Evidence map›Paper›PMID 38938169›Full record

Trial reportEuropace : 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

Closed loop stimulation reduces the incidence of atrial high-rate episodes compared with conventional rate-adaptive pacing in patients with sinus node dysfunctions.

Ennio C L Pisanò, Valeria Calvi, Miguel Viscusi, Antonio Rapacciuolo, Ludovico Lazzari, Luca Bontempi, Gemma Pelargonio, Giuseppe Arena, Vincenzo Caccavo, Chun-Chieh Wang and 16 more

Erratum issuedAbstract readRandomized Controlled TrialComparative StudyMulticenter Study
In one paragraph

Trial report 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. An erratum has been issued. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Physiological Pacing: Historical Review With an Eye to the Future.Journal of cardiovascular electrophysiology · 2025
    Review
  7. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Ennio C L PisanòCardiology and Intensive Care Unit, Vito Fazzi Hospital, Lecce, Italy.ORCID 0000-0002-0187-0492
Valeria CalviCardiology, G. Rodolico-San Marco University Hospital, Catania, Italy.
Miguel ViscusiClinical and Interventional Arrhythmology, Sant'Anna e San Sebastiano Hospital, Caserta, Italy.
Antonio RapacciuoloDepartment of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.ORCID 0000-0002-4739-7004
Ludovico LazzariClinical and Interventional Arrhythmology, Santa Maria Hospital, Terni, Italy.ORCID 0000-0002-9382-840X
Luca BontempiCardiology, Bolognini Hospital, Seriate, Italy.
Gemma PelargonioArrhythmology, Fondazione Policlinico Gemelli IRCCS Università Cattolica del Sacro Cuore, Roma, Italy.ORCID 0000-0003-3236-3458
Giuseppe ArenaCardiology and Intensive Care Unit, Apuane New Hospital, Massa, Italy.ORCID 0000-0002-0266-6493
Vincenzo CaccavoCardiology and Intensive Care Unit, Miulli Regional Hospital, Acquaviva delle Fonti, Italy.
Chun-Chieh WangCardiology, Chang Gung Memorial Hospital-Linkou-CGMH, Taipei, Taiwan.
Béla MerkelyHeart and Vascular Centre, Semmelweis University, Budapest, Hungary.ORCID 0000-0001-6514-0723
Lian-Yu LinCardiology, National Taiwan University Hospital, Taipei, Taiwan.ORCID 0000-0001-7505-6429
Il-Young OhCardiology, Seoul National University Bundang Hospital, Seongnam, Korea.ORCID 0000-0002-5584-605X
Emanuele BertagliaCardiology, Camposampiero Hospital, Padova, Italy.ORCID 0000-0002-3878-2904
Davide SaporitoCardiology, Infermi Hospital, Rimini, Italy.ORCID 0000-0002-9478-6950
Maurizio MenichelliCardiology, F. Spaziani Hospital, Frosinone, Italy.
Antonino NicosiaCardiology, Giovanni Paolo II Hospital, Ragusa, Italy.ORCID 0000-0002-7862-5751
Domenico M CarrettaCardiology and Intensive Care Unit, Policlinico Consorziale, Bari, Italy.
Aldo CoppolinoCardiology and Intensive Care Unit, Elecrophysiology, SS Annunziata Hospital, Savigliano, Cuneo, Italy.ORCID 0000-0002-9937-9940
Chi Keong ChingCardiology/Cardiovascular Surgery, National Heart Center, Singapore.ORCID 0000-0003-3454-3866
Álvaro Marco Del CastilloCardiology, Hospital Universitario 12 de Octubre, Madrid, Spain.ORCID 0000-0002-5322-2067
Xi SuCardiology, Wuhan Asia Heart Hospital, Wuhan, China.ORCID 0009-0004-4647-5965
Martina Del MaestroClinical Research Unit, BIOTRONIK Italia, Cologno Monzese, Milan, Italy.ORCID 0009-0001-7184-1195
Daniele GiacopelliClinical Research Unit, BIOTRONIK Italia, Cologno Monzese, Milan, Italy.ORCID 0000-0003-1584-7944
Alessio GargaroClinical Research Unit, BIOTRONIK Italia, Cologno Monzese, Milan, Italy.ORCID 0000-0002-7327-303X
Giovanni L BottoASST Rhodense, Rho & Garbagnate Hospitals, Viale Carlo Forlanini, 95, 20024 Garbagnate Milanese, Milan, Italy.ORCID 0000-0002-8049-7517

Funding

Biotronik SE & Co KG
6 · The paper itself

Abstract

aimsSubclinical atrial fibrillation (AF) is associated with increased risk of progression to clinical AF, stroke, and cardiovascular death. We hypothesized that in pacemaker patients requiring dual-chamber rate-adaptive (DDDR) pacing, closed loop stimulation (CLS) integrated into the circulatory control system through intra-cardiac impedance monitoring would reduce the occurrence of atrial high-rate episodes (AHREs) compared with conventional DDDR pacing. METHODS AND

resultsPatients with sinus node dysfunctions (SNDs) and an implanted pacemaker or defibrillator were randomly allocated to dual-chamber CLS (n = 612) or accelerometer-based DDDR pacing (n = 598) and followed for 3 years. The primary endpoint was time to the composite endpoint of the first AHRE lasting ≥6 min, stroke, or transient ischaemic attack (TIA). All AHREs were independently adjudicated using intra-cardiac electrograms. The incidence of the primary endpoint was lower in the CLS arm (50.6%) than in the DDDR arm (55.7%), primarily due to the reduction in AHREs lasting between 6 h and 7 days. Unadjusted site-stratified hazard ratio (HR) for CLS vs. DDDR was 0.84 [95% confidence interval (CI), 0.72-0.99; P = 0.035]. After adjusting for CHA2DS2-VASc score, the HR remained 0.84 (95% CI, 0.71-0.99; P = 0.033). In subgroup analyses of AHRE incidence, the incremental benefit of CLS was greatest in patients without atrioventricular block (HR, 0.77; P = 0.008) and in patients without AF history (HR, 0.73; P = 0.009). The contribution of stroke/TIA to the primary endpoint (1.3%) was low and not statistically different between study arms.

conclusionDual-chamber CLS in patients with SND is associated with a significantly lower AHRE incidence than conventional DDDR pacing.

Indexed as

Atrial FibrillationCardiac Pacing, ArtificialHeart RateIschemic Attack, TransientPacemaker, ArtificialSick Sinus SyndromeStrokeAccelerometryAgedAged, 80 and overDefibrillators, ImplantableElectrophysiologic Techniques, CardiacFemaleHumansIncidenceMaleAccelerometer pacemaker sensorAtrial fibrillationAtrial high-rate episodesClosed loop stimulationRate-adaptive pacingStroke

Identifiers

PMID38938169
PMCPMC11226787

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Registered trials

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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.