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 13 sources, which was discussed by the committee. The evidence included 2 systematic reviews, 4 retrospective registry analyses, 3 retrospective comparative studies and 3 case series (one of which resulted 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: technical success at 30 days, survival, haemodynamic improvement, reduction in mitral valve regurgitation symptom relief (improvement in New York Heart Association functional class) and improvement in quality of life.
3.3 The professional experts and the committee considered the key safety outcomes to be: device‑related mortality and morbidity, left ventricular outflow tract obstruction, cardiac perforation and paravalvular prosthetic leak.
3.4 Patient commentary was sought but none was received.
3.5 The committee was informed that 2 different access routes are used for this procedure, and the transseptal route is less invasive than the transapical route. This guidance refers to the transapical procedure.
3.6 The committee noted that several devices are used for the procedure. However, currently there is only 1 device CE marked for use through the transapical route and no devices with a CE mark are available for use through the transseptal route.