Over the past seven decades, significant advancements and innovations have occurred in the field of percutaneous atrial septal defect (ASD) closure using transcatheter-based devices. This article focuses on the current literature surrounding the three Food and Drug Administration (FDA)-approved devices for ASD and patent foramen ovale (PFO) closure in the United States, namely, the Amplatzer Septal Occluder (ASO), Amplatzer Cribriform Occluder, and Gore Cardioform ASD Occluder. The ASO has been widely used since its FDA approval in 2001. Studies have shown its high success rate in closing ASDs, especially small-sized defects. The RESPECT trial demonstrated that PFO closure using the ASO reduced the risk of recurrent ischemic stroke compared to medical therapy alone. The Closure of Atrial Septal Defects With the Amplatzer Septal Occluder Post-Approval Study (ASD PMS II) evaluated the safety and effectiveness of ASO in a large cohort of patients, reporting a high closure success rate and rare hemodynamic compromise. The Amplatzer Cribriform Occluder is designed for the closure of multifenestrated ASDs and has shown promising results in small-scale studies. It successfully closed the majority of fenestrated ASDs, leading to improved right ventricular diastolic pressure without major complications. The REDUCE trial compared PFO closure using the Gore Helex Septal Occluder and Gore Cardioform Septal Occluder with antiplatelet therapy alone. The study demonstrated that PFO closure significantly reduced the risk of recurrent stroke and brain infarction compared to antiplatelet therapy alone. However, the closure group had a higher incidence of atrial fibrillation or atrial flutter. There is a risk of atrial fibrillation with the use of ASO as well. The FDA-approved Gore Cardioform ASD Occluder showed excellent performance in the ASSURED clinical study. The device achieved high technical success and closure rates, with low rates of serious adverse events and device-related complications. A meta-analysis comparing transcatheter ASD closure with surgical closure revealed that the transcatheter approach had a high success rate, lower rates of adverse events, and shorter hospital stays compared to surgery, without any mortality. Complications associated with transcatheter ASD closure have been reported, including femoral arteriovenous fistulas, device embolization, cardiac erosion, aortic incompetence, and new-onset migraine. However, these complications are relatively rare. In conclusion, transcatheter ASD closure using FDA-approved devices has proven to be safe and effective in the majority of cases. These devices offer excellent closure rates, reduced risk of recurrent stroke, and shorter hospital stays compared to surgery. However, careful patient selection and follow-up are necessary to minimize complications and ensure optimal outcomes.
Copyright © 2023, Shrivastava et al.