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    Methods

    NICE identified studies and reviews relevant to aortic valve reconstruction with glutaraldehyde-treated autologous pericardium from the medical literature. The following databases were searched between the date they started to 19/10/2022: MEDLINE, PREMEDLINE, 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 not available in the published literature.

    • Patients with aortic valve diseases.

    • Intervention or test: aortic valve reconstruction with glutaraldehyde-treated autologous pericardium.

    • 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 (Ovid)

    19/10/2022

    1946 to October 18, 2022

    MEDLINE In-Process (Ovid)

    19/10/2022

    1946 to October 18, 2022

    MEDLINE Epubs ahead of print (Ovid)

    19/10/2022

    October 18, 2022

    EMBASE (Ovid)

    19/10/2022

    1974 to 2022 October 17

    EMBASE Conference (Ovid)

    19/10/2022

    1974 to 2022 October 17

    Cochrane Database of Systematic Reviews – CDSR (Cochrane Library)

    19/10/2022

    Issue 10 of 12, October 2022

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

    19/10/2022

    Issue 10 of 12, October 2022

    International HTA database (INAHTA)

    19/10/2022

    -

    Trial sources searched

    • 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

    The MEDLINE search strategy was translated for use in the other sources.

    1        Aortic Valve/        38262

    2        Heart Valve Diseases/        25387

    3        exp Aortic Valve Disease/        62415

    4        (aortic* adj4 (insufficient* or narrow* or stenos* or incompetenc* or regurgitat* or disease* or aneurysm)).tw.        62048

    5        Endocarditis, Bacterial/        20359

    6        ((infect* or bacterial*) adj4 endocarditis).tw.        18473

    7        or/1-6        153840

    8        Heart Valve Prosthesis/        39516

    9        Heart Valve Prosthesis Implantation/        26536

    10        (valve adj4 (neocuspidi?ation or neo-cuspidi?ation or reconstruct* or repair* or replace*)).tw.        43778

    11        or/8-10        73739

    12        7 and 11        44074

    13        Pericardium/        16775

    14        (pericardium or pericardial or epicardium).tw.        34383

    15        13 or 14        41386

    16        12 and 15        1867

    17        Glutaral/        7236

    18        glutaraldehyde*.tw.        16055

    19        17 or 18        18317

    20        16 and 19        192

    21        ((Ozaki* adj4 (sizer or procedure* or technique*)) or AVNEO or (aortic adj4 valve adj4 neocuspidization) or xAVNEO or (xenologous adj4 AVNEO)).tw.        86

    22        Ozaki*.tw.        176

    23        22 and 7        62

    24        20 or 21 or 23        261

    25        Animals/ not Humans/        5023025

    26        24 not 25        220