Major Complications Associated with Transcatheter Atrial Septal Occluder Implantation: A Review of the Medical Literature and the Manufacturer and User Facility Device Experience (MAUDE) Database

Abstract

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.

Recent Changes in Instructions for Use for the Amplatzer Atrial Septal Defect Occluder: How to Incorporate These Changes While Using Transesophageal Echocardiography or Intracardiac Echocardiography?

“…However, the procedure carries a risk of early and late complications, including thrombus formation, device embolization, wire fracture, nickel allergy, arrhythmias, cerebrovascular accident, and atrial wall with occasional aortic wall erosion. The worst of these complications is atrial wall erosion, also called ''perforation'' [2,6,7]. Based on the description of surgeons, the erosions occur in the anteriorsuperior region of the atrial wall, an area that corresponds to the aortic and the superior rim on echocardiography.…”

Effect of Resident Performance on Midurethral Sling Cure and Complication Rates

“…Veriler sayı(%) olarak gösterilmiştir. * Ki kare testi uygulanmıştır nadir görülen çok ciddi komplikasyonlar da bildirilmeye başlan-mıştır [11][12][13]. Ciddi komplikasyonların bildirilmeye başlanması ile, asistan eğitirken bir tedirginlik ve çekingenlik olması muhtemeldir.…”

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

“…[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.…”

“…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.…”

“…[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. 20,21 Given the rarity of this event, it is unlikely that there are discrete absolute risk factors that are sufficiently strong to contraindicate device closure of an ASD.…”