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Second Vasovagal Pacemaker Study (VPS II): A Randomized Trial

Stuart J. Connolly, MD; Robert Sheldon, MD; Kevin E. Thorpe, MMath; Robin S. Roberts, MTech; Kenneth A. Ellenbogen, MD; Bruce L. Wilkoff, MD; Carlos Morillo, MD; Michael Gent, DSc; for the VPS II Investigators

JAMA. 2003;289:2224-2229.

Context  Three previous small randomized trials have reported that pacemaker therapy is beneficial for patients with severe recurrent vasovagal syncope. However, because these trials were not double blind, they may have been biased in their assessment of outcomes and had a placebo effect of surgery.

Objective  To determine if pacing therapy reduces the risk of syncope in patients with vasovagal syncope.

Design, Setting, and Patients  A randomized double-blind trial of pacemaker therapy in outpatients referred to syncope specialists at 15 centers from September 1998 to April 2002. In the year prior to randomization, patients had had a median of 4 episodes of syncope. Patients were followed up for up to 6 months.

Intervention  After implantation of a dual chamber pacemaker, 100 patients were randomly assigned to receive dual-chamber pacing (DDD) with rate drop response or to have only sensing without pacing (ODO).

Main Outcome Measure  Time to first recurrence of syncope.

Results  No patients were lost to follow-up. Of the 52 patients randomized to ODO, 22 (42%) had recurrent syncope within 6 months compared with 16 (33%) of 48 patients in the DDD group. The cumulative risk of syncope at 6 months was 40% (95% confidence interval [CI], 25%-52%) for the ODO group and 31% (95% CI, 17%-43%) for the DDD group. The relative risk reduction in time to syncope with DDD pacing was 30% (95% CI, –33% to 63%; 1-sided P = .14). Lead dislodgement or repositioning occurred in 7 patients. One patient had vein thrombosis, another had pericardial tamponade leading to removal of the pacemaker system, and a third had infection involving the pacemaker generator.

Conclusions  In this double-blind randomized trial, pacing therapy did not reduce the risk of recurrent syncope in patients with vasovagal syncope. Because of the weak evidence of efficacy of pacemaker therapy and the risk of complications, pacemaker therapy should not be recommended as first-line therapy for patients with recurrent vasovagal syncope.

Author Affiliations: Departments of Medicine (Drs Connolly and Morillo) and Clinical Epidemiology and Biostatistics (Messrs Thorpe and Roberts, and Dr Gent), McMaster University, Hamilton, Ontario; Department of Cardiovascular Medicine, University of Calgary, Calgary, Alberta (Dr Sheldon); Department of Medicine, Medical College of Virginia, Richmond (Dr Ellenbogen); Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (Dr Wilkoff); and Department of Cardiology and Cardiovascular Sciences, Instituto del Corazon, Floridablanca, Colombia (Dr Morillo).

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