“…Erosion events associated with the ASO device have occurred at the roof of the right or left atrium or at the atrial junction with the aorta, causing hemopericardium, tamponade or aortic fistula [3–26]. The reasons for erosion are unknown, but several risk factors have been proposed, all of which increase the chance of contact between the device and the atrial wall: absent or deficient superior–anterior rim [4, 6, 9, 16, 17, 20–22, 24–26], device‐sizing (over‐sizing [6, 13, 20, 22, 24, 25] vs. under‐sizing [9]), both of which predispose toward contact of the device with the aortic root [3, 6, 9, 25]; and/or device‐straddling of the aorta (presence [4, 18] versus absence [10]). Early risk factors have also been proposed such as deformation of the device at the aortic root at 24 h and early pericardial effusion [24].…”
Cardiac erosion is a rare but serious complication of the ASO device. Erosion events are most often ascribed to device over-sizing or deficient retro-aortic rims; however, both consensus and evidence for a cogent risk factor(s) is lacking. Further assessment of the root cause of erosion and true incidence of this complication is required; analyses using control patients and/or device registry establishment represent logical next steps.
“…Erosion events associated with the ASO device have occurred at the roof of the right or left atrium or at the atrial junction with the aorta, causing hemopericardium, tamponade or aortic fistula [3–26]. The reasons for erosion are unknown, but several risk factors have been proposed, all of which increase the chance of contact between the device and the atrial wall: absent or deficient superior–anterior rim [4, 6, 9, 16, 17, 20–22, 24–26], device‐sizing (over‐sizing [6, 13, 20, 22, 24, 25] vs. under‐sizing [9]), both of which predispose toward contact of the device with the aortic root [3, 6, 9, 25]; and/or device‐straddling of the aorta (presence [4, 18] versus absence [10]). Early risk factors have also been proposed such as deformation of the device at the aortic root at 24 h and early pericardial effusion [24].…”
Cardiac erosion is a rare but serious complication of the ASO device. Erosion events are most often ascribed to device over-sizing or deficient retro-aortic rims; however, both consensus and evidence for a cogent risk factor(s) is lacking. Further assessment of the root cause of erosion and true incidence of this complication is required; analyses using control patients and/or device registry establishment represent logical next steps.
“…31,42 They included device migration/malposition, infection, severe arrhythmias, thromboembolism, device-related valvular regurgitation, and cardiac erosion/perforation. 5,[9][10][11]43,44 Device erosion has been reported in 0.1% of cases, chiefly in patients with aortic rim deficiency and is probably ascribable to the use of an oversized device. 5,6,35 Whether device closure of ASD carries a risk of progressive aortic insufficiency remains controversial.…”
Section: Long-term Outcomes After Large Asd Closurementioning
confidence: 99%
“…Concern about deploying large devices has been exacerbated by recent reports of severe complications such as aortic erosion, cardiac perforation, atrioventricular block, or device-related aortic regurgitation. [9][10][11][12] The Amplatzer Septal Occluder (ASO, Saint Jude Medical, St Paul, MN) is the most widely used device for percutaneous ASD closure worldwide.…”
Background-Data are needed on the safety and efficacy of device closure of large atrial septal defects. Methods and Results-Between 1998 and 2013, 336 patients (161 children <15 years) with large, isolated, secundum atrial septal defects (balloon-stretched diameter ≥34 mm in adults or echocardiographic diameter >15 mm/m 2 in children) were managed using the Amplatzer device, at the Marie Lannelongue Hospital. Transthoracic echocardiographic guidance was used starting in 2005 (n=219; 65.2%). Balloon-stretched diameter was >40 mm in 36 adults; mean values were 37.6±3.3 mm in other adults and 26.3±6.3 mm/m 2 in children. Amplatzer closure was successful in 311 (92.6%; 95% confidence interval, 89%-95%) patients. Superior and posterior rim deficiencies were more common in failed than in successful procedures (superior, 24.0% versus 4.8%; P=0.002; and posterior, 32.0% versus 4.2%; P<0.001). Device migration occurred in 4 adults (2 cases each of surgical and transcatheter retrieval); in the 21 remaining failures, the device was unreleased and withdrawn. After a median follow-up of 10.0 years (2.5-17 years), all patients were alive with no history of late complications. Conclusions-Closure of large atrial septal defects using the Amplatzer device is safe and effective in both adults and children. Superior and posterior rim deficiencies are associated with procedural failure. Closure can be performed under transthoracic echocardiographic guidance in experienced centers. Early device migration is rare and can be safely managed by device extraction. Long-term follow-up showed no deaths or major late complications in our population of 311 patients. (Circ Cardiovasc Interv. 2014;7:837-843.)
“…[2][3][4][5][6] However, early and late cardiac erosion/perforation after ASD closure with the device, which is a rare but life-threatening complication, has been reported. [7][8][9][10][11][12][13][14] The cause of erosion has not yet been fully clarified. Meanwhile, there is a report that the profile of ASO becomes lower within 6 months after deployment.…”
As the device becomes thinner, loses its flexibility, and often changes from a flare-to-closed shape on the aortic side over time, the edges of ASO can start to compress the atrial and aortic walls. However, erosion was not recognized in these cases.
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