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 6 case series and 2 retrospective matched case-control studies and is presented in table 2 of the interventional procedures overview. There is an overlap of patients in the included studies. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: adequate pacing performance and quality of life.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: cardiac perforation, cardiac tamponade, pericardial effusion, device dislodgement, battery failure, revision rates and duration of device function.
3.4 Three submissions were received from patient organisations and were discussed by the committee.
3.6 Problems related to battery life have been reported for 1 device.
3.7 Different devices are available or in development for use in this procedure, and the technology and their attachment mechanisms are evolving. There is limited evidence on efficacy and safety for some of these devices.
3.8 The committee was informed that different manufacturers offer different types of training programmes.