Evidence map›Paper›PMID 33982093›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 Cardiology2021

Impact of closed loop stimulation on prognostic cardiopulmonary variables in patients with chronic heart failure and severe chronotropic incompetence: a pilot, randomized, crossover study.

Joachim Proff, Béla Merkely, Roland Papp, Corinna Lenz, Peter Nordbeck, Christian Butter, Juergen Meyerhoefer, Michael Doering, Dean J MacCarter, Katharina Ingel and 3 more

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

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

3 citing papers in PubMed, 12 citations in OpenAlex.

  1. Enhancement of bicycle exercise capacity in patients with chronotropic incompetence through closed-loop stimulation: a randomized crossover trial.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 · 2023
    Trial
  2. Review
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 2 countries.

Joachim ProffMedizinische Klinik für Kardiologie, Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.ORCID 0000-0002-2956-6708
Béla MerkelyHeart and Vascular Center, Semmelweis Medical University, Városmajorutca 68, 1122 Budapest, Hungary.
Roland PappHeart and Vascular Center, Semmelweis Medical University, Városmajorutca 68, 1122 Budapest, Hungary.
Corinna LenzKlinik für Innere Medizin/Kardiologie, Unfallkrankenhaus Berlin, Warener Str. 7, 12683 Berlin, Germany.
Peter NordbeckMedizinische Klinik I, Universitaetsklinikum Wuerzburg, Oberdürrbacher Str. 6, 97080 Wuerzburg, Germany.ORCID 0000-0002-2560-4068
Christian ButterKardiologie, Herzzentrum Brandenburg in Bernau & Medizinische Hochschule Brandenburt, Ladeburger Str. 17, 16321 Bernau bei Berlin, Germany.
Juergen MeyerhoeferInnere Medizin - Kardiologie und Chest Pain Unit, Maria Heimsuchung-Caritas-Klinik Pankow, Breite Str. 46/47, 13187 Berlin, Germany.
Michael DoeringAbteilung für Rhythmologie, Herzzentrum Leipzig, Struempellstr. 39, 04289 Leipzig, Germany.
Dean J MacCarter1324 Castle Point Circle, Castle Pines, CO, USA.
Katharina IngelCenter for Clinical Research, BIOTRONIK SE & Co. KG, Woermannkehre 1, 12359 Berlin, Germany.
Thomas ThouetCharite Universitaetsmedizin Berlin, Abteilung Sportmedizin, Philippstraße 13, Haus 11, 10115 Berlin, Germany.
Ulf LandmesserMedizinische Klinik für Kardiologie, Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.ORCID 0000-0002-0214-3203
Mattias J RoserMedizinische Klinik für Kardiologie, Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.
Charité - Universitätsmedizin Berlin · DESemmelweis University · HUBiotronik (Germany) · DEDeutsches Herzzentrum der Charité · DEImmanuel Klinikum Bernau · DEUnfallkrankenhaus Berlin · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsClinical effects of rate-adaptive pacing in heart failure patients with chronotropic incompetence (CI) undergoing cardiac resynchronization therapy (CRT) remain unclear. Closed loop stimulation (CLS) is a new rate-adaptive sensor in CRT devices. We evaluated the effectiveness of CLS in CRT patients with severe CI, focusing primarily on key prognostic variables assessed by cardiopulmonary exercise (CPX) testing. METHODS AND

resultsIn the randomized, crossover, multicentre BIO|CREATE study, 20 CRT patients with severe CI and NYHA Class II/III (60%/40%) were randomized 1:1 to the sequence DDD-40 mode to DDD-CLS mode, or the sequence DDD-CLS mode to DDD-40 mode (1 month in each mode). Patients underwent symptom-limited treadmill-based CPX test in each mode. An improvement (decrease) of the ventilatory efficiency (VE) slope of ≥5% during CLS was regarded as positive response to CLS. Seventeen patients with full data sets had a mean intra-individual VE slope change of -1.8 ± 3.0 (-4.1%) with CLS (P = 0.23). Eight patients (47%) were CLS responders, with a -6.1 ± 2.7 (-16.4%) slope change (P = 0.029). Compared to non-responders, CLS responders had a higher left ventricular (LV) ejection fraction (46 ± 3 vs. 36 ± 9%; P = 0.0070), smaller end-diastolic LV volume (121 ± 34 vs. 181 ± 41 mL; P = 0.0085), smaller end-systolic LV volume (65 ± 23 vs. 114 ± 39 mL; P = 0.0076), and were predominantly in NYHA Class II (P = 0.0498).

conclusionThe data of the present pilot study are compatible with the notion that CLS activation may improve VE slope in CRT patients with severe CI and less advanced heart failure. Further research is needed to determine the long-term clinical outcomes of CLS.

Indexed as

Cardiac Resynchronization TherapyHeart FailureCross-Over StudiesHumansPilot ProjectsPrognosisTreatment OutcomeCardiac resynchronization therapyCardiopulmonary exercise testingClosed loop stimulationRate-adaptive pacingSevere chronotropic incompetenceVentilatory efficiency slope

Identifiers

PMID33982093
PMCPMC8576282
OpenAlexW3163811049

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.