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 10 sources, which was discussed by the committee. The evidence included 1 systematic review and meta-analysis, 1 retrospective propensity-matched comparative study, 6 case series, data from the international fetal cardiac intervention registry, and safety data from 1 conference abstract. These are presented in table 2 of the interventional procedures overview. Other relevant literature is in additional relevant papers in the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: fetal survival to delivery, achieving a biventricular circulation, the need for subsequent complex cardiac surgical procedures, long-term survival and quality of life.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: fetal death, premature delivery, maternal safety.
3.4 No patient commentary was sought.
3.5 There is uncertainty about the natural progression of fetal aortic stenosis and about who may benefit from the procedure, so a study about the natural history of fetal aortic stenosis would be useful.
3.6 This is a very highly specialised and technically challenging procedure that is done on a small number of fetuses in specialised centres. It involves collaboration between specialists in fetal medicine and paediatric cardiology. The committee noted that there is some evidence that outcomes improve with experience of doing the procedure.
3.7 This procedure is rarely done in the UK, with 6 finished consultant episodes for 'Other specified therapeutic percutaneous operations on fetus (R04.8)' recorded in 2015/16.