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    Methods

    NICE identified studies and reviews relevant to CAVI for TR from the medical literature. The following databases were searched between the date they started to 13.10.2023: MEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the internet were also searched (see the literature search strategy). Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion.

    The following inclusion criteria were applied to the abstracts identified by the literature search.

    • Publication type: clinical studies were included with emphasis on identifying good quality studies. Abstracts were excluded if they did not report clinical outcomes. Reviews, editorials, and laboratory or animal studies, were also excluded and so were conference abstracts, because of the difficulty of appraising study methodology, unless they reported specific adverse events that were not available in the published literature.

    • Patients with CAVI.

    • Intervention or test: TR.

    • Outcome: articles were retrieved if the abstract contained information relevant to the safety, efficacy or both.

    If selection criteria could not be determined from the abstracts the full paper was retrieved.

    Potentially relevant studies not included in the main evidence summary are listed in the section on other relevant studies.

    Find out more about how NICE selects the evidence for the committee.

    Table 4 literature search strategy

    Databases

    Date searched

    Version/files

    MEDLINE ALL (Ovid)

    13/10/2023

    1946 to October 12, 2023

    EMBASE (Ovid)

    13/10/2023

    1974 to 2023 October 13

    EMBASE Conference (Ovid)

    13/10/2023

    1974 to 2023 October 13

    Cochrane Database of Systematic Reviews – CDSR (Cochrane Library)

    13/10/2023

    Issue 10 of 12, October 2023

    Cochrane Central Database of Controlled Trials – CENTRAL (Cochrane Library)

    13/10/2023

    Issue 10 of 12, October 2023

    International HTA database (INAHTA)

    13/10/2023

    -

    Trial sources searched 04/07/2023

    • Clinicaltrials.gov

    • ISRCTN

    • WHO International Clinical Trials Registry

    Websites searched

    • National Institute for Health and Care Excellence (NICE)

    • NHS England

    • Food and Drug Administration (FDA) - MAUDE database

    • Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP – S)

    • Australia and New Zealand Horizon Scanning Network (ANZHSN)

    • General internet search

    The following search strategy was used to identify papers in MEDLINE. A similar strategy was used to identify papers in other databases.

    MEDLINE search strategy

    Tricuspid Valve Insufficiency/

    ((Tricuspid or right atrioventricul*) adj4 (reflux or insufficien* or incompeten* or regurgitat* or disease* or dysfunct* or malfunct* or degenerat* or fail* or leak* or backflow* or back-flow* or flow-back* or defect*)).tw.

    (TR or FTR).tw.

    (Caval adj4 (reflux* or insufficien* or incompeten* or regurgitat* or disease* or dysfunct* or malfunct* or degenerat* or fail* or leak* or backflow* or back-flow or defect*)).tw.

    Right* side* heart* failur*.tw.

    (Function* adj tricusp* adj regurgitat*).tw.

    or/1-6

    (Transcathet* adj4 tricuspid adj4 valve* adj4 (implant* or Intervent* or device* or intervene* or therap* or solut*)).tw.

    ((Heart* or Cardiac* or Caval* or Bivalve*) adj4 valve* adj4 Implant*).tw.

    (CAVI or CAVR).tw.

    transcathet* tricuspid valve intervent*.tw.

    TTVIs.tw.

    ((Bicaval or tricaval) adj4 implant*).tw.

    (((Percutan* adj4 tricuspid) or Bicuspid*) adj4 valve* adj4 (device* or interven* or therap* or implant* or solution*)).tw.

    or/8-14

    7 and 15

    Tricvalve.tw.

    TriCentro.tw.

    17 or 18

    16 or 19

    Animals/ not Humans/

    20 not 21

    limit 22 to english language