Why the study?
Transcatheter tricuspid valve intervention offers an alternative to surgery for high-risk patients with severe symptomatic tricuspid regurgitation, prompting the evaluation of a novel dual-mechanism repair device.
Does the Versa Vascular transcatheter repair device safely reduce tricuspid regurgitation and improve functional status in a high-risk patient with severe functional tricuspid regurgitation?
Does the Versa Vascular transcatheter repair device safely reduce tricuspid regurgitation and improve functional status in a high-risk patient with severe functional tricuspid regurgitation?
This first-in-human case report demonstrates the feasibility, procedural safety, and early efficacy of the novel Versa Vascular transcatheter tricuspid repair system in reducing severe functional tricuspid regurgitation.
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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Nejjari et al. (2026) studied this question.
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