Case Study: When a Registry Becomes the SOLE Evidence Source

In 2025, NICE conducted a late-stage assessment of transcatheter aortic valve implantation (TAVI) devices.

The decision?

Rely ENTIRELY on UK registry data instead of international RCTs.

📊 THE UK TAVI REGISTRY + HES LINKAGE:

What made it work:

✓ 80,000+ procedures captured since 2007

✓ Device-level granularity (valve-to-valve comparisons possible)

✓ Linkage to Hospital Episode Statistics for post-discharge outcomes

✓ NHS trust, patient age, and sex matching enabled robust analysis

✓ "Reliable for routinely collected outcomes important for cost-effectiveness analyses, such as mortality and stroke"

🎯 NICE's Verdict:

"The strongest source of UK contemporary clinical evidence for evaluating valve performance, enabling adjusted comparisons between valves by recording relevant patient characteristics and outcomes within routine practice."

⚠️ The Limitation:

"Incomplete recording of some clinically important variables" — but still preferred over international trial data for NHS decision-making.

💡 The Strategic Lesson:

This is the GOLD STANDARD for registry-based HTA evidence:

• Long-term data collection (17+ years)
• National coverage with high capture rates
• Device-specific identifiers (not just procedure codes)
• Linkage to administrative data (HES) for hard outcomes
• UK-specific populations reflecting NHS practice For cardiac device manufacturers:

The UK TAVI Registry isn't supplementary evidence — it IS the evidence base.

Plan accordingly.

Have you seen other examples where registries replaced RCTs as primary evidence?