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 4 systematic reviews, 3 case series, 1 randomised controlled trial and 2 case reports, and is presented in table 2 of the interventional procedures overview. Other relevant literature is in appendix A of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: procedural success and completeness of revascularisation, haemodynamic stability, survival to hospital discharge, survival at 30 days, and rate of major adverse cardiac events.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: vascular damage, bleeding, haemolysis and left ventricle damage.
3.4 Four commentaries from patients who had experience of this procedure were received, which were discussed by the committee.
3.5 The committee noted that:
Evidence of benefit for patients with cardiogenic shock is limited. In the evidence reviewed, there were only a small number of patients with cardiogenic shock who could not have percutaneous coronary intervention and the outcomes of these patients are poor.
The use of the procedure may allow intervention in patients who would otherwise be unable to have percutaneous coronary intervention. This may include patients who have had previous coronary artery surgery.
The risks of bleeding has reduced with improvement in the design of the technology.
More than 1 device is available for use in this procedure and the technology is evolving.