The Health Information and Quality Authority (HIQA) has today published a health technology assessment (HTA) recommending that the Minister for Health and the Health Service Executive (HSE) consider extending transcatheter aortic valve implantation (TAVI) — a minimally invasive alternative to open heart surgery — to patients with severe symptomatic aortic stenosis at intermediate and low risk of surgical complications in the Irish public health care system.

HIQA undertook this HTA at the request of the HSE. Currently TAVI is primarily offered as an alternative to surgical aortic valve replacement (SAVR) in patients that are otherwise inoperable or at high risk of surgical complications.

Aortic stenosis arises when one of the four valves of the heart becomes narrowed, making it difficult for the heart to function properly. The condition typically affects older people, those aged 70 years or older, but it can also occur in younger patients.

HIQA’s Chief Scientist, Dr Conor Teljeur, said: “Clinical trials have demonstrated that TAVI is just as safe as SAVR in terms of cardiac and all-cause mortality. Although some other complications differ between TAVI and SAVR, the minimally invasive procedure is associated with a shorter length of stay in hospital and improved health-related quality of life gains in the short-term (up to three months) compared with open heart surgery.”

Between 3% and 4% of adults aged 75 years and older have severe aortic stenosis, of which three-quarters are symptomatic. If left untreated, 40% of patients with the condition will die within five years which is about double the mortality rate of their peers. Replacing or repairing the damaged valve is the only known cure. Standard care, or so called surgical aortic valve replacement (SAVR), involves open heart surgery to replace the damaged valve. As TAVI does not involve open surgery it may offer health benefits to patients, such as faster recovery from the procedure.

With fewer costs arising from a shorter hospital stay, and improved quality of life gains arising from a faster recovery time, TAVI is considered more cost-effective than SAVR in patients at intermediate and low surgical risk in Ireland. There would also be no additional cost to the HSE over the next five years if TAVI was provided to these patients instead of SAVR. However, the long-term durability of TAVI valves is uncertain, and there is limited evidence to support the use of TAVI in patients under 70 years of age.

Dr Teljeur continued: “Extending TAVI to patients at lower levels of surgical risk is likely to be no more expensive to the HSE over the next five years than if patients were to continue to be treated using SAVR. The economic advantage of TAVI is in the reduced length of stay in hospital. By switching patients from SAVR to TAVI, there will be an opportunity to release hospital beds, surgical staff, and theatre time to address other demands in the healthcare system.”

The HTA of TAVI in patients with severe symptomatic aortic stenosis at low and intermediate-risk of surgical complications was approved by the Board of HIQA last week and has been submitted to the Minister for Health, Department of Health, and the HSE for consideration. The HTA is available from the link below, and includes an executive summary and a plain English summary.
Ends.

For further information please contact:
Clare O’Byrne, Acting Media and Stakeholder Relations Manager, HIQA
01 828 6712 | 085 8030846| cobyrne@hiqa.ie
Notes to the Editor:

• Aortic stenosis is a chronic, slowly progressive disease resulting from thickening, fibrosis, and calcification of the aortic valve.
• The standard treatment for patients with aortic stenosis is surgical aortic valve replacement (SAVR), an open cardiovascular surgical procedure requiring general anaesthesia and use of cardiopulmonary bypass. The diseased aortic valve is surgically removed and replaced with an artificial valve prosthesis. Transcatheter aortic valve implantation (TAVI) is a minimally-invasive procedure whereby the aortic valve is functionally replaced by implanting a new valve within the existing diseased valve.
• Approximately 100 patients aged 70 years and older undergo SAVR (with a bioprosthetic valve) as an isolated procedure each year in Ireland, but could be eligible for TAVI.
• Based on a review of the effectiveness and safety evidence, TAVI is non-inferior to SAVR in terms of cardiac and all-cause mortality.
  • The risk of other complications varies by patient population and type of TAVI valve (1st vs 2nd generation devices).
  • TAVI is associated with a shorter length of stay (3-4 days) relative to SAVR.
  • TAVI is associated with greater improvements in health-related quality of life outcomes (one to three months from baseline) compared with SAVR.
  • Published randomised controlled trial data have limited follow up, therefore the long-term durability of TAVI valves is uncertain. Based on six year follow-up there was no difference between TAVI and SAVR valves in terms of durability.
• The cost-effectiveness of TAVI in intermediate and low-risk patients aged 70 years and older in Ireland is due to lower expected costs and higher quality-adjusted life year (QALY) gains relative to SAVR.
• Over a five year period, TAVI is estimated to save €0.1 million (95% CI: €-3.1 to €2.9 million) compared with SAVR, which may be considered budget neutral. The estimated budget impact is based on treating 100 patients each year, comprising 67 low and 33 intermediate surgical-risk patients.
• By switching patients from SAVR to TAVI there will be reduced demand for ICU beds, patients will have shorter lengths of hospital stay and there will be reduced demand for theatre time and associated staff.The uptake of TAVI will vary across each of the four designated centres in the TAVI model of care.
• Planning at a hospital level will be required, which should be aligned with regional plans. These plans should take consideration of other national strategies and policies, including the ongoing national review of specialist cardiac services and, in particular, any requirements for common support services.