Article

Interventional closure of atrial septal defects with the Solysafe Septal Occluder - Preliminary results in children

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Abstract

To report usability, safety, and efficacy of the self-centering Solysafe Septal Occluder for transcatheter closure of secundum type atrial septal defect (ASD) in paediatric patients. Retrospective observational clinical study in two tertiary care centers for congenital heart diseases. Patients: First 37 (median age 8.7 years, 68% female) consecutive patients with an ASD stretched diameter up to 22 mm in whom a Solysafe Septal Occluder was used to close a haemodynamically significant ASD. Interventions: Transcatheter closure of ASD was performed under general anaesthesia with trans-esophageal echo guidance. Stretched diameter of the ASD was assessed by balloon sizing. Main outcome measures: Rate of success, complete closure rate, and complications (defined as vascular complications, device-related complications such as embolism, thrombus formation, device erosions, infections, and arrhythmia) during follow up. 37 procedures were performed, success rate was 87% (32 of 37 pts.). A missing retroaortic rim was the main reason for device failure. Complete ASD closure rate was 78% immediately in cath lab (25 of 32 pts.), 90% after four weeks (28 of 31 pts.), 94% after three months (29 of 31 pts.), and 100% after six months (20 of 20 pts.). Procedure-related complication was femoral vein thrombosis in one patient. The Solysafe Septal Occluder is a feasible, safe, and clinically efficient new device for interventional closure of small to medium sized ASDs less than 23 mm stretched diameter in childhood. Limitations for the Solysafe device are ASDs with absent retroaortic rims and very small children with a body weight<10 kg.

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... [1][2][3][4][5][6] Solysafe ® septal occluder (SSO) (Swissimplant AG, Solothurn, Switzerland) was a self-centering device and was first introduced for transcatheter closure of secundum ASDs and PFOs. [7][8][9] The CE mark approval was obtained for both smaller (15, 20, and 25 mm) and larger (30-and 35-mm) devices in 2007 and 2009, respectively. [7][8][9] There were promising advantages of this device with the flat design and the reduced amount of foreign metal material. ...
... [7][8][9] The CE mark approval was obtained for both smaller (15, 20, and 25 mm) and larger (30-and 35-mm) devices in 2007 and 2009, respectively. [7][8][9] There were promising advantages of this device with the flat design and the reduced amount of foreign metal material. An additional possible advantage of this occluder is that it does not require a long sheath, which is also beneficial for young children. ...
... An additional possible advantage of this occluder is that it does not require a long sheath, which is also beneficial for young children. [7,9] After unpublished cases of device fracture and embolization, however, the manufacturer (Swissimplant AG, Solothurn, Switzerland) issued an "urgent field safety notice" on August 4 th , 2010, asking for an immediate discontinuation of implantation and distribution of device with diameters of 30 and 35 mm, and prompting all healthcare providers to check all patients with SSO. On August 13 th , 2010 this warning was extended to cover all models including implants of diameters 15 mm, 20 mm, and 25 mm. ...
Article
Background: In this article, we report mid-term follow-up results of the Solysafe® septal occluder for percutaneous closure of secundum atrial septal defects. Methods: A total of 25 patients (8 males, 17 females; mean age 8.4±3.6 years; range 5 to 12 years) who underwent percutaneous closure of secundum atrial septal defect between July 2008 and June 2010 were included in this study. Results: The mean follow-up was 6.1±0.5 (range, 5.2 to 7.2) years. The device was successfully implanted in 22 of 25 patients. The mean stretched diameter of the atrial septal defect as assessed by balloon sizing was 13.6±4.4 (range, 8 to 26) mm. Nine 15-mm devices, eight 20-mm devices, six 25-mm devices, and two 35-mm devices were used. A 20-mm and two 35-mm devices were used in three patients and the procedure failed in these patients. Among the remaining 22 patients, no pericardial effusion, endocarditis, hemolysis, electrocardiographic changes, valvular problems, or suspicious echocardiographic findings were observed during or after the procedure. Only in one patient, a wire fraction was seen at six years, while another patient had a residual shunt during a six-year follow-up. Device embolization (n=1) and hemiparesis (n=1) were the early major complications related to the procedure. Conclusion: Although percutaneous closure of secundum atrial septal defects is successful, it would be wiser to check the device regularly, at least once a year, as the manufacturing of the device has been discontinued due to wire fractions.
... Interventional closure of secundum type atrial septal defects (ASD II) and patent foramen ovale (PFO) has been developed as standard of care for the majority of pediatric patients, with different types of occlusion devices available [1]. The Solysafe™ Septal Occluder (Swissimplant AG, Solothurn, Switzerland) has been developed for interventional closure of ASD II and PFO and has been evaluated in clinical studies for adult [2,3] and pediatric patients [4]. ...
... Criteria for ASD closure using SSO were size of balloon stretched ASD diameter between 5 and 25 mm, relevant left to right shunt, determined by Fick with Qp: Qs ≥ 1.5:1, and/or echocardiographic signs of right atrial or right ventricular volume overload. The procedure was performed as recently published [2,4]. Post-procedural follow-up included clinical assessment, transthoracic echocardiography, electrocardiography (ECG) including Holter. ...
... In conclusion, lack of clinical signs, ECG changes, or suspicious echocardiographic findings should lead to regular fluoroscopic controls. Despite low peri-procedural complication rate of the SSO [4], at mid-term follow up, the rate of irregularities of wire loops of SSO warrants regular fluoroscopic controls at least every year in intact devices, every six months in devices with fixed fractures and every three months in device fragmentation as recommended by the company [www.swissimplant.com]. These fluoroscopies should be performed and recorded in four standardized projections in order to detect any wire irregularities. ...
... Te delivery system consists of two coaxial control catheters that permit independent control of the proximal and distal ends of the device, allowing for traditional deployment, with the right atrial disk delivered frst, or both the left and right atrial disks in parallel. Tis implantation technique has been proven feasible and was described in detail for the Solysafe septal occluder in pediatric patients before [7,8]. Te occluder is fully retrievable and redeployable at all stages of delivery [4,5]. ...
Article
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Background: Nowadays, transcatheter device closure of an atrial septal defect (ASD) is a standard approach in children. Potential early and long-term side effects or complications related to the metal framework of the devices are a known issue. A bioresorbable device such as the Carag Bioresorbable Septal Occluder™ (CBSO) could resolve such complications. Material and Results. The Carag Bioresorbable Septal Occluder™ (CBSO; Carag AG, Baar, Switzerland) is a self-centering double disk, repositionable, and retractable device with a bioresorbable framework (polylactic-co-glycolic acid), which is almost completely resorbed by 18-24 months postimplantation. This manuscript reports the four first-in-child ASD device closures using a CBSO. The patients' age was median (IQ1-IQ3), 4.5 years (4-7.25). Weight was 21.3 kg (17.6-32.7). We demonstrated procedural feasibility and safety. Effective defect closure with the device was 100%. Echocardiographic measurements of the thickness of the interatrial septum did not show any relevant increase over a 12-monthfollow-up period. There were no residual defects found after the procedure or later during the resorption process. The patients showed no evidence of any local or systemic inflammatory reaction. Conclusions: The CBSO device system could offer a new treatment option for transcatheter ASD device closure in the pediatric and adult fields. In our first-in-child experience, it was effectively and safely implanted. During the first 12 months of follow-up, no complications occurred.
... Its incidence is reported at approximately 1.6 per 1000 live births [1]. In the 1980s the predominately surgical closure of ASDs was revolutionized by the introduction of umbrella-like devices delivered through cardiac catheters for interventional ASD device closure [2][3][4][5]. Fluoroscopy has emerged as gold standard imaging technique for catheter manipulation, guidewire control, balloon measurement of ASD diameter, and correct device placement throughout the procedure. ...
Article
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Objective: The aim of this study was to compare feasibility, effectiveness, safety, and outcome of atrial septal defect (ASD) device closure in children with and without fluoroscopy guidance. Methods and results: Children undergoing transcatheter ASD closure between 2002 and 2016 were included into this single center, retrospective study. Patients were analysed in two groups [1: intraprocedural fluoroscopy ± transoesophageal echocardiography (TOE) guidance; 2: TOE guidance alone]. Three-hundred-ninety-seven children were included, 238 (97 male) in group 1 and 159 (56 male) in group 2. Two-hundred-twenty-nine of 238 (96%) patients underwent successful fluoroscopy guided ASD closures versus 154/159 (97%) successful procedures with TOE guidance alone. Median weight (IQR) at intervention was 20kg (16.0-35.0) in group 1 versus 19.3kg (16.0-31.2) in group 2. Mean (SD) preinterventional ASD diameter was 12.4mm (4.4) in group 1 versus 12.2mm (3.9) in group 2. There was no significant difference in number of defects or characteristics of ASD rims. Median procedure time was shorter in group 2 [60min (47-86) versus 34min (28-44)]. Device-size-to-defect-ratio was similar in both groups [group 1: 1.07 versus group 2: 1.09]. There were less technical intraprocedural events in group 2 [10 (6.3%) versus 47 (20%)]. Intraprocedural complications were less frequent in group 2 [1 (0.6%) versus 8 (3.3%)]. Conclusion: Transcatheter ASD device closure with TOE guidance alone (i.e., without fluoroscopy) is as effective and safe as ASD closure with fluoroscopy guidance. As fluoroscopy remains an important adjunct to transoesophageal echocardiography, especially in complex defects and complications, procedures are always performed in a fully equipped cardiac catheterization laboratory.
... An additional bias may represent that 5 patients (4 %) in our study were lost to follow-up. Moreover, Solysafe septal occluders were implanted in 11 patients before an urgent safety notice was issued by the manufacturer (Kretschmar et al. 2010;Knirsch et al. 2011). These patients are being followed by fluoroscopy (Knirsch et al. 2011). ...
Article
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Background In most patients with secundum atrial septal defects (ASD), transcatheter closure is the preferred treatment strategy, but whether device size affects clinical outcomes is unknown. We sought to study the efficacy and safety of large closure devices compared to the use of smaller devices. Methods Using a single-center, prospective registry of adult patients undergoing transcatheter ASD closure, patients receiving a large closure device (waist diameter ≥25 mm, n = 41) were compared to patients receiving smaller devices (waist diameter ≤24 mm, n = 66). We analyzed pre-interventional clinical, hemodynamic and echocardiographic data, interventional success and complication rates, and 6-month clinical and echocardiographic outcomes. The primary efficacy outcome was successful ASD closure achieved by a single procedure and confirmed by lack of a significant residual shunt at 6 months. The primary safety outcome was a composite of device embolization, major bleeding, and new-onset atrial arrhythmia occurring within 6 months. ResultsTranscatheter ASD closure using large devices was successful in 90 % compared to 97 % of patients receiving smaller devices as defined by the primary efficacy outcome (p = 0.20). The primary safety outcome occurred in 4 patients of the large and 6 patients of the small device group, resulting in an event-free rate of 90 and 91 %, respectively (p = 0.89). Similar significant symptomatic improvement was observed in both treatment groups after 6 months, indicated by a 50 % increase in the fraction of patients in NYHA class I (p < 0.0001 vs. baseline). Conclusions Transcatheter closure in this cohort of patients with large or small ASD was effective with similar complication rates during short-term follow-up irrespective of the size of the implanted device.
... In a pilot study of the Solysafe in 15 patients with ASD diameters 10-21 mm, no major complications occurred and 100% had complete closure at 6-month follow-up [36]. In a pediatric cohort of 37 patients, a success rate of 87% was reported due to several cases of absent aortic rims, but the closure rate remained 100% at 6-month follow-up [37]. ...
Article
Introduction: Since King and Mills' pioneering work in percutaneous closure devices of secundum atrial septal defects (ASD) four decades ago, developments in device shape, material and implantation technique led to adoption of percutaneous ASD closure as current treatment of choice. Not only was the feasibility of such a percutaneous procedure tested altogether, but pursuing the ideal device in terms of safety and efficacy became priority. Areas covered: In this review we present the historical development of ASD devices in design, material and technique with clinical data, and provide the future perspectives in percutaneous ASD closures. Expert opinion: An 'ideal device' requires complete defect closure with negligible risk of complications using a safe, straightforward delivery technique with repositioning and retrieving properties. Some of the devices currently at hand come close to fulfilling these criteria, however none seem to provide those prerequisites completely. By understanding how challenges in device development were overcome in the past, new insights into future improvements are given.
... Several sizes, 25 mm thru' 44 mm are manufactured (Ewert, 2010). Two clinical trials with 44 and 32 patients (Ewert et al., 2008, Kretschmar et al., 2010) respectively were reported with implantation rates of 87% and closure rate of 100% at six month follow-up. The worldwide experience with this device was said to approximate 1,400 patients (Ewert, 2010). ...
Article
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Transcatheter closure has been widely accepted as a highly effective way to treat abnormal blood flows and/or embolization of thrombus in the heart. It allows the closure of four types of congenital heart defects (CHDs) and stroke-associated left atrial appendage (LAA). The four types of CHDs include atrial septal defect (ASD), patent foramen ovale (PFO), patent ductus arteriosus (PDA), and ventricular septal defect (VSD). Advancements in the materials and configurations of occlusion devices have spurred the transition from open-heart surgery with high complexity and morbidity, or lifelong medication with a high risk of bleeding, to minimally invasive deployment. A variety of occlusion devices have been developed over the past few decades, particularly novel ones represented by biodegradable and 3D-printed occlusion devices, which are considered as next-generation alternatives to conventional Nitinol-based occlusion devices due to biodegradability, customization, and improved biocompatibility. The aim here is to comprehensively review the next-generation occlusion devices in terms of materials, configurations, manufacturing methods, deployment strategies, and (if available) experimental results or clinical data. The current challenges and the direction of future work are also proposed.
Thesis
Der katheterinterventionelle Verschluss von ASD II stellt bei Patienten mit geeigneten ana- tomischen Bedingungen eine effiziente Alternative zu chirurgischen Verfahren dar. Da es für das patch-ähnliche Verschlusssystem Gore Septal Occluder (W.L. Gore & Associates, Flagstaff, AZ) keine mittel- oder langfristigen Verlaufskontrolldaten bei pädiatrischen Patien- ten gibt, werden in dieser Arbeit die Ergebnisse einer retrospektiven, multizentrischen Studie im mittelfristigen Verlaufskontrollintervall dargestellt (GSO in situ >12 Monate). Es werden Sicherheit und Wirksamkeit des Verschlusses signifikanter ASD II unter Verwendung eines GSO untersucht. An den fünf Kinderherzzentren der Universitätskliniken Freiburg, Sankt Augustin, Mainz, Duisburg und Wien wurde im Zeitraum von Juli 2011 bis November 2014 bei insgesamt 206 Kindern und Jugendlichen erfolgreich ein GSO implantiert, von denen 173 Patienten in die Teilnahme an der Studie einwilligten. Bei der Implantation betrug das mediane Alter 6 Jahre (0,7 Jahre bis 17,9 Jahre), das mittlere Körpergewicht lag bei 21 kg (6,4 kg bis 95kg) und die mittlere Körpergröße betrug 119 cm (65 cm bis 193 cm). Die mediane Durchleuchtungszeit betrug 10 Minuten (0 Minuten bis 46 Minuten). Die mediane Nachbeobachtungszeit betrug 20 Monate (12 Monate bis 51 Monate). Anato- misch stellte sich der ASD bei 131 Patienten (76%) als einzelner Defekt dar, bei 42 Patienten (24%) gab es multiple Defekte und bei 33 Patienten (19%) lag ein unzureichend retroaortaler Rand vor. Die Nachuntersuchungen ergaben eine Verschlussrate von insgesamt 95,4%. Kleine Rest-Shunts (<3 mm) wurden bei acht Patienten (4,6%) festgestellt, jedoch ohne kli- nische Relevanz. Leichte Komplikationen im Zusammenhang mit dem primären Eingriff wur- den bei 9 Patienten (5,2%) dokumentiert, bei vier dieser Patienten (2,4%) war ein Snare- Retrieval notwendig. Im Rahmen der Verlaufskontrollen wurde bei weiteren 9 Patienten über leichte Komplikationen berichtet, einschließlich eines transienten AV-Blocks II° bei drei Pati- enten (1,8%). Unerwünschte Ereignisse von klinischer Relevanz wurden nicht dokumentiert, insbesondere keine Occluder-Malfunktion und auch keine Erosion. Der GSO bietet sich auf- grund seiner bauartbedingten hohen Flexibilität als ASD-II-Occluder der ersten Wahl insbe- sondere dann an, wenn ein schmaler retroaortaler Rand vorliegt und/oder wenn bei multiplen Defekten ein möglichst großer Teil des atrialen Septums abzudecken ist. Insgesamt zeigen die periprozeduralen Beobachtungen und die Ergebnisse trotz der Limita- tionen (mittelfristiger Nachbeobachtungszeitraum, begrenzte Studienpatientenzahl), dass die GSO-Implantation bei Kindern und Jugendlichen eine effiziente und sichere Methode ist, um ASD II mit bis zu 20 mm Durchmesser zu verschließen.
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We sought to assess the effects of transcatheter closure of atrial septal defect (ASD) on right and left ventricular form and functions, as well as atrial volumes and pulmonary venous flows. We enrolled 25 patients (mean age: 9.02) prospectively who underwent successful transcatheter closure of secundum ASD. We performed transthoracic echocardiography, including two-dimensional, pulsed wave Doppler, M-mode echocardiography, and tissue Doppler imaging before the procedure and 1 day, 1 month, 3 months and 6 months after the procedure. Serum brain natriuretic peptide (BNP) levels were measured prior to the procedure, and 1 day, 1 month, and 3 months there after. Mitral inflow early diastolic wave increased significantly, while isovolumetric relaxation time and deceleration time did not change during the follow-up. The E/E was also increased significantly during follow-up. After the closure, right ventricular size and right atrial volume reduced, while left ventricular size increased significantly. There was a statistically significant improvement in left and right ventricular Tei indices. Pulmonary vein systolic velocity and the ratio of systolic to diastolic wave decreased, while atrial reversal wave (ARW) velocity increased immediately after the procedure. Although the concentration of BNP was increased on the first day after the procedure, its levels reduced and had reached the pre-procedure values at 1 month of follow-up. In the study, a significant improvement in the right and left ventricular functions was detected after transcatheter closure of secundum ASD in the short-term follow-up. In addition, we found a significant reduction in right heart sizes with corresponding global functional improvement in the right ventricle after the procedure.
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Interventional cardiac catheterization in children and adolescents is traditionally performed with the patient under general anesthesia and endotracheal intubation. However, percutaneous closure of atrial septum defect (ASD) without general anaesthesia is currently being attempted in a growing number of children. The study objective was to evaluate the success and complication rate of percutaneous ASD closure in spontaneously breathing children under deep sedation. Retrospective single centre cohort study of consecutive children undergoing percutaneous ASD closure at a tertiary care pediatric cardiology centre. Transesophageal echocardiography (TEE) and percutaneous ASD closure were performed with the patient under deep sedation with intravenous bolus of midazolam and ketamine for induction and propofol continuous infusion for maintenance of sedation in spontaneously breathing children. One hundred and ninety-seven patients (median age 6.1 years [minimum 0.5; maximum 18.8]) underwent TEE and ASD balloon sizing. Percutaneous ASD closure was attempted in 174 patients (88 %), and device implantation was performed successfully in 92 %. To achieve sufficient deep sedation, patients received a median ketamine dose of 2.7 mg/kg (0.3; 7) followed by a median propofol continuous infusion rate of 5 mg/kg/h (1.1; 10.7). There were no major cardiorespiratory complications associated with deep sedation, and only two patients (1 %) required endotracheal intubation due to bronchial obstruction immediately after induction of sedation. Seventeen patients (8 %) had minor respiratory complications and required frequent oral suctioning or temporary bag-mask ventilation. TEE and percutaneous ASD closure can be performed safely and successfully under deep sedation in spontaneously breathing children of all ages.
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Percutaneous closure currently is widely considered to be the first-choice therapeutic option in the treatment of ostium secundum atrial septal defect (ASD). The Amplatzer Septal Occluder (ASO) device is the most used prosthesis, although its influence on cardiac function still is under active investigation. This study aimed to evaluate the impact of the ASO device size on left ventricular (LV) function in pediatric patients using the speckle-tracking strain imaging technology. The study enrolled 43 nonobese pediatric patients submitted to percutaneous ASD closure with the Amplatzer Septal Occluder device and grouped them according to the size of the occluding prosthesis into three groups: a small-device group (≤10 mm, group 1), a medium-size-device group (11-16 mm, group 2), and a large-device group (≥17 mm, group 3). Echocardiographic data were compared among the groups and with the data of an age-, weight-, and gender-matched control group (50 patients). The large-device group showed a significant impairment in the strain rate value of the basal LV segments. In particular, the mean basal circumferential and radial strain rate values were lower than either normal or the values of the small- and medium-device groups. However, only the absolute device diameter reached statistical significance in the multivariate analysis. The large Amplatzer Septal Occluding device significantly impaired LV systolic function, particularly that of juxtaprosthetic segments, as shown in the strain rate analysis.
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Transcatheter device closure (TCDC) and intraoperative device closure (IODC) have emerged as minimally invasive methods in the treatment of secundum atrial septal defects (ASDs), but the long-term safety and efficacy remains uncertain for the large ASDs. TCDC may be as safe and efficacious as IODC for closure of large ASDs in terms of long-term clinical outcomes. Ninety-two patients who had ASDs with a defect diameter of ≥30 mm were included in this study. The patients received either TCDC (n = 42) or IODC (n = 50). An Amplatzer septal occluder was used in both groups. The dumbbell-like device deploying technique was introduced in the TCDC group. Physical exams, electrocardiography, and echocardiography were performed preprocedurally and postprocedurally at the index follow-up visits. The procedural immediate success rate was 97.6% for TCDC and 98.0% for IODC (P = 0.328). The rate of periprocedural complications was 9.5% for TCDC and 28.0% for IODC (P = 0.026). The mean hospital stay was 7.5 ± 2.7 days for TCDC and 11.9 ± 3.8 days for IODC (P < 0.001). For the mean follow-up of 5.4 ± 0.5 years, there were no cardiac deaths and late complications in either group. No significant residual shunts were documented, and symptoms were significantly improved in both groups. Right and left ventricular diameter, pulmonary artery diameter, and pulmonary systolic pressure were all significantly decreased in both groups (P < 0.05). The present study confirmed the long-term safety and efficacy for closing a large ASD either by TCDC or IODC. Either of them could become an effective alternative to the surgery for large ASD closure. The authors have no funding, financial relationships, or conflicts of interest to disclose.
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To determine the incidence of device fractures (DF) after implantation of a Solysafe Septal Occluder (iSSO) and to assess the spectrum of associated problems. In August 2010, after initial unpublished reports on DF, the manufacturer issued an "urgent field safety notice," prompting all medical care providers to re-examine all patients after iSSO. Prospective single center study. Extended follow-up examination, including standardized fluoroscopy (sF), was performed in all patients after iSSO. A total of 111 patients had undergone iSSO at our institution between June 2005 and July 2010. Median age and body weight were 50 years (9.3-79.6) and 75 kg (29-122), respectively. Indications for iSSO were (1) patent foramen ovale in patients with a history of cryptogenic stroke (n = 84; 76%) and (2) hemodynamically significant atrial septal defect of the secundum type (n = 27; 24%). A total of 113 devices were implanted. Complete follow-up was available in 103 patients (92.8%). Median follow-up was 1.9 years (0-5.2). There were no postimplantation neurological events or symptoms. The closure rate was 97.1%. DF was suspected on a chest X-ray in one patient and documented in 10 patients by sF. The overall probability of freedom from DF was 82.3% after 5 years. One patient had embolization of a device fragment to the right pulmonary artery. So far, all patients with DF have been managed conservatively. The incidence of DF after iSSO is unacceptably high. sF is imperative for accurate diagnosis of DF. Further, follow-up is needed to determine the risk of clinical complications and to optimize management.
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To review the safety and efficacy of the Amplatzer septal occluder for transcatheter closure of interatrial communications (atrial septal defects (ASD), fenestrated Fontan (FF), patent foramen ovale (PFO)). Prospective study following a common protocol for patient selection and technique of deployment in all participating centres. Multicentre study representing total United Kingdom experience. First 100 consecutive patients in whom an Amplatzer septal occluder was used to close a clinically significant ASD or interatrial communication. All procedures performed under general anaesthesia with transoesophageal echocardiographic guidance. Interatrial communications were assessed by transoesophageal echocardiography with reference to size, position in the interatrial septum, proximity to surrounding structures, and adequacy of septal rim. Stretched diameter of the interatrial communications was determined by balloon sizing. Device selection was based on and matched to the stretched diameter of the communication. Success defined as deployment of device in a stable position to occlude the interatrial communication without inducing functional abnormality or anatomical obstruction. Occlusion status determined by transoesophageal echocardiography during procedure and by transthoracic echocardiography on follow up. Clinical status and occlusion rates assessed at 24 hours, one month, and three months. 101 procedures were performed in 100 patients (86 ASD, 7 FF, 7 PFO), age 1.7 to 64.3 years (mean (SD), 13.3 (13.9)), weight 9.2 to 100.0 kg (mean 32.5 (23.5)). Procedure time ranged from 30 to 180 minutes (mean 92.4 (29.0)) and fluoroscopy time from 6.0 to 49.0 minutes (mean 16.1 (8.0)). There were seven failures, all occurring in patients with ASD, and one embolisation requiring surgical removal. Immediate total occlusion rate was 20.4%, rising to 84.9% after 24 hours. Total occlusion rates at the one and three month follow up were 92.5% and 98.9%, respectively. Complications were: transient ST elevation (1), transient atrioventricular block (1), presumed deep vein thrombosis (1), presumed transient ischaemic attack (1). It appears feasible to close interatrial communications and atrial septal defects up to 26 mm stretched diameter safely with the Amplatzer septal occluder. Short term results confirm an early high occlusion rate with no major complications. Careful selection of cases based on the echocardiographic morphology of the ASD and accurate assessment of their stretched diameter is of utmost importance. Further experience with the larger devices and longer term results are required before a firm conclusion regarding its use can be made.
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To evaluate the safety and efficacy of transcatheter closure of secundum atrial septal defects (ASD) with the Amplatzer septal occluder. 236 consecutive patients with a significant ASD (age 6 months to 46 years, median 5 years; body weight 6.5-79 kg, median 18 kg) were considered for transcatheter closure with the Amplatzer septal occluder; 18 patients with defects that were too large or with a deficient inferior margin were excluded from attempted transcatheter closure after initial transthoracic (4) or transoesophageal echocardiography (14). At cardiac catheterisation, devices were not implanted in 18 patients because the stretched diameter of the ASD was too large (4), the device was unstable (4), compromised the mitral valve (1), or obstructed the upper right pulmonary vein (1); eight patients with additional systemic or pulmonary vein anomalies (5) or a Qp:Qs less than 1.5 (3) were excluded after angiographic and haemodynamic assessment. Thus ASD closure was done successfully in 200 patients (procedure time 25-210 minutes, median 66 minutes; fluoroscopy time 2.5-60 minutes, median 12 minutes), among whom 22 had multiple ASDs (14) or a septal aneurysm (8). The diameter of the devices ranged between 6-34 mm. Severe procedure related complications (retroperitoneal bleeding, air embolism) occurred in two cases. At follow up (33 days to 4.3 years, median 2.3 years) complete closure was documented in 94%, with a trivial residual shunt in 12 patients. The Amplatzer septal occluder is very efficient and offered interventional ASD closure in 84.7% of our group of consecutive patients, with excellent intermediate results.
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We report on a case of occlusion of two atrial septal defects in a modified catheter procedure. A 34 year-old patient was referred to our institution due to increasing dyspnea after transient ischemic attack. 26 years ago, surgical repair of a septum secundum defect was performed. Now, the transesophageal echocardiography revealed a double atrial septal defect with a small hole in the middle and a large eccentric hole without sufficient rim for fixation which is usually a contraindication for transcatheter occlusion. By placing an oversized double-umbrella in the smaller hole it was possible to occlude both defects.
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The rapidly growing population of adults surviving with congenital heart lesions along with the success of interventional cardiology in the child and adolescent has spawned an incredible interest in adapting the technology for the adult congenital patients. Dr. Mullins, a pioneer in this area, has written an outstanding reference which covers all aspects of performing diagnostic and therapeutic cardiac catheterization procedures on patients of all ages. This illustrated book details the equipment and techniques for performing safe and successful procedures, with a strong emphasis on avoiding complications. It also includes the requirements of a catheterization laboratory for congenital heart patients, as well as guidance for setting up and operating such a laboratory. Cardiac Catheterization in Congenital Heart Disease serves as an essential manual for pediatric and adult interventional cardiologists worldwide.
Article
Aim: To evaluate the safety and efficacy of transcatheter closure of secundum atrial septal defects (ASD) with the Amplatzer septal occluder. Methods: 236 consecutive patients with a significant ASD (age 6 months to 46 years, median 5 years; body weight 6.5–79 kg, median 18 kg) were considered for transcatheter closure with the Amplatzer septal occluder; 18 patients with defects that were too large or with a deficient inferior margin were excluded from attempted transcatheter closure after initial transthoracic (4) or transoesophageal echocardiography (14). Results: At cardiac catheterisation, devices were not implanted in 18 patients because the stretched diameter of the ASD was too large (4), the device was unstable (4), compromised the mitral valve (1), or obstructed the upper right pulmonary vein (1); eight patients with additional systemic or pulmonary vein anomalies (5) or a Qp:Qs less than 1.5 (3) were excluded after angiographic and haemodynamic assessment. Thus ASD closure was done successfully in 200 patients (procedure time 25–210 minutes, median 66 minutes; fluoroscopy time 2.5–60 minutes, median 12 minutes), among whom 22 had multiple ASDs (14) or a septal aneurysm (8). The diameter of the devices ranged between 6–34 mm. Severe procedure related complications (retroperitoneal bleeding, air embolism) occurred in two cases. At follow up (33 days to 4.3 years, median 2.3 years) complete closure was documented in 94%, with a trivial residual shunt in 12 patients. Conclusions: The Amplatzer septal occluder is very efficient and offered interventional ASD closure in 84.7% of our group of consecutive patients, with excellent intermediate results.
Article
JID: 8200291; 2008/11/17 [received]; 2008/11/17 [accepted]; 2008/11/28 [aheadofprint]; ppublish
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Article
Percutaneous closure of atrial septal defect (ASD) is a valid alternative to surgical approach. Current device has significantly improved the success rate also in complex cases. The aim of this study is to assess the impact of age, defect size, and morphologic features on successfully percutaneous ASD closure. Between January 2000 and September 2004, 1,013 consecutive patients underwent closure of an isolated type II ASD at our institution. The following outcomes have been evaluated: (1) role of percutaneous ASD closure as alternative to surgical repair, in current daily practice; (2) impact of age on the selected closure approach; (3) analysis of morphologic variety of ASD and its effect on the closure technique; (4) possible role of specific device selection according to ASD morphology to improve procedural success. During the study period, up to 80% of secundum ASDs were suitable for percutaneous closure with the currently available devices. Need for surgical ASD closure was more common in pediatric patients, likely reflecting the more frequent diagnosis of larger and complex defects at a young age. Accurate ADS morphology assessment and appropriate device selection are key elements to obtain procedural success. In particular, among all the ASD characteristics, the rim absence is the main limiting factor to a successful percutaneous ASD closure. A trend of reduction in peri-procedural adverse events was observed during the study period, with complications needing immediate cardiac surgery occurred only in 1% of cases. Percutaneous ASD closure is feasible and associated with low complication rate. A thorough analysis of morphologic aspects is mandatory in order to select the appropriate device and the optimal approach. Surgical closure remains the treatment of choice in selected patients.
Article
To judge whether an Amplatzer Septal Occluder can be used as standard therapy instead of surgery for closure of atrial septal defects we report our experiences in 200 patients. Of these patients, 127 had an atrial septal defect with haemodynamically significant left-to-right shunt, 68 patients a persistent oval foramen after presumed paradoxical embolism, and 5 had a fenestration after Fontan-repair. Mean age was 29.8 years (0.8 to 77.7 years). Body weight ranged from 6.9 to 120.0 kg (mean 51.5 kg). After diagnostic cardiac catheterization, and balloon-sizing of the defect, we implanted Amplatzer Septal Occluders with stents of 4 to 28 mm diameter. Follow-up studies were obtained after 48 hours, and one, six, and twelve months. Transcatheter closure of the atrial septal defect proved successful in all without any relevant residual shunts. In particular, complete closure was achieved in all patients after presumed paradoxical embolism. The mean period of follow-up is 9.5 months, with a range from 0.4 to 23.5 months, giving a total of 1898 patient months. The occlusion rate after three month was 98.1%. A trivial haemodynamically insignificant residual shunt remained in 1.9% of the patients. Fluoroscopy times ranged from 0 to 43.5 minutes, with a median of 8.7 minutes. The excellent results in the short and medium term in children and adults have resulted in using this device routinely at the present time for closure of central atrial septal defects up to a diameter of 28 mm. Final judgement, however, is only possible after long-term follow-up.
Article
In an effort to reduce x-ray exposure, we developed a technique for transcatheter closure of atrial septal defects under echocardiographic guidance without fluoroscopy. To assess the efficiency of this procedure for routine use, we compared our initial results with those for the conventional procedure. Twenty-two randomly selected patients (median age 18 years; range 2 to 66 years) with atrial septal defects (n=13) or patent foramen ovale (n=9) underwent cardiac catheterization for possible interventional defect closure with echocardiography as the only imaging tool. Median stretched diameter was 9 mm (range 6 to 26 mm); median left-to-right shunt over the atrial septal defects was Qp/Qs=1.8 (range 1.5 to 2.6). An Amplatzer septal occluder was successfully implanted in 19 defects without fluoroscopy and in 3 with the help of radiography. After 1 month, complete defect closure was documented in all patients. Compared with the conventional procedure of a control group of 131 patients, procedure times were not significantly different (88 versus 100 minutes; P=0.09). However, the study group received significantly higher doses of propofol for sedation (9.9 versus 5.6 mg/kg body weight; P=0.002) owing to extended transesophageal echocardiography. In the majority of patients in whom transcatheter closure of interatrial communications with the Amplatzer septal occluder is possible, the procedure can be safely performed under echocardiographic guidance without fluoroscopy.
Article
Transcatheter closure of atrial septal defects is a new and less traumatic technique than open heart surgery. In recent years, patients with a patent foramen ovale sustaining potential paradoxical embolism have also become candidates for interventional closure devices. One of the more popular occluding devices is the Amplatzer septal occluder, which, like many other occluders, is made of nitinol. Nitinol-based alloys are widely used in medical products, for example, in orthopedics and orthodontics. However, the clinical use of nitinol, which contains 55% nickel, is still controversial because of concerns about its biocompatibility. Therefore, we examined the systemic nickel release after implantation of the Amplatzer occluder. In 67 patients with no history of nickel sensitivity, blood samples were taken 24 hours before and 24 hours, 1, 3, and 12 months after occluder implantation. Nickel serum concentrations were measured by atomic absorption spectrometry; a value of <2 ng/mL of nickel was considered to be normal. A rise in mean serum levels of nickel was observed, from 0.47 ng/mL before implantation to 1.27 ng/mL (24 hours after), to a maximum of 1.50 ng/mL 1 month after implantation, which was statistically significant (P =.008 and P = 0.022, Wilcoxon Test). During follow-up, the values decreased to those measured before implantation. Nickel seems to be released from the device, causing a systemic rise in serum levels of nickel, possibly until a calcium-phosphate layer has formed on the passive oxide film of the device or until endothelialization is complete. Possible biological effects should be considered, particularly in young patients or patients with nickel hypersensitivity.
Article
The objectives of this study were to identify possible risk factors that may lead to erosion of the Amplatzer septal occluder (ASO) and recommend ways to minimize future risk. There have been rare occurrences of adverse events with development of pericardial effusion after ASO placement. Identification of high-risk cases, early recognition, and prompt intervention may minimize the future risks of adverse events. In all patients who developed hemodynamic compromise after ASO placement, echocardiograms (pre-, intra-, and postprocedure), atrial septal defect (ASD) size (nonstretched, stretched), size of the device used, cineangiograms, and operative records were reviewed by a panel selected by AGA Medical Corporation. The findings were compared to the premarket approval data obtained from FDA-approved clinical trials that were conducted in the United States, before the device was approved. A total of 28 cases (14 in United States) of adverse events were reported to AGA Medical. All erosions occurred at the dome of the atria, near the aortic root. Deficient aortic rim was seen in 89% and the defect described as high ASD, suggesting deficient superior rim. The device to unstretched ASD ratio was significantly larger in the adverse event group when compared to the FDA trial group. The incidence of device erosion in the United States was 0.1%. The risk of device erosion with ASO is low and complications can be decreased by identifying high-risk patients and following them closely. Patients with deficient aortic rim and/or superior rim may be at higher risk for device erosion. Oversized ASO may increase the risk of erosion. The defect should not be overstretched during balloon sizing. Patients with small pericardial effusion at 24 hr should have closer follow-up.
Article
The objective of this study was to evaluate a new technique of sizing atrial septal defects (ASDs) for transcatheter device closure. ASD closure using the Amplatzer septal occluder (ASO) device is commonly performed. Complications, including arrhythmias, pericardial effusions, and perforations, may be related to oversizing ASDs and choosing larger devices. Two methods were used to size ASDs using a compliant balloon. In some patients, the balloon was inflated until a waist was visible [(+)waist]; in others, only until no shunting was demonstrable by echocardiogram [echo; (-)waist]. The device was selected and implanted using standard procedure and echo guidance. One hundred seventeen patients underwent secundum ASD closure with an ASO device. There were 43 patients in the (-)waist group and 74 in the (+)waist group. All devices were implanted successfully. The initial echo ASD diameter was larger in the (-)waist group compared to the (+)waist group (P = 0.01). There was a smaller difference between the initial echo and balloon-sized ASD diameters in the (-)waist group (P < 0.02). ASO device size implanted (in mm greater than echo ASD diameter) was smaller in the (-)waist group (P < 0.01). There were 0/43 complications in the (-)waist group and 5/74 in the (+)waist group. The complete closure rate was the same in both groups. Sizing an ASD by inflating a compliant balloon just until shunting is eliminated, and not until a waist is visible, results in less overstretching of the ASD and selection of a smaller ASO device, achieving similar closure rates and potentially fewer complications.
Article
To evaluate the safety and feasibility of transcatheter closure of atrial septal defect (ASD) without balloon sizing. A total of 243 patients (group I), aged 2.1-76 years (median 22 years), underwent transcatheter closure of ASD without balloon sizing. The maximal diameter of the defect was measured on transesophageal echocardiographic (TEE) images. The size of device selected was generally 4-6 mm and 5-8 mm larger than the maximal diameter, if the defect was <14 mm and > or =14 mm, respectively. The results of ASD closure in group I were compared with those of 271 patients (group II, median age 11 years) who underwent ASD closure with balloon sizing prior to the study period. Of the 243 patients in group I, the maximal defect diameter ranged from 5.2 to 37 mm (mean 17.5 +/- 6.6 mm, median 17 mm). A total of 247 Amplatzer septal occluders were deployed in 240 patients. Two patients were found to develop distal embolization of a device the next day. Therefore, failure occurred in five patients. Comparing the results between group I and group II, there was no significant difference in success rate (238/243 vs. 263/271), incidence of embolization (2/243 vs. 2/271) and complete closure rate at 3-month follow-up (94.1% vs. 95.8%). There is significant difference in mean age (26.6 +/- 20.2 vs. 19.1 +/- 17.6), maximal defect diameter (17.5 +/- 6.6 vs. 14.1 +/- 5.9 mm) and Q(p)/Q(s) ratio (2.77 +/- 1.11 vs. 2.48 +/- 0.97) between group I and II. The mean diameter of device used was significantly larger in group I than in group II (23.1 +/- 8.1 vs. 19.6 +/- 7 mm, P < 0.001). Balloon sizing may not be necessary in transcatheter closure of ASD.
Article
Since the initial description of an atrial septal defect (ASD) occluding device in the mid-1970s by King and Mills, a number of devices have been developed. To date, various transcatheter devices and methods to close congenital heart defects are currently available commercially or within clinical trials. Devices have been designed specifically for the ASD and patent foramen ovale (PFO). The trend in interventional treatment of intracardiac shunts is toward defect-specific systems and new devices minimizing the foreign material left in the atria. This review first focuses on new devices that are not approved in the United States but are elsewhere, and then reviews the experimental devices for PFO and ASD closure.
Article
We report the results of a prospective multicenter pilot study performed in Germany, Sweden, and Switzerland with a new self-centering device for transcatheter closure of an atrial septal defect (ASD) or a patent foramen ovale (PFO) called the Solysafe Septal Occluder. The device was successfully implanted in 44 patients. In 15 patients with a median age of 40 years (range 6-76 years), a Solysafe device was successfully implanted in an ASD. The median size of the stretched defects was 17 mm (range 10-21 mm). Three 15-mm devices, eight 20-mm devices, and four 25-mm devices were used. Procedure time ranged from 40 to 107 min (median 66 min) and fluoroscopic time from 5.3 to 17.5 min (median 12 min). In 29 patients with a median age of 47 years (range 15-78 years), a Solysafe device was implanted in a PFO. The procedure time ranged from 21 to 155 min (median 51 min) and fluoroscopic time from 3.1 to 31.3 min (median 7.6 min). At discharge, 1 of the 29 patients (3%) had a small shunt. No patient in either the ASD or the PFO group had any major complication. Six months after implantation, the overall closure rate with the Solysafe septal occluder in both groups was 100% (44/44). With the self-centering Solysafe Septal Occluder, PFOs, and ASDs with a stretched diameter of up to 21 mm can be effectively closed with very high occlusion rates.
Article
To summarize major complications and outcome for patients receiving percutaneous closure of atrial septal communications. The Medline database and the United States Food and Drug Administration manufacturer and user facility device experience databases (MAUDE) were searched for reports related to complications with atrial septal occluding devices. The medical literature documenting complication rates for these devices were reviewed and summarized. The MAUDE database complication reports were compared with those reported in the medical literature using national implant estimates. The MAUDE database correlated in the type of complications most frequently encountered with each device. However, based on estimated total implant numbers, there is a higher incidence of major complications, including death. AGA devices had a 0.3% erosion/perforation rate with a higher morbidity and mortality (29%) than previously reported. NMT devices had a lower incidence of erosion/perforation rate of 0.05%. Embolization rates for the NMT devices were also lower than published European studies, possibly reflecting the US restriction of the device for closure of patent foramen ovale. Thrombus was more frequently encountered on the NMT device. Both AGA and NMT devices have been shown to be safe and effective alternatives to cardiac surgery. The MAUDE database correlated, with a very low overall complication rate, but showed a higher estimated major complication rate than the medical literature. These data demonstrate the difficulty in quantifying rare complications in the premarketing analysis and the obligation providers have to report and evaluate complications through vigilant postmarketing surveillance.
Closure of atrial septal defects with the Solysafe occluder
  • Daehnert
Daehnert I, Djukic M, Parezanovic V, et al. Closure of atrial septal defects with the Solysafe occluder. Cardiol Young 2008;18(Suppl 1):13.
Transcatheter closure as standard treatment for most interatrial defects: experience in 200 patients treated with the Amplatzer septal occluder.
  • Berger F.
  • Ewert P.
  • Bjornstad P.G.