Transcatheter closure of secundum atrial septal defect with a new self-expanding nitinol double disk device (Amplatzer device): experience in Nanjing

PURPOSE: Various devices have been developed for the transcatheter closure of secundum atrial septal defect (ASD II) to avoid the morbidity, discomfort, and thoracotomy scar associated with surgical closure. The purpose of this study was to evaluate the safety and efficacy of the Amplatzer septal occluder for transcatheter closure of ASD II. PATIENTS AND METHODS: Only patients who were clinically diagnosed with ASD II were selected. The anatomy of ASD had to meet certain echocardiographic criteria. Under the guidance of echocardiography and fluoroscopy, the implantation of the device was accomplished as recommended by the manufacturer. RESULTS: Thirty patients (median age 18.4 years) with an ASD II underwent transcatheter closure. Procedure time ranged from 30-200 minutes and fluoroscopy time from 10-50 minutes. The diameter of the ASD measured by echocardiography ranged from 13-25 mm, while both the stretched diameters of the ASDs and the sizes of the devices ranged from 18-34 mm. The successful placement rate was 100%. The residual shunt rate was 100% immediately after device implantation and 10% after 24 hours. After 3 months, 3.3% of the patients had a (trivial) residual shunt. The device did not affect the surrounding structures of ASD. No embolization of the device occurred. CONCLUSION: The Amplatzer device designed for the closure of ASD II can be implanted easily and also is retrievable. Due to a low ratio of residual shunt and few complications, this device is a good choice for transcatheter closure of ASD II. Long-term follow-up will be required for widespread clinical use.     

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.     

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。     

继发孔型房间隔缺损介入性封堵术27例临床报告

目的 评价应用ＡＧＡ Ａｍｐｌａｔｚｅｒ闭合器对非开胸手术闭合继发孔型房间隔缺损的疗效。方法 ２７例ＡＳＤ住院患者,男７例,女２０例。年龄３￣４９岁,平均３１．９岁。体重１８￣８８ｋｇ,平均５８．２ｋｇ。ＡＳＤ病理分型;中央型２４例,中央偏上型２例,下腔型１例。其中单一ＡＳＤ２５例,多发性ＡＳＤ２例（２处缺损１例,３处缺损１例）,合并肺动脉瓣狭窄（ＰＳ）和合并房间隔膨出瘤各１例,ＡＳＤ直径１．０￣     

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。     

Transcatheter closure of secundum atrial septal defects with the new self-centering Amplatzer Septal Occluder.

AIMS: The study was set up to find out whether a new self-centering prosthesis for transcatheter closure of secundum atrial septal defects could overcome the disadvantages of previously described devices. METHODS AND RESULTS: Fifty-two consecutive patients with a significant atrial septal defect were considered for transcatheter closure with the Amplatzer Septal Occluder. The device, made of a Nitinol and polyester fabric mesh, provides a different approach to defect occlusion by stenting the atrial septal defect up to a stretched diameter of 26 mm. Three infants whose large defects were demonstrated on a transthoracic echocardiogram were excluded from transcatheter treatment. On transoesophageal echocardiography, 49 defects ranged from 6-26 mm, in one adult the defect measured 28 mm and this patient was excluded from attempted transcatheter closure. At cardiac catheterization in five further patients, devices were not implanted, in two because the stretched diameter exceeded 26 mm and in three the device was withdrawn because it was unstable or compromised the mitral valve. Thus, device closure was performed in 43 patients. At follow-up after 3 months the complete closure rate was 97%. CONCLUSION: The self-centering Amplatzer Septal Occluder is very efficient and user-friendly and offers interventional closure in 83% of an unselected group of patients presented with an atrial septal defect.     

介入封堵术在老年继发孔型房间隔缺损患者中的临床应用

目的观察老年继发孔型房间隔缺损(ASD)患者进行介入封堵术的中、远期疗效和安全性。方法老年继发孔型ASD患者206例,缺损8～38(26.5±8.1)mm。封堵术前、术后行右心导管检测肺动脉压、右心室压,随访6个月,评价心功能(NYHA)改善情况。结果成功封堵203例,成功率98.5%。封堵器直径12～42(31.5±7.3)mm。与封堵术前比较,患者封堵术后肺动脉收缩压、右心室平均压明显下降(P<0.05,P<0.01);3～6个月随访时,患者右心室容积缩小、LVEF升高、心功能改善明显。术后心包积液1例(0.5%);即刻残余分流10例(4.9%);术后出现心律失常30例(14.8%)、出现急性心功能不全16例(7.9%)。6个月随访,患者均未发现有残余分流、脱落、栓塞。结论老年继发孔型ASD患者行介入封堵治疗中、远期相对安全、有效。     

经胸超声心动图监测下用Amplatzer封堵器治疗房间隔缺损

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

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

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

Percutaneous closure with Amplatzer device is a safe and efficient alternative to surgery in adults with large atrial septal defects

BACKGROUND: In adults with atrial septal defect (ASD) and large right-to-left shunt, closure of the defect is recommended. Percutaneous closure is still rarely used in this population. This study presents the results of transcatheter closure with the Amplatzer occluder in such patients. METHODS AND RESULTS: We studied 44 consecutive adult patients with a secundum ASD and 2 of the 3 following criteria: QP/QS >/=2 by oximetry, echocardiographic right ventricle overload, and ASD size >20 mm. Forty-two patients had a successful implantation. In 1 patient an unstable device was withdrawn; in another one, the device embolized in the pulmonary artery. At 6-month median follow-up, 95% had a complete closure; 2 patients with an additional defect had a small residual shunt. Major complications were the aforementioned embolization and a cerebrovascular accident in a patient with atrial fibrillation treated with aspirin. Others were minor and transitory: premature atrial beats in 3 patients, and paroxysmal atrial fibrillation and pulmonary edema in 1 patient each. CONCLUSIONS: Transcatheter closure of large ASDs with the Amplatzer device is efficient with less morbidity than surgical closure.     

Long-Term Follow Up of Secundum Atrial Septal Defect Closure with the Amplatzer Septal Occluder

Background. During the past 15 years, closure of a secundum atrial septal defect (ASD) has moved from a surgical to a percutaneous transcatheter approach. Few long-term studies of the efficacy and safety of closure of an ASD by an Amplatzer septal occluder (ASO) exist. Methods. To examine the long-term results of secundum ASD closure using the ASO, data on 94 patients who underwent secundum ASD closure with the ASO between 1998 and 2002 were available and reviewed. Data regarding residual shunt, chest pain, palpitations, arrhythmias, headaches, transient ischemic attacks, cerebrovascular accidents, and mortality were collected. Results. Seven (7.4%) subjects had residual shunts immediately following ASO placement. During follow-up, 4 residual shunts closed for a complete closure rate of 97%. Eighteen (19%) patients reported chest pain during the follow-up period. Twenty-three patients (24%) reported palpitations during the follow up period, 7 were documented arrhythmias, including supraventricular tachycardia, atrial fibrillation, and premature ventricular beats. Migraine headaches were new-onset in 4 patients. Migraine cessation occurred in 2 patients after secundum ASD closure. One child died from a cerebral vascular event 18 months following device placement. Only 1 patient developed mild aortic insufficiency. Conclusion. These data indicate that for up to 120 months of patient follow-up, the ASO continues to be a safe device. Residual shunts and arrhythmias have low incidence post-ASO placement. Given the mortality in one high-risk patient, further investigation into anti-platelet therapy after device placement is warranted.     

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     

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 defects with the Amplatzer septal occluder--a Japanese clinical trial.

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

经胸彩色多普勒超声心动图在房间隔缺损经导管封堵术中的应用价值

目的探讨经胸彩色多普勒超声心动图(TTE)在房间隔缺损(ASD)经心导管封堵治疗中的应用价值。方法应用TTE选择适于行Amplatzer式封堵术的继发孔型ASD患者27例，在TTE监测引导下经右心导管应用房间隔封堵器关闭ASD。结果26例ASD获成功封堵，术后即刻、1天、1个月和3个月TTE检查显示封堵器位置稳定良好，无残余分流。结论在TTE引导下行ASD封堵术是一种简便、可靠和安全的方法。     

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 closure of interatrial communications with Amplatzer device: results, unfulfilled attempts and special considerations in children and adolescents.

OBJECTIVE: We report our clinical experience with the Amplatzer device in transcatheter closure of 80 atrial septal defects (ASD) in children. METHODS: Among 99 patients (mean age: 7.2+/-3.8 years) with ASD selected by transthoracic echocardiography, procedures were performed in 80 patients under general anesthesia with fluoroscopic and transesophageal echocardiographic (TEE) guidance. Optimal device size was selected after stretched balloon sizing of the ASD's. The patients were discharged at 24 hours after an evaluation with X-ray, electrocardiography and echocardiography. RESULTS: The mean follow-up period (FUP) was 38+/-14 months. Mean ASD size was 11.5+/-3.7 mm at TEE (stretched size: 17.6+/-3.9 mm). The mean size of the device was 18.6+/-4.0 mm. Procedure and fluoroscopy time were 52.1+/-17.8 minutes and 11.0+/-4.9 minutes, respectively. Immediately after the procedure 35 patients (43.8%) had residual shunts. Trivial shunt remained in only 2 of them (2.5%) after FUP. None of the patients had major complications. Minor and transient rhythm abnormalities were observed in 5 patients and trivial mitral regurgitation was seen in 6 patients. CONCLUSION: Amplatzer is an effective and safe device for transcatheter closure of ASD especially in pediatric patients.     

应用Amplatzer封堵器经导管治疗直径≥8mm动脉导管未闭的疗效评价

目的 :应用 Amplatzer封堵器经导管治疗直径≥ 8mm的大型动脉导管未闭 （PDA）并对其疗效进行评价。方法 :全组 5 0例 ,年龄 2 6 .4± 2 3.2 （4.0～ 6 0 .0 ）岁。 PDA最窄处直径为 10 .2± 2 .3（8.0～ 15 .0 ） mm。封堵 10 m in后行侧位降主动脉造影 ,术后 1d及 1月行超声心动图检查 ,观察有无残余分流及 PDA再通。结果 :47例 PDA采用Amplatzer PDA封堵器治疗 ,2例采用 Amplatzer ASD封堵器治疗 ,1例 PDA伴有阻力性肺动脉高压未行介入治疗。术后 10 min降主动脉造影显示 ,19例存在微～少量残余分流 ,30例封堵完全无残余分流。术后 2 4h、术后 1月超声心动图未见残余分流及再通。结论 :应用 Am platzer封堵器治疗直径≥ 8mm的大型动脉导管未闭是一种安全有效的介入方法。     

Percutaneous closure of ostium secundum atrial septal defects using the Amplatz device. Preliminary study on 29 patients]

The aim of the study was to assess the results of percutaneous closure of ostium secundum atrial septal defects (ASD) by the Amplatz device and to compare them with those obtained by other methods. Over a one year period, closure of ASD was performed in 28 patients aged 7 to 66 years (mean of 32 years) with exclusive left-to-right shunts. The selection of patients was made by transthoracic echocardiography. Cardiac catheterisation was performed to measure the stretched diameter of the defect. After patient or parental consent, the procedure was performed under general anaesthesia. The implantation was performed under transoesophageal echocardiographic control. The diameter of the Amplatz device corresponded to the stretched diameter of the ASD. The patients were discharged from hospital 48 hours later under platelet anti-aggregant therapy for 6 months. Clinical, electrocardiographic, radiological and echocardiographic examinations were performed at 1 month, 3 months and 1 year after implantation. The stretched diameter was 12-27 mm (mean 22 mm). The device was withdrawn in one case because of a double ASD and, in another patient, failure was due to embolisation of the obturator to the pulmonary artery before its implantation. The closure was complete in 21 of the 26 cases immediately after the procedure; at one month, two residual shunts were observed but they had disappeared at 3 months and at 1 year. Out of 46 ASD closed by the Sidéris button prosthesis, occlusion was total in 29 cases and partial in 17 cases. The authors conclude that the Amplatz device is an effective prosthesis for closure of ostium secundum ASD. With strict selection procedures, the results are excellent.     

Simultaneous Transcatheter Closure of Two Secundum Atrial Septal Defects Using the Amplatzer™ Septal Occluder

Transcatheter closure of a single secundum atrial septal defect (ASD) is performed routinely using various investigational devices. A 37-year-old patient with two large secundum ASDs underwent successful simultaneous transcatheter closure using an 18-mm and 20-mm Amplatzer™ septal occluder device. At 3-month follow-up, transesophageal color Doppler echocardiography revealed one defect to be completely closed, and the other had trivial residual shunt with significant improvement in symptoms.