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Cited by 76Cardiovascular Syncope and Autonomic DisordersCardiac pacing and defibrillation studiesHeart Rate Variability and Autonomic Control

Standardized algorithm for cardiac pacing in older patients affected by severe unpredictable reflex syncope: 3-year insights from the Syncope Unit Project 2 (SUP 2) study

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Brignole, Michele, Arabia, Francesco, Ammirati, Fabrizio, Tomaino, Marco, Quartieri, Fabio, Rafanelli, Martina, Del Rosso, Attilio, Rita Vecchi, Maria +2 more·2016·Europace
DOI 10.1093/europace/euv343
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Abstract

AIMS: The aim of this study was to determine the long-term effects and determinants of success of cardiac pacing in patients affected by reflex syncope enrolled in the Syncope Unit Project 2 (SUP 2) study. Initial results have validated the effectiveness of a standardized guideline-based algorithm which can be used in clinical practice in order to select suitable candidates for cardiac pacing. METHODS AND RESULTS: In this prospective, multicentre, observational study, patients aged >40 years, affected by severe unpredictable recurrent reflex syncope, underwent carotid sinus massage (CSM), followed by tilt testing (TT) if CSM was negative, followed by implantation of an implantable loop recorder (ILR) if TT was negative. Those who had an asystolic response to one of these tests received a dual-chamber pacemaker. Of 281 patients who met the inclusion criteria, 137 (49%) received a pacemaker and were followed up for a mean of 26 ± 11 months: syncope recurred in 25 (18%) of them. At 3 years, the actuarial syncope recurrence rate was 20% [95% confidence interval (CI) 12-30] and was significantly lower than in 142 patients who did not receive a pacemaker and were observed by means of an ILR [43% (95% CI 29-57), P = 0.01]. The 3-year recurrence rate was not different among 78 CSM+, 38 TT+, and 21 ILR+ patients, whereas it was lower in 20 patients with negative TT [5% (95% CI 0-15)] than in 61 patients with positive TT [24% (95% CI 10-38)]. CONCLUSION: The benefit of cardiac pacing is maintained at 3 years, irrespective of the index diagnostic test, and is maximum in patients with negative TT. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01509534.

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Crossref · 10.1093/europace/euv343

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  • In the CSS subgroup of SUP 2, estimated syncope recurrence rates with pacing were 9% at 1 year, 18% at 2 years, and 20% at 3 years, significantly lower than untreated controls (21%, 33%, 43%).

    “In the CSS subgroup of the multicentre SUP 2 study, 292 the estimated syncope recurrence rates with pacing were 9% at 1 year, 18% at 2 years, and 20% at 3 years, and were significantly lower than the corresponding rates observed in untreated controls, which were 21%, 33%, and 43%, respectively.”

    From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [292]

    Table 2 reports 9%, 16%, and 16% recurrence for the paced CSS subgroup at 1, 2, and 3 years—not 9%, 18%, and 20%. The 18% and 20% figures are for all paced patients. The control rates of 21%, 33%, and 43% match, and the Outcome section says recurrence in the paced subgroups was significantly lower than in controls. (LLM, conf=0.93)

    Experimental — accuracy not yet measured

  • In the ILR subgroup of the SUP 2 study, estimated rates of syncope recurrence with pacing were 11% at 1 year, 24% at 2 years, and 24% at 3 years, significantly lower than untreated controls.

    “In the ILR subgroup of the multicentre Syncope Unit Project (SUP) 2 study, 292 the estimated rates of syncope recurrence with pacing were 11% at 1 year, 24% at 2 years, and 24% at 3 years, and were significantly lower than the corresponding rates observed in untreated control patients.”

    From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [292]

    Table 2 reports the claimed ILR-documented paced subgroup recurrence estimates: 11% at 1 year and 24% at both 2 and 3 years. But the Figure 1 caption says this subgroup's difference from the unpaced ILR control group was not statistically significant (P = 0.28). The significant comparison reported for all paced patients does not establish significance for the ILR subgroup. Page numbers are unavailable in our copy. (LLM, conf=0.94)

    Experimental — accuracy not yet measured

  • The SUP 2 study population was characterized by higher mean age, history of recurrent syncope beginning in middle or older age, and frequent injuries, probably due to presentation without warning.

    “The SUP 2 study population was characterized by higher mean age, history of recurrent syncope beginning in middle or older age, and frequent injuries, probably due to presentation without warning. 292”

    From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [292]

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Research works printed but not linked: 2

  1. Moya A, Sutton R, Ammirati F, Blanc JJ, Brignole M, Dahm JB et al. Guidelines for the diagnosis and management of syncope (version 2009). Eur Heart J 2009;30: 2631 -71.
  2. Brignole M, Donateo P, Tomaino M, Massa R, Iori M, Beiras X et al. Benefit of pace- maker therapy in patients with presumed neurally mediated syncope and docu- mented asystole is greater when tilt test is negative. Circ Arrhythm Electrophysiol 2014;7:10-6.

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Authors
Brignole, M., Arabia, F., Ammirati, F., Tomaino, M., Quartieri, F., Rafanelli, M., Del Rosso, A., Rita Vecchi, M., Russo, V., & Gaggioli, G.
Affiliations
  • Presidio Ospedaliero (IT)
  • Azienda Ospedaliera Pugliese Ciaccio (IT)
  • Ospedale di Bolzano (IT)
  • Santa Maria Nuova Hospital (IT)
  • Azienda Ospedaliero-Universitaria Careggi (IT)
  • Ospedale SS. Annunziata (IT)
  • Ospedale Villa Scassi (IT)
Corresponding author
Brignole, Michele
ORCID
Venue
Europace
Publisher
Oxford University Press (OUP)
Published
2015-11-26
Volume
18
Issue
9
Pages
1427-1433
ISSN
  • 1099-5129 (ISSN-L)
  • 1532-2092
DOI
10.1093/europace/euv343
OpenAlex
W2266260832
Cited by
76
References
27
Citations by year
2026: 3 · 2025: 5 · 2024: 5 · 2023: 4 · 2022: 5 · 2021: 10 · 2020: 7 · 2019: 11 · 2018: 14 · 2017: 9 · 2016: 3
FWCI
8.73
Type
journal article
Language
en
Open access
Locations
  • EP Europace (publishedVersion)
  • PubMed (publishedVersion)
  • HighWire Press Open Archive (submittedVersion)
  • INFM-OAR (INFN Catania) (submittedVersion, other-oa)
  • Zenodo (CERN European Organization for Nuclear Research) (cc-by)
Funders
Gruppo Italiano Multidisciplinare per lo studio della Sincope (GIMSI)
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
reflex syncope, cardiac pacing, dual-chamber pacemaker, syncope recurrence, carotid sinus massage, tilt table test, implantable loop recorder, elderly patients, candidate selection, long-term outcomes
MeSH terms
Aged, Aged, 80 and over, Algorithms, Cardiac Pacing, Artificial, Carotid Sinus, Equipment Design, Female, Humans, Italy, Male, Middle Aged, Pacemaker, Artificial, Predictive Value of Tests, Prospective Studies, Recurrence, Reflex, Severity of Illness Index, Time Factors, Treatment Outcome, Patient Selection, Tilt-Table Test, Syncope, Vasovagal

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