Excellent Endothelialization of the GORE CARDIOFORM Septal Occluder: First-in-Human in Vivo Angioscopic Assessment

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J INVASIVE CARDIOL 2025. doi:10.25270/jic/25.00030. Epub February 28, 2025.

Current guidelines recommend at least 6 months of antithrombotic and antibiotic prophylaxis following transcatheter closure of interatrial communication until device “endothelialization” is achieved. However, the exact time required for complete in vivo endothelialization remains unclear. A novel angioscopic approach from the right atrium was developed to visualize device coverage, and one-third of atrial septal defect closure devices were reported to have insufficient endothelialization at 6 months. It was also observed that an Amplatzer patent foramen ovale (PFO) Occluder (Abbott) was mostly endothelialized by 12 months, although incomplete coverage persisted in the central part, where metal volume is substantial. The GORE CARDIOFORM Septal Occluder (GSO) (W.L. Gore & Associates) is a novel, wireframe-type PFO closure device composed of a helical nitinol wireframe covered with expanded polytetrafluoroethylene (ePTFE), which is considered biocompatible and conducive to rapid endothelialization.

A 68-year-old woman with cryptogenic stroke underwent transcatheter PFO closure with a 25-mm GSO device. Angioscopic evaluation at 12-month follow-up revealed excellent endothelial coverage of the entire device (Figure A, Video 1), including the wireframes (Figure B, Video 2) and the central hook (Figure C, Video 3). This in vivo evaluation of the GSO indicates that robust endothelialization can be achieved by 12 months. These findings, along with a high closure success rate of this device, may support earlier termination of antithrombotic therapy.

Affiliations and Disclosures

Yasuhiro Tanabe, MD, PhD; Taturo Shouji, MD; Ryutaro Oda, MD; Daisuke Miyahara, MD; Yukio Sato, MD, PhD; Taishi Okuno, MD; Shingo Kuwata, MD, PhD; Masaki Izumo, MD, PhD; Yoshihiro J. Akashi, MD, PhD

From the Department of Cardiology, St. Marianna University School of Medicine, Kanagawa, Japan.

Disclosures: The authors report no financial relationships or conflicts of interest regarding the content herein.

Funding: This work was supported by a Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science.

Consent statement: The authors confirm that informed consent was obtained from the patients for the interventions described in the manuscript and for the publication thereof.

Adress for correspondence: Yasuhiro Tanabe, MD, PhD, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1, Sugao, Miyamae-ku, Kawasaki-City, Kanagawa 216-8511, Japan. Email: y-tanabe@marianna-u.ac.jp