Evidence‑to‑procurement clinical governance in the Emilia‑Romagna TAVI case

Issue/problem TAVI volumes and related device expenditure have increased rapidly across European health systems. The 2025 ESC/EACTS Guidelines lowered the recommended age threshold from 75 to 70 years, anticipating expansion of eligible populations. This creates a governance challenge for regional health systems: aligning technology adoption with evidence maturity, equity of access and financial sustainability. Description of the problem Administrative data from Emilia‑Romagna (Italy, 4.5M inhabitants) showed TAVI procedures rising from 699 (2019) to 1252 (2024) – 209 per million inhabitants, twice the 2019 projection – with an 82% increase in device expenditure (€17M/year). In response, the Region introduced an integrated governance framework (2025–2026) combining independent appraisal of international guidelines, regionally defined eligibility criteria, centralised procurement and real‑time outcome monitoring. Results Clinical governance was operationalised through binding organisational standards: mandatory Heart Team evaluation with geriatric assessment for frail patients (Clinical Frailty Scale 3–7); minimum activity thresholds (≥100 TAVI/year per hub; ≥50 per operator); unified waiting lists; a platform‑level clinical‑organisational coordinator; and explicit outcome targets. Independent appraisal supported the ≥75‑year age threshold, while preserving access for younger high‑risk or inoperable patients. Centralised procurement contributed to containing unit‑cost growth. Lessons Clinical governance of high‑cost devices is effective only when embedded in the organisational model itself. Integrating eligibility criteria, structured multidisciplinary assessment, volume standards and procurement into a coherent system strengthens accountability mechanisms that isolated policy instruments cannot achieve. The model is transferable to other high‑cost technologies and to health systems with comparable regional planning capacity. Key messages • The rapid expansion of high-cost device indications and rising expenditures challenge regional health systems to align technology adoption with evidence maturity and financial sustainability. • Effective clinical governance embeds eligibility, volume standards, multidisciplinary assessment and procurement across the health system.