Real world safety and efficacy of the Janus tacrolimus‐eluting stent: Long‐term clinical outcome and angiographic findings from the tacrolimus‐eluting stent (TEST) registry

A 83‐year‐old woman underwent percutaneous closure of postinfarction ventricular septal defect following anteroseptal myocardial infarction and percutaneous coronary intervention with stent implantation of the left anterior descending coronary artery. Postinfarction percutaneous ventricular septal defect closure was initially complicated by an iatrogenic left ventricular free‐wall perforation. Both defects were closed using two Amplatzer muscular VSD occluders during the same session. © 2009 Wiley‐Liss, Inc.     

Late tissue erosion after transcatheter closure of an atrial septal defect

We present the case of a 27‐year‐old male presenting with sudden‐onset retrosternal chest pain, dyspnea, and cardiac tamponade due to erosion of an Amplatzer Atrial Septal Occluder (ASO) through the left atrial wall 4 years after placement. Emergent surgical management of the hemopericardium, followed by surgical removal of the device, repair of the left atrial wall perforation, and patch closure of the atrial septal defect (ASD) were performed successfully. Tissue erosion leading to hemopericardium and cardiac tamponade should be suspected in subjects with a history of transcatheter ASD closure who present with acute chest pain or dyspnea and signs of hemodynamic instability © 2015 Wiley Periodicals, Inc.     

Port-a-Cath perforation of the right atrium closed with an amplatzer ASD occluder.

Right atrial perforation can lead to tamponade and death. Closure devices are used for sealing of shunts in the heart. We describe an indwelling catheter that caused perforation of the right atrium and was treated with a percutaneous closure device.     

Retrieval of an embolized amplatzer septal occluder

Percutaneous closure of secundum atrial septal defect (ASD) by various devices has been proven to be an effective and safe treatment modality for patients with congenital heart diseases. However, we have to be aware of the potential early and late complications like device embolization and formulate plan for rescue procedures. We have reported a case of successful closure of a large secundum ASD in a 23‐year‐old woman by a 40 mm Amplatzer septal occluder (ASO), which embolized into the right ventricle 4 hr after the procedure. This had caused palpitation and nonsustained ventricular tachycardia. Patient safety was our most important concern and after discussion with the cardiac surgeons and the patient, we would like to make a percutaneous stepwise attempt for retrieval. We first applied an endocardial biopsy forcep to grap the disk of the ASO to fix and stabilize the dislodged device. This would prevent the device from obstructing the inflow and outflow tract and causing catastrophic consequences. Then, a 15‐mm Amplatz gooseneck snare was used to catch exactly at the connecting hub of the ASO disk, and the whole apparatus could then be cautiously and safely retrieved out from her body without complications. This had saved her from an unplanned emergency open heart operation that carried significant bleeding complication. © 2009 Wiley‐Liss, Inc.     

Amplatzer vascular plug closure of a subclavian arteriovenous fistula associated with implantable cardioverter‐defibrillator implantation

Subclavian arteriovenous fistula (AVF) is a rare complication of implantable cardioverter‐defibrillator (ICD) implantation. This report illustrates the case of a subclavian AVF after ICD implantation in a patient with nonischemic cardiomyopathy and the successful closure of this AVF using an Amplatzer vascular occlusion plug. Given the increasing number of ICD implantations, physicians should be made aware of this uncommon complication. In addition, as more percutaneous endovascular techniques are developed to treat peripheral vascular and structural heart disease, iatrogenic AVFs may occur more frequently. The Amplatzer vascular plug should be considered as a potential treatment strategy for AVFs alongside other endovascular and surgical techniques. © 2011 Wiley‐Liss, Inc.     

Percutaneous catheter closure of atrial septal defect. Short-term and mid-term results

INTRODUCTION: Percutaneous closure of atrial septal defects (ASD) is becoming more frequent. PATIENTS AND METHOD: From October 1997 to October 2002, 209 patients, age 0.4-70 (mean 19.5) years, were catheterized to close an ASD or patent foramen ovale (PFO). Transesophageal echocardiography was performed simultaneously in all patients. Two hundred and six patients had ASD (25 multiple ASDs) and 3 had PFO. Three devices were used, the Amplatzer Atrial Septal Occluder (ASO), CardioSeal (CS), and Starflex (SF). RESULTS: Device implantation was achieved in 181 patients (87%) but had to be abandoned in 28 patients, generally because the ASD was too large. One hundred and seventy-four ASOs were implanted in 172 patients with ASD (2 ASOs were implanted in 2 patients with double ASD) and CS/SF in 9 patients (3 patients with PFO and 6 with ASD). The procedure was effective in 166/172 (96%) ASO implantations and in 8/9 (89%) CS/SF implantations. The procedure was unsuccessful in 7 patients and the device had to be removed (6 ASO and 1 SF). The occlusion rate with ASO was 88% after 24 hours, 91% after 1 month, 95% after 1 year, 97% after 2 years, and 100% after 4 and 5 years. All defects treated with SF/CS were closed successfully after 24 hours. In one case the ASO device was embolized to the aorta. In the first month after ASO implantation, supraventricular tachycardia appeared in 2 patients and transient left ventricular failure in 2 patients. No late complications were observed. CONCLUSION: Percutaneous catheter closure of selected types of ASD using the Amplatzer Atrial Septal Occluder, CardioSeal, or Starflex should be offered to patients as non-surgical alternative. The type of device used depends on the defect size and morphology as well as the surgeon's experience. The presence of multiple defects does not exclude the possibility of a successful percutaneous catheter closure.     

Aortic iatrogenic perforation during transseptal puncture and successful occlusion with Amplatzer ductal occluder in a case of mitral paravalvular leak closure

Complications of transseptal puncture are significant and potentially life threatening. Aortic perforation is one of these complications and it needs to be repaired immediately. We report the case of a 48‐year‐old female with a history of rheumatic mitral valve disease. She underwent three previous mitral valve replacements. Her last echocardiogram reported an anterolateral leak in the mitral prosthesis. Catheterization was performed. During the procedure, when attempting to perform transseptal puncture, catheterization was complicated by a forcefully puncture of the aortic root by the Brockenbrough needle followed by an immediately advancement of an 8‐Fr Mullins sheath. We decided to leave the 8‐Fr sheath in the aortic root recognizing the danger of removing the sheath and finally we advanced a 6/4 mm Amplatzer ductal occluder (ADO I) through the Mullins sheath and under fluoroscopy and TEE guidance we achieved a successful deployment of the device and closure of the perforation. Subsequently, the paravalvular leak was closed with an Amplatzer Vascular Plug (AVP III 10/5 mm). There are only three cases of a similar technique for the same injury in which the authors describe successful closing of aortic perforation with percutaneous closure devices. Our case is the first described during a mitral paravalvular leak closure. It is also the first to describe a different technique of leaving the Mullins sheath in the aortic root and advancing the Amplatzer device through it to achieve successful closure of the aortic perforation. We preferred the percutaneous closure over open‐heart repair. © 2015 Wiley Periodicals, Inc.     

Transcatheter aortic valve‐in‐valve implantation of a corevalve in a degenerated stenotic sapien heart valve prosthesis

Treatment options for re‐stenotic aortic valve prosthesis implanted by transcatheter technique have not been evaluated systematically. We describe the case of a 75‐year‐old dialysis patient who was treated by transcatheter aortic valve implantation 3.5 years ago and now presented with severe stenosis of the percutaneous heart valve. The patient was initially treated with a trans‐apical implantation of an Edwards Sapien 26 mm balloon expandable valve. The patient remained asymptomatic for 3 years when he presented with increasing shortness of breath and significant calcification of the valve prosthesis on transesophageal echocardiography. Valve‐in‐valve percutaneous heart valve implantation using a 26‐mm CoreValve prosthesis was performed under local anesthesia. The prosthesis was implanted without prior valvuloplasty. Pacing with a frequency of 140/min was applied during placement of the valve prosthesis. Positioning was done with great care using only fluoroscopic guidance with the aim to have the ventricular strut end of the CoreValve prosthesis 5 mm higher than the ventricular strut end of the Edwards Sapien prosthesis. After placement of the CoreValve prosthesis within the Edwards Sapien valve additional valvuloplasty with rapid pacing was performed in order to further expand the CoreValve prosthesis. The final result was associated with a remaining mean gradient of 5 mm Hg and no aortic regurgitation. In conclusion, implantation of a CoreValve prosthesis for treatment of a restenotic Edwards Sapien prosthesis is feasible and is associated with a good functional result. © 2012 Wiley Periodicals, Inc.     

Failing left ventricle to ascending aorta conduit—Hybrid implantation of a melody valve and NuMed covered stent

We present the case of a 36‐year‐old woman with increasing shortness of breath, a new 3/4 diastolic murmur, and a complex history of LV outflow tract obstruction. She has undergone multiple surgeries including the replacement of her old LV apex to ascending aorta conduit with a 20‐mm Gore‐Tex tube graft, addition of a 24‐mm homograft sutured between the conduit and the LV apex, and insertion of a 21‐mm Freestyle porcine valve conduit between the Gore‐Tex tube graft and allograft at age 23. The current assessment showed a failing Freestyle conduit prosthesis leading to left heart decompensation. Due to substantial surgical risk, the patient underwent successful implantation of a Melody valve into the Gore‐Tex tube and exclusion of the failing Freestyle bioprosthesis with a NuMed CP stent in a hybrid procedure. The case nicely illustrates the collaborative potential of cardiovascular surgeons and interventional cardiologists in the new arena of a hybrid operating room. Complex hybrid procedures like the current one, especially those including percutaneous placements of valves, offer therapeutic options for patients that are otherwise too high risk for conventional open heart surgery. © 2013 Wiley Periodicals, Inc.     

Interventional occlusion of atrial septum defects larter than 20 mm in diameter

Over the last few years, various devices for the interventional closure of atrial septal defects (ASD) up to a diameter of 20 mm have been developed. We report our clinical experience in closing ASD with a diameter larger than 20 mm diameter with the Amplatzer Septal Occluder (ASO). METHOD: The stretched diameter of the ASD was measured by inflating a sizing balloon within the defect until an indentation in the circumference in the balloon could be observed. An ASO with a stent diameter 2-4 mm larger than the indentation in the circumference of the balloon was chosen and implanted via 9-12 French sheaths. In contrast to the closure of smaller defects, pullback of the device onto the atrial septum was only performed when the connecting stent of the ASO was completely deployed in order to achieve maximal centering characteristics and optimal support of the retention skirt of the left atrial disc on the edges of the defect. Only then was the right atrial disc deployed and actively configured by advancing the sheath and the delivery cable against the atrial septum. Implantation was only attempted if the atrial septal rims (except the anterior rim around the aorta) measured more than 7 mm by echocardiography to avoid injury or disturbance of sensitive intracardiac structures. After placement, the fixation of the device and the mechanical stability was proven by an extensive "Minnesota wiggle". The ASO was released only when TEE showed no or a trivial residual color flow through the connecting stent; otherwise repositioning was performed. RESULTS: Out of 352 patients (P) with successful closure of interatrial defects, 70 P (age: 1.1-77.3 years) had stretched defects larger than 20 mm diameter (median 22 mm diameter (20-36), 25/75% quartiles = 20/26 mm). Mean shunt size was Qp:Qs 2.1:1 (0.7-3.9:1), mean fluoroscopy time 10.9 min (0-63). Complete closure could be achieved in 85.7/93.1/100% after 3 months, 1 and 2 years, respectively. Besides 3 P with persistent atrial fibrillation, only 5 P showed transient atrial tachyarrhythmias, 2 only periprocedural and 3 within the first 3 months after implantation were treated with beta-blocker. In one patient, an acute embolization of the device occurred because a diminished posterior rim was not visualized by a monoplane TEE probe necessitating surgical explantation and defect occlusion. Despite oversizing the device, no "mushrooming" misconfiguration were observed. CONCLUSION: Transcatheter closure of large atrial septal defects with the Amplatzer Septal Occluder is feasible, safe and effective. Risk of complications do not seem to occur more frequently than after closure of smaller defects if one adheres to certain sizing and implantation measures. The incidence of transient atrial tachyarrhythmias seems to be low.     

带膜支架对老年冠状动脉介入治疗术中冠状动脉穿孔患者的疗效

目的评价带膜支架治疗经皮冠状动脉介入治疗（PCI）术中发生冠状动脉穿孔老年患者的疗效。方法从2004年6月至2011年6月,本中心共对8例PCI术中发生冠状动脉穿孔后植入带膜支架的老年患者进行了1年随访,观察其主要心脏不良事件（MACE）发生率。结果8例患者中男4例,女4例,年龄65±76岁,平均（70．4±4．1）岁。植入带膜支架直径平均（3．2±O．3）mm,长度平均（21．0±3．4）mm,所有患者破口均被成功封闭,术中无死亡病例。随访1年,1例急性前壁心肌梗死患者术后19天因肺部感染导致多器官功能衰竭而死亡,其余患者均无心绞痛发作。随访期间死亡率为12．5％（1／8）,MACE发生率为12．5％（1／8）。结论带膜支架治疗老年冠状动脉穿孔能达到较好的近期和远期疗效。     

Multislice Computed Tomographic Findings in Symptomatic Patients After Amplatzer Septal Occluder Device Implantation

Background: Complications of transcatheter closure of atrial septal defects (ASDs) include pericardial effusion, tamponade, and even death. Transthoracic echocardiography in the adult is often limited by poor acoustic windows that lead to incomplete device assessment. Advances in multislice computed tomography (MSCT) provide an alternative modality to assess the anatomy of the Amplatzer Septal Occluder (ASO) device.
Objective: The purpose of this study was to determine the feasibility of MSCT in providing anatomic information in patients with persistent or recurrent symptoms after transcatheter closure of ASDs with ASO devices.
Methods: A retrospective analysis of adult patients who underwent ASO device implantation with subsequent MSCT imaging as a result of symptoms from June 2006 to May 2007 was performed. Data analysis included age, gender, size of ASO device, relationship of the device to surrounding structures, symptoms, and the length of time between device implantation and onset of symptoms.
Results: Eleven patients were identified with a mean age of 41 years. Patients presented with symptoms 1 week to 2.4 years after implantation. ASO size ranged from 8 to 36 mm. MSCT provided detailed information in all 11 cases regarding anatomic location of the device with respect to surrounding structures. Nonobstructive coronary plaque disease was identified in one patient. Two patients had pericardial effusions.
Conclusions: Cardiac symptoms after ASO implant deserve thorough investigation. MSCT is feasible in the assessment of such patients and offers a unique assessment of the device to surrounding anatomic structures and should be considered as a useful adjunct to echocardiography in symptomatic patients.     

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.     

Shunt reduction with a fenestrated Amplatzer device

Background : In specific high‐risk patients with congenital heart disease (CHD), a complete closure of an intracardiac defect/shunt is not possible for a variety of reasons. We report our experiences with an interventional approach for shunt‐reduction using various modifications of a self‐fabricated Amplatzer device in our institution. Methods : Retrospective analysis of patients with CHD having received an interventional partial shunt occlusion since 09/2005. Results : Five patients, mean age 18.6(3.4–66) years, mean weight 36.4(14–102) kg, have been treated. In three patients (3.4, 3.9, 66 years) with an atrial septal defect (ASD) and a restrictive left ventricle (LV) (n = 1) or pulmonary arterial hypertension (PAH) (n = 2), respectively, an Amplatzer Septal Occluder (ASO) with a predilated (n = 2) or a presutured (n = 1) central hole was implanted. After successful immediate volume release in all, the balloon‐dilated holes closed spontaneously during mid‐term follow‐up, pulmonary artery (PA) pressure and LV function remained normal. Two patients (2.7 and 17 years) with a Fontan circulation and severe cyanosis (saturation ≤80%) due to a large fenestration and elevated PA pressures received a partial occlusion of their shunt by implanting a centrally stented ASO or Amplatzer Vascular plug. After a follow‐up of 31 and 39 months both stents remained patent under oral anticoagulation, oxygen saturation remained >85% with PA pressures unchanged, and both patients were in good clinical conditions. Conclusions : In patients with an ASD and significant PAH and/or restrictive LV physiology as well as in Fontan patients with a large surgically created fenestration but failing Fontan circulation, a partial closure with a self‐fenestrated Amplatzer device can be a feasible and successful therapeutic option. Balloon‐dilated fenestrations in the Amplatzer device tend to close spontaneously during follow‐up. Nonresorbable sutures or stenting can ensure patency of the created holes. © 2010 Wiley‐Liss, Inc.     

Home-made fenestrated amplatzer occluder for atrial septal defect and pulmonary arterial hypertension

We report the management of a patient with secundum atrial septal defect (ASD) and severe pulmonary hypertension. A 65-year-old male with recently diagnosed atrial septal defect was referred to our centre for decompensated right heart failure with rest and exercise induced dispnea and severe pulmonary hypertension. Right heart catheterization confirmed a mean pulmonary pressure of about 55 mmHg and a Qp/Qs of 2.7. An occlusion test with a compliant large balloon demonstrated partial fall of pulmonary arterial pressure. The implantation of a home-made fenestrated Amplatzer ASD Occluder (ASO) was planned in order to decrease left-to-right shunt and promote further decrease of pulmonary arterial pressure in the long-term. Thus, by means of mechanical intracardiac echocardiography study with a 9F 9 MHz UltraIce catheter (Boston Scientific Corp.), we selected a 34 mm ASO for implantation. Four millimeter fenestration was made inflating a 4 mm non-compliant coronary balloon throughout the waist of the ASO, which was successfully implanted under intracardiac echocardiography. After six months, a decrease of pulmonary arterial pressure to 24 mmHg and full compensated right heart failure was observed on transthoracic echocardiography and clinical examination. This case suggests that transcatheter closure with home-made fenestrated ASD in elderly patients with severe pulmonary hypertension is feasible.     

Safety and Efficacy of the Amplatzer Septal Occluder: A Systematic Review and Meta-Analysis

ObjectivesTo assess the safety and efficacy of the Amplatzer Septal Occluder in the closure of secundum type atrial septal defects.BackgroundThe Amplatzer Septal Occluder (ASO; Abbott, St. Paul, MN) is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). Previous small cohort trials have shown a favorable safety and technical efficacy profile.MethodsWe conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. The primary endpoint was the technical success rate of implantations. Secondary outcomes included proportions of arrhythmias and embolism specific-adverse events.ResultsWe included a total of 12 studies with 2972 patients. The ratio of device implantation was 2:1 by sex [female: male]. Pooled technical success rate of implantation was 98% (95% CI: 0.968–0.990, P < 0.01). The cumulative adverse event rate was 5.1% (95% CI: 0.035–0.068, P < 0.01), which included arrhythmia and embolism specific adverse event rates of 1.8% (95% CI: 0.007–0.032, P < 0.01) and 0.7% (95% CI: 0.002–0.013, P < 0.01), respectively. Sensitivity analysis did not significantly affect pooled outcomes for success rate and adverse events; both forest plot and Begg's and Egger's regression tests supported symmetricity.ConclusionA high likelihood of technical success can be expected when implanting the ASO in secundum type ASDs. Adverse event rates are expected for one in twenty patients, and thus, our results support the safe use of ASO in secundum type ASDs closure.Condensed abstractThe AMPLATZER Septal Occluder is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. We included a total of 12 studies with 2972 patients. Pooled technical success rate of implantation was 98% (P < 0.01). The cumulative adverse event rate was 5.1% (P < 0.01), 1.8% (P < 0.01) rate of arrhythmias, and 0.7% (P < 0.01) rate of embolisms. A high likelihood of technical success can be expected with a low rate of adverse events.     

Primary endoscopic approximation suture under cap-assisted endoscopy of an ERCP-induced duodenal perforation

Duodenal perforation during endoscopic retrograde cholangiopancreatography(ERCP) is a rare complication,but it has a relatively high mortality risk.Early diagnosis and prompt management are key factors for the successful treatment of ERCP-related perforation.The management of perforation can initially be conservative in cases resulting from sphincterotomy or guide wire trauma.However,the current standard treatment for duodenal free wall perforation is surgical repair.Recently,several case reports of endosco...     

A comparative study of Cardi‐O‐Fix septal occluder versus Amplatzer septal occluder in percutaneous closure of secundum atrial septal defects

Aim: We sought to investigate the safety and efficacy of Cardio‐O‐Fix septal occluder (CSO) in percutaneous closure of atrial septal defects (ASD) as compared to the Amplatzer septal occluder (ASO). Methods: A consecutive of 351 patients received transcatheter ASD closure with CSO or ASO from July 2004 to October 2010 were studied. The ASDs were divided into simple‐ (isolated defects <26 mm) or complex‐types (isolated defect ≥26 mm, double or multifenestrated defects). The procedures were guided by fluoroscopy and transthoracic or transesophageal echocardiography. Clinical and echocardiographic follow‐ups were arranged before discharge, at 1 month and then every 6‐month after implantation. Results: During the study period, 185 (125 males, aged 18.5 ± 15.6 years) and 166 (103 males, aged 21.0 ± 15.7 years) patients attempted CSO and ASO implants, respectively. The CSO group had similar ASD and device sizes, prevalence of complex lesions (17 vs. 16%, P = 0.796), procedural times and success rates (97% vs. 96%, P = 0.635) as compared to the ASO group. Acute residual shunts were less prevalent in CSO than ASO group and most shunts closed spontaneously at 6‐month follow‐ups. The average equipment cost per patient was lower in CSO group (US$ 4,100 vs. US$ 5,900, P < 0.001). The prevalence of device embolization and atrial arrhythmia (all <2%) were similar in both patient groups. Conclusion: Transcatheter ASD occlusion with CSO is safe and effective and it appeared to be an attractive alternative to ASO in closing simple‐type ASD because of its relatively low cost. © 2013 Wiley Periodicals, Inc.     

Long-term outcome of transcatheter secundum-type atrial septal defect closure using Amplatzer septal occluders

OBJECTIVES: The aim of this study was to assess long-term results of percutaneous closure of secundum-type atrial septal defect (ASD II) using Amplatzer septal occluders (ASO). BACKGROUND: Only immediate-, short-, and intermediate-term results of ASO implantation are known so far. METHODS: Between September 1995 and January 2000, 151 patients underwent a successful percutaneous closure of ASD II in our institution. All were included in the present study and were followed up until September 2004. RESULTS: This group of patients was followed up from 56 to 108 months (median 78 months). The mean stretched defect diameter was 15.9 +/- 4.8 mm. There were no deaths or significant complications during the study. At three years of follow-up, all defects were completely closed and remained closed thereafter. CONCLUSIONS: Since the first human implantations in September 1995, the Amplatzer septal occluder proved as a safe and effective device for percutaneous closure of ASD II.     

Use of Amplatzer septal occluder in a case of residual atrial septal defect causing bidirectional shunting after percutaneous Inoue mitral balloon valvuloplasty

We describe a 70-year-old woman who underwent successful percutaneous Inoue antegrade-technique mitral valvuloplasty. Three months later, the patient developed right-sided heart failure. Color Doppler echocardiography and cardiac catheterization demonstrated an atrial septal defect with bidirectional shunting and no restenosis of the mitral valve (iatrogenic Lutembacher's syndrome). Percutaneous treatment was successfully accomplished using a 13 mm Amplatzer Septal Occluder (AGA Medical Corporation, Golden Valley, Minnesota). The causes of right-to-left shunting and the effects of body position on gas exchange in such patients are also discussed.