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 10 sources, which was discussed by the committee. The evidence included 1 systematic review and meta-analysis, 3 retrospective non-randomised studies, publications from 3 registries and 1 case series. It is presented in the summary of key evidence section in the interventional procedures overview. The committee also considered safety data from 1 conference abstract and 1 case report. 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: improvement in quality of life, improvement in heart failure (including the New York Heart Association Functional Classification), reduction in the size of paravalvular leaks, reduction in haemolysis and the need for blood transfusion.
3.3 The professional experts and the committee considered the key safety outcomes to be: haemorrhage, cardiac perforation, device embolisation, infection, stroke and mortality.
3.4 Patient commentary was sought but none was received. One patient organisation representing patients who have had this procedure provided submissions and these were discussed by the committee.
3.5 The committee noted that the degree of invasiveness of this procedure was much less than the alternative of further open-heart surgery.
3.6 The committee noted that an important effect of this procedure is the improvement of haemolytic anaemia and a reduction in the need for blood transfusions.
3.7 The committee noted that treatment of aortic and mitral paravalvular leaks were considered together in most of the studies and therefore not separated in this guidance recommendation.
3.8 The committee was informed that different devices are used for this procedure, that the device technology is evolving and that the current morbidity and mortality from this procedure may be lower than that in the published literature.
3.9 The committee was informed that having the procedure does not make subsequent open-heart valve surgery more difficult, if it is needed.
3.10 The committee was informed that there are substantial technical differences around closing the leak in mitral or aortic valves.
3.11 The procedures are usually elective but are sometimes done in an emergency. In these cases, the risk of adverse events is higher.