Authors' objectives: HTW undertook an evidence review to address the following question: Is transcatheter aortic valve implantation (TAVI) clinically and cost effective for severe symptomatic aortic stenosis in adults who are assessed by a heart team as being operable but at intermediate surgical risk? This review is an adaptation and update of the Scottish Health Technologies Group (SHTG) Evidence note 91: Transcatheter aortic valve implantation (TAVI) for the treatment of patients with severe symptomatic aortic stenosis at intermediate surgical risk (SHTG 2019).

Authors' results and conclusions: The clinical evidence included a EUnetHTA meta-analysis of two randomised controlled trials with 2-year follow-up, and 5-year outcomes for one of these trials. The evidence showed that TAVI was non-inferior to SAVR for all-cause mortality, cardiac mortality or disabling stroke. TAVI was also associated with reduced length of stay and new-onset fibrillation, but with increased paravalvular regurgitation compared to SAVR. The effect of TAVI compared to SAVR for other clinical and safety outcomes was less certain. The long-term durability of TAVI valves has not been established, but 5-year outcome data from one of the trials suggests that valve reinterventions are more common with TAVI compared to SAVR. Ten relevant studies were identified for the economic review. One of the studies was directly applicable as it considered the UK NHS perspective (SHTG report). The other nine studies were only partially applicable as they considered healthcare systems from other countries. Overall, the studies present contrasting results with TAVI found to be cost-effective in some studies but not in others. HTW developed a cost-utility analyses based on the methodology used in the SHTG analysis. TAVI was found to be more effective and more costly than SAVR with a resulting ICER of £94,512, which is above the threshold of £20,000 per QALY, indicating that it was not cost-effective. The cost-effectiveness result was mainly driven by the cost of the TAVI valve. Threshold analysis showed that TAVI would be cost-effective with a valve cost of £7,752 or lower. Sensitivity analysis showed that the conclusion of the analysis remained unchanged in most modelled scenarios. In probabilistic sensitivity analysis, TAVI was found to have a 27% probability of being cost-effective at a threshold of £20,000 per QALY.

Authors' recommendations: 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.

Authors' methods: This Evidence Appraisal Report is an adaptation of a 2019 Scottish Health Technologies Group (SHTG) report (Evidence note 91), with and updated literature search (strategy available on request) for published clinical and economic evidence on the health technology of interest. It is not a full systematic review but aims to identify the best available evidence on the health technology of interest. Researchers critically evaluate and synthesise this evidence. We include the following clinical evidence in order of priority: systematic reviews; randomised trials; non-randomised trials. We only include evidence for “lower priority” evidence where outcomes are not reported by a “higher priority” source. We also search for economic evaluations or original research that can form the basis of an assessment of costs/cost comparison. We carry out various levels of economic evaluation, according to the evidence that is available to inform this.

Project Status: Completed

Year Published: 2020

URL for published report: https://www.healthtechnology.wales/reports-guidance/transcatheter-aortic-valve-implantation/

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Wales, United Kingdom

Organisation Name: Health Technology Wales

Contact Address: c/o Digital Health Care Wales, 21 Cowbridge Road East Cardiff CF11 9AD

Contact Name: Susan Myles, PhD

Contact Email: healthtechnology@wales.nhs.uk

Copyright: Health Technology Wales