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 surgical AVR in adults with severe symptomatic aortic stenosis who are at high risk for surgical complications. Additional data from the UK and other European TAVI registries will also be included.

Authors' recommendations: One RCT, the PARTNER trial, showed that TAVI was not inferior to surgical AVR with regard to mortality in high-risk surgical patients. TAVI and surgery resulted in a similar improvement in QoL. TAVI was however associated with an increase in major vascular complications and neurological adverse events, and with a higher rate of moderate to severe paravalvular regurgitation compared with AVR, which in turn was associated with increased late mortality. The PARTNER trial used only the SAPIEN™ valve and utilised only TF or TA implantation in operable patients. There is no published RCT evidence comparing other TAVI devices or alternative implantation routes with surgical AVR. Several RCTs comparing TAVI with AVR are currently underway, one evaluating the second generation SAPIEN XT™ device, two evaluating the Medtronic CoreValve® System, and the UK TAVI trial in which any CE-mark device and implantation route in use at the point of recruitment will be eligible for inclusion. 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. Prospective data collated so far in this and other registries indicate better mortality outcomes among patients who are eligible for TF implantation. The registry data also indicate differences between TAVI devices such as the higher incidence of clinically important paravalvular regurgitation and requirement for new pacemaker implantation with CoreValve compared with SAPIEN devices in clinical use to date. A large body of evidence from observational studies of uncertain quality has been summarised in the secondary literature. TAVI outcomes from many clinically heterogeneous and mostly uncontrolled studies have been combined in large meta-analyses that are not useful for comparing TAVI with standard care or easily generalising pooled treatment effects to particular patient groups, TAVI devices or implantation routes. There is currently limited information on the durability of implanted TAVI devices because studies published to date lack sufficient follow up. The published cost-effectiveness evidence tends to indicate that compared with AVR, TAVI is not a cost-effective treatment option for AS patients at high surgical risk. Two out of six relevant published economic evaluations demonstrated that TAVI may be cost effective, while the other four studies found TAVI may be either dominated by AVR or associated with a high cost per QALY.

Project Status: Completed

Year Published: 2014

URL for published report: http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/shtg_-_evidence_notes/evidence_note_52.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