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.     

Transcatheter closure of large secundum atrial septal defects using the 40 mm Amplatzer septal occluder: results of an international registry.

Little is known about the efficacy and safety of the 40 mm Amplatzer septal occluder (ASO). Thirty-three patients (22 female, 11 male) with a large secundum atrial septal defect (ASD) underwent attempted device closure using the 40 mm ASO at a median age of 40 years (range, 14-81 years) and median weight of 65 kg (range, 48-98 kg). The median size of the ASD measured on 2D transesophageal echocardiography (27 patients) or intracardiac echocardiography (6 patients) was 30.5 mm (range, 24-39 mm) and the median balloon-stretched diameter was 37.7 mm (range, 32-43.7 mm). The median Qp:Qs ratio was 3.2:1 (range, 1.4-6.2). The attempt was unsuccessful in five patients; two had device embolization and one had left atrial wall perforation due to the sheath; all three required emergent surgery. The attempt was successful in the 28 remaining patients, resulting in complete immediate closure in 14 and a trivial residual shunt in 14. Fluoroscopy time ranged from 8.6 to 37.8 min (median, 12.2 min). At 24-hr follow-up, 2D transthoracic echocardiography with color flow Doppler revealed complete closure in 23 patients, and 5 had a trivial residual shunt. There were no complications encountered in patients who received the device. On follow-up, all patients are doing well. We conclude that the 40 mm ASO is safe and effective in most patients with a large ASD up to a diameter of 39 mm. However, the use of this device requires careful attention as the procedure may be unsuccessful or the device may embolize.     

Choice of device size and results of transcatheter closure of atrial septal defect using the amplatzer septal occluder

The impact of device size choice on closure results was analyzed in 138 (101 females, 37 males; age 0.5-84.0 years) consecutive patients who underwent transcatheter closure of the secundum atrial septal defect (ASD) using the Amplatzer septal occluder (ASO). The balloon stretched diameter (SD) of ASD was 19.5 +/- 7.2 mm in 123 patients with single defects, and 20.4 +/- 6.6 mm for the largest defects in 15 patients with multiple ASDs. The difference (delta) between ASO size chosen for closure and the stretched diameter of the defect was calculated and divided into groups: A (delta < -2 mm); B (delta -2.0 to -0.1 mm); C (delta = 0); D (delta 0.1-2.0 mm) and E (delta > 2 mm). The results demonstrated that immediate and 24-hour complete closure rates were significantly higher in patients in groups C and D (P < 0.001). However, at 6-month follow-up, the complete closure rates were similar in patients of groups A-D, while patients of group E had a lower closure rate of 75%. The complication rates were similar in all groups. In conclusion, a choice of a device size identical to or within 2 mm larger than the SD of the defect should be used to maximize the closure rates of ASD using the ASO.     

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.     

Real time three-dimensional transthoracic echocardiography for guiding Amplatzer septal occluder device deployment in patients with atrial septal defect

BACKGROUND: Transcatheter Amplatzer septal occluder (ASO) device closure of atrial septal defects (ASDs) has traditionally been guided by two-dimensional transesophageal echocardiography (2D-TEE) and intracardiac echocardiography (ICE) modalities. Real time three-dimensional transthoracic echocardiography (RT3D-TTE) provides rotating images to define ASD and adjacent structures with potential as an alternative to 2D-TEE or ICE for guiding the device closure of ASD. Our aim was to assess the feasibility and effectiveness of RT3D-TTE in parasternal four-chamber views to guide ASO device closure of ASD. METHODS AND RESULTS: From July 2004 to August 2005, 59 patients underwent transcatheter ASO device closure of ASD. The first 30 patients underwent 2D-TEE guidance under general anesthesia and the remaining 29 patients underwent RT3D-TTE guidance with local anesthesia. All interventions were successfully completed without complications. The clinical characteristics and transcatheter closure variables of RT3D-TTE and 2D-TEE were compared. Echocardiographic visualization of ASD and ASO deployment was found to be adequate when using either methods. Catheterization laboratory time (39.1 +/- 5.4 vs 78.8 +/- 14.1 minutes, P < 0.001) and interventional procedure length (7.6 +/- 4.2 vs 15.3 +/- 2.9 minutes, P < 0.001) were shortened by using RT3D-TTE as compared with 2DE-TEE. There was no difference in the rate of closure following either method, assessed after a 6-month follow-up. The maximal diameter measured by RT3D-TTE and 2D-TEE was correlated well with a balloon-stretched ASD size (y = 0.985x + 0.628, r = 0.924 vs y = 0.93x + 2.08, r = 0.885, respectively). CONCLUSION: RT3D-TTE may be a feasible, safe, and effective alternative to the standard practice of using 2D-TEE to guide ASO deployment.     

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.     

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.     

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.     

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.     

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.     

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.     

Assessment of atrial septal defect size with 3D-transesophageal echocardiography: comparison with balloon method

BACKGROUND: Transcatheter closure of atrial septal defect (ASD) is an alternative approach to surgery in selected patients. Balloon stretched diameter (BSD) is considered as the standard way of measuring ASD size. Three-dimensional transesophageal echocardiography (3D-TEE) provides views of the ASD allowing its measurement and identifying its spatial relation with neighboring structures. Our aim was to compare the BSD and 3D-TEE methods to measure the ASD size before transcatheter closure. METHODS AND RESULTS: Seventy-six consecutive patients were enrolled for ASD device closure. Three-dimensional transesophageal echocardiography and balloon sizing were adequately performed in 70 patients before the defect closure. The mean maximal diameter measured by 3D-TEE was 20 +/- 15 mm (range 10-28) while the mean BSD was 22 +/- 4.8 mm (range 9-31). When comparing the 3D-TEE and transcatheter measurements, there was a good correlation between the two methods (y = 3.15 + 0.77x; r = 0.8). The defect as viewed by 3D-TEE was unique in 54 patients and multiple in 16 patients. In patients with a single defect, the correlation between the two methods was high (y = 1.74 + 0.84x; r = 0.85) while patients with multiple ASDs, the correlation was poor (y = 12.4 + 0.4x; r = 0.45). Transcatheter closure was performed successfully in 86%. The mean size of the Amplatzer device was 23 +/- 4.8 mm (range 4-32). The reference to choose the size of the device was the BSD in single defects and the 3D-TEE maximal diameter in multiple defects. CONCLUSION: Three-dimensional transesophageal echocardiography and transcatheter methods are two complementary techniques for the success of transcatheter ASDs closure.     

Transcatheter closure of atrial septal defects in children & adults using the Amplatzer Septal Occluder

We are reporting the worldwide experience in closing atrial septal defects (ASDs) in children and adults using the Amplatzer Septal Occluder (ASO) as of July 2000. The outcome measures were safety and efficacy with special emphasis on: (1) immediate success of the ASD closure as measured by transesophageal echocardiography (TEE), (2) short- and medium-term follow-up at 24 hours and 1 and 3 months and long-term follow-up at 1, 2, and 3 years as assessed by transthoracic echocardiography (TTE); and (3) the incidence of complications. In all, 3580 procedures were performed in 3535 patients. In 75 patients, the device was not implanted for variety of reasons; 3460 patients received a single ASO device and 45 received two devices for multiple ASDs. The median age of the patients was 12.1 year, (range, 10 days-88 years, the median weight was 41.0 kg (range, 2.4-137 kg) and the median Qp/Qs ratio was 2 (range, 0.3-10). The median size of ASD by TEE was 14 mm (range, 1-38 mm) and the median stretched diameter was 18 mm (range, 4-44 mm). The median size of device implanted was 18 mm (range, 4-40 mm). The median fluoroscopy time was 17.1 minutes (range, 0.0-194.0 minutes). The immediate success rate including those patients with complete closure, trivial residual shunt, or with small residual shunt was 97.4%. This increased to 99.2% and 100% at 3 months and 3 years, respectively. Minor complications were encountered in 2.8% of procedures, while serious complications occurred in less than 0.3% of the cases. There were no device related deaths. We conclude that the ASO is a safe and effective device for catheter closure of small to large ASDs up to a stretched diameter of 40 mm in children and adults with very high short-, medium, and long-term success rates.     

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.     

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.     

Transcatheter atrial septal defect closure: modified balloon sizing technique to avoid overstretching the defect and oversizing the Amplatzer septal occluder.

The objective of this study was to evaluate a new technique of sizing atrial septal defects (ASDs) for transcatheter device closure. ASD closure using the Amplatzer septal occluder (ASO) device is commonly performed. Complications, including arrhythmias, pericardial effusions, and perforations, may be related to oversizing ASDs and choosing larger devices. Two methods were used to size ASDs using a compliant balloon. In some patients, the balloon was inflated until a waist was visible [(+)waist]; in others, only until no shunting was demonstrable by echocardiogram [echo; (-)waist]. The device was selected and implanted using standard procedure and echo guidance. One hundred seventeen patients underwent secundum ASD closure with an ASO device. There were 43 patients in the (-)waist group and 74 in the (+)waist group. All devices were implanted successfully. The initial echo ASD diameter was larger in the (-)waist group compared to the (+)waist group (P = 0.01). There was a smaller difference between the initial echo and balloon-sized ASD diameters in the (-)waist group (P < 0.02). ASO device size implanted (in mm greater than echo ASD diameter) was smaller in the (-)waist group (P < 0.01). There were 0/43 complications in the (-)waist group and 5/74 in the (+)waist group. The complete closure rate was the same in both groups. Sizing an ASD by inflating a compliant balloon just until shunting is eliminated, and not until a waist is visible, results in less overstretching of the ASD and selection of a smaller ASO device, achieving similar closure rates and potentially fewer complications.     

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.     

Short- and intermediate-term results of transcatheter closure of atrial septal defect with the Amplatzer Septal Occluder

Background

The Amplatzer Septal Occluder (ASO) (AGA Medical Corp, Golden Valley, Minn) has gained wide acceptance for transcatheter closure of atrial septal defect (ASD). We conducted this study to evaluate the short-and intermediate-term results of ASD closure with the ASO and to determine the impact of deficient rim on the results.

Methods

Between March 1999 and February 2003, 197 patients underwent attempted transcatheter closure of ASD with the ASO. The size of the selected device either equaled or was 1 to 2 mm larger than the stretched diameter of the defect. Transesophageal echocardiography was used to monitor the implantation procedure. One hundred and fourteen patients (58%) with a deficiency in 1 rim (<5 mm) were included as group I, and the remaining 83 patients with adequate rims comprised group II.

Results

The mean stretched diameter measured with the balloon catheter was 18.6 ± 6.7 mm (range 7.1-37.2 mm). Deployment of the ASO was successful in 191 (97%) patients and failed in 6. There was no significant difference between the 2 groups in the success rate for ASD closure (110/114 vs 81/83). Repositioning of the device was required in 28 patients: 21 in group I and 7 in group II (21/114 vs 7/83, P > .05) The mean stretched diameter of the defect in these 28 patients was significantly larger than that in those who did not require repositioning of the device (27.3 ± 5.7 vs 17.1 ± 5.5 mm, P < .01). Three patients experienced severe complications: 1 had transient complete atrioventricular block, 1 had tamponade requiring drainage, and 1 had dislodgement of the device requiring emergent operation. One had a distal embolism to a fingertip. Echocardiography at 1 day, 3 months, 6 months, 12 months, and 24 months after the procedure showed residual shunts in 37/191 (19%), 15/189 (8%), 11/176 (6%), 7/131 (5%), and 3/72 (4%) patients, respectively.

Conclusions

The ASO is a safe and effective device for the transcatheter closure of ASD. Deficiency in 1 rim, particularly the superior anterior rim, does not influence the success rate of ASD closure.     

Immediate and six-month results of the profile of the Amplatzer septal occluder as assessed by transesophageal echocardiography

Catheter closure of secundum atrial septal defect (ASD) using the Amplatzer septal occluder (ASO) is a potential alternative for open surgical repair. However, the large profile of the device obtained immediately after closure continues to raise some concerns regarding its long-term safety. To evaluate the changes in the profile of the device after being deployed, transesophageal echocardiography was performed in 70 patients (17 men and 53 women) who underwent catheter closure of ASDs immediately after and at 6-month follow-up. The median age at closure was 16 years (range 1.9 to 75) and the median size of the ASD as assessed by transesophageal echocardiography was 14 mm (range 3 to 25). The thickness (profile) of the device was assessed in the 4-chamber, short- and long-axis views of the interatrial septum, and measured at its middle and at the junction of the waist with the disc at its 2 ends. Seventy-three devices were deployed in the 70 patients. The median size of the device was 19 mm (range 8 to 34). Complete closure was achieved in 81.4% and 91.4% immediately after and at 6-months follow-up, respectively. The thickness of the device at its middle decreased from 12.2 +/- 4.3, 12.2 +/- 3.7, and 12.5 +/- 4.3 mm in the 4-chamber, short- and long-axis views to 6.5 +/- 2.0, 6.3 +/- 1.9, and 6.5 +/- 2.2 mm, respectively. The thickness of the device at its superior, inferior, anterior, and posterior edges also decreased by 41.8% +/- 14.0% to 43.7% +/- 9.8%. The changes in the thickness were related to device size. Larger devices were thicker after being deployed. We conclude that the thickness of the ASO decreases by 42% to 48% within 6 months after deployment, resulting in a lower profile.     

Transcatheter closure of multiple atrial septal defects. Initial results and value of two- and three-dimensional transoesophageal echocardiography.

AIMS: To examine the feasibility of transcatheter closure of multiple atrial septal defects using two Amplatzer devices simultaneously and to describe the importance and the role of two- and three-dimensional transoesophageal echocardiography in the selection and closure of such defects. METHODS: Twenty-two patients with more than one atrial septal defect underwent an attempt at transcatheter closure of their atrial septal defects at a mean+/-SD age of 30. 8+/-18.6 years (range 3.7-65.9 years) and mean weight of 56.6+/-25.5 kg (range 12.9-99 kg) using two Amplatzer devices implanted simultaneously via two separate delivery systems. During catheterization, two dimensional transoesophageal echocardiography was performed in all but one patient, during and after transcatheter closure, while three dimensional transoesophageal echocardiography was performed in six patients before and after transcatheter closure. RESULTS: Forty-four devices were deployed in all patients to close 45 defects (one patient with three defects closed by two devices). Two dimensional transoesophageal echocardiography was helpful in selection and in guiding correct deployment of the devices. The mean size of the larger defect, as measured by transoesophageal echocardiography was 12.8+/-5.9 mm and the mean size of the smaller defect was 6.6+/-3.0 mm. The mean size of the larger devices was 15+/-7.5 mm, and 8.4+/-3.7 mm for the smaller. Three dimensional transoesophageal echocardiography provided superior imaging and demonstrated the number, shape and the surrounding structures of the atrial septal defects in one single view. The median fluoroscopy time was 28.7 min. Device embolization with successful catheter retrieval occurred in one patient. Forty-four devices were evaluated by colour Doppler transoesophageal echocardiography immediately after the catheterization with a successful closure rate of 97.7%. On follow-up colour Doppler transthoracic echocardiography demonstrated successful closure in 97.5% at 3 months. CONCLUSIONS: The use of more than one Amplatzer septal occluder to close multiple atrial septal defects is safe and effective. The use of two- and three-dimensional transoesophageal echocardiography provided useful information for transcatheter closure of multiple atrial septal defects using two devices. Three-dimensional transoesophageal echocardiography enhanced our ability to image and understand the spatial relationship of the atrial septal defect anatomy.