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A randomized, double-blind, placebo-controlled study of permanent cardiac pacing for the treatment of recurrent tilt-induced vasovagal syncope. The vasovagal syncope and pacing trial (SYNPACE)
Open accessAbstract
AIMS: Recently, some studies revealed the efficacy of pacemaker implantation in decreasing recurrences in patients with vasovagal syncope. As these studies were not blinded or placebo-controlled, the benefits observed might have been due to a bias in the assessment of outcomes or to a placebo effect of the pacemaker. We performed a randomized, double-blind, placebo-controlled study in order to ascertain if pacing therapy reduces the risk of syncope relapse. METHODS AND RESULTS: Twenty-nine patients (53 +/- 16 years; 19 women) with severe recurrent tilt-induced vasovagal syncope (median 12 syncopes in the lifetime) and 1 syncopal relapse after head-up tilt testing underwent implantation of a pacemaker, and were randomized to pacemaker ON or to pacemaker OFF. During a median of 715 days of follow-up, 8 (50%) patients randomized to pacemaker ON had recurrence of syncope compared to 5 (38%) of patients randomized to pacemaker OFF (p = n.s.); the median time to first syncope was longer in the pacemaker ON than in pacemaker OFF group, although not significantly so (97 [38-144] vs 20 [4-302] days; p = 0.38). There was also no significant difference in the subgroups of patients who had had a mixed response and in those who had had an asystolic response during head-up tilt testing. CONCLUSION: Our data were unable to show a superiority of active pacing versus inactive pacing in preventing syncopal recurrence in patients with severe recurrent tilt-induced vasovagal 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 [137]
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“In this study, and in the similarly designed SYNPACE trial, no reduction in syncope was seen [30] .”
From Evaluating and managing bradycardia (2020) · cites this paper as [30]
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“In general, pacing was ineffective in trials that enrolled patients without an asystolic tilt response. 299,300”
From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [300]
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Cites
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Self-citationPermanent pacing for cardioinhibitory malignant vasovagal syndrome.
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Research works printed but not linked: 1
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2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy
Authors Task Force Members, Brignole, M., Auricchio, A., Barón‐Esquivias, G., Bordachar, P., Boriani, G., Breithardt, O. A., Cleland, J. G. F., Deharo, J.-C., Delgado, V., et al. (2013) · European Heart Journal · doi:10.1093/eurheartj/eht150 · Cited by 2,834
Self-citationDeveloped in collaboration with, European Heart Rhythm Association (EHRA), Heart Failure Association (HFA), and Heart Rhythm Society (HRS), societies, E. B. T. F., European Society of Emergency Medicine (EuSEM), European Federation of Internal Medicine (EFIM), European Union Geriatric Medicine Society (EUGMS), American Geriatrics Society (AGS), European Neurological Society (ENS), et al. (2009) · European Heart Journal · doi:10.1093/eurheartj/ehp298 · Cited by 2,040
Self-citation2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy
Glikson, M., Nielsen, J. C., Kronborg, M. B., Michowitz, Y., Auricchio, A., Barbash, I. M., Barrabés, J. A., Boriani, G., Braunschweig, F., Brignole, M., et al. (2021) · European Heart Journal · doi:10.1093/eurheartj/ehab364 · Cited by 2,019
Self-citation2018 ESC Guidelines for the diagnosis and management of syncope
Brignole, M., Moya, A., de Lange, F. J., Deharo, J.-C., Elliott, P. M., Fanciulli, A., Fedorowski, A., Furlan, R., Kenny, R. A., Martín, A., et al. (2018) · European Heart Journal · doi:10.1093/eurheartj/ehy037 · Cited by 1,951
“Cardiac pacing is not indicated in the absence of a documented cardioinhibitory reflex.(299,300) III B”
Self-citation2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy
Authors Task Force Members, Brignole, M., Auricchio, A., Barón‐Esquivias, G., Bordachar, P., Boriani, G., Breithardt, O. A., Cleland, J. G. F., Deharo, J., Delgado, V., et al. (2013) · EP Europace · doi:10.1093/europace/eut206 · Cited by 1,137
“The Second Vasovagal Pacemaker Study (VPS II) and the Vasovagal SYNcope and PACing trial (SYNPACE) gave totally different results.(22,23) The patients in these trials were younger (mean age: 50 years), had both cardio-inhibitory (mostly non-asystolic) and non-cardio-inhibitory responses during tilt test and patients i…”
ResultSelf-citation
Metadata
- Authors
- RAVIELE, A., GIADA, F., MENOZZI, C., SPECA, G., ORAZI, S., GASPARINI, G., SUTTON, R., & BRIGNOLE, M.
- Affiliations
- Santa Maria Nuova Hospital (IT)
- Royal Brompton Hospital (GB)
- Corresponding author
- RAVIELE, A
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2004-10
- Volume
- 25
- Issue
- 19
- Pages
- 1741-1748
- ISSN
- 0195-668X (ISSN-L)
- OpenAlex
- W1982517883
- Semantic Scholar
- fc5273c9844e2031f629c06b5ca6a054616c5cd2
- Cited by
- 323
- References
- 28
- Citations by year
- 2026: 7 · 2025: 4 · 2024: 3 · 2023: 2 · 2022: 5 · 2021: 17 · 2020: 15 · 2019: 13 · 2018: 12 · 2017: 23 · 2016: 16 · 2015: 12 · 2014: 23 · 2013: 21 · 2012: 17
- FWCI
- 17.37
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- European Heart Journal (publishedVersion)
- PubMed (publishedVersion)
- INFM-OAR (INFN Catania) (submittedVersion, other-oa)
- Zenodo (CERN European Organization for Nuclear Research) (other-oa)
- 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, permanent cardiac pacing, pacemaker implantation, syncope recurrence, head-up tilt
- MeSH terms
- Cardiac Pacing, Artificial, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Pacemaker, Artificial, Prospective Studies, Treatment Outcome, Tilt-Table Test, Syncope, Vasovagal, Secondary Prevention
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