Catheter closure of atrial septal defects and patent foramen ovale in patients with an atrial septal aneurysm using different devices

BACKGROUND: Atrial septal aneurysm is frequently associated with patent foramen ovale (PFO) and atrial septal defects (ASD). Moreover, a relationship between atrial septal aneurysm and embolic cerebrovascular events has been suggested. The aims of this study were to analyze morphological and functional characteristics of atrial septal aneurysm in PFO and ASD patients and to assess the feasibility and efficacy of different devices for transcatheter closure and the influence of atrial septal aneurysm. METHODS: Between March 1997 and May 2000 transcatheter ASD or PFO closure was attempted in 63 patients (mean age 47 +/- 13 years) with an atrial septal aneurysm using one of the following devices: Angelwings (n = 3), Cardioseal (n = 5), Cardioseal-Starflex (n = 7), Amplatzer (n = 11), Amplatzer-PFO (n = 5), PFO-Star (n = 25), or Helex (n = 7). RESULTS: Implantation was primarily successful (after the first or second attempt) in all patients. One PFO-Star device embolized 12 hours after the procedure. During follow-up (0.6-37 months, mean 10.4 +/- 9.2) a residual shunt could be detected by transesophageal echocardiography after 2 weeks in four patients and after 6 months in one patient. Three PFO patients had cerebrovascular events after implantation. Two patients had a transient ischemic attack (TIA) and one patient a stroke. A thrombus formation on the device detected in three patients disappeared after antithrombotic therapy. CONCLUSION: We conclude that ASDs and PFOs with an associated atrial septal aneurysm can be closed with different available devices. There seem to be no additional risks compared with patients without atrial septal aneurysm.     

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.     

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

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

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.     

国产封堵器介入治疗房间隔缺损的临床分析

目的总结应用国产封堵器介入治疗房间隔缺损（ASD）的临床疗效。方法本组22例ASD患者均为继发孔型，男性5例，女性17例，年龄3～67岁，体重11～65kg，缺损直径8～32mm，合并动脉导管未闭1例，多孔ASD2例，轻度肺动脉压升高6例，均经股静脉途径应用国产封堵器行封堵术，术后超声心动图随访。结果22例患者均成功封堵。术后即刻完全封堵19例，3例有少量残余分流，随访分流消失，无严重并发症。结论国产封堵器介入治疗房间隔缺损是一种安全、有效的方法。     

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。     

房间隔缺损并发心房纤颤患者应用Amplatzer伞封堵房缺后心房纤颤的电复律治疗

目的 :初步评价房间隔缺损并发心房纤颤患者应用 Am platzer伞封堵房间隔缺损后心房纤颤的电复律疗效。方法 :2例患者 （5 1～ 5 3岁 ）。在透视及食管超声心动图监视下经导管置入 Amplatzer伞封堵房间隔缺损。术后即时行超声心动图 ,术后 2 4h,和 1,3,6月 ,分别行经胸超声心动图评价房间隔缺损治疗效果。术后 6月行电复律。结果 :2例患者疗效均佳 ,房间隔未见残余分流 ,电复律成功 ,患者转为窦性心律 ,复律后无并发症及 Amplatzer伞移位。结论 :应用 Am platzer伞封堵房间隔缺损并发心房纤颤患者 ,电复律易成功 ,是一种安全有效的复律方法。     

Transcatheter closure of atrial septal defects

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

Transcatheter closure of large atrial septal defects in 18 patients

PURPOSE: This study was designed to evaluate the efficacy and safety of transcatheter closure of large atrial septal defects (ASD). METHODS: Eighteen patients diagnosed as ostium secundum defect with a diameter of 30-40 mm were enrolled in this study. With the guidance of echocardiography and fluoroscopy, the Amplazter occlusion devices were implanted percutaneously through the femoral vein. RESULTS: A small residual left-to-right shunt was detected with echocardiography immediately postprocedure but resolved after 1 week. The occlusion devices remained in proper position, and there was no residual shunt at 1- and 29-month follow-ups. Cardiac function and atrial sizes improved significantly as compared with the preclosure states. CONCLUSIONS: Transcatheter closure of large atrial septal defects with the Amplazter occlusion device is feasible, safe and effective.     

卵圆孔未闭封堵治疗隐源性脑卒中预防复发效果的meta分析

目的 卵圆孔未闭（PFO）封堵治疗隐源性脑卒中效果的meta分析。 方法 通过Web of Science，EMBASE，PubMed和Cochrane图书馆等数据库进行了以药物对照的随机对照试验的相关检索。主要终点是复发性卒中和短暂性脑缺血发作（TIA）。 提取原始数据、风险比（HR）及95%置信区间（95%CI）的数值用以计算汇总效应大小。 结果 Meta分析发现，在PFO患者缺血性脑卒中和（或）TIA的预防上，在意向性人群中封堵器组要明显优于药物治疗组（HR = 0.47，95% CI: 0.27-0.84，I2 = 55.4%，P<0.01）。随访期间封堵器组的全因死亡率较药物治疗组差异无统计学意义（OR = 0.83，95% CI: 0.37 - 1.85，I2 = 21.8%，P = 0.655）。在封堵器组患者中，发生新发房颤的风险较药物治疗组显著增加（OR = 5.44，95% CI: 2.92 - 10.15，I2 = 35.3%，P<0.01）。meta分析结果亦表明，在大量分流的患者中，经封堵器治疗后，卒中的复发率较药物治疗组显著减少（OR = 0.31，95% CI: 0.14 - 0.69，I2=0，P < 0.01）。而在与药物治疗相比中，PFO并发房间隔膨出瘤（ASA）的患者亦明显受益于封堵器治疗（OR = 0.44，95% CI: 0.23-0.81，I 2 = 63.3%，P<0.01）。 结论 与单纯药物治疗相比,PFO封堵治疗隐匿性脑卒中患者复发脑卒中的风险明显减低。在有大量分流和房间隔膨出瘤的患者中，PFO封堵的获益更大。PFO的封堵与新发心房颤动的发生率较高有关。      

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.     

Exclusion of patients with arteriosclerosis reduces long-term recurrence rate of presumed arterial embolism after PFO closure

BACKGROUND: Percutaneous transcatheter closure of patent interatrial communications after presumed paradoxical embolism is used as an alternative to surgery or long-term anticoagulation for the treatment of patients who are at risk for recurrent thromboembolism. To avoid atherosclerotic events to be judged as recurrent paradoxical embolism, we prospectively excluded all patients with detectable arteriosclerosis from our series and investigated long-term results. METHODS AND RESULTS: We report the outcome of 180 patients who underwent percutaneous transcatheter closure of patent foramen ovale (PFO), PFO like atrial septal defect (ASD), or an ASD because of paradoxical embolism. One hundred four patients had cerebral embolism, 57 had transient ischemic attacks, 16 coronary embolism, and 3 had peripheral embolism. Twenty-three patients experienced multilocal arterial embolism. One hundred twenty-five patients had a PFO, 63 of them with an atrial septal aneurysm (ASA), 24 a PFO-like ASD (7 of them with an ASA), and 31 had an ASD. After 18 months, only 5 patients (2.8%) showed a trivial residual shunt. At a mean follow-up of 40 months (range 4 to 88), resulting in 602 observed patient-years, only 1 patient experienced a presumed paradoxical (coronary) embolism (calculated annual risk to suffer a recurrent thromboembolic event: 0.16%). CONCLUSIONS: Percutaneous transcatheter closure of PFO/ASD is a safe and effective therapeutic option for the secondary prevention of presumed paradoxical embolism. It is associated with a high success rate, low incidence of hospital complications, and very low frequency of recurrent systemic embolic events.     

Encerramento percutâneo de defeitos do septo interauricular guiado por ecocardiograma intracardíaco − A experiência de um centro

IntroductionDevice closure of interatrial communications has become a well-established technique to treat left-to-right shunt associated with atrial septal defect (ASD) and to prevent paradoxical embolism in patients with patent foramen ovale (PFO). Guidance by transesophageal echocardiography (TEE) is the standard practice but intracardiac echocardiography (ICE) is a feasible and safe alternative for monitoring these procedures.ObjectivesTo report our experience in the percutaneous closure of ASD and PFO guided by ICE.MethodsWe retrospectively reviewed all patients with ASD or PFO who underwent percutaneous closure guided exclusively by ICE between January 2008 and December 2010. All patients were followed clinically with regular echocardiographic evaluation (at discharge, one month, three, six and twelve months) to exclude residual shunt and device malposition.ResultsA total of 127 patients (mean age 46.6±12.2 years; 71% female) underwent transcatheter device closure of ASD or PFO during the study period. Device deployment with ICE monitoring was 100% successful, with a low rate of complications and eliminating the need for additional imaging techniques.ConclusionsICE provides anatomical detail of ASD/PFO and cardiac structures, facilitating congenital cardiac interventional procedures. It eliminates the major drawbacks associated with TEE and enables the interventional cardiologist to control all aspects of the procedure without relying on additional echocardiographic support.     

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

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

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。     

Left atrial disc device thrombosis after atrial defect closure with the Gore® Cardioform septal occluder: A case series

Device thromboses after patent foramen ovale (PFO) and atrial septal defect (ASD) closure are rare but serious complications. They have been reported in different devices of virtually all manufacturers. Here, we report three cases of left atrial device thrombosis after atrial defect closure with the Gore® Cardioform septal occluder (GSO) in our recent institutional experience. All patients were symptomatic with new-onset neurological impairments and evidence of cerebral thromboembolism. Device thromboses have occurred despite antiplatelet therapy in two patients and moreover were observed late, at approximately 2 years after implantation, in two patients. One device was surgically explanted while in two cases, thrombi completely resolved with initiated anticoagulation. All patients had a favorable neurological recovery. Our observations suggest that regular follow-up echocardiography beyond 6 months after device implantation might be advisable in patients with GSO devices to rule out late device thromboses. More long-term follow-up data considering safety and late complications of contemporary PFO and ASD devices is required to establish confident evidence-based recommendations on long-term follow-up management and antithrombotic therapy regimen after PFO and ASD closure.     

Association of interatrial shunts and migraine headaches: impact of transcatheter closure

OBJECTIVES: To examine the relationship between patent foramen ovale (PFO) or atrial septal defect (ASD) with the incidence of migraine headache (MHA) and assess whether closure of the interatrial shunt in patients with MHA would result in improvement of MHA. BACKGROUND: Migraine headache is present in 12% of adults and has been associated with interatrial communications. This study examined the relationship between PFO or ASD with the incidence of MHA and assessed whether closure of the interatrial shunt in patients with MHA would result in improvement of MHA. METHODS: A sample of 89 (66 PFO/23 ASD) adult patients underwent transcatheter closure of an interatrial communication using the CardioSEAL (n = 22), Amplatzer PFO (n = 43), or the Amplatzer ASD (n = 24) device. RESULTS: Before the procedure, MHA was present in 42% of patients (45% of patients with PFO and 30% of patients with ASD). At three months after the procedure, MHA disappeared completely in 75% of patients with MHA and aura and in 31% of patients with MHA without aura. Of the remaining patients, 40% had significant improvement (>or=2 grades by the Migraine Disability Assessment Questionnaire) of MHA. CONCLUSIONS: Transcatheter closure of PFO or ASD results in complete resolution of MHA in 60% of patients (75% of patients with migraine and aura) and improvement in symptoms in 40% of the remaining patients. Interatrial communications may play a role in the etiology of MHA either through paradoxic embolism or humoral factors that escape degradation in bypassing the pulmonary circulation. A randomized trial is needed to determine whether transcatheter closure of interatrial shunts is an effective treatment for MHA.     

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.     

房间隔缺损或卵圆孔未闭联合左心耳一站式封堵治疗的安全及有效性

目的 评估先天性房间隔缺损或卵圆孔未闭并发心房颤动(房颤)患者同时行房间隔缺损或卵圆孔未闭联合左心耳封堵术的安全性、疗效及预后.方法 回顾性分析珠海市人民医院2017年10月至2019年6月收治的10例先天性房间隔缺损或卵圆孔未闭并发房颤的患者的术前、术中及术后临床资料,评估术中安全性及即刻手术疗效,并于术后的第45天...     

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.