The North American vasovagal pacemaker study (VPS) : randomized trial of permanent cardiac pacing for the prevention of vasovagal syncope

Objectives. This study was done to evaluate pacemaker therapy for severe recurrent vasovagal syncope. Background. Nonrandomized studies have suggested that permanent pacing might help control the symptoms of recurrent vasovagal syncope. The study goal was to evaluate the effect of permanent pacemaker implantation on syncope in patients with frequently recurrent vasovagal syncope. Methods. Patients with ≥6 lifetime episodes of syncope and with tilt-table test that induced syncope or presyncope, as well as relative bradycardia, were randomized to receive dual-chamber pacemaker or not. The pacemaker prevented bradycardi and provided high-rate pacing if predetermined drop in heart rate occurred (rate-drop response). The primary outcome was the first recurrence of syncope. Patients also completed detailed diary recording presyncopal episodes. Results. total of 284 patients was originally planned and pilot study of 60 patients was initiated. At the planned first formal interim analysis of efficacy of the pilot study, an unanticipated large treatment effect was observed which fulfilled the prespecified criteri for early termination of the study. At that time, there were 54 patients enrolled, randomized evenly to no pacemaker or to pacemaker. In the no-pacemaker and pacemaker groups the mean ages were 40 and 46 years; 74% and 70% patients, respectively, were female. The baseline tilt-table test showed slowest heart <60/min or longest heart period >1000 ms in 60% of no-pacemaker patients and 72% of pacemaker patients. There was marked reduction in the postrandomization risk of syncope in pacemaker patients (relative risk reduction 85.4%, 95% confidence interval 59.7% to 94.7%; 2p = 0.000022). Conclusions. Dual-chamber pacing with rate-drop response reduces the likelihood of syncope in patients with recurrent vasovagal syncope.