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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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 [137]
The Comparison with previous studies section reports positive results for dual-chamber observational studies and three randomized open studies, and says that VPS II and SYNPACE did not confirm pacing efficacy. It also says observational studies found single-chamber VVI pacing ineffective, so the earlier studies were not uniformly positive; the passage does not establish the claim about single-blind studies. No page number is available in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn the VPS II and SYNPACE trials, active pacing did not reduce syncope in patients with recurrent vasovagal syncope.
“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]
Pacing was ineffective in trials that enrolled patients without an asystolic tilt response.
“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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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 2,824 · see citing works
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 · see citing works
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 · see citing works
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 · see citing works
“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 1,125 · see citing works
“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-citationSheldon, R. S., Grubb, B. P., Olshansky, B., Shen, W.-K., Calkins, H., Brignole, M., Raj, S. R., Krahn, A. D., Morillo, C. A., Stewart, J. M., et al. (2015) · Heart Rhythm · doi:10.1016/j.hrthm.2015.03.029 · Cited by 1,013 · see citing works
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) · EP Europace · doi:10.1093/europace/euab232 · Cited by 927 · see citing works
Self-citationGuidelines for cardiac pacing and cardiac resynchronization therapy
Vardas, P. E., Auricchio, A., Blanc, J., Daubert, J., Drexler, H., Ector, H., Gasparini, M., Linde, C. M., Morgado, F. B., Oto, A., et al. (2007) · European Heart Journal · doi:10.1093/eurheartj/ehm305 · Cited by 892 · see citing works
Self-citation2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope
Shen, W.-K., Sheldon, R. S., Benditt, D. G., Cohen, M. I., Forman, D. E., Goldberger, Z. D., Grubb, B. P., Hamdan, M. H., Krahn, A. D., Link, M. S., et al. (2017) · Heart Rhythm · doi:10.1016/j.hrthm.2017.03.004 · Cited by 484 · see citing works
“In 2 RCTs, there was no statistically significant benefit seen with active pacing (407,408).”
Background2018 ESC Guidelines for the diagnosis and management of syncope
Brignole, M., Moya‐Mitjans, À., de Lange, F. J., Deharo, J., Elliot, P. M., Fanciulli, A., Fedorowski, A., Furlan, R., Kenny, R. A., Martiın, A., et al. (2018) · Kardiologia Polska · doi:10.5603/kp.2018.0161 · Cited by 474 · see citing works
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Self-citationShen, W.-K., Sheldon, R. S., Benditt, D. G., Cohen, M. I., Forman, D. E., Goldberger, Z. D., Grubb, B. P., Hamdan, M. H., Krahn, A. D., Link, M. S., et al. (2017) · Circulation · doi:10.1161/cir.0000000000000499 · Cited by 453 · see citing works
“2004 15451153 (264) Aim: if pacing reduces syncope recurrence”
BackgroundShen, W.-K., Sheldon, R. S., Benditt, D. G., Cohen, M. I., Forman, D. E., Goldberger, Z. D., Grubb, B. P., Hamdan, M. H., Krahn, A. D., Link, M. S., et al. (2017) · Circulation · doi:10.1161/cir.0000000000000498 · Cited by 408 · see citing works
Brignole, M., Sutton, R., Menozzi, C., Garcia-Civera, R., Moya, A., Wieling, W., Andresen, D., Benditt, D. G., & Vardas, P. (2006) · European Heart Journal · doi:10.1093/eurheartj/ehi842 · Cited by 376 · see citing works
Self-citation2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope
Shen, W.-K., Sheldon, R. S., Benditt, D. G., Cohen, M. I., Forman, D. E., Goldberger, Z. D., Grubb, B. P., Hamdan, M. H., Krahn, A. D., Link, M. S., et al. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.03.003 · Cited by 327 · see citing works
Guidelines for cardiac pacing and cardiac resynchronization therapy
Vardas, P. E., Auricchio, A., Blanc, J., Daubert, J., Drexler, H., Ector, H., Gasparini, M., Linde, C. M., Morgado, F. B., Oto, A., et al. (2007) · EP Europace · doi:10.1093/europace/eum189 · Cited by 289 · see citing works
Self-citationGuía de práctica clínica para el diagnóstico y manejo del síncope (versión 2009)
Moya‐Mitjans, À., Sutton, R., Ammirati, F., Blanc, J., Brignole, M., Dahm, J. B., Deharo, J., Gajek, J. J., Gjesdal, K., Krahn, A. D., et al. (2009) · Revista Española de Cardiología (English Edition) · doi:10.1016/s1885-5857(09)73541-8 · Cited by 277 · see citing works
Self-citationPachon M, J. C., Pachon M, E. I., Cunha Pachon, M. Z., Lobo, T. J., Pachon M, J. C., & Santillana P, T. G. (2011) · Europace · doi:10.1093/europace/eur163 · Cited by 230 · see citing works
Neurocardiogenic Syncope and Related Disorders of Orthostatic Intolerance
Grubb, B. P. (2005) · Circulation · doi:10.1161/circulationaha.104.482018 · Cited by 210 · see citing works
JCS/JHRS 2019 Guideline on Non-Pharmacotherapy of Cardiac Arrhythmias
Nogami, A., Kurita, T., Abe, H., Andò, K., Ishikawa, T., Imai, K., Usui, A., Okishige, K., Kusano, K., Kumagai, K., et al. (2021) · Circulation Journal · doi:10.1253/circj.cj-20-0637 · Cited by 203 · see citing works
2013 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy
Brignole, M., Auricchio, A., Barón‐Esquivias, G., Bordachar, P., Boriani, G., Breithardt, O. A., Cleland, J. G. F., Deharo, J.-C., Delgado, V., Elliott, P. M., et al. (2014) · Revista Española de Cardiología (English Edition) · doi:10.1016/j.rec.2013.11.003 · Cited by 198 · see citing works
“Исследования VPS II (Second Vasovagal Pacemaker Study — Второе исследование электростимуляции при вазовагальном синдроме) и SYNPACE (Vasovagal SYNcope and PACing trial — исследование вазовагальных синкопальных состояний и электростимуляции) дали совершенно другие результаты [22, 23].”
Self-citationParoxysmal atrioventricular block
Lee, S., Wellens, H. J. J., & Josephson, M. E. (2009) · Heart Rhythm · doi:10.1016/j.hrthm.2009.04.001 · Cited by 164 · see citing works
JCS/JHRS 2019 guideline on non‐pharmacotherapy of cardiac arrhythmias
Nogami, A., Kurita, T., Abe, H., Andò, K., Ishikawa, T., Imai, K., Usui, A., Okishige, K., Kusano, K., Kumagai, K., et al. (2021) · Journal of Arrhythmia · doi:10.1002/joa3.12491 · Cited by 164 · see citing works
Shen, W.-K., Sheldon, R. S., Benditt, D. G., Cohen, M. I., Forman, D. E., Goldberger, Z. D., Grubb, B. P., Hamdan, M. H., Krahn, A. D., Link, M. S., et al. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.03.002 · Cited by 155 · see citing works
“, and H eart Rhythm Society 40 IIb B-R SR Dual-chamber pacing might be reasonable in a select population of patients 40 years of age or older with recurrent VVS and prolonged spontaneous pauses (404-408,410).”
BackgroundThe expectation effect and cardiac pacing for refractory vasovagal syncope
Sud, S., Massel, D., Klein, G. J., Leong-Sit, P., Yee, R., Skanes, A. C., Gula, L. J., & Krahn, A. D. (2007) · The American Journal of Medicine · doi:10.1016/j.amjmed.2006.05.046 · Cited by 151 · see citing works
Brignole, M. (2006) · European Heart Journal · doi:10.1093/eurheartj/ehl164 · Cited by 145 · see citing works
Self-citationESC Guidelines on cardiac pacing and cardiac resynchronization therapy
Nielsen, J. C., Petersen, H. H., Karlsen, F. M., Chri, L. S., & Haarbo, J. (2014) · Cited by 146 · see citing works
Yao, Y., Shi, R., Wong, T., Zheng, L., Chen, W., Yang, L., Huang, W., Bao, J., & Zhang, S. (2012) · Circulation: Arrhythmia and Electrophysiology · doi:10.1161/circep.111.966465 · Cited by 155 · see citing works
“5 (3-100) Number of syncope in preceding 12 months, median (range) 3.”
BackgroundSun, W., Zheng, L., Yu, Q., Shi, R., Hou, B., Wu, L., Guo, J., Zhang, S., & Yao, Y. (2016) · Journal of the American Heart Association · doi:10.1161/jaha.116.003471 · Cited by 133 · see citing works
Cardiac pacing: the state of the art
Trohman, R. G., Kim, M. H., & Pinski, S. L. (2004) · The Lancet · doi:10.1016/s0140-6736(04)17358-3 · Cited by 132 · see citing works
Dual-Chamber Pacing With Closed Loop Stimulation in Recurrent Reflex Vasovagal Syncope
Barón‐Esquivias, G., Morillo, C. A., Moya‐Mitjans, À., Martínez-Alday, J. D., Ruiz‐Granell, R., Lacunza, J., García–Civera, R., Gutiérrez‐Carretero, E., & Romero-Garrido, R. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.08.026 · Cited by 131 · see citing works
“Our trial did not directly compare DDD-CLS pacing mode with other dualchamber pacing modes (DDI with hysteresis, DDD with rate drop response, and so on) that have had limited success in preventing recurrence of VVS (4,5).”
BackgroundMethodEvaluating and managing bradycardia
Sidhu, S., & Marine, J. E. (2020) · Trends in Cardiovascular Medicine · doi:10.1016/j.tcm.2019.07.001 · Cited by 134 · see citing works
Brignole, M., Donateo, P., Tomaino, M., Massa, R., Iori, M., Beiras, X., Moya, A., Kus, T., Deharo, J. C., Giuli, S., et al. (2014) · Circulation: Arrhythmia and Electrophysiology · doi:10.1161/circep.113.001103 · Cited by 127 · see citing works
Self-citationPathophysiology, Diagnosis, and Treatment of Orthostatic Hypotension and Vasovagal Syncope
Medow, M. S., Stewart, J. M., Sanyal, S., Mumtaz, A., Sica, D. A., & Frishman, W. H. (2007) · Cardiology in Review · doi:10.1097/crd.0b013e31815c8032 · Cited by 112 · see citing works
“However, more recent trials such as the Second Vasovagal Pacemaker Study (VPSII) and the Vasovagal Syncope and Pacing Trial were not able to reproduce those results, suggesting that pacemaker therapy should not be recommended as first-line treatment for patients with recurrent vasovagal syncope.(187,188) Alternatively…”
ResultAn Implantable Loop Recorder Study of Highly Symptomatic Vasovagal Patients
Deharo, J.-C., Jego, C., Lanteaume, A., & Djiane, P. (2006) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2005.09.043 · Cited by 110 · see citing works
“This observation might be part of n explanation for the results of two recently published andomized studies on pacing therapy in vasovagal patients: n both studies, pacing therapy failed to show effectiveness, ven in the subgroup of patients presenting with severe radycardia at HUT (8,9).”
ResultHRS/ACCF Expert Consensus Statement on Pacemaker Device and Mode Selection
Gillis, A. M., Russo, A. M., Ellenbogen, K. A., Swerdlow, C. D., Olshansky, B., Al‐Khatib, S. M., Beshai, J. F., McComb, J. M., Nielsen, J. C., Philpott, J. M., et al. (2012) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2012.06.011 · Cited by 100 · see citing works
2013 ESC GUIDELINES ON CARDIAC PACING AND CARDIAC RESYNCHRONIZATION THERAPY
Brignole, M., Auricchio, A., Barón‐Esquivias, G., Bordachar, P., Boriani, G., Breithardt, O. A., Cleland, J. G. F., Deharo, J., Delgado, V., Elliot, P. M., et al. (2014) · Russian Journal of Cardiology · doi:10.15829/1560-4071-2014-4-5-63 · Cited by 92 · see citing works
Self-citationCarotid sinus syndrome, should we pace? A multicentre, randomised control trial (Safepace 2)
Ryan, D. J., Nick, S., Colette, S. M., & Roseanne, K. (2010) · Heart · doi:10.1136/hrt.2009.176206 · Cited by 91 · see citing works
“SYNPACE, too has demonstrated similar findings to VPS2.(23)”
ResultInfluentialVasovagal Syncope in the Older Patient
Tan, M. P., & Parry, S. W. (2008) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2007.11.025 · Cited by 92 · see citing works
Saklani, P., Krahn, A. D., & Klein, G. J. (2013) · Circulation · doi:10.1161/circulationaha.112.138396 · Cited by 89 · see citing works
“The VPSII and SYNPACE trials were the first double blind randomized, controlled trials of permanent pacing in neurally mediated syncope designed to address these limitations.(102,103) All patients received pacemakers, and the control arm devices were functionally programmed off.”
ACC/AHA/HRS Versus ESC Guidelines for the Diagnosis and Management of Syncope
Goldberger, Z. D., Petek, B. J., Brignole, M., Shen, W.-K., Sheldon, R. S., Solbiati, M., Deharo, J.-C., Moya, A., & Hamdan, M. H. (2019) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.09.012 · Cited by 82 · see citing works
Self-citationPersistence of muscle sympathetic nerve activity during vasovagal syncope
Vaddadi, G., Esler, M. D., Dawood, T., & Lambert, E. (2010) · European Heart Journal · doi:10.1093/eurheartj/ehq071 · Cited by 84 · see citing works
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“possible placebo effect of pacing, as hypothesized in previous studies.(33) However, it should be noted that the study was not powered to evaluate individual end point events separately.”
ResultSelf-citationSUMNER, G. L., ROSE, M. S., KOSHMAN, M. L., RITCHIE, D., SHELDON, R. S., & for the Prevention of Syncope Trial Investigators (2010) · Journal of Cardiovascular Electrophysiology · doi:10.1111/j.1540-8167.2010.01848.x · Cited by 80 · see citing works
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Self-citationRaj, S. R., Rose, S., Ritchie, D., & Sheldon, R. S. (2006) · American Heart Journal · doi:10.1016/j.ahj.2006.03.013 · Cited by 78 · see citing works
Diagnosis and treatment of syncope
Brignole, M. (2006) · Heart · doi:10.1136/hrt.2005.080713 · Cited by 77 · see citing works
Self-citationThe treatment of ictal asystole with cardiac pacing
Moseley, B. D., Ghearing, G. R., Munger, T. M., & Britton, J. W. (2011) · Epilepsia · doi:10.1111/j.1528-1167.2010.02972.x · Cited by 77 · see citing works
“However, other studies of vasovagal syncope patients and dual-chamber pacing have failed to reproduce such findings (Connolly et al., 2003; Raviele et al., 2004).”
ResultImplications of mechanism of bradycardia on response to pacing in patients with unexplained syncope
Sud, S., Klein, G. J., Skanes, A. C., Gula, L. J., Yee, R., & Krahn, A. D. (2007) · EP Europace · doi:10.1093/europace/eum020 · Cited by 66 · see citing works
“In previous studies of neurally-mediated syncope, patients with cardioinhibitory vasovagal syncope were identified by history and response to tilt table testing.(18,19,21,23) Response to tilt table testing may not reflect the physiological events that occur during a spontaneous episode.”
BackgroundHRS/ACCF Expert Consensus Statement on Pacemaker Device and Mode Selection
Gillis, A. M., Russo, A. M., Ellenbogen, K. A., Swerdlow, C. D., Olshansky, B., Al‐Khatib, S. M., Beshai, J. F., McComb, J. M., Nielsen, J. C., Philpott, J. M., et al. (2012) · Heart Rhythm · doi:10.1016/j.hrthm.2012.06.026 · Cited by 66 · see citing works
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“These suboptimal results are probably justified by the inability of conventional electrical cardiac stimulation to counteract the vasodepressor component of the vasovagal reflex present in almost all subjects during syncopal episodes and usually precedes cardioinhibition and bradycardia.(29)”
BackgroundManagement and therapy of vasovagal syncope: A review
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High Remission Rates in Vasovagal Syncope
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Evidence-based treatment for vasovagal syncope
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Usefulness of physical maneuvers for prevention of vasovagal syncope
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Self-citationNorepinephrine transporter inhibition prevents tilt-induced pre-syncope
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Are treatments for vasovagal syncope effective? A meta-analysis
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“When studies comparing optimal pacer therapy were compared to other pacing [47,49,52], again a significant benefit was observed (three studies, n=92, OR 0.”
BackgroundMethodResultClinical Classification of Syncope
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Self-citationAutonomic Dysfunction in Cardiology: Pathophysiology, Investigation, and Management
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Pathophysiology of neurally mediated syncope: Role of cardiac output and total peripheral resistance
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“However, previous atropine and cardiac pacing studies have yielded conflicting results, indicating that bradycardia may not always be the only factor in restricting cardiac output (Weissler et al., 1957; Fujimura et al., 1989; Sra et al., 1993; Connolly et al., 1999; Sutton et al., 2000; Ammirati et al., 2001; Connoll…”
ResultMoya, A., Brignole, M., Sutton, R., Menozzi, C., Garcia-Civera, R., Wieling, W., Andresen, D., Benditt, D. G., Garcia-Sacristán, J. F., Beiras, X., et al. (2008) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2008.07.043 · Cited by 38 · see citing works
Self-citationPhysiological Phenomenology of Neurally-Mediated Syncope with Management Implications
Schroeder, C., Tank, J., Heusser, K., Diedrich, A., Luft, F. C., & Jordan, J. (2011) · PLoS ONE · doi:10.1371/journal.pone.0026489 · Cited by 39 · see citing works
“Indeed, prevention of bradycardia and asystole with cardiac pacemakers was largely ineffective [9,10] and is only recommended when severe spontaneous bradycardia is detected during prolonged EKG monitoring, but not on tilt test results alone [11].”
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Reflex syncope: Diagnosis and treatment
Sutton, R. (2017) · Journal of Arrhythmia · doi:10.1016/j.joa.2017.03.007 · Cited by 34 · see citing works
Self-citationCardiac Causes for Falls and Their Treatment
Cronin, H., & Kenny, R. A. (2010) · Clinics in Geriatric Medicine · doi:10.1016/j.cger.2010.07.006 · Cited by 35 · see citing works
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“In 2 RCTs, there was no statistically significant benefit seen with active pacing.(407,408) However, in a select population of patients .”
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Key challenges in the current management of syncope
Sutton, R., Brignole, M., & Benditt, D. G. (2012) · Nature Reviews Cardiology · doi:10.1038/nrcardio.2012.102 · Cited by 33 · see citing works
Self-citationGopinathannair, R., Salgado, B. C., & Olshansky, B. (2018) · Arrhythmia & Electrophysiology Review · doi:10.15420/aer.2018.22.2 · Cited by 32 · see citing works
“The RRR in time to syncope with DDD was 30 % (95 % CI [−33–63 %]; 1-sided p=0.14) Raviele et al., 2004 (SYNPACE Study)49 Randomised, double-blind, placebo-controlled; DDD with RDR comparison of PPM on versus off Severe recurrent tilt-induced vasovagal syncope (median 12 syncopal episodes in…”
BackgroundInfluentialTilt Training: Does It Have a Role in Preventing Vasovagal Syncope?
Gurevitz, O. T., Barsheshet, A., Bar-Lev, D. S., Zimlichman, E., Rosenfeld, G., Benderly, M., Luria, D. M., Amital, H., Kreiss, Y., Eldar, M., et al. (2007) · Pacing and Clinical Electrophysiology · doi:10.1111/j.1540-8159.2007.00898.x · Cited by 33 · see citing works
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Self-citationManagement of Syncope in Adults: An Update
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Placebo Control and Blinding in Randomized Trials of Procedural Interventions
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“Four trials assessed coprimary outcomes.(16,21,22,36) In 10 trials (33%), the null hypotheses were rejected for all predefined primary outcomes.”
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- 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 › 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, 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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