3 Committee considerations

3 Committee considerations

The evidence

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 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 interventional procedures overview.

3.2

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.

3.3

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.

3.4

One commentary from a patient who had this procedure was discussed by the committee.

Committee comments

3.5

The committee noted that a variety of different techniques are used for doing this procedure and the technology is evolving.

3.6

The committee was informed that people need anticoagulation after the procedure.

ISBN: 978-1-4731-6340-9