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Pacemaker risk following transcatheter aortic valve replacement - A Bayesian reanalysis

  • Author Footnotes
    1 This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
    Arthur M. Albuquerque
    Footnotes
    1 This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
    Affiliations
    School of Medicine, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil
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  • Author Footnotes
    2 This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
    James M. Brophy
    Correspondence
    Corresponding author at: Medicine & Epidemiology (McGill University), McGill University Health Center, 1001 Decarie Blvd Room C04.1410, Montreal, Qc H4A 3J1, Canada.
    Footnotes
    2 This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
    Affiliations
    McGill Health University Center, Montreal, Canada
    Search for articles by this author
  • Author Footnotes
    1 This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
    2 This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.

      Highlights

      • Many patients undergoing transcatheter aortic valve replacement (TAVR) require a permanent pacemaker
      • A study of TAVR patients concluded that a peri-procedural pacemaker was not associated with increased mortality
      • This Bayesian reanalysis shows a modest to high probability of increased mortality in the 4 years following the pacemaker

      Abstract

      Objectives

      To estimate the probability of increased total mortality risk in patients receiving a cardiac pacemaker following transcatheter aortic valve replacement (TAVR).

      Background

      A recent publication of a nationwide Swedish, population-based cohort study found no statistically significant difference for all-cause mortality. It is unknown if a Bayesian reanalysis would provide additional insights and lead to the same conclusion.

      Methods

      A digitalized approach to the published Kaplan – Meier curves was used to reconstruct the individual patient dataset. Bayesian survival analyses of this data using both vague, thereby allowing the posterior probability to be completely dominated by the observed data, as well as skeptical and informative priors, based on the mortality risk of pacemaker implantation following surgical aortic valve replacement, were performed.

      Results

      The individual patient data set was reliably reconstructed and showed a 4 year follow-up hazard ratio (HR) = 1.08, 95% credible interval (CrI) 0.85–1.36. The Bayesian analysis using a vague prior revealed a 74.9% probability of increased mortality in the pacemaker group. Using a skeptical, semi-informative, and fully informative priors, the posterior probabilities of increased mortality following pacemaker insertion was increased to 68.9%, 93.9% and 98.4%, respectively.

      Conclusions

      This Bayesian reanalysis suggests a moderate to high probability of an increased total mortality in TAVR patients requiring post procedural pacemaker implantation.

      Keywords

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