Case Study: When the UK TAVI Registry Became the Primary Evidence Source for NICE

Registry-Based Evidence in NICE HTG14

In NICE HTG14 (2025), NICE evaluated transcatheter heart valve technologies for transcatheter aortic valve implantation (TAVI).

A central aspect of the assessment was the extensive use of UK registry data — particularly the UK TAVI Registry linked with Hospital Episode Statistics (HES). According to NICE, this represented “the strongest source of UK contemporary clinical evidence for evaluating valve performance.”

The case provides an important example of how registry infrastructures can support Health Technology Assessment (HTA) decision-making within the NHS.

What Enabled the Registry to Support the Assessment

Several characteristics of the UK TAVI Registry contributed to its relevance for NICE:

- more than 80,000 procedures captured since 2007,
- national coverage of TAVI procedures,
- device-level granularity enabling valve-to-valve comparisons,
- linkage to Hospital Episode Statistics (HES),
- and matching using NHS trust, patient age and sex.

NICE further noted that the registry was considered reliable for routinely collected outcomes relevant to cost-effectiveness analyses, including mortality and stroke.

The linkage to HES data also enabled assessment of post-discharge outcomes and resource use, including readmissions and length of stay.

The Importance of Device-Level Granularity

One notable aspect of the registry infrastructure was the availability of device-level identifiers.

This enabled adjusted comparisons between different valve technologies rather than limiting analyses to broader procedural categories alone. NICE highlighted this as an important component of the evidence base.

The case illustrates how the structure and granularity of registry data can significantly influence its usefulness for comparative HTA assessments.

Registry Strengths — Despite Recognised Limitations

NICE also acknowledged limitations within the available data.

The assessment referred to “incomplete recording of some clinically important variables.”

However, despite these limitations, the UK registry evidence remained central to the evaluation because it reflected contemporary NHS practice and UK patient populations.

This demonstrates an important principle within registry-based evidence generation:

Even where limitations exist, mature national registries with broad coverage and relevant linkage infrastructure may still provide highly valuable evidence for HTA decision-making.

Implications for Evidence Generation Strategy

The UK TAVI Registry case highlights several factors that can strengthen the long-term HTA relevance of registry infrastructures:

- sustained longitudinal data collection,
- high procedural capture rates,
- device-specific coding structures,
- linkage to administrative datasets,
- and clinically relevant outcome tracking.

For manufacturers, the case also demonstrates that registry strategy is not solely a post-market evidence consideration. The structure, granularity and linkage capabilities of registries may directly influence future reimbursement and HTA assessments.

Conclusion

The NICE HTG14 assessment demonstrates how mature registry infrastructures can become a central evidence source for HTA and reimbursement evaluations.

The UK TAVI Registry combined long-term data collection, national coverage, device-level granularity and HES linkage to support comparative analyses relevant to NHS decision-making, despite acknowledged limitations in certain variables.

If you would like to discuss registry strategy, real-world evidence generation or HTA considerations for medical technologies, please feel free to contact the team at athagoras Medtech directly.