Transcatheter heart valves for transcatheter aortic valve implantation to treat aortic stenosis: late-stage assessment

  • Health technology evaluation
  • HTE31
  • Published: 
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1 Recommendations

1.1

There is not enough evidence to determine whether price variation is justified between different transcatheter heart valves for transcatheter aortic valve implantation (TAVI) in adults with aortic stenosis.

1.2

NHS trusts should provide access to a range of transcatheter heart valves, so that a clinically appropriate valve is available for everyone with aortic stenosis having TAVI.

1.3

If more than one transcatheter heart valve is clinically appropriate, use the least expensive valve.

1.4

Details of everyone having the procedure should be entered into the UK TAVI registry managed by the National Institute for Cardiovascular Outcomes Research. Contact [email protected] for details.

What information is needed

More information is needed to determine whether price variation between different transcatheter heart valves can be justified. This can be from primary studies or secondary analyses of real-world data sources, such as the UK TAVI registry.

Key outcomes and information that should be captured include:

  • mortality

  • stroke

  • paravalvular leak or aortic regurgitation

  • permanent pacemaker implantation

  • reintervention

  • resource use including for treatment and length of stay

  • the specific valve used

  • the person's surgical risk.

All studies and analyses of real-world data should adjust for a range of confounding factors including the:

  • impact of anatomical characteristics of the valve being replaced

  • impact of calcium around the valve

  • person's age, sex, ethnicity and medical history.

What this means in practice

Considerations for procurement and commissioning

  • The number of TAVI procedures done annually is rising (NICOR UK TAVI registry 2024 summary report). So, it is important that the NHS ensures the best value for money when buying transcatheter heart valves.

  • 'Added value' agreements between companies and the NHS Supply Chain allow for part of the cost of a valve to be returned to the NHS or to an NHS trust based on the number of valves purchased. Even after accounting for 'added value' agreements, the NHS may benefit more from negotiating lower list prices. This is because 'added value' agreements may not release resources for the NHS.

Considerations for healthcare professionals

  • When choosing a clinically appropriate transcatheter heart valve, consider the anatomy and characteristics of the valve being replaced, as well as the person's age, comorbidities and other factors that can make a particular valve more suitable. Also consider the preferences of the person with aortic stenosis when choosing which transcatheter heart valve to use, and follow the principles in NICE's guidance on shared decision making.

  • Healthcare professionals should work with commissioners and procurement specialists in their NHS trust to ensure access to a range of clinically appropriate valves and to understand the relative costs of the valves. Consider emerging evidence in these discussions.

Why the committee made these recommendations

Transcatheter heart valves are used to replace a narrowed aortic valve or a failed bioprosthetic valve in people with aortic stenosis. There are many transcatheter heart valves available, which vary in features and cost. This assessment aimed to determine whether the differences in clinical, economic and non-clinical outcomes attributed to different valves could justify price variation.

For many people with aortic stenosis, several of the available valves could be used. For some people, a specific valve may be more appropriate. The effectiveness of individual valves is likely to depend on both the features of the valve and the characteristics of the person with aortic stenosis.

Analyses of real-world data from the UK TAVI registry are limited because of unrecorded confounders (factors that may affect the results), missing data and short follow up. There is no high-quality published evidence that is as relevant to the UK population as the TAVI registry data. The results from an economic evaluation based on real-world data analyses in the UK are too uncertain to determine whether the differences in cost between valves are justified.

More evidence is needed to show whether differences in price between valves can be justified by differences in effectiveness. If a new valve costs more, this should be justified with evidence showing that it works better than existing valves. Evidence needs to be comparative and adjust for baseline characteristics that have a large impact on outcomes. These baseline characteristics should also be recorded in the UK TAVI registry. This is to ensure that results reflect how well the valve works and not the characteristics of the people it is used in.