Closure of the fenestration in the extracardiac Fontan with the Amplatzer duct occluder device.

We report the successful use of the Amplatzer duct occluder for the delayed closure of the fenestration in three patients who underwent an extracardiac modified Fontan procedure. At the moment of closure, the patients were 5.5, 2.7, and 3 years old (29 months, 3 months, and 14 months after the Fontan procedure, respectively). Immediate full occlusion was achieved in all cases. In addition, arterial saturation increased significantly (> 5%) with no hemodynamic deterioration. There were no complications during or after the procedure, and the patients were discharged in good conditions the day after and with uneventful follow-up. In conclusion, the Amplatzer duct is safe and effective for the closure of the fenestration in the extracardiac Fontan. Cathet Cardiovasc Intervent 2001;54:88-92.     

经导管封堵全腔静脉肺动脉连接术外管道开窗的初步临床应用

目的 探讨经导管封堵全腔静脉肺动脉连接术外管道开窗的方法及疗效.方法 2007年3至7月共行3例外管道开窗封堵术,男2例,女1例,年龄分别为7、14及8岁,术前诊断均为发绀,属复杂先天性心脏病,不能行双心室矫治,而行全腔静脉肺动脉连接术,术中均加行外管道开窗.术后患者持续存在口唇发绀,血氧饱和度降低.3例患者行心导管及造影检查后证实上、下腔静脉与肺动脉吻合口通畅,无狭窄改变,肺动脉平均压均小于15 mm Hg(1 mm Hg=0.133 kPa),分别采用AGA公司Amplatzer动脉导管未闭封堵器及房间隔缺损封堵器对外管道与右房之间的交通(开窗)进行封堵.结果 所有患者均封堵成功,封堵后即刻、15 min、30 min及1 h分别测肺动脉及腔静脉压,与封堵前比较无明显升高,且患者无明确不适症状,血氧饱和度较封堵术前均有提高,发绀减轻,超声心动图及造影证实封堵器形态及位置良好.无术中及术后并发症,术后随访3至6个月,经超声心动图证实封堵器形态及位置良好,无残余分流.结论 经导管外管道开窗封堵术技术成功率高、疗效确切,但远期疗效尚需密切随访.     

Occlusion of Fontan fenestrations using the Amplatzer septal occluder

Objective—To evaluate the efficacy and safety of the Amplatzer septal occluder device for occlusion of Fontan fenestrations.
Subjects—Five children aged 5-10 years who had undergone a fenestrated Fontan operation.
Setting—Tertiary paediatric cardiology centre.
Methods—Each patient had right and left heart catheterisation to assess haemodynamic suitability for fenestration closure. Sizing of the defect was achieved with a balloon wedge catheter and transoesphageal echocardiography. Transcatheter occlusion of the fenestration was accomplished using a 4 mm device in three patients, and 5 mm or 9 mm devices in the other two patients. Residual shunting following occlusion was assessed using angiography and echocardiography.
Results—100% occlusion rate of the fenestration was achieved in all patients. No complications or device failures were seen during the three month follow up period.
Conclusion—The Amplatzer septal occluder device is safe, and effectively occludes the Fontan fenestration.

Keywords: Fontan circulation;  fenestration occlusion;  Amplatzer septal occluder device;  congenital heart disease     

Closure of extracardiac Fontan fenestration by using the covered Cheatham Platinum stent.

OBJECTIVE: The purpose of this study was to describe our experience concerning the use of covered Cheatham Platinum (CP) stent in patients with fenestrated total cavopulmonary connection (TCPC). BACKGROUND: Closure of TCPC fenestrations has been achieved by utilizing different devices designed to close intra-cardiac or aorto-pulmonary communications. METHODS: We used the covered CP stent in 6 patients with fenestrated TCPC. Median age and weight were 11 years and 38 Kg, respectively. Femoral approach was used in all but 1 patient having bilateral thrombosis of femoral veins. The CP stent was crimped on a BiB balloon in 5 patients and on a simple balloon in 1 patient. The balloon's diameter was the same size or 1-2 mm larger than the TCPT conduit, according to angiographic diameter. RESULTS: Mean procedural and fluoroscopy time were 41 +/- 8 and 8 +/- 2 min, respectively. Immediate full occlusion of fenestration was obtained in all patients. Mean central venous pressure was not significantly increased from 10.8 +/- 2.5 to 11.8 +/- 2.8 mm Hg and oxygen saturation significantly increased from (91.5 +/- 4.4)% to (98.5 +/- 1.9)% (P = 0.003). No procedural or intra-hospital complications occurred. In particular, no arrhythmias, systemic embolism, or acute venous thrombosis were observed. At a median follow-up of 2.8 months all patients have normal oxygen saturation and are symptom-free. CONCLUSIONS: The covered CP stent can be easily and effectively used for closure of TCPC fenestrations. This method has the advantage to avoid protrusion of prosthetic material into the left atrium and to prevent early or late embolism.     

高原地区用Amplatzer封堵器介入治疗动脉导管未闭

目的 :应用 Amplatzer封堵器在高原地区治疗动脉导管未闭 （PDA）并评价其疗效。方法 :本组 2 0例 ,年龄 1.5～ 44 （2 2± 14）岁 ,PDA最窄处内径 5～ 14（9± 3） m m,均用 Am platzer封堵器介入治疗。结果 :19例成功 ,1例严重阻力性肺动脉高压不适宜封堵。术后即刻降主动脉造影显示 15例封堵完全无残余分流 ,4例少量残余分流。 1例术后 1h封堵器脱落入右肺动脉 ,第三小时急诊外科手术关闭 PDA并取出封堵器。 2 4h彩色多普勒检查显示封堵 18例患者均无分流 ,随访 2月～ 1.5年 ,无 1例分流。结论 :用 Amplatzer封堵器治疗 PDA是高原地区 1种适应性强 ,安全有效的介入治疗方法。     

Transcatheter closure of persistent ductus arteriosus in infants using the Amplatzer duct occluder

AIM—To evaluate whether transcatheter closure with the Amplatzer duct occluder offers an alternative to surgical treatment in infants with a persistent ductus arteriosus.
METHODS—12 patients under 1 year of age (age 1-11 months, body weight 2.6-8.7 kg) with clinical and echocardiographic findings of a significant duct were considered for transcatheter closure with the Amplatzer occluder. The device is made of a Nitinol and polyester fabric mesh and provides occlusion by stenting the duct. Measured angiographically, the narrowest diameter of the ducts ranged from 1.5-5 mm; in six patients pulmonary hypertension was also present.
RESULTS—The devices were implanted and complete duct occlusion was demonstrated during follow up in 10 patients. Procedure related difficulties occurred in nine of the 12 cases and led to relatively long procedure and fluoroscopy times (procedure time 50-180 minutes, median 80 minutes; fluoroscopy time 4.9-49 minutes, median 16 minutes). In two infants transcatheter closure could not be achieved and surgical duct ligation had to be carried out.
CONCLUSIONS—In small infants with a persistent ductus arteriosus the Amplatzer duct occluder offers an alternative to surgical treatment, but further improvement of the implantation system is necessary before the procedure can be recommended as the treatment of choice.


Keywords: persistent ductus arteriosus; transcatheter closure; infants; Amplatzer duct occluder     

Successful occlusion of a coronary arteriovenous fistula using an Amplatzer duct occluder

In an 11-year old boy with a large coronary arteriovenous fistula between the left coronary artery and the right atrium, we achieved successful closure using a 10-8 Amplatzer Duct Occluder introduced from the right internal jugular vein. Angiography 6 weeks later showed complete occlusion of the fistula, with normal opacification of the left coronary arterial system. This technique may be used as an alternative to coils and surgery in selected patients.     

经导管封堵主动脉窦瘤破口的初步临床应用

目的探讨经导管封堵主动脉窦瘤破口的可行性及有效性。方法4例患者,年龄7～57岁,均为主动脉右窦窦瘤破裂人右心室,破口直径2～10mm,其中3例为先天性,1例患者为获得性（医源性）。通过建立股动脉．主动脉窦瘤破口．右心室．右心房-股静脉的轨道,在透视和超声的引导下经股静脉顺行性置人合适的动脉导管未闭封堵器（Amplatzer duct occluder,ADO）,所选择的ADO直径较破口大1～2mm。结果主动脉窦瘤破口全部封堵成功,仅1例患者术后存在微量残余分流,次日超声证实分流消失。无并发症发生。随访3个月,4例患者症状和体征均消失,超声证实封堵器形态位置良好,无残余分流、栓塞、细菌性心内膜炎、主动脉瓣反流等发生。结论经导管主动脉窦瘤破口封堵术为一种微创、安全和有效的治疗方法,适合于不合并其他需外科处理心血管病变的主动脉窦瘤破裂。其近期疗效良好,中远期疗效有待于进一步观察。     

Successful percutaneous closure of paraprosthetic aorto-right ventricular leak using the Amplatzer duct occluder.

A 55-year-old male with persisting aorto-right ventricular paraprosthetic leak after mitroaortic valve replacement was hospitalized for recurrent heart failure. Depressed left ventricular ejection fraction and severe pulmonary hypertension with increased right and left ventricular filling pressures were associated with significant left to right shunting through the leak. Elective closure of the leak was obtained with a 6-4 mm Amplatzer duct occluder. No complications were observed, and the patient experienced complete resolution of heart failure symptoms, with NYHA class I heart failure 12 months after discharge.     

应用Amplatzer封堵器治疗动脉导管未闭的疗效评价

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Experimental evaluation of a modified Amplatzer duct occluder.

The purpose of this study was to evaluate a new device specifically designed for patent ductus arteriosus (PDA) occlusion based on PDA anatomy. Percutaneous closure of aortopulmonary shunts was attempted in 10 dogs. Shunts were surgically created in the location and orientation of PDA. The occlusion prosthesis consisted of a cylindrical frame filled with polyester and a 32 degree angled retention disk. The delivery system of the device included a 6 Fr thin-walled Teflon introducing sheath, an antirotating delivery catheter, and cable. Complete occlusion of the shunt was obtained in nine animals. One animal died before device placement. Temporary hemolysis occurred in one dog after device placement. The disk of device was completely covered by smooth glistening neoendothelium at 1-3 months postmortem examination. None of the devices protruded into the lumen of the aorta. The device is an improvement over the standard Amplatzer duct occluder. The angled retention disk lies flatly against the aortic wall, avoiding turbulence or an aortic pressure gradient.     

Further experience with transcatheter closure of the patent ductus arteriosus using the Amplatzer duct occluder

OBJECTIVE: The aim of this study was to report further experience with transcatheter closure of the patent ductus arteriosus (PDA) using the Amplatzer duct occluder (ADO). BACKGROUND: The design of previously used devices is not ideal for this purpose, and their use has been associated with several drawbacks, especially in large PDAs. METHODS: Forty-three patients, aged 0.3 to 33 years (mean 6.4+/-6.7 years), with a moderate to large, type A to E PDA, underwent attempted transcatheter closure using the ADO. The device is a plug-shaped repositionable occluder made of 0.004-in. nitinol wire mesh. It is delivered through a 5F to 6F long sheath. The mean PDA diameter (at the pulmonary end) was 3.9+/-1.2 mm (range 2.2 to 8 mm). All patients had color flow echocardiographic follow-up (6 to 24 months) at 24 h, 1 and 3 months after closure, and at 6-month intervals thereafter. RESULTS: The mean ADO diameter was 6.1+/-1.4 mm (range 4 to 10 mm). Complete angiographic closure was seen in 40 of 43 patients (93%; 95% confidence interval [CI] 85.4% to 100%). The remaining three patients had a trivial angiographic shunt through the ADO. At 24 h, color flow mapping revealed no shunt in all patients. A 9F long sheath was required for repositioning of a misplaced 8-mm device into the pulmonary artery. The mean fluoroscopy time was 7.9+/-1.6 min (range 4.6 to 12 min). There were no complications. No obstruction of the descending aorta or the pulmonary artery branches was noted on Doppler follow-up studies. Neither thromboembolization nor hemolysis or device failure was encountered. CONCLUSIONS: Transcatheter closure using the ADO is an effective and safe therapy for the majority of patients with patency of the arterial duct. Further studies are required to establish long-term results in a larger patient population.     

The Amplatzer duct occluder: experience in 209 patients

OBJECTIVES: The aim of the study was to assess the safety and efficacy of the Amplatzer ductal occluder (ADO) in transcatheter occlusion of patent ductus arteriosus (PDA). BACKGROUND: Transcatheter closure of small to moderate sized PDAs is an established procedure. The ADO is a self-expandable device with a number of salutary features, notably its retrievability, ease of delivery via small 5F to 7F catheters and a range of sizes suitable even for the larger PDAs. METHODS: Between November 1997 and August 1999, the ADO was successfully implanted in 205 of 209 patients with PDA. The inclusion criteria for this device occlusion method were patients with clinical and echocardiographic features of moderate to large PDA, weighing > or =3.5 kg as well as asymptomatic adolescents and adults with PDA measuring > or =5.0 mm on two-dimensional (2D) echocardiogram. Occlusion was achieved via the antegrade venous approach. Follow-up evaluations were performed with 2D echocardiogram, color-flow mapping and Doppler measurement of the descending aorta and left pulmonary artery velocity at 24 h and 1, 3, 6 and 12 months after implantation. RESULTS: Two hundred and five patients had successful PDA occlusion using this device. The patients were between two months and 50 years (median 1.9) and weighed between 3.4 kg and 63.2 (median 8.4). Infants made up 26% of the total patients. The PDA measured from 1.8 to 12.5 mm (mean 4.9) at the narrowest diameter. Forty-four percent of patients achieved immediate complete occlusion. On color Doppler the closure rates at 24 h and 1 month after implant were 66% and 97%, respectively. At 6 and 12 months all except one patient attained complete occlusion. Device embolization occurred in three patients; in two this was spontaneous, and in the other it was due to catheter manipulation during postimplant hemodynamic measurement. Mild aortic narrowing was seen in an infant. CONCLUSIONS: Patent ductus arteriosus occlusion using ADO is safe and efficacious. It is particularly useful in symptomatic infants and small children with relatively large PDA. Embolization can be minimized by selection of appropriate sized devices, and caution should be exercised in infants <5 kg.     

Closure of a very large patent ductus arteriosus using the amplatzer duct occluder

A very large patent ductus arteriosus was closed completely using an Amplatzer Duct Occluder. This represents the largest patent ductus arteriosus to undergo closure with this endovascular technique.     

Transcatheter closure of the patent ductus arteriosus using an Amplatzer duct occluder in adults.

Patent ductus arteriosus (PDA) is a congenital heart disease that frequently escapes detection until the patient reaches adulthood. Percutaneous closure of the PDA has been established as a safe alternative to surgery, the Amplatzer duct occluder (ADO) is a new device that has been recently reported in paediatric patients. Our initial experience with an of ADO in an adult population appears to be encouraging and as good as in paediatric patients.     

Percutaneous closure of patent ductus arteriosus with the Amplatzer duct occluder

BACKGROUND AND METHODS: Percutaneous closure of a moderate-to-large sized patent ductus arteriosus using multiple coils or a Rashkind double-umbrella may be technically demanding and raises a significant rate of embolization and residual shunting. This is why we tried a new self-expandable device called Amplatzer Duct Occluder to close transvenously large ductuses in eighteen patients at a median age of 2.8 years (range: 0.7 to 34). They had a patent ductus arteriosus with a minimal diameter > 3 mm (mean: 5 +/- 2 mm). The device had a mean diameter of 9 +/- 2 mm and was delivered through a 6F venous sheath. Aortography was done 5 to 10 minutes after the release and follow-up evaluation was performed with color Doppler echocardiography within 24 h, 1 and 3 to 6 months after the procedure. RESULTS: Placement was successful in all but the first patient (95%). Complete closure was achieved immediately in 4/17 patients (24%) and in 13/17 (76%) 24 h later. Two patients were lost for follow-up. Complete closure was confirmed in 14 of the 15 (93%) reviewed patients at 1 and 3 months. In all patients with a ductal diameter < or = 7.5 mm the closure was complete at 1 month. Embolization occurred in one patient with a 9.7 mm duct and surgery was undertaken. A mild and transient hematuria was observed in one patient. No pulmonary artery stenosis nor aortic obstruction were observed on follow-up. CONCLUSION: The Amplatzer Duct Occluder device offers a safe and effective option to treat patients with a ductus arteriosus which minimal diameter is up to 7.5 mm.