Novel technique to prevent prolapse of the Amplatzer septal occluder through large atrial septal defect.

We report on a new technique (holding the left atrial disk in the left atrium by a dilator) to prevent prolapse of the left atrial disk of the Amplatzer septal occluder during deployment in large atrial septal defects (ASDs). Two patients underwent successful closure of their ASDs using this new technique.     

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.     

Tips and tricks to prevent prolapse of the Amplatzer septal occluder through large atrial septal defects

We report on a new technique "using a partially inflated balloon through the atrial septal defect" to prevent prolapse of the left atrial disk of the Amplatzer septal occulder in large atrial septal defects (ASDs). Two patients underwent successful closure of their ASDs using this new technique.     

Three‐Dimensional Echocardiography Guided Closure of Complex Multiple Atrial Septal Defects

Transcatheter closure of complex multiple atrial septal defects (ASDs) remains a challenge. We describe our clinical experience with staged device deployment in a patient with multiple ASDs using four Amplatzer septal occluder devices. Three‐dimensional transesophageal echocardiography imaging contributed not only to the therapeutic guidance of successful device deployment but also to the decision making for the staged device delivery approach in a case of morphologically complex multiple ASDs.     

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.     

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。     

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.     

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

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

Transcatheter atrial septal defect closure assisted by intracardiac echocardiography: 3-year follow-up

Intracardiac echocardiographic (ICE) evaluation of secundum atrial septal defect (ASDs) shows several advantages over transesophageal echocardiography (TEE). The aim of our study is to describe the 3-year results of transcatheter ASDs closure using the Amplatzer septal occluder (ASO) and ICE as the sole imaging tool both to select the device size and to monitor the procedure. Under local anesthesia, 135 consecutive eligible patients with ASDs (male/female = 45/90; mean age 42.2 +/- 19.2 years; BSA 1.71 +/- 0.7 m(2); mean pulmonary arterial pressure 30.4 +/- 11.5 mmHg; mean Qp/Qs ratio 2.1 +/- 0.6) underwent transcatheter closure using ASO and ICE. A 9F-9MHz mechanical transducer was used. Two orthogonal views on the transverse aortic valve and on the longitudinal four-chamber planes were obtained for quantitative ICE measurements, from which the diameters of the implanting ASO waist were to be derived. In all cases, we obtained a proper evaluation of ICE ASDs dimensions, leading to an optimal device size selection (mean size 25.0 +/- 6.7 mm). Moreover, the ICE allowed us to monitor device deployment and to verify the effectiveness of the ASDs stented by ASO. There were no complications related to the procedure or to the use of ICE. During a mean follow-up period of 21.5 +/- 12 months, the cumulative complete occlusion rates were 97.7, 97.0, 97.1, and 98% at 24 hours, 3 month, and 1 and 3 years, respectively. ICE is an effective and safe alternative to TEE and balloon-sizing maneuver during ASDs transcatheter closure procedures, allowing us to avoid the need of general anesthesia and leading to a similarly high percentage of occlusion rates with respect to the conventional method.     

老年房间隔缺损患者经导管封堵治疗的可行性及疗效

目的　探讨经导管封堵治疗老年房间隔缺损患者的可行性及疗效。方法　 19例年龄≥ 6 0岁的老年房间隔缺损患者 ,术前经胸超声测量房间隔缺损直径为 10～ 34(2 4 .4± 8.2 )mm ,其中 3例患者为双孔型房间隔缺损。 11例患者合并心房颤动或阵发性心房颤动。X线胸片示心胸比例均 >0 .5 (0 .5 2～ 0 .70 )。术前心功能 (NYHA分级 )Ⅱ级8例 ,Ⅲ级 9例 ,Ⅳ级 2例。所有患者均在局麻下 ,应用X线透视和经胸心脏超声引导行房间隔缺损封堵术。结果术中测肺动脉平均压力 2 1～ 4 7mmHg(1mmHg=0 .133kPa) ,其中肺动脉平均压力 >2 5mmHg者 16例。所有患者均用Amplatzer房间隔缺损封堵器或国产双盘状封堵器一次封堵治疗成功。所用封堵器直径为 14～ 38mm。 3例双孔型缺损 ,2例用 2 8mm和 32mm封堵器一并封堵 ,另 1例用直径 14mm和直径 2 6mm的封堵器封堵成功。所有患者于术后 5～ 7d行经胸心脏超声检查 ,无残余分流。术后患者心功能明显改善 ,随访 1～ 30个月 ,无封堵器相关的并发症。结论　经导管封堵治疗老年房间隔缺损患者是一种安全有效的方法。     

Closure of Atrial Septal Defects With the Amplatzer Occlusion Device: Preliminary Results

Objectives. This study reports our clinical experience with transcatheter closure of secundum atrial septal defects (ASDs) in children, using the Amplatzer, a new occlusion device.Background. None of the devices previously used for transcatheter closure of interatrial communications has gained wide acceptance.Methods. We examined the efficacy and safety of the Amplatzer, a new self-centering septal occluder that consists of two round disks made of Nitinol wire mesh and linked together by a short connecting waist. Sixteen patients with secundum ASD met established two- and three-dimensional echocardiographic and cardiac catheterization criteria for transcatheter closure. The Amplatzer’s size was chosen to be equal to or 1 mm less than the stretched diameter. The device was advanced transvenously into a 7F long guiding sheath and deployed under fluoroscopic and ultrasound guidance. Once its position was optimal, it was released.Results. The mean ASD diameter by transesophageal echocardiography was 14.1 ± 2.3 mm and was significantly smaller (p < 0.001) than the stretched diameter of the ASD (16.8 ± 2.4 mm). The mean device diameter was 16.6 ± 2.3 mm. No complications were observed. After deployment of the prosthesis, there was no residual shunt in 13 (81.3%) of 16 patients. In three patients there was trivial residual shunt immediately after the procedure that had disappeared in two of them at the 3-month follow-up.Conclusions. The Amplatzer is an efficient prosthesis that can be safely applied in children with secundum ASD. However, a study including a large number of patients and a longer follow-up period are required before this technique can be widely used.     

经胸超声心动图在Amplatzer封堵器治疗成人巨大房间隔缺损中的应用

目的　评价经胸超声心动图监测 (TTE)Amplatzer封堵器介入治疗巨大房间隔缺损(ASD)的安全性和可行性。方法　 2 1例住院患者 ,男 12例 ,女 9例 ;年龄 17～ 4 5岁 ;均经临床及超声心动图证实的继发孔型ASD ,以充盈球囊最大伸展直径加 2～ 4mm为原则选择封堵器型号 ,TTE监测下放置Amplatzer封堵器。随访有无残余分流及是否影响周围瓣膜和静脉功能 ,记录临床事件 (血栓栓塞、心功能不全、心律失常等 )。结果　 2 1例全部封堵成功 ,TTE监测放置Amplatzer封堵成功 ,手术成功率 10 0 % ;术后即刻及 1天、3天、3个月、6个月、1年复查TTE观察无明显残余分流及影响周围瓣膜功能 ,也无腔、肺静脉狭窄 ,无血栓栓塞事件发生 ,无封堵器移位和脱落 ,心功能有不同程度的好转。1例发生频发房性心律失常 ,经心律平 4 5 0mg d治疗 1个月后消失 ,无其他并发症发生。结论　Amp latzer封堵器介入治疗成人巨大ASD是一种安全、有效的治疗方法 ,TTE监测ASD介入封堵治疗整个过程 ,可以提高一次释放成功率     

Left ventricular conditioning in the elderly patient to prevent congestive heart failure after transcatheter closure of atrial septal defect.

Transcatheter closure of atrial septal defects (ASDs) is a safe and effective treatment. Over the past years, an increasing number of elderly patients (age > 60 years) have been admitted for transcatheter closure to prevent ongoing congestive heart failure from volume overload. However, recent data point to the risk of serious acute left ventricular dysfunction leading to pulmonary edema immediately after surgical or transcatheter ASD closure in some patients. In this study, we used a technique described before to recognize in advance patients at risk of left heart failure after ASD closure. Those patients at risk were then treated with preventive conditioning medication for 48-72 hr before definitive transcatheter ASD closure was performed. Fifty-nine patients aged over 60 years (range, 60-81.8 years; median, 68 years) were admitted to our institution for transcatheter closure of an atrial septal defect. All patients received evaluation of atrial pressures before and during temporary balloon occlusion of the ASD. Patients with left ventricular restriction due to increased mean atrial pressures (> 10 mm Hg) during ASD occlusion received anticongestive conditioning medication with i.v. dopamine, milrinone, and furosemide for 48-72 hr before definitive ASD closure with an Amplatzer septal occluder was performed. In 44 patients without any signs of left ventricular restriction, ASD closure was performed within the first session. Fifteen (25%) out of 59 patients showed left ventricular restriction. In the majority of patients with LV restriction, the mean left atrial pressures with occluded ASD were significantly decreased after 48-72 hr of conditioning medication. Definitive ASD closure was then performed in a second session. Only two patients received a fenestrated 32 mm Amplatzer occluder due to persistent increased atrial pressures > 10 mm Hg even after conditioning medication. There were no significant differences in shunt, device size, or defect size between the two groups. Balloon occlusion of atrial septal defects identifies patients with left ventricular restrictive physiology before ASD closure. Intravenous anticongestive conditioning medication seems to be highly effective in preventing congestive heart failure after interventional closure of an ASD in the elderly patient with a restrictive left ventricle.     

Transcatheter Closure of Secundum Atrial Septal Defects Using the Amplatzer Septal Occluder: Clinical Experience and Technical Considerations

The Amplatzer septal occluder (AGA Medical Corporation, Golden Valley, MN) is designed to be an ideal device for the transcatheter closure of ostium secundum atrial septal defects. This device is user-friendly and has a complete closure rate of greater than 96% and few complications. It is easily retrievable and repositionable. It is also useful for closure of other types of shunts. Large atrial septal defects (ASDs) of up to 38 mm may now be closed. The use of the transesophageal echocardiogram (TEE) for evaluation of device placement is also reviewed.     

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

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

Closure of secundum atrial septal defects with the Amplatzer septal occluder device: techniques and problems.

Percutaneous transvenous closure of atrial septal defects (ASDs) has become feasible in recent years, as later-generation devices have largely overcome initial difficulties in device deployment and complication rates. The Amplatzer septal occluder (ASO) is one such device that we have used extensively and is, in our opinion, the most versatile and practical to use. It is capable of closing defects up to 40 mm in diameter via a relatively low-profile delivery sheath. More importantly, the ASO may be easily withdrawn into the sheath after deployment but prior to release, which is essential in safely closing difficult defects where successful positioning on the initial deployment is not guaranteed. In this article based on our experience, review of the literature, and communications with other operators, we describe the various problems encountered in closing atrial septal defects and make suggestions as to the best way of overcoming these difficulties.     

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.     

Transcatheter closure of atrial septal defect using self-expandable septal occluder

Transcatheter closure of atrial septal defect is an accepted alternative to surgical closure. It was attempted in 63 patients (age range 1.5-55 years) using self-expandable Amplatzer septal occluder (AGA Med. Co., USA). The atrial septal anatomy was evaluated by transthoracic and multiplane transoesophageal echocardiography with special reference to septal margins and adjacent structures. The size of atrial septal defect on echocardiographic evaluation varied from 9-28 (17.5 +/- 4.7) mm. Fifty (79.4%) patients had adequate septal margins of 5 mm or larger, while remaining 13 (20.6%) had insufficient anterosuperior margin. Cardiac catheterisation revealed Qp/Qs ranging from 1.5 to 5.3 and balloon-stretched atrial septal defect diameter of 10-32 (20.3 +/- 5.3) mm. The procedure was overall successful in 62 (98.4%) patients and in all patients with insufficient anterosuperior margin. Embolisation of the device occurred in one (1.6%) patient within five minutes of the device release, which could not be retrieved non-surgically. Size of the device used was either same or preferably 1-3 mm more than the balloon-stretched atrial septal defect diameter. Total procedure time was 40-90 (59 +/- 12.4) minutes and the fluoroscopy time was 12-30 (17.3 +/- 4.2) minutes. Immediate post-procedure and pre-discharge echocardiography in patients with successful deployment of the device revealed complete abolition of shunt in 61 (98.4%) and trivial residual shunt in one (1.6%) patient. No patient developed atrioventricular valve regurgitation or cardiac arrhythmias. Thus, atrial septal defect closure using self-expandable septal occluder is a safe and efficacious procedure requiring a short procedural time. There is full control in the system for proper positioning or repositioning of the device with excellent technical success rate even in cases with insufficient anterosuperior septal margin.     

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.