Clinical Study on Amplatzer Occluder Device to CloseVentricular Septal Defect

Objectives To evaluate the therapeutic effect of transcatheter Amplatzer device on the closure of ventricular septal defect （VSD）. Methods Among 143 patients with VSD, 135 patients with perimembrane VSD and 2 with muscular VSD aged 2.5 -28 years old, were successfully closed with Amplatzer oeeluder device by the pereutaneous guidwire through femoral artery-VSD-femoral vein route under the guidance of fluoroscopy, ventrieulography and transthoracic echocardiography （TIE）. The diameters of the VSDs were 2.3-15.7 （6.90±2.76）mm by left ventriculography. Results The success rate of transcatheter closure of VSD with Amplatzer devices was 96%（137/143）. Minimal residual amount of shunts were found in one patient, although the shunts was decreased one month after the procedure. There were one patient who had respiratory arrest during the procedure, 7 patients（5%）had conduction disturbance, 3 patients had complete left bundle branch block, 2 patients had complete right bundle branch block, 1 patient had Ⅰ degree atrial-ventricular block and 1 patient had Ⅲ degree atr/al-ventricular block during hospitalization. The diameters of the occluder ranged from 4 to 23 （9.13±3.31）mm and were symmetrical in 122 patients and asymmetrical in 15 patients. Conclusions Transcatheter closure of the perimembranous ventrieular septal defect using Amplatzer VSD occluder device is an efficient method for patients with the perimembranous VSD. The operation is simple with a high success rate and a good effect.     

Amplatzer Septal Occluder to treat iatrogenic cardiac perforations

Background : Iatrogenic free wall cardiac perforation is a rare but serious complication encountered during percutaneous cardiac procedures, which usually leads to tamponade and death. Septal occluder devices have been developed for sealing intracardiac shunts but may be also used in this emergency setting. Methods and Results : We report a small series of five consecutive cases of iatrogenic heart perforations that were treated with implantation of Amplatzer Septal Occluders (ASO). In the first case, iatrogenic left ventricle (LV) perforation occurred during LV biopsy and could be closed up with a 4 mm ASO. In the second case, a 4 mm ASO was used for sealing of a right atrial perforation allocated to Port‐a‐Cath dislodgment. The third case happened during transseptal puncture for implantation of a TandemHeart bVAD device in a patient suffering cardiogenic shock and was treated by implantation of a 5 mm ASO. The fourth patient was transferred to our facilities for percutaneous closure of an acute post‐infarct VSD after anteroseptal myocardial infarction. This procedure was complicated by perforation of the posterolateral free wall and led to the deployment of 12 mm ASO. The last patient suffered from free LV wall perforation during investigation of a severe aortic stenosis and was treated by implantation of 4 mm ASO. All patients were alive after 24 hrs but the last patient died during the in‐hospital stay of a right ventricular infarction complicated by multiple organ failure. Conclusions : Percutaneous device occlusion of iatrogenic heart perforation seems to be a safe and efficient method to treat iatrogenic heart perforation. In order to perform this elegant method, it is however imperative not to prematurely withdraw the perforating catheter to maintain access to the hole for closure. © 2011 Wiley Periodicals, Inc.     

Unusual Presentation of Nickel Allergy Requiring Explantation of an Amplatzer Atrial Septal Occluder Device

Systemic allergic reaction to a percutaneous patent foramen ovale (PFO) occlusion device is a rare event with only scattered reports in the literature. Serious allergic reactions to these devices have a poorly defined incidence, presentation, and natural history. We present a woman with a previously unknown nickel allergy who developed severe chest pain beginning the morning after percutaneous device closure of the PFO. Despite multiple visits to her cardiologists and primary care physicians, the cause of her chest pain remained unclear. After seeking a second opinion at our medical center, skin testing showed a severe reaction to nickel. These symptoms were refractory to treatment until device explantation 18 mo later. This case highlights the importance of recognizing nickel allergy as a cause of chest pain following implantation of certain types of devices used for closure of PFOs and other heart defects. Copyright © 2009 Wiley Periodicals, Inc.     

Figulla ASD Occluder versus Amplatzer Septal Occluder: A Comparative Study on Validation of a Novel Device for Percutaneous Closure of Atrial Septal Defects

Objectives: Occlutech Figulla ASD Occluder (FSO) is an alternative device to Amplatzer Septal Occluder (ASO) with some structural innovations including increased flexibility, minimizing the amount of material implanted, and absence of the left atrial clamp. We aimed to report our experiences with FSO and compare the outcomes of this novel device versus ASO. Interventions: Between December 2005 and February 2009, 75 patients diagnosed with secundum atrial septal defects underwent transcatheter closure. The FSO device was used in 33 patients, and the ASO was used in 42. Results: Patient characteristics, stretch size of the defect, device left disc size, procedure, and fluoroscopy time were similar between the groups. However, the difference between device waist size and stretched diameter of the defect was significantly higher, and device delivery sheath was significantly larger in FSO group and device left disc size was significantly lower in the FSO group. In all subjects, the residual shunt was small to trivial during follow‐up and the reduction in prevalence of residual shunt with time was similar in both groups (P = 0.68). We found no differences in complication rate between the two devices; however, device embolization to the pulmonary bifurcation in one patient was recorded as major complication in FSO device group. Conclusions: Both devices are clinically safe and effective in ASD closure. FSO device has similar outcomes when compared to ASO device. Difficulties in selecting the correct device size in larger defects and larger venous sheath requirement need to be evaluated in further studies.     

Complications Related to Transcatheter Occlusion of Atrial Septal Defect with Amplatzer Septal Occluder in Children

METHODSPatients From August 1998 to March 2004, a total of 289 children (mean age: 6.5 ±3.8 years) have undergone transcatheter occlusion of secundum type ASD with ASO. All cases performed transthoracic echocardio- graphy (TTE) evaluation before implantation and con- finned by balloon sizing in interventional procedure, partly confirmed by transoesophageal echocardiography(TEE). Patients with a residual rim of atrial septum <4mm, or diameter of ASD + 14mm > the maximal septal length…     

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.     

Endocarditis and Incomplete Endothelialization 12 Years after Amplatzer Septal Occluder Deployment

A 4-year-old boy had a 15-mm atrial septal defect repaired percutaneously with use of an Amplatzer Septal Occluder. At age 16 years, he presented with a week''s history of fever, chills, dyspnea, fatigue, and malaise. Cultures grew methicillin-sensitive Staphylococcus aureus. A transesophageal echocardiogram showed a 1.25 × 1.5-cm pedunculated mass on the left aspect of the atrial septum just superior to the mitral valve, and a smaller vegetation on the right inferior medial aspect of the septum. At surgery, visual examination of both sides of the septum revealed granulation tissue, the pedunculated mass, the small vegetation, and exposed metal wires that suggested incomplete endothelialization of the occluder. We removed the occluder and patched the septal defect. The patient returned to full activity after 4 months and was asymptomatic 3 years postoperatively.Our report reinforces the need for further investigation into prosthetic device endothelialization, endocarditis prophylaxis, and recommended levels of physical activity in patients whose devices might be incompletely endothelialized. In addition to reporting our patient''s case, we review the medical literature on this topic.     

经导管Amplatzer封堵装置治疗房间隔缺损的研究现状与进展

自1976年King和Mills首先使用经静脉双伞状堵塞装置环导管关闭继发孔房间隔缺损(ASD)取得成功。利用介入性方法治疗继发孔ASD已有近30年的历史。随着介入器材的不断改进、介入经验的积累和操作技术的提高，对房间隔缺损的介入封堵治疗已取得一定的临床应用规模，设备不断完善，技术日趋成熟。本文主要阐述Amplatzer双盘自膨胀ASD堵塞装置的特点及临床经验总结。综述如下：     

经导管置入Amplatzer封堵器治疗房间隔缺损前后血浆内皮素、一氧化氮、心钠素水平变化及意义

目的:探讨经导管置入Amplatzer封堵器治疗房间隔缺损前、后血浆内皮素1(ET-1)、一氧化氮(NO)、心钠素(ANP)水平变化。方法:22例房间隔缺损患者,按有、无肺动脉高压分为肺动脉高压组14例,无肺动脉高压组8例。分别测定术前、术后3天及3个月血浆ET-1、NO、ANP含量。结果:术前肺动脉高压组血浆ET-1、NO、ANP水平明显高于无肺动脉高压组(P<0.01)。无肺动脉高压组的ANP水平高于对照组。术后3天肺动脉高压组血浆ET-1、NO、ANP水平即出现下降(P<0.05),术后3个月已接近正常水平。结论:ET-1/NO动态平衡的改变,可能参与了肺动脉高压的发生、发展过程;ANP在肺动脉高压的发病机制中起着有益的生理调节作用;经导管置入AmpJatzer封堵器治疗房间隔缺损明显降低血浆ET-1、NO及ANP含量。     

Late Bacterial Endocarditis in an Intravenous Drug User With an Amplatzer Septal Occluder

Infective endocarditis of a fully endothelialized cardiac prosthesis, and especially the late presentation of endocarditis, challenges our current understanding of device-related complications. Late bacterial endocarditis associated with the Amplatzer Septal Occluder, a device frequently used to close atrial septal defects, has been documented only rarely. We report the case of an intravenous drug user who had late infective endocarditis associated with his Amplatzer Septal Occluder, secondary to methicillin-sensitive Staphylococcus aureus bacteremia nearly 14 years after device insertion. The patient recovered after surgical excision and débridement of the vegetative mass, which may be the first time that a surgical approach has been taken to treat this condition. This report corroborates the need for late screening of high-risk patients who have septal occluder devices.