Authors' objectives: This evidence note updates evidence note 38 published in August 2011. It will summarise the clinical and cost-effectiveness evidence from published secondary sources, randomised controlled trials and economic evaluations comparing TAVI with medical management in adults with severe symptomatic aortic stenosis who are not eligible for surgery. Additional data from the UK and other European TAVI registries will also be included.

Authors' recommendations: The only RCT, the PARTNER trial, showed that TF TAVI significantly reduced mortality for up to 2 years of follow up compared with medical management in inoperable patients, and QoL assessed up to 1 year was better following TAVI. TAVI was however associated with a significant increase in the risk of major vascular complications and neurological adverse events including stroke. The PARTNER trial used only the SAPIEN™ valve and excluded patients who were not eligible for TF implantation. The results may not therefore be generalisable to patients with severe peripheral vascular disease, or to other excluded subgroups such as patients requiring treatment of coronary stenosis. There is no published RCT evidence comparing other TAVI devices or non-TF implantation routes with medical management in inoperable patients, and no ongoing trials were identified. TAVI technology has advanced since the PARTNER trial was conducted and rapid progress is being made in device modification. TAVI registry data provide broader evidence for TAVI outcomes in clinical practice but the published data available for review does not fully capture the current stage of progress in the evolution of device modification and patient selection. The UK TAVI registry is still at an early stage of development. Data collated so far in this and other prospective European registries indicate better mortality outcomes among patients who are eligible for TF implantation. The registry data also indicate differences in outcomes among TAVI devices, such as the higher incidence of clinically important paravalvular regurgitation and requirement for new pacemaker implantation with CoreValve compared with SAPIEN devices. There is currently limited published information on the durability of implanted TAVI devices because few studies have reported sufficient longterm follow up. A large body of evidence from mostly uncontrolled observational studies of uncertain quality has been summarised in the secondary literature. Large meta-analyses that combined TAVI outcomes from heterogeneous studies were not included in this evidence note because, in the absence of a comparator, they are not useful for comparing TAVI with standard care, and the pooled effect estimates cannot be generalised to any particular patient group, TAVI device or implantation route. Regarding the cost effectiveness of TAVI for this patient group, there is evidence to support the cost effectiveness of TAVI relative to medical management. However, the evidence must be considered in light of the uncertainties highlighted in this report.

Project Status: Completed

Year Published: 2014

URL for published report: http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/shtg_-_evidence_notes/evidence_note_51.aspx

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Scotland, United Kingdom

Organisation Name: Scottish Health Technologies Group

Contact Address: Scottish Health Technologies Group, Delta House, 50 West Nile Street, Glasgow, G1 2NP Tel: 0141 225 6998

Contact Name: his.shtg@nhs.scot

Contact Email: his.shtg@nhs.scot

Copyright: Healthcare Improvement Scotland