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    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, 1 case control study, 5 case series and 1 review of US Food and Drug Administration 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 The committee noted that there is more than 1 device available for this procedure.

    3.6 The committee noted that evidence on the efficacy of the procedure focuses primarily on the reduction in hospital admissions.

    3.7 The committee noted that most of the evidence it 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 The committee noted that for 1 device for which it reviewed evidence, the patient was required 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.

    Tom Clutton-Brock
    Chair, interventional procedures advisory committee
    July 2021

    ISBN: