3 Committee considerations

3 Committee considerations

The evidence

3.1 To inform the committee, 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 8 sources, which was discussed by the committee. The evidence included 6 systematic reviews and meta‑analyses and 2 case series and is presented in table 2 of the interventional procedures overview. There is an overlap of studies included in systematic reviews and some of the studies did not specify the number of patients included. Other relevant literature is in the appendix of the overview.

3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: quality of life, clinical improvement, haemodynamic outcomes, valve durability and long‑term outcomes.

3.3 The specialist advisers and the committee considered the key safety outcomes to be: paravalvular leakage, in‑hospital mortality and need for pacemaker implantation.

3.4 Seventeen commentaries from patients who had experience of this procedure were received, which were discussed by the committee.

Committee comments

3.5 The committee noted that evidence presented on comparisons with TAVI was related to historical data and the technologies have advanced.

3.6 The committee was informed that one device currently on the market for this procedure uses temporary guide sutures to assist with device positioning.

3.7 The committee was informed that the risk of heart block leading to pacemaker implantation may be higher with sutureless aortic valve replacement compared with conventional aortic valve replacement, but the incidence may be falling as experience with the procedure increases.

3.8 The committee was informed that manufacturers deliver a specific training programme for surgeons using this procedure.

ISBN: 978-1-4731-3062-3

  • National Institute for Health and Care Excellence (NICE)