In response to a request from the HSE, the Health Information and Quality Authority (HIQA) agreed to undertake a health technology assessment (HTA) of transcatheter aortic valve implantation (TAVI) for the treatment of patients with severe symptomatic aortic stenosis at low and intermediate surgical risk.
HTA of transcatheter aortic valve implantation (TAVI)
Aortic stenosis is a chronic, slowly progressive disease resulting from thickening, fibrosis, and calcification of the aortic valve. The prevalence of severe aortic stenosis is 3 to 4% in high income countries, of which three quarters are symptomatic. Mortality associated with untreated severe symptomatic aortic stenosis is approximately 40% after 5 years.
Surgical aortic valve replacement (SAVR) is the standard treatment for patients with severe symptomatic aortic stenosis at low and intermediate risk of surgical complications. It is an open cardiovascular surgical procedure that involves surgically removing the diseased aortic valve and replacing it with an artificial valve. Transcatheter aortic valve implantation (TAVI) is an alternative to SAVR treatment. It is a minimally invasive procedure that is routinely used in patients who are inoperable or at high risk of surgical complications. It is now also considered as a treatment option in patients with a lower surgical risk profile.
The assessment considered the epidemiology of aortic valve disease. A systematic review was carried out to evaluate the clinical effectiveness and safety of TAVI compared with SAVR in those at intermediate and low surgical risk. The assessment also included a systematic review of international evidence on the cost-effectiveness, as well development of an economic model specific to Ireland to determine the cost-effectiveness and budget impact of extending TAVI for patients at low and intermediate risk of surgical complications. An analysis was undertaken of the social, organisational and ethical issues that may arise if a TAVI care pathway is expanded to patients at low and intermediate risk of surgical complications.
The project was supported by an expert advisory group with representation from the Department of Health, clinicians with specialist expertise in interventional cardiology and cardiothoracic surgery, HSE’s clinical programmes for older persons, and a patient representative.
Advice to Minister for Health
TAVI should be available for patients aged 70 years and over with severe symptomatic aortic stenosis at low and intermediate surgical risk in the Irish public healthcare system. The current clinical evidence suggests TAVI is no less effective than SAVR in terms of cardiac and all-cause mortality. TAVI is associated with a shorter length of stay in hospital following the procedure than SAVR and, as a less invasive procedure, delivers additional health gains in terms of patients’ health-related quality of life in the short-term.