3 Committee considerations

The evidence

3.1

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 10 sources, which was discussed by the committee. The evidence included 5 systematic review and meta-analyses, 1 prospective study, 1 retrospective propensity score-matched study and 3 retrospective studies. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

3.2

The professional experts and the committee considered the key efficacy outcomes to be:

  • symptomatic relief

  • reduction in aortic regurgitation (AR)

  • improvement in quality of life.

3.3

The professional experts and the committee considered the key safety outcomes to be:

  • mortality

  • stroke

  • myocardial infarction

  • major valvular complications, including:

    • embolisation

    • bleeding

    • residual AR

    • reintervention.

3.4

Patient commentary was sought but none was received.

Committee comments

3.5

Some of the evidence comes from prosthetic aortic valves that do not have regulatory approval for use in AR. The evidence shows worse safety outcomes when valves not indicated for AR are used.

3.6

Bioprosthetic valves are made from porcine or bovine tissue. Some people may not want to have these.

3.7

This procedure may not be appropriate for people with significant aortic root dilatation.

ISBN: 978-1-4731-7055-1