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 9 sources, which was discussed by the committee. The evidence included 2 randomised controlled trials, 1 case control study, 5 case series and 1 review of US Food and Drug Administration MAUDE (Manufacturer and User Facility Device Experience) database. 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: reduction in hospital admissions for heart failure, improvement in heart failure symptoms and improvement in quality of life.

3.3 The professional experts and the committee considered the key safety outcomes to be: device failure, malfunction or migration, cardiac perforation, pulmonary artery injury and infection.

3.4 Patient commentary was sought but none was received.

Committee comments

3.5 There is more than 1 device available for this procedure.

3.6 Evidence on the efficacy of the procedure focuses primarily on reducing hospital admissions.

3.7 Most of the evidence the committee considered was for patients with New York Heart Association class 3 heart failure. The clinical expert confirmed that this reflects current clinical practice.

3.8 One device for which the committee reviewed evidence required the patient to lie on a special pillow for 18 seconds every day.

3.9 The committee encourages data entry to a suitable registry with a commitment to publish all outcomes.

ISBN: 978-1-4731-4340-1

  • National Institute for Health and Care Excellence (NICE)