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 randomised controlled trial and 8 case series, 1 of which is reported in 2 publications. It is presented in the summary of key evidence section in the interventional procedures overview. 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: symptomatic relief, reduction in medications for angina and improved quality of life.
3.3 The professional experts and the committee considered the key safety outcomes to be: vascular perforation, device migration, worsening of symptoms and procedure related mortality.
3.4 Patient commentary was sought but none was received.
3.5 The committee noted that the exact mechanism of action is unclear.
3.6 The committee noted that the intention of the procedure is to improve symptoms and quality of life, rather than to improve survival.
3.7 The committee was informed that the procedure is indicated for angina that is refractory to medication or further coronary artery intervention.