Evidence note 64

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Contact Healthcare Improvement Scotland with any SHTG questions:

Email: shtg.hcis@nhs.net

Lead Health Services Researcher
Karen Macpherson

Lead for SHTG
Susan Myles

SHTG Project Officer
Shonagh Ramsey

Evidence note 64

Is Transcatheter aortic valve implantation (TAVI) clinically and cost effective for severe symptomatic aortic stenosis in adults at high surgical risk?

Key points

  • Continuing development of new transcatheter aortic valve implantation (TAVI) devices and evolving patient selection procedures mean that the published evidence base may not fully capture the outcomes associated with the latest generation of TAVI devices.
  • In the PARTNER trial (cohort A), TAVI was not inferior to surgical aortic valve replacement (AVR) with respect to death from any cause after 1 year in candidates for surgery who were at high risk of operative complications and death. No difference in all-cause mortality was shown after 5 years of follow-up.
  • In the CoreValve United States (US) trial, TAVI was superior to AVR with respect to mortality from any cause after 1 year and 2 years in patients at high risk of operative complications and death.
  • In both the PARTNER trial and CoreValve US trial, the trial inclusion criteria to be considered high surgical risk was ≥15% predicted risk of mortality at 30-days post AVR. However, across both studies, the mean patient the Society of Thoracic Surgeons (STS) score and the observed mortality in the AVR group was found to be below this threshold. This highlights the challenges around the interpretation of the evidence base to the population under review.
  • In the PARTNER trial (cohort A), at 1 year, TAVI was associated with a significantly higher incidence of major vascular complications and neurological adverse events including stroke. Major bleeding was less common with TAVI. At 5 year follow-up, the trend for major vascular complications and major bleeding continued, but rates of stroke became similar between the two groups.
  • In the CoreValve US trial, at 1 year, TAVI was associated with significantly higher incidence of major vascular complications and permanent pacemaker implantation compared to AVR. TAVI was also associated with a lower incidence of strokes, major bleeding, acute kidney injury and new or worsening atrial fibrillation.
  • A recent economic evaluation utilising the CoreValve US trial data was adapted to the NHSScotland setting. The results indicate that TAVI may be a cost-effective treatment option for severe aortic stenosis (AS) patients at high surgical risk. However, cost-effectiveness is contingent upon the TAVI device costs being less than £19,500-£24,000 and survival benefits from TAVI being comparable to those observed in the CoreValve US trial.
  • In addition to the CoreValve analysis, six previously published cost-effectiveness studies, using either PARTNER A or observational data, tended to indicate that, compared with AVR, TAVI is not a cost-effective treatment option. Two of these six previous economic evaluations suggested that TAVI may be cost effective, whilst the other four studies found TAVI may be dominated (that is, higher cost and less benefit) by AVR or associated with a high cost per quality-adjusted life year (QALY).

 

Review

The content of this evidence note was accurate and based upon the most up to date evidence available at the date of first publication. Readers are asked to consider that new trials and technologies may have emerged since first publication and the evidence presented may no longer be current.

This evidence note will be considered for review 2 years post-publication, and at 2-yearly intervals thereafter.

Published Date: 21 March 2017