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Pacing in Elderly Recurrent Fallers with Carotid Sinus Hypersensitivity (PERF- CSH): A Randomised, Double-blind, Placebo Controlled Cross-over Trial
  1. Steve W Parry (swparry{at}hotmail.com)
  1. Royal Victoria Infirmary and Insitute for Ageing and Health, United Kingdom
    1. Nick Steen (nick.steen{at}ncl.ac.uk)
    1. Institute of Health and Society, Newcastle University, United Kingdom
      1. Rodney Bexton (rodney.bexton{at}nuth.nhs.uk)
      1. Freeman Hospital, United Kingdom
        1. Margaret Tynan (margaret.tynan{at}nuth.nhs.uk)
        1. Freeman Hospital, United Kingdom
          1. Rose Anne Kenny (rkenny{at}tcd.ie)
          1. Trinity College, Eire

            Abstract

            Objectives: While carotid sinus syndrome (CSS) is traditionally defined by the association of carotid sinus hypersensitivity (CSH) with syncope, uncertainty remains over the role, if any, of complex pacing in patients with CSH and unexplained or recurrent falls. We sought to clarify the role of dual chamber pacing in this patient group in the first placebo-controlled study in CSH.

            Design: Randomised, double-blind, cross-over, placebo-controlled trial.

            Setting: Specialist falls and syncope facility.

            Patients: Consecutive subjects aged over 55 years with CSH as the sole attributable cause of 3 or more unexplained falls in the 6 months preceding enrolment.

            Intervention: Dual chamber permanent pacing with rate drop response programming. The pacemaker was switched on (DDD/RDR) or off (ODO [placebo]) for 6 months, then crossed-over to the alternate mode for a further 6 months, in randomised, double-blind fashion.

            Main outcome measure: The primary outcome measure was number of falls in paced and non-paced modes.

            Results: Twenty five of 34 subjects (mean 76.8 years[sd9.0], 27[79%] female) recruited completed the study. Pacing intervention had no effect on number of falls (4.04[sd 9.54] in DDD/RDR mode, 3.48[sd 7.22] in ODO; relative risk of falling in ODO mode 0.82, 95% confidence interval 0.62,1.10).

            Conclusion: Permanent pacing intervention had no effect on fall rates in older patients with CSH. Further work is urgently needed to clarify the role, if any, of complex pacing in this patient group.

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