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    Table 1 Abbreviations

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    References

    1. Garweg C, Duchenne J, Vandenberk B et al. (2023) Evolution of ventricular and valve function in patients with RV pacing – A randomized controlled trial comparing leadless and conventional pacing. Pacing Clin Electrophysiol 46(12): 1455–64.

    2. Inoue N, Ito Y, Imaizumi T, Morikawa S et al. (2024) Assessment of adverse events stratified by timing of leadless pacemaker implantation with cardiac implantable electronic devices extraction due to infection: A systematic review and meta‐analysis. J Arrhythm 41(1).

    3. Mhasseb C, Kiwan M, Merhi ME et al. (2024) Comparative safety of transvenous and leadless pacemakers in patients with cardiovascular diseases: A meta-analysis study. Heliyon 11(1): e40982.

    4. Oliveira VMR, Rivera A, Oliveira IC et al. (2024) The effectiveness and safety of leadless pacemakers: An updated meta-analysis. Curr Cardiol Rep 26(8): 789–99.

    5. Wu S, Jin Y, Lu W et al. (2023) Efficacy and safety of leadless pacemakers for AV synchronous pacing: A systematic review and meta-analysis. J Clin Med 12(7): 2512.

    6. El-Chami MF, Garweg C, Clementy N et al. (2024) Leadless pacemakers at 5-year follow-up: The Micra transcatheter pacing system post-approval registry. Eur Heart J 45(14): 1241–51.

    7. El-Chami MF, Higuera L, Longacre C et al. (2024) Two-year outcomes of Micra AV leadless pacemakers in the Micra AV CED study. EP Europace 26(11).

    8. Shah MJ, Borquez AA, Cortez D et al. (2023) Transcatheter leadless pacing in children: A PACES collaborative study in the real-world setting. Circ Arrhythm Electrophysiol 16(4).

    9. Strik M, Clementy N, Mondoly P et al. (2022) Implantation of a leadless pacemaker in young adults. J Cardiovasc Electrophysiol 34(2): 412–7.

    10. Amrani AE, Campos B, Alonso-Martín C et al. (2019) Performance of the Micra cardiac pacemaker in nonagenarians. Rev Esp Cardiol (Engl Ed) 73(4): 307–12.

    11. Panico A, Flahault A, Guillemin F et al. (2024) Improved outcomes with leadless versus single-chamber transvenous pacemaker in hemodialysis patients. EP Europace 26(11).

    12. Molitor N, Saleem-Talib S, Ramanna H et al. (2024) Leadless pacemaker implantation via the internal jugular vein. EP Europace 26(8).

    13. Knops RE, Reddy VY, Ip JE, Doshi R, Exner DV, Defaye P, et al. (2023) A dual-chamber leadless pacemaker. N Engl J Med 388(25): 2360–70.

    14. Tjong FVY, Beurskens NEG, de Groot JR et al. (2018) Health-related quality of life impact of a transcatheter pacing system. J Cardiovasc Electrophysiol. Dec;29(12):1697-1704. 

    15. Cabanas-Grandío P, García Campo E, Bisbal F et al. (2020) Quality of life of patients undergoing conventional vs leadless pacemaker implantation: A multicenter observational study. J Cardiovasc Electrophysiol. Jan;31(1):330-336. 

    16. Ueyama HA, Miyamoto Y, Hashimoto K et al. (2024) Comparison of patient outcomes between leadless vs transvenous pacemakers following transcatheter aortic valve replacement. J Am Coll Cardiol Intv. 2024;17(15):1779-1791
      Appendix A: Methods and literature search strategy

    Methods and literature search strategy

    NICE has identified studies and reviews relevant to LP implantation for bradyarrhythmias from the medical literature.

    Search strategy design and peer review

    This search report is informed by the Preferred Reporting Items for Systematic reviews and Meta-Analyses literature search extension (PRISMA-S).

    A NICE information specialist ran the literature searches on 17 January 2025. See the search strategy history for the full search strategy for each database. Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion.

    The principal search strategy was developed in MEDLINE ALL (Ovid interface). It was adapted for use in each of the databases listed in table 4a, taking into account the database's size, search functionality and subject coverage. The MEDLINE ALL strategy was quality assured by a NICE senior information specialist. All translated search strategies were peer reviewed to ensure their accuracy. The quality assurance and peer review procedures were adapted from the Peer Review of Electronic Search Strategies (PRESS) 2015 evidence-based checklist.

    Review management

    The search results were managed in EPPI‑Reviewer version 5 (EPPI‑R5). Duplicates were removed in EPPI‑R5 using a 2‑step process. First, automated deduplication was done using a high-value algorithm. Second, manual deduplication was used to assess low probability matches. All decisions about inclusion, exclusion and deduplication were recorded and stored.

    Limits and restrictions

    The CENTRAL database search removed trial registry records and conference material. The Embase search excluded conference material.

    English language limits were applied to the search when possible, in the database. This is standard NICE practice for review topics.

    The limit to remove animal studies in the searches is standard NICE practice, which has been adapted from Dickersin K, Scherer R, Lefebvre C (1994) Systematic Reviews: Identifying relevant studies for systematic reviews. BMJ 309(6964): 1286

    Inclusion criteria

    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 not available in the published literature.

    • People with bradyarrhythmias.

    • Intervention or test: leadless cardiac pacemakers.

    • 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 Appendix B: Other relevant studies.

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