Key result
TOPAZ transcatheter tricuspid valve replacement successfully treats failed annuloplasty ring with early symptomatic improvement.
Why the study?
Recurrent tricuspid regurgitation after surgical annuloplasty is common and redo surgery carries high risk; transcatheter valve-in-ring approaches are limited by paravalvular leak especially with incomplete rings.
Case Report (n=1)
No
This first-in-human case demonstrates that the TOPAZ transcatheter tricuspid valve replacement device is a feasible treatment option for recurrent regurgitation in large, incomplete surgical annuloplasty rings, minimizing paravalvular leak.
Successful TOPAZ implantation after failed annuloplasty supports feasibility; hypothesis-generating and requires prospective trials before wider use.
BACKGROUND: Recurrent tricuspid regurgitation (TR) after surgical annuloplasty is a common challenge, and redo surgery carries high risk. Transcatheter valve-in-ring approaches are often limited by paravalvular leak (PVL), especially with incomplete bands. FIRST-IN-HUMAN/EARLY REPORTS SUMMARY: The novel transcatheter tricuspid valve replacement (TTVR) system TOPAZ (TRiCares) offers a therapeutic option for high-risk patients with severe TR. DISCUSSION: The TOPAZ dual-stent design includes a conformable outer frame that may improve annular sealing, reduce paravalvular leak, limit patient-prosthesis mismatch, and minimize right ventricular interaction. NOVELTY: This case describes the first-in-human use of TOPAZ TTVR to treat recurrent TR in a failed incomplete surgical annuloplasty band. TAKE-HOME MESSAGES: TOPAZ TTVR is feasible in failed annuloplasty rings/bands. Its conformable design may reduce paravalvular leak and provide a treatment alternative to patients with large surgical rings/bands.
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Saad et al. (2026) conducted a case report in Recurrent tricuspid regurgitation (n=1). TOPAZ Transcatheter Tricuspid Valve Replacement (TTVR) was evaluated on Procedural success and clinical improvement at 30 days. The TOPAZ transcatheter tricuspid valve replacement system was successfully implanted in a patient with a failed annuloplasty ring, resulting in symptomatic improvement to NYHA class II and only mild paravalvular leak at 30 days.
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