US Societies Lay Out Requirements for Transcatheter Tricuspid Valve Procedures

Why It Matters

By defining clear volume and team standards, the societies seek to ensure safety and efficacy while enabling broader adoption of TTVI, a rapidly growing segment of structural heart disease therapy.

Key Takeaways

• Minimum 50 open-heart surgeries required for TTVI program launch.
• Operators need ≥50 structural cases, including 20 TEER, to start.
• Multidisciplinary heart team must include cardiology, surgery, EP, imaging.
• CMS will reimburse TTVI under evidence development, mandating registry reporting.
• Quality metrics track 30‑day mortality, complications, and 1‑year outcomes.

Pulse Analysis

The transcatheter tricuspid valve space has moved from experimental to mainstream as FDA‑approved devices like Evoque and TriClip address a patient population with limited medical options. Industry analysts project double‑digit growth in TTVI volumes over the next five years, driven by an aging demographic and rising prevalence of severe tricuspid regurgitation. However, the rapid expansion has outpaced systematic oversight, prompting professional societies to codify best‑practice thresholds that safeguard outcomes while preserving access for high‑need centers.

The consensus document lays out concrete volume benchmarks that align with data from the STS Adult Cardiac Surgery Database and the TVT Registry. Hospitals must demonstrate robust structural programs—at least 50 open‑heart surgeries and 20 tricuspid surgeries in recent years—while operators need a track record of 50 structural cases, including 20 TEER procedures, before launching a TTVI service. A multidisciplinary heart team, encompassing interventional cardiology, cardiac surgery, electrophysiology, and advanced imaging, is required for each case, ensuring comprehensive patient evaluation and procedural expertise.

CMS’s decision to reimburse TTVI under a coverage‑with‑evidence‑development (CED) pathway adds a regulatory incentive for institutions to meet these standards. Mandatory reporting to the TVT Registry will generate real‑world safety and efficacy data, informing future guideline updates and payer policies. As quality metrics—such as 30‑day mortality, procedural complications, and one‑year rehospitalization—become integral to program accreditation, hospitals that invest early in meeting the outlined criteria are likely to capture market share and position themselves as leaders in this emerging therapeutic arena.