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Transvenous atrial septal defect occlusion in piglets with a "buttoned" double-disk device
E B Sideris1, S E Sideris, J P Fowlkes
1Heart Institute for CARE, Amarillo, Texas.
Circulation
|January 1, 1990
Summary
A novel device effectively closed atrial septal defects in piglets, demonstrating feasibility for human use. This transvenous closure method showed no thrombogenicity and complete occlusion within two months.
Area of Science:
- Cardiovascular Research
- Medical Device Innovation
- Interventional Cardiology
Background:
- Atrial septal defects (ASDs) are congenital heart conditions requiring closure.
- Transvenous device closure is a minimally invasive alternative to surgery.
- Novel devices are needed to improve safety and efficacy.
Purpose of the Study:
- To evaluate the feasibility and safety of a new transvenous device for atrial septal defect closure.
- To assess the device's performance and biocompatibility in a preclinical animal model.
Main Methods:
- Twenty piglets underwent creation of atrial septal defects via foramen ovale dilatation.
- A novel, hookless foam occluder device (20-25 mm) was deployed via a 7F or 8F sheath.
- Animals were monitored by angiography and color flow mapping for up to 2 months post-procedure.
Main Results:
- Complete occlusion of all atrial septal defects was achieved.
- The device demonstrated no thrombogenicity and achieved endothelialization within 2-3 weeks.
- Initial complications with prototype devices were resolved through design modifications and improved operator experience.
Conclusions:
- Transvenous closure of moderate-sized atrial septal defects using this new device is feasible and safe in piglets.
- The device's design and deployment method show promise for future human clinical application.
- Further refinement and clinical trials are warranted to confirm efficacy in patients.