Single-center experience with the HELEX septal occluder for closure of atrial septal defects in children

Catheter closure of atrial septal defects (ASDs) is an accepted procedure among pediatric cardiologists. We report our early experience with the newest of these devices in clinical trials in the United States. Between April and October 2001, 14 patients were enrolled in an FDA phase II multicenter trial comparing the results of ASD closure using the HELEX Septal Occluder to a surgical control group. Of the 14 patients, devices were placed and left in 13, one being removed for an excessive residual leak despite placing the largest device available. Of the remaining 13 patients, all patients had successful closure of their defects. An average of 1.8 devices/patient were deployed, reflecting the learning curve for this new device and new delivery style. Six devices were replaced because of excessive residual leaks, three for premature lock release, and two for improper seating of the device. There were no procedural complications, however, one patient required device removal 4 months postimplant for possible allergic reaction to nickel. The same patient had removal of stainless steel sternal wires for the same reason. At the 6-month follow-up, 11 of 13 patients had complete closure of the ASD, the other two having small, hemodynamically insignificant left to right shunts. In one of these patients, there was complete closure at the 12-month follow-up, whereas the other patient awaits the 1-year evaluation. Early experience at our institution has demonstrated the ease of use of this device, its complete retrievability, and excellent closure of small to moderate ASDs in children.     

Helex device closure of multiple atrial septal defects

Objectives : To describe the effectiveness of the Helex Septal Occluder (HSO) to close multiple atrial septal defects (mASDs). Background : Limited information is available describing closure of mASDs with the HSO. Methods : A total of 28 patients who underwent closure of mASDs with the HSO were identified by retrospective review of our catheterization database between 2001 and 2012. Procedural details and follow up information were collected. Results : Median age was 19.2 years, median weight 48 kg, with 10 (36%) patients weighing <25 kg. Indication for closure was RV enlargement (RVE) in all patients and additionally neurologic events occurred in 3/28 (11%). Median stop‐flow diameter for the largest ASD was 14 (4–23) mm. One HSO was implanted in 21/28 (75%), 2 in 6/28 (21%), and 3 in 1/28 (4%). One embolization and one transient arrhythmia occurred with no sequelae. Immediate residual shunt was absent in 5/28 (18%), trivial in 15/28 (54%), small in 6/28 (21%), and moderate in 2/28 (7%). Of the 25 patients with ≥6 months follow‐up (median 53 months), residual shunt was absent in 13/25 (52%), trivial in 5/25 (20%), and small in 7/25 (28%). RVE resolved in all but one patient with no other associated lesions and ≥6 months of follow‐up. No patient with prior neurological event had recurrence at last follow‐up. Conclusions : We conclude that closure of mASDs with ≥1 HSO is effective with a low complication rate. The ability of HSO devices to overlap or sandwich each other may facilitate safe implantation of multiple devices in smaller patients. © 2013 Wiley Periodicals, Inc.     

Transcatheter closure of secundum atrial septal defects using the new self-centering amplatzer septal occluder: Initial human experience

Transcatheter closure of secundum atrial septal defect (ASD) using clamshell or buttoned devices is accompanied by a high incidence of residual shunt. Recently, a new self-centering device, the Amplatzer septal occluder (ASO), has been evaluated in an animal model with very good results. Therefore, our purpose is to report on our initial clinical experience with this device. Thirty patients underwent an attempt at catheter closure of their ASDs at a median age of 6.1 yr (range, 2.9–62.4 yr) and median weight of 22 kg (range, 13–69 kg) using the ASO. The median ASD diameter measured by transesophageal echocardiography (TEE) was 12.5 mm (range, 5–21 mm), and the median ASD balloon stretched diameter was 14 mm (range, 7–19 mm). All patients had right atrial and ventricular volume overload with a mean ± SD Qp/Qs of 2.3 ± 0.6. A 7F catheter was used for delivery of the device in all patients. The device was placed correctly in all patients. There was immediate and complete closure (C) in 17/30 patients, 10 patients had trivial residual shunt (TS), and 3 had moderate residual shunt (MS). The median fluoroscopy time was 15 min (range, 8–35 min), and the median total procedure time was 92.5 min (range, 40–135 min). There was no episode of device embolization or any other complication. Follow-up was performed using transthoracic echocardiography (TTE) 1 day, 1 mo, 3 mo, and yearly thereafter. At 1 day, there was C of the ASD in 24/30 patients, 3 had TS, 1 had small shunt (SS), and 2 had MS. At a median follow-up interval of 6 mo, there have been no episodes of endocarditis, thromboembolism, or wire fracture. We conclude that the use of the new ASO is safe and effective in complete closure of secundum ASDs up to a diameter of 21 mm in the majority of patients. Further clinical trials are underway. Cathet. Cardiovasc. Diagn. 42:388–393, 1997. © 1997 Wiley-Liss, Inc.     

First experience with the new GORE® septal occluder for the closure of multiple atrial septal defects

Transcatheter closure of an atrial septal defect (ASD) is considered the standard of care for most of the patients with secundum ASD. The existence of multiple or fenestrated ASD may constitute a challenge to achieve a satisfactory result. Data on the usage of multiple devices for closing multiple defects are limited. The GORE^® Septal Occluder (GSO) represents a new generation of transcatheter ASD occluders with a design that provides superior conformability, apposition, and closure performance compared with the previous GORE^® HELEX device. The present case report describes the first clinical experience with the implantation of two GSO devices in a patient with multiple ASDs and fenestrated septum. © 2012 Wiley Periodicals, Inc.     

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.     

Sequential implantation of two Helex septal occluder devices in a patient with complex atrial septal anatomy.

We report the first implantation of two Helex septal occluder devices in a 10-year-old boy with complex atrial septal anatomy. The unique characteristics of this new device are discussed in the following case report.     

经静脉闭合房间隔缺损的疗效观察

目的 :评价经静脉置入 Amplatzer封堵器治疗继发孔型房间隔缺损 (ASD)的疗效。方法 :2 4例患者术前经多普勒超声心动图检查 ASD直径为 6～ 30 (18.96± 7.0 3) m m。在透视及经超声心动图引导下经静脉置入Am platzer封堵器闭合 ASD。结果 :2 4例 ASD直径的球囊测量值为 15～ 36 (2 6 .2 5± 7.5 7) mm ,选择的封堵器直径为 14～ 36 (2 6 .5 2± 7.15 ) m m。 2 4例封堵器置入均获得成功 ,术中无并发症 ,1例在术后第 3天出现 度 型房室传导阻滞 ,2周后恢复。 7例术后即刻超声检查显示微量残余分流 ,术后 1周复查均无分流。结论 :经静脉置入 Amplatzer封堵器治疗 ASD是一种有效的非外科手术方法。     

Transcatheter closure of atrial septal defects in adults with the Amplatzer septal occluder

OBJECTIVE—To assess the efficacy and complications of device occlusion of atrial septal defects in adults, using the Amplatzer septal occluder (ASO).
DESIGN—A prospective interventional study.
SETTING—Paediatric cardiology departments in two European teaching hospitals.
PATIENTS—The first 20 patients accepted for atrial septal defect device occlusion, on the basis of transoesophageal echocardiography. Sixteen patients had larger defects with right heart dilatation, while the primary indication for closure in four was a history of early paradoxical embolism.
INTERVENTIONS—Transcatheter atrial septal defect occlusions performed under transoesophageal echocardiography and fluoroscopic guidance between December 1996 and June 1998.
OUTCOME MEASURES—Success of deployment of ASO devices, procedure and fluoroscopic times, complications, and symptoms.
RESULTS—The ASO device was successfully implanted in all 20 patients (14 female), median age 44.2 years, with no complications. Of the 16 patients with right heart dilatation, the median Qp:Qs was 2.5:1. Defects measured 11-22 mm (median 18) on transoesophageal echocardiography, with balloon sized diameter (and device size) of 13-28 mm (median 20). For all 20 patients, the procedure time ranged from 38-78 minutes (median 61), and fluoroscopy 8.4-24.7 minutes (median 15.2). There were residual shunts in three patients at the end of the procedure, which were trivial ( 1 mm) as assessed by transoesophageal echocardiography, and persisted for more than six months in only one patient. Follow up ranged from 0.1-1.5 years (median 0.7). There have been no late complications.
CONCLUSIONS—The ASO device can be used successfully to close selected oval fossa defects in adults, with minimal procedural morbidity and excellent early results.


Keywords: atrial septal defect; interventional cardiac catheterisation; Amplatzer septal occluder     

Initial experience with the Amplatzer membranous septal occluder in adults

OBJECTIVES: Most perimembranous ventricular septal defects (pmVSD) that are still patent in adult life are small, hemodynamically and clinically unimportant, and do not require any intervention. However, surgery in adulthood for those that need to be closed carries significant morbidity. A trans-catheter technique for closing pmVSDs has been developed, and this paper describes our initial experience using the Amplatzer membranous septal occluder (AMSO). PATIENTS/METHODS: Twelve patients, 9 female and 3 male, median age 34.5 years (range: 21-67) underwent catheterization for attempted pmVSD closure. Ten of the defects were native and 2 were post-operative residual defects. Transcatheter VSD closure was performed as previously described, under general anesthesia and with trans-esophageal echocardiographic (TEE) monitoring. Patients had a moderate to large left to right shunt (mean Qp/Qs = 2.0+/-0.4) with mild left heart volume overload and near normal pulmonary pressure. All 10 native pmVSDs were closed successfully, 9 with AMSO and one with an Amplatzer muscular VSD occluder, after failure to implant the AMSO. There was one post procedural complication--self-limiting retroperitoneal bleeding. Three patients had a residual leak. Attempted VSD closure in the 2 patients with post surgery residual shunt was unsuccessful. CONCLUSION: We conclude that transcatheter mVSD closure with the AMSO is an efficient and safe alternative to surgery in carefully selected adult patients with native pmVSDs.     

Transcatheter closure of atrial septal defects with the CardioSEAL occluder

Data on mid- and long-term follow-up for the recent devices for closure of secundum-type atrial septal defects are limited. The purpose of our retrospective study was to report the effectiveness of transcatheter closure in patients with various morphological types of atrial septal defect other than centrally located defects within the oval fossa using the CardioSEAL and CardioSEAL-Starflex occluder. A total of 91 patients (age 1.5-71 years, median 6 years) underwent transcatheter closure. On the transesophageal echocardiogram, defect size varied from 6 to 18 mm with an estimated stretched diameter of 11 to 24 mm, median 15 mm; the ratio of the stretched diameter to septal length ranged from 0.28 to 0.68. Mean follow-up was 28.7 +/- 11,9 months (range 3-46 months). Isolated secundum-type defects were present in 59 patients (65%), multiple septal defects including patients with perforated atrial septal aneurysms and defects with deficient atrial rim in 32 patients (35%). Occlusion rate using device diameters from 23 to 40 mm increased from 66% (60/91 patients) immediately after implantation to 86% (48/56 patients) 24 months after implantation. Patients with isolated secundum-type defects presented with a significantly higher primary closure rate (45/59 patients, 76%) compared to patients with various defect morphology. Closure rate did not depend on the type of implanted device modification. No thrombus formation, sustained atrial arrhythmia or infective endocarditis occurred. Serial transthoracic echocardiographic findings revealed protrusion of one left-sided arm onto the right atrial aspect in 5 patients; malposition of one right-sided superior arm of the device was observed in 7 patients. Fluoroscopy showed single fatigue fracture in 7 patients (7.7%) within the first 6 months after implantation. These results demonstrate that transcatheter closure with the double umbrella device was effective and safe on medium-term follow-up and could be extended to atrial septal defects of various morphology.     

Initial experience with the amplatzer membranous septal occluder in adults

Objectives: Most perimembranous ventricular septal defects (pmVSD) that are still patent in adult life are small, hemodynamically and clinically unimportant, and do not require any intervention. However, surgery in adulthood for those that need to be closed carries significant morbidity. A trans‐catheter technique for closing pmVSDs has been developed, and this paper describes our initial experience using the amplatzer membranous septal occluder (AMSO). Patients/methods: Twelve patients, 9 female and 3 male, median age 34.5 years (range: 21–67) underwent catheterization for attempted pmVSD closure. Ten of the defects were native and 2 were post‐operative residual defects. Transcatheter VSD closure was performed as previously described, under general anesthesia and with trans‐esophageal echocardiographic (TEE) monitoring. Patients had a moderate to large left to right shunt (mean Qp/Qs = 2.0±0.4) with mild left heart volume overload and near normal pulmonary pressure. All 10 native pmVSDs were closed successfully, 9 with AMSO and one with an Amplatzer muscular VSD occluder, after failure to implant the AMSO. There was one post procedural complication—self‐limiting retroperitoneal bleeding. Three patients had a residual leak. Attempted VSD closure in the 2 patients with post surgery residual shunt was unsuccessful. Conclusion: We conclude that transcatheter mVSD closure with the AMSO is an efficient and safe alternative to surgery in carefully selected adult patients with native pmVSDs.     

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.     

房间隔缺损介入治疗封堵器选择的影响因素

目的 探讨房间隔缺损(ASD)介入治疗封堵器选择的影响因素.方法 1114例ASD患者,男388例,女726例,年龄2～75(26.3±17.0)岁.按14岁作为儿童与成人的划分点,成人组779例,平均年龄(34.4±13.5)岁;儿童组335例,平均年龄(7.3±3.9)岁.经胸超声心动图测量不同切面缺损大小及边缘长短,根据ASD最大直径选择封堵器,分析不同年龄、缺损形态和边缘大小时,选择封堵器的差别.结果 1114例ASD患者,成功封堵1085例,技术成功率为97.4%.1085例患者中,ASD最大直径为(19.7±7.8)mm,所选择的封堵器直径为(25.8±8.9)mm,封堵器与ASD最大直径差值为(6.1±3.4)mm,封堵器/最大直径为1.3∶1.成人和儿童组ASD大小相近,但成人组封堵器直径、封堵器加大值明显大于儿童组(P<0.05);封堵器/ASD最大直径成人组为1.2～1.8∶1,儿童组为1.1～1.6∶1.随着缺损直径的增大,成人组选择封堵器的加大值亦增加,但非成比例增加.儿童组随着缺损直径的增大,选择封堵器的加大值有增大的趋势,但差异无统计学意义.ASD的最大直径与封堵器的大小显著相关,成人和儿章组其相关系数分别为0.911和0.944(均P<0.01).以ASD最小直径/ASD最大直径的比例来描述缺损的形态,发现随着最小直径与最大直径比值的增大,各组间ASD最大直径或封堵器直径虽无差异,但封堵器加大值明显增大.主动脉侧无缘组选择的封堵器、封堵器加大值明显大于有缘组(均P<0.01).结论 介入治疗ASD,封堵器选择应以测量的ASD最大直径为主体,尚需参考年龄、缺损的形态及其边缘的状况适当增减.     

Secondary embolization of a Helex occluder implanted into a secundum atrial septal defect.

We report on a 2-year-old patient with atrial septal defect with a stretched diameter of 11 mm. The defect was closed uneventfully by use of a 25 mm Helex device. There was only trivial residual shunting (1 mm at the cranial margin of the device). After 36 hr, routine postinterventional echocardiography confirmed device embolization into the pulmonary artery. The child was asymptomatic. Transcatheter device retrieval with snares of different sizes, bioptomes, and retrieval forceps failed due to the mismatch of the diameter of the device and the small diameter of the pulmonary artery. Therefore, the device was retrieved surgically and the ASD closed by primary sutures. Secondary embolization of a Helex device complicated the closure of an uncomplicated atrial septal defect with a device-to-defect ratio according to the manufacturer's suggestion due to a mechanism not yet understood.     

Feasibility of percutaneous closure of atrial septal defects in adults under transthoracic echocardiography guidance using the Figulla atrial septal defect occluder device

Background

Closure of atrial septal defect (ASD) among adults under transthoracic echocardiography (TTE) guidance using devices other than the Amplatzer Septal Occluder has not been extensively tested.

A comparative study of Cardi‐O‐Fix septal occluder versus Amplatzer septal occluder in percutaneous closure of secundum atrial septal defects

Aim: We sought to investigate the safety and efficacy of Cardio‐O‐Fix septal occluder (CSO) in percutaneous closure of atrial septal defects (ASD) as compared to the Amplatzer septal occluder (ASO). Methods: A consecutive of 351 patients received transcatheter ASD closure with CSO or ASO from July 2004 to October 2010 were studied. The ASDs were divided into simple‐ (isolated defects <26 mm) or complex‐types (isolated defect ≥26 mm, double or multifenestrated defects). The procedures were guided by fluoroscopy and transthoracic or transesophageal echocardiography. Clinical and echocardiographic follow‐ups were arranged before discharge, at 1 month and then every 6‐month after implantation. Results: During the study period, 185 (125 males, aged 18.5 ± 15.6 years) and 166 (103 males, aged 21.0 ± 15.7 years) patients attempted CSO and ASO implants, respectively. The CSO group had similar ASD and device sizes, prevalence of complex lesions (17 vs. 16%, P = 0.796), procedural times and success rates (97% vs. 96%, P = 0.635) as compared to the ASO group. Acute residual shunts were less prevalent in CSO than ASO group and most shunts closed spontaneously at 6‐month follow‐ups. The average equipment cost per patient was lower in CSO group (US$ 4,100 vs. US$ 5,900, P < 0.001). The prevalence of device embolization and atrial arrhythmia (all <2%) were similar in both patient groups. Conclusion: Transcatheter ASD occlusion with CSO is safe and effective and it appeared to be an attractive alternative to ASO in closing simple‐type ASD because of its relatively low cost. © 2013 Wiley Periodicals, Inc.     

Cardiac perforation after device closure of atrial septal defects with the Amplatzer septal occluder

OBJECTIVES: Amplatzer septal occluder (ASO)-associated cardiac perforation (CP) at our institution prompted this retrospective review. BACKGROUND: Cardiac perforation is a rare complication after transcatheter atrial septal defect (ASD) closure. METHODS: To identify CP after transcatheter ASD closure with ASO, cardiac events (CE) describing definite CP, hemopericardium, pericardial effusion, cardiovascular collapse, or sudden death were analyzed. Cardiac events were identified from published literature (MEDLINE), medical device regulating agencies in North America and the European Commission, and AGA Medical Corporation (Golden Valley, Minnesota). Institutional cases were reviewed. Cardiac events were defined as early (pre-discharge) or late (post-discharge). RESULTS: Twenty-nine CEs were identified. Five were excluded because findings were inconclusive for device-related CP. Ten patients were <18 years of age. Late CEs occurred in 66.6%; 25% presented weeks later (longest, three years). Three deaths were reported. Cardiac perforation occurred predominantly in the anterosuperior atrial walls and/or adjacent aorta. CONCLUSIONS: Amplatzer septal occluder-associated CP uniquely involves the anterosuperior atrial walls and adjacent aorta. Pathophysiology remains poorly understood.     

Echocardiographic considerations during deployment of the Helex Septal Occluder for closure of atrial septal defects

The Helex Septal Occluder is a new device used to close atrial septal defects via interventional catheterization. In order to study the role of echocardiography during its use, and to describe the morphologic variants of defects suitable for closure with this occluder, we evaluated all patients undergoing intended closure of an atrial septal defect with the Helex occluder. A combination of transthoracic, transesophageal, three-dimensional, and intracardiac echocardiography were used before, during, and after the procedure to characterize anatomy, assess candidacy for closure, guide the device during its deployment, and evaluate results. Among the 60 candidates included in the study, 11 were excluded because of transesophageal echocardiographic and/or catheterization data obtained in the laboratory. Attempts at closure were successful in 46 patients, and unsuccessful in 3. We successfully treated four types of defects. These were defects positioned centrally within the oval fossa with appreciable rims along the entire circumference of the defect, defects with deficient or absent segments of the rim, defects with aneurysm of the primary atrial septum, and defects with multiple fenestrations. Follow-up transthoracic echocardiograms taken at a median of 7 months demonstrated no residual defects in 21, trivial residual defects in 17, and small residual defects in 8 patients. In 20 patients, three-dimensional reconstructions were used to characterize the morphology of the defect and the position of the device. Because transesophageal echocardiography was often limited by acoustic interference from the device, intracardiac echocardiography was utilized in 3 cases to overcome this limitation.     

Percutaneous closure of multiple atrial septal defects with three Amplatzer septal occluder devices

We report on the successful closure of three atrial septal defects with three Amplatzer septal occluders in a 55‐year‐old woman. Catheter Cardiovasc Interv 2004;62:526–529. © 2004 Wiley‐Liss, Inc.