Abstract | 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: 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:
|
Authors | Stuart J Connolly, Robert Sheldon, Kevin E Thorpe, Robin S Roberts, Kenneth A Ellenbogen, Bruce L Wilkoff, Carlos Morillo, Michael Gent, VPS II Investigators |
Journal | JAMA
(JAMA)
Vol. 289
Issue 17
Pg. 2224-9
(May 07 2003)
ISSN: 0098-7484 [Print] United States |
PMID | 12734133
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Topics |
- Adult
- Aged
- Bradycardia
(complications, therapy)
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Pacemaker, Artificial
(adverse effects)
- Proportional Hazards Models
- Recurrence
- Syncope, Vasovagal
(etiology, prevention & control)
|