First-in-Human Use of a Novel Dual-Mechanism Transcatheter Tricuspid Repair Device

新型双机制经导管三尖瓣修复装置首次人体应用

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Abstract

BACKGROUND: Transcatheter tricuspid valve intervention offers an alternative to surgery in high-risk patients with severe symptomatic tricuspid regurgitation (TR). FIRST-IN-HUMAN/EARLY REPORTS SUMMARY: We report the first-in-human use of a novel transcatheter tricuspid valve repair device (Versa Vascular) that stabilizes annular dilation and induces regurgitant orifice sealing. The patient, an 85-year-old woman with symptomatic severe isolated functional TR, was considered high risk for open surgery, with unsuitable anatomy for other transcatheter-based options. DISCUSSION: As transcatheter tricuspid valve intervention evolves, devices must balance clinical outcomes and procedural versatility. Multimodal mechanisms of action that reduce TR across varied anatomies while preserving procedural safety and simplicity are essential. This technology shows promise with ease of use and reproducible results. NOVELTY: The Versa Vascular system limited annular dilatation and reduced TR severity without affecting right ventricular function. TAKE-HOME MESSAGE: This first-in-human experience demonstrated safe implantation of a novel transcatheter repair device, with sustained TR reduction and improved functional status at 90 days.

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