Guidance
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 8 sources, which was discussed by the committee. The evidence included 1 meta-analysis, 1 case series and meta-analytic comparison study, 1 systematic review, 2 case series, 1 non-randomised comparative study and 2 case reports. 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: restoration in heart valve function, improved survival, longevity of the valve and quality of life.
3.3 The professional experts and the committee considered the key safety outcomes to be: operative mortality, bypass time and cross clamp time, infections including endocarditis and embolic events including stroke.
3.4 The committee discussed 13 commentaries from people who have had this procedure.
Committee comments
3.5 This procedure has evolved over time. The optimum concentration and time for glutaraldehyde use for fixation of the pericardium have not yet been determined. A few operations have been done without using glutaraldehyde fixation.
3.6 This is a complex procedure and should only be done by cardiac surgeons with special training and experience in this procedure.
3.7 The committee was told that glutaraldehyde-treated autologous pericardium provides another alternative to mechanical or biological valves for young people.
3.8 The committee recommended that details of everyone having the procedure should be entered into a registry.
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