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 5 sources, which was discussed by the committee. The evidence included 4 case series (1 of which was reported with 9 and 16 years of follow‑up) and 1 case report, and is presented in table 2 of the interventional procedures overview. Other relevant literature is in appendix A of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: reduction in aortic valve gradient, health-related quality-of-life measures and exercise tolerance.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: mortality, bypass time and cross-clamp time, valve durability, embolic events including stroke, and infection and bleeding.
3.4 Commentary from 1 patient who had experience of this procedure was received, which was discussed by the committee.
3.5 This guidance covers the use of processed bovine pericardium, and does not cover the Ozaki procedure which uses glutaraldehyde-treated autologous pericardium.
3.6 The processed bovine pericardium is used as a scaffold in this procedure and has different properties to the bovine pericardium that is routinely used in cardiac surgery.
3.7 The committee was informed that patients who have this procedure receive aspirin but do not need lifelong anticoagulation.