Evidence‑to‑procurement clinical governance in the Emilia‑Romagna TAVI case
Abstract
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.
Related
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- Clinical efficacy and safety of medicines procured through China’s national volume-based procurement policy: a systematic review of 81 studies
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BibTeX
@article{rallo2026evidencetoprocurement,
title = {{Evidence‑to‑procurement clinical governance in the Emilia‑Romagna TAVI case}},
author = {F Rallo and A Bortolami and L Sciolino and A Puccini and A Negro and D Di Lorenzo and MD Camerlingo and V Barbagallo and F Casoni and A Gentili},
journal = {The European Journal of Public Health},
year = {2026},
month = oct,
doi = {10.1093/eurpub/ckag169.1907},
url = {https://doi.org/10.1093/eurpub/ckag169.1907},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Evidence‑to‑procurement clinical governance in the Emilia‑Romagna TAVI case
AU - F Rallo
AU - A Bortolami
AU - L Sciolino
AU - A Puccini
AU - A Negro
AU - D Di Lorenzo
AU - MD Camerlingo
AU - V Barbagallo
AU - F Casoni
AU - A Gentili
PY - 2026
DA - 2026/10/01
JO - The European Journal of Public Health
DO - 10.1093/eurpub/ckag169.1907
UR - https://doi.org/10.1093/eurpub/ckag169.1907
AB - 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.
SN - 1101-1262
SN - 1464-360X
ER -