Transcatheter closure of atrial septal defect by "buttoned" devices.

During a 21-month period ending in August 1991, 12 patients underwent transcatheter closure of atrial septal defect (ASD) with a "buttoned" device through an 8Fr sheath, using an institutional review board-approved, custom-made device protocol initially, and Food and Drug Administration-approved clinical trials subsequently. Ten children had left-to-right shunts across the ASD and 2 adults had their patent foramen ovale closed to prevent recurrent paradoxical embolism (including cerebrovascular accidents). The device dislodged in 1 of the 4 patients in whom a first-generation device was used, and retrieval of the device, and surgical closure of the ASD were performed without incident. In the remaining 11 patients (age range 7 months to 45 years, weight 3.6 to 64 kg), the device remained intact, and pulmonary-to-systemic flow ratio decreased from 2.1 +/- 0.3 to 1.04 +/- 0.06. Follow-up chest x-ray and echo-Doppler studies were available in all patients 0.5 to 18 months after the procedure. The device was intact in all patients. Small residual shunt detected by color Doppler was seen in 2 children. Right ventricular size decreased (23 +/- 6 to 17 +/- 3 mm; p less than 0.01), and paradoxical septal motion disappeared in all patients. There was no recurrence of paradoxical embolism in the 2 adults. No complications occurred during follow-up. It is concluded that transcatheter closure of ASD with the buttoned device is feasible, effective and safe, and can be accomplished with small, 8Fr sheaths (even in infants weighing 3.6 kg), follow-up results are excellent, and clinical trials on a larger number of patients are needed.     

Role of "buttoned" double-disc device in the management of atrial septal defects.

Sixteen patients seen over a 9-month period ending in August 1990 were offered transcatheter closure of their ASD with a custom-made "buttoned" double-disc device. The study was approved by the Institutional Review Board and informed consent was obtained in each case. The device consists of an occluder, a counteroccluder, and a loading wire and is delivered to the ASD site via an 8F sheath. Parents of two children elected surgical closure. In five children the stretched diameter of the ASD was too large (greater than 20 mm) and transcatheter closure was not attempted. These seven children underwent elective surgical closure without incident. In one child the defect measured 5 mm and the Qp:Qs was 1.4:1 and therefore ASD closure was not recommended. In the remaining eight children transcatheter closure was attempted. In two of the children the occluder pulled through the ASD and was successfully retrieved and the children later underwent uneventful elective surgical closure. The device was implanted across the ASD in six children. In one child the device dislodged from the ASD site within minutes after implantation and the child was sent to emergency surgery, where the device was removed and the ASD was closed. In the remaining five patients, aged 7 months to 45 years (weight 3.6 to 50 kg), with a Qp:Qs range of 1.3 to 2.3 and a stretched diameter of 10 to 19 mm, the ASD closure was successful with 25 to 40 mm size devices. Repeat echo-Doppler studies 2 weeks and 3 months after the procedure in all patients and 6 months later in two children did not reveal any residual shunt. It is concluded that (1) the custom-made "buttoned" double-disc device can be implanted across the ASD safely and effectively via an 8F sheath, thus making transcatheter ASD closure feasible even in very young infants; (2) measurement of stretched diameter of the ASD in the catheterization laboratory is a useful guide for selection of an appropriate-sized device; and (3) additional clinical trials are warranted to confirm the efficacy and safety of the device.     

Transcatheter closure of secundum atrial defect in small children.

OBJECTIVE: To assess safety and efficacy of transcatheter atrial septal defect (ASD) closure in small children. BACKGROUND: Percutaneous closure of ASD is a well accepted alternative to surgery. Reported experience in small children remains, however, scarce. METHODS: Fifty-two children underwent percutaneous ASD closure at a weight < or =15 kg, in four Belgian tertiary referral paediatric cardiology centers. Indication for treatment, device implantation rate, procedural details, complication rate, residual shunt on echocardiography, and impact of procedure on symptoms were retrospectively analyzed. RESULTS: Mean age at procedure was 36 months (7-60), mean weight 13 kg (4.7-15). Associated cardiac lesions were seen in 21% of the patients and noncardiac in 32.7%. Most patients (69.2%) were symptomatic. Mean ASD size was 12 mm (range 5-20 mm). A device could be inserted in 49 patients (94%). No major complications occurred. Minor complications occurred in 8 patients (15.4%) including device embolization in 2, successfully treated with transcatheter retrieval and second device insertion. Mean follow-up reached 27 months (0.03-61.2). Residual shunt was absent, trivial, or small in 93% (n = 42) at latest follow-up. Clinical improvement was noted in 91.7% of the symptomatic patients. Minor complications were more frequent in the presence of large ASDs (>15 mm) but not in smaller babies (<10 kg). CONCLUSION: Patients < or =15 kg requiring ASD closure form a special population with high incidence of associated anomalies and medical conditions. For this particular set of patients, percutaneous closure is a valid alternative. Asymptomatic or mildly symptomatic children should be treated at a later age.     

Platypnea-orthodeoxia: management by transcatheter buttoned device implantation.

Dyspnea and arterial desaturation on upright position in elderly subjects is described as platypnea-orthodeoxia syndrome (POS) and in some patients it is due to right-to-left shunt across the atrial septal defect (ASD)/patent foramen ovale (PFO). Surgical closure of ASD/PFO has been the only available treatment option. Buttoned device has been used for occlusion of ostium secundum ASD, PFO associated with presumed paradoxical embolism and cerebrovascular accidents and ASD/PFO in association with other congenital heart defects causing right-to-left shunt. The objective of this article is to describe the use of buttoned device in effectively occluding ASD/PFO to relieve hypoxemia of POS. During a 4-year period ending January 2000, 10 patients, ages 71 +/- 9 (range 60-83) years with POS underwent buttoned device closure of their ASD/PFO. Echocardiographic and balloon-stretched atrial defect sizes were 8 +/- 3 mm and 12 +/- 3 mm, respectively. The ASD/PFO were occluded with devices ranging in size from 25 to 40 mm delivered via 9 French, long, blue Cook sheaths; eight had an additional 25- or 35-mm occluder placed on the right atrial side. The oxygen saturation increased (P < 0.001) from 76 +/- 7% (range 69-86%) to 95 +/- 2% (range 92-98%). No complications were encountered. Relief of symptoms was seen in all patients. Follow-up of 1-36 months (median 12 months) revealed persistent improvement of symptoms. Buttoned device occlusion of ASD/PFO to relieve hypoxemia of POS is feasible, safe, and effective and is an excellent alternative to surgery. Cathet Cardiovasc Intervent 2001;54:77-82.     

纽扣式补片术治疗成人先天性心脏病113例

目的 :评价纽扣式补片术治疗成人先天性心脏病的疗效及总结其经验。方法 :采用经导管纽扣式补片治疗先天性心脏病 113例 ,其中房间隔缺损 (ASD) 45例 ,动脉导管未闭 (PDA) 45例 ,室间隔缺损 (VSD) 2 3例。结果 :ASD、PDA、VSD成功率分别为 10 0 % (4 5/45例 )、95.6 % (4 3/45例 )和 83.0 % (19/2 3例 ) ,总成功率为 94 .6 %。手术并发症主要见于 VSD患者 ,束支传导阻滞发生率为 2 6 .4 3% (6 /2 3例 )。结论 :纽扣式补片术治疗成人先天性心脏病成功率高 ,即时疗效显著 ,并发症少 ,是一种安全的介入治疗方法     

Intermediate-Term Results of Phase I Food and Drug Administration Trials of Buttoned Device Occlusion of Secundum Atrial Septal Defects

Objectives. This study was conducted to evaluate the intermediate-term results of the multi-institutional U.S. trial of the buttoned device for transcatheter closure of atrial septal defects (ASDs).Background. The trial was conducted in three centers (University of Arizona, University of Michigan and University of Wisconsin) under a Food and Drug Administration (FDA)-approved clinical trial with investigational device exemption. Only short-term follow-up is known.Methods. All 46 patients who had successful implantation of the device were prospectively followed up. Patients were evaluated at 1, 6 and 12 months after device occlusion and yearly thereafter.Results. This cohort was followed up from 51 to 68 months (mean 60.8, median 62). Patient ages ranged from 1 to 62 years (median 4); weights ranged from 10 to 105 kg (median 18); and stretched ASD sizes were 14 ± 4 mm (left to right shunts) and 10 ± 3 mm (right to left shunts). Of the 46 patients, 45 (98%) had effective occlusion of their ASD, and 34 (74%) had complete ASD closure. The incidence of residual shunts decreased from 65% (30 of 46 patients) at 1 month after device placement to 27% (12 of 45 patients) at last follow-up. All residual shunts were quantitated as trivial. Only two patients (4%) required reintervention for significant residual defects. There were no cases of endocarditis or thromboembolism in 224 patient-years of follow-up.Conclusions. In up to 5.5 years of follow-up, the buttoned device provided effective closure in 98% of patients in whom the device was successfully implanted. The incidence of residual shunts decreased during follow-up, and no instances of endocarditis or thromboembolism were observed.     

Intracardiac echocardiography to guide closure of atrial septal defects in children less than 15 kilograms.

BACKGROUND: Intracardiac echocardiography (ICE) is increasingly replacing transesophageal echocardiography (TEE) as the primary imaging technique to guide device closure of atrial septal defects (ASD). Owing to the length of the procedure, the use of TEE requires general anesthesia. Investigators have reported the usefulness of ICE in adults and children. However, little is known about the use of ICE in children whose weight is <15 kg. Therefore, this study examines the use of ICE guided secundum ASD closure in children <15 kg. METHODS: Nineteen patients with a median age of 3.1 years (range 1.8-4.8), and median weight of 13.2 kg (range 8.0-14.4) underwent transcatheter occlusion (Amplatzer occluder) of a secundum ASD using ICE guidance. ICE was performed using an Acunav catheter. The ICE catheter (10 F shaft) was introduced into an 11 F sheath in a contralateral femoral vein. Diagnostic as well as periprocedure imaging was obtained. RESULTS: Sixteen patients had single, and three had multiple defects. Median defect size as measured by ICE was 16 mm (range 2.5-25). The median balloon stretched diameter (obtained in eight patients) was 18 mm (range 10-21); the median size of the defect for these eight patients was 15 mm (range of 8-20). Both techniques for measuring the defect correlated well with r = 0.94. The ASD occluder size ranged from 7 to 26 mm with a median of 18 mm. The procedure was successful in 16 patients who had a device implanted and no residual shunt. ASD occlusion was not attempted in two patients due to deficient rims and in one patient, the attempt failed due to left atrial disk prolapse through the ASD. Four patients experienced transient complications during the catheter procedure, including supra ventricular tachycardia, sinus bradycardia, and two with complete heart block (resolving with device removal); all had subsequent successful device placement. No complications were attributed to the use of ICE and specifically, no vascular injury was noted. CONCLUSIONS: Comparable to results with larger patients, ICE provides adequate imaging (preprocedure diagnosis and periprocedure guidance) during device occlusion of secundum ASDs with no significant complications. Thus, ICE can successfully be used in the closure of ASD in smaller patients (<15 kg) and eliminate the need for endotracheal intubation.     

The Sideris buttoned devices for transcatheter closure of patent ductus arteriosus

This article reviews the experience in the last decade with Sideris buttoned devices for occlusion of patent ductus arteriosus (PDA). The devices used were the regular buttoned device, the infant buttoned device, the device with the folding plug, and the wireless device. The buttoned devices were implanted transvenously and introduced through 7Fr-8Fr long sheaths for PDAs up to 12 mm; wireless devices required 9Fr-11Fr sheaths for PDAs up to 22 mm. All different shapes of ductus were occluded. The records of 356 patients in the international and Food and Drug Administration (FDA) supervised United States (US) clinical trials were reviewed. Despite excellent long-term full occlusion rates and the absence of significant complications with the regular buttoned device, modifications were necessary to improve the full occlusion rates in 24 hours. The 24-hour rates improved from 60% with the regular device to 85% with the folding plug device. Most residual shunts disappeared on long-term follow-up without significant complications. Wireless devices were developed for very large PDAs and have excellent occlusion rates. The buttoned device with the incorporated folding plug and the wireless devices are currently under clinical trial. The safety record of the new devices needs to be established with larger clinical trials.     

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.     

Results of transvenous occlusion of secundum atrial septal defects with the fourth generation buttoned device: comparison with first, second and third generation devices. International Buttoned Device Trial Group

OBJECTIVES: The purpose of this study was to assess safety and effectiveness of the fourth generation buttoned device in dosing atrial septal defects (ASDs) and to test the hypothesis that introduction of double button reduces unbuttoning rate without reducing effectiveness. BACKGROUND: Because of the high unbuttoning rate (7.2%) with first, second and third generation buttoned devices, the device was modified (fourth generation) so that there were two radiopaque spring buttons 4 mm apart on the button loop attached to the occluder. METHODS: During a four-year period ending in September 1997, 423 patients, ages 1.5 to 80 years (median 16 years), underwent closure of ASD at 40 medical centers around the world. RESULTS: The ASD size varied between 5 and 30 mm (median 17 mm). The device size varied between 25 and 60 mm. Unbuttoning occurred in 4 (0.9%) of 423 patients. Effective occlusion, defined as no (n = 343) or trivial (n = 34) residual shunt on echo-Doppler studies performed within 24 h of the procedure, was demonstrated in 377 patients (90%). Thus, the unbuttoning rate (0.9 vs. 7.2%) decreased (p<0.01) while effective occlusion rate (90 vs. 92%) remained unchanged (p>0.1) with this device, compared with earlier generation devices. During follow-up from one month to five years (23+/-15 months), 21 (5%) of 417 patients required surgical (n = 12) or transcatheter (n = 9) reintervention, mostly to treat significant residual shunt. In the remaining patients there was gradual reduction and disappearance of the residual shunt. No wire integrity problems were observed. CONCLUSIONS: These data suggest that the fourth generation buttoned device is as effective as earlier generation devices, but without significant unbuttoning. Follow-up results remained good, with a reintervention-free rate of 89% at five years.     

小儿特殊类型房间隔缺损介入治疗

目的:探讨小儿特殊类型房间隔缺损(ASD)封堵术的方法和疗效。方法:1998年11月至2009年12月,应用双盘伞ASD封堵器治疗390例继发孔ASD,其中88例为特殊类型的ASD,分别为:多发性ASD 24例、短残边ASD 64例。其中男性39例,女性49例;年龄3～18岁,平均6岁;术前均经体检、心电图、X线片及超声心动图确诊,术后行心脏超声及临床检查随访。结果:85例患者介入治疗手术获得成功,技术成功率96.6%。ASD直径为5～26 mm,平均直径为(12.7±4.7)mm。24例多孔ASD,有23例置入1个封堵器,1例应用2个封堵器。在平均5年随访中没有严重并发症。结论:小儿特殊类型ASD可通过心导管介入技术来治愈。     

Long-Term Outcomes After Percutaneous Closure of Ostium Secundum Atrial Septal Defect in the Young: A Nationwide Cohort Study

Objectives

This study sought to assess procedural characteristics, early clinical outcome, and long-term complications after transcatheter closure of atrial septal defect (ASD) in children.

Transcatheter Closure of Atrial Communications Using the Amplatzer™ Septal Occluder

Certain types of atrial septal defects (ASDs) are amenable for transcatheter closure using various investigational devices. The use of the clamshell or buttoned devices is accompanied with a high incidence of residual shunt. The experience of ASD closure using the Amplatzer™ Septal Occluder (ASO) is limited. Therefore, the purpose of this article is to discuss the protocol of closure and report on the acute results using this device. Nineteen patients (17 ASD/2 fenestrated Fontan [FF]) underwent an attempt at catheter closure of their defects at a median age of 13.3 years (range 5.5–67.4 years) and a median weight of 49 kg (range 18–94 kg) using the ASO. The median ASD diameter measured by transesophageal echocardiography (TEE) was 12 mm (range 6–23.8 mm), and the median defect balloon stretched diameter was 17 mm (range 6–31 mm). All ASD patients had right atrial and ventricular volume overload with a mean ± SD Qp/Qs of 2.4 ± 0.9. A 7 to 8Fr catheter was used for delivery of the device in all patients. The device was placed correctly in all but one patient. There were immediate and complete closures (C) in 13 of 18 patients; 3 patients had trivial residual shunts (TS), and 2 patients had small residual shunts (SS). In the two patients with FF, oxygen saturation improved from 85% to 95% and 88% to 96%, respectively. One patient received two devices for two separate defects. The median fluoroscopy time was 15.5 minutes (range 7.4–33.4 minutes), and the median total procedural time was 78 minutes (range 52–180 minutes). There was one episode of device embolization in one patient. The device was successfully retrieved and 2 months later a second closure was performed successfully. No other complications were encountered during or after the procedure. Follow-up was performed using transthoracic echocardiography (TTE) at 1 day and 1 month and by TEE at 3 months. At day 1, there was C of the defect in 15 of 19 patients and 4 had TS; 18 patients completed 1-month follow-up, 16 of 18 had C and 2 patients had TS. Eleven patients completed 3-month follow-up, all with C. So far 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 atrial communications up to 23.8 mm in diameter.     

Buttoned Device for Atrial Septal Defect Occlusion

This article reviews the most recent results of the latest modification of the buttoned device (Custom Medical Devices, Amarillo, TX), the 4th generation. The latest advances in atrial septal defect (ASD) occlusion with further modifications of the buttoned device--inverted buttoned device, hybrid buttoned device, and centering- on-demand device (COD) (Custom Medical Devices)--that have led to the evolution of wireless and deviceless ASD occlusion are also presented.     

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.     

Safety and efficacy of larger ASD devices in small children of less than 2 years

We herein report our single center experience of safety and efficacy of device closure of large sized ostium secundum atrial septal defects (OS ASD) in small children with less than 2 years of age performed over the period of 10 years from 2009 to 2019.148 symptomatic children with ASD size of more than 8 mm were included in our study. We obtained a high rate of successful deployment (98 %) with no major complications.     

多孔筛状房间隔封堵器封堵小儿多孔型房间隔缺损

目的介绍使用多孔筛状房间隔封堵器（amplatzer cribriform occluder,ACO）封堵多孔型房间隔缺损（multi-fenestrated ASD,mf ASD）的经验,并评估其可行性、有效性及安全性。方法回顾2013年8月至2014年5月上海交通大学医学院附属新华医院使用ACO经导管介入封堵mf ASD的5例患儿,并介绍手术及术后随访结果。结果 3例mf ASD（Ⅱ）患儿2处缺损距离分别为5 mm、7.4 mm和3.8 mm,选择25 mm ACO进行封堵。1例ASD（Ⅱ）4.5 mm、2.0 mm（位置略偏前）,选择18 mm ACO。1例房间隔瘤形成,瘤底8.5 mm,瘤高12.2 mm,ASD 2处,一处位于中央8 mm×8 mm,另一处位于房间隔瘤下方,大小为2.5 mm,两处缺损相距5.2 mm,选择25 mm ACO。术中及术后超声心动图均显示无残余分流,术后第2天及1、3个月心电图检查结果均正常。短期随访结果令人满意,尚未见并发症发生。结论 ACO应用于封堵mf ASD操作简便,并发症少,封堵效率较高,是患儿mf ASD封堵的选择之一。     

Transvenous atrial septal defect occlusion in piglets with a "buttoned" double-disk device

The feasibility and safety of transvenous closure of atrial septal defects by a new device was tested in 20 piglets, in which atrial septal defects were created by foramen ovale dilatation with angioplasty balloons. The device was small enough to be introduced in a 7F or 8F sheath, and it measured 20-25 mm. It has no hooks and consists of a foam occluder from the left atrium and a counter-occluder from the right atrium, buttoned independently. The animals were observed by angiography and color flow mapping, and they were electively killed at various intervals up to 2 months after occlusion. The device was not thrombogenic and had endothelialized by 2-3 weeks. All atrial defects were found to be completely occluded. Complications occurred only with the first three prototype devices, including counter-occluder detachment, right atrial perforation, and need for double occlusion and pulmonary artery embolization. No such complications occurred in the last 17 experiments because of modifications of the device and operator experience. These observations showed the feasibility of occlusion of moderate-size atrial septal defects in piglets by a new device introduced through a small sheath. The method appears promising for potential human application.     

Transcatheter occlusion of complex atrial septal defects.

Percutaneous device occlusion of secundum atrial septal defects (ASDs) is becoming an accepted alternative to surgical closure. This method allows us to evaluate patients with complex conditions for treatment. From a total of 70 patients with ASD evaluated for percutaneous closure, we selected for analysis 28 who had complex conditions. The mean age was 36+/-23 yr (range, 4-72). Six had heart failure, and of these six, three had atrial fibrillation. At cardiac catheterization, the pulmonary pressure was 47+/-24 mm Hg, and the QP/QS was 1.7+/-0.4; two patients had bidirectional shunt and systemic pulmonary pressure. Two patients received a buttoned device and 26 an Amplatzer septal occluder. The groups of patients with complex conditions were separated into the following groups. Group I (n = 4) underwent combined treatment of associated anomalies. Two patients had pulmonary stenosis, one had mitral stenosis, and one had an aortic root-left atrium fistula. They were treated in or during with the same procedure by combined transcatheter techniques (balloon valvuloplasty and fistula occlusion) before ASD occlusion. Group II (n = 9) had multiple defects (cribiform or two separate holes). They were treated with a single device in five instances and with two separate devices in four cases. Group III (n = 14) had large (32+/-3 mm) single defects. Nine of them underwent successful implantation using a device 33+/-3 mm in diameter; in the remaining five patients the device was removed because of instability. Group IV (n = 3) had residual defects after previous partial device occlusion. All three defects were successfully occluded with a second device. No movement or interference with the first device was observed. Group V (n = 6) had severe pulmonary hypertension (86+/-16 mm Hg). Immediately after ASD occlusion we observed significant relief in these patients (67+/-14 mm Hg; P<0.01). There were no major complications; all 23 patients with successful implants were discharged without symptoms 2-7 days later; one patient with atrial fibrillation recovered sinus rhythm. The follow-up (8+/-5 mo) Doppler echo study showed complete ASD occlusion in 22 patients and a peak pulmonary pressure of 30+/-14 mm Hg. We conclude that transcatheter occlusion of ASDs is an effective and safe treatment for patients with complex anatomic or physiopathologic conditions, as evaluated by short-term follow-up.     

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.