Long-Term Follow Up of Secundum Atrial Septal Defect Closure with the Amplatzer Septal Occluder (original) (raw)
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American Heart Journal, 2004
Background: The transcatheter closure of the atrial septal defect (ASD) has become an alternative technique to surgical procedures. The aim of this study was to assess the immediate, short, and intermediate-term results of the transcatheter closure of the secundum ASD with the Amplatzer Septal Occluder (ASO) in adult Iranian patients. Methods: Between December 2004 and July 2008, the transcatheter closure of the ASD using the ASO was attempted in 58 consecutive, adult patients. The mean age of the patients was 37.1 ± 12.7 years (range = 19 -75 years).
Journal of Interventional Cardiology, 1998
We report 5-year follow-up data of patients following atrial septal defect (ASD) closure with the Amplatzer septal occluder (ASO). Patients completed a questionnaire related to symptoms pre-and post-ASO implantation. Complete transthoracic echocardiography was used to assess residual atrial septal defect, right ventricular volume overload, and degree of mitral regurgitation. Mean follow-up duration was 4.8 6 0.6 years (range, 5.7-3.0 years). Complete closure was observed in all patients. Right ventricular volume overload, present in all patients prior to ASD closure, had resolved in 82% of patients. No mitral valve sequelae were found; 75% of patients were asymptomatic or felt much improved compared to their preclosure symptoms. New onset of migraine-type headaches was encountered in two patients, one for 12 months and one patient persisted with intermittent migrainous episode. In conclusion, we report 100% closure rate of ASD with ASO device, with return of right ventricular size to normal in the majority of patients. New onset of migraine headaches after ASO implantation can persist more than a few months.
Catheterization and Cardiovascular Interventions, 2004
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.Catheter Cardiovasc Interv 2004;63:496–502. © 2004 Wiley-Liss, Inc.
Journal of the American College of Cardiology, 2002
The goal of this study was to report the early and late complications experienced in atrial septal defect (ASD) transcatheter closure. BACKGROUND Atrial septal defect transcatheter occlusion techniques have become an alternative to surgical procedures. A number of different devices are available for transcatheter ASD closure. The type and rate of complications are different for different devices. METHODS Between December 1996 and January 2001, 417 patients (mean age: 26.6 Ϯ 19 years) underwent transcatheter occlusion of secundum type ASD. Complications were categorized into major and minor. Two different devices were used: the CardioSEAL/STARFlex in 159 patients and the Amplatzer septal occluder in 258 patients.
J Interv Card Electrophysiol, 2000
Conduction abnormalities and arrhythmias may occur in patients following secundum atrial septal defect (ASD) closure using the Amplatzer 1 septal occluder (ASO). Therefore, the aim of this study was to prospectively perform ambulatory ECG monitoring to assess the electrocardiographic effects of transcatheter closure (TCC) of ASD using the ASO device. From 5a97 to 3a99, 41 patients with secundum ASD, underwent TCC using the ASO device at a median age of 9.2 y. (0.5±87 y.) and median weight of 34 kg (5.6± 88 kg.). Ambulatory Holter monitoring was performed pre-and immediately post TCC. Holter analysis included heart rate (HR), ECG intervals, supraventricular ectopy (SVE), ventricular ectopy (VE), and AV block. No change in baseline rhythm was noted in 37 patients (90%). Changes in AV conduction occurred in 3 patients (7%), including intermittent second degree AV block type II, and complete AV dissociation post closure. SVE was noted in 26 patients (63%) post closure, ranging from 5±2207 supraventricular premature beats (SVPB), including 9 patients (23%) with nonsustained supraventricular tachycardia (SVT), 3 of whom had short runs of SVT prior to closure. A signi®cant increase in post-closure number of SVPB per hour (p 0.047) was noted. No signi®cant difference was noted in PR interval, ventricular premature beats per hour, or QRS duration. Conclusions: Based on ambulatory ECG analysis, TCC of ASD with the ASO device is associated with an acute increase in SVE and a small risk of AV conduction abnormalities, including complete heart block. Long term follow-up studies will be necessary to determine late arrhythmia prevalence and relative frequency compared with standard surgical ASD repair.
Cardiovascular Diagnosis and Therapy
Background: The last decades have brought remarkable improvements in treatment strategy and occluder modification of secundum atrial septal defect (ASD) closure. Approval, efficacy and safety of ASD closure devices have previously been demonstrated. This study investigated the clinical efficacy and safety of the LifeTech CeraFlex TM ASD occluder for interventional closure of secundum ASD with a 6-month follow-up (FU). Methods: Procedure specific data was collected on patients considered for ASD closure with the CeraFlex TM occluder between April 2016 and December 2019 in three German centers. Efficacy and safety were assessed after device closure, at discharge, and at 6-month FU. Results: The primary endpoint (successful ASD closure without severe complications) was reached by 102/103 patients (99%). Device embolization occurred in two patients (one early and one late embolization). After early snare-retrieval of an embolized device, this ASD was closed surgically and in the other patient with late device embolization the defect was closed with a larger CeraFlex TM occluder. The secondary endpoint (clincal efficacy after 6 months) was reached by 94/98 patients since new onset of arrhythmia occurred in four patients. Three patients had withdrawn their study-participation and one patient had moderate residual shunt, but not related to the occluder. Incomplete right bundle branch block (iRBBB) was seen in 31 patients. At last FU only 17 patients had remaining iRBBB documenting effective volume unloading of the right ventricle. Conclusions: Catheter interventional closure of secundum ASDs with the CeraFlex TM ASD occluder was feasible, safe and effective in this study.
Journal of Ayub Medical College, Abbottabad : JAMC
Device closure of Secundum atrial septal defect (ASD) is an accepted mode of treatment in selected patients with a suitable defect. The major initial concern over the long-term outcome has been erosions and more recently development of aortic regurgitation. Objective was to assess the intermediate and long term outcome of patients with device closure of ASD with special reference to complications. Two hundred and four patients with significant Secundum ASD, 16 months to 55 years (median 8 years) were considered for transcatheter closure with the Amplatzer septal occluder from October 1999 to April 2009 with follow up examinations at 1, 3, 6, and 12 months and thereafter at yearly interval. Device closure of ASD was done successfully in 202/204 patients. The immediate (first 24-hour) major complications included device embolization (n = 4), pericardial effusion (n = 1) and 2:1 heart block (n = 1). At a mean follow up of 4.9 years (90 days to 9.6 years, median 5.3 years) complete clos...
Atrial septal defect (ASD) device trans-catheter closure: limitations
Journal of Thoracic Disease, 2018
Systematic review Transcatheter closure is a widespread technique used to treat secundum atrial septal defects (ASDs). When compared to surgery, it provides a less invasive approach with quicker recovery and reduced physical and psychological impact (1-4). The first case was performed in 1976 by King and Mills (5). However, the percutaneous ASD closure fully entered the clinical arena with the introduction of Amplatzer septal occluder devices (ASO) (6). Since then, many other devices have been developed and used, such as the Gore Cardioform septal occluder (GSO), the Figulla Flexible Occlutech device, the Cardioseal/Starflex and the bio absorbable devices Biostar or Biotrek (7,8). Nowadays, almost 85-90% of all secundum ASD can be closed by using a transcatheter approach (9,10). However, several limitations may have a significant impact on the feasibility and success of percutaneous ASD closure (11,12). Limitations can be grouped as follows: (I) anatomical limitations; (II) device-related limitations; (III) associated defects and natural history associated issues; (IV) physiological limitations; (V) complications. Anatomical limitations A common underlying structure apply to all available devices: they are made of two disks and a connecting segment that keeps them together across the ASD. Two different engineering concepts have been developed, so that occluder devices can be classified as self-centering and nonself-centering ones. The Amplatzer and the Amplatzer-like devices, in which a central connecting waist fills the defect improving stability and occlusion, belong to the former, while devices such as GSO, where the connecting segment is linear, belong to the latter. All the currently available devices need to have surrounding "walls" supporting their stability. In particular, the disks of non-self-centering ones should be 1.8-2 times the diameter of the defect in order to have complete defect closure and avoid mal position or embolization (8). Main anatomical limitations to percutaneous ASD closure may be insufficient surrounding rims, multiple defects and excessively bulging atrial septal aneurisms (ASA). Typical of ostium primum ASD and sinus venosus-type defects, deficiency of surrounding rims can affect ostium
Device therapy for atrial septal defects in a multicenter cohort: Acute outcomes and adverse events
Catheterization and Cardiovascular Interventions, 2014
Background: Secundum atrial septal defect (ASD) closure devices were granted approval based on industry-sponsored, prospective, nonrandomized, single device studies, demonstrating acceptable efficacy and safety in selected patients. We sought to report community practice and outcomes. Methods and Results: Procedure specific data was collected on cases considered for ASD closure in the congenital cardiac catheterization project on outcomes (C3PO) between February 1, 2007 and June 31, 2010. Eight centers contributed data during this time period. All adverse events (AE) were independently reviewed and classified by a five level severity scale. In 40 months (2/07-6/10), 653 of 688 ASDs were occluded with a single device using an AMPLATZER V R Septal Occluder (ASO) in 566 (87%), GORE V R HELEX V R Septal Occluder (HSO) in 33 (5%), and a CardioSEAL V R or STARFlex TM device (CSD) in 54 (8%). Most patients had an isolated ASD (93%). 85% were >2 years of age. The ASD median diameter was 12 mm [8,16] for ASO, with smaller diameters in HSO 8 mm [7,10] and CSD 8 mm [5,10] (P < 0.001). AE (n 5 82) were recorded in 76 cases, 11.5% (95% CI 9.2%, 14.1%) and classified as high severity in 4.7% (95% CI 3.2%, 6.5%), with no mortality. A new conduction abnormality was detected during 15 cases and did not resolve in one. Transcatheter device retrieval was possible in 7 of 10 device embolizations. Device erosion occurred in 3 of 566, 0.5% (95% CI 0.1%, 1.5%), ASO implants. Conclusion: Although device closure of ASDs is associated with low morbidity and rare mortality, ongoing assessment of device safety profiles are warranted, and registries offer opportunities to facilitate the required surveillance. V
Cureus, 2022
Transcatheter atrial septal defect (ASD) device closure in the older population presents a greater challenge due to the long-standing effect of atrial left-to-right shunt. This study analyzes the challenges encountered in transcatheter ASD device closure in older patients in their fifth decade and beyond. Methods Adults aged 40 years and above with significant secundum ASD who underwent transcatheter ASD device closure between June 2015 and April 2021 were analyzed. Challenges were classified as major and minor challenges based on their impact on the alteration of the treatment protocol. Patients were categorized into three subgroups according to age. Group 1 consisted of patients aged 40-49 years (n = 13), Group 2 consisted of patients aged 50-59 years (n = 16), and Group 3 consisted of patients aged 60 years and above (n = 8). Results A total of 37 patients were analyzed. The challenges encountered were arrhythmia, pulmonary hypertension, left ventricular diastolic dysfunction, bleeding, stroke, coronary artery disease (CAD), hypertension, and airway disease. Thirteen percent of challenges were seen in pre-procedure time, whereas 79% of challenges during the procedure and 8% of challenges during post-procedure were seen. Thirty-five patients (94.6%) underwent transcatheter ASD device closure. Two patients (5.4%) did not undergo transcatheter ASD device closure due to severe diastolic dysfunction and associated CAD, respectively. Eleven major challenges were encountered in 10 patients in which one patient had a dual challenge of bleeding and arrhythmia. Thirteen patients (35.1%) had smooth procedures without any challenges encountered. Twentyseven minor challenges were encountered in 20 patients with some patients having an overlap of multiple major and minor challenges. The patients were doing well at the mean follow-up of 28 months. Conclusions Transcatheter ASD device closure in older patients who are 40 years and above is safe and effective. Such high-risk patients are prone to various challenges that can be effectively managed if optimally monitored on the basis of a proper understanding of the altered physiology and anticipation of the deviated course at various stages of the procedure.