Syncope: a permanent pacemaker reduced recurrent episodes in recurrent vasovagal syncope

Clinical bottom line (level 1b)

  1. Patients with recurrent vasovagal syncope who had a permanent pacemaker were less likely to have recurrent syncope than patients who did not (NNT = 2 at 12 months) .
Connolly et al: Journal of the American College of Cardiology 1999; 33 (1): 16-20
Expires November 2004

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: 15 centres, North America

54 patients (aged mean 43, 72% female) with recurrent vasovagal syncope (at least 6 episodes) and a positive tilt-table test with syncope or presyncope and with relative bradycardia)

Excluded if
  • major chronic non-cardiovascular disease
  • other cause of loss of consciousness (ventricular tachycardia, complete heart block, postural hypotension, hypersensitive carotid sinus syndrome or seizures)
  • important valvular, coronary, myocardial or conduction abnormality
  • contraindication to permanent pacemaker


    • Control Group: (n = 27, 27 analysed): no pacemaker
    Experimental Group: (n = 27, 27 analysed): dual-chamber permanent pacemaker (preventing bradycardia and providing high-rate pacing if a predetermined drop in heart rate)

    100% followed for 12 months

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    recurrent syncope 12 months 19
    (70.4%)    		 6
    (22.2%)    		 68%
    (33% to 85%)    		 48.2%
    (24.9% to 71.4%)    		 2
    (1 to 4)

    Comments

    1. Note: the trial was open, the assessment of patients was not blinded; a pronounced placebo effect of pacemaker implantation is suggested and the medical regimen was not standardized.

    Citation

    1. Connolly SJ, Sheldon R, Roberts RS, et al: the North American Vasovagal Pacemaker Study (VPS): a randomized trial of permanent cardiac pacing for the prevention of vasovagal syncope. Journal of the American College of Cardiology 1999; 33 (1): 16-20
    Contributor: Chris Ball and Clare Wotton, November 1999
    Reviewer: Wouter Wieling

    Clinical Question.
    Patient recurrent vasovagal syncope
    Intervention or Exposure permanent pacemaker
    Outcome recurrent syncope