Transcatheter closure of secundum ASD using a permanent implant is considered the standard of care for treatment of clinically significant ASD. Over the past twenty years, devices have evolved such that safety and effectiveness are equal or superior to surgical techniques while reducing the economic and psychological costs of care. Industry sources estimate that, globally, over half a million patients have received a septal occluder to treat atrial level shunts.
A key remaining drawback to all such devices is that they are permanent implants placed in a typically young population. Unlike surgical suture, which resorbs over time, all currently available septal occlusion implants are constructed with a metal framework that incorporates some amount of fabric-based material.
The reSept ASD Occluder is unique in that the framework of the implant is comprised of a bioresorbable material (PLGA) and is intended for use in patients with a clinically significant secundum ASD, who, in the judgment of their physician, require closure of the ASD and in whom a transcatheter approach is deemed appropriate.
Adults with Cognitive Heart Disease (ACHD) now outnumber children with CHD. ACHD patients can demonstrate some neurocognitive deficits which may reduce their quality of life. The goal of this research is to determine if the mind's ability to resist damage of the brain can impact the development and neurocognitive outcomes in ACHD patients.
REDUCE study is researching the safety and effectiveness of GORE® CARDIOFORM Septal Occluder (GSO ) device in closing the patent foramen ovale (PFO) in patients who have a PFO and had a stroke of unknown origin (cryptogenic stroke). This device has been approved by the United States Food and Drug Administration for this indication.
A PFO is a common opening in the wall (septum) between the two upper chambers (the right and left atria) of the heart. In most cases, this opening closes around the time of birth. If the opening remains after birth, it can allow the blood to mix in the two upper chambers of the heart.
In most people, leaving the opening untreated has no negative consequences. However, in some patients who have had a stroke of unknown origin (cryptogenic stroke), the presence of a PFO may increase the risk of having another stroke if the opening is left untreated.
This is a multicenter cross-sectional pilot analysis of objective and subjective neurocognitive deficits (NCD) and genetics in the Adults with Congenital Heart Disease (ACHD) population ages 18-30 years with moderate and severe complexity of congenital heart disease (CHD).
The expectation is that studying NCD in ACHD will help to guide access to resources and appropriate medical care for these patients. This research should facilitate the use of targeted interventions in the ACHD population with NCD to enhance both long term quality of care and quality of life (QOL).