ventricular (LV) function assessed by myocardial performance index (MPI), as well as left atrial (LA) volumes. BACKGROUND: The hemodynamic response to the closure of ASD is well-documented in surgically treated patients. However, few studies have documented echocardiographic evaluation of ventricular function in patients undergoing transcatheter closure of ASDs. METHODS: Pre- and post-ASD device closure echocardiograms of 25 consecutive patients were retrospectively reviewed. Measurements of RV and LV MPI and LA volumes were made. RESULTS: Twenty-five patients with an average age of 45.5 +/- 16.3 years underwent transcatheter closure of ASD. There was statistically significant improvement in RV MPI (0.35 to 0.28, p = 0.004), LV MPI (0.37 to 0.31, p = 0.04), and LA volume index (25.7 to 21.8 ml/m(2), p < 0.001) after closure of ASD. CONCLUSIONS: Device closure of ASDs leads to improvement of both RV and LV function as well as reduction in LA volume. These hemodynamic improvements provide insights into the symptomatic benefits gained in closure of ASDs using the transcatheter approach.     

Characteristics of adult patients with atrial septal defects presenting with paradoxical embolism

Background : The association between patent foramen ovale (PFO), atrial septal aneurysm, and cryptogenic stroke due to paradoxical embolism has been established. The correlation between atrial septal defect (ASD) in adults and paradoxical embolism is less well defined. Methods : We examined our single center experience with 329 adult patients undergoing percutaneous device closure of interatrial communication defects to identify clinical and morphologic differences among adult patients with ASDs who presented with or without paradoxical embolism. Comparison was made with patients with PFO. Results : Although a significant left‐to‐right shunt was the predominant indication for ASD closure, 20 patients (14%) presented with a paradoxical embolism. These patients tended to be younger and had smaller defects (both by size and shunt ratio) than ASD patients without paradoxical embolism, and were more likely to be female than PFO patients. Conclusions : The incidence of adult patients with ASD who presented with paradoxical embolism is higher than expected and suggests that this diagnosis should be considered in patients with cryptogenic stroke. © 2009 Wiley‐Liss, Inc.     

Transcatheter closure of atrial septal defects

The first transcatheter closure of an atrial septal defect (ASD) was performed by King and Mills in 1976. The Lock Clamshell occluder and the buttoned device are the latest devices to undergo clinical trials. Successful transcatheter closure has been possible with minimal morbidity and mortality. Small residual shunts may remain, however, in up to 20% of patients 1 year after the procedure. The clinical significance and natural history of these small residual atrial communications remains to be determined. This article reviews the history and development of the current ASD closure techniques, with emphasis on the experience with the Lock Clamshell occluder and the buttoned device.     

Interventional occlusion of foramen ovale and atrial septal defects after paradoxical embolism incidents

Two hundred and fifty-one patients with a persistent foramen ovale (PFO), mean age 43.3 +/- 12.4 years, underwent catheter closure between 6/1995 and 6/2001. One hundred and forty-one had an ischemic stroke, 99 a transient ischemic attack (TIA) or prolonged reversible ischemic neurologic deficit, 5 peripheral arterial embolism, 4 suffered from decompression sickness after diving and 2 had transient global amnesia. Fifty-nine of them had multiple events in spite of antiplatelet or anticoagulant therapy. The patients received five different devices: 13 Rashkind Occluders, 20 Amplatzer septal Occluders, 109 Amplatzer PFO-Occluders, 73 CardioSEAL and 36 STAR-Flex devices. Time of fluoroscopy was 8.3 +/- 4.5 min. In three patients a device embolized and had to be removed from the groin vessels. We saw five inguinal or retroperitoneal venous hematomas with the need for operation in one patient. One early and one late perforation of the left atrium caused by a guide wire and a left-atrial disc, respectively, also needed surgery. Fourteen patients had documented late arrhythmias. Six patients with atrial fibrillation needed drugs or cardioversion while the other patients with runs of supraventricular tachycardia, atrial flutter and multiple extrasystoles needed no therapy. On transesophageal echocardiography (TEE) 6 months after implantation we found four significant residual leaks. These patients had the defect closed with a second device. In addition a secundum atrial septal defect (ASD) was closed in 17 patients (mean age 38 +/- 10.5 years) with Amplatzer septal Occluders (12) and CardioSEAL devices (5). These patients had experienced eight strokes and nine TIAs, 3 of them had had multiple events. Two of these patients had a significant residual defect and one had atrial flutter following the procedure. Two hundred and two PFO-patients and 12 ASD patients were followed for 6-62 (24.6 +/- 14.2) months; 2 died due to a traffic accident and a myocardial infarction, respectively. Four patients had another neurologic event following PFO-closure. We now overlook 210 patients with 348.6 symptom-free patient years and have a 1-year recurrence rate of neurologic events of 1.9%. Catheter closure of the PFO and atrial septal defect is a simple, effective and quick method which ensures a high closure rate, avoids life-long anticoagulation and has a low recurrence rate of neurologic events.     

Transcatheter closure of atrial septal defect by "buttoned" devices.

During a 21-month period ending in August 1991, 12 patients underwent transcatheter closure of atrial septal defect (ASD) with a "buttoned" device through an 8Fr sheath, using an institutional review board-approved, custom-made device protocol initially, and Food and Drug Administration-approved clinical trials subsequently. Ten children had left-to-right shunts across the ASD and 2 adults had their patent foramen ovale closed to prevent recurrent paradoxical embolism (including cerebrovascular accidents). The device dislodged in 1 of the 4 patients in whom a first-generation device was used, and retrieval of the device, and surgical closure of the ASD were performed without incident. In the remaining 11 patients (age range 7 months to 45 years, weight 3.6 to 64 kg), the device remained intact, and pulmonary-to-systemic flow ratio decreased from 2.1 +/- 0.3 to 1.04 +/- 0.06. Follow-up chest x-ray and echo-Doppler studies were available in all patients 0.5 to 18 months after the procedure. The device was intact in all patients. Small residual shunt detected by color Doppler was seen in 2 children. Right ventricular size decreased (23 +/- 6 to 17 +/- 3 mm; p less than 0.01), and paradoxical septal motion disappeared in all patients. There was no recurrence of paradoxical embolism in the 2 adults. No complications occurred during follow-up. It is concluded that transcatheter closure of ASD with the buttoned device is feasible, effective and safe, and can be accomplished with small, 8Fr sheaths (even in infants weighing 3.6 kg), follow-up results are excellent, and clinical trials on a larger number of patients are needed.     

Single pediatric center experience with multiple device implantation for complex secundum atrial septal defects

Objectives : We analyzed the efficacy and complications of placing multiple transcatheter devices to correct complex ASD in a primarily pediatric population. Background : Limited pediatric information exists regarding the safety and efficacy of using multiple devices for secundum atrial septal defects (ASD) when multiple defects are present. Methods : Cath lab, echo, and clinical data were reviewed for 238 patients who underwent device closure of secundum ASD from 2000 to 2007 at a single pediatric center. Of those requiring multiple devices (n = 15), residual shunting and complications were assessed. Results : 238 patients (mean age 12 yrs; 80% < 16 yrs) underwent transcatheter ASD closure. 34 (14%) had multiple ASD, but only 15 received multiple devices (2 devices in 14 and 3 devices in 1). The mean age and weight (12 yrs; 35 kg) represent a younger population than previously reported. Only 3 were > 15 yrs, with a median age of 10.8 yrs (range 2–31). There was no compromise or obstruction to surrounding structures, and no device embolization or erosion was noted. A tiny thrombus was observed on the right sided screw of one device with no clinical sequelae. One patient (age 31 yrs) died at home 30 days post procedure from cardiac tamponade. Autopsy revealed the 3 intact devices in stable position without evidence of erosion. Latest available echo follow‐up for the group revealed functional resolution of atrial level shunting in all patients. Conclusion : Multiple devices can safely and effectively be implanted in the pediatric population to close complex ASD. © 2008 Wiley‐Liss, Inc.     

Percutaneous transcatheter closure of atrial septal defects: initial single-centre experience and follow-up results. Initial experience with three-dimensional echocardiography

OBJECTIVE: Registry to report our single-centre experience in closing defects of the atrial septum. METHODS: Between 1996 and 2001, transcatheter device closure of significant atrial septal defects was performed in 32 adults (mean age 45.1 years, range from 15 to 76 years), using different device types. Six patients had a patent foramen ovale (PFO) and 26 patients had a secundum atrial septal defect (ASD II). Defects were selected by means of two-dimensional transoesophageal echocardiography (2D TOE). For 12 defects additional three-dimensional transoesophageal echocardiography (3D TOE) was performed. RESULTS: Mean balloon-stretched diameter was 19.3 mm (range from 11 to 24 mm). A device was successfully placed in all PFO patients (100%) without complications at follow-up. Successful immediate device placement occurred in 24 out of 26 ASD patients. Two immediate placement failures, 1 device embolisation and 1 device non-fixation, occurred and required urgent surgery. There was 1 patient with pericardial effusion after the intervention, requiring pericardiocentesis. Three late placement failures occurred: 2 device embolisations and 1 device dislocation. Clinical success after 3 to 6 months follow-up, defined as the absence of shunt or small shunt, was achieved in all 6 PFO patients and in 21 out of 23 ASD patients (1 device embolisation, requiring surgery, occurred before follow-up was completed). Two patients with significant shunt, 1 late device dislocation and 1 late device embolisation, underwent elective surgery. For patient selection, 3D TOE proved useful in the evaluation of large and/or complex defects. CONCLUSION: Transcatheter device closure of carefully selected atrial septal defects is an alternative to surgery. Although the results are promising, surgical back-up is often needed.     

Frequency of atrial tachyarrhythmias following transcatheter closure of patent foramen ovale

BACKGROUND: Transcatheter closure of patent foramen ovale (PFO) in patients with a history of cryptogenic stroke is performed with increasing frequency. However, the long-term effects of these closure devices on atrial tachyarrhythmias (ATs) are not known. METHODS AND RESULTS: The study population included 71 patients [31 (44%) men, aged 54 +/- 14 years] with PFO, diagnosed by transesophageal echocardiography (TEE), and greater than or equal to 1 cryptogenic stroke (n = 70) or orthodoxia (n = 1). Patients underwent transcatheter closure of PFO using a 28 mm (n = 53) or a 33 mm (n = 18) CardioSEAL closure device (n = 67) or an Amplatzer occluder (n = 4). Five (7%) patients presented with newly diagnosed (n = 4) or recurrent (n = 1) episodes of AT (3 atrial fibrillation and 2 typical atrial flutter) within 1 to 480 days following the procedure, with an average time to onset of 175 +/- 221 days. ATs were more frequent in those who received a 33 mm device than those who received a 28 mm device [4/18 (22%) vs. 1/53 (2%); p < 0.05]. Patients with ATs showed a trend toward a larger left atrium only on apical view (6.5 +/- 1.4 cm vs. 5.1 +/- 0.9 cm; p = 0.05). However, the difference in left atrial size on parasternal view and right atrial size between the 2 groups was not statistically significant (4.5 +/- 1.1 cm vs. 3.7 +/- 0.8 cm and 5.9 +/- 2.4 cm vs. 4.6 +/- 0.7 cm). Conclusion. Compared to the age-matched population, sustained ATs appear to be relatively common following transcatheter closure of PFO. In our series, they seemed to occur more frequently in patients who received larger devices.