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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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“dual-chamber pacemaker randomly assigned to DDD or ODO mode, there was no significant difference between those two groups in terms of syncope recurrence at 24 months of follow-up.(18) In all the studies above, patients were selected using Tilt-test results.”
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“Although the two blinded randomized trials are small (VPS II and SYNPACE), it seems pacing may not benefit most patients with vasovagal syncope.”
ResultInfluentialFive cases of complete atrioventricular block induced by bending forward: unusual but not unique
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BackgroundDefinitive Pacing Therapy in Patients With Neuromediated Syncope. Lessons From the SPAIN Study
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“Both had negative results showing that DDD-RDR pacing did not significantly reduce the risk of syncope recurrence.(9,10) These findings indicated that, as with drugs, DDDRDR PM does not have a place in the therapeutic arsenal against VVS even if patients have recurrent syncope and asystole during the TTT.”
ResultLong-Term Prognosis and Impact Factors of Metoprolol Treatment in Children with Vasovagal Syncope
Wang, J., Liu, P., Wang, Y., Du, J., Liao, Y., & Jin, H. (2025) · Biomedicines · doi:10.3390/biomedicines14010075 · Cited by 1
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ResultSíncope reflexa vasovagal – haverá benefício da terapêutica com pacemaker?
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BackgroundMethodWhat Can We Expect from the ISSUE 3 Trial?
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“The next wave of trials implanted a pacemaker in all the patients and essentially disabled function of the device in those randomized to no therapy [20,21].”
BackgroundSelf-citationPacing in Neurally Mediated Syncope Syndromes
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ResultPacing in neurocardiogenic/vasovagal syncope
Sutton, R. (2018) · Herzschrittmachertherapie + Elektrophysiologie · doi:10.1007/s00399-018-0564-0 · Cited by 1
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Self-citationSyncope for the General Pediatrician
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Update on Cardiac Pacing in Reflex Syncope
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Cardiac pacing in vasovagal syncope in the light of the latest recommendations
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Self-citationRecurrent falls: pace now or wait for another fall?
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Head up tilt試験を用いた神経調節性失神(Neurally mediated syncope:NMS)の病型診断と治療戦略の検討
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Was ist neu in der ESC-Leitlinie von 2009?
von Scheidt, W., & Seidl, K. (2011) · Herzschrittmachertherapie + Elektrophysiologie · doi:10.1007/s00399-011-0133-2
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Syncope Relapse in a Patient with Cardioinhibitory Neuromediated Syncope Treated with Pacing
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“The main fi nding of the SYNPACE study [ 17 ] is that active cardiac pacing is not more effective than inactive pacing in preventing syncopal recurrences in patients with severe vasovagal syncope: neither the number of patients with syncopal recurrence nor the time to the 20 Role of Loop Recorder and Pacemaker Implant…”
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“Nachkontrolle: Die Diagnose des Ereignisrezidivs (Synkope oder Präsynkope) erfolgte überwiegend aufgrund subjektiver Kriterien: Führung eines Tagebuchs [44, 53] oder Aufforderung, sich alsbald nach erneutem Ereignis zu melden [45, 55], „klinisch“ bei Nachkontrolle oder durch Telefoninterview [35, 54].”
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Self-citationMalignant Neurally-Mediated Syncope: Pathophysiology and Treatment
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“The following, controlled and randomized studies VPS II and SYNPACE [49,50] showed that the positive results of pacing were a placebo effect of the implantation procedure.”
BackgroundNon-Pharmacological Management of Neurocardiogenic Syncope
Abe, H., Kohno, R., Sumiyoshi, M., Oginosawa, Y., Takemasa, H., Tsurugi, T., Nagatomo, T., & Otsuji, Y. (2007) · Journal of Arrhythmia · doi:10.1016/s1880-4276(07)80012-3
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Qual a Contribuiçao do Tilt Training (treinamento postural) na Prevençao da Síncope Vasovagal?
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When Do We Need a Permanent Pacemaker in Neuromediated Syncope?
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Self-citationWas ist neu in der ESC-Leitlinie von 2009?
Augsburg, K., Augsburg-Schwaben, H., & Ingolstadt, K. (2011)
Tse, H., Lau, C.-P., Park, E., Bornzin, G. A., YU, C., Benser, M. E., Bloomfield, D. M., & Padeletti, L. (2007) · Journal of Cardiac Arrhythmias
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“[8] Other studies have indicated that permanent pacemakers are also used to treat vasovagal (neutrally mediated) syncope,[9] and sick sinus syndrome.”
BackgroundThomas, H. E., Cunnington, M. S., & McComb, J. M. (2011) · Reviews in Clinical Gerontology · doi:10.1017/s0959259811000086
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Clinical Aspects of Arrhythmias
de Luna, A. B., & FCCS, A. B. M. F. F. (2017) · Wiley eBooks · doi:10.1002/9781119212782.ch1
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Pacing in Reflex (Neurally-Mediated) Syncopes
Brignole, M., & Abe, H. (2016) · Elsevier eBooks · doi:10.1016/b978-0-323-37804-8.00015-8
Self-citationBrignole, M., Blanc, J., Sutton, R., & Moyá, A. (2009)
Self-citationIs pacemaker therapy the right key to patients with vasovagal syncope?
Radovanović, N. N., Kirćanski, B., Raspopović, S., Pavlović, S. U., Jovanovic, V., & Milašinović, G. (2016) · Srpski arhiv za celokupno lekarstvo · doi:10.2298/sarh1612597r
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Marcapasos con sensor de asa cerrada en disautonomía secundaria a enfermedad de Sandhoff
Velásquez, J. E., Gaviria, M. C., Vargas, L. V. E., Díaz-Martínez, J. C., Aristizábal, J. M., Marín, J. E., Uribe, W., & Duque, M. (2017) · Revista Colombiana de Cardiología · doi:10.1016/j.rccar.2017.06.010
Editorial commentary: To pace, or not to pace in vasovagal syncope?
Morita, H. (2018) · Trends in Cardiovascular Medicine · doi:10.1016/j.tcm.2018.06.005
Selective ablation of atrial ganglionated plexus as a therapeutic option for vasovagal syncope
Kishihara, J. (2018) · Pacing and Clinical Electrophysiology · doi:10.1111/pace.13548
Podsumowanie wskazań do implantacji układów stymulujących serce
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Cardioneuroablation as a method of therapy in vasovagal syncope
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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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