Transcatheter aortic valve implantation (TAVI) for people with severe aortic stenosis who are at low surgical risk
Scottish Health Technologies Group (SHTG)
SHTG Recommendations for NHSScotland
Transcatheter aortic valve implantation (TAVI) should be considered for people with symptomatic severe aortic stenosis who are at low surgical risk. TAVI is likely to be cost effective compared with surgical aortic valve replacement (SAVR) in this population, depending on TAVI device costs. Procurement decisions should be coordinated to ensure that Scotland achieves the best value when purchasing TAVI valves.
Approximately 80% of people with symptomatic severe aortic stenosis are at low surgical risk. Offering TAVI to patients who are at low surgical risk will require increasing the capacity of healthcare services to deliver equitable access to TAVI across NHSScotland. Priority access to TAVI services should be maintained for people in higher surgical risk categories.
NHSScotland is required to consider the Scottish Health Technologies Group (SHTG) advice.
How the Council reached the recommendation
- The Council recognised that not all patients who are classed as low surgical risk are suitable for TAVI. The decision on whether TAVI is the best treatment option for each patient is made by a multidisciplinary team as part of the shared decision making process. This ensures that each patient is offered the most appropriate treatment for their individual circumstances.
- The Council agreed that TAVI was clinically beneficial and offered an improved safety profile compared with SAVR for patients in the low surgical risk group. The Council also agreed that TAVI may lead to an improved procedure related experience for patients compared with SAVR, based on quality of life evidence and qualitative studies.
- The Council discussed the significance of people who had TAVI being more likely to
experience paravalvular leaks compared with SAVR. An invited clinical expert explained that it is difficult to compare rates of paravalvular leaks between the two interventions, and that only moderate or severe leaks were likely to affect patient outcomes. The Council noted that newer TAVI valves had a lower risk of paravalvular leaks. - The Council asked the clinical expert for insight into the relative length of hospital stay for
patients after TAVI or SAVR. The expert stated that TAVI patients tend to leave hospital
after no more than a day in a general ward or outpatient clinic, whereas SAVR patients may require 1–2 days in intensive care and remain on a post-surgical ward for 4–5 days. - The Council discussed the UK based evidence on the cost effectiveness of TAVI and how the cost of TAVI devices appeared to be a key driver of the conclusions. The Council highlighted the draft NICE late stage assessment which estimated that TAVI valves would need to cost less than £14,800 for the procedure to be cost effective for patients at all levels of surgical risk.28 The Council agreed that procurement decisions should be coordinated to ensure that Scotland achieves the best value when purchasing TAVI valves, taking into account the possibility of volume based rebates from device manufacturers.
- The Council highlighted that patients with symptomatic severe aortic stenosis who are at
low surgical risk represent a much larger population than those currently eligible for TAVI in Scotland (inoperable or high surgical risk). The Council recognised that offering TAVI to low surgical risk patients would present challenges for the delivery of TAVI services across
NHSScotland because of limited capacity. The Council was clear in their opinion that if
capacity were to increase, then access to TAVI should be prioritised based on surgical risk,
so that patients who have the fewest alternative treatment options are offered TAVI first. - Concerns were voiced by the Council that there appeared to be unequal access to TAVI
depending on where people lived, both within Scotland and compared with other areas of
the UK and Europe. A clinical expert informed the Council that the number of TAVI
procedures per million population was expected to increase nationally, across all TAVI
centres, to align with rates in NHS England. They also advised, specifically in relation to the potential unequal access to TAVI within Scotland, that the small number of people getting TAVI in some board areas could lead to exaggerated differences in TAVI procedures per million population. The Council agreed it was important that there was equal access to TAVI for all suitable patients living in Scotland. - The Council understood that patients who are categorised as low surgical risk tend to be
younger and have a longer life expectancy than higher risk patients, and that life expectancy
for this patient group could exceed the durability of TAVI valves. It was accepted that the
results from the NOTION trial after 10 years follow up suggest this may not be an issue with newer TAVI valves
Date of publication: 13 February 2025