AMPLATZER Septal Occluder Failure Resulting in Paradoxical Cerebral Embolism

Patent foramen ovale and atrial septal defect are risk factors for paradoxical embolism and subsequent cerebral ischemic events. The transseptal passage of emboli from the right to the left cardiac chambers appears to play an important role. The therapeutic options are medical therapy (anti-aggregation or anticoagulation), surgical closure, or transcatheter closure. Transcatheter closure of atrial septal defects affords the advantage of closing an atrial defect without the associated morbidity of open-heart surgery and the bleeding sequelae of oral anticoagulation. After closure, however, the presence of a residual shunt is independently associated with an increased risk of recurrent ischemic events. Newer devices, such as the AMPLATZER Septal Occluder, have decreased the risk of residual shunting and thromboembolic events. In addition, they have a very low risk of device dislodgement, migration, and embolization.We describe the case of a 60-year-old woman with Ebstein anomaly and recurrent ischemic strokes who presented with acute ischemic infarcts and paradoxical embolism 3 years after undergoing transcatheter closure of an atrial septal defect. A right-to-left shunt through a displaced AMPLATZER Septal Occluder was detected. Pulmonary hypertension and resultant right ventricular failure and right atrial dilation could have contributed to the persistent shunting and paradoxical embolism.To our knowledge, the delayed dysfunction of an AMPLATZER Septal Occluder has not been reported. In addition to describing the patient''s case, we review the relevant medical literature.Key words: Ebstein anomaly/pathology, echocardiography, embolism, paradoxical/complications/epidemiology/etiology/physiopathology, foramen ovale, patent/therapy, heart septal defects, atrial/therapy, ischemic attack, transient/etiology/prevention & control, risk factors, septal occluder device, stroke/etiology/prevention & control, thrombosis/etiologyA right-to-left intracardiac shunt due to patent foramen ovale (PFO) or atrial septal defect (ASD) increases the risk of cerebrovascular events (stroke, transient ischemic attack [TIA], or peripheral emboli) due to paradoxical embolism. The transseptal passage of emboli from the right to the left cardiac chambers due to transient increases in right-side pressures (from the Valsalva maneuver or coughing) or persistent elevation (as in pulmonary hypertension or Eisenmenger syndrome) appears to play an important role. The therapeutic options are medical therapy (anti-aggregation or anticoagulation), which yields an annual recurrence rate of 3% to 4% for stroke or TIA; surgical closure; or percutaneous transcatheter closure. Whereas long-term medical therapy increases the risk of bleeding sequelae, percutaneous closure of ASDs has been equally efficacious and offers the advantage of closing a defect without the associated morbidity of open-heart surgery or the bleeding sequelae of oral anticoagulation. Several single-center, nonrandomized studies have shown the safety of transcatheter PFO closure and its protective effects against recurrent neurologic events.^1–4 The totality of evidence suggests that device closure is a safe and effective alternative to surgical closure for preventing recurrent episodes of paradoxical embolism.^5,6 Along with fewer complications, percutaneous treatment offers other advantages over open surgery, such as shorter hospital stays, earlier return to normal activities, and better cosmesis.⁷ Although rare, device displacement leading to failure and cardiac erosion is a known and severe sequela of device closure.Ebstein anomaly is a congenital cardiac malformation characterized by apical displacement of the septal and posterior tricuspid valve leaflets, leading to various degrees of hypertrophy and thinning of the atrialized portion of the right ventricle. An associated atrial septal communication, whether an ASD or a PFO, can enable right-to-left shunting with right atrial pressure elevation, particularly upon exertion (when cardiac output is increased and the right ventricle is required to accept more volume).⁸ We report the case of a woman with Ebstein anomaly in whom device displacement occurred, and we review other cases of device-related sequelae.     

Comparative effectiveness of devices for transcatheter closure of atrial septal defects: Systematic review and network meta-analysis

Atrial septal defect is a common congenital heart disease, producing a left-to-right shunt in the atrial septum; the current preferred treatment is transcatheter device closure. The aim is to conduct a systematic review to synthesize information on the comparative effectiveness and safety of atrial septal defect closure devices. The methods used: a comprehensive search of Ovid MEDLINE®, Embase, and Cochrane Central databases was conducted. Studies comparing procedural and follow-up outcomes of atrial septal defect devices were included. Network meta-analyses were conducted to generate direct and indirect evidence for comparative effectiveness and safety outcomes between devices. The results are as follows: Twelve studies met our inclusion criteria and were compared in network meta-analyses. The meta-analyses evaluated contemporary devices: the AMPLATZER Septal Occluder; the GORE CARDIOFORM Septal Occluder; the Figulla Flexible II Occluder; the CeraFlex Septal Occluder; and the HELEX Septal Occluder. These studies represented 3998 patients. The primary safety and efficacy outcomes were device embolization and follow-up residual shunt, respectively. Secondary clinical outcomes included procedural success and major and minor complications. No differences were found between devices in terms of device embolization and secondary clinical outcomes. Follow-up residual shunt was higher with the HELEX Septal Occluder compared with the AMPLATZER Septal Occluder (odds ratio 2.92, 95% confidence interval 1.12–7.61). To conclude: although most outcomes were similar between devices, evidence was largely based on observational low-quality studies. There were inconsistencies in outcome reporting and definitions; this merits future studies, with head-to-head device comparisons and standardization of outcomes.     

Intraoperative Device Closure of Atrial Septal Defects with Minimal Transthoracic Invasion: A Single-Center Experience

Atrial septal defect is one of the most common congenital heart defects. Open-heart repair via midline sternotomy or right thoracotomy and cardiopulmonary bypass has been considered the standard treatment for the closure of atrial septal defects, but transcatheter closure with the Amplatzer septal occluder has recently become a viable option. We have adopted a 3rd alternative: intraoperative device closure with minimal transthoracic invasion.From May 2007 through June 2011, 250 patients with secundum atrial septal defect underwent cardiac surgery at our institution. Open-heart repair with cardiopulmonary bypass was performed in 72 patients, and intraoperative device closure was performed in 178 patients. This minimally invasive approach, which required a full evaluation of the atrial septal defect by transthoracic echocardiography, was performed by deploying the device through the delivery sheath to occlude the atrial septal defect. The approach was successful in 175 of the 178 patients. The size of the implanted occluder ranged from 12 to 46 mm in diameter. Minor complications included transient arrhythmias (n=7) and pleural effusion (n=25). After complete release, the intraoperative occluder device dislodged in the right atrium in 3 patients, who then underwent immediate surgical repair with cardiopulmonary bypass. All discharged patients were monitored for 2.3 years to 5 years.As monotherapy, intraoperative device closure of atrial septal defect with minimal transthoracic invasion is a safe and feasible technique. It is particularly beneficial for elderly patients or patients with pulmonary hypertension and is associated with better cosmetic results and less trauma than is surgical closure.Key words: Heart defects, congenital; heart septal defects, atrial/therapy; prosthesis implantation; retrospective studies; septal occluder device; surgery, minimally invasive; treatment outcome; ultrasonography, interventionalAtrial septal defect (ASD), one of the most common congenital cardiac defects, accounts for approximately 6% to 10% of all congenital heart disease.¹ Most pediatric patients with ASD are asymptomatic and could await elective surgical or catheter-based closure until reaching school age. Open-heart repair via a midline sternotomy or right thoracotomy and with the aid of cardiopulmonary bypass (CPB) has been considered the standard treatment for closure of ASDs. In recent years, transcatheter closure with the AMPLATZER septal occluder (St. Jude Medical, Inc.; St. Paul, Minn) has become another standard treatment for most ostium secundum ASDs.² Although the safety and feasibility of both methods have been demonstrated, the use of CPB is still necessary in association with surgical secundum ASD closure, and the midline incisions cause physical and psychological trauma. Catheter-based closure requires “selective and suitable” patients, and the exposure to radiation is contraindicated for small children.^3–5 Our approach is to use an intraoperative device and minimally invasive surgery for ASD closure, which improves the cosmetic results compared with open-heart surgery. The aim of the present retrospective study was to evaluate the safety and feasibility of intraoperative device closure of secundum ASDs via minimal transthoracic invasion.     

Experience using the new GORE® septal occluder at the margins

Complex atrial anatomy continues to challenge transcatheter device closure of septal defects. Devices and technology continue to evolve. We report three cases from our institution where the new Gore^® Septal Occluder was utilized for the closure of a lateral tunnel fenestration, a moderate‐sized secundum atrial septal defect and a long tunnel patent foramen ovale. Each case highlights the successful use of this new generation device in challenging circumstances. © 2013 Wiley Periodicals, Inc.     

Retrograde Percutaneous Closure of a Ventricular Septal Defect after Myectomy for Hypertrophic Obstructive Cardiomyopathy

In patients with hypertrophic obstructive cardiomyopathy, hemodynamically significant ventricular septal defect after septal myectomy is a rare sequela that warrants closure. Percutaneous closure provides a safer alternative to repeated sternotomy, which is associated with significant morbidity and mortality rates. We report a possibly unique case of successful retrograde percutaneous closure, with an AMPLATZER Muscular VSD Occluder, of an iatrogenic ventricular septal defect consequent to surgical therapy for hypertrophic obstructive cardiomyopathy.Key words: Cardiac catheterization/methods, cardiomyopathy, hypertrophic/therapy, heart septal defects, ventricular/therapy, iatrogenic disease, myectomy, postoperative complications, prosthesis implantation/methods, septal occluder device, ventricular septal defectPatients with hypertrophic obstructive cardiomyopathy (HOCM) are candidates for surgical myectomy or ethanol ablation if, despite medical therapy, they remain symptomatic with New York Heart Association functional class III disease and severe left ventricular outflow tract (LVOT) gradients.¹ A rare sequela of myectomy via the Morrow procedure is iatrogenic ventricular septal defect (VSD). Although surgical closure remains the mainstay of treatment for most VSDs, treatment of clinically significant postoperative residual VSDs remains a challenge. Percutaneous closure provides a safer alternative to reoperation.^2,3 We report a possibly unique case of successful retrograde percutaneous closure of an iatrogenic VSD, consequent to surgical therapy for HOCM, by means of an AMPLATZER® Muscular VSD Occluder (St. Jude Medical, Inc.; St. Paul, Minn).     

Transcatheter closure of secundum atrial septal defects with the new self-centering Amplatzer Septal Occluder.

AIMS: The study was set up to find out whether a new self-centering prosthesis for transcatheter closure of secundum atrial septal defects could overcome the disadvantages of previously described devices. METHODS AND RESULTS: Fifty-two consecutive patients with a significant atrial septal defect were considered for transcatheter closure with the Amplatzer Septal Occluder. The device, made of a Nitinol and polyester fabric mesh, provides a different approach to defect occlusion by stenting the atrial septal defect up to a stretched diameter of 26 mm. Three infants whose large defects were demonstrated on a transthoracic echocardiogram were excluded from transcatheter treatment. On transoesophageal echocardiography, 49 defects ranged from 6-26 mm, in one adult the defect measured 28 mm and this patient was excluded from attempted transcatheter closure. At cardiac catheterization in five further patients, devices were not implanted, in two because the stretched diameter exceeded 26 mm and in three the device was withdrawn because it was unstable or compromised the mitral valve. Thus, device closure was performed in 43 patients. At follow-up after 3 months the complete closure rate was 97%. CONCLUSION: The self-centering Amplatzer Septal Occluder is very efficient and user-friendly and offers interventional closure in 83% of an unselected group of patients presented with an atrial septal defect.     

Transcatheter Retrieval and Repositioning of Embolized Stent from the Right Ventricle in an Infant

Intracardiac stent embolization is a challenging complication in a small infant. A Palmaz stent was placed across the atrial septum in a 3-month-old boy to relieve symptoms of right-side heart failure. On routine chest radiography one week later, the stent was found to have embolized into the right ventricle. The stent was retrieved and repositioned by means of transcatheter technique, without subsequent complications. We found this method to be a viable alternative to surgery in a high-risk infant. To our knowledge, this is the first report of the successful transcatheter retrieval and repositioning of an expandable intravascular stent from an intraventricular position in an infant.Key words: Angioplasty, balloon/adverse effects; aortic diseases/complications; device removal; foreign-body migration/radiography; heart catheterization; heart defects, congenital/therapy; infant; stents; surgical procedures, minimally invasive/methods; vascular surgical procedures/methodsStent placement is widely used to relieve hemodynamically significant stenosis in children and adults.¹ Several transcatheter techniques have been described for atrial septal stent implantation in patients with complex congenital heart disease.^2,3 Stent embolization is one of the challenging complications. A few case reports have documented the successful transcatheter retrieval of embolized stents from the pulmonary arteries (PAs) of adults,^4–7 and one stent was similarly retrieved from the right ventricle (RV) of a 9-year-old girl.⁸ We describe the retrieval and repositioning of an embolized stent from the RV of an infant.     

A novel double snare technique to retrieve embolized septal and left atrial appendage occluders

Background

Device embolization is the most frequent procedural complication during transcatheter closure of congenital cardiac defects. Retrieval of an embolized device may often be complicated by failure to introduce the right atrial (RA) disk hub into the sheath or difficulty in securely grasping the hub pin of RA disk. We aimed to evaluate the efficiency and success rate of device retrieval using a novel double snare technique.

Methods

We reviewed retrieval procedures of embolized atrial septal defect (ASD) or left atrial appendage (LAA) occluder using double snare technique reported from five tertiary referral centers in Korea, Japan, and Uzbekistan. A total of 16 retrieval procedures in 15 patients were reported, including 14 patients who were planned for ASD device closure while 1 patient was planned for LA appendage occlusion.

Results

Retrieved devices included 15 ASD occluders from six different manufacturers and one Amplantzer cardiac plug. Success rate of retrieval procedure was 100% using the double snare technique. There were no complications related to device retrieval. Most (15/16, 93.8%) of these devices could be retrieved through their original delivery sheaths. In six patients for whom retrieval was unsuccessful with conventional single snare technique and switched to double snare technique, the retrieval time was shortened significantly (P = 0.004*) by using the double snare technique.

Conclusions

The double snare technique enables effective retrieval of various embolized devices. It abolishes the need of changing the sheath to a larger one in most patients.

     

Surgical Removal of an Atrial Septal Occluder Device Embolized to the Main Pulmonary Artery

Percutaneous closure of atrial septal defects in adults has emerged as an alternative to surgery. We report a sequela of such closure in a 16-year-old boy: embolization of the atrial septal defect occluder into the main pulmonary artery when the patient experienced an episode of intense coughing immediately after device deployment. We removed the device surgically and closed the atrial septal defect in a standard manner, with an autologous pericardial patch.Key words: Adolescent, device removal, foreign-body migration, heart septal defects, atrial/therapy, male, prosthesis implantation/adverse effects, pulmonary artery/surgery, septal occluder device/adverse effectsPercutaneous occlusion of atrial septal defect (ASD) in adults has emerged as an alternative to surgery.¹ Percutaneous closure is associated with less surgical morbidity, avoidance of a scar, and shorter hospital stay.¹ However, its increased use has brought recognition of several fairly frequent sequelae. One sequela associated with the procedure is embolization of the device into the pulmonary artery (PA).² We describe the case of a teenager in whom this occurred.     

Analysis of atrial and ventricular performance by tissue Doppler imaging in patients with atrial septal defects before and after surgical and catheter closure

OBJECTIVE: To compare the effects of surgical and device closure of atrial septal defects on atrial and ventricular performance assessed by the novel tissue Doppler derived strain rate. BACKGROUND: Despite the increasing number of transcatheter closures, there is no information comparing the effect of the transcatheter closure technique on atrial performance with that of conventional surgery. Tissue Doppler derived strain rate can effectively quantify local myocardial function independent of the overall heart motion. DESIGN AND PATIENTS: Twenty-four patients [aged 21.5 (6-70) years] with isolated atrial septal defect of the secondum type before and 1 week after surgical (n = 12) or Amplatzer Septal Occluder closure (n = 12) and 30 healthy controls [aged 26.0 (2-58) years] were studied. Atrial and ventricular strain rate curves were assessed in the middle of their corresponding lateral walls in an apical four-chamber view. The systolic, early diastolic, and late diastolic strain rates peaks were measured. RESULTS: Compared to preclosure condition, the right atrial late diastolic (P < 0.01), right ventricular systolic (P < 0.01), right ventricular early diastolic (P < 0.01), and left atrial late diastolic peak (P < 0.01) strain rates were reduced after surgery but not after Amplatzer Septal Occluder closure. The LV parameters did not significantly differ before and after atrial septal defect closure by either technique. CONCLUSIONS: In contrast to surgery, transcatheter closure of atrial septal defect preserves atrial and right ventricular function. Tissue Doppler derived strain rate can be applied to provide quantitative analysis of regional atrial and ventricular performance.     

Severe Spinal Cord Ischemic Injury Secondary to Device Embolization after Transcatheter Closure of a Patent Arterial Duct

Percutaneous closure of patent arterial ducts with the Amplatzer Ductal Occluder has become an effective and widely accepted alternative to surgical management. Although rarely, the occluder can be dislodged after an initially successful deployment, and with catastrophic consequences. We describe such a case in a 12-month-old girl who underwent transcatheter closure of a patent arterial duct. After device deployment, the occluder embolized in the patient''s descending thoracic aorta, and severe spinal cord ischemic injury resulted. To our knowledge, ours is the first report of this complication after the deployment of an Amplatzer Ductal Occluder. We discuss pathophysiologic mechanisms that could expose patients to the risk of device dislodgment, and we review the relevant medical literature.Key words: Aorta, thoracic/surgery; device removal/methods; ductus arteriosus, patent/therapy; embolization, therapeutic/instrumentation; foreign-body migration/surgery; spinal cord injuries/etiology/ prevention & controlTranscatheter device closure of patent arterial ducts has become a well-established alternative to surgical management: the procedure is associated with a high success rate and an excellent long-term outcome.¹ Rarely, severe complications can occur, such as device embolization, hemolysis, device-related infective endocarditis, iatrogenic aortic coarctation, and left pulmonary artery stenosis.^1,2 We present the case of an infant in whom an Amplatzer® Ductal Occluder (ADO) (St. Jude Medical, Inc.; St. Paul, Minn) was used to close a patent arterial duct. The device embolized into the patient''s descending thoracic aorta, causing ischemic injury to the spinal cord. We discuss possible reasons and review the relevant medical literature.     

Percutaneous catheter closure of secundum atrial septal defects: a review.

Attempts at catheter closure of atrial septal defects began over 3 decades ago. Several devices have been designed attempting to achieve this objective safely and effectively. These devices have been (or are being) subjected to extensive clinical trials. This review outlines the background and current status of these devices. It addresses the design, delivery method, results and complications. In addition to historical background, the devices discussed here include (in alphabetical order) the Amplatzer Septal Occluder, the Atrial Septal Defect Occlusion System, the Buttoned Device, the Guardian Angel (Angel Wings), the Helex Septal Occluder, the StarFlex (Cardioseal, Clamshell), and transcatheter patch closure of atrial septal defects. These devices have come a long way to avoid potential complications and a number of them show very promising results. Issues to consider when choosing the device/atrial septal defect compatibility are also discussed. It is hoped that a number of these devices will be available in the near future to allow the physician and patient to choose the most appropriate method or device.     

Transcatheter closure of atrial septal defects under echocardiographic guidance without X-ray: initial experiences.

BACKGROUND: Transcatheter closure of atrial septal defects is performed under fluoroscopy, but echocardiography has gained an important role in the procedure. With the new Amplatzer Septal Occluder a device has become available which is easy to implant with minimal fluoroscopy time. We developed an interventional procedure with this device under transesophageal echocardiography alone without fluoroscopy. METHODS AND RESULTS: Four patients (3 to 16 years of age, bodyweight 14 to 60 kg) with atrial septal defects centrally located in the oval fossa were elected for transcatheter closure. After sedation with midazolam and propofol a diagnostic and interventional catheterization was performed in all cases without fluoroscopy. Oxymetric shunt was Qp: Qs = 1.7 (1.5 to 2.1). Under transesophageal echocardiography, the defects were sized over the wire with a balloon catheter. Mean balloon stretched diameter was 10 mm (7 to 14 mm). Under transesophageal echocardiography an Amplatzer Septal Occluder was placed into the defect. In two patients this was achieved with a 5 MHz monoplane pediatric transducer, in two patients a 10mm 5 MHz multiplane probe was used. Complete closure was achieved in all patients and no complications were encountered. CONCLUSION: We conclude that in selected cases with an atrial septal defect located in the oval fossa and clear-cut echocardiographic findings, an Amplatzer Septal Occluder can be safely deployed under echocardiographic guidance alone.     

Embolization of Patent Foramen Ovale Closure Devices: Incidence,Role of Imaging in Identification,Potential Causes,and Management

Transcatheter patent foramen ovale (PFO) closure is an alternative to antiplatelet or anticoagulative therapy in patients with cryptogenic stroke, and it is associated with a small incidence of periprocedural sequelae. Because embolization of PFO closure devices is a very rare procedural complication, data on its frequency, causes, and management are sparse. We sought to review the medical literature and the cases of PFO closure-device embolization at our institution with the aim of identifying likely problems and reporting potential solutions. Out of 310 adult patients who underwent transcatheter PFO closure from June 2002 through April 2011, there were 2 cases (0.6%) of PFO closure-device embolization. In both patients, hypermobile septum primum and thick septum secundum were present. In one patient, failure to use a sizing balloon might have resulted in an underestimation of the PFO''s size. In both patients, device embolization was identified in a timely fashion, the embolized device was safely retrieved, and the PFO was percutaneously closed with success.The incidence of PFO closure-device embolization is very low. The cases described here underscore the importance of imaging in the identification of morphologic predispositions to closure-device malpositioning, in the recognition of impending embolization, and in the timely management of embolization.Key words: Contrast media/diagnostic use, device removal/methods, echocardiography, transesophageal, fluoroscopy, foramen ovale, patent/radiography/therapy/ultrasonography, foreign body migration, ischemic attack, transient/prevention & control, prosthesis implantation/adverse effects, septal occluder device/adverse effects, stroke/prevention & controlSeveral studies^1–3 have shown the feasibility of transcatheter patent foramen ovale (PFO) closure as an adjunct or alternative to antiplatelet or anticoagulative therapy in patients with cryptogenic stroke. Procedural sequelae are rare. In a meta-analysis of 10 studies consisting of more than 1,350 patients with transcatheter PFO closure,⁴ major sequelae (death, tamponade, hemorrhage requiring blood transfusion, fatal pulmonary embolism, and need for surgical intervention) occurred in 1.5% of patients, and minor sequelae (device embolization with percutaneous retrieval, arrhythmias, device fracture, asymptomatic device thrombosis, symptomatic air embolism, and groin sequelae) occurred in 7.9% of patients. Data exist on the predisposing factors for embolization of atrial-septal-defect closure devices (inadequate rim and undersized device)^5–8; but PFO closure-device embolization is such a rare complication that data on its frequency, causes, and management are sparse.^1,9,10 We sought to review the literature on PFO closure-device embolization and to describe such cases at our institution with the aim of identifying likely problems and reporting potential solutions. Open in a separate window     

Transcatheter closure of secundum atrial septal defect in a patient with dextrocardia using the Amplatzer septal occluder

Transcatheter closure of secundum atrial septal defects (ASD) in patients with levocardia is performed routinely using various investigational devices. A 6-yr-old child with dextrocardia, situs inversus, and secundum ASD measuring 13 mm by TEE underwent successful transcatheter closure using a 15 mm Amplatzer Septal Occluder with complete closure of the defect. Cathet. Cardiovasc. Diagn. 43:291–294, 1998. © 1998 Wiley-Liss, Inc.     

Transcatheter closure of muscular ventricular septal defect using the Amplatzer devices

TECHNIQUE: From November 1997 to June 2002, percutaneous transcatheter closure of muscular ventricular septal defects was attempted in seven patients. Four patients had single and three had multiple defects. Surgical closure was performed in two patients in an attempt to close a perimembranous defect, leaving behind a large apical muscular defect, which was successfully closed using a device in one patient, whilst the second patient succumbed to septicemia/endocarditis 3 weeks after failure of device implantation. One patient had previous pulmonary artery banding and in another intraoperative placement of two Clamshell devices followed by additional transcatheter closure using Gianturco coils in two different sessions was performed. RESULTS: Transcatheter closure of ventricular septal defect was successful in six patients. Three patients underwent closure of their ventricular septal defects using the Amplatzer Septal Occluder and in the remaining three patients. Amplatzer Muscular Ventricular Septal Defect Occluder was used. The median age was 15 months (range 14 months to 10 years) and the median weight was 7.8 kg (range 7-16 kg). The devices were deployed antegradely in all patients. Immediate complete closure was obtained in three patients while two patients had small and one had a large residual following the procedure. The later was due to another multiple muscular septal defect. Transient heart block occurred in one patient during the procedure and another patient developed heart block on day 3 post-procedure. The latter required temporary pacemaker. During the follow up, one patient who had residual multiple muscular defects underwent a successful redo transcatheter closure using two Amplatzer Muscular Ventricular Septal Occluder devices. CONCLUSIONS: We conclude that transcatheter closure of muscular ventricular septal defect using Amplatzer devices is feasible and effective.     

Cobrahead Deformity in the Right Atrial Disc of a New-Generation Occlutech Figulla Flex II Atrial Septal Defect Occluder Device

Cobrahead deformity is a known (but uncommon) phenomenon associated with the left atrial disc of the Amplatzer or Occlutech Figulla septal occluder device during percutaneous transcatheter atrial septal defect closure. It has also been postulated that the right atrial disc of the Amplatzer septal occluder device might upon occasion exhibit the cobrahead malformation. To date, only one case report concerning the cobrahead deformity in the right atrial disc of an Amplatzer septal occluder has been published, if we discount a report published as a letter to the manufacturer.Here we present the first report (known to us) of a cobrahead deformity in the right atrial disc of an Occlutech Figulla Flex II atrial septal defect occluder device during transcatheter closure of a complex atrial septal defect.     

Echocardiographic considerations during deployment of the Helex Septal Occluder for closure of atrial septal defects

The Helex Septal Occluder is a new device used to close atrial septal defects via interventional catheterization. In order to study the role of echocardiography during its use, and to describe the morphologic variants of defects suitable for closure with this occluder, we evaluated all patients undergoing intended closure of an atrial septal defect with the Helex occluder. A combination of transthoracic, transesophageal, three-dimensional, and intracardiac echocardiography were used before, during, and after the procedure to characterize anatomy, assess candidacy for closure, guide the device during its deployment, and evaluate results. Among the 60 candidates included in the study, 11 were excluded because of transesophageal echocardiographic and/or catheterization data obtained in the laboratory. Attempts at closure were successful in 46 patients, and unsuccessful in 3. We successfully treated four types of defects. These were defects positioned centrally within the oval fossa with appreciable rims along the entire circumference of the defect, defects with deficient or absent segments of the rim, defects with aneurysm of the primary atrial septum, and defects with multiple fenestrations. Follow-up transthoracic echocardiograms taken at a median of 7 months demonstrated no residual defects in 21, trivial residual defects in 17, and small residual defects in 8 patients. In 20 patients, three-dimensional reconstructions were used to characterize the morphology of the defect and the position of the device. Because transesophageal echocardiography was often limited by acoustic interference from the device, intracardiac echocardiography was utilized in 3 cases to overcome this limitation.     

Transcatheter closure of a large residual shunt after deployment of the Das-Angel Wings device using the Amplatzer septal occluder.

A 35-year-old female patient with a large residual shunt following transcatheter closure of a large secundum atrial septal defect using the Das-Angel Wings device underwent successful complete closure of the residual shunt using a 15-mm Amplatzer Septal Occluder. Transesophageal (two- and three-dimensional) echocardiography was of great help during the closure procedure. Cathet. Cardiovasc. Intervent. 48:184-187, 1999.     

The Design and Deployment of the HELEX Septal Occluder

The GORE HELEX Septal Occluder? (W.L. Gore and Associates, Flagstaff, Ariz, USA) is the latest device to pursue U.S. Food and Drug Administration (FDA) approval for the closure of secundum atrial septal defects. The device is soft and compliant with comparatively little metal framework. It can be deployed and retrieved without damaging the device, and has a safety cord attached that allows retrieval even after it has been disconnected from the delivery mandrel. With FDA approval, operators will now have a choice of devices for the closure of atrial septal defects. Significant differences exist between the HELEX device and existing atrial septal occluders. This article explains the HELEX device design, provides recommendations for preprocedural screening and preparation, and discusses the deployment technique in detail. The device may be particularly advantageous for patients with small‐ to moderate‐sized atrial septal defects.