Device therapy for atrial septal defects in a multicenter cohort: Acute outcomes and adverse events

El‐Said, Howaida; Hegde, Sanjeet; Foerster, Susan; Hellenbrand, William E.; Kreutzer, Jacqueline; Trucco, Sara M.; Holzer, Ralf; Burch, Grant H.; Mirani, Ajay; Nicolas, Ramzi; Porras, Diego; Bergersen, Lisa; Moore, John W.

doi:10.1002/ccd.25684

Cited by 53 publications

(75 citation statements)

References 16 publications

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“…Our successful ASD device implant rate of 96.7% was similar to procedural success rates of 95.7% in the IMPACT Registry, 96% in the MAGIC report, 95% in the C3PO report, and 95.7% in the Amplatzer Septal Occluder FDA study (2,29,37,38). Major adverse events were observed in 1.3% in our study.…”

Section: Discussionsupporting

confidence: 81%

“…Major adverse events were observed in 1.3% in our study. This rate compares with 1.2% in IMPACT patients, 1.1% in MAGIC patients, 4.7% in C3PO patients and 1.6% in the FDA study (2,29,37,38). As previously described, device embolization was successfully managed percutaneously in most cases (34).…”

Section: Discussionmentioning

confidence: 52%

“…Moreover we did not observe late adverse events. Although rare, late complications like conduction abnormality, endocarditis, thrombo-embolism or aortic valve regurgitation have been occasionally described (38)(39)(40). Device related aortic erosion remains a dreaded complication occurring in 0.5% in the literature (40).…”

Section: Discussionmentioning

confidence: 99%

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Transthoracic echocardiography is a safe alternative for assessment and guidance of transcatheter closure of secundum atrial septal defect in children

Baruteau¹,

Hascoët²,

Fraisse³

2017

J. Thorac. Dis.

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Background: 2D-transesophageal echocardiography (TEE) is routinely performed to guide percutaneous ASD closure in children. We aimed to assess whether two-dimensional (2D)-transthoracic echocardiography (TTE) is a safe alternative for assessment and guidance of atrial septal defect (ASD) closure in unselected children.Methods: We performed a retrospective single-center study including 389 consecutive children aged Results: ASDs were larger and rims deficiencies were more frequent in the TTE-guided group. The procedure was successful in 376 patients [96.7%; 95% confidence interval (CI), 94.4-98.2%]. The success rate tended to be higher in the TTE-versus TEE-guided group (98.0% versus 94.0%, P=0.069). Device migration occurred in 4 patients (1.0%; 95% CI: 0.3-1.6%), all after TEE-guided procedure (P=0.013).Early major adverse events were observed in 5 patients (1.3%; 95% CI: 0.4-3.0%), all in the TEE group (P=0.004). Fluroroscopic time and irradiation dose were not different among the 2 groups (P=0.450 and P=0.130 respectively). After a median follow-up of 7 years (range, 1-16 years), no adverse events was reported. One (0.3%, 95% CI: 0-1.4%) 12-year-old patient developed atrial fibrillation 5 years after the procedure. Pregnancies were uneventful in 72 cases.Conclusions: When a balloon sizing is performed, 2D-TTE imaging is as efficient as 2D-TEE to guide percutaneous ASD closure in children. The procedure can safely be done in spontaneously breathing children under TTE guidance alone in experienced centers.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 52%

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Transthoracic echocardiography is a safe alternative for assessment and guidance of transcatheter closure of secundum atrial septal defect in children

Baruteau¹,

Hascoët²,

Fraisse³

2017

J. Thorac. Dis.

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“…[1][2][3][4] However, erosion of the device through an atrial wall into the aorta or pericardial space (cardiac erosion) is a rare but serious adverse event that can occur early or late after ASD closure. [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17] The absolute risk of erosion after ASO implant has been estimated to range from 0.043% to 0.3%. 2,6,8,[17][18][19] The specific mechanisms and risk factors for device erosion remain unclear, and are likely to be multifactorial.…”

mentioning

confidence: 99%

“…However, there may be anatomic, patient-related, and procedural variables that are associated with an increased risk of erosion relative to the general population of patients undergoing ASD closure (ie, relative risk). Although multiple case reports, reviews, and analyses of the Manufacturer And User Facility Device Experience (MAUDE) database have been published, [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17] there are no studies that adequately speak to the question of relative or absolute erosion risk.…”

mentioning

confidence: 99%

Relative Risk Factors for Cardiac Erosion Following Transcatheter Closure of Atrial Septal Defects

et al. 2016

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Background-Transcatheter closure of secundum atrial septal defects (ASD) using the Amplatzer septal occluder is generally safe and effective, but erosion into the pericardial space or aorta has been described. Although the absolute risk of this complication is low, there has been no assessment of relative risk factors. Methods and Results-All erosions reported to St. Jude Medical after ASD closure with an Amplatzer septal occluder (cases) were compared with controls (matched 2:1) who underwent ASD closure but did not develop an erosion. A total of 125 erosions were reported between 2002 and 2014, including 95 with an available echocardiogram. The median duration from implant to erosion was 14 days, but was >1 year in 16 patients. Nine patients (all age ≥17 years) who died were more likely to have an oversized device, and to have erosion into the aorta, than survivors. Aortic or superior vena cava rim deficiencies were more common in cases than in controls. In addition, larger balloon-sized ASD diameter, Amplatzer septal occluder device size, and device size-ASD diameter difference, and smaller weight:device size ratio were associated with erosion. On multivariable analysis, deficiency of any rim, device >5 mm larger than ASD diameter, and weight:device size ratio were associated with erosion. Conclusions-In addition to aortic rim deficiency, which was almost universal among erosion cases, there were several relative risk factors for erosion after ASD closure with the Amplatzer septal occluder device. To understand the mechanisms of and absolute risk factors for this uncommon but serious complication, an adequately powered prospective study with thorough echocardiographic evaluation will be critical.

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Growth of the atrial septum after amplatzer device closure of atrial septal defects in young children

Gossett

Mansfield

Acevedo

et al. 2015

Cathet Cardio Intervent

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ASDs in young children are not central in the septum, but proximate to the aorta. After ASO, the device remains in close proximity to the aorta. With somatic growth, the septum grows asymmetrically, and device position relative to the aorta is constant. Our study was not powered to detect rare serious adverse events such as erosion, but aortic rims were consistently zero and yet no events occurred.

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Device therapy for atrial septal defects in a multicenter cohort: Acute outcomes and adverse events

Abstract: 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.

Cited by 53 publications

References 16 publications

Transthoracic echocardiography is a safe alternative for assessment and guidance of transcatheter closure of secundum atrial septal defect in children

Transthoracic echocardiography is a safe alternative for assessment and guidance of transcatheter closure of secundum atrial septal defect in children

Relative Risk Factors for Cardiac Erosion Following Transcatheter Closure of Atrial Septal Defects

Growth of the atrial septum after amplatzer device closure of atrial septal defects in young children

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