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Cited by 299Cardiovascular Syncope and Autonomic DisordersCardiac pacing and defibrillation studiesHeart Rate Variability and Autonomic Control

Permanent Cardiac Pacing Versus Medical Treatment for the Prevention of Recurrent Vasovagal Syncope: A Multicenter, Randomized, Controlled Trial

Ammirati, Fabrizio, Colivicchi, Furio, Santini, Massimo·2001·Circulation
DOI 10.1161/hc2601.091708
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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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  • Earlier observational, open-label, and single-blind pacing studies were uniformly positive, but two subsequent double-blind studies in adults were negative.

    “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]

    The Discussion (page not provided) reports a favorable pacing result and describes earlier studies as suggesting benefit. The Study Limitations (page not provided) state that this trial was not blinded. Our copy does not report two subsequent negative double-blind studies, so it supports only the earlier-positive part of the sentence. (LLM, conf=0.86)

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Research works printed but not linked: 5

  1. [4]4. Sheldon R. Role of pacing in the treatment of vasovagal syncope. Am J Cardiol. 1999;84:26Q-32Q.
  2. [6]6. Calkins H. Pharmacologic approaches to the therapy for vasovagal syncope. Am J Cardiol. 1999;84:20Q-25Q.
  3. [15]15. Eagle KA, Black HR, Cook EF, et al. Evaluation and prognostic classi- fication of patients with syncope. Am J Med. 1985;79:455-460.
  4. [25]25. Benditt DG. Cardiac pacing for the prevention of vasovagal syncope. J Am Coll Cardiol. 1999;33:21-23.
  5. [28]28. is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Circulation doi: 10.1161/hc2601.091708 2001;104:52-57 Circulation. http://circ.ahajournals.org/content/104/1/52 Wide Web at: The online version of this article, along with updated information and services, is located on the World http://circ.ahajournals.org//subscriptions/ is online at: Circulation Information about subscribing to Subscriptions: http://www.lww.com/reprints Information about reprints can be found online at: Reprints: document. and Rights Question and Answer Permissions the middle column of the Web page under Services. Further information about this process is available in the the online version of the published article for which permission is being requested is located, click Request Permissions in can be via RightsLink, a service of the Copyright Clearance Center, not the Editorial Office. Once Circulation Requests for permissions to reproduce figures, tables, or portions of articles originally published in Permissions:

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Authors
Ammirati, F., Colivicchi, F., & Santini, M.
Affiliations
Ospedale San Filippo Neri (IT)
Corresponding author
Ammirati, Fabrizio
ORCID
Venue
Circulation
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2001-07-03
Volume
104
Issue
1
Pages
52-57
ISSN
  • 0009-7322 (ISSN-L)
  • 1524-4539
DOI
10.1161/hc2601.091708
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 › Surgery › 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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