Evidence map›Paper›PMID 38340330›Full record

Observational studyEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2024

Temporal relationship between haemodynamic changes and activation of closed-loop stimulation during a tilt-induced vasovagal syncope.

Vincenzo Russo, Marco Tomaino, Erika Parente, Angelo Comune, Daniele Giacopelli, Paola Napoli, Alessio Gargaro, Michele Brignole

Registry-linked trialOpen access · hybridAbstract readVideo-Audio MediaObservational Study
In one paragraph

Observational study in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06038708 (BIO|Sync-HUTT), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
6.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06038708 completednot on this map

BIO|Sync-HUTT: Head-up Tilt Test in Patients With Reflex Syncope and Asystolic Response Who Received a Dual-chamber Pacemaker With the Closed Loop Stimulation (CLS) and Participated in the BIOSync Trial

Typeobservational_patient_registrySponsorBiotronik SE & Co. KGRan2022 to 2023Enrolled20ConditionsSyncope, Syncope, Vasovagal
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 11 citations in OpenAlex.

  1. Sensor detection and pacing for impending reflex syncope.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Review
  2. Article
  3. Review
  4. Syncope: Advances in Diagnosis and Treatment 2024.Journal of cardiovascular electrophysiology · 2025
    Review
  5. Review
  6. Article
  7. Mechanism-based therapy of non-cardiac syncope: a practical guide.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024
    Article
  8. Understanding how closed-loop stimulation pacing suppresses cardioinhibition in vasovagal syncope.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024
    Article
  9. Closed loop stimulation for carotid sinus syncope.Indian pacing and electrophysiology journal
    Article
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Vincenzo RussoCardiology and Syncope Unit, Department of Translational Medical Sciences, University of Campania 'Luigi Vanvitelli'-Monaldi Hospital, 80126 Naples, Italy.ORCID 0000-0002-9227-0360
Marco TomainoDepartment of Cardiology, Ospedale Generale Regionale, Bolzano, Italy.
Erika ParenteCardiology and Syncope Unit, Department of Translational Medical Sciences, University of Campania 'Luigi Vanvitelli'-Monaldi Hospital, 80126 Naples, Italy.
Angelo ComuneCardiology and Syncope Unit, Department of Translational Medical Sciences, University of Campania 'Luigi Vanvitelli'-Monaldi Hospital, 80126 Naples, Italy.ORCID 0009-0007-2619-8368
Daniele GiacopelliResearch Clinical Unit, Biotronik Italy, Milan, Italy.ORCID 0000-0003-1584-7944
Paola NapoliResearch Clinical Unit, Biotronik Italy, Milan, Italy.
Alessio GargaroResearch Clinical Unit, Biotronik Italy, Milan, Italy.ORCID 0000-0002-7327-303X
Michele BrignoleIRCCS Istituto Auxologico Italiano, Faint and Fall Research Centre, Department of Cardiology, S. Luca Hospital, Piazzale Brescia 20, 20149 Milan, Italy.ORCID 0000-0002-1845-5607
Medtronic (Italy) · ITUniversity of Campania "Luigi Vanvitelli" · ITIRCCS Istituto Auxologico Italiano · ITOspedale di Bolzano · IT

Funding

BIOTRONIK SE & Co . KG, Center for Clinical Research
6 · The paper itself

Abstract

aimsA dual-chamber pacemaker with closed-loop stimulation (CLS) mode is effective in reducing syncopal recurrences in patients with asystolic vasovagal syncope (VVS). In this study, we explored the haemodynamic and temporal relationship of CLS during a tilt-induced vasovagal reflex. METHODS AND

resultsTwenty patients underwent a tilt test under video recording 3.9 years after CLS pacemaker implantation. Three patients were excluded from the analysis because of no VVS induced by the tilt test (n = 1) and protocol violation (n = 2). In 14 of the remaining 17 patients, CLS pacing emerged during the pre-syncopal phase of circulatory instability when the mean intrinsic heart rate (HR) was 88 ± 12 b.p.m. and systolic blood pressure (SBP) was 108 ± 19 mmHg. The CLS pacing rate thereafter rapidly increased to 105 ± 14 b.p.m. within a median of 0.1 min [inter-quartile range (IQR), 0.1-0.7 min] when the SBP was 99 ± 21 mmHg. At the time of maximum vasovagal effect (syncope or pre-syncope), SBP was 63 ± 17 mmHg and the CLS rate was 95 ± 13 b.p.m. The onset of CLS pacing was 1.7 min (IQR, 1.5-3.4) before syncope or lowest SBP. The total duration of CLS pacing was 5.0 min (IQR, 3.3-8.3). Closed-loop stimulation pacing was not observed in three patients who had a similar SBP decrease from 142 ± 22 mmHg at baseline to 69 ± 4 mmHg at the time of maximum vasovagal effect, but there was no significant increase in HR (59 ± 1 b.p.m.).

conclusionThe reproducibility of a vasovagal reflex was high. High-rate CLS pacing was observed early during the pre-syncopal phase in most patients and persisted, although attenuated, at the time of maximum vasovagal effect. REGISTRATION: ClinicalTrials.gov identifier: NCT06038708.

Indexed as

Pacemaker, ArtificialSyncope, VasovagalCardiac Pacing, ArtificialHemodynamicsHumansReproducibility of ResultsTilt-Table TestClose-loop stimulationPacemaker therapyTilt table testVasovagal syncope

Identifiers

PMID38340330
PMCPMC10886438
OpenAlexW4391714373

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.