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 11 sources, which was discussed by the committee. The evidence included 3 systematic reviews and meta-analysis and 8 case series, and is presented in table 2 of the interventional procedures overview. 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: survival, haemodynamic improvement, symptom relief and improvement in quality of life.

3.3 The specialist advisers and the committee considered the key safety outcomes to be: mortality, stroke, myocardial infarction and paravalvular leak.

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

Committee comments

3.5 There is a move towards using sedation rather than general anaesthesia for this procedure.

3.6 The longer-term evidence for valve-in-valve transcatheter aortic valve implantation (ViV‑TAVI) is from earlier-generation TAVI devices and the technology is evolving. Longer-term evidence is needed and this should be taken into account by the multidisciplinary team.

3.7 The replacement valve used for ViV‑TAVI can be smaller than the original, increasing the risk of aortic outflow obstruction.

3.8 There is a risk of patient−prosthesis mismatch.

3.9 Some of the patients having this procedure may have concomitant coronary artery disease, and this needs to be considered by the multidisciplinary team when planning treatment.

ISBN: 978-1-4731-3436-2

  • National Institute for Health and Care Excellence (NICE)