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Carotid Sinus Syndrome and falls, should we pace? A multi-centre, randomised control trial (Safepace 2)
  1. Daniel Ryan1,*,
  2. Nick Steen2,
  3. Colette Seifer3,
  4. Rose Anne Kenny4
  1. 1 St. James's Hospital, Dublin, Ireland;
  2. 2 Freeman Hospital, Newcastle, United Kingdom;
  3. 3 St. Boniface Hospital, Winnipeg, Canada;
  4. 4 Trinity College Dublin, Ireland
  1. Correspondence to: Daniel J Ryan, Geriatrics, St. James Hospital, Dublin, Stradbally, Castleconnell, Co. Limerick, Limerick, 0000, Ireland; d_jamesryan{at}


Objective: Cardioinhibitory Carotid Sinus Hypersensitivity (CICSH) is highly prevalent amongst older persons with falls. This study assessed the efficacy of dual-chamber pacing in older patients with CICSH and unexplained falls.

Design: A multi-centre, double blind randomised controlled trial

Setting: Selection from emergency room, geriatric medicine and orthopaedic departments.

Patients: Patients over 50 years, with 2 unexplained falls +/- one syncopal event in the previous 12 months for which no other cause is evident apart from CICSH.

Interventions: Patients randomised to either a 700/400 Kappa, rate responsive pacemaker or implantable loop recorder (Medtronic Reveal thera RDR, Medtronic, mineapolis, Minnesota).

Main outcome measures: The primary outcome was the number falls post implant. Secondary outcomes were time to fall event, presyncope, quality of life and cognitive function.

Results: 141 patients were recruited from 22 centres. Mean age was 78 years and mean follow up 24 months. The overall relative risk of falling after device implant compared with before was 0.23 (0.15-0.32). No significant falls reduction was observed between paced and loop recorder groups (RR 0.79; 95% CI: 0.41, 1.50). Data was also consistent in both groups for syncope, quality of life and cognitive function.

Conclusions: These results question the use of pacing in CICSH and are at variance with our seminal paper. We note, however, that the study was underpowered and also patient characteristics differed from the SAFEPACE 1 - participants were physically and cognitively frailer. Further work is necessary to assess cardiac pacing in this setting.

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