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Permanent Cardiac Pacing Versus Medical Treatment for the Prevention of Recurrent Vasovagal Syncope: A Multicenter, Randomized, Controlled Trial
Abstract
Background —This clinical investigation was performed to compare the effects of permanent dual-chamber cardiac pacing with pharmacological therapy in patients with recurrent vasovagal syncope. Methods and Results —Patients from 14 centers were randomized to receive either a DDD pacemaker provided with rate-drop response function or the β-blocker atenolol at the dosage of 100 mg once a day. Inclusion criteria were age >35 years, ≥3 syncopal spells in the preceding 2 years, and positive response to tilt table testing with syncope occurring in association with relative bradycardia. The primary outcome was the first recurrence of syncope after randomization. Enrollment was started in December 1997, and the first formal interim analysis was performed on July 30, 2000. By that time, 93 patients (38 men and 55 women; mean age, 58.1±14.3 years) had been enrolled and randomized, although follow-up data were available for all patients (46 patients in the pacemaker arm, 47 patients in the pharmacological arm). The interim analysis showed a significant effect in favor of permanent cardiac pacing (recurrence of syncope in 2 patients [4.3%] after a median of 390 days) compared with medical treatment (recurrence of syncope in 12 patients [25.5%] after a median of 135 days; OR, 0.133; 95% CI, 0.028 to 0.632; P =0.004). Consequently, enrollment and follow-up were terminated. Conclusions —DDD pacing with rate-drop response function is more effective than β-blockade for the prevention of syncopal recurrences in highly symptomatic vasovagal fainters with relative bradycardia during tilt-induced syncope.
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“Although earlier observational, open-label, and single-blind studies have been uniformly positive, the results of 2 subsequent double-blind studies in adults were negative.133–138”
From 2015 Heart Rhythm Society Expert Consensus Statement on the Diagnosis and Treatment of Postural Tachycardia Syndrome, Inappropriate Sinus Tachycardia, and Vasovagal Syncope (2015) · cites this paper as [135]
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Metadata
- Authors
- Ammirati, F., Colivicchi, F., & Santini, M.
- Affiliations
- Ospedale San Filippo Neri (IT)
- Corresponding author
- Ammirati, Fabrizio
- Venue
- Circulation
- Published
- 2001-07-03
- Volume
- 104
- Issue
- 1
- Pages
- 52-57
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W3021591942
- Semantic Scholar
- c890ceac17fe5e7b27b0c4d8bb091029686884f0
- Cited by
- 299
- References
- 24
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 1 · 2023: 1 · 2022: 3 · 2021: 11 · 2020: 8 · 2019: 6 · 2018: 5 · 2017: 13 · 2016: 8 · 2015: 11 · 2014: 17 · 2013: 18 · 2012: 16
- FWCI
- 18.86
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Circulation (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Syncope and Autonomic Disorders
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Rate Variability and Autonomic Control
- Keywords
- vasovagal syncope, recurrent syncope, permanent cardiac pacing, DDD pacemaker, atenolol, beta-blockers, bradycardia, tilt table test, syncope prevention
- MeSH terms
- Anti-Arrhythmia Agents, Atenolol, Electrocardiography, Female, Follow-Up Studies, Heart Function Tests, Humans, Male, Middle Aged, Prospective Studies, Cohort Studies, Treatment Outcome, Defibrillators, Implantable, Disease-Free Survival, Tilt-Table Test, Syncope, Vasovagal, Endpoint Determination, Secondary Prevention
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