Minimal Invasive Retrieval of Dislodged Amplatzer Occluder with Subsequent Impediments
ABSTRACT A 47-year-old female underwent interventional patent foramen ovale (PFO) closure with an Amplatzer septal occluder (AGA Medical Corporation, USA). After 48 hours of implantation, she experienced intermittent pulse synchronous retrosternal pain. Subsequently, device-associated compression of the aortic root was diagnosed. Occluder retrieval and surgical PFO-closure was accomplished successfully via minimal invasive, video-assisted anterolateral thoracotomy.
[Show abstract] [Hide abstract]
ABSTRACT: 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.Catheterization and Cardiovascular Interventions 12/2004; 63(4):496-502. DOI:10.1002/ccd.20211 · 2.51 Impact Factor
The Annals of thoracic surgery 04/2005; 79(3):e28. DOI:10.1016/j.athoracsur.2004.04.077 · 3.45 Impact Factor
[Show abstract] [Hide abstract]
ABSTRACT: Amplatzer (AGA Medical Corporation, Plymouth, Minn) septal and vascular occluder devices have significantly altered the care of patients with congenital heart disease. The relative frequency and consequence of complications resulting from the attempted placement of such devices, however, have not been well assessed. The purpose of this study is to use large databases to assess the frequency and severity of such complications and compare them with those of surgical atrial septal defect closure. The US Food and Drug Administration Manufacturer and User Facility Device Experience database was quarried for all adverse events for Amplatzer septal occluder devices, which were categorized and analyzed with particular emphasis on management and outcome. The Society of Thoracic Surgery database was likewise quarried for the same data regarding atrial septal defect closures over a contemporaneous time period. By using a literature-derived denominator for total Amplatzer implant numbers, the results of the 2 therapies were compared. Since July 1, 2002, 223 adverse events in patients undergoing Amplatzer atrial septal defect closure were submitted to the Food and Drug Administration, resulting in 17 deaths (7.6%) and 152 surgical rescue operations (68.2%). Society of Thoracic Surgery data demonstrated 1537 primary operations with 2 deaths (0.13%) and 6 reoperations (0.39%). By extrapolating on published estimates of Amplatzer implantation to provide an implant denominator (n = 18,333), there was no difference between overall mortality for surgical (0.13%) and device closure (0.093%, P = .649). Rescue operation for device adverse events (0.83%) was 2.1 times more likely than reoperation for surgical closure (0.39%, P = .063). Mortality per adverse event was higher for device closure (7.6%) than for surgical closure (1.2%, P = .004), and the need for surgery per adverse event was higher for device closure (68.2%) than for surgical closure (3.6%, P < .001). The mortality for surgical management of a device adverse event (2.6%) was 20-fold higher than for primary elective atrial septal defect closure (0.13%, P < .0001). Overall crude mortality for device and surgical closure atrial septal defect closure is equivalent, and the need for subsequent operation (surgical rescue) is more common in patients undergoing device closure than reoperation is in patients undergoing surgical closure. Complications from device closure tend to be serious and most often require urgent or emergency operative management, whereas the mortality for surgical management of a device complication appears higher than that of elective atrial septal defect closure. Further information is required in the form of postmarketing surveillance, such as a mandatory user registry with periodic end-user notification.The Journal of thoracic and cardiovascular surgery 06/2009; 137(6):1334-41. DOI:10.1016/j.jtcvs.2009.02.032 · 3.41 Impact Factor