What is Helex septal occluder?
The GORE® HELEX® Septal Occluder is an approved medical device indicated for the transcatheter closure of atrial septal defects (ASDs). The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).
What is an atrial septal occluder?
The AMPLATZER Septal Occluder (ASO; St. Jude Medical [now Abbott], St. Paul, MN) is a self-expandable, double-disc, occlusion device made of Nitinol mesh, approved by the US Food and Drug Administration in 2001 for percutaneous closure of secundum atrial septal defect (ASD).
What is erosion of the heart?
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. The absolute risk of erosion after ASO implant has been estimated to range from 0.043% to 0.3%.
Can we survive with an atrial septal defect?
Several patients tolerate large unrepaired defects for 80 years or even longer without serious disability. However, it is assumed that, as a rule, atrial septal defect reduces life expectancy, the average age at death not exceeding 50 years.
What is an Amplatzer device?
An AMPLATZER PFO Occluder is a device specifically designed to stop blood flow through all types of PFO (Figure 3). The device is placed in the PFO during a catheter-based procedure and will remain permanently implanted. The AMPLATZER PFO Occluder is made from a Nitinol wire mesh with shape memory characteristics.
Is ASD life threatening?
In severe cases, ASD can cause life-threatening effects such as chest pain, irregular heartbeats (arrhythmias), abnormal heart enlargement, heart fluttering (atrial fibrillation), and heart failure. Surgery may be necessary to prevent serious complications.
Does atrial septal defect require surgery?
Your health care provider will discuss with you when you or your child needs treatment. Many persistent atrial septal defects eventually require surgery. However, closure isn’t recommended if severe pulmonary hypertension is present.
What do you understand by erosion?
Erosion is the geological process in which earthen materials are worn away and transported by natural forces such as wind or water. A similar process, weathering, breaks down or dissolves rock, but does not involve movement.
How do they fix a hole in the heart?
Open-heart surgery. This type of atrial septal defect repair surgery involves an incision through the chest wall to access the heart directly. The surgeons use patches to close the hole. This open-heart repair surgery is the only way to fix primum, sinus venosus and coronary sinus atrial defects.
How serious is an atrial septal defect?
Severe cases of atrial septal defects may lead to life-threatening complications such as chest pain, irregular heartbeats (arrhythmias), abnormal enlargement of the heart, a “fluttering” of the heart (atrial fibrillation), and/or heart failure.
How would you treat a patient with an atrial septal defect?
Many cardiologists recommend surgery to repair a medium to large atrial septal defect that’s diagnosed during childhood or adulthood to prevent future complications. For adults and children, atrial septal defect repair surgery involves closing the hole in the heart. This can be done two ways: Catheter-based repair.
What is an occluder for the heart?
Device Description The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. The two discs are linked together by a short, connecting waist, allowing free motion of each disc. In order to increase its closing ability, the discs contain thin polyester fabric.
Are atrial septal defect occluder devices associated with delayed erosion?
Objective: To systematically review all cases in the literature of erosion associated with atrial septal defect (ASD) occluder devices. Background: Delayed erosion of the aortic or atrial wall is an infrequent but potentially lethal complication of percutaneous septal defect closure using an ASD device.
Is the Gore HeLEX septal occluder device complicated 9 years after placement?
We describe the case of a partially embolised and fractured Gore Helex Septal Occluder device recognised nearly 9 years after placement requiring surgical explant.
Is cardiac erosion a cogent risk factor for ASO devices?
Conclusion: 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.