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 randomised controlled trial, 2 registries, 2 non-randomised studies, 1 observational study and 2 case reports. It is presented in the summary of key evidence section in the overview.
The professional experts and the committee considered the key efficacy outcomes to be: improved cardiac function (New York Heart Association functional class) and quality of life.
The professional experts and the committee considered the key safety outcomes to be: mortality, cardiac adverse events, stroke, bleeding, reoperation, worsening heart failure and end organ failure, and infection.
One commentary from a patient who had this procedure was discussed by the committee.
The committee noted that a variety of different techniques are used for doing this procedure and the technology is evolving.
The committee was informed that people need anticoagulation after the procedure.