Transcatheter aortic valve implantation
Topic Status Complete
Transcatheter aortic valve implantation for the treatment of patients with severe symptomatic aortic stenosis who are at intermediate surgical risk.
Outcome of the appraisal
Transcatheter aortic valve implantation (TAVI) is non-inferior to surgical aortic valve replacement (SAVR) in people with severe symptomatic aortic stenosis who are at intermediate surgical risk. However, the cost effectiveness evidence does not currently support the case for routine adoption.
TAVI was non-inferior to SAVR for all-cause mortality, cardiac mortality or disabling stroke, and shows similar improvements in both symptoms and quality of life. However, due to a lack of long-term data, there is uncertainty around the durability of TAVI valves and the potential need for reintervention.
A cost-utility analysis developed by HTW showed that TAVI is unlikely to be cost effective in this patient group. The cost-effectiveness result was mainly driven by the cost of the TAVI valve.
Why was this topic appraised?
Aortic stenosis (AS) is an obstruction of normal blood flow across the aortic valve. People with severe AS are likely to develop symptoms that are associated with the narrowing of the valve and an overload of the left ventricle, such as syncope, exercise-induced angina, dyspnoea and congestive heart failure. The prevalence of severe symptomatic AS is around 3% in those aged over 75 years old, but this rises steeply with age; therefore, the prevalence is likely to increase over time due to an aging population.
Surgical aortic valve replacement (SAVR) is the standard treatment for people with severe AS who are well enough for surgery. Transcatheter aortic valve implantation (TAVI) is an alternative procedure that can be used for people of an increased operable risk, and is currently a treatment option for inoperable or high surgical risk cases in Wales. However, more focus is turning to the use of TAVI in lower or intermediate risk populations.
This topic was suggested through the Welsh Health Specialised Services Committee (WHSSC).
Plain language summary
Aortic stenosis (AS) occurs when the heart’s aortic valve becomes narrower. This stops the valve from opening fully, which in turn reduces the flow of blood from your heart to the main artery to the rest your body (the aorta). It’s the most common heart valve disease in adults and occurs most often in older people. People with severe symptomatic AS can experience fainting or passing out (syncope), chest pain (angina), difficulty breathing (dyspnoea) and heart failure. Standard procedure for people with severe symptomatic AS is surgical aortic valve replacement (SAVR). Transcatheter aortic valve implantation (TAVI) is an alternative procedure for people who have a higher level of surgical risk or where surgery is not appropriate.
TAVI involves replacing the damaged heart valve with an artificial one. Access to the heart is achieved by threading a long, thin, flexible tube (catheter) through the artery in the leg to the heart. Because this method does not involve open heart surgery, it is considered to be a safer approach for older, frail and more vulnerable patients.
Health Technology Wales (HTW) looked for evidence that TAVI is an effective treatment option for people with severe symptomatic AS who are assessed as being operable but at intermediate surgical risk. The evidence found suggests that TAVI is as effective as traditional SAVR for reducing the risk of mortality and disabling stroke. However, for other outcomes, such as the risk of stroke and bleeding, the evidence is unclear. HTW developed an economic analysis, which showed that, compared to SAVR, TAVI was more effective and more costly.
HTW Guidance does not support routine adoption of TAVI for people with severe symptomatic AS, who are deemed intermediate surgical risk. This is because the evidence showed that TAVI was not cost-effective compared to SAVR.