First Experience Using a Nonfenestrated Cardioform Septal Occluder for Closure of Giant Mitral Paravalvular Leak

Abstract

A variety of fenestrated vascular plugs have been used to seal paravalvular leaks with meaningful success; however, incomplete closure and refractory hemolysis remains a common problem. We describe the feasibility and rationale of their first experience using a nonfenestrated Cardioform Septal Occluder (Gore Medical, Flagstaff, Arizona) to treat a giant mitral paravalvular leak. ( Level of Difficulty: Advanced. )

The Gore Cardioform Atrial Septal Defect Occluder: A novel solution to the management of severe hemolysis following transcatheter septal defect closure

“…However, the wire frame is externally wrapped in expanded polytetrafluoroethylene (ePTFE), which is imporous, 14 a potentially advantageous design limiting red blood cell exposure to the wire frame and porous polyester weave. The use of a Gore ASD Occluder to effectively seal a high‐velocity shunt is not without some precedent and has recently been described in the successful occlusion of a perivalvular leak, 15 although, to the best of our knowledge, this is the first case report of successful transcatheter occlusion of a Gerbode defect using the Gore ASD Occluder.…”

Cardioform Septal Occluder for the Closure of a Peri-Device Leak After Initial Watchman Implantation

“…CSO is a non-fenestrated endovascular plug that is available in three different sizes (20, 25, and 30 mm) and approved for the closure of interatrial septal defects. Similar to other off-label indications [ 13 ], the CSO adequately conformed within the residual leak gap given its ability to provide unique conformability and adapt to a broad variability morphology. Device selection was based on a) the size and shape of the PDL and b) the soft-atraumatic, non-fenestrated, and conformable nature of the CSO.…”

Paravalvular Leak Closure With a Nonfenestrated Device

“…We commend Cubeddu et al. ( 4 ) for their excellent case presentation and share their interest in the use of a nonfenestrated device. In patients with severe, transfusion-dependent hemolysis, there is a drive to achieve complete resolution of the aberrant flow (although reducing the leak size can paradoxically increase hemolysis).…”

“…In this issue of JACC: Case Reports , Cubeddu et al. ( 4 ) describe a case in which they offered symptomatic relief to an unwell patient with a large PVL after bioprosthetic mitral valve replacement by using the Cardioform Septal Occluder device (CSO, Gore Medical, Flagstaff, Arizona).…”