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 8 sources, which was discussed by the committee. The evidence included 1 systematic review, 3 randomised controlled trials (2 of which were also included in the review), 1 non-randomised comparative study (included in the review) and 3 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 committee considered the key efficacy outcomes to be improved ejection fraction, oxygen consumption during and following stimulation, New York Heart Association classification, rate of hospitalisation and quality of life.
3.3 The committee considered the key safety outcomes to be pneumothorax, infection, bleeding, arrhythmias and lead displacement.
3.4 Patient commentary was sought but none was received.
3.5 The committee noted that there was a large placebo effect reported in some of the studies.
3.6 The committee noted that the efficacy may be better in people with less severe heart failure and this underpinned their recommendation for more research to identify the group of patients most likely to benefit from this procedure.